CFR Title 42 Public Health

CFR Title 42 – Public Health

CFR DataTable of FEDERAL REGISTER Activity

PublishedTypeAgenciesNameTitleExcerptFRDocPDFHTMLAbstract
PublishedTypeAgenciesNameTitleExcerptFRDocPDFHTMLAbstract
2018-08-30Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury TableThis document announces a public hearing to receive information and comments regarding the notice of proposed rulemaking (NPRM) titled ``National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the...2018-18873"https://www.gpo.gov/fdsys/pkg/FR-2018-08-30/pdf/2018-18873.pdfhttps://www.federalregister.gov/documents/2018/08/30/2018-18873/national-vaccine-injury-compensation-program-adding-the-category-of-vaccines-recommended-forThis document announces a public hearing to receive information and comments regarding the notice of proposed rulemaking (NPRM) titled ``National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table.''
2018-08-27Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMPThis request for information seeks input from the public on how to address any regulatory provisions that may act as barriers to coordinated care or value-based care.2018-18519"https://www.gpo.gov/fdsys/pkg/FR-2018-08-27/pdf/2018-18519.pdfhttps://www.federalregister.gov/documents/2018/08/27/2018-18519/medicare-and-state-health-care-programs-fraud-and-abuse-request-for-information-regarding-theThis request for information seeks input from the public on how to address any regulatory provisions that may act as barriers to coordinated care or value-based care.
2018-08-23RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Certain Changes to the Low-Volume Hospital Payment Adjustment Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Years 2011 Through 2017This document announces changes to the payment adjustment for low-volume hospitals under the hospital inpatient prospective payment systems (IPPS) for acute care hospitals for fiscal years (FYs) 2011 through 2017 in accordance with section 429 of the...2018-18271"https://www.gpo.gov/fdsys/pkg/FR-2018-08-23/pdf/2018-18271.pdfhttps://www.federalregister.gov/documents/2018/08/23/2018-18271/medicare-program-certain-changes-to-the-low-volume-hospital-payment-adjustment-under-the-hospitalThis document announces changes to the payment adjustment for low-volume hospitals under the hospital inpatient prospective payment systems (IPPS) for acute care hospitals for fiscal years (FYs) 2011 through 2017 in accordance with section 429 of the Consolidated Appropriations Act, 2018.
2018-08-20RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs: Announcement of Revisions to the Provider Enrollment Moratoria Access Waiver Demonstration for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Moratoria-Designated Geographic LocationsThis document announces revisions to the Provider Enrollment Moratoria Access Waiver Demonstration (PEWD) for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies. The demonstration was implemented in accordance with section...2018-17809"https://www.gpo.gov/fdsys/pkg/FR-2018-08-20/pdf/2018-17809.pdfhttps://www.federalregister.gov/documents/2018/08/20/2018-17809/medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-revisions-to-the-providerThis document announces revisions to the Provider Enrollment Moratoria Access Waiver Demonstration (PEWD) for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies. The demonstration was implemented in accordance with section 402(a)(1)(J) of the Social Security Amendments of 1967 and, as revised, gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues and previously denied enrollment applications because of statewide moratoria implementation, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.
2018-08-17Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to SuccessUnder the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and...2018-17101"https://www.gpo.gov/fdsys/pkg/FR-2018-08-17/pdf/2018-17101.pdfhttps://www.federalregister.gov/documents/2018/08/17/2018-17101/medicare-program-medicare-shared-savings-program-accountable-care-organizations-pathways-to-successUnder the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. The policies included in this proposed rule would provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These proposed policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles. The proposed rule also would provide new tools to support coordination of care across settings and strengthen beneficiary engagement; ensure rigorous benchmarking; promote interoperable electronic health record technology among ACO providers/ suppliers; and improve information sharing on opioid use to combat opioid addiction.
2018-08-17Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 019-Irritable Bowel Syndrome; Finding of Insufficient EvidenceOn May 17, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 019) to add irritable bowel syndrome (IBS) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical...2018-17711"https://www.gpo.gov/fdsys/pkg/FR-2018-08-17/pdf/2018-17711.pdfhttps://www.federalregister.gov/documents/2018/08/17/2018-17711/world-trade-center-health-program-petition-019-irritable-bowel-syndrome-finding-of-insufficientOn May 17, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 019) to add irritable bowel syndrome (IBS) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add IBS to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2018-08-17RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of ClaimsWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these...2018-16766"https://www.gpo.gov/fdsys/pkg/FR-2018-08-17/pdf/2018-16766.pdfhttps://www.federalregister.gov/documents/2018/08/17/2018-16766/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long- term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital- Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.
2018-08-09Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability ProgramC1-2018-14985"https://www.gpo.gov/fdsys/pkg/FR-2018-08-09/pdf/C1-2018-14985.pdfhttps://www.federalregister.gov/documents/2018/08/09/C1-2018-14985/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions
2018-08-08RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting ProgramThis final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This final rule also replaces the existing case-mix classification methodology, the Resource...2018-16570"https://www.gpo.gov/fdsys/pkg/FR-2018-08-08/pdf/2018-16570.pdfhttps://www.federalregister.gov/documents/2018/08/08/2018-16570/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This final rule also replaces the existing case-mix classification methodology, the Resource Utilization Groups, Version IV (RUG-IV) model, with a revised case-mix methodology called the Patient-Driven Payment Model (PDPM) beginning on October 1, 2019. The rule finalizes revisions to the regulation text that describes a beneficiary's SNF ``resident'' status under the consolidated billing provision and the required content of the SNF level of care certification. The rule also finalizes updates to the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program.
2018-08-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019)This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical...2018-16518"https://www.gpo.gov/fdsys/pkg/FR-2018-08-06/pdf/2018-16518.pdfhttps://www.federalregister.gov/documents/2018/08/06/2018-16518/medicare-program-fy-2019-inpatient-psychiatric-facilities-prospective-payment-system-and-qualityThis final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These changes are effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2018 through September 30, 2019 (FY 2019). This final rule also updates the IPF labor-related share, the IPF wage index for FY 2019, and the International Classification of Diseases 10th Revision, Clinical Modification (ICD- 10-CM) codes for FY 2019. It also makes technical corrections to the IPF regulations, and updates quality measures and reporting requirements under the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program. In addition, it updates providers on the status of IPF PPS refinements.
2018-08-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting RequirementsThis final rule updates the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also makes conforming regulations text changes to recognize physician assistants as designated hospice attending physicians effective...2018-16539"https://www.gpo.gov/fdsys/pkg/FR-2018-08-06/pdf/2018-16539.pdfhttps://www.federalregister.gov/documents/2018/08/06/2018-16539/medicare-program-fy-2019-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis final rule updates the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also makes conforming regulations text changes to recognize physician assistants as designated hospice attending physicians effective January 1, 2019. Finally, the rule includes changes to the Hospice Quality Reporting Program.
2018-08-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act (the Act), this final rule includes the classification and weighting factors...2018-16517"https://www.gpo.gov/fdsys/pkg/FR-2018-08-06/pdf/2018-16517.pdfhttps://www.federalregister.gov/documents/2018/08/06/2018-16517/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act (the Act), this final rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2019. This final rule also alleviates administrative burden for IRFs by removing the Functional Independence Measure (FIM\TM\) instrument and associated Function Modifiers from the IRF Patient Assessment Instrument (IRF-PAI) beginning in FY 2020 and revises certain IRF coverage requirements to reduce the amount of required paperwork in the IRF setting beginning in FY 2019. Additionally, this final rule incorporates certain data items located in the Quality Indicators section of the IRF-PAI into the IRF case-mix classification system using analysis of 2 years of data beginning in FY 2020. For the IRF Quality Reporting Program (QRP), this final rule adopts a new measure removal factor, removes two measures from the IRF QRP measure set, and codifies a number of program requirements in our regulations.
2018-08-02RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic LocationsThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies and branch locations in Florida, Illinois,...2018-16547"https://www.gpo.gov/fdsys/pkg/FR-2018-08-02/pdf/2018-16547.pdfhttps://www.federalregister.gov/documents/2018/08/02/2018-16547/medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-the-extension-of-temporaryThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non- emergency ground ambulance suppliers and home health agencies and branch locations in Medicaid and the Children's Health Insurance Program in those states.
2018-07-31Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Requests for Information on Promoting Interoperability and Electronic Health Care Information, Price Transparency, and Leveraging Authority for the Competitive Acquisition Program for Part B Drugs and Biologicals for a Potential CMS Innovation Center ModelThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2019 to implement changes arising from our continuing experience with these...2018-15958"https://www.gpo.gov/fdsys/pkg/FR-2018-07-31/pdf/2018-15958.pdfhttps://www.federalregister.gov/documents/2018/07/31/2018-15958/medicare-program-proposed-changes-to-hospital-outpatient-prospective-payment-and-ambulatory-surgicalThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2019 to implement changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. The proposed rule also includes requests for information on promoting interoperability and electronic health care information exchange, improving beneficiary access to provider and supplier charge information, and leveraging the authority for the Competitive Acquisition Program (CAP) for Part B drugs and biologicals for a potential CMS Innnovation Center model. In addition, we are proposing to modify the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure under the Hospital Inpatient Quality Reporting (IQR) Program by removing the Communication about Pain questions.
2018-07-27Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability ProgramThis major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services,...2018-14985"https://www.gpo.gov/fdsys/pkg/FR-2018-07-27/pdf/2018-14985.pdfhttps://www.federalregister.gov/documents/2018/07/27/2018-14985/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
2018-07-19Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOSThis proposed rule would update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD...2018-14986"https://www.gpo.gov/fdsys/pkg/FR-2018-07-19/pdf/2018-14986.pdfhttps://www.federalregister.gov/documents/2018/07/19/2018-14986/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysisThis proposed rule would update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, it proposes a rebasing of the ESRD market basket for CY 2019. This proposed rule also proposes to update requirements for the ESRD Quality Incentive Program (QIP), and to make technical amendments to correct existing regulations related to the CBP for certain DMEPOS. Finally, this proposed rule proposes changes to bidding and pricing methodologies under the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding program (CBP); adjustments to DMEPOS Fee Schedule amounts using information from competitive bidding for items furnished from January 1, 2019 through December 31, 2020; new payment classes for oxygen and oxygen equipment and a new methodology for ensuring that new payment classes for oxygen and oxygen equipment are budget neutral; payment rules for multi-function ventilators or ventilators that perform functions of other durable medical equipment (DME); and payment methodology revisions for mail order items furnished in the Northern Mariana Islands. This rule also includes a request for information related to establishing fee schedule amounts for new DMEPOS items and services. It also includes Requests for Information on promoting interoperability and electronic healthcare information exchange, and improving beneficiary access to dialysis facility and DMEPOS charge information.
2018-07-12Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting OrganizationsThis proposed rule would update the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion...2018-14443"https://www.gpo.gov/fdsys/pkg/FR-2018-07-12/pdf/2018-14443.pdfhttps://www.federalregister.gov/documents/2018/07/12/2018-14443/medicare-and-medicaid-programs-cy-2019-home-health-prospective-payment-system-rate-update-and-cyThis proposed rule would update the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. It also proposes updates to the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; proposes a rebasing of the HH market basket (which includes a decrease in the labor-related share); proposes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 hereinafter referred to as the ``BBA of 2018''; proposes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and proposes to define ``remote patient monitoring'' and recognize the cost associated as an allowable administrative cost. Additionally, it proposes case-mix methodology refinements to be implemented for home health services beginning on or after January 1, 2020, including a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the BBA of 2018; includes information on the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020, as required by section 50401 of the BBA of 2018; solicits comments regarding payment for home infusion therapy services for CY 2021 and subsequent years; proposes health and safety standards for home infusion therapy; and proposes an accreditation and oversight process for home infusion therapy suppliers. This rule proposes changes to the Home Health Value-Based Purchasing (HHVBP) Model to remove two OASIS-based measures, replace three OASIS-based measures with two new proposed composite measures, rescore the maximum number of improvement points, and reweight the measures in the applicable measures set. Also, the Home Health Quality Reporting Program provisions include a discussion of the Meaningful Measures Initiative and propose the removal of seven measures to further the priorities of this initiative. In addition, the HH QRP offers a discussion on social risk factors and an update on implementation efforts for certain provisions of the IMPACT Act. This proposed rule clarifies the regulatory text to note that not all OASIS data is required for the HH QRP. Finally, it would require that accrediting organization surveyors take CMS-provided training.
2018-07-12Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Reassignment of Medicaid Provider ClaimsThis proposed rule would remove the regulatory text that allows a state to make payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. We are...2018-14786"https://www.gpo.gov/fdsys/pkg/FR-2018-07-12/pdf/2018-14786.pdfhttps://www.federalregister.gov/documents/2018/07/12/2018-14786/medicaid-program-reassignment-of-medicaid-provider-claimsThis proposed rule would remove the regulatory text that allows a state to make payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. We are concerned that these provisions are overbroad, and insufficiently linked to the exceptions expressly permitted by the statute. As we noted in our prior rulemaking, section 1902(a)(32) of the Act provides for a number of exceptions to the direct payment requirement, but it does not authorize the agency to create new exceptions.
2018-06-27RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRemoving Outmoded Regulations Regarding the National Health Service Corps ProgramThis action removes outmoded regulations for the National Health Service Corps (NHSC) Program. The regulations were promulgated to implement Section 338G of the Public Health Service (PHS) Act, relating to private practice loans. The regulations have...2018-13837"https://www.gpo.gov/fdsys/pkg/FR-2018-06-27/pdf/2018-13837.pdfhttps://www.federalregister.gov/documents/2018/06/27/2018-13837/removing-outmoded-regulations-regarding-the-national-health-service-corps-programThis action removes outmoded regulations for the National Health Service Corps (NHSC) Program. The regulations were promulgated to implement Section 338G of the Public Health Service (PHS) Act, relating to private practice loans. The regulations have not been updated since they were issued in 1986. The regulations are no longer relevant or needed as the NHSC has not made private practice loan opportunities available since the 1980s, and does not plan to do so in the foreseeable future. The removal of these regulations will not create any challenges for other programs, as the law and regulations apply solely to NHSC clinicians.
2018-06-27RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRemoving Outmoded Regulations Regarding the Rural Physician Training Grant Program, Definition of “Underserved Rural Community”This action removes the outmoded regulations for the Rural Physician Training Grant Program, Definition of ``Underserved Rural Community.'' Funding was authorized at section 749B(i) Public Health Service Act for fiscal years 2010-2013, but never...2018-13835"https://www.gpo.gov/fdsys/pkg/FR-2018-06-27/pdf/2018-13835.pdfhttps://www.federalregister.gov/documents/2018/06/27/2018-13835/removing-outmoded-regulations-regarding-the-rural-physician-training-grant-program-definition-ofThis action removes the outmoded regulations for the Rural Physician Training Grant Program, Definition of ``Underserved Rural Community.'' Funding was authorized at section 749B(i) Public Health Service Act for fiscal years 2010-2013, but never appropriated for the Rural Physician Training Grant Program, and the program was not implemented. Therefore, this regulation is no longer relevant, and HRSA suggested the regulations defining underserved rural communities for the Rural Physician Training Grant Program be removed.
2018-06-27RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRemoving Outmoded Regulations Regarding the Ricky Ray Hemophilia Relief Fund ProgramThis action removes the outmoded regulations for the Ricky Ray Hemophilia Relief Fund Program. The program and its implementing regulation have been rendered obsolete by the statutory language in the authorizing legislation stating that the Fund should...2018-13836"https://www.gpo.gov/fdsys/pkg/FR-2018-06-27/pdf/2018-13836.pdfhttps://www.federalregister.gov/documents/2018/06/27/2018-13836/removing-outmoded-regulations-regarding-the-ricky-ray-hemophilia-relief-fund-programThis action removes the outmoded regulations for the Ricky Ray Hemophilia Relief Fund Program. The program and its implementing regulation have been rendered obsolete by the statutory language in the authorizing legislation stating that the Fund should terminate on the expiration of the 5-year period beginning on the date of the enactment of the Act. The statute was enacted on November 12, 1998; thus, the fund expired on November 12, 2003.
2018-06-25Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Request for Information Regarding the Physician Self-Referral LawThis request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.2018-13529"https://www.gpo.gov/fdsys/pkg/FR-2018-06-25/pdf/2018-13529.pdfhttps://www.federalregister.gov/documents/2018/06/25/2018-13529/medicare-program-request-for-information-regarding-the-physician-self-referral-lawThis request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.
2018-06-20Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims; CorrectionThis document corrects technical and typographical errors in the proposed rule that appeared in the May 7, 2018 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the...2018-13152"https://www.gpo.gov/fdsys/pkg/FR-2018-06-20/pdf/2018-13152.pdfhttps://www.federalregister.gov/documents/2018/06/20/2018-13152/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theThis document corrects technical and typographical errors in the proposed rule that appeared in the May 7, 2018 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims''.
2018-06-15RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; CorrectionThis document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on April 16, 2018 titled ``Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare...2018-12843"https://www.gpo.gov/fdsys/pkg/FR-2018-06-15/pdf/2018-12843.pdfhttps://www.federalregister.gov/documents/2018/06/15/2018-12843/medicare-program-medicare-program-contract-year-2019-policy-and-technical-changes-to-the-medicareThis document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on April 16, 2018 titled ``Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program.''
2018-06-08RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Changes to the Comprehensive Care for Joint Replacement Payment Model (CJR): Extreme and Uncontrollable Circumstances Policy for the CJR ModelThis final rule finalizes a policy that provides flexibility in the determination of episode spending for Comprehensive Care for Joint Replacement Payment Model (CJR) participant hospitals located in areas impacted by extreme and uncontrollable...2018-12379"https://www.gpo.gov/fdsys/pkg/FR-2018-06-08/pdf/2018-12379.pdfhttps://www.federalregister.gov/documents/2018/06/08/2018-12379/medicare-program-changes-to-the-comprehensive-care-for-joint-replacement-payment-model-cjr-extremeThis final rule finalizes a policy that provides flexibility in the determination of episode spending for Comprehensive Care for Joint Replacement Payment Model (CJR) participant hospitals located in areas impacted by extreme and uncontrollable circumstances for performance years 3 through 5.
2018-06-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of PaymentThis document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior...2018-11953"https://www.gpo.gov/fdsys/pkg/FR-2018-06-05/pdf/2018-11953.pdfhttps://www.federalregister.gov/documents/2018/06/05/2018-11953/medicare-program-update-to-the-required-prior-authorization-list-of-durable-medical-equipmentThis document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide.
2018-06-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties RegulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth...2018-12103"https://www.gpo.gov/fdsys/pkg/FR-2018-06-05/pdf/2018-12103.pdfhttps://www.federalregister.gov/documents/2018/06/05/2018-12103/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On May 7, 2018, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2019. HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for any additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2019.
2018-06-01Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCompliance With Statutory Program Integrity RequirementsThe Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise its Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory...2018-11673"https://www.gpo.gov/fdsys/pkg/FR-2018-06-01/pdf/2018-11673.pdfhttps://www.federalregister.gov/documents/2018/06/01/2018-11673/compliance-with-statutory-program-integrity-requirementsThe Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise its Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. In addition, OPA proposes amendments to the Title X regulations that would, among other things, clarify grantee responsibilities to provide a broad range of family planning methods; to require documented compliance with State and local laws requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, and human trafficking; to provide free or low cost access to family planning services for those women who are unable to obtain employer-sponsored insurance coverage for certain contraceptive services due to their employers' religious beliefs or moral convictions; to provide for the appropriate expenditure of federal Title X funds on family planning services, rather than on lobbying or related activities; and to appropriately encourage family participation in family planning decisions, all as required by Federal law.
2018-05-30RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentControl of Communicable Diseases; Technical CorrectionThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a technical correction to the final rule published on July 10, 2017. The July 10, 2017, technical correction provided amendments to a...2018-11539"https://www.gpo.gov/fdsys/pkg/FR-2018-05-30/pdf/2018-11539.pdfhttps://www.federalregister.gov/documents/2018/05/30/2018-11539/control-of-communicable-diseases-technical-correctionThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a technical correction to the final rule published on July 10, 2017. The July 10, 2017, technical correction provided amendments to a final rule published on January 19, 2017, but contained an error. HHS/CDC is therefore submitting a new correction to correct that error.
2018-05-22RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year; CorrectionsThis document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 16, 2017 entitled ``Medicare Program; CY 2018 Updates to the Quality...2018-10923"https://www.gpo.gov/fdsys/pkg/FR-2018-05-22/pdf/2018-10923.pdfhttps://www.federalregister.gov/documents/2018/05/22/2018-10923/medicare-program-cy-2018-updates-to-the-quality-payment-program-and-quality-payment-program-extremeThis document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 16, 2017 entitled ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' (hereinafter referred to as the ``CY 2018 Quality Payment Program final rule'').
2018-05-11RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous AreasThis interim final rule with comment period makes technical amendments to the regulation to reflect the extension of the transition period from June 30, 2016 to December 31, 2016 that was mandated by the 21st Century Cures Act for phasing in fee...2018-10084"https://www.gpo.gov/fdsys/pkg/FR-2018-05-11/pdf/2018-10084.pdfhttps://www.federalregister.gov/documents/2018/05/11/2018-10084/medicare-program-durable-medical-equipment-fee-schedule-adjustments-to-resume-the-transitional-5050This interim final rule with comment period makes technical amendments to the regulation to reflect the extension of the transition period from June 30, 2016 to December 31, 2016 that was mandated by the 21st Century Cures Act for phasing in fee schedule adjustments for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). In addition, this interim final rule with comment period amends the regulation to resume the transition period's blended fee schedule rates for items furnished in rural areas and non-contiguous areas (Alaska, Hawaii, and United States territories) not subject to the CBP from June 1, 2018 through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to reflect the exclusion of infusion drugs used with DME from the DMEPOS CBP.
2018-05-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting RequirementsThis proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also proposes to make conforming regulations text changes to recognize physician assistants as designated hospice attending...2018-08773"https://www.gpo.gov/fdsys/pkg/FR-2018-05-08/pdf/2018-08773.pdfhttps://www.federalregister.gov/documents/2018/05/08/2018-08773/medicare-program-fy-2019-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also proposes to make conforming regulations text changes to recognize physician assistants as designated hospice attending physicians effective January 1, 2019. Finally, the rule proposes changes to the Hospice Quality Reporting Program.
2018-05-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019)This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or...2018-09069"https://www.gpo.gov/fdsys/pkg/FR-2018-05-08/pdf/2018-09069.pdfhttps://www.federalregister.gov/documents/2018/05/08/2018-09069/medicare-program-fy-2019-inpatient-psychiatric-facilities-prospective-payment-system-and-qualityThis proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These changes would be effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2018 through September 30, 2019 (FY 2019). This rule also proposes to update the IPF labor- related share, to update the IPF wage index for FY 2019, update the International Classification of Diseases 10th Revision, Clinical Modification (ICD-10-CM) codes for FY 2019, make technical corrections to the IPF regulations, and update quality measures and reporting requirements under the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program. In addition, it would update providers on the status of IPF PPS refinements. Finally, this proposed rule includes a Request for Information related to health information technology.
2018-05-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Proposed Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting ProgramThis proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This proposed rule also proposes to replace the existing case-mix classification...2018-09015"https://www.gpo.gov/fdsys/pkg/FR-2018-05-08/pdf/2018-09015.pdfhttps://www.federalregister.gov/documents/2018/05/08/2018-09015/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This proposed rule also proposes to replace the existing case-mix classification methodology, the Resource Utilization Groups, Version IV (RUG-IV) model, with a revised case-mix methodology called the Patient-Driven Payment Model (PDPM) effective October 1, 2019. It also proposes revisions to the regulation text that describes a beneficiary's SNF ``resident'' status under the consolidated billing provision and the required content of the SNF level of care certification. The proposed rule also includes proposals for the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.
2018-05-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act (the Act), this proposed rule includes the classification and...2018-08961"https://www.gpo.gov/fdsys/pkg/FR-2018-05-08/pdf/2018-08961.pdfhttps://www.federalregister.gov/documents/2018/05/08/2018-08961/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act (the Act), this proposed rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2019. We are also proposing to alleviate administrative burden for IRFs by removing the Functional Independence Measure (FIMTM) instrument and associated Function Modifiers from the IRF Patient Assessment Instrument (IRF-PAI) and revising certain IRF coverage requirements to reduce the amount of required paperwork in the IRF setting. In addition, we are soliciting comments on removing the face-to-face requirement for rehabilitation physician visits and expanding the use of non-physician practitioners (that is, nurse practitioners and physician assistants) in meeting the IRF coverage requirements. For the IRF Quality Reporting Program (QRP), we are proposing to adopt a new measure removal factor, remove two measures from the IRF QRP measure set, and codify in our regulations a number of requirements.
