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Medicaid › Drug Pricing › Final Rules

Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +
Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with children.  less -
Alston & Bird

Health Care Week in Review: CMS Releases PFS, OPPS, ESRD, and Home Health Final Rules; Senators Cassidy and Hassan Release a...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

CMS Releases Final Rule on the Medicaid Drug Rebate Program

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The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #3

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This Week in Washington: CBO releases analysis of health insurance rates; Senate Finance Committee Chairman releases draft legislation concerning labor and delivery unit closures; House Oversight and Accountability Committee...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024

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This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024

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This Week in Washington: CMS releases 2025 MA and Part D proposed payment Advance Notice; CMS sends first fair drug price offers to Drug Price Negotiation Program companies; SAMHSA releases final rule making virtual...more

McGuireWoods Consulting

Washington Healthcare Update - June 2023 #2

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This Week in Washington: Fallout from debt ceiling holds up House floor action; SCOTUS rules to allow patients to sue nursing homes...more

McGuireWoods Consulting

Washington Healthcare Update - May 2022 #4

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Congress - The House and Senate are in recess for Memorial Day. House - Rep. Underwood Leads 26 Democratic House Members in Letter Calling for Measures to Lower Healthcare Costs to be Included in Reconciliation...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - November 2021

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Drug Pricing Initiatives: Late on Nov. 5, 2021, the House of Representatives passed H.R. 3684 (the Infrastructure Investment and Jobs Act). This $1 trillion infrastructure bill, which was passed earlier by the Senate, is part...more

McGuireWoods Consulting

Washington Healthcare Update - August 2021 #3

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This week in Washington: Senate passes infrastructure bill; Senate passes budget resolution with reconciliation instructions; Congress enters recess with House members to return Aug. 23....more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

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Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Sheppard Mullin Richter & Hampton LLP

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

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On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

K&L Gates LLP

K&L Gates Triage: Looking Ahead to 2020: Developing Issues in Pharmacy Law and the 340B Drug Pricing Program

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In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more

Sheppard Mullin Richter & Hampton LLP

340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information...

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Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”),...more

Polsinelli

CMS Delays Price Transparency, Doubles Down on Site-Neutral and 340B Payment Policies in CY 2020 OPPS Final Rule

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Late last week, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment System (“OPPS”) final rule [CMS-1717-FC]. While many hospitals had hoped for relief from recent...more

Dorsey & Whitney LLP

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

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In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May...more

Arnall Golden Gregory LLP

CMS Finalizes Rule Requiring Prescription Drug Price Information in Direct-to-Consumer Television Advertisements

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On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule requiring that direct-to-consumer television advertisements for prescription drugs and biological products include certain pricing...more

King & Spalding

CMS Delays Effective Date for “5i AMP” Provision in Medicaid Outpatient Drug Final Rule

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On March 31, 2016, CMS announced that it was delaying the April 1, 2016 effective date for manufacturers to calculate the average manufacturer price (“AMP”) for the so-called “5i-drugs” – i.e., inhalation, infusion,...more

Mintz - Health Care Viewpoints

CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note

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Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and...more

Mintz

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

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In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

King & Spalding

Also In The News - Health Headlines - January 2016 #4

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CBO Projects Medicare Spending Growth – In a report published January 25, 2016, the Congressional Budget Office (CBO) estimates that expenditures for Medicare, Medicaid, and other major healthcare programs will equal...more

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