News & Analysis as of

Medicare Part D Medicare Healthcare Reform

DLA Piper

Keeping Watch on the IRA: Co-pays Increasing for Diabetes Medications

DLA Piper on

The Inflation Reduction Act (IRA) made changes to the way drugs are covered and reimbursed in Medicare. It has been anticipated that this could result in more restrictive formularies in drug plans or higher co-pays for...more

Holland & Knight LLP

HHS Secretary Kennedy Dismisses Entire CDC Vaccine Advisory Panel

Holland & Knight LLP on

In a surprising move, the U.S. Department of Health and Human Services (HHS) announced it is reconstituting the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), removing...more

McDermott+

A Deep Dive Into the CMS Program Management FY 2026 Budget Request

McDermott+ on

As discussed in last week’s Regs & Eggs blog post, the US Department of Health and Human Services (HHS) recently released additional budget documents to support the department’s fiscal year (FY) 2026 discretionary request....more

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

Lathrop GPM on

Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

DLA Piper

Medicare Drug Price Negotiation: Saving Money for Medicare, but What About Patients?

DLA Piper on

Evaluating current formulary access for the 25 drugs selected for Drug Price Negotiation in Medicare Part D shows several selected drugs have higher co-pays in 2025 relative to 2024 - Introduction - The Inflation Reduction...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The IRA in 2025: The Future of Medicare Part D

Last year was a pivotal year for the pharmaceutical industry. Under the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), the US government negotiated the prices of 10 selected high-expenditure,...more

McDermott+

The Future of Medicare Advantage: Q&A with McDermott+’s Lynn Nonnemaker

McDermott+ on

A few weeks ago, Regs & Eggs provided insights into Medicare Advantage (MA), the private insurance option under Medicare, and explored both short- and long-term actions that the Trump administration could take to modify MA...more

DLA Piper

CMS Releases New Proposed Rule for Medicare Advantage and Part D

DLA Piper on

On December 10, 2024, the Centers for Medicare and Medicaid Services (CMS) released a Proposed Rule for revisions to the regulations governing the Medicare Advantage (MA) program, Medicare Prescription Benefit (Part D),...more

Wilson Sonsini Goodrich & Rosati

The Inflation Reduction Act’s Medicare Price Negotiation Program: Two Years Later

The Inflation Reduction Act (the Act) of 2022 was controversial at the time the Act was signed into law and remains so. To date, multiple legal challenges have been asserted against the Act, with more expected in the future....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

McDermott+

CMS Releases CY 2025 Rate Announcement for Medicare Advantage and Part D

McDermott+ on

On April 1, 2024, the US Centers for Medicare & Medicaid Services (CMS) released the Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and D Payment Policies (Rate Announcement). CMS...more

Sheppard Mullin Richter & Hampton LLP

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more

McDermott+

Regs During an Election Year: What’s on the Menu?

McDermott+ on

Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more

Epstein Becker & Green

Hospital and MA Plan Considerations for CMS Final Rule to Remedy 340B Drug Payment Policy

In November 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule, “Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar...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

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

Sheppard Mullin Richter & Hampton LLP

The Drug Price Negotiation Program Faces Pushback from Private and Public Industry Participants

This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced...more

Epstein Becker & Green

CMS Seeks Comment on Initial Guidance for the Part D Manufacturer Discount Program: Inflation Reduction Act Updates

Epstein Becker & Green on

On May 12, 2023, the Centers for Medicare & Medicaid Services (CMS) issued Draft Guidance on the Part D Manufacturer Discount Program (“Discount Program”)—a key component of the Part D Redesign provisions of the Inflation...more

Groom Law Group, Chartered

CMS Charts the Future of Medicare Advantage and Part D in 2024

CMS published the Calendar Year (“CY”) 2024 Medicare Advantage (“MA”) Capitation Rates and Part C and Part D Payment Policies (“Rate Announcement“) on March 31 and, five days later, issued the MA and Part D final rule for...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

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

Sheppard Mullin Richter & Hampton LLP

Elijah E. Cummings Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform

As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower...more

Hogan Lovells

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

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The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

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