News & Analysis as of

Medicare Medicaid Drug Rebate Program

Holland & Knight LLP

CMS Releases CY 2025 Medicare Physician Fee Schedule Final Rule

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The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2024, released the calendar year (CY) 2025 Revisions to Payment Policies under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Harris Beach PLLC

OIG January 2024 Enforcement Summary

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Hogan Lovells

CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

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On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The First Anniversary of the Inflation Reduction Act: A Year in Review

August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more

McDermott Will & Emery

HHS Takes Steps to Resolve 340B Medicaid MCO Duplicate Discount Confusion

On May 26, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed an update to the Medicaid Drug Rebate Program (MDRP) rules, which includes provisions aimed at preventing 340B duplicate discounts on claims...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs

On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”)...more

Foley Hoag LLP

OIG Technical Assistance on Part B Inflation Rebates Implementation Barriers and CMS’ Proposed Solutions in Recent Part B...

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On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

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After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

King & Spalding

Price Negotiation, Medicare Rebates, and Benefit Reform

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Key Drug Pricing Implications of the Inflation Reduction Act of 2022 - I. Introduction - On Sunday, August 7, 2022, the United States Senate passed the most consequential drug and biologics pricing legislation in almost...more

Goodwin

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

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​​​​​​​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

Hogan Lovells

D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

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On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

Hogan Lovells

MDRP multiple best prices option and territory exclusion update plus Part B discarded drug refund

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While Congress continues to consider significant drug pricing legislation, separate regulatory and statutory changes have been finalized this week with potential implications for manufacturers that report prices into the...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - October 2021 #2

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2021 Medicaid Drug Rebate Program Conference Concludes: The conference took place in New Brunswick, N.J., Oct. 11-13 and virtually Oct. 18-20. Christopher H. Schott spoke in person as part of the “Fireside Chat: External...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - October 2021

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Drug Pricing Initiatives: The fate of the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing, remains in limbo as Democrats continue to debate...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2021 #3

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Drug Pricing Initiatives: On Aug. 24, 2021, the House of Representatives approved a $3.5 trillion budget framework, S. Cons. Res. 14, while also voting to advance the $1 trillion infrastructure bill. The deadline for the...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2021

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Drug Pricing Initiatives: US lawmakers continue to debate the drug pricing measure introduced by House Democrats, H.R. 3 (the Elijah E. Cummings Lower Drug Costs Now Act). Among other things, H.R. 3 would empower the...more

Foley Hoag LLP - Medicaid and the Law

Supreme Court Will Hear Several Health Care Cases in 2022 Term

Recently, my colleague Regina DeSantis told you about the ongoing saga involving disputes between 340B contract pharmacies and pharmaceutical manufacturers.  We often write about the 340B program on our blog because of the...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021 #2

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Supreme Court Upholds Affordable Care Act: On June 17, 2021, the Supreme Court ruled 7 to 2 to dismiss for lack of standing a challenge to the Affordable Care Act (ACA) brought by Texas and other states. The states had...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

Foley Hoag LLP - Medicaid and the Law

A Deeper Dive into CMS’ Multiple Best Prices Policy

As my colleague Tom wrote about in a recent post, the Centers for Medicare & Medicaid Services (CMS) has finally responded to a growing chorus of stakeholders that government price reporting requirements, particularly...more

Sheppard Mullin Richter & Hampton LLP

CMS’ Proposed Rule Promoting Value-Based Purchasing for Medicaid-Covered Drugs: The Comments are In!

On June 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based...more

White & Case LLP

Uncertainty on Drug Pricing Remains Following Trump Administration Executive Orders

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On July 24 2020, President Trump signed three Executive Orders targeting prescription drug prices and proposed a fourth.  The Orders represent the Trump Administration's latest effort to implement previously outlined...more

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