Whether a hospital, retail, compounding, home care, or research pharmacy, Hancock Daniel’s attorneys are experienced and knowledgeable in working with these heavily regulated entities. The everchanging legal landscape in the pharmacy arena requires providers to be up to date on relevant legislative and regulatory activities and programs. Hancock Daniel’s Pharmacy team provides legal guidance and advice to further your organization’s business goals and needs.
Hancock Daniel has broad experience with the 340B Drug Pricing Program. This experience includes assisting “covered entities” with enrollment, compliance with the prohibition against obtaining covered outpatient drugs through a group purchasing organization, and responding to audit requests. The firm’s capability includes review of disproportionate share percentage eligibility, reporting on how providers bill Medicaid fee-for-service drugs on the Medicaid Exclusion File, and evaluation of auditable records to confirm compliance with 340B Program guidance. Hancock Daniel’s knowledge of the 340B Program helps healthcare providers ensure that they remain eligible to receive discounts on all 340B eligible covered outpatient drugs.
- Structuring pharmacy arrangements
- DEA and CLIA Registrations
- 340B Programs
- Compliance Program Development, Assessment and Support
- Risk Management
- Survey Management
- Civil Monetary Penalty/Termination Appeals
- Government Relations
- Board of Pharmacy (“BOP)”) Licensure
- Controlled Substances Registrations
- Representation is disciplinary actions at the BOP
- Licensure and Medicare/Medicaid Certification Enrollment
- Responding to Government Investigations
- Employment Matters