2018-05-07Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties RegulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on further delaying the effective...2018-09711"https://www.gpo.gov/fdsys/pkg/FR-2018-05-07/pdf/2018-09711.pdfhttps://www.federalregister.gov/documents/2018/05/07/2018-09711/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on further delaying the effective date of the January 5, 2017, final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to further delay the effective date of the final rule published in the Federal Register from July 1, 2018, to July 1, 2019. HHS proposes this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.
2018-05-07Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of ClaimsWe are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019....2018-08705"https://www.gpo.gov/fdsys/pkg/FR-2018-05-07/pdf/2018-08705.pdfhttps://www.federalregister.gov/documents/2018/05/07/2018-08705/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theWe are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these proposed changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are proposing to provide the market basket update that would apply to the rate[dash]of[dash]increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2019. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS[dash]exempt cancer hospitals, and LTCHs). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are proposing changes to the requirements that apply to States operating Medicaid Promoting Interoperability Prrograms. We are proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing to make changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.
2018-05-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act; CorrectionThis document corrects a technical error that appeared in the final rule published in the Federal Register on July 5, 2017 entitled ``Medicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid...2018-09347"https://www.gpo.gov/fdsys/pkg/FR-2018-05-03/pdf/2018-09347.pdfhttps://www.federalregister.gov/documents/2018/05/03/2018-09347/medicaidchip-program-medicaid-program-and-childrens-health-insurance-program-chip-changes-to-theThis document corrects a technical error that appeared in the final rule published in the Federal Register on July 5, 2017 entitled ``Medicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act'' (hereinafter referred to as the ``PERM final rule'').
2018-04-27RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentManaged Care2018-09060"https://www.gpo.gov/fdsys/pkg/FR-2018-04-27/pdf/2018-09060.pdfhttps://www.federalregister.gov/documents/2018/04/27/2018-09060/managed-care
2018-04-24Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 018-Hypertension; Finding of Insufficient EvidenceOn January 5, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 018) to add hypertension (high blood pressure) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and...2018-08456"https://www.gpo.gov/fdsys/pkg/FR-2018-04-24/pdf/2018-08456.pdfhttps://www.federalregister.gov/documents/2018/04/24/2018-08456/world-trade-center-health-program-petition-018-hypertension-finding-of-insufficient-evidenceOn January 5, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 018) to add hypertension (high blood pressure) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add hypertension to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2018-04-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE ProgramThis final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to further reduce the...2018-07179"https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdfhttps://www.federalregister.gov/documents/2018/04/16/2018-07179/medicare-program-contract-year-2019-policy-and-technical-changes-to-the-medicare-advantage-medicareThis final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to further reduce the number of beneficiaries who may potentially misuse or overdose on opioids while still having access to important treatment options; implement certain provisions of the 21st Century Cures Act; support innovative approaches to improve program quality, accessibility, and affordability; offer beneficiaries more choices and better care; improve the CMS customer experience and maintain high beneficiary satisfaction; address program integrity policies related to payments based on prescriber, provider and supplier status in MA, Medicare cost plan, Medicare Part D and the PACE programs; provide an update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.
2018-04-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury TableAs required by a recent amendment to the VICP's authorizing statute, the Secretary of the Department of Health and Human Services (Secretary) proposes to amend the National Vaccine Injury Compensation Program (VICP) Vaccine Injury Table (Table) to...2018-06770"https://www.gpo.gov/fdsys/pkg/FR-2018-04-04/pdf/2018-06770.pdfhttps://www.federalregister.gov/documents/2018/04/04/2018-06770/national-vaccine-injury-compensation-program-adding-the-category-of-vaccines-recommended-forAs required by a recent amendment to the VICP's authorizing statute, the Secretary of the Department of Health and Human Services (Secretary) proposes to amend the National Vaccine Injury Compensation Program (VICP) Vaccine Injury Table (Table) to include vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in pregnant women. Thus, the Secretary is only seeking public comment on how the addition of this new category is proposed to be formatted on the Table.
2018-03-30RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary UtilizationThis document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of...2018-06552"https://www.gpo.gov/fdsys/pkg/FR-2018-03-30/pdf/2018-06552.pdfhttps://www.federalregister.gov/documents/2018/03/30/2018-06552/medicare-program-prior-authorization-process-for-certain-durable-medical-equipment-prostheticsThis document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.
2018-03-23Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Methods for Assuring Access to Covered Medicaid Services-Exemptions for States With High Managed Care Penetration Rates and Rate Reduction ThresholdThis proposed rule would amend the process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with the statute. States have...2018-05898"https://www.gpo.gov/fdsys/pkg/FR-2018-03-23/pdf/2018-05898.pdfhttps://www.federalregister.gov/documents/2018/03/23/2018-05898/medicaid-program-methods-for-assuring-access-to-covered-medicaid-services-exemptions-for-states-withThis proposed rule would amend the process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with the statute. States have raised concerns over the administrative burden associated with the current requirements, particularly for states with high rates of Medicaid managed care enrollment. This proposed rule would provide burden relief and address those concerns.
2018-03-22Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentClarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators; Technical AmendmentsThe Department of Health and Human Services (HHS) proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should...2018-05775"https://www.gpo.gov/fdsys/pkg/FR-2018-03-22/pdf/2018-05775.pdfhttps://www.federalregister.gov/documents/2018/03/22/2018-05775/clarification-of-post-approval-testing-standards-for-closed-circuit-escape-respirators-technicalThe Department of Health and Human Services (HHS) proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should clarify that post-approval testing of CCERs may exclude human subject testing and environmental conditioning, at the discretion of the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS. The revision to the text in this paragraph will clarify the scope of post-approval testing conducted by NIOSH.
2018-01-31RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting ProgramsC1-2017-27949"https://www.gpo.gov/fdsys/pkg/FR-2018-01-31/pdf/C1-2017-27949.pdfhttps://www.federalregister.gov/documents/2018/01/31/C1-2017-27949/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
2018-01-30RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic LocationsThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida,...2018-01783"https://www.gpo.gov/fdsys/pkg/FR-2018-01-30/pdf/2018-01783.pdfhttps://www.federalregister.gov/documents/2018/01/30/2018-01783/medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-the-extension-of-temporaryThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states. For purposes of these moratoria, providers that were participating as network providers in one or more Medicaid managed care organizations prior to January 1, 2018 will not be considered ``newly enrolling'' when they are required to enroll with the State Medicaid agency pursuant to a new statutory requirement, and thus will not be subject to the moratoria.
2018-01-09Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRequest for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been...2017-27887"https://www.gpo.gov/fdsys/pkg/FR-2018-01-09/pdf/2017-27887.pdfhttps://www.federalregister.gov/documents/2018/01/09/2017-27887/request-for-information-revisions-to-personnel-regulations-proficiency-testing-referralThis request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT) referral. In addition, we are seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its PT samples to another laboratory and has reported the other laboratory's result as their own. This request for information also seeks public comment regarding the updating of fees for determination of program compliance and additional fees for laboratories established under the CLIA regulations. We are also seeking public comment regarding the collection of other fees we are authorized to collect such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions. We intend to consider public comments (including information such as evidence, research, and trends) received in response to this request for information when we draft proposals, in consultation, as appropriate, with the Centers for Disease Control and Prevention (CDC), to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.
2018-01-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConfidentiality of Substance Use Disorder Patient RecordsThis final rule makes changes to the Substance Abuse and Mental Health Services Administration's (SAMHSA) regulations governing the Confidentiality of Substance Use Disorder Patient Records. These changes are intended to better align the regulations...2017-28400"https://www.gpo.gov/fdsys/pkg/FR-2018-01-03/pdf/2017-28400.pdfhttps://www.federalregister.gov/documents/2018/01/03/2017-28400/confidentiality-of-substance-use-disorder-patient-recordsThis final rule makes changes to the Substance Abuse and Mental Health Services Administration's (SAMHSA) regulations governing the Confidentiality of Substance Use Disorder Patient Records. These changes are intended to better align the regulations with advances in the U.S. health care delivery system while retaining important privacy protections for individuals seeking treatment for substance use disorders. This final rule addresses the prohibition on re-disclosure notice by including an option for an abbreviated notice. This final rule also addresses the circumstances under which lawful holders and their legal representatives, contractors, and subcontractors may use and disclose patient identifying information for purposes of payment, health care operations, and audits and evaluations. Finally, this final rule is making minor technical corrections to ensure accuracy and clarity in SAMHSA's regulations.
2017-12-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; CorrectionThis document corrects technical and typographical errors in the proposed rule that appeared in the November 28, 2017 issue of the Federal Register titled ``Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage,...2017-27943"https://www.gpo.gov/fdsys/pkg/FR-2017-12-28/pdf/2017-27943.pdfhttps://www.federalregister.gov/documents/2017/12/28/2017-27943/medicare-program-contract-year-2019-policy-and-technical-changes-to-the-medicare-advantage-medicareThis document corrects technical and typographical errors in the proposed rule that appeared in the November 28, 2017 issue of the Federal Register titled ``Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program''.
2017-12-27RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; CorrectionThis document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 14, 2017 entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and...2017-27949"https://www.gpo.gov/fdsys/pkg/FR-2017-12-27/pdf/2017-27949.pdfhttps://www.federalregister.gov/documents/2017/12/27/2017-27949/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 14, 2017 entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.''
2017-12-27Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentSolicitation of New Safe Harbors and Special Fraud AlertsIn accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the...2017-27117"https://www.gpo.gov/fdsys/pkg/FR-2017-12-27/pdf/2017-27117.pdfhttps://www.federalregister.gov/documents/2017/12/27/2017-27117/solicitation-of-new-safe-harbors-and-special-fraud-alertsIn accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (Sec. 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
2017-12-26RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017This interim final rule with comment period establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and...2017-27920"https://www.gpo.gov/fdsys/pkg/FR-2017-12-26/pdf/2017-27920.pdfhttps://www.federalregister.gov/documents/2017/12/26/2017-27920/medicare-program-medicare-shared-savings-program-extreme-and-uncontrollable-circumstances-policiesThis interim final rule with comment period establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and uncontrollable circumstances during performance year 2017, including the applicable quality reporting period for the performance year. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs in performance-based risk agreements may also share in losses. This interim final rule with comment period establishes extreme and uncontrollable circumstances policies for the Shared Savings Program that will apply to ACOs subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, effective for performance year 2017, including the applicable quality data reporting period for the performance year.
2017-12-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting ProgramsThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with...R1-2017-23932"https://www.gpo.gov/fdsys/pkg/FR-2017-12-14/pdf/R1-2017-23932.pdfhttps://www.federalregister.gov/documents/2017/12/14/R1-2017-23932/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
2017-12-01RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model: Extreme and Uncontrollable Circumstances Policy for the Comprehensive Care for Joint Replacement Payment ModelThis final rule cancels the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) Incentive Payment Model and rescinds the regulations governing these models. It also implements certain revisions to the Comprehensive Care for Joint Replacement...2017-25979"https://www.gpo.gov/fdsys/pkg/FR-2017-12-01/pdf/2017-25979.pdfhttps://www.federalregister.gov/documents/2017/12/01/2017-25979/medicare-program-cancellation-of-advancing-care-coordination-through-episode-payment-and-cardiacThis final rule cancels the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) Incentive Payment Model and rescinds the regulations governing these models. It also implements certain revisions to the Comprehensive Care for Joint Replacement (CJR) model, including: Giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (Advanced APM) track. An interim final rule with comment period is being issued in conjunction with this final rule in order to address the need for a policy to provide some flexibility in the determination of episode costs for providers located in areas impacted by extreme and uncontrollable circumstances.
2017-11-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE ProgramThis proposed rule would revise the Medicare Advantage program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century...2017-25068"https://www.gpo.gov/fdsys/pkg/FR-2017-11-28/pdf/2017-25068.pdfhttps://www.federalregister.gov/documents/2017/11/28/2017-25068/medicare-program-contract-year-2019-policy-and-technical-changes-to-the-medicare-advantage-medicareThis proposed rule would revise the Medicare Advantage program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act; improve program quality, accessibility, and affordability; improve the CMS customer experience; address program integrity policies related to payments based on prescriber, provider and supplier status in Medicare Advantage, Medicare cost plan, Medicare Part D and the PACE programs; provide a proposed update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.
2017-11-17Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentTotal Inward Leakage Requirements for RespiratorsThe National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2009 notice of proposed rulemaking...2017-24950"https://www.gpo.gov/fdsys/pkg/FR-2017-11-17/pdf/2017-24950.pdfhttps://www.federalregister.gov/documents/2017/11/17/2017-24950/total-inward-leakage-requirements-for-respiratorsThe National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2009 notice of proposed rulemaking (NPRM). The 2009 NPRM proposed to establish total inward leakage requirements for half- mask, air-purifying particulate respirators approved by NIOSH.
2017-11-17Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentForeign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation RegulationsThe Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2007 advance notice of proposed rulemaking (ANPRM). The 2007 ANPRM was issued to begin the process of...2017-24951"https://www.gpo.gov/fdsys/pkg/FR-2017-11-17/pdf/2017-24951.pdfhttps://www.federalregister.gov/documents/2017/11/17/2017-24951/foreign-quarantine-regulations-proposed-revision-of-hhscdc-animal-importation-regulationsThe Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2007 advance notice of proposed rulemaking (ANPRM). The 2007 ANPRM was issued to begin the process of revising the regulations concerning importation of animals and animal products.
2017-11-17Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPossession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and ToxinsThe Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2015 notice of proposed rulemaking (NPRM). The 2015 NPRM proposed to add certain influenza virus...2017-24952"https://www.gpo.gov/fdsys/pkg/FR-2017-11-17/pdf/2017-24952.pdfhttps://www.federalregister.gov/documents/2017/11/17/2017-24952/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-certain-influenza-virus-strainsThe Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2015 notice of proposed rulemaking (NPRM). The 2015 NPRM proposed to add certain influenza virus strains to the list of HHS select agents and toxins.
2017-11-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition YearThe Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment...2017-24067"https://www.gpo.gov/fdsys/pkg/FR-2017-11-16/pdf/2017-24067.pdfhttps://www.federalregister.gov/documents/2017/11/16/2017-24067/medicare-program-cy-2018-updates-to-the-quality-payment-program-and-quality-payment-program-extremeThe Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This final rule with comment period provides updates for the second and future years of the Quality Payment Program. In addition, we also are issuing an interim final rule with comment period (IFC) that addresses extreme and uncontrollable circumstances MIPS eligible clinicians may face as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria.
2017-11-15RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention ProgramThis major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in...2017-23953"https://www.gpo.gov/fdsys/pkg/FR-2017-11-15/pdf/2017-23953.pdfhttps://www.federalregister.gov/documents/2017/11/15/2017-23953/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.
2017-11-13RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting ProgramsThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with...2017-23932"https://www.gpo.gov/fdsys/pkg/FR-2017-11-13/pdf/2017-23932.pdfhttps://www.federalregister.gov/documents/2017/11/13/2017-23932/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
2017-11-07RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsThis final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor,...2017-23935"https://www.gpo.gov/fdsys/pkg/FR-2017-11-07/pdf/2017-23935.pdfhttps://www.federalregister.gov/documents/2017/11/07/2017-23935/medicare-and-medicaid-programs-cy-2018-home-health-prospective-payment-system-rate-update-and-cyThis final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: Updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the third year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule.
2017-11-01RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive ProgramThis rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2018. It also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with...2017-23671"https://www.gpo.gov/fdsys/pkg/FR-2017-11-01/pdf/2017-23671.pdfhttps://www.federalregister.gov/documents/2017/11/01/2017-23671/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysisThis rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2018. It also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also sets forth requirements for the ESRD Quality Incentive Program (QIP), including for payment years (PYs) 2019 through 2021.
2017-10-20RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentClinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) TestingThis final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.2017-22813"https://www.gpo.gov/fdsys/pkg/FR-2017-10-20/pdf/2017-22813.pdfhttps://www.federalregister.gov/documents/2017/10/20/2017-22813/clinical-laboratory-improvement-amendments-of-1988-clia-fecal-occult-blood-fob-testingThis final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
2017-10-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Revisions to Certain Patient's Rights Conditions for Participation and Conditions for Coverage; WithdrawalThis document withdraws a proposed rule that was published in the Federal Register on December 12, 2014. This proposed rule would revise the applicable conditions of participation for certain providers, conditions for coverage for certain suppliers,...2017-21419"https://www.gpo.gov/fdsys/pkg/FR-2017-10-04/pdf/2017-21419.pdfhttps://www.federalregister.gov/documents/2017/10/04/2017-21419/medicare-and-medicaid-programs-revisions-to-certain-patients-rights-conditions-for-participation-andThis document withdraws a proposed rule that was published in the Federal Register on December 12, 2014. This proposed rule would revise the applicable conditions of participation for certain providers, conditions for coverage for certain suppliers, and requirements for long-term care facilities, to ensure that the requirements are consistent with the Supreme Court decision in United States v. Windsor (570 U.S.12, 133 S. Ct. 2675 (2013)), and HHS policy. Specifically, it proposed to revise certain definitions and patient's rights provisions that currently defer to state law, in order to ensure that same-sex spouses are recognized and afforded equal rights in certain Medicare and Medicaid-participating facilities.
2017-10-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Part B Drug Payment Model; WithdrawalThis document withdraws a proposed rule that was published in the Federal Register on March 11, 2016. The proposed rule discussed our proposal to implement a new Medicare payment model under section 1115A of the Social Security Act (the Act).2017-21420"https://www.gpo.gov/fdsys/pkg/FR-2017-10-04/pdf/2017-21420.pdfhttps://www.federalregister.gov/documents/2017/10/04/2017-21420/medicare-program-part-b-drug-payment-model-withdrawalThis document withdraws a proposed rule that was published in the Federal Register on March 11, 2016. The proposed rule discussed our proposal to implement a new Medicare payment model under section 1115A of the Social Security Act (the Act).
2017-10-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Correction of the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020; CorrectionThis document corrects technical errors in the final rule that appeared in the August 4, 2017 Federal Register, which will update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year...2017-21327"https://www.gpo.gov/fdsys/pkg/FR-2017-10-04/pdf/2017-21327.pdfhttps://www.federalregister.gov/documents/2017/10/04/2017-21327/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis document corrects technical errors in the final rule that appeared in the August 4, 2017 Federal Register, which will update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018.
2017-10-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices; CorrectionThis document corrects technical and typographical errors in the final rule that appeared in the August 14, 2017, issue of the Federal Register, which will amend the Medicare hospital inpatient prospective payment systems (IPPS) for operating and...2017-21325"https://www.gpo.gov/fdsys/pkg/FR-2017-10-04/pdf/2017-21325.pdfhttps://www.federalregister.gov/documents/2017/10/04/2017-21325/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theThis document corrects technical and typographical errors in the final rule that appeared in the August 14, 2017, issue of the Federal Register, which will amend the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018.
2017-10-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics; WithdrawalThis document withdraws a proposed rule that was published in the Federal Register on January 12, 2017. The proposed rule specified the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate...2017-21425"https://www.gpo.gov/fdsys/pkg/FR-2017-10-04/pdf/2017-21425.pdfhttps://www.federalregister.gov/documents/2017/10/04/2017-21425/medicare-program-establishment-of-special-payment-provisions-and-requirements-for-qualifiedThis document withdraws a proposed rule that was published in the Federal Register on January 12, 2017. The proposed rule specified the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom- fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, the proposed rule removed the current exemption from accreditation and quality standards for certain practitioners and suppliers.
2017-09-29RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties RegulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth...2017-20911"https://www.gpo.gov/fdsys/pkg/FR-2017-09-29/pdf/2017-20911.pdfhttps://www.federalregister.gov/documents/2017/09/29/2017-20911/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On August 21, 2017, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 39553). HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2018.
2017-09-12RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentAdjustment of Civil Monetary Penalties for Inflation; Correcting AmendmentIn the September 6, 2016 Federal Register (81 FR 61538), we published an interim final rule (IFR) issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all...2017-19311"https://www.gpo.gov/fdsys/pkg/FR-2017-09-12/pdf/2017-19311.pdfhttps://www.federalregister.gov/documents/2017/09/12/2017-19311/adjustment-of-civil-monetary-penalties-for-inflation-correcting-amendmentIn the September 6, 2016 Federal Register (81 FR 61538), we published an interim final rule (IFR) issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. This correcting amendment corrects a limited number of technical and typographical errors identified in the CMS provisions of the September 6, 2016 IFR.
2017-08-21Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties RegulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on delaying the...2017-17633"https://www.gpo.gov/fdsys/pkg/FR-2017-08-21/pdf/2017-17633.pdfhttps://www.federalregister.gov/documents/2017/08/21/2017-17633/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on delaying the effective date of the January 5, 2017 final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to delay the effective date of the final rule published in the Federal Register (82 FR 1210, January 5, 2017) to July 1, 2018. HHS proposes this action in order to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking, as set forth below.
2017-08-17Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model (CMS-5524-P)This proposed rule proposes to cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and to rescind the regulations governing these models. It also proposes to revise certain aspects of the Comprehensive Care...2017-17446"https://www.gpo.gov/fdsys/pkg/FR-2017-08-17/pdf/2017-17446.pdfhttps://www.federalregister.gov/documents/2017/08/17/2017-17446/medicare-program-cancellation-of-advancing-care-coordination-through-episode-payment-and-cardiacThis proposed rule proposes to cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and to rescind the regulations governing these models. It also proposes to revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model, including: Giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (APM) track.
2017-08-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination NoticesWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these...2017-16434"https://www.gpo.gov/fdsys/pkg/FR-2017-08-14/pdf/2017-16434.pdfhttps://www.federalregister.gov/documents/2017/08/14/2017-16434/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these changes implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making changes relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the market basket update that will apply to the rate- of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.
2017-08-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting RequirementsThis final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2018. Additionally, this rule includes new quality measures and provides an update on the hospice quality reporting program.2017-16294"https://www.gpo.gov/fdsys/pkg/FR-2017-08-04/pdf/2017-16294.pdfhttps://www.federalregister.gov/documents/2017/08/04/2017-16294/medicare-program-fy-2018-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2018. Additionally, this rule includes new quality measures and provides an update on the hospice quality reporting program.
2017-08-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Correction of the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also revises and rebases the market basket index by updating the base year from 2010 to 2014,...2017-16256"https://www.gpo.gov/fdsys/pkg/FR-2017-08-04/pdf/2017-16256.pdfhttps://www.federalregister.gov/documents/2017/08/04/2017-16256/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also revises and rebases the market basket index by updating the base year from 2010 to 2014, and by adding a new cost category for Installation, Maintenance, and Repair Services. The rule also finalizes revisions to the SNF Quality Reporting Program (QRP), including measure and standardized resident assessment data policies and policies related to public display. In addition, it finalizes policies for the Skilled Nursing Facility Value-Based Purchasing Program that will affect Medicare payment to SNFs beginning in FY 2019. The final rule also clarifies the regulatory requirements for team composition for surveys conducted for investigating a complaint and aligns regulatory provisions for investigation of complaints with the statutory requirements. The final rule also finalizes the performance period for the National Healthcare Safety Network (NHSN) Healthcare Personnel (HCP) Influenza Vaccination Reporting Measure included in the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for Payment Year 2020.
2017-08-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2018This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2018 as required by the statute. As required by section 1886(j)(5) of the Social Security Act (the Act), this rule...2017-16291"https://www.gpo.gov/fdsys/pkg/FR-2017-08-03/pdf/2017-16291.pdfhttps://www.federalregister.gov/documents/2017/08/03/2017-16291/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2018 as required by the statute. As required by section 1886(j)(5) of the Social Security Act (the Act), this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2018. This final rule also revises the International Classification of Diseases, 10th Revision, Clinical Modification (ICD- 10-CM) diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule,'' removes the 25 percent payment penalty for inpatient rehabilitation facility patient assessment instrument (IRF-PAI) late transmissions, removes the voluntary swallowing status item (Item 27) from the IRF-PAI, summarizes comments regarding the criteria used to classify facilities for payment under the IRF PPS, provides for a subregulatory process for certain annual updates to the presumptive methodology diagnosis code lists, adopts the use of height/weight items on the IRF-PAI to determine patient body mass index (BMI) greater than 50 for cases of single-joint replacement under the presumptive methodology, and revises and updates measures and reporting requirements under the IRF quality reporting program (QRP).
2017-07-28RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic LocationsThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida,...2017-15961"https://www.gpo.gov/fdsys/pkg/FR-2017-07-28/pdf/2017-15961.pdfhttps://www.federalregister.gov/documents/2017/07/28/2017-15961/medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-the-extension-of-temporaryThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states.
