With more than 30 years of experience, Michael Dowell provides regulatory and transactional counsel to a variety of sectors within the healthcare industry, including federally qualified health centers (FQHCs), pharmacies—including retail, multi-state, wholesale distributors, specialty, mail order, veterinary, compounding, long-term care, and pharmaceutical manufacturers, telemedicine and digital health providers, managed care plans (Medicaid Managed Care Plans and Medicare Advantage Plans, and PACE Programs), physician organizations, MSOs, and ancillary service providers.
Michael advises 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 Medical and 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
Michael frequently represents clients before state agencies and state professional boards such as the California Department of Health Care Services, the California Department of Public Health, the Office of Administrative Hearings, as well as before the FDA, DEA, OIG, CMS, and HRSA.
- American Health Lawyers Association
- American Society for Pharmacy Law
- Board of Directors
- California Society for Healthcare Attorneys
- Board of Directors
- Education Committee
- Diversity Committee
- California Pharmacists Association
- Los Angeles County Bar Association
- Health Law Section, Past Chair
Some of Michael’s representative matters and transactions include:
Federally Qualified Health Centers (FQHCs)
- Establishment of FQHCs, including preparation of organizational matters, community license applications and federal qualification, board governance, conflicts of interest, and tax-exempt organization requirements.
- Conducted pre-HRSA visit surveys and site visit preparation and assistance with corrective actions and responses regarding HRSA site visit and audit findings.
- Counseled multiple FQHCs on mergers, acquisitions, joint ventures, affiliations, and contracts.
- Represented clients regarding Medicare and Medi-Cal enrollment, overpayments, PPS reconciliation, PPS audits, costs reports, and other audits and investigations.
Michael is a pharmacist and his career as a pharmacist included employment in chain store, independent, and inpatient hospital pharmacies. His knowledge of the pharmacy industry provides him with the tools to represent pharmacy industry clients in all 50 states.
- Handled pharmacy license, permit applications, change of control requests, board disciplinary matters and petitions for reinstatement, administrative hearings, and administrative writs.
- Represented clients in multi-state mergers, acquisitions, and dispositions of pharmacies.
- Prepared Medicare and Medi-Cal enrollment, audits, suspension orders, and termination appeals.
- Defended Investigations and audits on DEA Controlled Substances Act Compliance.
- Provided advice and counsel to multiple clients regarding PBM contracting, audits, and dispute resolution – withholds, appeals, invoice shortages, mail order, and credentialing.
Health Care Transactions and Regulatory Matters
- Structured, negotiated, and documented an $80 million sale of a management company and affiliated physician practices to a large publicly-traded company in multiple states.
- Conducted corporate transactions for multiple health care entities, including representation of client in its acquisition of a healthcare system, including multiple hospitals and clinics.
- For multiple health care organizations, developed and implemented corporate compliance plans, including code of conduct and policies and procedures.
- Counseled physician and dental practice management companies on acquiring medical and dental practices.
- Knox-Keene Health Care Services Plan (HMO, PPO, and EPO) licensure and regulatory advice, including the formation of Medicare Advantage Plans and Medicaid HMOs.
- Advised numerous health care providers and entities regarding Anti-Kickback Law, self-referrals, and False Claims Act.
Telemedicine and Telehealth
- Provided advice and counsel to multiple telemedicine and telehealth companies, entrepreneurs, investors, and institutions on a broad range of telemedicine and telehealth legal issues.
- Represented a health system with an electronic health records software physician donation program, data privacy, and security issues.
- Represented a national mail order pharmacy in providing pharmacy fulfillment services for telemedicine companies.
- Represented a long-term care pharmacy in providing data aggregation and data analytics, 340B specialty pharmacy, and telemedicine services for FQHCs and rural health centers.
- Prepared telemedicine contracts that addressed medical practice, scope of practice, tele-prescribing and licensure requirements.
