Pharmacy, 340B and Pharmacy Benefits Consulting
Our consultants have diverse and extensive experience addressing issues unique to all major participants in the pharmaceutical delivery ecosystem. With respect to the provision of care, these include retail chain pharmacies, specialty pharmacies, mail-order pharmacies, institutional pharmacies, home infusion pharmacies, long-term care pharmacies, compounding pharmacies, outsourcing facilities, central fill pharmacies, in-office physician pharmacies and wholesale distributors. With respect to coverage, these include both payors and pharmacy benefit managers (“PBMs”).
We have extensive experience advising providers and suppliers on matters common in the pharmacy space including pharmacy benefit management, government reimbursement, drug supply chain optimization, distribution, repackaging, long-term care/hospice, group purchasing organization matters and manufacturing, along with the full spectrum of ancillary pharmacy and drug-related matters for both controlled and non-controlled drugs.
Our experience encompasses a broad range of pharmacy-related services including licensure and certification (federal and state), development and maintenance of compliance programs, policy and procedure development, Medicare and Medicaid reimbursement matters, limited distribution drug access and payor network access.
We also routinely advise 340B Covered Entities on a variety of matters including program optimization (e.g., provider-based, telehealth), opportunity assessment and enrollment, drug sourcing (class of trade, GPO, WAC and Prime Vendor account planning) and virtually any other operational issue facing 340B Program Covered Entities and contract pharmacies.
In carrying out these services, we advise institutional and retail pharmacy clients related to the following matters: controlled substances (DEA and state); wholesale distribution, mail-order drugs, pharmacy and PBM implementation issues, pharmacy technology, security and EMR; e-prescribing and telemedicine; automated dispensing; drug recalls; 503 A and 503 B compounding; sterile procedures; institutional and individual licensure/enrollment; payor certifications (Medicare, Medicaid, private payors); Medicare Part D compliance; 340B Program implementation, oversight and optimization; pharmaceutical pricing issues; infusion services; home health pharmacy service; pharmaceutical environmental issues; supply chain (product and related services agreements); HIPAA/HITECH; immunizations; PBM audits; and payor reimbursement validation.