News & Analysis as of

Life Sciences Department of Health and Human Services (HHS) Drug Pricing

Quarles & Brady LLP

The 340B Program in 2024: A Tumultuous Year in Review

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The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in...more

Alston & Bird

Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules;...

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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

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

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On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to the IRA and Other Drug Pricing Initiatives: Impact on Life Sciences Investments

The Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022, and includes key sections addressing climate and clean energy, corporate taxes and health care. The health care provisions...more

Alston & Bird

Health Care Week in Review: HHS Finalizes Rule Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; Senate Finance...

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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

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

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In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

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The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

A&O Shearman

HHS selects the first drugs for Medicare drug price negotiation

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\On August 29, 2023, Health and Human Services (“HHS”) announced the first ten drugs covered by Medicare Part D selected for negotiation under President Biden’s Inflation Reduction Act of 2022 (“IRA”), which was signed into...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senate Once Again Tries to Address Drug Pricing

Over the past several years Congress has tried to address high drug prices, with variable success  (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived Remedies from Congress Regarding...more

Goodwin

Federal Court of Appeals Rejects HHS Stance on Section 340B Contract Pharmacies

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On January 30, 2023, the Court of Appeals for the Third Circuit issued a precedential decision rejecting a policy of the Department of Health and Human Services (HHS) in implementing the 340B Program. Under that policy, HHS...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

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2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - September 2022

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Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022. Republican leaders on the House Energy & Commerce and...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2022

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2022 Medicaid & Government Pricing Congress Concludes: The annual Medicaid & Government Pricing Congress took place in Philadelphia from May 23-25 and virtually from June 1-2. On May 25, Latham partner Christopher H. Schott...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2022

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Drug Pricing Initiatives: In advance of the midterm elections in November, discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - April 2022

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Biden Administration Releases FY 2023 Budget - The Biden Administration’s proposed Budget of the U.S. Government for FY 2023 (see also the accompanying fact sheet) includes proposals relevant to drug manufacturers....more

Latham & Watkins LLP

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

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2021 Medicaid Drug Rebate Program Conference Concludes: The conference took place in New Brunswick, N.J., Oct. 11-13 and virtually Oct. 18-20. Christopher H. Schott spoke in person as part of the “Fireside Chat: External...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - October 2021

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Drug Pricing Initiatives: The fate of the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing, remains in limbo as Democrats continue to debate...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2021 #3

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Drug Pricing Initiatives: On Aug. 24, 2021, the House of Representatives approved a $3.5 trillion budget framework, S. Cons. Res. 14, while also voting to advance the $1 trillion infrastructure bill. The deadline for the...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2021

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Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021

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Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...more

Foley Hoag LLP

Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care...

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On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more

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