News & Analysis as of

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

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

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

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

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

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

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

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

Jones Day

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

Jones Day on

The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

McDermott+

McDermottPlus Check-Up: October 27, 2023

McDermott+ on

CONGRESS - House Republicans Elect New Speaker. After weeks of turmoil, the House elected Rep. Mike Johnson (R-LA) as the new Speaker of the House on Wednesday with 220 votes secured on the floor. The House is now able to...more

Burr & Forman

Medicare Announced First 10 Drugs for Upcoming Price Negotiations

Burr & Forman on

In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more

Epstein Becker & Green

CMS Names Its First Ten Negotiated Part D Drugs: Inflation Reduction Act Updates

On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...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

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

Knobbe Martens

Merck Sues Federal Government Over Medicare Drug Price Negotiation Program

Knobbe Martens on

On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices...more

Epstein Becker & Green

Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care

The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions. What key compliance issues must industry stakeholders consider as these provisions are put...more

Epstein Becker & Green

Is CMS Ignoring the Realities of Biopharmaceutical Costs?

On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of...more

Epstein Becker & Green

CMS Issues New Guidance on Medicare Drug Price Negotiation Program: Inflation Reduction Act Updates

Epstein Becker & Green on

IRA Provision: The Medicare Drug Price Negotiation Program - The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and initial guidance for the implementation of the Medicare Drug Price Negotiation...more

ArentFox Schiff

10 Legal Challenges for the Health Care Industry in 2023

ArentFox Schiff on

With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023. End of the COVID-19 Public Health Emergency. After being in effect for more than...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 Inflation Reduction Act of 2022: Medicare Drug Pricing Provisions Will Change the Health Care Industry

Foley & Lardner LLP on

President Biden has now signed into law the $700 billion Inflation Reduction Act of 2022, a package comprised of health care, climate change, and taxation policy reforms. It is a scaled-back version of the Build Back Better...more

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