Michael A. Dowell

Mr. Dowell practices in the areas of healthcare, regulatory, and corporate law. With more than 30 years of experience, he represents clients in a variety of sectors within the healthcare industry, including federally qualified health centers, managed care plans, Medicaid Managed Care Plans, Medicare Advantage Plans, PACE Programs, pharmacy benefit managers, pharmaceutical manufacturers, retail pharmacies, long-term care pharmacies, specialty pharmacies, compounding pharmacies, mail order pharmacies, wholesale drug distributors, hospitals, health systems, long-term care providers, physician organizations, management companies, and ancillary service providers.

Mr. Dowell provides advice and counsel to clients regarding a variety of corporate and contractual transactions, including mergers and acquisitions, joint ventures, affiliations, licensing, financing and services-related transactions. He also advises clients in federal and state fraud and abuse matters, compliance program development, governmental audits and investigations, Medicare, Medicaid, HIPAA and data privacy, meaningful use of electronic medical records, telemedicine and telehealth, digital health, value-based payments, pay-for-performance, concierge medicine, and managed care law.

Mr. Dowell has published several articles and spoken at conferences regarding various health law issues.

Mr. Dowell has significant experience in the following areas:

Federally Qualified Health Centers
Mr. Dowell has significant experience counseling nonprofit health care organizations, including state licensed primary care clinics, community health centers, and federally qualified health centers, on a broad range of legal matters. He has advised clients on compliance with state licensure and Section 330 requirements, joint ventures, affiliations, vendor contracts, reimbursement matters, compliance programs, preparing for and responding to government audits, and challenging disputed government findings/actions, including, but not limited to, the areas listed below:

• FQHC Formation, Community Governance and HRSA Requirements
• Clinic Licensure and Federal Qualification
• Non-Profit Governance
• Federal Grants and Procurement Law
• Section 330 Public Health Service Act Compliance
• Scope of Project Issues
• Medicare and Medi-Cal PPS Audit Recovery Defense
• Regulatory Defense and Government Audits and Investigations
• Mergers, Acquisitions, Joint Ventures and Affiliations
• General Contracts and Agreements
• Employment Law, Executive Compensation, and Employee Benefits
• Healthcare Corporate Compliance
• Tax-Exempt Organization Regulation and Policy
• Real Estate
• Political Activity and Federal Election Campaign Law
• Dispute resolution regarding overpayment assessments, PPS reconciliation reports, PPS rate settings audits and costs reports.

Pharmacy Law
Mr. Dowell is a graduate of the Purdue University School of Pharmacy. His career as a pharmacist includes employment in chain store and independent pharmacies, and inpatient hospital pharmacies. As a Pharmacy Lawyer and Pharmacist Lawyer, Mr. Dowell counsels and represents pharmacies (including chain and independent retail, hospital (inpatient/outpatient), internet and mail order, long-term care, specialty, compounding, telepharmacy, nuclear, wholesale distributor, veterinary, and prison) in all 50 states, and pharmacists, pharmaceutical manufacturers, pharmacy benefit management companies, and Medicare Part D Plans. Mr. Dowell has counseled such clients regarding licensure, pharmacy regulatory matters, contracts, acquisitions and sales, federal and state laws and regulations governing pharmacy and controlled substances, third party payer audits, matters before the Food and Drug Administration, State Boards of Pharmacy and the Drug Enforcement Administration, including, but not limited to, the areas listed below:

• Pharmacy Licensing and Reporting Requirements
• Pharmacy License or Permit Applications and Change of Control Requests
• Pharmacy Board Accusations, Administrative Hearing Licensure Defense, and Administrative Writs
• Pharmacy Board Petitions for Reinstatement and Petitions for Modification or Early Termination of Probation
• Mergers, Acquisitions, and Dispositions of Pharmacies
• 340B Program Participation and Compliance
• PBM Contracting, Audits and Disputes Resolution (Withholds, Appeals, Invoice Shortages, Mail Order, Credentialing)
• Issues with Pharmacy Services Administrative Organizations (PSAOs) and Third Party Administrators (TPAs)
• DIR Fees and Maximum Allowable Cost (MAC) Pricing and Appeals
• Medicaid and Medicare Enrollment, Audits, Suspension Orders, and Termination Appeals
• DEA Controlled Substances Act Audits, Investigations, and Compliance
• Compliance with the Drug Supply Chain Security Act and Drug Quality and Security Act
• Sterile and Non-Sterile Compounding (503A)
• Outsourcing Facilities (503B)
• Telehealth, Telepharmacy, Telemedicine, and E-Prescribing Issues
• Multistate Pharmacy Issues
• Medicare Part D Plans
• Pharmacy and pharmacy management company agreements and relationships with vendors, manufacturers, pharmaceutical companies, wholesalers, suppliers, and group purchasing organizations (GPOs)
• Pharmacy Accreditation Support and Corrective Action Remediation
• Veterinary Pharmacies
• Pharmaceutical Manufacturers and Repackagers
• Pharmaceutical Distributor and Wholesalers
• Internet Pharmacies and Mail Order Drugs
• Compliance with state laws related to physician referrals, kickbacks, fee-splitting, the corporate practice of medicine doctrine, pharmacy, and dispensing laws, and other state laws impacting physician practices and their relationship with pharmacies
• Development of pharmacy compliance plans and governing documents
• Specialty Drug Pharmacies, Manufacturers and Distributors
• Reimbursement Hubs, Prior Authorization Programs, and Patient Assistance Programs
• Pharmaceutical Pricing and Rebates
• Prescription Drug Marketing Act
• Food, Drug and Cosmetic Act Regulatory Issues (including GPP and GMP)
• Biologics and Dietary Supplements
• Medical Marijuana and Industrial Hemp

Healthcare Law Transactions and Regulatory Matters
Mr. Dowell provides health insurers and other managed care organizations regulatory advice concerning compliance with various state and federal health care and state managed care plan and insurance laws and regulations, including Medicare Advantage, Medicaid Managed Care, PACE programs, the Affordable Care Act and other health reform initiatives. He helps them obtain regulatory approvals from federal and state agencies, including the Centers for Medicare and Medicaid Services, and The California Department of Managed Health Care, Department of Insurance, and Department of Health Care Services. He represents clients in related federal and state agency enforcement matters and transactional matters, including, but not limited to, the areas listed below:

• Managed Care Plan Licensure and Regulation
• Managed Care Payment and Contracting
• Health Care Provider Certification, Accreditation, and Licensure
• IPAs, Medical Groups, and Physician Organizations
• Management Services Organization formation, contracting, and ongoing compliance matters
• Physician Compensation, Benefits, Recruitment, and Contracts
• HIPAA Privacy and Security
• Digital Health (including Telemedicine, E-Prescribing, Data Analytics, Transactions, Information Privacy, and Security)
• Electronic Health Records
• Representation of Dialysis, Radiology, and Laboratory Facilities
• Value Based Payments
• Retail/Concierge Medicine
• Compliance Program Development, Counseling, and Defense
• Anti-Kickback Law, Self-Referrals, and False Claims Act Matters
• Mergers, Acquisitions, Joint Ventures and Affiliations
• Government Audits, Investigations, and Self-Disclosure Protocols
• Healthcare Contracting, Disputes, Litigation, and Risk Management

Telemedicine and Digital Health
Mr. Dowell helps health care companies and legal and regulatory issues regarding the provision of telemedicine and digital health services. The firm advises digital health companies, entrepreneurs, investors and institutions on a broad range of services, including financings, mergers and acquisitions, and company formation. Mr. Dowell has extensive experience representing digital health clients in commercial transactions. Mr. Dowell advises clients on all aspects of the law and the rapidly developing regulatory landscape as they related to telemedicine and digital health, including, but not limited to, the areas listed below:

• Telemedicine Scope of Practice Issues
• Telemedicine and Remote Prescribing
• Telemedicine Fraud and Abuse Issues
• Telemedicine Reimbursement
• Telemedicine State Licensure Issues
• Telemedicine Credentialing
• Telemedicine Privacy and Security
• Telemedicine and Mobile Devices (mHealth)
• Telemedicine Contracts and Transactions
• Electronic medical records and electronic transmission of health information
• E-prescribing

Mr. Dowell joined Hinshaw & Culbertson LLP in December 2009. Previously he was a co-chair of the Health Care Industry Group at Theodora Oringher Miller & Richman PC in Los Angeles.

