News & Analysis as of

Medicare Rebates

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

Holland & Knight LLP

CMS Releases CY 2025 Medicare Physician Fee Schedule Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1807-P) Proposed...more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Ankura

Summary: The Government Accountability Office's Report on Medicare Part D Rebates

Ankura on

On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...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

McDermott+

Drug Payment Reform and Transparency: It’s What’s on the Menu for Policymakers

McDermott+ on

August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more

American Conference Institute (ACI)

[Event] 21st Annual Rx Drug Pricing Boot Camp - May 4th - 5th, New York City, NY

The American Conference Institute is hosting the 21st Annual Rx Drug Pricing Boot Camp in New York. With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when...more

MoFo Life Sciences

CMS Announces Part B Prescription Drugs With Lower Coinsurance Amounts For Q2 2023

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The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs. This inflation rebate applies to Medicare Part...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases First Set of Part B Rebatable Drugs for Coinsurance Adjustment Under IRA

The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the...more

Epstein Becker & Green

Comments to CMS Guidance on the Medicare Prescription Drug Inflation Rebate Program Due March 11, 2023

On February 9, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued a fact sheet and its initial guidance documents addressing the Medicare Prescription Drug Inflation Rebate Program for Medicare Parts B and D...more

Goodwin

CMS Issues Proposed Guidance on Inflation Rebates Under Medicare Part B

Goodwin on

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...more

White & Case LLP

Five Drug Pricing Issues to Watch in 2023

White & Case LLP on

Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - August 2022 #3

Latham & Watkins LLP on

Latham's Government Price Reporting Team covers general developments, the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, Medicare Part B, and state law developments. ...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 3: Medicare Part D...

Hogan Lovells on

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 2: Medicare Part B and...

Hogan Lovells on

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 1: Drug price...

Hogan Lovells on

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Manatt, Phelps & Phillips, LLP

The Inflation Reduction Act: Implementation of the Medicare Prescription Drug Inflation Rebates

On August 16, President Joe Biden signed into law H.R. 5376 , the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more

Manatt, Phelps & Phillips, LLP

[Webinar] Preparing for Change: A Guide to the Inflation Reduction Act Drug Pricing Provisions - August 23rd, 1:00 pm - 2:00 pm ET

The Inflation Reduction Act (IRA) will make arguably the most significant changes to U.S. prescription drug pricing regulations ever, but certainly since the creation of the Medicaid Drug Rebate Program in 1990. For the first...more

Latham & Watkins LLP

Inflation Reduction Act: Roadmap of Drug Pricing Provisions

Latham & Watkins LLP on

Historic statute introduces mandatory Medicare price negotiations, Medicare Part B and D inflation rebates, and Medicare Part D benefit redesign. H.R. 5376, the Inflation Reduction Act of 2022 (the Act), marks Congress’s...more

Goodwin

U.S. Senate Passes Significant Drug Pricing Reform in the Inflation Reduction Act of 2022

Goodwin on

​​​​​​​On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more

ArentFox Schiff

Investigations Newsletter: Jury Orders Eli Lilly To Pay $61 Million

ArentFox Schiff on

Jury Orders Eli Lilly To Pay $61 Million - A federal jury in Illinois found that, beginning around 2004, drug manufacturer Eli Lilly deliberately underpaid rebates to Medicare programs by excluding retroactive drug prices...more

White & Case LLP

Drug Pricing Issues to Watch in 2022

White & Case LLP on

Among the drug pricing developments to watch in 2022, those at the top include legislation that would allow Medicare price negotiation and alter antitrust rules for the pharmaceutical industry, Federal Trade Commission...more

ArentFox Schiff

Contract Year 2023 Part D Proposed Rule Released: Changes To 'Negotiated Price' Would Require Potential DIR Fees at the Point of...

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on...more

MoFo Life Sciences

Ninth Circuit Weighs In On Fraud-On-The-FDA Theory, Marketing Devices For Off-Label Use, And Kickbacks

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The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining...more

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