2017-07-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and Proposed CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsThis proposed rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor,...2017-15825"https://www.gpo.gov/fdsys/pkg/FR-2017-07-28/pdf/2017-15825.pdfhttps://www.federalregister.gov/documents/2017/07/28/2017-15825/medicare-and-medicaid-programs-cy-2018-home-health-prospective-payment-system-rate-update-andThis proposed rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 3rd- year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. This rule proposes case-mix methodology refinements, as well as a change in the unit of payment from 60-day episodes of care to 30-day periods of care, to be implemented for home health services beginning on or after January 1, 2019; and finally, this rule proposes changes to the Home Health Value- Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP).
2017-07-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; State Disproportionate Share Hospital Allotment ReductionsThe Affordable Care Act requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with fiscal year (FY) 2018. This proposed rule delineates a methodology to implement the annual allotment...2017-15962"https://www.gpo.gov/fdsys/pkg/FR-2017-07-28/pdf/2017-15962.pdfhttps://www.federalregister.gov/documents/2017/07/28/2017-15962/medicaid-program-state-disproportionate-share-hospital-allotment-reductionsThe Affordable Care Act requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with fiscal year (FY) 2018. This proposed rule delineates a methodology to implement the annual allotment reductions.
2017-07-21Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention ProgramThis major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies.2017-14639"https://www.gpo.gov/fdsys/pkg/FR-2017-07-21/pdf/2017-14639.pdfhttps://www.federalregister.gov/documents/2017/07/21/2017-14639/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies.
2017-07-20Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting ProgramsThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these...2017-14883"https://www.gpo.gov/fdsys/pkg/FR-2017-07-20/pdf/2017-14883.pdfhttps://www.federalregister.gov/documents/2017/07/20/2017-14883/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems and certain provisions under the 21st Century Cures Act (Pub. L. 114-255). In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
2017-07-13Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petitions 016 and 017-Parkinson's Disease and Parkinsonism, Including Manganese-Induced Parkinsonism; Finding of Insufficient EvidenceOn February 22, 2017, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 016) to add Parkinson's disease and parkinsonism, including manganese-induced parkinsonism, to the List of WTC-Related Health...2017-14559"https://www.gpo.gov/fdsys/pkg/FR-2017-07-13/pdf/2017-14559.pdfhttps://www.federalregister.gov/documents/2017/07/13/2017-14559/world-trade-center-health-program-petitions-016-and-017-parkinsons-disease-and-parkinsonismOn February 22, 2017, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 016) to add Parkinson's disease and parkinsonism, including manganese-induced parkinsonism, to the List of WTC-Related Health Conditions (List). On May 10, 2017, the Administrator received a second petition (Petition 017) to add the same health conditions to the List. Upon reviewing the scientific and medical literature, including information provided by the two petitioners, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add Parkinson's disease and/or parkinsonism, including manganese-induced parkinsonism, to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2017-07-13RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Reform of Requirements for Long-Term Care FacilitiesIn the October 4, 2016 issue of the Federal Register, we published a final rule revising the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. The effective date was November 28, 2016....2017-14646"https://www.gpo.gov/fdsys/pkg/FR-2017-07-13/pdf/2017-14646.pdfhttps://www.federalregister.gov/documents/2017/07/13/2017-14646/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilitiesIn the October 4, 2016 issue of the Federal Register, we published a final rule revising the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. The effective date was November 28, 2016. This document corrects technical and typographical errors identified in the October 4, 2016 final rule.
2017-07-10RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Delay of Effective DateThis final rule delays the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017 (82 FR 4504). The published effective...2017-14347"https://www.gpo.gov/fdsys/pkg/FR-2017-07-10/pdf/2017-14347.pdfhttps://www.federalregister.gov/documents/2017/07/10/2017-14347/medicare-and-medicaid-programs-conditions-of-participation-for-home-health-agencies-delay-ofThis final rule delays the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017 (82 FR 4504). The published effective date for the final rule was July 13, 2017, and this rule delays the effective date for an additional 6 months until January 13, 2018. This final rule also includes two conforming changes to dates that are included in the regulations text.
2017-07-10RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentControl of Communicable Diseases; CorrectionThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces technical corrections to the final rule (82 FR 6890) published on January 19, 2017. These technical corrections remove grammatical...2017-14393"https://www.gpo.gov/fdsys/pkg/FR-2017-07-10/pdf/2017-14393.pdfhttps://www.federalregister.gov/documents/2017/07/10/2017-14393/control-of-communicable-diseases-correctionThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces technical corrections to the final rule (82 FR 6890) published on January 19, 2017. These technical corrections remove grammatical errors, remove a reference to reports of deaths or illness by ``radio,'' change regulatory text to match previously updated and approved language, and amend a reporting date for a retrospective review so that the date does not coincide with a Federal holiday.
2017-07-05Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive ProgramThis rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2018, as well as to update the payment rate for renal dialysis services furnished by an ESRD facility to...2017-13908"https://www.gpo.gov/fdsys/pkg/FR-2017-07-05/pdf/2017-13908.pdfhttps://www.federalregister.gov/documents/2017/07/05/2017-13908/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysisThis rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2018, as well as to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also proposes to set forth requirements for the ESRD Quality Incentive Program (QIP), including for payment years (PYs) 2019 through 2021.
2017-07-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care ActThis final rule updates the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and the Children's Health Insurance Program (CHIP) eligibility under the Patient Protection and...2017-13710"https://www.gpo.gov/fdsys/pkg/FR-2017-07-05/pdf/2017-13710.pdfhttps://www.federalregister.gov/documents/2017/07/05/2017-13710/medicaidchip-program-medicaid-program-and-childrens-health-insurance-program-chip-changes-to-theThis final rule updates the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and the Children's Health Insurance Program (CHIP) eligibility under the Patient Protection and Affordable Care Act. This rule also implements various other improvements to the PERM program.
2017-06-30Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; CY 2018 Updates to the Quality Payment ProgramThe Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment...2017-13010"https://www.gpo.gov/fdsys/pkg/FR-2017-06-30/pdf/2017-13010.pdfhttps://www.federalregister.gov/documents/2017/06/30/2017-13010/medicare-program-cy-2018-updates-to-the-quality-payment-programThe Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This rule provides proposed updates for the second and future years of the Quality Payment Program.
2017-06-14Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities: Revisions to Case-Mix Methodology; Extension of Comment PeriodThis document extends the comment period for the advance notice of proposed rulemaking with comment entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities: Revisions to Case-mix Methodology''...2017-12324"https://www.gpo.gov/fdsys/pkg/FR-2017-06-14/pdf/2017-12324.pdfhttps://www.federalregister.gov/documents/2017/06/14/2017-12324/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis document extends the comment period for the advance notice of proposed rulemaking with comment entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities: Revisions to Case-mix Methodology'' that appeared in the May 4, 2017 Federal Register (82 FR 20980) (the ANPRM). The comment period for the ANPRM, which would end on June 26, 2017, is extended until August 25, 2017.
2017-06-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Revision of Requirements for Long-Term Care Facilities: Arbitration AgreementsThis proposed rule would revise the requirements that Long- Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, it would remove provisions prohibiting binding pre-dispute arbitration and strengthen...2017-11883"https://www.gpo.gov/fdsys/pkg/FR-2017-06-08/pdf/2017-11883.pdfhttps://www.federalregister.gov/documents/2017/06/08/2017-11883/medicare-and-medicaid-programs-revision-of-requirements-for-long-term-care-facilities-arbitrationThis proposed rule would revise the requirements that Long- Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, it would remove provisions prohibiting binding pre-dispute arbitration and strengthen requirements regarding the transparency of arbitration agreements in LTC facilities. This proposal would support the resident's right to make informed choices about important aspects of his or her health care. In addition, this proposal is consistent with our approach to eliminating unnecessary burden on providers.
2017-05-19RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties RegulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set...2017-10149"https://www.gpo.gov/fdsys/pkg/FR-2017-05-19/pdf/2017-10149.pdfhttps://www.federalregister.gov/documents/2017/05/19/2017-10149/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.
2017-05-19RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR); Delay of Effective DateThis final rule finalizes May 20, 2017 as the effective date of the final rule titled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint...2017-10340"https://www.gpo.gov/fdsys/pkg/FR-2017-05-19/pdf/2017-10340.pdfhttps://www.federalregister.gov/documents/2017/05/19/2017-10340/medicare-program-advancing-care-coordination-through-episode-payment-models-epms-cardiacThis final rule finalizes May 20, 2017 as the effective date of the final rule titled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)'' originally published in the January 3, 2017 Federal Register. This final rule also finalizes a delay of the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to January 1, 2018 and delays the effective date of the specific CJR regulations listed in the DATES section from July 1, 2017 to January 1, 2018.
2017-05-15Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2018C1-2017-08428"https://www.gpo.gov/fdsys/pkg/FR-2017-05-15/pdf/C1-2017-08428.pdfhttps://www.federalregister.gov/documents/2017/05/15/C1-2017-08428/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal
2017-05-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities: Revisions to Case-Mix MethodologyWe are issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comments on potential options we may consider for revising certain aspects of the existing skilled nursing facility (SNF) prospective payment system (PPS) payment...2017-08519"https://www.gpo.gov/fdsys/pkg/FR-2017-05-04/pdf/2017-08519.pdfhttps://www.federalregister.gov/documents/2017/05/04/2017-08519/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesWe are issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comments on potential options we may consider for revising certain aspects of the existing skilled nursing facility (SNF) prospective payment system (PPS) payment methodology to improve its accuracy, based on the results of our SNF Payment Models Research (SNF PMR) project. In particular, we are seeking comments on the possibility of replacing the SNF PPS' existing case-mix classification model, the Resource Utilization Groups, Version 4 (RUG-IV), with a new model, the Resident Classification System, Version I (RCS-I). We also discuss options for how such a change could be implemented, as well as a number of other policy changes we may consider to complement implementation of RCS-I.
2017-05-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Proposal To Correct the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also proposes to revise and rebase the market basket index by updating the base year...2017-08521"https://www.gpo.gov/fdsys/pkg/FR-2017-05-04/pdf/2017-08521.pdfhttps://www.federalregister.gov/documents/2017/05/04/2017-08521/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also proposes to revise and rebase the market basket index by updating the base year from 2010 to 2014, and by adding a new cost category for Installation, Maintenance, and Repair Services. The rule also includes proposed revisions to the SNF Quality Reporting Program (QRP), including measure and standardized patient assessment data proposals and proposals related to public display. In addition, it includes proposals for the Skilled Nursing Facility Value-Based Purchasing Program that will affect Medicare payment to SNFs beginning in FY 2019 and clarification on the requirements regarding the composition of professionals for the survey team. The proposed rule also seeks to clarify the regulatory requirements for team composition for surveys conducted for investigating a complaint and to align regulatory provisions for investigation of complaints with the statutory requirements. The proposed rule also includes one proposal related to the performance period for the National Healthcare Safety Network (NHSN) Healthcare Personnel (HCP) Influenza Vaccination Reporting Measure included in the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP).
2017-05-03Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2018This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2018 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the...2017-08428"https://www.gpo.gov/fdsys/pkg/FR-2017-05-03/pdf/2017-08428.pdfhttps://www.federalregister.gov/documents/2017/05/03/2017-08428/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2018 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2018. We are also proposing to remove the 25 percent payment penalty for inpatient rehabilitation facility patient assessment instrument (IRF-PAI) late transmissions, remove the voluntary swallowing status item (Item 27) from the IRF-PAI, revise the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule,'' solicit comments regarding the criteria used to classify facilities for payment under the IRF PPS, provide for automatic annual updates to presumptive methodology diagnosis code lists, use height/weight items on the IRF- PAI to determine patient body mass index (BMI) greater than 50 for cases of single-joint replacement under the presumptive methodology, and revise and update quality measures and reporting requirements under the IRF quality reporting program (QRP).
2017-05-03Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting RequirementsThis proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2018. Additionally, this rule proposes changes to the hospice quality reporting program, including proposing new quality measures, soliciting...2017-08563"https://www.gpo.gov/fdsys/pkg/FR-2017-05-03/pdf/2017-08563.pdfhttps://www.federalregister.gov/documents/2017/05/03/2017-08563/medicare-program-fy-2018-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2018. Additionally, this rule proposes changes to the hospice quality reporting program, including proposing new quality measures, soliciting feedback on an enhanced data collection instrument, and describing plans to publicly display quality measures and other hospice data.
2017-04-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination NoticesWe are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018....2017-07800"https://www.gpo.gov/fdsys/pkg/FR-2017-04-28/pdf/2017-07800.pdfhttps://www.federalregister.gov/documents/2017/04/28/2017-07800/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theWe are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making proposals relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the proposed estimated market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.
2017-04-12RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPossession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and ToxinsOn September 14, 2016, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published in the Federal Register (81 FR 63138) an interim final rule and request for comments which added Bacillus cereus...2017-07210"https://www.gpo.gov/fdsys/pkg/FR-2017-04-12/pdf/2017-07210.pdfhttps://www.federalregister.gov/documents/2017/04/12/2017-07210/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-bacillus-cereus-biovar-anthracisOn September 14, 2016, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published in the Federal Register (81 FR 63138) an interim final rule and request for comments which added Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. CDC received two comments, both of which supported the rule change.
2017-04-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital; Correcting AmendmentIn the November 14, 2016 issue of the Federal Register (81 FR 79562), we published a final rule with comment period entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ...2017-06903"https://www.gpo.gov/fdsys/pkg/FR-2017-04-06/pdf/2017-06903.pdfhttps://www.federalregister.gov/documents/2017/04/06/2017-06903/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentIn the November 14, 2016 issue of the Federal Register (81 FR 79562), we published a final rule with comment period entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital'' that made changes to the demonstration of meaningful use criteria under Sec. 495.40. This correcting amendment corrects a technical error in Sec. 495.40 resulting from an error in that final rule with comment period.
2017-04-03Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Delay of Effective DateThis proposed rule would delay the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017. The current effective date for...2017-06540"https://www.gpo.gov/fdsys/pkg/FR-2017-04-03/pdf/2017-06540.pdfhttps://www.federalregister.gov/documents/2017/04/03/2017-06540/medicare-and-medicaid-programs-conditions-of-participation-for-home-health-agencies-delay-ofThis proposed rule would delay the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017. The current effective date for the final rule is July 13, 2017, and this rule proposes to delay the effective date for an additional 6 months until January 13, 2018. This proposed rule would also make two conforming changes to dates that are included in the regulations text.
2017-04-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Disproportionate Share Hospital Payments-Treatment of Third Party Payers in Calculating Uncompensated Care CostsThis final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act (Act), and the application of such limitation in the annual DSH audits required...2017-06538"https://www.gpo.gov/fdsys/pkg/FR-2017-04-03/pdf/2017-06538.pdfhttps://www.federalregister.gov/documents/2017/04/03/2017-06538/medicaid-program-disproportionate-share-hospital-payments-treatment-of-third-party-payers-inThis final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act (Act), and the application of such limitation in the annual DSH audits required under section 1923(j) of the Act, by clarifying that the hospital-specific DSH limit is based only on uncompensated care costs. Specifically, this rule makes explicit in the text of the regulation, an existing interpretation that uncompensated care costs include only those costs for Medicaid eligible individuals that remain after accounting for payments made to hospitals by or on behalf of Medicaid eligible individuals, including Medicare and other third party payments that compensate the hospitals for care furnished to such individuals. As a result, the hospital-specific limit calculation will reflect only the costs for Medicaid eligible individuals for which the hospital has not received payment from any source.
2017-03-22RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; CorrectionsThis document corrects technical errors in the addenda to the final rule published in the November 15, 2016, Federal Register entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for...2017-05675"https://www.gpo.gov/fdsys/pkg/FR-2017-03-22/pdf/2017-05675.pdfhttps://www.federalregister.gov/documents/2017/03/22/2017-05675/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis document corrects technical errors in the addenda to the final rule published in the November 15, 2016, Federal Register entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
2017-03-21RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective DateThis interim final rule with comment period (IFC) further delays the effective date of the final rule entitled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the...2017-05692"https://www.gpo.gov/fdsys/pkg/FR-2017-03-21/pdf/2017-05692.pdfhttps://www.federalregister.gov/documents/2017/03/21/2017-05692/medicare-program-advancing-care-coordination-through-episode-payment-models-epms-cardiacThis interim final rule with comment period (IFC) further delays the effective date of the final rule entitled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model'' published in the January 3, 2017 Federal Register (82 FR 180) from March 21, 2017 until May 20, 2017. This IFC also delays the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to October 1, 2017 and effective date of the specific CJR regulations itemized in the DATES section from July 1, 2017 to October 1, 2017. We seek comment on the appropriateness of this delay, as well as a further applicability date delay until January 1, 2018.
2017-03-20RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties RegulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' The January 5, 2017 final rule sets forth the...2017-05491"https://www.gpo.gov/fdsys/pkg/FR-2017-03-20/pdf/2017-05491.pdfhttps://www.federalregister.gov/documents/2017/03/20/2017-05491/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' The January 5, 2017 final rule sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This interim final rule delays the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. Commenters are also invited to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate.
2017-03-10RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentSelect Agents and Toxins2017-04799"https://www.gpo.gov/fdsys/pkg/FR-2017-03-10/pdf/2017-04799.pdfhttps://www.federalregister.gov/documents/2017/03/10/2017-04799/select-agents-and-toxins
2017-03-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective DateIn accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action temporarily delays for 60 days from the date of the memorandum the effective date...2017-04337"https://www.gpo.gov/fdsys/pkg/FR-2017-03-06/pdf/2017-04337.pdfhttps://www.federalregister.gov/documents/2017/03/06/2017-04337/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-delay-of-effectiveIn accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,'' published in the January 5, 2017, Federal Register. This document announces that the effective date is delayed until March 21, 2017.
2017-03-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; CorrectionsThis document corrects technical errors that appeared in the correcting amendment published in the January 3, 2017 Federal Register (82 FR 37 through 40) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed...2017-04307"https://www.gpo.gov/fdsys/pkg/FR-2017-03-06/pdf/2017-04307.pdfhttps://www.federalregister.gov/documents/2017/03/06/2017-04307/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-deliveredThis document corrects technical errors that appeared in the correcting amendment published in the January 3, 2017 Federal Register (82 FR 37 through 40) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Corrections.''
2017-02-22RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Delay of Effective DateOn January 19, 2017, the Department of Health and Human Services published in the Federal Register a final rule to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by revising the Vaccine Injury Table...2017-03416"https://www.gpo.gov/fdsys/pkg/FR-2017-02-22/pdf/2017-03416.pdfhttps://www.federalregister.gov/documents/2017/02/22/2017-03416/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table-delay-ofOn January 19, 2017, the Department of Health and Human Services published in the Federal Register a final rule to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by revising the Vaccine Injury Table (Table). That final rule is scheduled to take effect on February 21, 2017. This document announces that the effective date is delayed until March 21, 2017.
2017-02-21Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 014-Autoimmune Diseases; Finding of Insufficient EvidenceOn September 29, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition to add autoimmune diseases, including rheumatoid arthritis, to the List of WTC-Related Health Conditions (List). Upon reviewing the information...2017-03336"https://www.gpo.gov/fdsys/pkg/FR-2017-02-21/pdf/2017-03336.pdfhttps://www.federalregister.gov/documents/2017/02/21/2017-03336/world-trade-center-health-program-petition-014-autoimmune-diseases-finding-of-insufficient-evidenceOn September 29, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition to add autoimmune diseases, including rheumatoid arthritis, to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 014 is not substantially different from Petitions 007, 008, 009, 011, and 013, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator has published responses to the five previous petitions in the Federal Register and has determined that Petition 014 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including rheumatoid arthritis. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2017-02-17RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective DateIn accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review'', this action delays for 60 days from the date of the memorandum the effective date of the rule...2017-03347"https://www.gpo.gov/fdsys/pkg/FR-2017-02-17/pdf/2017-03347.pdfhttps://www.federalregister.gov/documents/2017/02/17/2017-03347/medicare-program-advancing-care-coordination-through-episode-payment-models-epms-cardiacIn accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review'', this action delays for 60 days from the date of the memorandum the effective date of the rule entitled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model'' published in the January 3, 2017 Federal Register (82 FR 180). That rule implements three new Medicare Parts A and B episode payment models and a Cardiac Rehabilitation (CR) Incentive Payment model, and implements changes to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act (the Act). Under the three new episode payment models, acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. Under the CR Incentive Payment model, acute care hospitals in certain selected geographic areas will receive retrospective incentive payments for beneficiary utilization of cardiac rehabilitation/intensive cardiac rehabilitation services during the 90 days following discharge from a hospitalization treatment of an acute myocardial infarction or coronary artery bypass graft surgery. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.
2017-02-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPossession, Use, and Transfer of Select Agents and Toxins; Biennial Review and Enhanced Biosafety Requirements; Delay of Effective DateThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a delay in the effective date of the final rule titled ``Possession, Use, and Transfer of Select Agents and Toxins, Biennial Review and...2017-03044"https://www.gpo.gov/fdsys/pkg/FR-2017-02-16/pdf/2017-03044.pdfhttps://www.federalregister.gov/documents/2017/02/16/2017-03044/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-and-enhanced-biosafetyThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a delay in the effective date of the final rule titled ``Possession, Use, and Transfer of Select Agents and Toxins, Biennial Review and Enhanced Biosafety Requirements'' that published on January 19, 2017. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) is making a parallel change in the effective date of their final rule. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled ``Regulatory Freeze Pending Review.''
2017-02-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConfidentiality of Substance Use Disorder Patient Records; Delay of Effective DateOn January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule on Confidentiality of Substance Use Disorder Patient Records. That rule is scheduled to take effect on February 17, 2017. In accordance...2017-03185"https://www.gpo.gov/fdsys/pkg/FR-2017-02-16/pdf/2017-03185.pdfhttps://www.federalregister.gov/documents/2017/02/16/2017-03185/confidentiality-of-substance-use-disorder-patient-records-delay-of-effective-dateOn January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule on Confidentiality of Substance Use Disorder Patient Records. That rule is scheduled to take effect on February 17, 2017. In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' published in the Federal Register on January 24, 2017 (82 FR 8346), this action delays for 60 days from the date of the memorandum the effective date of the rule entitled ``Confidentiality of Substance Use Disorder Patient Records'' published in the Federal Register on January 18, 2017 (82 FR 6052).
2017-02-15RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentControl of Communicable Diseases; Delay of Effective DateThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a change in the effective date of the final rule titled ``Control of Communicable Diseases'' that was published on January 19, 2017....2017-03042"https://www.gpo.gov/fdsys/pkg/FR-2017-02-15/pdf/2017-03042.pdfhttps://www.federalregister.gov/documents/2017/02/15/2017-03042/control-of-communicable-diseases-delay-of-effective-dateThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a change in the effective date of the final rule titled ``Control of Communicable Diseases'' that was published on January 19, 2017. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled ``Regulatory Freeze Pending Review.''
2017-01-26Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIPC1-2016-27848"https://www.gpo.gov/fdsys/pkg/FR-2017-01-26/pdf/C1-2016-27848.pdfhttps://www.federalregister.gov/documents/2017/01/26/C1-2016-27848/medicaid-and-childrens-health-insurance-programs-eligibility-notices-fair-hearing-and-appeal
2017-01-19RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPossession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety RequirementsIn accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed...2017-00726"https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00726.pdfhttps://www.federalregister.gov/documents/2017/01/19/2017-00726/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-of-the-list-of-select-agentsIn accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.
2017-01-19Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting a Rulemaking ProceedingIn accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting a rulemaking proceeding to add neurological disorders or conditions as injuries...2017-00700"https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00700.pdfhttps://www.federalregister.gov/documents/2017/01/19/2017-00700/national-vaccine-injury-compensation-program-statement-of-reasons-for-not-conducting-a-rulemakingIn accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting a rulemaking proceeding to add neurological disorders or conditions as injuries associated with seasonal influenza vaccines to the Vaccine Injury Table.
2017-01-19RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Revisions to the Vaccine Injury TableOn July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program)...2017-00701"https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00701.pdfhttps://www.federalregister.gov/documents/2017/01/19/2017-00701/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-tableOn July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by proposing revisions to the Vaccine Injury Table (Table). The Secretary based the Table revisions primarily on the 2012 Institute of Medicine (IOM) report, ``Adverse Effects of Vaccines: Evidence and Causality,'' the work of nine HHS workgroups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' (ACCV) recommendations. The Secretary amends the Table through the changes in this final rule. These changes will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.