Mr. Dowell began his legal career in 1983 as a staff attorney with the National Health Law Program in both Washington, D.C. and Los Angeles. In 1989, he became corporate counsel to CIGNA Healthcare of California. From 1991 to 2006, he was Chair of the Health Care Practice Group at Miller & Holguin in Los Angeles.

• American Health Lawyers Association
• American Society for Pharmacy Law
• American Bar Association
  • Health Law Section
• California Society for Healthcare Attorneys
  • Education Committee
• California Pharmacists Association
• Los Angeles County Bar Association
  • Health Law Section, Past Chair

• Recognized on the Super Lawyers list by Southern California Super Lawyers magazine, 2005 – 2012

Some of Mr. Dowell's representative matters and transactions include:

Federally Qualified Health Centers

• Advice and counsel to FQHCs regarding board governance issues, including fiduciary responsibility and conflict of interest
• Assisting organizations in establishing FQHCs, including spin-offs
• Advising on compliance issues, including governance and Board structure
• Assisting with preparation of necessary FQHC legal documents and FQHC application
• Counseled and advised FQHCs on a wide variety of transactions to ensure compliance with tax-exemption requirements and avoidance of intermediate
• Represented a FQHC in a merger with another
• Drafted and negotiated affiliation agreement and related contracts between a FQHC and Non-Profit Hospital
• Updating and revising bylaws (e.g., board composition, board responsibilities, etc.)
• Preparing and/or reviewing conflict of interest policies
• Preparing and/or reviewing all types of contracts and services agreements
• Attending Board meetings, advising FQHCs on Board actions and preparing board resolutions
• FQHC Board of Directors workshops and seminars regarding federal grant applications; compliance with Federal program requirements; corporate compliance programs; grants management; provider affiliations and networks; nonprofit governance; and managed care
• Represented a FQHC in its $9 million equipment and construction loan funded from tax exempt bond
• Represented a FQHC in negotiations with Bank of the West and Wells Fargo Bank for Letters of Credit to secure loans obtained through municipal finance transactions
• Conducting pre-HRSA visit surveys and assisting with preparation for the visit
• Participating in HRSA on-site visits
• Assisting with corrective actions and responses regarding HRSA Site Visit and Audit findings
• Drafted and negotiated Community Benefit Grant agreements on behalf of
• Drafting, reviewing and negotiating agreements with 340(b) administrators, vendors and pharmacies.

