Overview
Attorney Alan Arville* provides strategic, transactional, and regulatory guidance to the health care industry.
His practice focuses on matters relating to the distribution, dispensing, and reimbursement of pharmaceuticals, including Medicare Part D, Medicare Advantage, the 340B Drug Discount Program, federal anti-kickback and anti-inducement laws, HIPAA privacy and security, health care licensing, drug purchase agreements, payor contracting, and affiliations and other collaborative arrangements. Alan’s clients include regional and national pharmacy chains; specialty pharmacies; health care systems; disproportionate share hospitals, federal grantees, and other 340B-covered entities; drug manufacturers and distributors; group purchasing organizations; and pharmacy services administrative organizations. Alan also devotes a substantial portion of his practice to representing private equity firms in the evaluation, due diligence, and acquisition of health care companies.
Pharmacies (chain and independent pharmacies, retailers with pharmacy operations, and specialty pharmacies) seek Alan’s advice on a diverse array of transactions and compliance issues. For example, Alan advises on patient reward and drug discount programs, manufacturer and third-party payor relations, Medicare Part D compliance, medication therapy management services, health and wellness programs, data sharing arrangements, 340B contract pharmacy arrangements, and limited distribution network and other specialty pharmacy models.
Alan also has extensive experience working with disproportionate share hospitals, federal grantees, and other 340B covered entities, contract pharmacies, and 340B management service providers on 340B compliance, outlook, and strategy. Covered entities turn to Alan for assistance with implementing 340B compliance policies and procedures, contract pharmacy arrangements, self-assessments, and independent audits. He also helps covered entities with HRSA audits, manufacturer audits, and self-disclosures.
Alan is an editor of and contributor to the firm’s Health Law Advisor blog, the editor of Epstein Becker Green’s Antitrust Byte client alerts, the author of numerous articles, and a frequent speaker on health care topics. He is a current member of the Board of Trustees of the Academy of Managed Care Pharmacy Foundation (AMCP Foundation).
*Admitted in the District of Columbia; not admitted in Illinois.
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Focus Areas
Services
Trending Issues
Experience
- Represented a national digital pharmacy in its sale to a multinational e-commerce and technology company. Alan served as lead health regulatory counsel in negotiating the terms of the purchase agreement, navigating regulatory approvals for the change of ownership, and responding to the buyer’s health regulatory due diligence.
- Advised a national delivery service company on its expansion to pharmacy and telemedicine, including the structure, licensing, and regulatory compliance of new pharmacy and telemedicine business lines.
- Advised a ride-sharing technology company on the U.S. Food and Drug Administration (FDA), board or pharmacy, and privacy requirements applicable to home delivery of COVID-19 tests and prescription drugs.
- Served as lead counsel on the creation, structure, and compliant operations of a new pharmacy services administrative organization to contract with health plans and pharmacy benefit managers on behalf of regional pharmacies.
- Negotiated the terms of, and drafted contracts to implement, numerous 340B contract pharmacy arrangements among hospitals, retail pharmacy chains, and 340B technology services vendors.
- Represented a national pharmacy network in its sale to a specialty health care management company. As health regulatory counsel, Alan responded to the buyer’s due diligence inquiries, conducted health regulatory due diligence of the buyer, negotiated health regulatory-related aspects of the merger agreement and other transactional documents, and coordinated federal and state health regulatory filings.
Recognition
- Chambers USA: The World's Leading Lawyers for Business: District of Columbia—Healthcare, "Leader in Their Field" (2024); "Up and Coming" (2022-2023)
- The Best Lawyers in America©, Health Care Law (2022 to 2025)
- Washington DC Rising Stars, Health Care (2013)
- Nightingale's Healthcare News, One of the "Outstanding Young Healthcare Lawyers" (2008)
Credentials
Education
- Georgetown University Law Center (J.D., cum laude, 2003)
- University of Dayton (B.A., 2000)
Bar Admissions
- District of Columbia
Court Admissions
- U.S. Court of Appeals for the District of Columbia Circuit
Professional & Community Involvement
- Academy of Managed Care Pharmacy Foundation (AMCP Foundation), Board of Trustees
- American Bar Association
- American Health Lawyers Association, Hospitals and Health Systems Practice Group
- District of Columbia Bar Association, Health Law Section Steering Committee, 2012-2015; Programs Committee, Chair; Nominating Committee, Chair
Media
Events
Upcoming Events
Past Events
- August 2, 2022
- June 7, 2022
Insights
Insights
- BlogsDEA Telemedicine Rules Further Delayed Until (Nearly) 20263 minute read
