Overview
The legal landscape surrounding drug pricing policy and reporting is constantly changing. Pharmaceutical and biologics companies have to navigate ever-evolving rules and regulations, ensuring compliance on both the federal and state levels. One misstep could cause a company to face a potentially costly investigation or enforcement action.
That is why working with experienced counsel who stay up to date with the latest legal changes is so important. Epstein Becker Green’s drug pricing policy and reporting team has deep knowledge of drug price reporting requirements and compliance obligations under Medicaid, Medicare, 340B Drug Discount, and other programs and keeps clients informed of critical legal developments. We leverage years of experience to provide comprehensive counsel tailored to our clients’ specific needs and goals.
Providing Strategic Advice and Solutions
Our drug pricing policy and reporting team works closely with pharmaceutical and biologics manufacturers, advising them on compliance, strategy, and outlook in this high-stakes area. Clients turn to us for advice on pricing-related matters, reporting requirements, and their rights and obligations relating to:
- Medicare Average Sales Price
- Medicaid Drug Rebate Statute
- Medicare Part B, C, and D Program
- 340B Drug Discount Program
- Medicare Advantage Program
- TRICARE Program
- Veterans Health Care Act/Federal Supply Schedule Program
- State Drug Pricing Initiatives
We help pharmaceutical and biologics manufacturers develop methodologies and reasonable assumptions to support their drug pricing submissions, assist with responses to regulatory inquiries, and represent clients in drug pricing-related investigations, enforcement proceedings, and civil litigation. Physicians, hospitals, and insurers also look to us for guidance on drug pricing policy and reporting matters.
Keeping Our Clients Compliant
Our team drafts policies to help ensure that clients remain compliant with current federal legal standards and state drug pricing policy and transparency obligations. Clients also rely on us to keep them informed about legislative changes to drug pricing and reimbursement policies that may be on the horizon. In addition, we provide thorough compliance reviews that assess and update, if necessary, our clients’ existing compliance policies. At Epstein Becker Green, our drug pricing policy and reporting team provides diligent and effective counsel designed to help protect our clients from future legal exposure.
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Focus Areas
Experience
- Assisted an emerging pharmaceutical manufacturer in developing a full suite of government program compliance and price reporting policies before the commercial launch of its first product.
- Drafted and negotiated commercial supply, distribution, and pricing agreements for pharmaceuticals and other therapeutics for manufacturers and other industry stakeholders.
- Assisted a large biotechnology and pharmaceutical company with various product launch activities and provided a comprehensive range of services that included legal and pricing training.
- Represented the subsidiary of a global pharmaceutical company in a multimillion-dollar settlement in connection with a legacy government program pricing matter. We served as health care defense counsel in the negotiation of the amended Corporate Integrity Agreement with the Department of Health and Human Services’ Office of the Inspector General.
Contacts
Member of the Firm
Board of Directors / Member of the Firm
Member of the Firm
Media
Events
Past Events
- December 10-11, 2024
Insights
Insights
- Media CoverageWilliam Walters Quoted in “Ruling Could Give Kennedy More Power Over Health Care Coverage”4 minute read
- Media CoverageRichard Hughes Quoted in “ACA Preventive Care Case Reaches Supreme Court”4 minute read
- Media Coverage
What's at Stake as Oral Arguments Are Presented in the Braidwood Case? Q&A with Richard Hughes, IV
4 minute read - Media CoverageRichard Hughes Quoted in “Supreme Court Grapples with Challenge to ObamaCare Preventive Care Panel”6 minute read
- Media CoverageWilliam Walters Quoted in “Supreme Court Appears Willing to Save ACA Preventive Services Task Force”3 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear Challenge to Obamacare Rule on Free Preventive Care”4 minute read
- Media CoverageRichard Hughes Quoted in “‘At the Mercy of Insurance Companies’: Supreme Court Braces for ACA Preventive Coverage ...4 minute read
- Media CoverageRichard Hughes Quoted in “States Echo RFK Jr. Agenda in Push for Ban on Vaccine Mandates”2 minute read
- Media CoverageRichard Hughes Quoted in “Idaho Restricts Vaccine Mandates”3 minute read
- Media CoverageJames Boiani Quoted in “Drug Industry Worries About FDA Delays”3 minute read
- PublicationsUS Courts Health Disaster as It Drops the Ball on Flu Preparedness2 minute read
- PublicationsACIP’s Upcoming Meningococcal Recommendations: Added Complexity, Reduced Choice1 minute read
- Media CoverageRichard Hughes Quoted in “CDC Plans Study on Vaccines and Autism Despite Research Showing No Link”4 minute read
- Media CoverageRichard Hughes Quoted in “Trump’s FDA Nominee Grilled on Vaccine Meeting, Agency Staffing”8 minute read
- Media CoverageRichard Hughes Quoted in “Kennedy's Early Warning Signs on Vaccine Policy”4 minute read
- PublicationsExpanding Vaccination Provider Types and Administration Sites Can Increase Vaccination Uptake: A Systematic Literature ...2 minute read
- Media Coverage
Richard Hughes Discusses Why Payer Responsibility for Preventative Services May Hinge on Braidwood Management Inc. v ...
