Ross Margulies

Ross Margulies

Foley Hoag LLP

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Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

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

5/13/2024  /  Advisory Opinions , Anti-Kickback Statute , Cost-Sharing , Department of Health and Human Services (HHS) , Inflation Reduction Act (IRA) , Manufacturers , Medicare Part D , OIG , Patients , Pharmaceutical Industry , Regulatory Agenda , Regulatory Requirements

CMS Identifies First 10 Drugs for Medicare Price Negotiation

This morning the Centers for Medicare & Medicaid Services (CMS) published, for the first time, a list of drugs subject to price negotiation under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation program....more

8/30/2023  /  Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Negotiations

Inflation Reduction Act Drug Pricing Provisions – What to Expect in 2023

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

1/4/2023  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Healthcare Reform , Inflation Reduction Act (IRA) , Medicare , Medicare Part B , Medicare Part D , Prescription Drugs

How does Pfizer’s New Warranty Program for XALKORI get around Medicaid Best Price?

On October 13th our friends over at STAT broke the news [sorry, Paywall] about a “warranty” pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a...more

10/15/2021  /  Alternative Payment Models (APM) , Centers for Medicare & Medicaid Services (CMS) , Medicaid , Medicare Part D , Patients , Pfizer , Pharmaceutical Industry , Pilot Programs , Prescription Drug Coverage , State Health Plans , Value-Based Purchasing

CMS Reneges on Historic “Grand Bargain” with Manufacturers in Tennessee Wavier Approval

Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more

1/12/2021  /  Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Essential Health Benefits , Health Insurance , Manufacturers , Medicaid , Medicare Part D , Medication-Assisted Treatment (MAT) , Prescription Drugs , Rebates , Section 340B , Waivers

Centers for Medicare & Medicaid Services Proposes Changes to Six Protected Class Rule under Medicare Part D

On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (the “MMA”) was signed into law by former President George W. Bush1. Prior to the enactment of the MMA, Medicare prescription drug...more

1/13/2014  /  Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Healthcare , Medicaid , Medicare , Medicare Modernization Act , Medicare Part D , Prescription Drugs
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