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Drug Pricing Proposed Rules Prescription Drugs

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

McDermott Will & Schulte

Reducing hospital payments: CMS proposes expanded site-neutral payment policy for drug administration services

Consistent with recent attention from Congress and rhetoric from the Trump administration, the Calendar Year 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (the Proposed Rule) includes...more

McDermott Will & Schulte

CMS CY 2026 proposed rules: 340B in PFS and OPPS

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Outpatient Prospective Payment System (OPPS) proposed rule. The proposed rule includes a provision that would increase the reduction in...more

Sheppard Mullin Richter & Hampton LLP

Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

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On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

King & Spalding

Executive Order to Deliver Lower Prescription Drug Prices

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On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #3

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

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

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 - December 2023 #3

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This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more

Epstein Becker & Green

Medicare Advantage, Part D, and More: Proposed Rule Outlines Significant Policy and Technical Changes for CY 2025

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On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

McGuireWoods Consulting

Washington Healthcare Update - November 2023

This Week in Washington: Senate Finance Committee releases discussion draft for Nov. 8 markup; White House issues executive order on AI; House passes two appropriations bills; Senate passes minibus....more

Holland & Knight LLP

Holland & Knight Health Dose: September 12, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott+

McDermottPlus Check-Up: September 8, 2023

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CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

Foley & Lardner LLP

CMS Proposes Remedy for 340B-Acquired Drug Payment Policy for CY 2018-2022

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Along with its calendar year (CY) 2024 Medicare Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) have also published the long-awaited proposal to remediate the...more

Bricker Graydon LLP

340B Update: Proposed Rule on Drug Acquisition Cost Cuts Suggests Lump Sum Repayment

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The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more

Holland & Knight LLP

CMS Proposes Returning $9 Billion to More Than 1,600 Hospitals

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The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more

Polsinelli

CMS Proposes $9B in Relief for 340B Hospitals

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340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022.  CMS discussed a...more

McDermott Will & Schulte

CMS Releases Proposed Remedy for 340B-Acquired Drugs Purchased in CYs 2018–2022

On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule, Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased for Calendar Years 2018–2022, to...more

McGuireWoods Consulting

Washington Healthcare Update - June 2023 #4

This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare...more

McGuireWoods Consulting

Washington Healthcare Update - June 2023 #3

This Week in Washington: FDA funding bill passes House Appropriations Committee, MedPAC and MacPAC release June 2023 report to Congress, RSC budget blueprint brings back premium support concept for Medicare...more

McGuireWoods Consulting

Washington Healthcare Update - June 2023 #2

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

King & Spalding

CMS Issues Proposed Rule Regarding the Medicaid Drug Rebate Program

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On May 26, 2023, CMS published a proposed rule that would implement new policies under the Medicaid Drug Rebate Program (MDRP) to: (1) address situations in which drug manufacturers incorrectly report or misclassify their...more

McGuireWoods Consulting

Washington Healthcare Update - May 2023 #3

This Week in Washington: President and Speaker McCarthy to meet on debt limit with 10 days to go, House Energy and Commerce Subcommittee on Health marks up 17 bills, House Appropriations Committee begins moving appropriation...more

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