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Alston & Bird

Health Care Week in Review | Draft MAHA Commission Strategy Document Circulated; President Trump Signs EO Aiming to Fill Drug...

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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

Mintz - Health Care Viewpoints

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

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

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

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On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Foley & Lardner LLP

Direct-to-Consumer Drug Ads Are Under Attack – Pharmaceutical Companies Beware

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On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged 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

A&O Shearman

China advances pharmaceutical data protection regime with new Draft Measures

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On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...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

McDermott+

CY 2026 MA and Part D Final Reg: Policies Under Consideration

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Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Axinn, Veltrop & Harkrider LLP

Pounding the Compounders: FDA’s “No Compound” Lists

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more

Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

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On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

Jones Day

DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

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The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

Morgan Lewis

DEA Proposed Telemedicine Prescribing Rule Could Burden Hospice Physicians and Hospice Operations

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Signaling a possible future approach to regulating Schedule II-V prescribing via telemedicine in lieu of in-person examinations, on January 17 the DEA issued a notice of proposed rulemaking regarding its next iteration of...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

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Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

Sheppard Mullin Richter & Hampton LLP

Key Proposals from the CY 2026 Medicare Advantage and Part D Proposed Rule

On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

Bass, Berry & Sims PLC

CMS CY 2026 Parts C and D Proposals Focus on Informed Choice

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On December 10, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule, which, if finalized as proposed, has potentially significant implications for Medicare Advantage (MA) plans and Medicare...more

DLA Piper

CMS Releases New Proposed Rule for Medicare Advantage and Part D

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On December 10, 2024, the Centers for Medicare and Medicaid Services (CMS) released a Proposed Rule for revisions to the regulations governing the Medicare Advantage (MA) program, Medicare Prescription Benefit (Part D),...more

Venable LLP

Novo Nordisk Pushes for FDA Listing of Semaglutide Products

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On October 22, Novo Nordisk (Novo) nominated semaglutide products, which include its popular drugs marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, for inclusion on FDA's Demonstrable...more

Benesch

Dialysis & Nephrology Digest - October 2024

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The House Ways and Means Committee has postponed discussions on several healthcare bills, including those related to physician pay, due to scheduling conflicts and disagreements over legislative language. This delay affects...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....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

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