Specialty Pharmacy and 340B

Goodwin has extensive experience representing specialty pharmacies serving hospitals, health systems, health centers, care clinics, special-care facilities, long term care facilities, group homes, and outpatient behavioral health facilities. Our pharmacy team has extensive experience concerning pharmacy operation and the high cost/high touch medications provided to individuals with specific target conditions, including Chemotherapy, Hemophilia, Hepatitis, Multiple Sclerosis, Rheumatoid Arthritis, Human Immune Deficiency Virus (“HIV”), Pulmonary Arterial Hypertension, Asthma, Pediatric Endocrinology, Transplant, Crohn’s Disease, or Hepatitis C. We also have extensive experience with medication therapy management, quality management, data reporting, pharmacy-to-pharmacy sales of specialty medications, representation of non-dispensing pharmacies providing telepharmacy and management services to hospital-based and other dispensing pharmacies, and payor specialty network exclusion/participation.

Since its creation in 1992, the 340B Program has grown exponentially both in the number of healthcare providers eligible to participate and the volume of drugs purchased through the program. The expanding and evolving nature of the 340B Program—including what facilities participate, how 340B Program patients are defined, and what pharmacies can dispense to those patients—has resulted in a shifting landscape of obligations with respect to 340B Program compliance. Goodwin has extensive experience advising contract pharmacies, covered entities, health systems and pharmaceutical manufacturers regarding 340B eligibility, registration, contracting, compliance, inventory tracking and reporting, and supply chain. Our representations have included, among other things reimbursement, management, structuring, reporting, payment arrangements, Medicaid refunds and regulatory. Our pharmacy clients provide contract pharmacy services to 340B covered entities ranging from small non-profit healthcare clinics to county and state agencies to disproportionate share hospitals in major cities. Goodwin serves as outside regulatory counsel to several specialty pharmacies, health systems care clinics and a wide range of retail, specialty compounding and long-term care pharmacies, as well as pharmacy group purchasing organizations and co-ops, pharmacy networks and other industry entities.