4 minute read - Media CoverageRichard Hughes Quoted in “Expert: Removing Shots from Childhood Schedule Would Nix Compensation”2 minute read
- Media CoverageRichard Hughes Quoted in “F.D.A. Cancels Meeting of Vaccine Experts Scheduled to Advise on Flu Shots”2 minute read
- Media CoverageRichard Hughes Quoted in “Could ACIP Delay Wind Up in Court?”2 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court Schedules Arguments in Case Where Trump Administration Is Defending ACA” ...2 minute read
- Media CoverageRichard Hughes Quoted in “Key CDC Vaccine Committee Meeting Pushed Back”2 minute read
- Media Coverage
Richard Hughes Discusses the Major Implications of Braidwood Management Inc. v. Becerra on Available Preventive Services ...
3 minute read - Media CoverageRichard Hughes Quoted in “Parents, Medical Providers, Vaccine Experts Brace for RFK Jr.’s HHS Takeover”4 minute read
- BlogsVideo: 2025 Outlook - the Department of Health and Human Services Under the Second Trump Administration – Diagnosing ...3 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr. Says Vaccines Aren’t Tested Enough. Experts Say That’s Baseless.”2 minute read
- Media CoverageRichard Hughes Quoted in “The $8 Billion Children’s Vaccine Fund Kennedy Would Oversee”2 minute read
- PublicationsThe Lingering Legacy of Thimerosal2 minute read
- Media CoverageRichard Hughes Quoted in “ACA Suit Threatens Overhaul of Preventive Care in Employer Plans”2 minute read
- Media CoverageRichard Hughes Quoted in “How RFK Jr. Drove Mistrust of a Cancer Prevention Vaccine”7 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court Case Offers Trump Path to Dismantle Obamacare Mandates”5 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear ACA Preventive Coverage Suit”4 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear ACA Preventive Care Case”1 minute read
- Media CoverageRichard Hughes Quoted in “Biden Admin Finalizes NBPP, MA Pay Rules Ahead of Departure”2 minute read
- Media CoverageRichard Hughes Quoted in “SCOTUS to Review ACA’s Free Preventative Services Mandate”2 minute read
- Media CoverageJames Boiani Quoted in “Supplement Makers Try to Latch On to GLP-1 Boom”2 minute read
- PublicationsMedicare Coverage of Antiobesity Medicines1 minute read
- Media CoverageRichard Hughes Featured in “‘How Far Will RFK Go?’ 2 Experts Talk Kennedy’s Potential Impact on Child Health” ...4 minute read
- Media CoveragePhilo Hall Quoted in “A Medicare Minefield Awaits Oz”2 minute read
- Media CoverageRichard Hughes Explores the Impact of President-Elect Trump’s Nomination of Robert F. Kennedy Jr. as Secretary of Health ...13 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2025 Promotions4 minute read
- Media CoverageRichard Hughes Quoted in “FDA Science, Vaccine Policy to Face ‘Firm Hand’ in Trump Return”2 minute read
- PublicationsNow Is Not the Time to Undo Adolescent Vaccination Policies2 minute read
- Media CoverageRichard Hughes Quoted in “Scientists and RFK Jr. Want Vaccine Data—for Very Different Reasons”3 minute read
- PublicationsThe Advent and Future of Self-Administered Vaccines2 minute read
- Media CoverageErin Sutton Quoted in “3 Things to Know About Proposed OTC Contraception Regs”3 minute read
- PublicationsAre We Ready for a Bird Flu Vaccination Campaign?2 minute read
- Media CoverageRichard Hughes Quoted in “DOJ Asks SCOTUS to Reverse Braidwood Ruling, Uphold ACA’s Preventative Mandate” ...3 minute read
- Media Coverage
Richard Hughes Quoted in “DOJ Will Ask SCOTUS to Take Up Braidwood”
3 minute read - PublicationsInteragency Strike Force on Unfair and Illegal Pricing Holds First Public Meeting1 minute read