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Inflation Reduction Act (IRA) Department of Health and Human Services (HHS)

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

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

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

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

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...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

Axinn, Veltrop & Harkrider LLP

One Down, Eight to Go: Texas Judge Dismisses Medicare Drug Price Case – Will Others Follow?

A domino has fallen, but the question remains whether there are more to come. On February 12, 2024, the U.S. District Court for the Western District of Texas dismissed a challenge to the Department of Health and Human...more

Goodwin

Court Dismisses PhRMA Lawsuit Challenging IRA

Goodwin on

Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...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

King & Spalding

The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights

King & Spalding on

The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more

Axinn, Veltrop & Harkrider LLP

The Inflation Reduction Act’s First Potential Impact on Biosimilars

On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services...more

McDermott+

McDermottPlus Check-Up: October 27, 2023

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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

Goodwin

IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and...

Goodwin on

Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program

As discussed throughout this Update, the implementation of the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) has been subject to a number of legal challenges. To date, six manufacturers and...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...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

ArentFox Schiff

There’s One for You, Nineteen for Me: IRS Issues Guidance on 1900% Pharmaceutical Excise Tax

ArentFox Schiff on

The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...more

Goodwin

Legal Challenges to the Inflation Reduction Act: An Update on Pending Challenges and Reactions to Oral Argument in Dayton Area...

Goodwin on

Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other...more

Venable LLP

First List of Drugs for Medicare Price Negotiations Published Includes Three Biologics

Venable LLP on

The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. ...more

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Wiley Rein LLP

Medicare Drug Price Negotiation Program: Selected Drugs for 2026

Wiley Rein LLP on

On Tuesday, August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) released the first ten prescription drugs selected for price negotiation with manufacturers (Selected Drugs) under the Inflation Reduction Act of...more

White & Case LLP

Where Things Stand on Drug Pricing at the Halfway Point of 2023

White & Case LLP on

While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more

Goodwin

First Drugs Selected for Price Negotiations Under The Inflation Reduction Act

Goodwin on

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program has now officially kicked off. Earlier today (August 29, 2023), the White House announced the list of the first 10 selected drugs under the program, prior...more

A&O Shearman

HHS selects the first drugs for Medicare drug price negotiation

A&O Shearman on

\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

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