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

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

Latham & Watkins LLP on

Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

McDermott+

McDermott+ Check-Up: September 20, 2024

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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

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

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

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

Venable LLP

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

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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

Wiley Rein LLP

Medicare Drug Price Negotiation Program: Selected Drugs for 2026

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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

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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

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

MoFo Life Sciences

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

MoFo Life Sciences on

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...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

Foley Hoag LLP

Inflation Reduction Act Drug Pricing Provisions – What to Expect in 2023

Foley Hoag LLP on

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). The drug pricing provisions in Subtitle B of Title I of the IRA, entitled “Prescription Drug Pricing Reform,” enact government...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

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

Latham & Watkins LLP on

2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Hogan Lovells

Inflation Reduction Act’s Drug Price Negotiation Program explained

Hogan Lovells on

In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more

McDermott Will & Emery

The Inflation Reduction Act of 2022: Healthcare Provisions

After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more

Sheppard Mullin Richter & Hampton LLP

Healthcare Reforms Under the IRA: Expanding Access to Care

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

Jackson Walker

Next Steps for Healthcare and the Inflation Reduction Act

Jackson Walker on

On August 16, the President signed the Inflation Reduction Act of 2022 (IRA) into law. While this post focuses on key healthcare provisions in the IRA, the law likewise has significant implications for the energy sector and...more

Holland & Knight LLP

With Inflation Reduction Act Signed, Other Health Policy Issues Ahead for Congress

Holland & Knight LLP on

Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more

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