News & Analysis as of

Medicare Part D

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

Foley & Lardner LLP

Medicare Advantage: A Circuit Court Addresses What is (or is not) Material in False Claims Act Cases

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Friday the 13th is not all bad luck. On September 13, 2024, the United States Court of Appeals for the Eighth Circuit’s published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors,...more

Ankura

New Health Information Technology Standards for Medicare Part D

Ankura on

On June 17, 2024, the final rule for Medicare Part D introduced new health IT standards, mandating the adoption of NCPDP SCRIPT Standard version 2023011 by January 1, 2028, while the NCPDP Formulary and Benefit (F&B) Standard...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

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

King & Spalding on

On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

Verrill

Prepare for Cooler Weather, Annual Enrollment, and 2025

Verrill on

Summer is ending and fall is rapidly approaching. For employee benefit professionals with calendar-year health and welfare benefit plans that means preparing for annual enrollment and year-end compliance requirements. This...more

McCarter & English, LLP

Medicare Technology Standards for Prescribing Part D Drugs

The Centers for Medicare & Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC), and thr Department of Health and Human Services (HHS) published 89 FR 51238 (the Final Rule),...more

Ankura

Are You Paying Attention to Prior Authorization? Your Regulators Are.

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With recent CMS mandates and state-level reforms, the healthcare industry faces a pivotal moment to improve prior authorization processes, ensuring timely access to care and integrating health equity considerations....more

Latham & Watkins LLP

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

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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

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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

Manatt, Phelps & Phillips, LLP

Five Things to Watch When First “Maximum Fair Prices” for Selected Drugs Announced

The Centers for Medicare & Medicaid Services (CMS) is required to make public by September 1 the “maximum fair prices” (MFP) that CMS is setting for the first ten drugs subject to the Medicare Drug Price Negotiation Program...more

Alston & Bird

Health Care Week in Review: CMS Released Negotiated Medicare Part D Prices for 10 Drugs and ARPA-H Awarded $150 Million in Funding...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

Manatt, Phelps & Phillips, LLP

CMS Announces Part D Premium Parameters, New Policy to Stabilize Standalone Part D Premiums

The Centers for Medicare & Medicaid Services (CMS) released the Part D national average bid amount and Part D base beneficiary premiums for 2025. These figures set the premium costs and government subsidies for Medicare...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

Hall Benefits Law

32 State AGs Urge Justices to Review 10th Circuit Ruling Concerning ERISA Preemption of State PBM Law

Hall Benefits Law on

​​​​​​​A bipartisan group of attorneys general from 31 states and the District of Columbia filed an amicus brief in support of a petition for certiorari by Oklahoma’s insurance commissioner to review a decision by the U.S....more

Proskauer - Health Care Law Brief

CMS Proposes Additional Modifications to the Overpayment Rule Relating to the Deadline for Reporting and Returning Overpayments

In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. §...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

Manatt, Phelps & Phillips, LLP

CMS Finalizes Part D Cost-Sharing Smoothing Guidance

The Centers for Medicare & Medicaid Services (CMS) finalized the second part of its guidance on implementation of the IRA’s Medicare Prescription Payment Plan (MPPP), known informally as Part D monthly out of-pocket...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

McDermott Will & Emery

CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

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On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims...more

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