Michael A. Dowell

Michael has a long track record of advising clients across all sectors of the healthcare industry on complex regulatory and transactional matters. His clients include federally qualified health centers (FQHCs), pharmacies including retail, multi-state, wholesale distributors, specialty, mail order, veterinary, compounding, long-term care providers, pharmaceutical manufacturers, telemedicine and digital health companies, managed care plans including Medicaid Managed Care Plans and Medicare Advantage Plans, physician organizations, management service organizations (MSO), and ancillary service providers.

He counsels clients on federal and state laws, including:

• Section 330 of the Public Health Service Act
• HRSA Health Center Program Requirements, including Scope of Project and, HRSA Operational Site Visits (OSVs)
• Federal Tort Claims Act
• State Boards of Pharmacy Practice Acts
• FDA Drug Quality and Security Act and the Drug Supply Chain Security Act
• DEA Controlled Substances Act and Regulations
• Data Privacy and Security (HIPAA and HITECH)
• Corporate Practice of Medicine, Fee-splitting, and Scope of Practice Restrictions
• Anti-kickback, Self-Referral and Civil Monetary Penalties Laws
• Health Care Provider and Facility Licensure Requirements
• Medicare and Medicaid Enrollment and Reimbursement Rules
• Managed Care Plan Licensure and Operational Laws