News & Analysis as of

Medicare Part D Inflation Reduction Act (IRA)

Morgan Lewis

How the US Election May Affect Drug Pricing, Medicare, and Medicaid Programs – Key Areas to Watch

Morgan Lewis on

Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more

ArentFox Schiff

The 2025 Final Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need to...

ArentFox Schiff on

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now...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

Pullman & Comley, LLC

Substantially Increased Medicare Benefits For Prescription Drugs in 2025 – What You Need to Know

Pullman & Comley, LLC on

There are important new rules this year relating to prescription drug coverage which may be relevant to your Medicare plan beginning January 1, 2025. The “Open Enrollment” period this year during which eligible individuals...more

Akin Gump Strauss Hauer & Feld LLP

No Slowdown in Sight When It Comes to Focus on Drug Pricing Policy

Congress may be in recess, but that has not slowed down drug pricing policy developments. In recent days, the Centers for Medicare & Medicaid Services (CMS) and the Congressional Budget Office (CBO) have rolled out a series...more

Hogan Lovells

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

Hogan Lovells on

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

Morgan Lewis - ML Benefits

CMS Disclosures Due October 15: Is Your Plan’s Rx Coverage Still Creditable?

The Inflation Reduction Act (IRA) made several changes to Medicare Part D that may impact whether employer-sponsored coverage will be creditable for the 2025 plan year. With open enrollment season about to begin, plan...more

McDermott+

McDermott+ Check-Up: September 20, 2024

McDermott+ on

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

Venable LLP

2025 Changes to Medicare Part D Will Impact Group Health Plans' Creditable Coverage Determination

Venable LLP on

The Inflation Reduction Act of 2022 made significant design changes to Medicare Part D effective January 1, 2025. The changes will cause an increase in the actuarial value of Medicare Part D coverage, which will impact...more

Latham & Watkins LLP

Podcast — Drug Pricing: How Are Payers Responding to the IRA?

Latham & Watkins LLP on

In this podcast, explore how health insurance companies are adapting to the Inflation Reduction Act's new requirements, including the Part D redesign. The US healthcare landscape is undergoing significant changes as the...more

Wiley Rein LLP

Medicare Drug Price Negotiation Program: CMS Releases New Discounted Prices for 2026 Selected Drugs

Wiley Rein LLP on

As many have now heard, on Thursday, August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the prices for the first 10 prescription drugs selected for negotiation with manufacturers (Selected Drugs)...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

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

Morgan Lewis - Health Law Scan

The Ins and Outs of Medicare’s Prescription Payment Plan

Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government....more

Akin Gump Strauss Hauer & Feld LLP

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

Wiley Rein LLP

CMS Releases Final Part Two Guidance on the Medicare Prescription Payment Plan: What’s Changed for Part D Plans?

Wiley Rein LLP on

The Centers for Medicare & Medicaid Services (CMS) updated its guidance on the Inflation Reduction Act of 2022’s (P.L. 117-169) (IRA) Medicare Prescription Payment Plan (M3P) with its release of the Final Part Two Guidance on...more

Whiteford

CMS Releases Final Part Two Guidance of the Medicare Prescription Drug Payment Plan

Whiteford on

The Department of Health and Human Services (HHS), in conjunction with the Centers for Medicare and Medicaid Services (CMS), is striving to alleviate the financial strain of medication costs on the elderly and disabled...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

Akin Gump Strauss Hauer & Feld LLP

Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations

Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more

Wiley Rein LLP

Recent Developments in Pharmacy-Related Legislation and Regulations

Wiley Rein LLP on

Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...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

Sheppard Mullin Richter & Hampton LLP

CMS Announces Medicare Advantage and Part D Rates for CY 2025

On April 1st, the Centers for Medicare & Medicaid Services (“CMS”) announced its Medicare Advantage (“MA”) Capitation Rates and Part C and Part D Payment Policies for Calendar Year (“CY”) 2025. This announcement builds on the...more

Polsinelli

Medicare Changes to Make Drug Coverage More Manageable in 2025

Polsinelli on

Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines...more

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