Pharmacy Law

• Analysis, revision and negotiation of PBM contracts for pharmacies and managed care plans, including review and drafting of Medicare Part D Prescription Drug Program agreements and
• Assisted covered entities in drafting and/or negotiating agreements with contract pharmacies and in complying with their reporting, audit, and other regulatory obligations
• Represented a national specialty pharmacy specializing in Hemophilia patient drugs with all licensure, transactional, and regulatory matters, including 340b contract pharmacy matters, Medicaid and Medicare Part D compliance, and fraud and abuse
• Analyzing regulatory implications of mergers and acquisitions and addressing issues related to sale or closure of pharmacies
• Managing complex, licensure issues including multi-pharmacy change of ownership (CHOW) projects in all 50 states
• Pharmacy Attorney for hospitals on all aspects of pharmacy licensure, certification and accreditation, including Medicare and Medicaid enrollment, change of ownership, and operational
• Represented numerous pharmacies in buy/sell arrangements, stock purchases, asset purchases and stock recapitalization ventures, among other arrangements
• Advising on multiple patient assistance, co-pay waiver and coupon programs
• Provision of advice and guidance regarding the Drug Quality and Security Act, Compounding Quality Act, and the Drug Supply Chain Security
• Representation of pharmacies, pharmacists and pharmacy technicians in Board of Pharmacy licensure, regulatory, and disciplinary
• Representation of pharmacies, pharmacists and pharmacy technicians in DEA investigations, administrative or other enforcement proceedings and Controlled Substances Act
• Drafting and negotiating prescription drug distribution agreements, group purchasing organization agreements, specialty services agreements, and marketing
• Advice and counsel on compliance with federal and state laws including issues specific to prescription drug rebates, coupons, PAP programs, AKS safe harbors, usual and customary price, and “switching programs
• Represented infusion pharmacy in all start up and operating matters including licensure, Medicare reimbursement matters, physician contracts and relationships, fraud and abuse analysis, and negotiations with pharmaceutical manufacturers and wholesale distributors
• Advising pharmacies on HIPAA and HITECH privacy and security
• Development of template contracts and Policies and
• Identification of regulatory and compliance issues for radiopharmaceutical
• Assisted pharmacies in the implementation of electronic prescribing and electronic health
• Provision of advice to covered entities and contract pharmacies on 340B program
• Structuring contract arrangements for hospitals, FQHCs, Ryan White Clinics and hemophilia treatment centers to access 340B discounted drugs for eligible patients.
• Advice and counsel on appropriate billing of prescription medications, including auditing of pharmacies, developing internal audit procedures, corporate compliance guidelines
• Assisted clients in developing compliance strategies, including review and analysis of pharmacy laws and regulation in all USA States and
• Provision of advice and counsel on DEA requirements for controlled substance distribution and

Health Care Transactions and Regulatory Matters

• Structured, negotiated and documented $80 million sale of a management company and affiliated physician practices located in multiple states to a large publicly traded
• Conducted health care regulatory due diligence and general corporate representation of client in its acquisition of a four-hospital Health
• Developed and implemented a Corporate Compliance Plan, code of conduct, and policies and procedures for a nonprofit integrated delivery system comprised of an HMO, physician organization, federally qualified health clinic, and community health
• Counsel to Physician Practice Management Companies and Dental Practice Management Companies and Acquisition of Medical and Dental
• Drafted and Negotiated Medical Director and Hospital-Based Physician coverage agreements for radiology, emergency medicine, anesthesiology, and
• Counseled a chain of Dialysis clinics in legal and regulatory matters related to their sale to a publicly traded
• Knox-Keene Health Care Services Plan (HMO), PPO, EPO, and Health Insurance Company licensure and regulatory advice for numerous
• Advised numerous health care providers and entities regarding anti-kickback laws, self-referral prohibitions, Medicare and Medicaid certification, and licensure
• Counseled numerous healthcare organizations on all aspects of licensure, certification and accreditation, including Medicare and Medicaid enrollment, change of ownership, and operational
• Conducted an internal investigation for a Medicare and Medicaid HMO to determine compliance with Medicare marketing
• Counseled hospitals and health systems, health plans, insurers, governmental entities, physician organizations and personal health record vendors with respect to a wide range of privacy and security compliance
• HIPAA and HITECH Act audits and investigations.
• Representation of physicians and medical groups, including IPAs, in the review, analysis and negotiation of all types of managed care plan agreements, including multi-year payor
• Development of physician and dental practice management services agreements to conform to corporate practice of medicine, fee splitting, and anti-kickback
• Development and formation of Medicare Advantage Plans, Medicaid HMOs, commercial plans, and specialized health plans (vision, dental, chiropractic and mental health).
• Drafting, negotiating, and analyzing fee-for-service and capitation physician organization and managed care plan contracts and related
• Conducted an internal investigation for a Medicare and Medicaid HMO to determine compliance with Medicare marketing

Telemedicine and Digital Health

• Represented a Health System with licensing issues and physician donation program concerning an electronic health records system and software
• Represented a national mail order pharmacy providing pharmacy fulfillment services for telemedicine companies
• Represented a long-term care pharmacy in providing data aggregation and data analytics, 340bspecialty pharmacy and telemedicine services for federally qualified health centers and rural health centers
• Addressing medical practice licensure issues involving telemedicine practice
• Representation of pharmacy providers establishing internet prescribing and fulfillment practices
• Provision of legal advice to medical group that provides online second opinions to patients
• Provision of advice and counsel on telepsychiatry issues

