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Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2022
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the proposed rule includes a proposed forecast error adjustment for FY 2022, proposes updates to the diagnosis code mappings used under the Patient Driven Payment Model...
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Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements
This rule proposes updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. This rule proposes changes to the labor shares of the hospice payment rates, proposes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020, includes information on hospice...
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Medicare Program; FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)
This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access...
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Electronic Import Entries; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The present revisions are necessary to correct editorial errors and to...
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Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections
On August 31, 2016, the Food and Drug Administration (FDA or Agency) published an amended final rule that listed inaccurate cross- references to FDA's drug establishment registration and drug listing regulations. This document corrects the inaccurate cross-references used in the final regulations.
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New Animal Drugs; Approval of New Animal Drug Applications
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2020. FDA is informing the public of the availability of summaries of the basis of...
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Medical Devices; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete office with updated information. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to...
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New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2020. FDA is informing the public of the availability of summaries of the basis of approval...
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New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2020. FDA is informing the public of the availability of summaries of the basis of approval and of...
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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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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.