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 and a company could face a potentially costly investigation or enforcement action.
That is why working with experienced counsel who keep 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 that is 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
Insights
Insights
- BlogsLast Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future10 minute read
- PublicationsFTC Continues Investigation into PBM Practices2 minute read
- Publications
Will Religious Freedom Claims Trump Public Health? Braidwood and HIV Prevention
2 minute read - Media CoverageRichard Hughes Quoted in “ObamaCare Faces Key Hearing After Texas Ruling”2 minute read
- Media CoverageRichard Hughes Quoted in “4 Argument Sessions Benefits Attys Should Watch in March”4 minute read
- BlogsVideo: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – ...2 minute read
- Media CoverageRichard Hughes Quoted in “Affordable Care Act Preventive Services Under Threat: Previewing Braidwood Oral Arguments” ...4 minute read
- Media CoverageLesley Yeung Quoted in “How Trump Could Weaken Medicare Drug Pricing Negotiations”4 minute read
- PublicationsEnsure Equity and Feasibility in Updating Meningococcal Vaccine Recommendations2 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved” ...2 minute read
- Media CoverageJames Boiani Quoted in “FDA Braces for High Court, Final Rule Moves in Election Year”3 minute read
- Media CoverageRichard Hughes Quoted in “The RSV Shot for Babies Was Supposed to Save Lives. Then Nobody Could Get It.”13 minute read
- Publications
In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute
9 minute read - Media CoverageConnie Wilkinson Quoted in “Stelara Biosimilar Tests Market Impact of Drug Price Program”3 minute read
- PublicationsCMS Seeks Stakeholder Feedback About Medicare Transaction Facilitator Services for the Medicare Drug Price Negotiation ...4 minute read
- Media CoverageRichard Hughes Quoted in “Webinar Highlights Recommendations to Improve Disparities in CRC Screening”3 minute read
- Publications
Checking In on How SuperValu Has Altered FCA Litigation
4 minute read - Media CoverageRichard Hughes Quoted in “New RSV Vaccines Aren’t Covered by Some Health Insurance Plans”3 minute read
- PublicationsInsult to the Injured: The Case for Modernizing Vaccine Injury Compensation2 minute read
- Media CoverageRichard Hughes Quoted in “Lawsuit Against Affordable Care Act Targets PrEP”4 minute read
- PublicationsVaccines Deserve Immunity from the IRA’s Pricing Provisions2 minute read
- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
- PublicationsManufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates4 minute read
- PublicationsCMS Seeks Comment on Initial Guidance for the Part D Manufacturer Discount Program: Inflation Reduction Act Updates ...2 minute read
- PublicationsFalse Claims Act: Businesses Should Consider How to Document Their Interpretations3 minute read
- Media CoverageWill Walters Quoted in “Senators Pull Few Punches at PBM Execs During Insulin-Cost Hearing”2 minute read
- PublicationsCMS Issues an Information Collection Request for the Drug Price Negotiation Process: Inflation Reduction Act Updates ...3 minute read
- Media CoverageGeorge Breen Quoted in “Landmark FCA Showdown Looking Like Defense Bar Letdown"2 minute read
- Media CoverageRichard Hughes Quoted in “Biden's Next Steps on Preventive Services Coverage”3 minute read
- Media CoverageGeorge Breen Quoted in “Justices Appear Open to Whistleblowers’ Drug Fraud Arguments”2 minute read
- PublicationsIs CMS Ignoring the Realities of Biopharmaceutical Costs?2 minute read
- PublicationsCMS’s Initial Guidance on Medicare Drug Price Negotiation Program Suggests Familiar Pharmacy Chargeback Process ...12 minute read
- Publications
Repairing the US Preventive Services Task Force After Braidwood v. Becerra
2 minute read - PublicationsCMS Issues an Information Collection Request on Negotiation Data Elements: Inflation Reduction Act Updates3 minute read
- BlogsIs CMS Ignoring the Realities of Biopharmaceutical Costs?6 minute read
- Media CoveragePhilo Hall Quoted in “Lawyer: Legal Issues on Preemption of PBM Regulation Unresolved”3 minute read
- Media CoverageInsulin as Preventive Care: Why Not Eliminate Patient Cost Sharing?4 minute read
- PublicationsCMS Issues New Guidance on Medicare Drug Price Negotiation Program: Inflation Reduction Act Updates2 minute read
- PublicationsCMS Releases Its List of 27 Part B Rebatable Drugs for Q2 of 2023: Inflation Reduction Act Updates3 minute read
- BlogsComments to CMS Guidance on the Medicare Prescription Drug Inflation Rebate Program Due March 11, 202310 minute read
- PublicationsCMS Launches First Federal Regulatory Action to Implement Medicare Drug Price Negotiation Program6 minute read
- Media CoverageRichard Hughes Quoted in “COVID Vaccine Prices Set to Rise After Commercialization — but Are They Fair?”2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- PublicationsCongressional Legislation Seeks to Ensure “Equitable Treatment” in the 340B Program2 minute read
- Media CoverageMagic Mushrooms in the Garden State? A Look into the Proposed Psilocybin Legal Landscape in New Jersey2 minute read
- Media CoverageRichard Hughes, Kala Shankle Featured in “Viewpoint: Pharmacists Need Standard Pathway to Bill for Paxlovid” ...2 minute read
- PublicationsPharmacists Can Now Prescribe Paxlovid, but Barriers Persist4 minute read
- PublicationsMore Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act18 minute read
- Media CoverageDelia Deschaine Quoted in “Can States Legally Ban FDA-Approved Abortion Pills?”2 minute read