Michael speaks regularly to many organizations, including the American Association of Health Plans, American Health Lawyers Association, California Association of Health Plans, National Dental Association, State Bar of California, and the Health Care Law Section of the Los Angeles County Bar Association. His presentations include:
- "Federally Qualified Health Center Mergers and Acquisitions," Illinois Primary Health Care Association, Annual Conference, October 2020
- "Telehealth is Essential For Health Centers: Today and Beyond," Illinois Primary Health Care Association, Annual Conference, October 2020
- "340B Drug Program Challenges and Opportunities," Nevada Primary Care Association's (NPCA) Virtual 2020 Annual Health Care Conference, Virtual Event, September 16, 2020
- "DEA Inspections and Audits Warrant Compliance Plan, Part 2," Compliance Today, December 2019
- "DEA Inspections and Audits Warrant Compliance Plan, Part 1," Compliance Today, November 2019
- "Compliance Tips on How to Pass State Board of Pharmacy Inspections," Journal of Health Care Compliance, September/October 2019
- "Federally Qualified Health Center and Rural Health Center Telemedicine Compliance and Legal Issues," Journal of Health Care Compliance, March/April 2019
- "OIG Issues New Safe Harbor on Free or Discounted Local Transportation Services," BNA's Health Care Fraud Report, February 2017
- "California Appellate Court Upholds Pharmacist-In-Charge Responsibility for Pharmacy Technician $1 Million Drug Theft," California Pharmacist Magazine, Winter 2016
- "Recent OCR Enforcement Actions Emphasize the Importance of Executing HIPAA Business Associate Agreements," BNA's Health Law Reporter, June 2016
- "HIPAA Settlement with Community Pharmacy Highlights Best Practices for the Handling and Disposal of Paper PHI," BNA's Health Law Reporter, May 21, 2015
- Co-Author, "Federally Qualified Health Center and Look-Alike Sliding Fee Discount and Related Billing and Collections Program Requirements," Journal of Health Care Compliance, January/February 2015
- Michael Dowell Discusses Impact on Pharmacies of U.S. Supreme Court Ruling that DEA Must Prove Knowing and Intentional Violations of the CSADecember 8, 2022
- November 21, 2022
- September 13, 2022
- May 16, 2022
- Mike Dowell Discusses Need for Compliance Plans in Light of DEA Controlled Substance Compliance Inspections and AuditsFebruary 12, 2020
- April 30, 2019
- February 15, 2017
- July 10, 2014
- OIG Permits Health System and Federally Qualified Health Center Look-Alike Collaboration Agreement Restructuring Which Includes Forgiveness of Debt, Free Medical Office Space, and Free Medical Office Furnishings and EquipmentJanuary 12, 2023Health Care Alert
- August 3, 2022Health Care Alert
- OIG Advisory Opinion 22-08 Permits a Federally Qualified Health Center to Provide Smartphones to Patients to Promote Access to Telehealth and Social Isolation/Loneliness BenefitsMay 20, 2022Health Care Alert
- January 11, 2022Health Care Alert
- New California Law Prohibits Chain Community Pharmacy Productivity Quotas for Pharmacists and Pharmacy TechniciansOctober 27, 2021Health Care Alert
- California Appellate Court Rules That Federally Qualified Health Center Outreach Expenses Do Not Qualify For Cost-Based ReimbursementSeptember 29, 2021Health Care Alert
- New OIG Guidance Permits Federally Qualified Health Centers to Offer Remote Patient Monitoring, Big-Box Store Gift Cards, and Other Incentives to Medicare and Medicaid PatientsFebruary 22, 2021Health Care Alert
- December 21, 2020Health Care Alert
- Attention Pharmacies and Prescribers: New California Controlled Substances Prescription Form and CURES Reporting Requirements Are ComingNovember 19, 2020Health Care Alert
- California Board of Pharmacy Approves "No Pharmacist Left Alone" Regulations for Retail Pharmacy ChainsSeptember 21, 2020Health Care Alert
- August 26, 2020Health Care Alert
- OPA Program Update 2020 Highlights Changes to 340B Program Registration and Recertification RequirementsAugust 13, 2020Health Care Alert
- May 14, 2020Health Care Alert
- April 9, 2020Health Care Alert
- April 9, 2020Health Care Alert
- April 3, 2020Health Care Alert
- April 3, 2020Health Care Alert
- Medicare Telehealth COVID-19 Waivers Expand Opportunities to Provide Telehealth Services to Medicare BeneficiariesApril 3, 2020Health Care Alerts
- July 29, 2019Health Care Alert
- August 26, 2016Health Law Alert
J.D., Indiana University Maurer School of Law
B.S., Pharmacy, Purdue University