Joe is a member of the Life Sciences Health Industry Group, practicing in the area of health care regulatory law. His practice focuses on counseling health care manufacturers, distributors and providers on reimbursement, regulatory, and fraud and abuse issues.
Experience
Representative matters
Representative matters
Conducted internal investigation and review of pricing, promotional and medical affairs functions across three therapeutic areas for biopharmaceutical manufacturer.
Conducted internal investigation of Medicare Part D contracting issues in response to employee compliance allegations.
Advised multiple pharmaceutical manufacturers with respect to development of innovative contracting arrangements, including bundled pricing arrangements and outcomes-based pricing and rebate contracts.
Conducted internal investigation and review of pricing, promotional and medical affairs functions across three therapeutic areas for biopharmaceutical manufacturer.
Conducted internal investigation of Medicare Part D contracting issues in response to employee compliance allegations.
Advised multiple pharmaceutical manufacturers with respect to development of innovative contracting arrangements, including bundled pricing arrangements and outcomes-based pricing and rebate contracts.
Routine counseling of drug and device manufacturers with respect to marketing initiatives and patient assistance programs, coupons, and similar arrangements.
Conducted audits and counseled manufacturers with respect to government pricing compliance matters following issuance of Medicaid rebate final rule and 340B omnibus proposed guidance.
Led regulatory due diligence team in acquisition of oncology physician practice management organization and medical device distribution entities.
Negotiated transition agreement pricing provisions for manufacturers buying and divesting pharmaceutical products.
Developed innovative patient assistance and patient support programs for products subject to REMS and similar procedures.
Conducted internal investigation of pharmaceutical manufacturer pharmacovigilance function in response to employee hotline complaints.
Regulatory subject matter lead and leading DOJ discussions in pharmaceutical manufacturer false claims matters involving bundled pricing arrangements for medical devices, safe harbor discounting arrangements, product reporting and classification under the Medicaid rebate program, and kickback and government price reporting issues associated with PBM and distributor relationships.
Advised device manufacturer with respect to development of “virtual” direct-to-patient selling channel and process for new medical device.
Recognitions
- Named to Thomson Reuters' Stand-Out Lawyers list (2024-2025)
- Selected through peer review for inclusion in The Best Lawyers in America© for Health Care Law, 2021-2025
- Shortlisted by the LMG Life Sciences Guide for Regulatory Attorney of the Year: Pricing & Reimbursement, 2022-2023
Credentials
Education
Education
- The George Washington University Law School, 1989, J.D., high honors, Selected as a member of the Order of the Coif; Member of the George Washington University Law Review
- Dickinson College, 1986, B.A., Political Science and Russian/Soviet Area Studies , Magna Cum Laude, Elected to the Dickinson chapter of Phi Beta Kappa
Professional admissions & qualifications
Professional admissions & qualifications
- District of Columbia
- Pennsylvania
Court admissions
Court admissions
- U.S. District Court - District of Columbia
- U.S. Court of Appeals - Federal Circuit
- U.S. Court of Appeals - Third Circuit
- U.S. Court of Appeals - Sixth Circuit
- U.S. Court of Appeals - Tenth Circuit
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Insights
Blogs
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Events
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