News & Analysis as of

Inflation Reduction Act (IRA) Centers for Medicare & Medicaid Services (CMS) Drug Pricing

Goodwin

The Centers for Medicare & Medicaid Services Announces Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation

Goodwin on

As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more

Latham & Watkins LLP

Podcast — Drug Pricing: How Are Payers Responding to the IRA?

Latham & Watkins LLP on

In this podcast, explore how health insurance companies are adapting to the Inflation Reduction Act's new requirements, including the Part D redesign. The US healthcare landscape is undergoing significant changes as the...more

Wiley Rein LLP

Medicare Drug Price Negotiation Program: CMS Releases New Discounted Prices for 2026 Selected Drugs

Wiley Rein LLP on

As many have now heard, on Thursday, August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the prices for the first 10 prescription drugs selected for negotiation with manufacturers (Selected Drugs)...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Epstein Becker & Green

CMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin Supplements...

Epstein Becker & Green on

On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...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

Manatt, Phelps & Phillips, LLP

CMS Finalizes Part D Cost-Sharing Smoothing Guidance

The Centers for Medicare & Medicaid Services (CMS) finalized the second part of its guidance on implementation of the IRA’s Medicare Prescription Payment Plan (MPPP), known informally as Part D monthly out of-pocket...more

Cozen O'Connor

Cozen Currents: Is Harris the Answer?

Cozen O'Connor on

The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more

Wiley Rein LLP

CMS Releases Final Part Two Guidance on the Medicare Prescription Payment Plan: What’s Changed for Part D Plans?

Wiley Rein LLP on

The Centers for Medicare & Medicaid Services (CMS) updated its guidance on the Inflation Reduction Act of 2022’s (P.L. 117-169) (IRA) Medicare Prescription Payment Plan (M3P) with its release of the Final Part Two Guidance on...more

Kramer Levin Naftalis & Frankel LLP

Just Opt Out! Boehringer Ingelheim’s IRA Challenge Is Latest To Fail

Since its enactment in 2022, the validity of the Inflation Reduction Act (IRA) and its drug price negotiation program (Program) has been repeatedly challenged in District Court, with little success. Boehringer Ingelheim’s...more

Whiteford

CMS Releases Final Part Two Guidance of the Medicare Prescription Drug Payment Plan

Whiteford on

The Department of Health and Human Services (HHS), in conjunction with the Centers for Medicare and Medicaid Services (CMS), is striving to alleviate the financial strain of medication costs on the elderly and disabled...more

Mintz - Health Care Viewpoints

Mintz IRA Update — IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Learning From Experience: Medicare Drug Price Negotiation Program Updates

Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

Manatt, Phelps & Phillips, LLP

Patient Impact of the Inflation Reduction Act - Administrative Options to Address Changed Incentives for Formulary and Utilization...

Executive Summary- The Inflation Reduction Act (IRA) makes significant changes to the Medicare Part D prescription drug benefit and also directs the Centers for Medicare and Medicaid Services (CMS) to enforce...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

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

Wiley Rein LLP

Recent Developments in Pharmacy-Related Legislation and Regulations

Wiley Rein LLP on

Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more

Goodwin

IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal

Goodwin on

On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program....more

Hogan Lovells

CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

Hogan Lovells on

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more

Kramer Levin Naftalis & Frankel LLP

Potential Effects of the Inflation Reduction Act on Orphan Drug Development

President Biden signed the Inflation Reduction Act (IRA) into law on Aug. 16, 2022, with the goal of reducing health care costs for the government and participants in Medicare and Medicaid programs. The IRA includes a section...more

Akin Gump Strauss Hauer & Feld LLP

The Road Ahead for Private Equity: Health Care & Life Sciences

Despite strong private equity interest in drug and device targets, policy changes in the healthcare industry have made the M&A market tricky to navigate. Healthcare has been one of the most active policy focus areas in 2023...more

Knobbe Martens

Medicare Drug Price Negotiation Program Steadily Progressing Despite Lawsuits

Knobbe Martens on

The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges....more

Polsinelli

Medicare Changes to Make Drug Coverage More Manageable in 2025

Polsinelli on

Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines...more

Mintz

Mintz IRA Update — The IRA in 2024: The Medicare Drug Price Negotiation Program in Full Swing and Other Developments

Mintz on

Our team’s preparation for the year includes a review of the anticipated impact of the IRA on the health care industry in 2024. Many of the IRA’s key provisions that go into effect this year are centered around two main...more

101 Results
 / 
View per page
Page: of 5

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide