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Health and Human Services Grants Regulation
The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (D.D.C. Feb. 2, 2021), has postponed the effectiveness of portions of the final rule making amendments to the Uniform Administrative Requirements, promulgated on January 12, 2021. Those provisions are now effective August 11, 2021.
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Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19); Correction
This document corrects technical and typographical errors in the final rule with comment period and interim final rule with comment period published in the Federal Register on December 29, 2020, titled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for...
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Enforcement Discretion Regarding Online or Web-Based Scheduling Applications for the Scheduling of Individual Appointments for COVID-19 Vaccination During the COVID-19 Nationwide Public Health Emergency
This Notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical...
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New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications (NADAs) for lack of compliance with the reporting requirements in an FDA regulation.
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New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.
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National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Delay of Effective Date
In accordance with the Presidential directive as expressed in the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action delays until April 23, 2021, the effective date of the rule entitled ``National Vaccine Injury Compensation Program: Revisions to the...
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Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Delayed Effective Date
As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (``Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving...
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Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correcting Amendment
This document corrects a typographical error in the final rule that appeared in the December 28, 2020 Federal Register (hereinafter referred to as the CY 2021 PFS final rule). The effective date was January 1, 2021.
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Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' and given the pendency of litigation, Pharmaceutical Care Management Association v. U.S. Department of Health and Human Services, et al., Civil Action No. 21-95 (JDB) (D.D.C.), challenging...
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Medicare Program; Secure Electronic Prior Authorization for Medicare Part D Program; Delay in Effective Date
In accordance with the memorandum of January 20, 2021 from the Assistant to the President and the Chief of Staff, entitled ``Regulatory Review,'' this action temporarily delays for 60 days the effective date of the December 31, 2020 final rule entitled, ``Medicare Program; Secure Electronic Prior Authorization For Medicare Part D'', which...
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Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations; Public Comment Period; Delay of Effective Date
In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action temporarily delays for 60 days the effective date of part of the final rule entitled, ``Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage:...
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Implementation of Executive Order on Access to Affordable Life-Saving Medications
In accordance with the memorandum of January 20, 2021, 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 ``Implementation of Executive Order on Access to Affordable...
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National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
The Secretary finalizes the proposed rule to amend the Vaccine Injury Table (Table) by regulation. This final rule will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after this final rule become effective. This final rule does not impact COVID-19 vaccines or PREP Act immunity...
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Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations
This final rule sets forth provisions related to user fees for federally-facilitated Exchanges and State-based Exchanges on the Federal Platform. It includes changes related to acceptance of payments by issuers of individual market Qualified Health Plans and clarifies the regulation imposing network adequacy standards with regard to Qualified...
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Securing Updated and Necessary Statutory Evaluations Timely
The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department's regulations have...
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Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correction
This document corrects technical errors in the final rule that appeared in the December 28, 2020, Federal Register under the same as title above. Hereinafter, the December 28 rule is referred to as the CY 2021 PFS final rule.
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Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly
This final rule will revise regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly (PACE) to implement certain sections of the Bipartisan Budget Act of 2018 and the Substance Use Disorder...
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Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is January 14, 2022.
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Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions
The Department of Health and Human Services is issuing regulations promoting transparency and fairness in civil enforcement actions. These regulations will help to ensure that regulated parties receive fair notice of laws and regulations they are subject to, and have an opportunity to contest an agency determination prior to the agency taking an...
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Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage...