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Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...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

Bradley Arant Boult Cummings LLP

DEA Proposed Rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations

On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more

Holland & Knight LLP

New York State Department of Health Issues Long-Awaited Guidance on Material Transactions Law

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The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...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

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

Holland & Knight LLP

U.S. Drug Enforcement Administration Proposes Reclassification of Marijuana

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The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug, thereby loosening federal DEA restrictions....more

McDermott Will & Schulte

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

McDermott Will & Schulte

Trending in Telehealth: January 4 – 15, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Seyfarth Shaw LLP

The Week in Weed: December 2023 # 3

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. Ohio legislators are busy writing a marijuana law. STATES 2.0 makes an appearance in Congress. The Department of...more

McDermott Will & Schulte

New York Withdraws Proposed Market Conduct Regulations for PBMs, Adopts Licensure Rules

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On October 31, 2023, the New York State Department of Financial Services (DFS) released a notice withdrawing its proposed market conduct rules for pharmacy benefit managers (PBMs). The proposed rules, announced August 16,...more

Quarles & Brady LLP

Mississippi Board of Pharmacy Approves Final Rule on Shared Pharmacy Services with Minor Modifications

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On September 21, 2023, the Mississippi Board of Pharmacy (the “Board”) voted to approve and finalize modifications to its proposed rule on shared services. The Board had initially published the proposed rule on June 10, 2022....more

Quarles & Brady LLP

New York Abandons Proposed Rule Addressing Central Fill Arrangements, Will Seek Statutory Change

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On Sept.12, 2023, the New York State Education Department announced its new plan to address central fill arrangements. The Department informed stakeholders who had submitted comments to its proposed central fill rule that it...more

Quarles & Brady LLP

After Years of Silence, New York Proposes New Rule Addressing Central Fill Arrangements

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On June 28, 2023, the New York Education Department, which oversees the Office of Professions and Board of Pharmacy in the state, published long-awaited proposed regulations governing central fill arrangements in the state....more

Mintz - Health Care Viewpoints

Telehealth Update: DEA Issues Long-Awaited Proposed Rule on Prescribing Controlled Substances via Telehealth

With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances...more

McDermott Will & Schulte

Court Rules in Favor of Manufacturers in 340B Contract Pharmacy Case

Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to...more

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

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On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

Quarles & Brady LLP

Hot Off the Press: Mississippi Board of Pharmacy Files Proposed Rule on Shared Pharmacy Services

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On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

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Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

McDermott Will & Schulte

FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics...

The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more

Holland & Knight LLP

Proposed FDA Rules Could Be Game Changers for the Pharmaceutical Supply Chain

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New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more

Mintz - Health Care Viewpoints

CMS Proposes Changes to Part D Regulations: Pharmacy Price Concessions

The next post in our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rule (Proposed Rule) focuses on a...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

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PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

ArentFox Schiff

CMS Releases Proposed Changes for Medicare Advantage and Medicare Part D

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The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more

King & Spalding

CMS Issues Medicare Advantage and Part D Proposed Rule for Contract Year 2021 and 2022

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On February 5, 2020, CMS issued a proposed rule advancing multiple updates and changes to Medicare Advantage (MA) and Medicare prescription drug benefit (Part D) programs (Proposed Rule). Unlike in past years, CMS will not...more

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