2017-01-19RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentControl of Communicable DiseasesThe Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing its domestic (interstate) and foreign quarantine regulations to best...2017-00615"https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00615.pdfhttps://www.federalregister.gov/documents/2017/01/19/2017-00615/control-of-communicable-diseasesThe Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments have been made to aid public health responses to outbreaks of new or re-emerging communicable diseases and to accord due process to individuals subject to Federal public health orders. In response to public comment received, the updated provisions in this final rule clarify various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate.
2017-01-18RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery SystemsThis rule finalizes changes to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). This final...2017-00916"https://www.gpo.gov/fdsys/pkg/FR-2017-01-18/pdf/2017-00916.pdfhttps://www.federalregister.gov/documents/2017/01/18/2017-00916/medicaid-program-the-use-of-new-or-increased-pass-through-payments-in-medicaid-managed-care-deliveryThis rule finalizes changes to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). This final rule prevents increases in pass-through payments and the addition of new pass-through payments beyond those in place when the pass-through payment transition periods were established, in the final Medicaid managed care regulations effective July 5, 2016.
2017-01-18Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConfidentiality of Substance Use Disorder Patient RecordsOn Feb. 9, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a Notice of Proposed Rulemaking (NPRM) that proposed policy changes to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records...2017-00742"https://www.gpo.gov/fdsys/pkg/FR-2017-01-18/pdf/2017-00742.pdfhttps://www.federalregister.gov/documents/2017/01/18/2017-00742/confidentiality-of-substance-use-disorder-patient-recordsOn Feb. 9, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a Notice of Proposed Rulemaking (NPRM) that proposed policy changes to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records (42 CFR part 2). SAMHSA explained in the NPRM that these changes were intended to better align the regulations with advances in the U.S. health care delivery system while retaining important privacy protections for individuals seeking treatment for substance use disorders. The last substantive update to these regulations was in 1987. SAMHSA is issuing this Supplemental Notice of Proposed Rulemaking (SNPRM) to propose additional clarifications to the part 2 regulations as amended by the concurrently issued final rule. As noted in the final rule, 42 CFR part 2 Confidentiality of Substance Use Disorder Patient Records, questions raised by commenters highlighted varying interpretations of the 1987 rule's restrictions on lawful holders and their contractors and subcontractors' use and disclosure of part 2-covered data for purposes of carrying out payment, health care operations, and other health care related activities. In consideration of this feedback and given the critical role that third-party payers, other lawful holders, and their contractors, subcontractors, and legal representatives play in the provision of health care services, SAMHSA is issuing this SNPRM to seek further comments on our proposals to address and help clarify these matters before establishing any appropriate restrictions on disclosures to contractors, subcontractors and legal representatives.
2017-01-18RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConfidentiality of Substance Use Disorder Patient RecordsThe Department of Health and Human Services (HHS) is issuing this final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations and facilitate information exchange within new health care models while...2017-00719"https://www.gpo.gov/fdsys/pkg/FR-2017-01-18/pdf/2017-00719.pdfhttps://www.federalregister.gov/documents/2017/01/18/2017-00719/confidentiality-of-substance-use-disorder-patient-recordsThe Department of Health and Human Services (HHS) is issuing this final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations and facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. These modifications also help clarify the regulations and reduce unnecessary burden.
2017-01-17RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals ProceduresThis final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare...2016-32058"https://www.gpo.gov/fdsys/pkg/FR-2017-01-17/pdf/2016-32058.pdfhttps://www.federalregister.gov/documents/2017/01/17/2016-32058/medicare-program-changes-to-the-medicare-claims-and-entitlement-medicare-advantage-organizationThis final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this final rule revises procedures that the Department of Health and Human Services follows at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.
2017-01-13RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Program: Conditions of Participation for Home Health AgenciesThis final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an...2017-00283"https://www.gpo.gov/fdsys/pkg/FR-2017-01-13/pdf/2017-00283.pdfhttps://www.federalregister.gov/documents/2017/01/13/2017-00283/medicare-and-medicaid-program-conditions-of-participation-for-home-health-agenciesThis final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad- based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.
2017-01-12RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentHealth Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion AuthoritiesThis final rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The final rule incorporates statutory changes,...2016-31390"https://www.gpo.gov/fdsys/pkg/FR-2017-01-12/pdf/2016-31390.pdfhttps://www.federalregister.gov/documents/2017/01/12/2016-31390/health-care-programs-fraud-and-abuse-revisions-to-the-office-of-inspector-generals-exclusionThis final rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The final rule incorporates statutory changes, early reinstatement provisions, and policy changes, and clarifies existing regulatory provisions.
2017-01-12Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated OrthoticsThis proposed rule would specify the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics; accreditation requirements that qualified suppliers must...2017-00425"https://www.gpo.gov/fdsys/pkg/FR-2017-01-12/pdf/2017-00425.pdfhttps://www.federalregister.gov/documents/2017/01/12/2017-00425/medicare-program-establishment-of-special-payment-provisions-and-requirements-for-qualifiedThis proposed rule would specify the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom-fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, this rule would remove the current exemption from accreditation and quality standards for certain practitioners and suppliers.
2017-01-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties RegulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This final rule will apply to all drug manufacturers...2016-31935"https://www.gpo.gov/fdsys/pkg/FR-2017-01-05/pdf/2016-31935.pdfhttps://www.federalregister.gov/documents/2017/01/05/2016-31935/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThe Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).
2017-01-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)This final rule implements three new Medicare Parts A and B episode payment models, a Cardiac Rehabilitation (CR) Incentive Payment model and modifications to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social...2016-30746"https://www.gpo.gov/fdsys/pkg/FR-2017-01-03/pdf/2016-30746.pdfhttps://www.federalregister.gov/documents/2017/01/03/2016-30746/medicare-program-advancing-care-coordination-through-episode-payment-models-epms-cardiacThis final rule implements three new Medicare Parts A and B episode payment models, a Cardiac Rehabilitation (CR) Incentive Payment model and modifications to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act. Acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee- for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.
2017-01-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital; Correction and Extension of Comment PeriodThis document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 14, 2016, entitled ``Hospital Outpatient Prospective Payment and...2016-31774"https://www.gpo.gov/fdsys/pkg/FR-2017-01-03/pdf/2016-31774.pdfhttps://www.federalregister.gov/documents/2017/01/03/2016-31774/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 14, 2016, entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital.'' This document extends the comment period to January 3, 2017 for both the final rule with comment period and the interim final rule with comment period.
2017-01-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; CorrectionsThis document corrects technical errors that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP...2016-31650"https://www.gpo.gov/fdsys/pkg/FR-2017-01-03/pdf/2016-31650.pdfhttps://www.federalregister.gov/documents/2017/01/03/2016-31650/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-deliveredThis document corrects technical errors that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability.'' The effective date for the rule was July 5, 2016.
2016-12-29RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; CorrectionsThis document corrects technical and typographical errors that appeared in the final rule published in the November 15, 2016 Federal Register (81 FR 80170). That rule is entitled, ``Medicare Program; Revisions to Payment Policies under the Physician...2016-31649"https://www.gpo.gov/fdsys/pkg/FR-2016-12-29/pdf/2016-31649.pdfhttps://www.federalregister.gov/documents/2016/12/29/2016-31649/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis document corrects technical and typographical errors that appeared in the final rule published in the November 15, 2016 Federal Register (81 FR 80170). That rule is entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
2016-12-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentSolicitation of New Safe Harbors and Special Fraud AlertsIn accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal...2016-31170"https://www.gpo.gov/fdsys/pkg/FR-2016-12-28/pdf/2016-31170.pdfhttps://www.federalregister.gov/documents/2016/12/28/2016-31170/solicitation-of-new-safe-harbors-and-special-fraud-alertsIn accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
2016-12-23RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Quality Incentive Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure, and Appeals Process for Breach of Contract Actions; CorrectionThis document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 4, 2016, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for...2016-31019"https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-31019.pdfhttps://www.federalregister.gov/documents/2016/12/23/2016-31019/medicare-program-end-stage-renal-disease-quality-incentive-program-durable-medical-equipmentThis document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 4, 2016, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model.''
2016-12-21RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Implementation of Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items and Publication of the Initial Required Prior Authorization List of DMEPOS Items That Require Prior Authorization as a Condition of PaymentThis document announces the implementation of the prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items in two phases and the issuance of the initial Required Prior Authorization List of...2016-30273"https://www.gpo.gov/fdsys/pkg/FR-2016-12-21/pdf/2016-30273.pdfhttps://www.federalregister.gov/documents/2016/12/21/2016-30273/medicare-program-implementation-of-prior-authorization-process-for-certain-durable-medical-equipmentThis document announces the implementation of the prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items in two phases and the issuance of the initial Required Prior Authorization List of DMEPOS items that require prior authorization as a condition of payment.
2016-12-20RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentFlexibility, Efficiency, and Modernization in Child Support Enforcement ProgramsThis rule is intended to carry out the President's directives in Executive Order 13563: Improving Regulation and Regulatory Review. The final rule will make Child Support Enforcement program operations and enforcement procedures more flexible, more...2016-29598"https://www.gpo.gov/fdsys/pkg/FR-2016-12-20/pdf/2016-29598.pdfhttps://www.federalregister.gov/documents/2016/12/20/2016-29598/flexibility-efficiency-and-modernization-in-child-support-enforcement-programsThis rule is intended to carry out the President's directives in Executive Order 13563: Improving Regulation and Regulatory Review. The final rule will make Child Support Enforcement program operations and enforcement procedures more flexible, more effective, and more efficient by recognizing the strength of existing State enforcement programs, advancements in technology that can enable improved collection rates, and the move toward electronic communication and document management. This final rule will improve and simplify program operations, and remove outmoded limitations to program innovations to better serve families. In addition, the final rule clarifies and corrects technical provisions in existing regulations. The rule makes significant changes to the regulations on case closure, child support guidelines, and medical support enforcement. It will improve child support collection rates because support orders will reflect the noncustodial parent's ability to pay support, and more noncustodial parents will support their children.
2016-12-19RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCompliance With Title X Requirements by Project Recipients in Selecting SubrecipientsThe Department is amending the regulations that apply to Title X Project Grants for Family Planning Services. The final rule amends eligibility requirements to require that no recipient making subawards for the provision of services as part of its...2016-30276"https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30276.pdfhttps://www.federalregister.gov/documents/2016/12/19/2016-30276/compliance-with-title-x-requirements-by-project-recipients-in-selecting-subrecipientsThe Department is amending the regulations that apply to Title X Project Grants for Family Planning Services. The final rule amends eligibility requirements to require that no recipient making subawards for the provision of services as part of its Title X project may prohibit an entity from participating for reasons other than its ability to provide Title X services.
2016-12-15RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Amendments to Definitions, Appeals, and Other RequirementsIn 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may...2016-29957"https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-29957.pdfhttps://www.federalregister.gov/documents/2016/12/15/2016-29957/world-trade-center-health-program-amendments-to-definitions-appeals-and-other-requirementsIn 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may apply for enrollment in the Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions, as well as a process to add new conditions to the List of WTC-Related Health Conditions (List). After using the regulations for a number of years, the Administrator of the WTC Health Program identified potential improvements to certain existing provisions, including, but not limited to, appeals of enrollment, certification, and treatment decisions, as well as the procedures for the addition of health conditions for WTC Health Program coverage. He also identified the need to add new regulatory provisions, including, but not limited to, standards for the disenrollment of a WTC Health Program member and decertification of a certified WTC-related health condition. A notice of proposed rulemaking was published on August 17, 2016; this action addresses public comments received on that proposed rulemaking, as well as three interim final rules promulgated since 2011, and finalizes the proposed rule and three interim final rules.
2016-12-14Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 012-Atherosclerosis; Finding of Insufficient EvidenceOn April 11, 2016, the Administrator of the World Trade Center (WTC) Health Program received two petitions (combined into Petition 012) to add atherosclerosis to the List of WTC-Related Health Conditions (List). The Program conducted a literature...2016-29816"https://www.gpo.gov/fdsys/pkg/FR-2016-12-14/pdf/2016-29816.pdfhttps://www.federalregister.gov/documents/2016/12/14/2016-29816/world-trade-center-health-program-petition-012-atherosclerosis-finding-of-insufficient-evidenceOn April 11, 2016, the Administrator of the World Trade Center (WTC) Health Program received two petitions (combined into Petition 012) to add atherosclerosis to the List of WTC-Related Health Conditions (List). The Program conducted a literature search for the term in response to the Petition and found no relevant studies regarding atherosclerosis among 9/11-exposed populations. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2016-12-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party PaymentThis interim final rule with comment period implements new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. These requirements apply to dialysis facilities that make such...2016-30016"https://www.gpo.gov/fdsys/pkg/FR-2016-12-14/pdf/2016-30016.pdfhttps://www.federalregister.gov/documents/2016/12/14/2016-30016/medicare-program-conditions-for-coverage-for-end-stage-renal-disease-facilities-third-party-paymentThis interim final rule with comment period implements new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. These requirements apply to dialysis facilities that make such payments directly, through a parent organization, or through a third party. These requirements are intended to protect patient health and safety; improve patient disclosure and transparency; ensure that health insurance coverage decisions are not inappropriately influenced by the financial interests of dialysis facilities rather than the health and financial interests of patients; and protect patients from mid-year interruptions in coverage.
2016-12-07RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary InducementsIn this final rule, OIG amends the safe harbors to the anti- kickback statute by adding new safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. The OIG also amends the civil...2016-28297"https://www.gpo.gov/fdsys/pkg/FR-2016-12-07/pdf/2016-28297.pdfhttps://www.federalregister.gov/documents/2016/12/07/2016-28297/medicare-and-state-health-care-programs-fraud-and-abuse-revisions-to-the-safe-harbors-under-theIn this final rule, OIG amends the safe harbors to the anti- kickback statute by adding new safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. The OIG also amends the civil monetary penalty (CMP) rules by codifying revisions to the definition of ``remuneration,'' added by the Balanced Budget Act (BBA) of 1997 and the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010 (ACA). This rule updates the existing safe harbor regulations and enhances flexibility for providers and others to engage in health care business arrangements to improve efficiency and access to quality care while protecting programs and patients from fraud and abuse.
2016-12-07RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty RulesThis final rule amends the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments, and...2016-28293"https://www.gpo.gov/fdsys/pkg/FR-2016-12-07/pdf/2016-28293.pdfhttps://www.federalregister.gov/documents/2016/12/07/2016-28293/medicare-and-state-health-care-programs-fraud-and-abuse-revisions-to-the-office-of-inspectorThis final rule amends the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments, and exclusions to improve readability and clarity.
2016-11-30RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIPThis final rule implements provisions of the Affordable Care Act that expand access to health coverage through improvements in Medicaid and coordination between Medicaid, CHIP, and Exchanges. This rule finalizes most of the remaining provisions from...2016-27844"https://www.gpo.gov/fdsys/pkg/FR-2016-11-30/pdf/2016-27844.pdfhttps://www.federalregister.gov/documents/2016/11/30/2016-27844/medicaid-and-childrens-health-insurance-programs-eligibility-notices-fair-hearing-and-appealThis final rule implements provisions of the Affordable Care Act that expand access to health coverage through improvements in Medicaid and coordination between Medicaid, CHIP, and Exchanges. This rule finalizes most of the remaining provisions from the ``Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing; Proposed Rule'' that we published in the January 22, 2013, Federal Register. This final rule continues our efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment changes required by the Affordable Care Act.
2016-11-30Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIPThis proposed rule proposes to implement provisions of the Medicaid statute pertaining to Medicaid eligibility and appeals. This proposed rule continues our efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment...2016-27848"https://www.gpo.gov/fdsys/pkg/FR-2016-11-30/pdf/2016-27848.pdfhttps://www.federalregister.gov/documents/2016/11/30/2016-27848/medicaid-and-childrens-health-insurance-programs-eligibility-notices-fair-hearing-and-appealThis proposed rule proposes to implement provisions of the Medicaid statute pertaining to Medicaid eligibility and appeals. This proposed rule continues our efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment changes required by the Affordable Care Act.
2016-11-22Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery SystemsThis proposed rule addresses changes, consistent with the CMCS Informational Bulletin (CIB) concerning ``The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems,'' published on July 29, 2016, to the pass-through...2016-28024"https://www.gpo.gov/fdsys/pkg/FR-2016-11-22/pdf/2016-28024.pdfhttps://www.federalregister.gov/documents/2016/11/22/2016-28024/medicaid-program-the-use-of-new-or-increased-pass-through-payments-in-medicaid-managed-care-deliveryThis proposed rule addresses changes, consistent with the CMCS Informational Bulletin (CIB) concerning ``The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems,'' published on July 29, 2016, to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). The changes prevent increases in pass-through payments and the addition of new pass-through payments beyond those in place when the pass-through payment transition periods were established in the final Medicaid managed care regulations.
2016-11-18RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program RequirementsThis document corrects technical errors in the final rule that was placed on public inspection at the Office of the Federal Register on November 2, 2016 and scheduled for publication in the Federal Register on November 15, 2016. That rule is entitled,...2016-27733"https://www.gpo.gov/fdsys/pkg/FR-2016-11-18/pdf/2016-27733.pdfhttps://www.federalregister.gov/documents/2016/11/18/2016-27733/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis document corrects technical errors in the final rule that was placed on public inspection at the Office of the Federal Register on November 2, 2016 and scheduled for publication in the Federal Register on November 15, 2016. That rule is entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
2016-11-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers; CorrectionThis document corrects typographical errors that appeared in the final rule published in the Federal Register on September 16, 2016 entitled ``Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating...2016-27478"https://www.gpo.gov/fdsys/pkg/FR-2016-11-16/pdf/2016-27478.pdfhttps://www.federalregister.gov/documents/2016/11/16/2016-27478/medicare-and-medicaid-programs-emergency-preparedness-requirements-for-medicare-and-medicaidThis document corrects typographical errors that appeared in the final rule published in the Federal Register on September 16, 2016 entitled ``Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers.''
2016-11-15RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United StatesThe Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment, we amended the regulatory definitions of ``States'' and ``United States'' to include the U.S....2016-27423"https://www.gpo.gov/fdsys/pkg/FR-2016-11-15/pdf/2016-27423.pdfhttps://www.federalregister.gov/documents/2016/11/15/2016-27423/medicaid-program-covered-outpatient-drug-delay-in-change-in-definitions-of-states-and-united-statesThe Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment, we amended the regulatory definitions of ``States'' and ``United States'' to include the U.S. territories (American Samoa, the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands) beginning April 1, 2017. This interim final rule with comment period delays the inclusion of the territories in the definition of ``States'' and ``United States'' until April 1, 2020.
2016-11-15RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program RequirementsThis major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the...2016-26668"https://www.gpo.gov/fdsys/pkg/FR-2016-11-15/pdf/2016-26668.pdfhttps://www.federalregister.gov/documents/2016/11/15/2016-26668/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans. In addition, this final rule expands the Medicare Diabetes Prevention Program model.
2016-11-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a HospitalThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes...2016-26515"https://www.gpo.gov/fdsys/pkg/FR-2016-11-14/pdf/2016-26515.pdfhttps://www.federalregister.gov/documents/2016/11/14/2016-26515/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, in this final rule with comment period, we are making changes to tolerance thresholds for clinical outcomes for solid organ transplant programs; to Organ Procurement Organizations (OPOs) definitions, outcome measures, and organ transport documentation; and to the Medicare and Medicaid Electronic Health Record Incentive Programs. We also are removing the HCAHPS Pain Management dimension from the Hospital Value-Based Purchasing (VBP) Program. In addition, we are implementing section 603 of the Bipartisan Budget Act of 2015 relating to payment for certain items and services furnished by certain off-campus provider-based departments of a provider. In this document, we also are issuing an interim final rule with comment period to establish the Medicare Physician Fee Schedule payment rates for the nonexcepted items and services billed by a nonexcepted off-campus provider-based department of a hospital in accordance with the provisions of section 603.
2016-11-09Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Request for Information (RFI): Federal Government Interventions To Ensure the Provision of Timely and Quality Home and Community Based ServicesThis request for information seeks information and data on additional reforms and policy options that we can consider to accelerate the provision of home and community-based services (HCBS) to Medicaid beneficiaries taking into account issues affecting...2016-27040"https://www.gpo.gov/fdsys/pkg/FR-2016-11-09/pdf/2016-27040.pdfhttps://www.federalregister.gov/documents/2016/11/09/2016-27040/medicaid-program-request-for-information-rfi-federal-government-interventions-to-ensure-theThis request for information seeks information and data on additional reforms and policy options that we can consider to accelerate the provision of home and community-based services (HCBS) to Medicaid beneficiaries taking into account issues affecting beneficiary choice and control, program integrity, ratesetting, quality infrastructure, and the homecare workforce.
2016-11-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Fire Safety Requirements for Certain Dialysis FacilitiesThis proposed rule would update fire safety standards for Medicare and Medicaid participating ESRD facilities, adopt the 2012 edition of the Life Safety Code and eliminate references in our regulations to all earlier editions of the Life Safety Code...2016-26583"https://www.gpo.gov/fdsys/pkg/FR-2016-11-04/pdf/2016-26583.pdfhttps://www.federalregister.gov/documents/2016/11/04/2016-26583/medicare-and-medicaid-programs-fire-safety-requirements-for-certain-dialysis-facilitiesThis proposed rule would update fire safety standards for Medicare and Medicaid participating ESRD facilities, adopt the 2012 edition of the Life Safety Code and eliminate references in our regulations to all earlier editions of the Life Safety Code and adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
2016-11-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment ModelsThe Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment...2016-25240"https://www.gpo.gov/fdsys/pkg/FR-2016-11-04/pdf/2016-25240.pdfhttps://www.federalregister.gov/documents/2016/11/04/2016-25240/medicare-program-merit-based-incentive-payment-system-mips-and-alternative-payment-model-apmThe Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs). Alternative Payment Models are payment approaches, developed in partnership with the clinician community, that provide added incentives to deliver high-quality and cost-efficient care. APMs can apply to a specific clinical condition, a care episode, or a population. This final rule with comment period also establishes the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS will consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and will continue the focus on quality, cost, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. In this final rule with comment period we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that will be more easily identified and understood by our stakeholders.
2016-11-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care ModelThis rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to...2016-26152"https://www.gpo.gov/fdsys/pkg/FR-2016-11-04/pdf/2016-26152.pdfhttps://www.federalregister.gov/documents/2016/11/04/2016-26152/medicare-program-end-stage-renal-disease-prospective-payment-system-coverage-and-payment-for-renalThis rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also implements statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also expands suppliers' appeal rights in the event of a breach of contract action taken by CMS, by revising the appeals regulation to extend the appeals process to all types of actions taken by CMS for a supplier's breach of contract, rather than limit an appeal for the termination of a competitive bidding contract. The rule also finalizes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from CBPs and for submitting bids and establishing single payment amounts under the CBPs for certain groupings of similar items with different features to address price inversions. Final changes also are made to the method for establishing bid limits for items under the DMEPOS CBPs. In addition, this rule summarizes comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule also summarizes comments received in response to a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
2016-11-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsThis final rule updates the Home Health Prospective Payment System (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor;...2016-26290"https://www.gpo.gov/fdsys/pkg/FR-2016-11-03/pdf/2016-26290.pdfhttps://www.federalregister.gov/documents/2016/11/03/2016-26290/medicare-and-medicaid-programs-cy-2017-home-health-prospective-payment-system-rate-update-homeThis final rule updates the Home Health Prospective Payment System (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor; effective for home health episodes of care ending on or after January 1, 2017. This rule also: Implements the last year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates; updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 2nd-year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014; finalizes changes to the methodology used to calculate payments made under the HH PPS for high-cost ``outlier'' episodes of care; implements changes in payment for furnishing Negative Pressure Wound Therapy (NPWT) using a disposable device for patients under a home health plan of care; discusses our efforts to monitor the potential impacts of the rebasing adjustments; includes an update on subsequent research and analysis as a result of the findings from the home health study; and finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model, which was implemented on January 1, 2016; and updates to the Home Health Quality Reporting Program (HH QRP).
2016-10-31RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; CorrectionThis document corrects a typographical error in the final rule that appeared in the August 22, 2016 Federal Register as well as additional typographical errors in a related correction to that rule that appeared in the October 5, 2016 Federal Register....2016-26182"https://www.gpo.gov/fdsys/pkg/FR-2016-10-31/pdf/2016-26182.pdfhttps://www.federalregister.gov/documents/2016/10/31/2016-26182/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theThis document corrects a typographical error in the final rule that appeared in the August 22, 2016 Federal Register as well as additional typographical errors in a related correction to that rule that appeared in the October 5, 2016 Federal Register. The final rule was titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals''.
