Organizations providing specialty pharmacy, infusion items and services, medical supplies and home health are subject to complex and evolving regulations and market forces. Bryan Cave’s Specialty Pharmacy, Infusion, Medical Supplies and Home Health Industry Team has become the choice for these types of organizations to position themselves to ensure compliance and efficiency within this dynamic industry.

Our Clients

The Team has experience representing a broad range of specialty pharmacy, infusion, medical supply and home health clients, including publicly traded and privately held companies, private equity and venture capital funds, for profit and not for profit organizations, providers affiliated with hospitals or health systems, and retail, mail order and wholesale providers.

Our Practice

Transactional and Regulatory Practice

The Team’s transactional and regulatory practice is broad-based. We represent specialty pharmacy, infusion, medical supply and home health clients in all facets of transactional, regulatory, operations, licensure, and reimbursement matters. We also counsel providers and suppliers on managed care contracting, including insurance and risk contracting. Our transactional work includes mergers and acquisitions, joint ventures, strategic affiliations and contract relationships. Our regulatory work includes counseling specialty pharmacy, infusion, medical supply and home health companies with regard to licensure (at the federal, state and local levels), accreditation, scope of practice, reimbursement, compensation methodologies, Medicare/Medicaid anti-kickback, physician self-referral and Certificate of Need issues. We also provide advice and assistance in analyzing the impact of various federal and state privacy laws and regulations, including HIPAA. Our regulatory work also includes tax (including tax-exempt) and antitrust counseling in connection with transactional matters.

Mergers and Acquisitions

The Team has been involved in numerous merger and acquisition transactions. Our merger and acquisition representation includes due diligence, health care regulatory matters, drafting and negotiating transaction documents and new enrollment or change of ownership applications for licensure and third party payors. We have been involved with both stock and asset transactions, transactions involving nonprofit tax-exempt organizations, and work with LLCs.

Joint Ventures and Strategic Affiliations

The regulatory aspects of the health care industry and the changing needs of patients often call for strategic relationships among providers. These relationships may take the form of a partnership, joint venture, other co-owned entity, management agreement, operating lease or other arrangement. These relationships often involve vertical or horizontal integration of providers with different specialties, facilities and expertise. The relationships are structured to take into account reimbursement issues, tax-exemption issues, regulatory issues including licensure, certificate of need, anti-kickback and physician self-referral and capital sourcing. The Team finds compliant solutions based on the parties’ business objectives.

OIG Investigations and Enforcement Proceedings

The Team has substantial experience representing specialty pharmacy, infusion, medical supplies and home health clients in connection with regulatory agency investigations and other controversy work.

Payor Disputes/Medicare/Medicaid Audits and Appeals

The Team has significant experience managing and, in some cases, litigating both commercial and government payor disputes. We represent clients in payor disputes before arbitration panels and administrative agencies, including the Provider Reimbursement Review Board and the Social Security Administration’s Office of Hearings and Appeals, as well as in state and federal courts throughout the United States.