Pharmacy and Reimbursement

Overview

BakerHostetler’s Pharmacy and Reimbursement team is set apart by our in-depth knowledge and real-world experience of the pharmacy industry. One of the few legal teams across the country to have multiple attorneys who are also registered pharmacists or healthcare practitioners, we bring real-world experience with our ability to help resolve legal, practical, and compliance-related issues. We have long-standing experience in advising retail, mail-order, specialty, compounding, and institutional pharmacies, as well as in working with pharmacy benefit managers (PBMs), managed care/insurance entities, academic medical centers, and wholesale distributors.

We have a wealth of firsthand knowledge and capabilities for successfully handling matters involving regulatory, reimbursement, or litigation-related issues at both the state and federal levels. Our attorneys have handled matters involving numerous state boards of pharmacy, the Food and Drug Administration, Drug Enforcement Administration, Center for Medicare and Medicaid Services, Health Resource and Services Administraiton, Office of the Inspector General, and Department of Justice. We use that firsthand knowledge to provide clients with advice tailored to meet real-world needs. We work closely with many different client functions, such as:

  • Executive management teams
  • Executive legal departments
  • Compliance officers
  • Pharmacist-in-charges (PICs)
  • Reimbursement departments
  • Formulary review committees
  • Diligence and acquisition teams
  • Wholesale distributors
More »
Pharmacy Capabilities

With our focus on pharmacy, we develop strategies that improve our clients’ presence in the marketplace and posture in regulatory and compliance litigation.

  • State Board of Pharmacy and Insurance licensure and compliance
  • FDA and DEA registration, compliance, and investigations
  • Compounding registration and development of USP- and cGMP-compliant policies
  • Assist with cGMP compliance and FDA inspections
  • Regulatory and compliance issues:
    • Anti-Kickback and Stark laws
    • False Claims Act
    • HIPAA and HITECH
    • Billing issues
  • Audits and proceedings initiated by fiscal intermediaries, program integrity contractors, and federal and state governmental authorities
  • Internal investigations and corporate oversight
  • Medicare, Medicaid and 340B reimbursement disputes, appeals, and audits
  • Managed care negotiations, contracting, and payment disputes
  • Civil and criminal healthcare enforcement matters
  • Communication with Capitol Hill and administration policymakers, administrative agencies, and enforcement officials
  • Transactional diligence assistance with various acquisitions and transactions
  • Privacy law compliance, both federal and state

Select Experience

  • Defended two pharmaceutical wholesalers, in one of the largest antitrust class actions in U.S. history, involving prescription drug pricing claims.
  • Represented a pharmacy on matters in front of numerous state boards of pharmacy following an inspection of its compounding facility.
  • Represented a compounding pharmacy during a recall of compounded medications following an FDA and state board of pharmacy inspection.
  • Assisted pharmacies and PBMs with Office of the Inspector General (OIG) self-disclosures.
  • Represented two pharmaceutical wholesalers in one of the largest antitrust class actions in U.S. history involving prescription drug pricing claims.
  • Advised a private equity fund in connection with a high-value and multifaceted sale of a large specialty pharmacy company; representation included regulatory filings for almost 300 pharmacy licenses as well as permits and Medicare and Medicaid applications involving significant coordination among agencies.
  • Represented a pharmacy during a DEA investigation into the loss of a Schedule II substance, which resulted in no charges being filed.
  • Assisted in the registration of several entities with the FDA as a 503B Outsourcing Facility and with developing SOPs on cGMP compliance.
More »