2016-10-24RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentSpecifications for Medical Examinations of Coal MinersWith this action, the Department of Health and Human Services (HHS), in accordance with recent rulemaking by the Department of Labor's Mine Safety and Health Administration (MSHA), finalizes amendments to Coal Workers' Health Surveillance Program...2016-24405"https://www.gpo.gov/fdsys/pkg/FR-2016-10-24/pdf/2016-24405.pdfhttps://www.federalregister.gov/documents/2016/10/24/2016-24405/specifications-for-medical-examinations-of-coal-minersWith this action, the Department of Health and Human Services (HHS), in accordance with recent rulemaking by the Department of Labor's Mine Safety and Health Administration (MSHA), finalizes amendments to Coal Workers' Health Surveillance Program regulations to establish standards for the approval of facilities to conduct spirometry and requires that all coal mine operators submit a plan for the provision of spirometry testing and X-ray examinations to all surface and underground coal miners.
2016-10-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings; CorrectionThis document corrects a technical error that appeared in the document published in the Federal Register on January 22, 2016 entitled ``Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings.''2016-24917"https://www.gpo.gov/fdsys/pkg/FR-2016-10-14/pdf/2016-24917.pdfhttps://www.federalregister.gov/documents/2016/10/14/2016-24917/medicare-program-explanation-of-fy-2004-outlier-fixed-loss-threshold-as-required-by-court-rulingsThis document corrects a technical error that appeared in the document published in the Federal Register on January 22, 2016 entitled ``Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings.''
2016-10-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; CorrectionThis document corrects technical and typographical errors in the final rule that appeared in the August 22, 2016 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care...2016-24042"https://www.gpo.gov/fdsys/pkg/FR-2016-10-05/pdf/2016-24042.pdfhttps://www.federalregister.gov/documents/2016/10/05/2016-24042/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theThis document corrects technical and typographical errors in the final rule that appeared in the August 22, 2016 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals.''
2016-10-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Reform of Requirements for Long-Term Care FacilitiesThis final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years...2016-23503"https://www.gpo.gov/fdsys/pkg/FR-2016-10-04/pdf/2016-23503.pdfhttps://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilitiesThis final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These revisions are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.
2016-09-27RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedication Assisted Treatment for Opioid Use Disorders Reporting RequirementsThis final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide information on their...2016-23277"https://www.gpo.gov/fdsys/pkg/FR-2016-09-27/pdf/2016-23277.pdfhttps://www.federalregister.gov/documents/2016/09/27/2016-23277/medication-assisted-treatment-for-opioid-use-disorders-reporting-requirementsThis final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide information on their annual caseload of patients by month, the number of patients provided behavioral health services and referred to behavioral health services, and the features of the practitioner's diversion control plan. These reporting requirements will help the Department of Health and Human Services (HHS) ensure compliance with the requirements of the final rule, ``Medication Assisted Treatment for Opioid Use Disorders,'' published in the Federal Register on July 8, 2016.
2016-09-21RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentClinical Trials Registration and Results Information SubmissionThis final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for...2016-22129"https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22129.pdfhttps://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submissionThis final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.
2016-09-20Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid; Revisions to State Medicaid Fraud Control Unit RulesThis proposed rule would amend the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The proposed rule would incorporate statutory changes affecting the MFCUs as well as policy and practice changes that have occurred since the...2016-22269"https://www.gpo.gov/fdsys/pkg/FR-2016-09-20/pdf/2016-22269.pdfhttps://www.federalregister.gov/documents/2016/09/20/2016-22269/medicaid-revisions-to-state-medicaid-fraud-control-unit-rulesThis proposed rule would amend the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The proposed rule would incorporate statutory changes affecting the MFCUs as well as policy and practice changes that have occurred since the regulation was initially issued in 1978. These changes include a codification of OIG's delegated authority, MFCU authority, functions, and responsibilities; disallowances; and issues related to organization, prosecutorial authority, staffing, recertification, and the MFCUs' relationship with Medicaid agencies.
2016-09-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and SuppliersThis final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional,...2016-21404"https://www.gpo.gov/fdsys/pkg/FR-2016-09-16/pdf/2016-21404.pdfhttps://www.federalregister.gov/documents/2016/09/16/2016-21404/medicare-and-medicaid-programs-emergency-preparedness-requirements-for-medicare-and-medicaidThis final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to adequately prepare to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Despite some variations, our regulations will provide consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid- participating facilities, and establish a more coordinated and defined response to natural and man-made disasters.
2016-09-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPossession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and ToxinsThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to...2016-22049"https://www.gpo.gov/fdsys/pkg/FR-2016-09-14/pdf/2016-22049.pdfhttps://www.federalregister.gov/documents/2016/09/14/2016-22049/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-bacillus-cereus-biovar-anthracisThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.
2016-09-13RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRemoving Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation ProgramThis action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox...2016-21888"https://www.gpo.gov/fdsys/pkg/FR-2016-09-13/pdf/2016-21888.pdfhttps://www.federalregister.gov/documents/2016/09/13/2016-21888/removing-outmoded-regulations-regarding-the-smallpox-vaccine-injury-compensation-programThis action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox Countermeasures under the Smallpox Emergency Personnel Protection Act of 2003 and incorporation of the smallpox countermeasure injury coverage under the Public Readiness and Emergency Preparedness Act of 2005 and its authorization of the Countermeasures Injury Compensation Program.
2016-09-09RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedication Assisted Treatment for Opioid Use Disorders; CorrectionThe Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register on July 8, 2016. The final rule increased the maximum number of patients to whom an individual practitioner may dispense or prescribe...2016-21674"https://www.gpo.gov/fdsys/pkg/FR-2016-09-09/pdf/2016-21674.pdfhttps://www.federalregister.gov/documents/2016/09/09/2016-21674/medication-assisted-treatment-for-opioid-use-disorders-correctionThe Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register on July 8, 2016. The final rule increased the maximum number of patients to whom an individual practitioner may dispense or prescribe certain medications, including buprenorphine, from 100 to 275. Practitioners are eligible for the increased patient limit if they have prescribed covered medications to up to 100 patients for at least one year pursuant to secretarial approval, provided that they meet certain criteria and adhere to several additional requirements aimed at ensuring that patients receive the full array of services that comprise evidence- based medication-assisted treatment (MAT) and minimize the risks that medications provided for treatment are misused or diverted. One pathway through which practitioners may become eligible to increase their patient limit is by obtaining additional credentialing from one of several credentialing bodies. In the final rule, the name of one of the credentialing bodies listed was incorrect. This action provides the correct name.
2016-09-07Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCompliance With Title X Requirements by Project Recipients in Selecting SubrecipientsThis document seeks comment on the proposed amendment of Title X regulations specifying the requirements Title X projects must meet to be eligible for awards. The amendment precludes project recipients from using criteria in their selection of...2016-21359"https://www.gpo.gov/fdsys/pkg/FR-2016-09-07/pdf/2016-21359.pdfhttps://www.federalregister.gov/documents/2016/09/07/2016-21359/compliance-with-title-x-requirements-by-project-recipients-in-selecting-subrecipientsThis document seeks comment on the proposed amendment of Title X regulations specifying the requirements Title X projects must meet to be eligible for awards. The amendment precludes project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an effective manner.
2016-09-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentAdjustment of Civil Monetary Penalties for InflationThe Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action...2016-18680"https://www.gpo.gov/fdsys/pkg/FR-2016-09-06/pdf/2016-18680.pdfhttps://www.federalregister.gov/documents/2016/09/06/2016-18680/adjustment-of-civil-monetary-penalties-for-inflationThe Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.
2016-09-01Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient EvidenceOn April 4, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 013) to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the List of WTC-Related Health Conditions (List). Upon reviewing the...2016-21070"https://www.gpo.gov/fdsys/pkg/FR-2016-09-01/pdf/2016-21070.pdfhttps://www.federalregister.gov/documents/2016/09/01/2016-21070/world-trade-center-health-program-petition-013-autoimmune-disease-finding-of-insufficient-evidenceOn April 4, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 013) to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 013 is not substantially different from Petitions 007, 008, 009, and 011, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator recently published responses to the four previous petitions in the Federal Register and has determined that Petition 013 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including multiple sclerosis. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2016-08-31RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017; CorrectionThis document corrects typographical errors in the final rule that appeared in the August 5, 2016 Federal Register entitled, ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017''.2016-20897"https://www.gpo.gov/fdsys/pkg/FR-2016-08-31/pdf/2016-20897.pdfhttps://www.federalregister.gov/documents/2016/08/31/2016-20897/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis document corrects typographical errors in the final rule that appeared in the August 5, 2016 Federal Register entitled, ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017''.
2016-08-23Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRequest for Information: Inappropriate Steering of Individuals Eligible for or Receiving Medicare and Medicaid Benefits to Individual Market PlansThis request for information seeks public comment regarding concerns about health care providers and provider-affiliated organizations steering people eligible for or receiving Medicare and/or Medicaid benefits to an individual market plan for the...2016-20034"https://www.gpo.gov/fdsys/pkg/FR-2016-08-23/pdf/2016-20034.pdfhttps://www.federalregister.gov/documents/2016/08/23/2016-20034/request-for-information-inappropriate-steering-of-individuals-eligible-for-or-receiving-medicare-andThis request for information seeks public comment regarding concerns about health care providers and provider-affiliated organizations steering people eligible for or receiving Medicare and/or Medicaid benefits to an individual market plan for the purpose of obtaining higher payment rates. CMS is concerned about reports of this practice and is requesting comments on the frequency and impact of this issue from the public. We believe this practice not only could raise overall health system costs, but could potentially be harmful to patient care and service coordination because of changes to provider networks and drug formularies, result in higher out-of-pocket costs for enrollees, and have a negative impact on the individual market single risk pool (or the combined risk pool in states that have chosen to merge their risk pools). We are seeking input from stakeholders and the public regarding the frequency and impact of this practice, and options to limit this practice.
2016-08-22RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume HospitalsWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2017. Some of these...2016-18476"https://www.gpo.gov/fdsys/pkg/FR-2016-08-22/pdf/2016-18476.pdfhttps://www.federalregister.gov/documents/2016/08/22/2016-18476/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2017. Some of these changes will implement certain statutory provisions contained in the Pathway for Sustainable Growth Reform Act of 2013, the Improving Medicare Post- Acute Care Transformation Act of 2014, the Notice of Observation Treatment and Implications for Care Eligibility Act of 2015, and other legislation. We also are providing the estimated market basket update to apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2017. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2017. In addition, we are making changes relating to direct graduate medical education (GME) and indirect medical education payments; establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities), including related provisions for eligible hospitals and critical access hospitals (CAHs) participating in the Electronic Health Record Incentive Program; updating policies relating to the Hospital Value-Based Purchasing Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition Reduction Program; implementing statutory provisions that require hospitals and CAHs to furnish notification to Medicare beneficiaries, including Medicare Advantage enrollees, when the beneficiaries receive outpatient observation services for more than 24 hours; announcing the implementation of the Frontier Community Health Integration Project Demonstration; and making technical corrections and changes to regulations relating to costs to related organizations and Medicare cost reports; we are providing notice of the closure of three teaching hospitals and the opportunity to apply for available GME resident slots under section 5506 of the Affordable Care Act. We are finalizing the provisions of interim final rules with comment period that relate to a temporary exception for certain wound care discharges from the application of the site neutral payment rate under the LTCH PPS for certain LTCHs; application of two judicial decisions relating to modifications of limitations on redesignation by the Medicare Geographic Classification Review Board; and legislative extensions of the Medicare-dependent, small rural hospital program and changes to the payment adjustment for low-volume hospitals.
2016-08-17Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Amendments to Definitions, Appeals, and Other RequirementsIn 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may...2016-18679"https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-18679.pdfhttps://www.federalregister.gov/documents/2016/08/17/2016-18679/world-trade-center-health-program-amendments-to-definitions-appeals-and-other-requirementsIn 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may apply for enrollment in the Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions, as well as a process to add new conditions to the List of WTC-Related Health Conditions. After using the regulations for a number of years, the Administrator of the WTC Health Program has identified potential improvements to certain existing provisions, including, but not limited to, appeals of enrollment, certification, and treatment decisions, as well as the procedures for the addition of health conditions for WTC Health Program coverage. He has also identified the need to add new regulatory provisions, including, but not limited to, standards for the disenrollment of a WTC Health Program member and decertification of a certified WTC-related health condition.
2016-08-16Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Programs of All-Inclusive Care for the Elderly (PACE)This proposed rule would revise and update the requirements for the Programs of All-Inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The proposed rule addresses application and waiver procedures, sanctions, enforcement...2016-19153"https://www.gpo.gov/fdsys/pkg/FR-2016-08-16/pdf/2016-19153.pdfhttps://www.federalregister.gov/documents/2016/08/16/2016-19153/medicare-and-medicaid-programs-programs-of-all-inclusive-care-for-the-elderly-paceThis proposed rule would revise and update the requirements for the Programs of All-Inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The proposed rule addresses application and waiver procedures, sanctions, enforcement actions and termination, administrative requirements, PACE services, participant rights, quality assessment and performance improvement, participant enrollment and disenrollment, payment, federal and state monitoring, data collection, record maintenance, and reporting. The proposed changes would provide greater operational flexibility, remove redundancies and outdated information, and codify existing practice.
2016-08-15Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentControl of Communicable DiseasesThrough this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is amending its domestic (interstate) and foreign quarantine regulations to best protect the...2016-18103"https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-18103.pdfhttps://www.federalregister.gov/documents/2016/08/15/2016-18103/control-of-communicable-diseasesThrough this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is amending its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments are being proposed to aid public health responses to outbreaks of communicable diseases such as the largest recorded outbreak of Ebola virus disease (Ebola) in history, the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and repeated outbreaks and responses to measles in the United States, as well as the ongoing threat of other new or re-emerging communicable diseases. The provisions contained herein provide additional clarity to various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate.
2016-08-15Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Disproportionate Share Hospital Payments-Treatment of Third Party Payers in Calculating Uncompensated Care CostsThis proposed rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act (Act), and the application of such limitation in the annual DSH audits...2016-19107"https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-19107.pdfhttps://www.federalregister.gov/documents/2016/08/15/2016-19107/medicaid-program-disproportionate-share-hospital-payments-treatment-of-third-party-payers-inThis proposed rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act (Act), and the application of such limitation in the annual DSH audits required under section 1923(j) of the Act, by clarifying that the hospital-specific DSH limit is based only on uncompensated care costs. Specifically, this rule would make clearer in the text of the regulation an existing interpretation that uncompensated care costs include only those costs for Medicaid eligible individuals that remain after accounting for payments received by hospitals by or on behalf of Medicaid eligible individuals, including Medicare and other third party payments that compensate the hospitals for care furnished to such individuals. As a result, the hospital-specific limit calculation would reflect only the costs for Medicaid eligible individuals for which the hospital has not received payment from any source (other than state or local governmental payments for indigent patients).
2016-08-12Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program; Administrative Dispute ResolutionThe Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug...2016-18969"https://www.gpo.gov/fdsys/pkg/FR-2016-08-12/pdf/2016-18969.pdfhttps://www.federalregister.gov/documents/2016/08/12/2016-18969/340b-drug-pricing-program-administrative-dispute-resolutionThe Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.
2016-08-10Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; CorrectionThis document corrects a technical error in the proposed rule that appeared in the July 15, 2016 Federal Register (81 FR 46162-46476) entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to...2016-19012"https://www.gpo.gov/fdsys/pkg/FR-2016-08-10/pdf/2016-19012.pdfhttps://www.federalregister.gov/documents/2016/08/10/2016-19012/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis document corrects a technical error in the proposed rule that appeared in the July 15, 2016 Federal Register (81 FR 46162-46476) entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model.''
2016-08-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2017, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and SNF Payment Models ResearchThis final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it specifies a potentially preventable readmission measure for the Skilled Nursing...2016-18113"https://www.gpo.gov/fdsys/pkg/FR-2016-08-05/pdf/2016-18113.pdfhttps://www.federalregister.gov/documents/2016/08/05/2016-18113/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it specifies a potentially preventable readmission measure for the Skilled Nursing Facility Value- Based Purchasing Program (SNF VBP), and implements requirements for that program, including performance standards, a scoring methodology, and a review and correction process for performance information to be made public, aimed at implementing value-based purchasing for SNFs. Additionally, this final rule includes additional polices and measures in the Skilled Nursing Facility Quality Reporting Program (SNF QRP). This final rule also responds to comments on the SNF Payment Models Research (PMR) project.
2016-08-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017This final rule will update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification...2016-18196"https://www.gpo.gov/fdsys/pkg/FR-2016-08-05/pdf/2016-18196.pdfhttps://www.federalregister.gov/documents/2016/08/05/2016-18196/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis final rule will update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS's) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2017. This final rule also revises and updates quality measures and reporting requirements under the IRF quality reporting program (QRP).
2016-08-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting RequirementsThis final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule changes the hospice quality reporting program, including adopting new quality measures. Finally, this final rule...2016-18221"https://www.gpo.gov/fdsys/pkg/FR-2016-08-05/pdf/2016-18221.pdfhttps://www.federalregister.gov/documents/2016/08/05/2016-18221/medicare-program-fy-2017-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule changes the hospice quality reporting program, including adopting new quality measures. Finally, this final rule includes information regarding the Medicare Care Choices Model (MCCM).
2016-08-03Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care ModelC1-2016-15188"https://www.gpo.gov/fdsys/pkg/FR-2016-08-03/pdf/C1-2016-15188.pdfhttps://www.federalregister.gov/documents/2016/08/03/C1-2016-15188/medicare-program-end-stage-renal-disease-prospective-payment-system-coverage-and-payment-for-renal
2016-08-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Implementation and Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations and Lifting of the Temporary Moratoria on Enrollment of Part B Emergency Ground Ambulance Suppliers in All Geographic LocationsThis document announces the extension of temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers and Medicare home health agencies (HHAs), subunits, and branch locations in specific locations within...2016-18383"https://www.gpo.gov/fdsys/pkg/FR-2016-08-03/pdf/2016-18383.pdfhttps://www.federalregister.gov/documents/2016/08/03/2016-18383/medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-the-implementation-andThis document announces the extension of temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers and Medicare home health agencies (HHAs), subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. It also announces the implementation of temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers and Medicare HHAs, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey on a statewide basis. In addition, it announces the lifting of the moratoria on all Part B emergency ground ambulance suppliers. These moratoria, and the changes described in this document, also apply to the enrollment of HHAs and non- emergency ground ambulance suppliers in Medicaid and the Children's Health Insurance Program.
2016-08-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Moratoria-Designated Geographic LocationsThis notice announces the Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in 6 states. The demonstration is being implemented in accordance with section 402 of the...2016-18381"https://www.gpo.gov/fdsys/pkg/FR-2016-08-03/pdf/2016-18381.pdfhttps://www.federalregister.gov/documents/2016/08/03/2016-18381/medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-the-provider-enrollmentThis notice announces the Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in 6 states. The demonstration is being implemented in accordance with section 402 of the Social Security Amendments of 1967 and gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.
2016-08-02Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)This proposed rule proposes to implement three new Medicare Parts A and B episode payment models under section 1115A of the Social Security Act. Acute care hospitals in certain selected geographic areas will participate in retrospective episode payment...2016-17733"https://www.gpo.gov/fdsys/pkg/FR-2016-08-02/pdf/2016-17733.pdfhttps://www.federalregister.gov/documents/2016/08/02/2016-17733/medicare-program-advancing-care-coordination-through-episode-payment-models-epms-cardiacThis proposed rule proposes to implement three new Medicare Parts A and B episode payment models under section 1115A of the Social Security Act. Acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. We believe this model will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures. This proposed rule also includes several proposed modifications to the Comprehensive Care for Joint Replacement model.
2016-07-20RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Correcting AmendmentThis document corrects a technical error that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP...2016-17157"https://www.gpo.gov/fdsys/pkg/FR-2016-07-20/pdf/2016-17157.pdfhttps://www.federalregister.gov/documents/2016/07/20/2016-17157/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-deliveredThis document corrects a technical error that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability.'' The effective date for the rule was July 5, 2016.
2016-07-15Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program ModelThis major proposed rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the...2016-16097"https://www.gpo.gov/fdsys/pkg/FR-2016-07-15/pdf/2016-16097.pdfhttps://www.federalregister.gov/documents/2016/07/15/2016-16097/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis major proposed rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes proposals related to the Medicare Shared Saving Program, and the release of certain pricing data from Medicare Advantage bids and medical loss ratio reports from Medicare health and drug plans. In addition, this rule proposes to expand the Medicare Diabetes Prevention Program model.
2016-07-14Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Certain Off-Campus Outpatient Departments of a Provider; Hospital Value-Based Purchasing (VBP) ProgramThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our...2016-16098"https://www.gpo.gov/fdsys/pkg/FR-2016-07-14/pdf/2016-16098.pdfhttps://www.federalregister.gov/documents/2016/07/14/2016-16098/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, in this proposed rule, we are proposing to make changes to tolerance thresholds for clinical outcomes for solid organ transplant programs; to Organ Procurement Organizations (OPOs) definitions, outcome measures, and organ transport documentation; and to the Medicare and Medicaid Electronic Health Record Incentive Programs. We also are proposing to remove the HCAHPS Pain Management dimension from the Hospital Value-Based Purchasing (VBP) Program. In addition, we are proposing to implement section 603 of the Bipartisan Budget Act of 2015 relating to payment for certain items and services furnished by certain off-campus outpatient departments of a provider.
2016-07-08RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedication Assisted Treatment for Opioid Use DisordersThis final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/ naloxone (hereinafter referred to as buprenorphine) in the office-based setting as authorized under the United States Code....2016-16120"https://www.gpo.gov/fdsys/pkg/FR-2016-07-08/pdf/2016-16120.pdfhttps://www.federalregister.gov/documents/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disordersThis final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/ naloxone (hereinafter referred to as buprenorphine) in the office-based setting as authorized under the United States Code. Section 303(g)(2) of the Controlled Substances Act (CSA) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA). Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. This final rule will expand access to MAT by allowing eligible practitioners to request approval to treat up to 275 patients under section 303(g)(2) of the CSA. The final rule also includes requirements to ensure that patients receive the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted.
2016-07-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedication Assisted Treatment for Opioid Use Disorders Reporting RequirementsOn March 30, 2016, the U.S. Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the...2016-16069"https://www.gpo.gov/fdsys/pkg/FR-2016-07-08/pdf/2016-16069.pdfhttps://www.federalregister.gov/documents/2016/07/08/2016-16069/medication-assisted-treatment-for-opioid-use-disorders-reporting-requirementsOn March 30, 2016, the U.S. Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA). On July 6, 2016, HHS published a final rule based on the NPRM but delayed finalizing the reporting requirements outlined in the NPRM. In this Supplemental Notice of Proposed Rulemaking (SNPRM), HHS seeks further comment on the same reporting requirements outlined in the NPRM. These reporting requirements would require annual reporting by practitioners who are approved to treat up to 275 patients under subpart F to help HHS ensure compliance with the requirements of the ``Medication Assisted Treatment for Opioid Use Disorders'' final rule published elsewhere in this issue of the Federal Register. HHS will consider the public comments on this SNPRM as well as any comments already received on the March 30, 2016 NPRM before issuing a final rule pertaining to the reporting requirements.
2016-07-07RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Expanding Uses of Medicare Data by Qualified EntitiesThis final rule implements requirements under Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 that expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with...2016-15708"https://www.gpo.gov/fdsys/pkg/FR-2016-07-07/pdf/2016-15708.pdfhttps://www.federalregister.gov/documents/2016/07/07/2016-15708/medicare-program-expanding-uses-of-medicare-data-by-qualified-entitiesThis final rule implements requirements under Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 that expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. This rule also explains how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. In addition, this rule implements certain privacy and security requirements, and imposes assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement required by the qualified entity program.
2016-07-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Addition of New-Onset Chronic Obstructive Pulmonary Disease and WTC-Related Acute Traumatic Injury to the List of WTC-Related Health ConditionsThe World Trade Center (WTC) Health Program conducted a review of published, peer-reviewed epidemiologic studies regarding potential evidence of chronic obstructive pulmonary disease (COPD) and acute traumatic injury among individuals who were...2016-15799"https://www.gpo.gov/fdsys/pkg/FR-2016-07-05/pdf/2016-15799.pdfhttps://www.federalregister.gov/documents/2016/07/05/2016-15799/world-trade-center-health-program-addition-of-new-onset-chronic-obstructive-pulmonary-disease-andThe World Trade Center (WTC) Health Program conducted a review of published, peer-reviewed epidemiologic studies regarding potential evidence of chronic obstructive pulmonary disease (COPD) and acute traumatic injury among individuals who were responders to or survivors of the September 11, 2001, terrorist attacks. The Administrator of the WTC Health Program (Administrator) found that these studies provide substantial evidence to support a causal association between each of these health conditions and 9/11 exposures. As a result, the Administrator is publishing a final rule to add both new-onset COPD and WTC-related acute traumatic injury to the List of WTC-Related Health Conditions eligible for treatment coverage in the WTC Health Program.
