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In Brief: A Digest of Specialty Pharmacy Healthcare Projects

Client Success
  • Strategically expanded specialty pharmacy provider to operate in all 50 states.
  • Drafted and negotiated contractual arrangements of all types including: limited distribution pharmacy agreements, data sales agreements, discount agreements, pharmacy services agreements and patient assistance program agreements between specialty pharmacy and pharmaceutical manufacturers.
  • Successfully represented specialty pharmacy providers in administrative hearings involving adverse audit findings in Medicare and Medicaid billing matters.
  • Negotiated network payer agreements and provided strategic legal counsel when disputes arose between payers and specialty pharmacy.
  • Provided legal oversight and advice to teams developing, contracting and implementing 340B programs, product offerings, share savings arrangements and contract pharmacy agreements;
  • Represented healthcare companies in the formation, sale, acquisition and operation of hospitals, surgery centers, pharmacies, medical practices, diagnostic imaging facilities and management companies.
  • Assumed the role of outside general counsel for pharmaceutical services provider during a period of short staffing in the legal department. Reviewed and negotiated contracts for CRO services, pharmacovigilance services, REMS services, HUB/commercial services, nursing services and Patient Assistance Program services.
  • Drafted specialty pharmacy response to implementation of HIPAA Omnibus Final Rule and practical effect that implementation of the marketing rule would have on refill reminder communications paid for by pharmaceutical manufacturers. Provided recommended refill reminder exception that HHS ultimately accepted and published as FAQs;
  • Provided legal oversight for the review and mitigation of risk associated with the HIPAA Omnibus Final Rule on specialty pharmacy contract portfolio including amendment of contractual agreements to ensure compliance with the HIPAA marketing requirements.
  • Provided dedicated attorneys to serve as outside general counsel for specialty pharmacy providers and pharmaceutical manufacturer service providers during periods of high demand;
  • Analyzed and advised specialty pharmacy on HIPAA and other privacy issues arising from contracting, data sales and specialty pharmacy operations.
  • Engaged and oversaw a third-party statistician’s development of a de-identification report in order for specialty pharmacy to report date of dispense and other identifiers to third parties.