News & Analysis as of

Medicare Part D Inflation Reduction Act (IRA)

Hogan Lovells

CMS issues draft guidance on IRA 2028 Drug Price Negotiation Program, 2026-28 MFP Effectuation

Hogan Lovells on

On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2028 of the Drug Price Negotiation Program (DPNP) established by the Inflation Reduction...more

Groom Law Group, Chartered

CMS Finalizes Annual Medicare Advantage and Part D Rulemaking Updates

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Advantage plans and Medicare Part D prescription drug coverage, including the Final CY 2026 Part D...more

Mintz - Health Care Viewpoints

CMS’s 2026 Final Medicare Advantage Rule Focuses on Implementing the IRA and Deregulation

In April, CMS finalized its Contract Year (CY) 2026 Medicare Advantage and Part D Final Rule (Final Rule). With CMS releasing the 2026 Medicare Advantage and Part D Proposed Rule in December under the Biden Administration,...more

Groom Law Group, Chartered

CMS Finalizes Updates to the Prescription Creditable Coverage Methodology Determination

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Part D prescription drug coverage, including the Final CY 2026 Part D Redesign Program Instructions....more

Epstein Becker & Green

CMS Issues CY 2026 MA & Part D Rate Announcement, Final Rule on CY 2026 Policy and Technical Changes to Programs, While Seeking...

Epstein Becker & Green on

Several April releases seem to signal some basis for optimism for stakeholders in Medicare Advantage and Part D, though with sufficient undertones to recommend caution....more

DLA Piper

Keeping Watch on the Inflation Reduction Act: Medicare Poses Part D Formulary Access Challenges

DLA Piper on

Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more

Holland & Knight LLP

CMS Final Rule on CY 2026: Policy and Technical Changes

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

McDermott+ on

This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...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

McDermott+

CY 2026 MA and Part D Final Reg: Policies Under Consideration

McDermott+ on

Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...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

Mintz - Health Care Viewpoints

Mintz IRA Update — Fourth Edition: Q1 2025

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...more

Mintz

Mintz IRA Update — Operationalizing the Medicare Prescription Payment Plan and Medicare Inflation Rebate Program

Mintz on

In addition to the Part D Benefit Redesign, the IRA’s Medicare Prescription Payment Plan (MPPP) went into effect beginning January 1, 2025. The MPPP requires Part D Sponsors (PDPs) to allow Part D beneficiaries to pay for...more

Morgan Lewis

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Morgan Lewis on

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

DLA Piper

Keeping Watch on Medicare as the IRA is Implemented: Formulary Management Practices

DLA Piper on

The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more

DLA Piper

Keeping Watch on Medicare: Access Prescription Drug Plans and Premiums

DLA Piper on

The Inflation Reduction Act (IRA) significantly changed the popular Medicare drug programs. While an IRA policy goal is to reduce the out-of-pocket drug spending, beneficiaries may experience higher drug plan premiums and...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

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

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