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Inflation Reduction Act (IRA) Drug Pricing Prescription Drugs

Hogan Lovells

2024 U.S. elections - Health industry impact

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In the wake of the biggest American political comeback in more than 100 years, stakeholders in the health industry are asking themselves: What does this portend for health policy—patients, providers, manufacturers, and...more

Manatt, Phelps & Phillips, LLP

CMS Releases Proposed Forms to Effectuate Medicare MFP Under the IRA of IPAY 2026 and IPAY 2027

On October 28, CMS requested public comment​ on four proposed information collections (ICRs) it intends to impose on drug manufacturers and pharmacies in order to effectuate maximum fair prices (MFP) under the Inflation...more

Pullman & Comley, LLC

Substantially Increased Medicare Benefits For Prescription Drugs in 2025 – What You Need to Know

Pullman & Comley, LLC on

There are important new rules this year relating to prescription drug coverage which may be relevant to your Medicare plan beginning January 1, 2025. The “Open Enrollment” period this year during which eligible individuals...more

Manatt, Phelps & Phillips, LLP

CMS Releases Final 2027 IRA Negotiation Guidance

On October 2, the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining how the agency will implement the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (the “Program”) for...more

Hogan Lovells

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

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On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

Latham & Watkins LLP

Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry

Latham & Watkins LLP on

Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies...more

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

White & Case LLP

Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024

White & Case LLP on

It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...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

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 — The Growing Use of State Prescription Drug Affordability Boards

In recent years, several states have implemented independent state boards — called Prescription Drug Affordability Boards (“PDABs”) — to address high drug prices in their health care systems. Amid federal implementation of...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Opposition to the Use of March-In Rights to Lower Drug Prices

In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...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

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

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2024

We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher....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

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