2016-07-05Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsThis proposed rule would update the Home Health Prospective Payment System (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion...2016-15448"https://www.gpo.gov/fdsys/pkg/FR-2016-07-05/pdf/2016-15448.pdfhttps://www.federalregister.gov/documents/2016/07/05/2016-15448/medicare-and-medicaid-programs-cy-2017-home-health-prospective-payment-system-rate-update-homeThis proposed rule would update the Home Health Prospective Payment System (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2017. This proposed rule also: Implements the last year of the 4- year phase-in of the rebasing adjustments to the HH PPS payment rates; updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 2nd-year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014; proposes changes to the methodology used to calculate outlier payments (with regards to payments made under the HH PPS for high-cost ``outlier'' episodes of care (that is, episodes of care with unusual variations in the type or amount of medically necessary care)); proposes changes in payment for Negative Pressure Wound Therapy (NPWT) performed using a disposable device for patient's under a home health plan of care; discusses our efforts to monitor the potential impacts of the rebasing adjustments mandated; includes an update on subsequent research and analysis as a result of the findings from the home health study; solicits comments on a potential process for grouping HH PPS claims centrally during claims processing; and proposes changes to the Home Health Value-Based Purchasing (HHVBP) Model, which was implemented on January 1, 2016; and proposes updates to the Home Health Quality Reporting Program (HH QRP).
2016-07-05Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals ProceduresThis proposed rule would revise the procedures that the Department of Health and Human Services would follow at the Administrative Law Judge level for appeals of payment and coverage determinations for items and services furnished to Medicare...2016-15192"https://www.gpo.gov/fdsys/pkg/FR-2016-07-05/pdf/2016-15192.pdfhttps://www.federalregister.gov/documents/2016/07/05/2016-15192/medicare-program-changes-to-the-medicare-claims-and-entitlement-medicare-advantage-organizationThis proposed rule would revise the procedures that the Department of Health and Human Services would follow at the Administrative Law Judge level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this proposed rule would revise procedures that the Department of Health and Human Services would follow at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the Administrative Law Judge level.
2016-06-30RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; CorrectionThis document corrects technical errors that appeared in the final rule published in the Federal Register on May 4, 2016, entitled ``Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities.''2016-15460"https://www.gpo.gov/fdsys/pkg/FR-2016-06-30/pdf/2016-15460.pdfhttps://www.federalregister.gov/documents/2016/06/30/2016-15460/medicare-and-medicaid-programs-fire-safety-requirements-for-certain-health-care-facilitiesThis document corrects technical errors that appeared in the final rule published in the Federal Register on May 4, 2016, entitled ``Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities.''
2016-06-30Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care ModelThis rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017 as well as proposing to implement policies for coverage and payment for renal dialysis services furnished by...2016-15188"https://www.gpo.gov/fdsys/pkg/FR-2016-06-30/pdf/2016-15188.pdfhttps://www.federalregister.gov/documents/2016/06/30/2016-15188/medicare-program-end-stage-renal-disease-prospective-payment-system-coverage-and-payment-for-renalThis rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017 as well as proposing to implement policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also proposes to set forth requirements for the ESRD Quality Incentive Program, and proposes to establish and revise requirements for quality reporting and measurement, including the inclusion of new quality measures for payment year (PY) 2020 and beyond and updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also proposes to implement statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also proposes to expand suppliers' appeal rights in the event of a breach of contract action by CMS. In particular, this rule proposes a revision to current regulations to provide that the appeals process is applicable to all breach of contract actions taken by CMS, rather than just for the termination of a competitive bidding contract. It also proposes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from Competitive Bidding Programs and for submitting bids and establishing single payment amounts under the Competitive Bidding Programs for certain groupings of similar items with different features. Changes are also proposed to the methodology for establishing bid limits for items under the DMEPOS Competitive Bidding Programs. In addition, this rule also solicits comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule announces a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
2016-06-23RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment SystemThis final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which significantly revises the Medicare payment system for clinical diagnostic laboratory tests. This final rule also announces an...2016-14531"https://www.gpo.gov/fdsys/pkg/FR-2016-06-23/pdf/2016-14531.pdfhttps://www.federalregister.gov/documents/2016/06/23/2016-14531/medicare-program-medicare-clinical-diagnostic-laboratory-tests-payment-systemThis final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which significantly revises the Medicare payment system for clinical diagnostic laboratory tests. This final rule also announces an implementation date of January 1, 2018 for the private payor rate-based fee schedule required by PAMA.
2016-06-22Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care ActThis proposed rule would update the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and the Children's Health Insurance Program (CHIP) eligibility under the Patient...2016-14536"https://www.gpo.gov/fdsys/pkg/FR-2016-06-22/pdf/2016-14536.pdfhttps://www.federalregister.gov/documents/2016/06/22/2016-14536/medicaidchip-program-medicaid-program-and-childrens-health-insurance-program-chip-changes-to-theThis proposed rule would update the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and the Children's Health Insurance Program (CHIP) eligibility under the Patient Protection and Affordable Care Act. This proposed rule would also implement various other improvements to the PERM program.
2016-06-16Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient CareThis proposed rule would update the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These proposals are intended to conform the requirements to current standards of...2016-13925"https://www.gpo.gov/fdsys/pkg/FR-2016-06-16/pdf/2016-13925.pdfhttps://www.federalregister.gov/documents/2016/06/16/2016-13925/medicare-and-medicaid-programs-hospital-and-critical-access-hospital-cah-changes-to-promoteThis proposed rule would update the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These proposals are intended to conform the requirements to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.
2016-06-10RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial CalculationsUnder the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and...2016-13651"https://www.gpo.gov/fdsys/pkg/FR-2016-06-10/pdf/2016-13651.pdfhttps://www.federalregister.gov/documents/2016/06/10/2016-13651/medicare-program-medicare-shared-savings-program-accountable-care-organizations-revised-benchmarkUnder the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This final rule addresses changes to the Shared Savings Program, including: Modifications to the program's benchmarking methodology, when resetting (rebasing) the ACO's benchmark for a second or subsequent agreement period, to encourage ACOs' continued investment in care coordination and quality improvement; an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program; and policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
2016-06-09Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; CorrectionThis document corrects technical and typographical errors in the proposed rule that appeared in the Federal Register on April 27, 2016 titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term...2016-13685"https://www.gpo.gov/fdsys/pkg/FR-2016-06-09/pdf/2016-13685.pdfhttps://www.federalregister.gov/documents/2016/06/09/2016-13685/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theThis document corrects technical and typographical errors in the proposed rule that appeared in the Federal Register on April 27, 2016 titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost Reports.''
2016-06-03RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentState Health Insurance Assistance Program (SHIP)The Department of Health and Human Services is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``State Health Insurance Assistance Program (SHIP).'' This final rule implements a provision enacted by the...2016-13136"https://www.gpo.gov/fdsys/pkg/FR-2016-06-03/pdf/2016-13136.pdfhttps://www.federalregister.gov/documents/2016/06/03/2016-13136/state-health-insurance-assistance-program-shipThe Department of Health and Human Services is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``State Health Insurance Assistance Program (SHIP).'' This final rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of Health and Human Services (HHS) to the Administration for Community Living (ACL) in HHS. Prior to the interim final rule, prior regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA), Section 4360.
2016-06-01RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; CorrectionsThis document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled ``Medicare Program; Revisions to Payment Policies...2016-12841"https://www.gpo.gov/fdsys/pkg/FR-2016-06-01/pdf/2016-12841.pdfhttps://www.federalregister.gov/documents/2016/06/01/2016-12841/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016.'' The effective date for the rule was January 1, 2016.
2016-06-01RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting AmendmentThis document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to...2016-12853"https://www.gpo.gov/fdsys/pkg/FR-2016-06-01/pdf/2016-12853.pdfhttps://www.federalregister.gov/documents/2016/06/01/2016-12853/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3-and-modificationsThis document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017.''
2016-05-24RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPatient Safety and Quality Improvement Act of 2005-HHS Guidance Regarding Patient Safety Work Product and Providers' External ObligationsThis guidance sets forth guidance for patient safety organizations (PSOs) and providers regarding questions that have arisen about the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21--b-26 (Patient Safety Act), and its...2016-12312"https://www.gpo.gov/fdsys/pkg/FR-2016-05-24/pdf/2016-12312.pdfhttps://www.federalregister.gov/documents/2016/05/24/2016-12312/patient-safety-and-quality-improvement-act-of-2005-hhs-guidance-regarding-patient-safety-workThis guidance sets forth guidance for patient safety organizations (PSOs) and providers regarding questions that have arisen about the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21--b-26 (Patient Safety Act), and its implementing regulation, the Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule). In particular, this Patient Safety and Quality Improvement Act of 2005--Guidance Regarding Patient Safety Work Product and Providers' External Obligations (Guidance) is intended to clarify what information that a provider creates or assembles can become patient safety work product (PSWP) in response to recurring questions. This Guidance also clarifies how providers can satisfy external obligations related to information collection activities consistent with the Patient Safety Act and Patient Safety Rule.
2016-05-17RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Obtaining Final Medicare Secondary Payer Conditional Payment Amounts via Web PortalThis final rule specifies the process and timeline for expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to conform to section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The...2016-11270"https://www.gpo.gov/fdsys/pkg/FR-2016-05-17/pdf/2016-11270.pdfhttps://www.federalregister.gov/documents/2016/05/17/2016-11270/medicare-program-obtaining-final-medicare-secondary-payer-conditional-payment-amounts-via-web-portalThis final rule specifies the process and timeline for expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to conform to section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The final rule specifies a timeline for developing a multifactor authentication solution to securely permit authorized users other than the beneficiary to access CMS' MSP conditional payment amounts and claims detail information via the MSP Web portal. It also requires that we add functionality to the existing MSP Web portal that permits users to: Notify us that the specified case is approaching settlement; obtain time and date stamped final conditional payment summary statements and amounts before reaching settlement; and ensure that relatedness disputes and any other discrepancies are addressed within 11 business days of receipt of dispute documentation.
2016-05-09Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment ModelsMedicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS...2016-10032"https://www.gpo.gov/fdsys/pkg/FR-2016-05-09/pdf/2016-10032.pdfhttps://www.federalregister.gov/documents/2016/05/09/2016-10032/medicare-program-merit-based-incentive-payment-system-mips-and-alternative-payment-model-apmMedicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the PFS. This proposed rule would establish the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models. In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders.
2016-05-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party LiabilityThis final rule modernizes the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The final rule aligns, where feasible, many of the rules governing Medicaid managed care with those of other major...2016-09581"https://www.gpo.gov/fdsys/pkg/FR-2016-05-06/pdf/2016-09581.pdfhttps://www.federalregister.gov/documents/2016/05/06/2016-09581/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-deliveredThis final rule modernizes the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The final rule aligns, where feasible, many of the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans; implements statutory provisions; strengthens actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; and promotes the quality of care and strengthens efforts to reform delivery systems that serve Medicaid and CHIP beneficiaries. It also ensures appropriate beneficiary protections and enhances policies related to program integrity. This final rule also implements provisions of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses third party liability for trauma codes.
2016-05-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care FacilitiesThis final rule will amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID),...2016-10043"https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10043.pdfhttps://www.federalregister.gov/documents/2016/05/04/2016-10043/medicare-and-medicaid-programs-fire-safety-requirements-for-certain-health-care-facilitiesThis final rule will amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Further, this final rule will adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions of the Life Safety Code. It will also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
2016-04-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting RequirementsThis proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule proposes changes to the hospice quality reporting program, including proposing new quality measures. The proposed...2016-09631"https://www.gpo.gov/fdsys/pkg/FR-2016-04-28/pdf/2016-09631.pdfhttps://www.federalregister.gov/documents/2016/04/28/2016-09631/medicare-program-fy-2017-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule proposes changes to the hospice quality reporting program, including proposing new quality measures. The proposed rule also solicits feedback on an enhanced data collection instrument and describes plans to publicly display quality measures and other hospice data beginning in the middle of 2017. Finally, this proposed rule includes information regarding the Medicare Care Choices Model (MCCM).
2016-04-27Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost ReportsWe are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2017....2016-09120"https://www.gpo.gov/fdsys/pkg/FR-2016-04-27/pdf/2016-09120.pdfhttps://www.federalregister.gov/documents/2016/04/27/2016-09120/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theWe are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2017. Some of the proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Notice of Observation Treatment and Implications for Care Eligibility Act of 2015, and other legislation. We also are providing the estimated market basket update to apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2017. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2017. In addition, we are proposing to make changes relating to direct graduate medical education (GME) and indirect medical education (IME) payments to hospitals with rural track training programs. We are proposing to establish new requirements or revise requirements for quality reporting by specific providers (acute care hospitals, PPS- exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities) that are participating in Medicare, including related provisions for eligible hospitals and critical care hospitals (CAHs) participating in the Electronic Health Record (EHR) Incentive Program. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing to: Implement statutory provisions that require hospitals and CAHs to furnish notification to Medicare beneficiaries, including Medicare Advantage enrollees, when the beneficiaries receive outpatient observation services for more than 24 hours; announce the implementation of the Frontier Community Health Integration Project Demonstration; and make technical corrections and changes to regulations relating to costs to organizations and Medicare cost reports.
2016-04-25Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 011-Autoimmune Diseases; Finding of Insufficient EvidenceOn January 25, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 011) to add ``autoimmune disease, lupus, and rheumatoid arthritis'' to the List of WTC-Related Health Conditions (List). Upon reviewing...2016-09527"https://www.gpo.gov/fdsys/pkg/FR-2016-04-25/pdf/2016-09527.pdfhttps://www.federalregister.gov/documents/2016/04/25/2016-09527/world-trade-center-health-program-petition-011-autoimmune-diseases-finding-of-insufficient-evidenceOn January 25, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 011) to add ``autoimmune disease, lupus, and rheumatoid arthritis'' to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 011 is not substantially different from Petitions 007, 008, and 009, which also requested the addition of autoimmune diseases. The Administrator recently published responses to Petitions 007, 008, and 009 in the Federal Register and has determined that Petition 011 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2016-04-25Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities Proposed Rule for FY 2017, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and SNF Payment Models ResearchThis proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it includes a proposal to specify a potentially preventable readmission...2016-09399"https://www.gpo.gov/fdsys/pkg/FR-2016-04-25/pdf/2016-09399.pdfhttps://www.federalregister.gov/documents/2016/04/25/2016-09399/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it includes a proposal to specify a potentially preventable readmission measure for the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP), and other proposals for that program aimed at implementing value-based purchasing for SNFs. Additionally, this proposed rule proposes additional polices and measures in the Skilled Nursing Facility Quality Reporting Program (SNF QRP). This proposed rule also includes an update on the SNF Payment Models Research (PMR) project.
2016-04-25Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the...2016-09397"https://www.gpo.gov/fdsys/pkg/FR-2016-04-25/pdf/2016-09397.pdfhttps://www.federalregister.gov/documents/2016/04/25/2016-09397/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS's) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2017. We are also proposing to revise and update quality measures and reporting requirements under the IRF quality reporting program (QRP).
2016-04-21RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Temporary Exception for Certain Severe Wound Discharges From Certain Long-Term Care Hospitals Required by the Consolidated Appropriations Act, 2016; Modification of Limitations on Redesignation by the Medicare Geographic Classification Review BoardThis interim final rule with comment period (IFC) implements section 231 of the Consolidated Appropriations Act of 2016 (CAA), which provides for a temporary exception for certain wound care discharges from the application of the site neutral payment...2016-09219"https://www.gpo.gov/fdsys/pkg/FR-2016-04-21/pdf/2016-09219.pdfhttps://www.federalregister.gov/documents/2016/04/21/2016-09219/medicare-program-temporary-exception-for-certain-severe-wound-discharges-from-certain-long-term-careThis interim final rule with comment period (IFC) implements section 231 of the Consolidated Appropriations Act of 2016 (CAA), which provides for a temporary exception for certain wound care discharges from the application of the site neutral payment rate under the Long- Term Care Hospital (LTCH) Prospective Payment System (PPS) for certain long-term care hospitals. This IFC also amends our current regulations to allow hospitals nationwide to reclassify based on their acquired rural status, effective with reclassifications beginning with fiscal year (FY) 2018. Hospitals with an existing Medicare Geographic Classification Review Board (MGCRB) reclassification would also have the opportunity to seek rural reclassification for IPPS payment and other purposes and keep their existing MGCRB reclassification. We would also apply the policy in this IFC when deciding timely appeals before the Administrator under our regulations for FY 2017 that were denied by the MGCRB due to existing regulations, which do not permit simultaneous rural reclassification for IPPS payment and other purposes and MGCRB reclassification. These regulatory changes implement the decisions in Geisinger Community Medical Center v. Secretary, United States Department of Health and Human Services, 794 F.3d 383 (3d Cir. 2015) and Lawrence + Memorial Hospital v. Burwell, No. 15-164, 2016 WL 423702 (2d Cir. Feb. 4, 2015) in a nationally consistent manner.
2016-04-19Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services Department340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Reopening of Comment PeriodThis document reopens the comment period for the June 17, 2015, proposed rule entitled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.'' The comment period for the proposed rule, which ended on August 17,...2016-09017"https://www.gpo.gov/fdsys/pkg/FR-2016-04-19/pdf/2016-09017.pdfhttps://www.federalregister.gov/documents/2016/04/19/2016-09017/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulationThis document reopens the comment period for the June 17, 2015, proposed rule entitled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.'' The comment period for the proposed rule, which ended on August 17, 2015, is reopened for 30 days.
2016-04-12RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Deadline for Access Monitoring Review Plan SubmissionsIn the November 2, 2015 Federal Register, we published a final rule with comment period entitled ``Medicaid Program: Methods for Assuring Access to Covered Medicaid Services.'' The final rule with comment period established that states must develop and...2016-08368"https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08368.pdfhttps://www.federalregister.gov/documents/2016/04/12/2016-08368/medicaid-program-deadline-for-access-monitoring-review-plan-submissionsIn the November 2, 2015 Federal Register, we published a final rule with comment period entitled ``Medicaid Program: Methods for Assuring Access to Covered Medicaid Services.'' The final rule with comment period established that states must develop and submit to CMS an access monitoring review plan by July 1, 2016. This document revises the deadline for states' access monitoring review plan submission to CMS until October 1, 2016.
2016-04-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 010-Peripheral Neuropathy; Finding of Insufficient EvidenceOn January 5, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 010) to add peripheral neuropathy to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical...2016-07567"https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07567.pdfhttps://www.federalregister.gov/documents/2016/04/04/2016-07567/world-trade-center-health-program-petition-010-peripheral-neuropathy-finding-of-insufficientOn January 5, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 010) to add peripheral neuropathy to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add peripheral neuropathy to the List. The Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/ Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2016-03-30RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid and Children's Health Insurance Programs; Mental Health Parity and Addiction Equity Act of 2008; the Application of Mental Health Parity Requirements to Coverage Offered by Medicaid Managed Care Organizations, the Children's Health Insurance Program (CHIP), and Alternative Benefit PlansThis final rule will address the application of certain requirements set forth in the Public Health Service Act, as amended by the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, to coverage offered by Medicaid...2016-06876"https://www.gpo.gov/fdsys/pkg/FR-2016-03-30/pdf/2016-06876.pdfhttps://www.federalregister.gov/documents/2016/03/30/2016-06876/medicaid-and-childrens-health-insurance-programs-mental-health-parity-and-addiction-equity-act-ofThis final rule will address the application of certain requirements set forth in the Public Health Service Act, as amended by the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, to coverage offered by Medicaid managed care organizations, Medicaid Alternative Benefit Plans, and Children's Health Insurance Programs.
2016-03-30Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedication Assisted Treatment for Opioid Use DisordersThe Secretary of the Department of Health and Human Services (the Secretary) (HHS) proposes a rule to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act...2016-07128"https://www.gpo.gov/fdsys/pkg/FR-2016-03-30/pdf/2016-07128.pdfhttps://www.federalregister.gov/documents/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disordersThe Secretary of the Department of Health and Human Services (the Secretary) (HHS) proposes a rule to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA) from 100 to 200. The purpose of the proposed rule is to increase access to treatment for opioid use disorder while reducing the opportunity for diversion of the medication to unlawful use.
2016-03-29Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rulemaking ProceedingsIn accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting rulemaking proceedings to add food allergies as an injury associated with vaccines...2016-06666"https://www.gpo.gov/fdsys/pkg/FR-2016-03-29/pdf/2016-06666.pdfhttps://www.federalregister.gov/documents/2016/03/29/2016-06666/national-vaccine-injury-compensation-program-statement-of-reasons-for-not-conducting-rulemakingIn accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting rulemaking proceedings to add food allergies as an injury associated with vaccines to the Vaccine Injury Table.
2016-03-21RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPayment for Physician and Other Health Care Professional Services Purchased by Indian Health Programs and Medical Charges Associated With Non-Hospital-Based CareThe Secretary of the Department of Health and Human Services (HHS) hereby issues this final rule with comment period to implement a methodology and payment rates for the Indian Health Service (IHS) Purchased/Referred Care (PRC), formerly known as the...2016-06087"https://www.gpo.gov/fdsys/pkg/FR-2016-03-21/pdf/2016-06087.pdfhttps://www.federalregister.gov/documents/2016/03/21/2016-06087/payment-for-physician-and-other-health-care-professional-services-purchased-by-indian-healthThe Secretary of the Department of Health and Human Services (HHS) hereby issues this final rule with comment period to implement a methodology and payment rates for the Indian Health Service (IHS) Purchased/Referred Care (PRC), formerly known as the Contract Health Services (CHS), to apply Medicare payment methodologies to all physician and other health care professional services and non-hospital- based services. Specifically, it will allow the health programs operated by IHS, Tribes, Tribal organizations, and urban Indian organizations (collectively, I/T/U programs) to negotiate or pay non-I/ T/U providers based on the applicable Medicare fee schedule, prospective payment system, Medicare Rate, or in the event of a Medicare waiver, the payment amount will be calculated in accordance with such waiver; the amount negotiated by a repricing agent, if applicable; or the provider or supplier's most favored customer (MFC) rate. This final rule will establish payment rates that are consistent across Federal health care programs, align payment with inpatient services, and enable the I/T/U to expand beneficiary access to medical care. A comment period is included, in part, to address Tribal stakeholder concerns about the opportunity for meaningful consultation on the rule's impact on Tribal health programs.
2016-03-11Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCatastrophic Health Emergency FundThis document extends the comment period for the Catastrophic Health Emergency Fund (CHEF) notice of proposed rulemaking which was published in the Federal Register on January 26, 2016. The comment period for the notice, which would have ended on March...2016-05555"https://www.gpo.gov/fdsys/pkg/FR-2016-03-11/pdf/2016-05555.pdfhttps://www.federalregister.gov/documents/2016/03/11/2016-05555/catastrophic-health-emergency-fundThis document extends the comment period for the Catastrophic Health Emergency Fund (CHEF) notice of proposed rulemaking which was published in the Federal Register on January 26, 2016. The comment period for the notice, which would have ended on March 11, 2016, is extended by 60 days.
2016-03-11Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Part B Drug Payment ModelThis proposed rule discusses the implementation of a new Medicare payment model under section 1115A of the Social Security Act (the Act). We propose the Part B Drug Payment Model as a two-phase model that would test whether alternative drug payment...2016-05459"https://www.gpo.gov/fdsys/pkg/FR-2016-03-11/pdf/2016-05459.pdfhttps://www.federalregister.gov/documents/2016/03/11/2016-05459/medicare-program-part-b-drug-payment-modelThis proposed rule discusses the implementation of a new Medicare payment model under section 1115A of the Social Security Act (the Act). We propose the Part B Drug Payment Model as a two-phase model that would test whether alternative drug payment designs will lead to a reduction in Medicare expenditures, while preserving or enhancing the quality of care provided to Medicare beneficiaries. The first phase would involve changing the 6 percent add-on to Average Sales Price (ASP) that we use to make drug payments under Part B to 2.5 percent plus a flat fee (in a budget neutral manner). The second phase would implement value-based purchasing tools similar to those employed by commercial health plans, pharmacy benefit managers, hospitals, and other entities that manage health benefits and drug utilization. We believe this model will further our goals of smarter, that is, more efficient spending on quality care for Medicare beneficiaries.
2016-03-10RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentEligibility in the States, District of Columbia, the Northern Mariana Islands, and American Samoa2016-05484"https://www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05484.pdfhttps://www.federalregister.gov/documents/2016/03/10/2016-05484/eligibility-in-the-states-district-of-columbia-the-northern-mariana-islands-and-american-samoa
2016-03-08RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; CorrectionsThis document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled ``Medicare Program; Revisions to Payment Policies...2016-05054"https://www.gpo.gov/fdsys/pkg/FR-2016-03-08/pdf/2016-05054.pdfhttps://www.federalregister.gov/documents/2016/03/08/2016-05054/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016.''
2016-03-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Electronic Health Record Initiative Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting AmendmentThis document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to...2016-04785"https://www.gpo.gov/fdsys/pkg/FR-2016-03-04/pdf/2016-04785.pdfhttps://www.federalregister.gov/documents/2016/03/04/2016-04785/medicare-and-medicaid-programs-electronic-health-record-initiative-program-stage-3-and-modificationsThis document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017.''
2016-03-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; Corrections and Correcting AmendmentsIn the November 24, 2015 Federal Register (80 FR 73274), we published a final rule to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model,...2016-04786"https://www.gpo.gov/fdsys/pkg/FR-2016-03-04/pdf/2016-04786.pdfhttps://www.federalregister.gov/documents/2016/03/04/2016-04786/medicare-program-comprehensive-care-for-joint-replacement-payment-model-for-acute-care-hospitalsIn the November 24, 2015 Federal Register (80 FR 73274), we published a final rule to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement (LEJR) or reattachment of a lower extremity. The effective date was January 15, 2016. This correcting amendment corrects a limited number of technical and typographical errors identified in the November 24, 2015 final rule.
2016-03-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentEligibility in the States, District of Columbia, the Northern Mariana Islands, and American Samoa2016-04872"https://www.gpo.gov/fdsys/pkg/FR-2016-03-04/pdf/2016-04872.pdfhttps://www.federalregister.gov/documents/2016/03/04/2016-04872/eligibility-in-the-states-district-of-columbia-the-northern-mariana-islands-and-american-samoa
2016-03-01Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment ProcessThis proposed rule would implement sections of the Affordable Care Act that require Medicare, Medicaid, and Children's Health Insurance Program (CHIP) providers and suppliers to disclose certain current and previous affiliations with other providers...2016-04312"https://www.gpo.gov/fdsys/pkg/FR-2016-03-01/pdf/2016-04312.pdfhttps://www.federalregister.gov/documents/2016/03/01/2016-04312/medicare-medicaid-and-childrens-health-insurance-programs-program-integrity-enhancements-to-theThis proposed rule would implement sections of the Affordable Care Act that require Medicare, Medicaid, and Children's Health Insurance Program (CHIP) providers and suppliers to disclose certain current and previous affiliations with other providers and suppliers. This proposed rule would also provide CMS with additional authority to deny or revoke a provider's or supplier's Medicare enrollment. In addition, this proposed rule would require that to order, certify, refer or prescribe any Part A or B service, item or drug, a physician or, when permitted, an eligible professional must be enrolled in Medicare in an approved status or have validly opted-out of the Medicare program.
2016-02-29RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentBasic Health Program; Federal Funding Methodology for Program Years 2017 and 2018This document provides the methodology and data sources necessary to determine Federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits...2016-03902"https://www.gpo.gov/fdsys/pkg/FR-2016-02-29/pdf/2016-03902.pdfhttps://www.federalregister.gov/documents/2016/02/29/2016-03902/basic-health-program-federal-funding-methodology-for-program-years-2017-and-2018This document provides the methodology and data sources necessary to determine Federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges (hereinafter referred to as the Exchanges).
2016-02-12RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Reporting and Returning of OverpaymentsThis final rule requires providers and suppliers receiving funds under the Medicare program to report and return overpayments by the later of the date that is 60 days after the date on which the overpayment was identified; or the date any corresponding...2016-02789"https://www.gpo.gov/fdsys/pkg/FR-2016-02-12/pdf/2016-02789.pdfhttps://www.federalregister.gov/documents/2016/02/12/2016-02789/medicare-program-reporting-and-returning-of-overpaymentsThis final rule requires providers and suppliers receiving funds under the Medicare program to report and return overpayments by the later of the date that is 60 days after the date on which the overpayment was identified; or the date any corresponding cost report is due, if applicable. The requirements in this rule are meant to ensure compliance with applicable statutes, promote the furnishing of high quality care, and to protect the Medicare Trust Funds against fraud and improper payments. This rule provides needed clarity and consistency in the reporting and returning of self-identified overpayments.
2016-02-09Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConfidentiality of Substance Use Disorder Patient RecordsThis proposed rule addresses changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations. This proposal was prompted by the need to update and modernize the regulations. These laws and regulations governing the confidentiality...2016-01841"https://www.gpo.gov/fdsys/pkg/FR-2016-02-09/pdf/2016-01841.pdfhttps://www.federalregister.gov/documents/2016/02/09/2016-01841/confidentiality-of-substance-use-disorder-patient-recordsThis proposed rule addresses changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations. This proposal was prompted by the need to update and modernize the regulations. These laws and regulations governing the confidentiality of substance abuse records were written out of great concern about the potential use of substance abuse information against an individual, preventing those individuals with substance use disorders from seeking needed treatment. The last substantive update to these regulations was in 1987. Over the last 25 years, significant changes have occurred within the U.S. health care system that were not envisioned by the current regulations, including new models of integrated care that are built on a foundation of information sharing to support coordination of patient care, the development of an electronic infrastructure for managing and exchanging patient information, and a new focus on performance measurement within the health care system. SAMHSA wants to ensure that patients with substance use disorders have the ability to participate in, and benefit from new integrated health care models without fear of putting themselves at risk of adverse consequences. These new integrated models are foundational to HHS's triple aim of improving health care quality, improving population health, and reducing unnecessary health care costs. SAMHSA strives to facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. These concerns include: The potential for loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration. This proposal is also an effort to make the regulations more understandable and less burdensome. We welcome public comment on this proposed rule.
2016-02-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentState Health Insurance Assistance Program (SHIP)This rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of...2016-02055"https://www.gpo.gov/fdsys/pkg/FR-2016-02-04/pdf/2016-02055.pdfhttps://www.federalregister.gov/documents/2016/02/04/2016-02055/state-health-insurance-assistance-program-shipThis rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of Health and Human Services (HHS) to the Administration for Community Living (ACL) in HHS. The previous regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA `90), Section 4360.
2016-02-03Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial CalculationsUnder the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and...2016-01748"https://www.gpo.gov/fdsys/pkg/FR-2016-02-03/pdf/2016-01748.pdfhttps://www.federalregister.gov/documents/2016/02/03/2016-01748/medicare-program-medicare-shared-savings-program-accountable-care-organizations-revised-benchmarkUnder the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This proposed rule addresses changes to the Shared Savings Program that would modify the program's benchmark rebasing methodology to encourage ACOs' continued investment in care coordination and quality improvement, and identifies publicly available data to support modeling and analysis of these proposed changes. In addition, it would streamline the methodology used to adjust an ACO's historical benchmark for changes in its ACO participant composition, offer an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program, and establish policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
2016-02-02RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home HealthThis final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of...2016-01585"https://www.gpo.gov/fdsys/pkg/FR-2016-02-02/pdf/2016-01585.pdfhttps://www.federalregister.gov/documents/2016/02/02/2016-01585/medicaid-program-face-to-face-requirements-for-home-health-services-policy-changes-andThis final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to add requirements that, for home health services, physicians document, and, for certain medical equipment, physicians or certain authorized non-physician practitioners (NPP) document the occurrence of a face-to- face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes. This rule also aligns the timeframes for the face-to-face encounter with similar regulatory requirements for Medicare home health services. In addition, this rule amends the definitions of medical supplies, equipment, and appliances. We expect minimal impact with the implementation of section 6407 of the Affordable Care Act and section 504 of MACRA. We recognize that states may have budgetary implications as a result of the amended definitions of medical supplies, equipment and appliances. Specifically, this rule may expand coverage of medical supplies, equipment and appliances under the home health benefit. There will be items that had previously only been offered under certain sections of the Act that will now be covered under the home health benefit.
2016-02-02Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Expanding Uses of Medicare Data by Qualified EntitiesThis proposed rule would implement new statutory requirements that would expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws,...2016-01790"https://www.gpo.gov/fdsys/pkg/FR-2016-02-02/pdf/2016-01790.pdfhttps://www.federalregister.gov/documents/2016/02/02/2016-01790/medicare-program-expanding-uses-of-medicare-data-by-qualified-entitiesThis proposed rule would implement new statutory requirements that would expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. In doing so, this proposed rule would explain how qualified entities may create non- public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. This proposed rule would also implement certain privacy and security requirements, and impose assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement (DUA) required by the qualified entity program.
2016-02-01RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Covered Outpatient DrugsThis final rule implements provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) pertaining to Medicaid...2016-01274"https://www.gpo.gov/fdsys/pkg/FR-2016-02-01/pdf/2016-01274.pdfhttps://www.federalregister.gov/documents/2016/02/01/2016-01274/medicaid-program-covered-outpatient-drugsThis final rule implements provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) pertaining to Medicaid reimbursement for covered outpatient drugs (CODs). This final rule also revises other requirements related to CODs, including key aspects of their Medicaid coverage and payment and the Medicaid drug rebate program.
2016-01-26Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCatastrophic Health Emergency FundThe Indian Health Service (IHS) administers the Catastrophic Health Emergency Fund, The purpose of CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the...2016-01138"https://www.gpo.gov/fdsys/pkg/FR-2016-01-26/pdf/2016-01138.pdfhttps://www.federalregister.gov/documents/2016/01/26/2016-01138/catastrophic-health-emergency-fundThe Indian Health Service (IHS) administers the Catastrophic Health Emergency Fund, The purpose of CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This proposed rule: Proposes definitions governing the CHEF; establishes that a Service Unit shall not be eligible for reimbursement for the cost of treatment until the episode of care's cost has reached a certain threshold; establishes a procedure for reimbursement for certain services exceeding a threshold cost; establishes a procedure for payment for certain cases; and, establishes a procedure to ensure payment will not be made from CHEF if other sources of payment (Federal, state, local, private) are available.
2016-01-26RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Examination of Aliens-Revisions to Medical Screening ProcessThe Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing medical examinations that aliens must undergo before they may be admitted...2016-01418"https://www.gpo.gov/fdsys/pkg/FR-2016-01-26/pdf/2016-01418.pdfhttps://www.federalregister.gov/documents/2016/01/26/2016-01418/medical-examination-of-aliens-revisions-to-medical-screening-processThe Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing medical examinations that aliens must undergo before they may be admitted to the United States. Based on public comment received, HHS/CDC did not make changes from the NPRM published on June 23, 2015. Accordingly, this FR will: Revise the definition of communicable disease of public health significance by removing chancroid, granuloma inguinale, and lymphogranuloma venereum as inadmissible health-related conditions for aliens seeking admission to the United States; update the notification of the health-related grounds of inadmissibility to include proof of vaccinations to align with existing requirements established by the Immigration and Nationality Act (INA); revise the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction; clarify and revise the evaluation requirements for tuberculosis; clarify and revise the process for the HHS/CDC-appointed medical review board that convenes to reexamine the determination of a Class A medical condition based on an appeal; and update the titles and designations of federal agencies within the text of the regulation.
2016-01-22RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court RulingsIn accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004 outlier fixed-loss threshold rulemaking, this document provides further explanation of certain methodological choices made in the FY 2004 fixed-loss threshold...2016-01309"https://www.gpo.gov/fdsys/pkg/FR-2016-01-22/pdf/2016-01309.pdfhttps://www.federalregister.gov/documents/2016/01/22/2016-01309/medicare-program-explanation-of-fy-2004-outlier-fixed-loss-threshold-as-required-by-court-rulingsIn accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004 outlier fixed-loss threshold rulemaking, this document provides further explanation of certain methodological choices made in the FY 2004 fixed-loss threshold determination.
2016-01-20RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentFederal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Technical AmendmentsThis document contains technical amendments to HHS regulations regarding Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The regulatory content is being amended to add information that was erroneously...2015-32101"https://www.gpo.gov/fdsys/pkg/FR-2016-01-20/pdf/2015-32101.pdfhttps://www.federalregister.gov/documents/2016/01/20/2015-32101/federal-awarding-agency-regulatory-implementation-of-office-of-management-and-budgets-uniformThis document contains technical amendments to HHS regulations regarding Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The regulatory content is being amended to add information that was erroneously omitted, to include updated cross-references within HHS' regulations, and to make grammatical corrections.
2016-01-19Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPossession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety RequirementsIn accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed...2016-00758"https://www.gpo.gov/fdsys/pkg/FR-2016-01-19/pdf/2016-00758.pdfhttps://www.federalregister.gov/documents/2016/01/19/2016-00758/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-of-the-list-of-select-agentsIn accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and proposes to amend and republish the list. Specifically, we are proposing to remove six biological agents; add provisions to address the inactivation of select agents; add specific provisions to the section of the regulations addressing biosafety; and clarify regulatory language concerning security, training, incident response, and records.
2016-01-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Revisions to the Vaccine Injury TableThis document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''2016-00156"https://www.gpo.gov/fdsys/pkg/FR-2016-01-08/pdf/2016-00156.pdfhttps://www.federalregister.gov/documents/2016/01/08/2016-00156/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-tableThis document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''
2015-12-31RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program; CorrectionThis document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 6, 2015, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive...2015-32967"https://www.gpo.gov/fdsys/pkg/FR-2015-12-31/pdf/2015-32967.pdfhttps://www.federalregister.gov/documents/2015/12/31/2015-32967/medicare-program-end-stage-renal-disease-prospective-payment-system-and-quality-incentive-programThis document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 6, 2015, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program.''
2015-12-30RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and SuppliesThis final rule establishes a prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization. This rule defines unnecessary utilization and...2015-32506"https://www.gpo.gov/fdsys/pkg/FR-2015-12-30/pdf/2015-32506.pdfhttps://www.federalregister.gov/documents/2015/12/30/2015-32506/medicare-program-prior-authorization-process-for-certain-durable-medical-equipment-prostheticsThis final rule establishes a prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization. This rule defines unnecessary utilization and creates a new requirement that claims for certain DMEPOS items must have an associated provisional affirmed prior authorization decision as a condition of payment. This rule also adds the review contractor's decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.
2015-12-23Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentSolicitation of New Safe Harbors and Special Fraud AlertsIn accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual document solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal...2015-32267"https://www.gpo.gov/fdsys/pkg/FR-2015-12-23/pdf/2015-32267.pdfhttps://www.federalregister.gov/documents/2015/12/23/2015-32267/solicitation-of-new-safe-harbors-and-special-fraud-alertsIn accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual document solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
2015-12-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Mechanized Claims Processing and Information Retrieval Systems (90/10)This final rule will extend enhanced funding for Medicaid eligibility systems as part of a state's mechanized claims processing system, and will update conditions and standards for such systems, including adding to and updating current Medicaid...2015-30591"https://www.gpo.gov/fdsys/pkg/FR-2015-12-04/pdf/2015-30591.pdfhttps://www.federalregister.gov/documents/2015/12/04/2015-30591/medicaid-program-mechanized-claims-processing-and-information-retrieval-systems-9010This final rule will extend enhanced funding for Medicaid eligibility systems as part of a state's mechanized claims processing system, and will update conditions and standards for such systems, including adding to and updating current Medicaid Management Information Systems (MMIS) conditions and standards. These changes will allow states to improve customer service and support the dynamic nature of Medicaid eligibility, enrollment, and delivery systems.
2015-11-27RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals; CorrectionThis document corrects technical and typographical errors in the correcting document that appeared in the October 5, 2015 Federal Register, entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the...2015-30248"https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-30248.pdfhttps://www.federalregister.gov/documents/2015/11/27/2015-30248/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theThis document corrects technical and typographical errors in the correcting document that appeared in the October 5, 2015 Federal Register, entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals; Correction.''
2015-11-25RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentOccupational Safety and Health Research and Related Activities: Removal of Regulations Regarding Administrative Functions, Practices, and ProceduresWith this action, the Department of Health and Human Services (HHS) removes its regulations pertaining to fees for direct training in occupational safety and health conducted by the National Institute for Occupational Safety and Health (NIOSH) in the...2015-29827"https://www.gpo.gov/fdsys/pkg/FR-2015-11-25/pdf/2015-29827.pdfhttps://www.federalregister.gov/documents/2015/11/25/2015-29827/occupational-safety-and-health-research-and-related-activities-removal-of-regulations-regardingWith this action, the Department of Health and Human Services (HHS) removes its regulations pertaining to fees for direct training in occupational safety and health conducted by the National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC). As a part of the retrospective review conducted by all Federal agencies, HHS has determined that these regulations are no longer in use by NIOSH and should be removed.
2015-11-24RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement ServicesThis final rule implements a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas...2015-29438"https://www.gpo.gov/fdsys/pkg/FR-2015-11-24/pdf/2015-29438.pdfhttps://www.federalregister.gov/documents/2015/11/24/2015-29438/medicare-program-comprehensive-care-for-joint-replacement-payment-model-for-acute-care-hospitalsThis final rule implements a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement (LEJR) or reattachment of a lower extremity. All related care within 90 days of hospital discharge from the joint replacement procedure will be included in the episode of care. We believe this model will further our goals in improving the efficiency and quality of care for Medicare beneficiaries with these common medical procedures.
2015-11-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016This major final rule with comment period addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of...2015-28005"https://www.gpo.gov/fdsys/pkg/FR-2015-11-16/pdf/2015-28005.pdfhttps://www.federalregister.gov/documents/2015/11/16/2015-28005/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis major final rule with comment period addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
2015-11-13RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare-Dependent, Small Rural Hospitals Under the Hospital Inpatient Prospective Payment System; Provider Administrative Appeals and Judicial ReviewThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2016 to implement applicable statutory requirements and changes...2015-27943"https://www.gpo.gov/fdsys/pkg/FR-2015-11-13/pdf/2015-27943.pdfhttps://www.federalregister.gov/documents/2015/11/13/2015-27943/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2016 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, this document includes certain finalized policies relating to the hospital inpatient prospective payment system: Changes to the 2- midnight rule under the short inpatient hospital stay policy; and a payment transition for hospitals that lost their status as a Medicare- dependent, small rural hospital (MDH) because they are no longer in a rural area due to the implementation of the new Office of Management and Budget delineations in FY 2015 and have not reclassified from urban to rural before January 1, 2016. In addition, this document contains a final rule that finalizes certain 2015 proposals, and addresses public comments received, relating to the changes in the Medicare regulations governing provider administrative appeals and judicial review relating to appropriate claims in provider cost reports.
2015-11-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive ProgramThis rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2016. This rule is necessary to ensure that ESRD facilities receive accurate Medicare payment amounts for furnishing...2015-27928"https://www.gpo.gov/fdsys/pkg/FR-2015-11-06/pdf/2015-27928.pdfhttps://www.federalregister.gov/documents/2015/11/06/2015-27928/medicare-program-end-stage-renal-disease-prospective-payment-system-and-quality-incentive-programThis rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2016. This rule is necessary to ensure that ESRD facilities receive accurate Medicare payment amounts for furnishing outpatient maintenance dialysis treatments during calendar year 2016. This rule will also set forth requirements for the ESRD Quality Incentive Program (QIP), including for PYs 2017 through 2019.
2015-11-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsThis final rule will update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the...2015-27931"https://www.gpo.gov/fdsys/pkg/FR-2015-11-05/pdf/2015-27931.pdfhttps://www.federalregister.gov/documents/2015/11/05/2015-27931/medicare-and-medicaid-programs-cy-2016-home-health-prospective-payment-system-rate-update-homeThis final rule will update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2016. As required by the Affordable Care Act, this rule implements the 3rd year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking and provides a clarification regarding the use of the ``initial encounter'' seventh character applicable to certain ICD-10-CM code categories. This final rule will also finalize reductions to the national, standardized 60-day episode payment rate in CY 2016, CY 2017, and CY 2018 of 0.97 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014. In addition, this rule implements a HH value-based purchasing (HHVBP) model, beginning January 1, 2016, in which all Medicare-certified HHAs in selected states will be required to participate. Finally, this rule finalizes minor changes to the home health quality reporting program and minor technical regulations text changes.
2015-11-03Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health AgenciesThis proposed rule would revise the discharge planning requirements that Hospitals, including Long-Term Care Hospitals and Inpatient Rehabilitation Facilities, Critical Access Hospitals, and Home Health Agencies must meet in order to participate in the...2015-27840"https://www.gpo.gov/fdsys/pkg/FR-2015-11-03/pdf/2015-27840.pdfhttps://www.federalregister.gov/documents/2015/11/03/2015-27840/medicare-and-medicaid-programs-revisions-to-requirements-for-discharge-planning-for-hospitalsThis proposed rule would revise the discharge planning requirements that Hospitals, including Long-Term Care Hospitals and Inpatient Rehabilitation Facilities, Critical Access Hospitals, and Home Health Agencies must meet in order to participate in the Medicare and Medicaid programs. The proposed rule would also implement the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014.
2015-11-02RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Methods for Assuring Access to Covered Medicaid ServicesThis final rule with comment period provides for a transparent data-driven process for states to document whether Medicaid payments are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with section...2015-27697"https://www.gpo.gov/fdsys/pkg/FR-2015-11-02/pdf/2015-27697.pdfhttps://www.federalregister.gov/documents/2015/11/02/2015-27697/medicaid-program-methods-for-assuring-access-to-covered-medicaid-servicesThis final rule with comment period provides for a transparent data-driven process for states to document whether Medicaid payments are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with section 1902(a)(30)(A) of the Social Security Act (the Act) and to address issues raised by that process. The final rule with comment period also recognizes electronic publication as an optional means of providing public notice of proposed changes in rates or ratesetting methodologies that the state intends to include in a Medicaid state plan amendment (SPA). We are providing an opportunity for comment on whether future adjustments would be warranted to the provisions setting forth requirements for ongoing state reviews of beneficiary access.
2015-11-02Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Request for Information (RFI)-Data Metrics and Alternative Processes for Access to Care in the Medicaid ProgramIn this request for information (RFI), we seek public input to inform the potential development of standards with regard to Medicaid beneficiaries' access to covered services under the Medicaid program. Specifically, we are interested in obtaining...2015-27696"https://www.gpo.gov/fdsys/pkg/FR-2015-11-02/pdf/2015-27696.pdfhttps://www.federalregister.gov/documents/2015/11/02/2015-27696/medicaid-program-request-for-information-rfi-data-metrics-and-alternative-processes-for-access-toIn this request for information (RFI), we seek public input to inform the potential development of standards with regard to Medicaid beneficiaries' access to covered services under the Medicaid program. Specifically, we are interested in obtaining information on core access to care measures and metrics that could be used to measure access to care for beneficiaries in the Medicaid program (including in fee-for- service and managed care delivery systems) and used to develop local, state and national thresholds and goals to inform and improve access in the program. We are also interested in feedback on approaches to using the metrics, which could include setting access goals and thresholds and formal processes for beneficiaries to raise access concerns.
2015-10-28Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 009-Autoimmune Diseases; Finding of Insufficient EvidenceOn September 14, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 009) to add the autoimmune disease multiple sclerosis to the List of WTC-Related Health Conditions (List). Upon reviewing the...2015-27435"https://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27435.pdfhttps://www.federalregister.gov/documents/2015/10/28/2015-27435/world-trade-center-health-program-petition-009-autoimmune-diseases-finding-of-insufficient-evidenceOn September 14, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 009) to add the autoimmune disease multiple sclerosis to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 009 is not substantially different from Petitions 007 and 008, which also requested the addition of autoimmune diseases. The Administrator recently published responses to both Petition 007 and Petition 008 in the Federal Register and has determined that Petition 009 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2015-10-23RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentChange of Address for the Interior Board of Indian AppealsThe Department of Health and Human Services (HHS or the Department) is revising its regulations governing administrative appeals to reflect a change of address for the Interior Board of Indian Appeals (IBIA). The IBIA moved to a new address at 801...2015-27025"https://www.gpo.gov/fdsys/pkg/FR-2015-10-23/pdf/2015-27025.pdfhttps://www.federalregister.gov/documents/2015/10/23/2015-27025/change-of-address-for-the-interior-board-of-indian-appealsThe Department of Health and Human Services (HHS or the Department) is revising its regulations governing administrative appeals to reflect a change of address for the Interior Board of Indian Appeals (IBIA). The IBIA moved to a new address at 801 North Quincy St., Suite 300, Arlington, VA 22203 effective February 11, 2002.