Experience

  • Defended two pharmaceutical wholesalers, in one of the largest antitrust class actions in U.S. history, involving prescription drug pricing claims.
  • Represented a pharmacy on matters in front of numerous state boards of pharmacy following an inspection of its compounding facility.
  • Represented a compounding pharmacy during a recall of compounded medications following an FDA and state board of pharmacy inspection.
  • Assisted pharmacies and PBMs with Office of the Inspector General (OIG) self-disclosures.
  • Represented two pharmaceutical wholesalers in one of the largest antitrust class actions in U.S. history involving prescription drug pricing claims.
  • Advised a private equity fund in connection with a high-value and multifaceted sale of a large specialty pharmacy company; representation included regulatory filings for almost 300 pharmacy licenses as well as permits and Medicare and Medicaid applications involving significant coordination among agencies.
  • Represented a pharmacy during a DEA investigation into the loss of a Schedule II substance, which resulted in no charges being filed.
  • Assisted in the registration of several entities with the FDA as a 503B Outsourcing Facility and with developing SOPs on cGMP compliance.
  • Assisted a pharmaceutical company with an Office of the Inspector General (OIG) self-disclosure involving government pricing of an FDA-regulated product. The company turned to our team based on our experience with the FDA and Center for Medicare & Medicaid Services (CMS) elements of the project. We drafted documents and interacted with the government for the company. We specifically reviewed the company’s pricing and government reporting compliance policies, advised on enhancing these policies, drafted a disclosure to OIG explaining the compliance lapse involving the price reporting to CMS, discussed the conflict between CMS regulations and the FDA’s authorized generic drug regulations and assisted with OIG negotiations. We also drafted compliance policies for the company that addressed CMS- and FDA-authorized generic drug price reporting issues.
  • Represented a chain of nursing homes and pharmacies in their out-of-court debt restructuring.
  • Provided advice related to the importation and regulatory clearance of a product regulated by the FDA. We helped the company obtain importation approval despite the company’s name appearing on the FDA’s Import Alert list. We drafted responses and worked with the FDA and U.S. Customs after the product’s quarantine. We ultimately obtained clearance for the product’s importation into the U.S. Resolving this matter was critical to the company as it had waiting purchase orders. Our handling of this project demonstrated our ability to build credibility with the FDA by showing the company had the required regulatory and compliance initiatives in place to overcome the fact that the exporting company was on the Import Alert list.
  • Advised a pharmacy benefit manager in an acquisition of another pharmacy benefits management company. We served as the lead healthcare and FDA regulatory counsel for the transaction in matters involving FDA, Centers for Medicare and Medicaid Services (CMS) and state pharmacy boards. During our representation, we drafted several disclosures to CMS and FDA involving the acquired company related to their employment of an excluded/debarred individual.
  • Served as healthcare regulatory counsel in connection with a high-value and multifaceted sale of a large specialty pharmacy company; representation included regulatory filings for almost 300 pharmacy licenses, permits, and Medicare and Medicaid applications, involving significant coordination among agencies.
  • Served as healthcare regulatory counsel in connection with a complex and high-stakes sale of a national, full-service pharmacy benefit management company. Our representation involved all aspects of the sale including a corporate reorganization and numerous regulatory filings that required significant interaction with healthcare regulatory agencies throughout the process.
  • Represented a major workers’ compensation pharmacy as outside counsel. We acted as lead regulatory counsel on the buy-sell diligence for the pharmacy in its sale to a private equity fund. This was an extremely large transaction for the workers’ compensation specialty pharmacy and required a significant amount of regulatory due diligence. The transaction required the transfer of licenses in 50 states in addition to the transfer of FDA registrations with respect to a DEA-controlled substance. We worked with all the implicated regulatory agencies to ensure an efficient and effective transfer of licenses. We also helped the pharmacy navigate a significant DEA audit so the company and its executives did not face civil or criminal penalties in connection with oxycodone, a Schedule II controlled substance.
  • Provided one of the world’s largest specialty pharmacies with healthcare regulatory counsel. We represented the company in its interactions with the FDA and with state boards of pharmacy. We counseled on the company’s registration as a 503B Outsourcing Facility (compounding pharmacy). This project involved working with the company’s executive team to develop a risk strategy and business development plan regarding registration with the FDA and new revenue streams. Given that the matter resulted in one of the first 503B registrations ever issued by the FDA, the matter is noteworthy for its unique and unchartered legal issues.

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