- BlogsEffective Dates of DEA Final Rules for Telemedicine Prescribing Delayed3 minute read
- BlogsThe 340B Reimbursement Battle: What Hospitals and Insurers Need to Know14 minute read
- BlogsAt Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming ...18 minute read
- BlogsCMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin ...13 minute read
- Firm Announcements
Epstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 2025
14 minute read - Firm Announcements
Epstein Becker Green Honored for Exceptional Performance in Key Practice Areas by Chambers USA 2024
5 minute read - PublicationsHospital and MA Plan Considerations for CMS Final Rule to Remedy 340B Drug Payment Policy11 minute read
- Publications
In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute
9 minute read - PublicationsState Regulation of Pharmacy Benefit Managers: Tenth Circuit Holds That ERISA and Medicare Part D Preempt Key Parts of ...25 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession
12 minute read - Firm Announcements
Epstein Becker Green Recognized for Focused Excellence Across Core Practice Areas in Chambers USA 2023
5 minute read - BlogsMore Federal Action in the Pharmaceutical Sector as PBM Bill Advances in the Senate12 minute read
- PublicationsCMS’s Initial Guidance on Medicare Drug Price Negotiation Program Suggests Familiar Pharmacy Chargeback Process ...12 minute read
- BlogsThe Wait Is Over . . . Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways ...21 minute read
- PublicationsCongressional Legislation Seeks to Ensure “Equitable Treatment” in the 340B Program2 minute read
- PublicationsMore Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act18 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2023 Best Lawyers for Excellence in the Legal Profession
11 minute read - PublicationsFTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector23 minute read
- Firm AnnouncementsChambers USA 2022 Recognizes Epstein Becker Green's Focused Excellence in Core Practice Areas: Distinguished in ...4 minute read
- PublicationsCMS Finalizes Changes to Pharmacy DIR in Part D Starting with Contract Year 202414 minute read
- Firm AnnouncementsFifty-Eight Epstein Becker Green Attorneys Recognized for Professional Excellence–Three Attorneys Distinguished as ...7 minute read
- PublicationsFinalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge ...20 minute read
- PublicationsLowering Drug Prices with the Anti-Kickback Statute: Future and Impact of HHS Final Rule to Disrupt Drug Formulary Rebates ...2 minute read
- Media CoverageAlan Arville Quoted in “340B Provider Camp Cheers HHS Letter to Lilly, Pharma Camp Says the Fight Isn’t Over” ...2 minute read
- PublicationsPresident Trump Signs Executive Orders on Drug Pricing and Domestic Supply Chain Reform22 minute read
- PublicationsStates Are Questioning Medicaid MCO Rx Benefits3 minute read
- PublicationsA Chance for Pharmacies to Showcase Health Care Services2 minute read
- BlogsFace or Fingerprint? The DEA Revisits Biometric Identifiers for e-Prescribing Controlled Substances4 minute read
- PublicationsTelehealth Growth = Expansion of Fraud & Abuse Enforcement2 minute read
- PublicationsHHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration ...19 minute read
- PublicationsCMS Releases Medicare Advantage and Part D Drug Pricing Proposed Rule for Contract Year 202028 minute read
- BlogsHRSA Establishes January 1, 2019 Effective Date for 340B Ceiling Price and Civil Monetary Penalty Rule3 minute read
- BlogsNew Federal Laws Banning “Gag Clauses” in the Pharmacy4 minute read
- BlogsCMS Finalizes Policy and Technical Changes to the Medicare Advantage and Part D Programs for CY 20195 minute read
- BlogsWhite House 2019 Budget and White Paper Shape Ambitious Policy to Reduce Drug Prices8 minute read
- PublicationsComment Deadline Approaches for CMS's Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2 ...21 minute read
- BlogsCMS Final Rule Will Reduce Medicare Part B Drug Payments by Nearly 30% for 340B Hospitals5 minute read
- Publications
Paul Gomez, Katherine Lofft, Alan Arville Contributed to AHLA Representing Hospitals and Health Systems Handbook
1 minute read - PublicationsCMS Issues Final Rule on Covered Outpatient Drugs38 minute read
- BlogsU.S. District Court Vacates HRSA's Interpretative Rule on Orphan Drugs9 minute read
- BlogsHRSA Issues Proposed "Omnibus Guidance"11 minute read
- Media CoverageAlan Arville Quoted in "Attorneys Have Concerns with 340B Program Guidance"2 minute read
- PublicationsHouse Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation ...1 minute read
- BlogsHouse Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation ...4 minute read
- PublicationsConstance Wilkinson, Alan Arville Comment on Specialty Drug Cost Upswing2 minute read
- PublicationsMembers of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency ...1 minute read
- BlogsMembers of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency ...6 minute read
- BlogsHRSA Withdraws 340B "Mega-Reg;" Plans to Issue Guidance in 20156 minute read
- PublicationsOIG Warns Pharmaceutical Manufacturers of Improper Part D Beneficiary Coupon Use9 minute read