News & Analysis as of

Inflation Reduction Act (IRA) Medicare Food and Drug Administration (FDA)

Mintz - ML Strategies

2024 Post-Election Analysis

Mintz - ML Strategies on

Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more

McDermott+

McDermott+ Check-Up: September 20, 2024

McDermott+ on

Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...more

Akin Gump Strauss Hauer & Feld LLP

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

Akin Gump Strauss Hauer & Feld LLP

Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations

Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

MoFo Life Sciences

Medicare Drug Price Negotiation Program Final Guidance

MoFo Life Sciences on

On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more

Paul Hastings LLP

Finance in Five Minutes: Healthcare Finance Checkup

Paul Hastings LLP on

While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more

Foley Hoag LLP

Medicare Drug Price Negotiation Program Initial Guidance

Foley Hoag LLP on

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more

Hogan Lovells

CMS issues initial guidance on Drug Price Negotiation Program

Hogan Lovells on

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more

Akin Gump Strauss Hauer & Feld LLP

Drug Pricing Déjà Vu: The Biden-Harris Administration’s Fiscal Year 2024 Budget Doubles Down on Inflation Reduction Act Reforms;...

Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...more

Foley Hoag LLP

HHS Issues Report Outlining Three New Drug Models for Testing by CMMI

Foley Hoag LLP on

On February 14, 2023, and in response to Executive Order 14087 (“Lowering Prescription Drug Costs for Americans”), the Secretary of Health and Human Services (HHS) issued a report announcing the selection of three models that...more

MoFo Life Sciences

CMS Reveals New Details On Medicare Drug Price Negotiation Program

MoFo Life Sciences on

For the first time in history, the Centers for Medicare and Medicaid Services (CMS) will engage in price negotiations with drug manufacturers for a subset of high-cost, name-brand drugs covered by Medicare....more

Foley & Lardner LLP

What’s Next in Washington? - January 2023 Edition

Foley & Lardner LLP on

The dust from the 2022 Midterm Elections has settled and the 118th Congress has begun. Republicans were successfully able to flip control of the House and now have a 222-212 majority with one vacancy to be filled. Democratic...more

ArentFox Schiff

Pharmacy Benefit Manager Reform Remains Legislative Priority

ArentFox Schiff on

The 2022 midterms have concluded, but the Republican underperformance is not expected to dampen Congressional enthusiasm for Pharmacy Benefit Manager (PBM) reform. The issue remains at the forefront of the healthcare pricing...more

Foley & Lardner LLP

The Results Are In... A Recap of the 2022 Midterm Elections and a Preview of the Lame-Duck Session

Foley & Lardner LLP on

Votes in the 2022 Midterm Elections are still being tallied. It will likely take several more days, if not weeks, to be able to confirm who will hold the majority in the House and Senate.Please note that House, Senate, and...more

McDermott Will & Emery

Medicare Drug Price Negotiation Program and Drug Pricing Reform: Eligible Drugs to Know and Understanding What’s Next

McDermott Will & Emery on

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA), which contains prescription drug pricing reform provisions. The three main Medicare prescription drug pricing reform provisions...more

Holland & Knight LLP

Holland & Knight Health Dose: October 18, 2022

Holland & Knight LLP on

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

Latham & Watkins LLP

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

Latham & Watkins LLP on

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

Faegre Drinker Biddle & Reath LLP

Fall 2022 Federal Healthcare Legislative Landscape

With President Biden signing the Inflation Reduction Act (IRA) into law on August 16, the next big question is what the last third of 2022 will bring. Enacting the IRA takes the “will it or won’t it happen” issue of...more

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