Mr. Dowell also speaks regularly to many organizations, including the American Association of Health Plans, American Health Lawyers Association, California Association of Dental Plans, California Association of Health Plans, California Black Health Network, National Black Prosecutors Association, National Dental Association, National Health Law Program, National Health Lawyers Association, State Bar of California, and the Health Care Law Section of the Los Angeles County Bar Association. His presentations include:

• "340B Drug Program Challenges and Opportunities," Nevada Primary Care Association's (NPCA) Virtual 2020 Annual Health Care Conference, Virtual Event, September 16, 2020
• "Mid-Level Practitioners: A Primer on the Legal Issues Affecting a Growing Segment of the Health Care Delivery Workforce," Orange County Bar Association, Health Care Law Section Meeting, Newport Beach, California, September 2014

• "Fraud & Abuse," California Society for Healthcare Attorneys Annual Meeting & Spring Seminar, Olympic Valley, California, April 2014
• "EHR, PHI, HIPAA, HITECH: Deciphering the Alphabet Soup for Data Privacy and Security in Health Care Delivery," 88th Annual Convention & Exhibits, National Bar Association, Miami, Florida, July 2013
• "The Omnibus Rule and Its Impact on HIPAA Compliance," National Bar Association Health Law Section Webinar Series, June 2013
• "A Map to Healthcare Reform Compliance," Minority Corporate Counsel Association's 12th Annual CLE Expo, San Diego, California, March 2013
• "HIPAA Security Breaches and Cyber- Liability," Hinshaw's Annual Health Care Conference, Lisle, Illinois, November 2012
• "Defending Against False Claims Actions and Identifying the Other Fraud & Abuse Implications of Managed Care Litigation," American Conference Institute's 2nd Advanced Forum on Management Care Disputes and Litigation, Phoenix, Arizona, November 2011
• "Basics of Health Plan Law," California Society of Healthcare Attorneys 2011 Fall Seminar & Back to Basics, Los Angeles, California, November 2011
• "Effective Collaboration Between Hospitals and Federally Qualified Health Centers/Rural Health Centers," National Association of Health Services Executives 26th Annual Education Conference, Henderson, Nevada, October 2011
• "Managed Care Contracting After Health Care Reform," Hinshaw's 2010 Health Care Conference, Lisle, Illinois, November 2010
• "Healthcare Fraud and Abuse in a Tougher Enforcement Environment," Strafford Publications, , live webinar, April 2010
• "Recent Healthcare Fraud Enforcement Efforts Under the Obama Administration and Impact to Plans, Payors and Providers," American Health Lawyers Association, live webinar, February 2010

Mr. Dowell is a prolific author. A selection of his publications includes:

• "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
• "Recent OCR Enforcement Actions Emphasize the Importance of Executing HIPAA Business Associate Agreements," BNA's Health Law Reporter, June 2016
• "Federally Qualified Health Center Federal Tort Claims Act Insurance Coverage," co-author, The Health Lawyer, February 2015
• "HIPAA Settlement with Community Pharmacy Highlights Best Practices for the Handling and Disposal of Paper PHI," BNA's Health Law Reporter, May 21, 2015
• "Federally Qualified Health Center and Look-Alike Sliding Fee Discount and Related Billing and Collections Program Requirements," co-author, Journal of Health Care Compliance, January/February 2015
• "Federally Qualified Health Center and Look-Alike Bureau of Primary Health Care Operational Site Visit Compliance Audits," co-author, Journal of Health Care Compliance, July/August 2014
• "Executive Summary: New Health Center Governance Requirements," co-author, American Health Lawyers Association Practice Group Executive Summary, April 2014
• "Hospital-Physician Transaction Compliance Strategies to Address Recent Fraud and Abuse Enforcement Actions," Journal of Health Care Compliance, March/April 2014
• "The Case for Federal Oversight of EHR Vendors to Promote Interoperability and Usability," co-author, Electronic Health Reporter, February 10, 2014
• "Sharing of Secure Patient Information Requires Strong Breach and Notification Policies," co-author, Electronic Health Reporter, January 15, 2014
• "Risk Management Concerns Arising Out of HITECH and the Hospital Re-admission Penalties Program," co-author, Electronic Health Reporter, November 14, 2013
• "Commentary: the case for extending MU Stage 2," co-author, Government Health IT, August 30, 2013
• "Healthcare Risk Management Challenges Created by Federal Regulation of Electronic Medical Records and Care Management," Journal of Healthcare Risk Management, July 16, 2013
• "Commentary: Concerns About Quality Improvement Organizations Actions Around Meaningful Use," co-author, Government Health IT, June 25, 2013
• "Commentary: Delving into HIPAA Breach Notification," co-author, Government Health IT, May 1, 2013
• "Commentary: The Litigation and Risk-Management Concerns Meaningful Use Triggers," co-author,Government Health IT, March 29, 2013
• "Meaningful Use Electronic Health Record Incentive Payment Audits: Are You Ready," BNA's Health Law Reporter, November 29, 2012
• "Medical Spas Now Subject to New California Regulatory Requirements," Los Angeles Daily Journal and San Francisco Daily Journal, August 31, 2012
• "2013 Medicare Marketing Guidelines Present New Compliance Challenges," BNA's Medicare Report, July 13, 2012
• "HIPAA Compliance Audits and Heightened Enforcement Are Coming: Are You Ready?" BNA's Health Law Reporter, August 30, 2011
• "The OIG's Hospital Compliance Initiative," BNA's Health Care Fraud Report, August 10, 2011
• "Compliance Program Implications of Recent HIPAA Privacy Enforcement Activities," BNA Health Law Reporter, Vol. 20, No. 11, March 17, 2011
• "HRSA Issues New Section 340B Guidance for Contract Pharmacy Services," CCH Health Care Compliance Letter, Commerce Clearing House, Volume 13, Issue 8, April 20, 2010
• "Outsourcing: A Cost-Effective Way to Achieve Health Care Compliance," Journal of Health Care Compliance, March-April 2010
• "President Obama Targets Healthcare Fraud: Payors, Plans and Providers Beware!" Payors Plans & Managed Care, a publication of the American Health Lawyers Association, Volume 12, Issue 3, December 2009
• "HHS and FTC Release Guidance on HITECH Act Requirements," Journal of Health Care Compliance, July/August 2009
• "Federal Funding and Regulation of Health Care Information Technology and Electronic Health Records under the HITECH Act," CCH Health Care Compliance Letter, June 2009
• "Revised Anti-Markup Rule Will Have Significant Impact on Physician Diagnostic Testing Service, Billing Arrangements," BNA Medicare Report 19, No. 14, April 2008
• "New Safe Harbor Protects Certain Financial Arrangements Involving Federally Qualified Health Centers," CCH Health Care Compliance Letter 10, no. 24, December 2007
• "Beware of the Office of Inspector General: OIG 2007 Work Plan Challenges and Solutions for Medical Groups," Group Practice Journal 56, No. 1, January 2007
• "Update Your Compliance Plan Now: The OIG's 2006 Work Plan Targets May Impact You!" Journal of Health Care Compliance 8, No. 2, March–April 2006
• "Phase II of the Final Stark II Regulations: Practical Implications for Medical Groups," Group Practice Journal 53, No. 8, September 2004
• "Phase II of The Final Stark II Regulations: Implications for Medical Groups," California Association of Physician Groups Update 6, No. 8, August 2004
• "Fraud and Abuse Issues in Forming and Operating Hospital-Physician Joint Ventures" and "Factors to Consider When Selecting a Joint Venture Organizational Structure," Journal of Health Care Compliance 4, No. 6, November/December 2002
• "Developing Mechanisms for Reporting Compliance Violations," co-author, Healthcare Financial Management 55, No. 8, August 2001
• "The Importance of Being Earnest: Assessing the Effectiveness of a Health Plan's Compliance Program," co-author, Healthplan 42, March/April 2001
• "OIG Urges Review of Physician Office Space Rental Arrangements," co-author, Group Practice Journal 49, No. 6, June 2000