2015-10-22Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentBasic Health Program; Federal Funding Methodology for Program Years 2017 and 2018This document provides the methodology and data sources necessary to determine federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits...2015-26907"https://www.gpo.gov/fdsys/pkg/FR-2015-10-22/pdf/2015-26907.pdfhttps://www.federalregister.gov/documents/2015/10/22/2015-26907/basic-health-program-federal-funding-methodology-for-program-years-2017-and-2018This document provides the methodology and data sources necessary to determine federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Marketplaces.
2015-10-20Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Request for Information Regarding Implementation of the Merit Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment ModelsThis document extends the comment period for the October 1, 2015 document entitled ``Request for Information Regarding Implementation of the Merit-based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for...2015-26568"https://www.gpo.gov/fdsys/pkg/FR-2015-10-20/pdf/2015-26568.pdfhttps://www.federalregister.gov/documents/2015/10/20/2015-26568/medicare-program-request-for-information-regarding-implementation-of-the-merit-based-incentiveThis document extends the comment period for the October 1, 2015 document entitled ``Request for Information Regarding Implementation of the Merit-based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models'' (80 FR 59102, referred to in this document as ``the October 1 RFI''). The comment period for the October 1 RFI, which would have ended on November 2, 2015, is extended for an additional 15 days. This document also advises the public and stakeholders of CMS priorities for the information sought in the October 1 RFI, and suggests that commenters may choose to focus their attention and comments accordingly.
2015-10-16RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017This final rule with comment period specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive...2015-25595"https://www.gpo.gov/fdsys/pkg/FR-2015-10-16/pdf/2015-25595.pdfhttps://www.federalregister.gov/documents/2015/10/16/2015-25595/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3-and-modificationsThis final rule with comment period specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. In addition, it changes the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. This final rule with comment period also removes reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR Incentive Programs. In addition, this final rule with comment period establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. The final rule with comment period continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs.
2015-10-15RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentDesignation of Health Professional(s) Shortage Areas2015-26249"https://www.gpo.gov/fdsys/pkg/FR-2015-10-15/pdf/2015-26249.pdfhttps://www.federalregister.gov/documents/2015/10/15/2015-26249/designation-of-health-professionals-shortage-areas
2015-10-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data Collection; CorrectionThis document corrects technical errors in the final rule that appeared in the Federal Register on August 4, 2015 entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) for FY 2016, SNF...2015-25268"https://www.gpo.gov/fdsys/pkg/FR-2015-10-05/pdf/2015-25268.pdfhttps://www.federalregister.gov/documents/2015/10/05/2015-25268/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis document corrects technical errors in the final rule that appeared in the Federal Register on August 4, 2015 entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data Collection.''
2015-10-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements; CorrectionThis document corrects technical errors that appeared in the final rule published in the Federal Register on August 6, 2014 entitled ``Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.''2015-25267"https://www.gpo.gov/fdsys/pkg/FR-2015-10-05/pdf/2015-25267.pdfhttps://www.federalregister.gov/documents/2015/10/05/2015-25267/medicare-program-fy-2016-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis document corrects technical errors that appeared in the final rule published in the Federal Register on August 6, 2014 entitled ``Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.''
2015-10-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals; CorrectionThis document corrects technical and typographical errors in the final rule and interim final rule with comment period that appeared in the Federal Register on August 17, 2015 titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems...2015-25269"https://www.gpo.gov/fdsys/pkg/FR-2015-10-05/pdf/2015-25269.pdfhttps://www.federalregister.gov/documents/2015/10/05/2015-25269/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theThis document corrects technical and typographical errors in the final rule and interim final rule with comment period that appeared in the Federal Register on August 17, 2015 titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare- Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals.''
2015-10-01Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRequest for Information Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment ModelsSection 101 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment...2015-24906"https://www.gpo.gov/fdsys/pkg/FR-2015-10-01/pdf/2015-24906.pdfhttps://www.federalregister.gov/documents/2015/10/01/2015-24906/request-for-information-regarding-implementation-of-the-merit-based-incentive-payment-systemSection 101 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible professionals (MIPS EPs) under the PFS. Section 101 of the MACRA sunsets payment adjustments under the current Physician Quality Reporting System (PQRS), the Value-Based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive Program. It also consolidates aspects of the PQRS, VM, and EHR Incentive Program into the new MIPS. Additionally, section 101 of the MACRA promotes the development of Alternative Payment Models (APMs) by providing incentive payments for certain eligible professionals (EPs) who participate in APMs, by exempting EPs from MIPS if they participate in APMs, and by encouraging the creation of physician-focused payment models (PFPMs). In this request for information (RFI), we seek public and stakeholder input to inform our implementation of these provisions.
2015-10-01RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2014 (FY 2015); CorrectionThis document corrects technical errors that appeared in the final rule published in the Federal Register on August 6, 2014 entitled ``Inpatient Psychiatric Facilities Prospective Payment System--Update for Fiscal Year Beginning October 1, 2014 (FY...2015-24998"https://www.gpo.gov/fdsys/pkg/FR-2015-10-01/pdf/2015-24998.pdfhttps://www.federalregister.gov/documents/2015/10/01/2015-24998/medicare-program-inpatient-psychiatric-facilities-prospective-payment-system-update-for-fiscal-yearThis document corrects technical errors that appeared in the final rule published in the Federal Register on August 6, 2014 entitled ``Inpatient Psychiatric Facilities Prospective Payment System--Update for Fiscal Year Beginning October 1, 2014 (FY 2015); Final Rule.''
2015-10-01Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment SystemThis proposed rule would significantly revise the Medicare payment system for clinical diagnostic laboratory tests and would implement other changes required by section 216 of the Protecting Access to Medicare Act of 2014.2015-24770"https://www.gpo.gov/fdsys/pkg/FR-2015-10-01/pdf/2015-24770.pdfhttps://www.federalregister.gov/documents/2015/10/01/2015-24770/medicare-program-medicare-clinical-diagnostic-laboratory-tests-payment-systemThis proposed rule would significantly revise the Medicare payment system for clinical diagnostic laboratory tests and would implement other changes required by section 216 of the Protecting Access to Medicare Act of 2014.
2015-09-15Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities; Reopening of Comment PeriodThis document reopens the comment period for the July 16, 2015 proposed rule entitled ``Reform of Requirements for Long-Term Care Facilities''. The comment period for the proposed rule, which ends on September 14, 2015, is reopened for 30 days.2015-23110"https://www.gpo.gov/fdsys/pkg/FR-2015-09-15/pdf/2015-23110.pdfhttps://www.federalregister.gov/documents/2015/09/15/2015-23110/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities-reopening-ofThis document reopens the comment period for the July 16, 2015 proposed rule entitled ``Reform of Requirements for Long-Term Care Facilities''. The comment period for the proposed rule, which ends on September 14, 2015, is reopened for 30 days.
2015-09-11Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Addition of New-Onset Chronic Obstructive Pulmonary Disease and Acute Traumatic Injury to the List of WTC-Related Health ConditionsThe World Trade Center (WTC) Health Program, at the direction of the Administrator, conducted a review of published studies regarding potential evidence of chronic obstructive pulmonary disease (COPD) and acute traumatic injury among individuals who...2015-22599"https://www.gpo.gov/fdsys/pkg/FR-2015-09-11/pdf/2015-22599.pdfhttps://www.federalregister.gov/documents/2015/09/11/2015-22599/world-trade-center-health-program-addition-of-new-onset-chronic-obstructive-pulmonary-disease-andThe World Trade Center (WTC) Health Program, at the direction of the Administrator, conducted a review of published studies regarding potential evidence of chronic obstructive pulmonary disease (COPD) and acute traumatic injury among individuals who were responders to or survivors of the September 11, 2001, terrorist attacks. The Administrator of the WTC Health Program found that these studies provided substantial support for a causal relationship between the health conditions and 9/11 exposures. As a result, the Administrator has determined to publish a proposed rule to add new- onset COPD and to add acute traumatic injury to the List of WTC-Related Health Conditions eligible for treatment coverage in the WTC Health Program.
2015-09-08RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Institute on Minority Health and Health Disparities Research EndowmentsThe National Institutes of Health (NIH), through the Department of Health and Human Services (HHS), is issuing regulations governing the National Institute on Minority Health and Health Disparities (NIMHD) endowment grants awarded to section 736 and...2015-22018"https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-22018.pdfhttps://www.federalregister.gov/documents/2015/09/08/2015-22018/national-institute-on-minority-health-and-health-disparities-research-endowmentsThe National Institutes of Health (NIH), through the Department of Health and Human Services (HHS), is issuing regulations governing the National Institute on Minority Health and Health Disparities (NIMHD) endowment grants awarded to section 736 and section 464z-4 Centers of Excellence to facilitate minority health disparities research and other health disparities research.
2015-09-02Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; End-Stage Renal Disease Prospective Payment System; CorrectionThis document corrects a technical error that appeared in the proposed rule published in the Federal Register on July 1, 2015, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program.''2015-21783"https://www.gpo.gov/fdsys/pkg/FR-2015-09-02/pdf/2015-21783.pdfhttps://www.federalregister.gov/documents/2015/09/02/2015-21783/medicare-program-end-stage-renal-disease-prospective-payment-system-correctionThis document corrects a technical error that appeared in the proposed rule published in the Federal Register on July 1, 2015, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program.''
2015-08-25RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPayment for Part B Medical and Other Health Services2015-21003"https://www.gpo.gov/fdsys/pkg/FR-2015-08-25/pdf/2015-21003.pdfhttps://www.federalregister.gov/documents/2015/08/25/2015-21003/payment-for-part-b-medical-and-other-health-services
2015-08-25RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentQuality Improvement Organization Review2015-20993"https://www.gpo.gov/fdsys/pkg/FR-2015-08-25/pdf/2015-20993.pdfhttps://www.federalregister.gov/documents/2015/08/25/2015-20993/quality-improvement-organization-review
2015-08-25Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; CorrectionsThis document corrects technical and typographical errors that appeared in the proposed rule published in the July 14, 2015 Federal Register entitled ``Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals...2015-20994"https://www.gpo.gov/fdsys/pkg/FR-2015-08-25/pdf/2015-20994.pdfhttps://www.federalregister.gov/documents/2015/08/25/2015-20994/medicare-program-comprehensive-care-for-joint-replacement-payment-model-for-acute-care-hospitalsThis document corrects technical and typographical errors that appeared in the proposed rule published in the July 14, 2015 Federal Register entitled ``Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services.''
2015-08-18Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements; CorrectionThis document corrects technical errors in the proposed rule that appeared in the July 10, 2015 Federal Register entitled ``Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value- Based Purchasing...2015-20336"https://www.gpo.gov/fdsys/pkg/FR-2015-08-18/pdf/2015-20336.pdfhttps://www.federalregister.gov/documents/2015/08/18/2015-20336/medicare-and-medicaid-programs-cy-2016-home-health-prospective-payment-system-rate-update-homeThis document corrects technical errors in the proposed rule that appeared in the July 10, 2015 Federal Register entitled ``Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value- Based Purchasing Model; and Home Health Quality Reporting Requirements.''
2015-08-17RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for HospitalsWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2016. Some of these...2015-19049"https://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-19049.pdfhttps://www.federalregister.gov/documents/2015/08/17/2015-19049/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theWe are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2016. Some of these changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act), the Pathway for Sustainable Growth Reform (SGR) Act of 2013, the Protecting Access to Medicare Act of 2014, the Improving Medicare Post- Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, and other legislation. We also are addressing the update of the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2016. As an interim final rule with comment period, we are implementing the statutory extensions of the Medicare-dependent, small rural hospital (MDH) Program and changes to the payment adjustment for low-volume hospitals under the IPPS. We also are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2016 and implementing certain statutory changes to the LTCH PPS under the Affordable Care Act and the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 and the Protecting Access to Medicare Act of 2014. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs) that are participating in Medicare, including related provisions for eligible hospitals and critical access hospitals participating in the Medicare Electronic Health Record (EHR) Incentive Program. We also are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.
2015-08-13Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentOccupational Safety and Health Research and Related Activities; Administrative Functions, Practices, and ProceduresThe Department of Health and Human Services (HHS) proposes the removal of its regulations pertaining to administrative functions, practices, and procedures for occupational safety and health research and related activities conducted by the National...2015-19856"https://www.gpo.gov/fdsys/pkg/FR-2015-08-13/pdf/2015-19856.pdfhttps://www.federalregister.gov/documents/2015/08/13/2015-19856/occupational-safety-and-health-research-and-related-activities-administrative-functions-practicesThe Department of Health and Human Services (HHS) proposes the removal of its regulations pertaining to administrative functions, practices, and procedures for occupational safety and health research and related activities conducted by the National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC). As a part of the retrospective review conducted by all Federal agencies, HHS has determined that these regulations are no longer in use by NIOSH and should be removed.
2015-08-12RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Institutes of Health Undergraduate Scholarship Program Regarding Professions Needed by National Research InstitutesThe National Institutes of Health (NIH), through the Department of Health and Human Services (HHS), is issuing regulations to implement provisions of the Public Health Service Act authorizing the NIH Undergraduate Scholarship Program Regarding...2015-19739"https://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19739.pdfhttps://www.federalregister.gov/documents/2015/08/12/2015-19739/national-institutes-of-health-undergraduate-scholarship-program-regarding-professions-needed-byThe National Institutes of Health (NIH), through the Department of Health and Human Services (HHS), is issuing regulations to implement provisions of the Public Health Service Act authorizing the NIH Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes (UGSP). The purpose of the program is to recruit appropriately qualified undergraduate students from disadvantaged backgrounds to conduct research in the intramural research program as employees of the NIH by providing scholarship support.
2015-08-12RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentClosed-Circuit Escape Respirators; Extension of Transition PeriodIn March 2012, the Department of Health and Human Services (HHS) published a final rule establishing a new standard for the certification of closed-circuit escape respirators (CCERs) by the National Institute for Occupational Safety and Health (NIOSH)...2015-19750"https://www.gpo.gov/fdsys/pkg/FR-2015-08-12/pdf/2015-19750.pdfhttps://www.federalregister.gov/documents/2015/08/12/2015-19750/closed-circuit-escape-respirators-extension-of-transition-periodIn March 2012, the Department of Health and Human Services (HHS) published a final rule establishing a new standard for the certification of closed-circuit escape respirators (CCERs) by the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC). The new standard was originally designed to take effect over a 3-year transition period. HHS has determined that extending the concluding date for the transition is necessary to allow sufficient time for respirator manufacturers to meet the demands of the mining, maritime, railroad and other industries. Pursuant to this final action, NIOSH extends the phase-in period until 1 year after the date that the first approval is granted to certain CCER models.
2015-08-07RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCountermeasures Injury Compensation Program: Pandemic Influenza Countermeasures Injury TableHHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services...2015-19228"https://www.gpo.gov/fdsys/pkg/FR-2015-08-07/pdf/2015-19228.pdfhttps://www.federalregister.gov/documents/2015/08/07/2015-19228/countermeasures-injury-compensation-program-pandemic-influenza-countermeasures-injury-tableHHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services (Secretary) adds regulations for the purpose of creating Covered Countermeasures Injury Tables. The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus (hereafter referred to as the 2009 H1N1 virus) and other potential pandemic strains, such as H5N1 avian influenza.
2015-08-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting RequirementsThis final rule will update the hospice payment rates and the wage index for fiscal year (FY) 2016 (October 1, 2015 through September 30, 2016), including implementing the last year of the phase-out of the wage index budget neutrality adjustment factor...2015-19033"https://www.gpo.gov/fdsys/pkg/FR-2015-08-06/pdf/2015-19033.pdfhttps://www.federalregister.gov/documents/2015/08/06/2015-19033/medicare-program-fy-2016-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reportingThis final rule will update the hospice payment rates and the wage index for fiscal year (FY) 2016 (October 1, 2015 through September 30, 2016), including implementing the last year of the phase-out of the wage index budget neutrality adjustment factor (BNAF). Effective on January 1, 2016, this rule also finalizes our proposals to differentiate payments for routine home care (RHC) based on the beneficiary's length of stay and implement a service intensity add-on (SIA) payment for services provided in the last 7 days of a beneficiary's life, if certain criteria are met. In addition, this rule will implement changes to the aggregate cap calculation mandated by the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act), align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the federal fiscal year starting in FY 2017, make changes to the hospice quality reporting program, clarify a requirement for diagnosis reporting on the hospice claim, and discuss recent hospice payment reform research and analyses.
2015-08-06RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2016This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2016 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and...2015-18973"https://www.gpo.gov/fdsys/pkg/FR-2015-08-06/pdf/2015-18973.pdfhttps://www.federalregister.gov/documents/2015/08/06/2015-18973/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscalThis final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2016 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF PPS's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2016. This final rule also finalizes policy changes, including the adoption of an IRF-specific market basket that reflects the cost structures of only IRF providers, a 1-year phase-in of the revised wage index changes, a 3-year phase-out of the rural adjustment for certain IRFs, and revisions and updates to the quality reporting program (QRP).
2015-08-05RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2015 (FY 2016)This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) (which are freestanding IPFs and psychiatric units of an acute care hospital or critical access...2015-18903"https://www.gpo.gov/fdsys/pkg/FR-2015-08-05/pdf/2015-18903.pdfhttps://www.federalregister.gov/documents/2015/08/05/2015-18903/medicare-program-inpatient-psychiatric-facilities-prospective-payment-system-update-for-fiscal-yearThis final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) (which are freestanding IPFs and psychiatric units of an acute care hospital or critical access hospital). These changes are applicable to IPF discharges occurring during fiscal year (FY) 2016 (October 1, 2015 through September 30, 2016). This final rule also implements: a new 2012-based IPF market basket; an updated IPF labor- related share; a transition to new Core Based Statistical Area (CBSA) designations in the FY 2016 IPF Prospective Payment System (PPS) wage index; a phase-out of the rural adjustment for IPF providers whose status changes from rural to urban as a result of the wage index CBSA changes; and new quality measures and reporting requirements under the IPF quality reporting program. This final rule also reminds IPFs of the October 1, 2015 implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), and updates providers on the status of IPF PPS refinements.
2015-08-04RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data CollectionThis final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2016. In addition, it specifies a SNF all-cause all-condition hospital readmission measure, as well as...2015-18950"https://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-18950.pdfhttps://www.federalregister.gov/documents/2015/08/04/2015-18950/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilitiesThis final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2016. In addition, it specifies a SNF all-cause all-condition hospital readmission measure, as well as adopts that measure for a new SNF Value-Based Purchasing (VBP) Program, and includes a discussion of SNF VBP Program policies we are considering for future rulemaking to promote higher quality and more efficient health care for Medicare beneficiaries. Additionally, this final rule will implement a new quality reporting program for SNFs as specified in the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). It also amends the requirements that a long-term care (LTC) facility must meet to qualify to participate as a skilled nursing facility (SNF) in the Medicare program, or a nursing facility (NF) in the Medicaid program, by establishing requirements that implement the provision in the Affordable Care Act regarding the submission of staffing information based on payroll data.
2015-08-04Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements; CorrectionThis document corrects technical errors in the proposed rule that appeared in the July 10, 2015 Federal Register entitled ``Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing...2015-19079"https://www.gpo.gov/fdsys/pkg/FR-2015-08-04/pdf/2015-19079.pdfhttps://www.federalregister.gov/documents/2015/08/04/2015-19079/medicare-and-medicaid-programs-cy-2016-home-health-prospective-payment-system-rate-update-homeThis document corrects technical errors in the proposed rule that appeared in the July 10, 2015 Federal Register entitled ``Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements.''
2015-07-29Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Revisions to the Vaccine Injury TableThe Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final...2015-17503"https://www.gpo.gov/fdsys/pkg/FR-2015-07-29/pdf/2015-17503.pdfhttps://www.federalregister.gov/documents/2015/07/29/2015-17503/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-tableThe Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.
2015-07-16Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; Reform of Requirements for Long-Term Care FacilitiesThis proposed rule would revise the requirements that Long- Term Care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances that have been made over the past...2015-17207"https://www.gpo.gov/fdsys/pkg/FR-2015-07-16/pdf/2015-17207.pdfhttps://www.federalregister.gov/documents/2015/07/16/2015-17207/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilitiesThis proposed rule would revise the requirements that Long- Term Care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These proposals are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.
2015-07-16Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPossession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and ToxinsThe Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is proposing to add certain influenza virus strains to the list of HHS select agents and toxins. Specifically, we are proposing to add the...2015-17435"https://www.gpo.gov/fdsys/pkg/FR-2015-07-16/pdf/2015-17435.pdfhttps://www.federalregister.gov/documents/2015/07/16/2015-17435/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-certain-influenza-virus-strainsThe Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is proposing to add certain influenza virus strains to the list of HHS select agents and toxins. Specifically, we are proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. We have determined that these influenza viruses have the potential to pose a severe threat to public health and safety.
2015-07-15Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016This major proposed rule addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as...2015-16875"https://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdfhttps://www.federalregister.gov/documents/2015/07/15/2015-16875/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsThis major proposed rule addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
2015-07-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConditions of Participation for Hospitals2015-17127"https://www.gpo.gov/fdsys/pkg/FR-2015-07-14/pdf/2015-17127.pdfhttps://www.federalregister.gov/documents/2015/07/14/2015-17127/conditions-of-participation-for-hospitals
2015-07-14RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentAcquisition, Protection, and Disclosure of Quality Improvement Organization Information2015-17128"https://www.gpo.gov/fdsys/pkg/FR-2015-07-14/pdf/2015-17128.pdfhttps://www.federalregister.gov/documents/2015/07/14/2015-17128/acquisition-protection-and-disclosure-of-quality-improvement-organization-information
2015-07-14Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement ServicesThis proposed rule proposes to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CCJR) model, in which acute care hospitals in certain selected...2015-17190"https://www.gpo.gov/fdsys/pkg/FR-2015-07-14/pdf/2015-17190.pdfhttps://www.federalregister.gov/documents/2015/07/14/2015-17190/medicare-program-comprehensive-care-for-joint-replacement-payment-model-for-acute-care-hospitalsThis proposed rule proposes to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CCJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement or reattachment of a lower extremity. All related care within 90 days of hospital discharge from the joint replacement procedures will be included in the episode of care. We believe this model will further our goals in improving the efficiency and quality of care for Medicare beneficiaries for these common medical procedures.
2015-07-10Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsThis proposed rule would update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under...2015-16790"https://www.gpo.gov/fdsys/pkg/FR-2015-07-10/pdf/2015-16790.pdfhttps://www.federalregister.gov/documents/2015/07/10/2015-16790/medicare-and-medicaid-programs-cy-2016-home-health-prospective-payment-system-rate-update-homeThis proposed rule would update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2016. As required by the Affordable Care Act, this proposed rule implements the third year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This proposed rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments. This proposed rule also proposes: reductions to the national, standardized 60-day episode payment rate in CY 2016 and CY 2017 of 1.72 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014; a HH value-based purchasing (HHVBP) model to be implemented beginning January 1, 2016 in which all Medicare-certified HHAs in selected states will be required to participate; changes to the home health quality reporting program requirements; and minor technical regulations text changes. Finally, this proposed rule would update the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking and provide an update on the Report to Congress regarding the home health (HH) study.
2015-07-10Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWorld Trade Center Health Program; Petition 008-Autoimmune Diseases; Finding of Insufficient EvidenceOn May 11, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 008) to add autoimmune diseases to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the...2015-16942"https://www.gpo.gov/fdsys/pkg/FR-2015-07-10/pdf/2015-16942.pdfhttps://www.federalregister.gov/documents/2015/07/10/2015-16942/world-trade-center-health-program-petition-008-autoimmune-diseases-finding-of-insufficient-evidenceOn May 11, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 008) to add autoimmune diseases to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 008 is not substantially different from Petition 007, which also requested the addition of autoimmune diseases. The Administrator recently published a response to Petition 007 in the Federal Register and has determined that Petition 008 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
2015-07-08Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare-Dependent, Small Rural Hospitals Under the Hospital Inpatient Prospective Payment SystemThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2016 to implement applicable statutory requirements and changes arising from our...2015-16577"https://www.gpo.gov/fdsys/pkg/FR-2015-07-08/pdf/2015-16577.pdfhttps://www.federalregister.gov/documents/2015/07/08/2015-16577/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-paymentThis proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2016 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, this proposed rule includes certain proposals relating to the hospital inpatient prospective payment system: proposed changes to the 2-midnight rule under the short inpatient hospital stay policy, as well as a discussion of the related -0.2 percent payment adjustment; and a proposed transition for Medicare-dependent, small rural hospitals located in all-urban States.
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