Overview
The pharmacy industry is one of the most highly regulated and evolving industries in the United States. Companies in the pharmacy industry have the arduous task of improving clinical effectiveness and efficiency and responding to new reimbursement models while maintaining compliance with the myriad of ever-changing federal and state laws and regulations affecting their business. Epstein Becker Green has a deep bench of lawyers with the experience necessary to help pharmacy industry clients navigate this complex and challenging environment, stay compliant, and manage and minimize their liability exposure.
Epstein Becker Green represents regional and national pharmacy chains; specialty, compounding, mail-order, and independent pharmacies; hospitals and retailers with pharmacy operations; group purchasing organizations; pharmacy services administrative organizations; and technology vendors supporting pharmacy operations. Our attorneys have extensive experience providing such clients with strategic, transactional, regulatory, and litigation services and support.
Epstein Becker Green attorneys’ experience is supplemented by a thorough knowledge of Medicare Advantage and Part D Program requirements, including issues relating to payment policies, compliance plan obligations, reporting requirements, enrollment and disenrollment rules, coordination of benefits, and marketing guidelines. Our attorneys are also frequent lecturers at pharmacy conferences and write on a broad range of pharmacy law-related topics. We stay on top of new developments and inform our clients about emerging issues and trends that may impact their business or the pharmacy industry as a whole.
Services/Scope of Practice
Federal and State Regulatory Compliance
- Providing compliance counseling on federal and state anti-kickback and anti-inducement laws, Medicare Part D, the 340B Drug Pricing Program, and privacy and security matters under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act
- Structuring rewards programs (gas rewards, coupons, “buy one, get one free,” and other loyalty programs) under the federal anti-kickback and anti-inducement laws
- Advising on patient co-payment coupons sponsored by manufacturers in response to the recent Office of Inspector General (OIG) study questioning the effectiveness of manufacturing safeguards to prevent fraud and abuse
- Structuring arrangements with drug manufacturers in compliance with fraud and abuse and privacy laws, patient adherence and medication therapy management (MTM) service programs, data sharing arrangements, co-payment coupons, and limited distribution network and other specialty pharmacy models
- Advising on controlled substances, Drug Enforcement Administration (DEA) registration requirements, electronic-prescribing software and telemedicine issues, auto-dispensing, drug recalls and market withdrawals, and seizures and injunctions
- Representing pharmacy service administrative organizations with respect to contracting, antitrust, and other regulatory compliance issues
Licensure, Registration, and Accreditation
- Advising national and regional pharmacies with mail service and specialty operations on pharmacy benefit manager (PBM) credentialing requirements and the applicability of in-state and out-of-state licensing requirements
- Assisting private equity groups in conducting the health regulatory due diligence of specialty pharmacy and health care technology companies; such due diligence includes assessing compliance with licensing requirements and shepherding all necessary filings, such as federal and state “change of ownership” requirements
- Counseling resident and non-resident pharmacies on change of ownership, transfer matters, and other federal and state approvals
Drug Reimbursement and Pricing
- Advising pharmacies on Medicaid, Medicare Advantage, and Part D Program requirements and the reimbursement landscape in general, including issues relating to payment policies, compliance plan obligations, reporting requirements, enrollment and disenrollment rules, coordination of benefits, and marketing guidelines
- Assessing usual and customary rate issues related to a pharmacy’s drug discount programs (payor and government enforcement agencies routinely target generic discount, gift card, and other rewards programs)
- Providing strategic advice to pharmacies regarding the applicability of federal and state “any willing provider” laws to prevent payor lockouts, PBM credentialing requirements, drug manufacturer limited distribution requirements, and other potential obstacles relating to patient and drug product access
Audits, Investigations, and Litigation
- Representing pharmacy industry clients in inspections, investigations, and litigation initiated by governmental agencies, such as the Food and Drug Administration, DEA, OIG, and Department of Justice; state regulatory and professional licensing agencies; and state Attorneys General, among others; such investigations have related to matters involving brand versus generic billing, customer discount programs, proof of delivery, rebates, and administrative services
- Representing pharmacies and distributors with respect to investigations involving inventory control and reverse distribution issues
- Providing representation to pharmacies, including specialty pharmacies, in a significant number of Board of Pharmacy actions throughout the country
- Representing a variety of clients involved in the drug distribution chain with matters relating to the alleged diversion of drug products, including prohibited diversion under the Controlled Substance Act and 340B drug discount program
- Representing pharmacy clients in government and commercial payor reimbursement audits, proceedings, and appeals
- Providing representation to pharmacies in antitrust litigation involving prescription drug pricing issues, including discriminatory pricing practices
Mergers, Acquisitions, Joint Ventures, Affiliations, and Outsourcing
- Representing private equity sponsors with structuring, implementing, and coordinating the due diligence of various pharmacy-related transactions, including mergers and acquisitions, dispositions, and strategic alliances
- Drafting and negotiating contracts specific to the pharmacy industry, including network agreements; product and data purchase, medication adherence, rebate, and other arrangements with drug manufacturers and “hub” service providers; pharmacy services agreements with hospitals and accountable care organizations; and 340B contract pharmacy services agreements
- Representing pharmacies, specialty pharmacies, and pharmacy vendors in company sales, acquisitions, mergers, and joint ventures
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Events
Past Events
- October 12, 2022
- September 9, 2022
- August 2, 2022
- June 13-15, 2022
Insights
Insights
- PublicationsBraidwood v Becerra’s Vaccine Access Threat3 minute read
- Publications
In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute
9 minute read - Media CoverageConnie Wilkinson Quoted in “Stelara Biosimilar Tests Market Impact of Drug Price Program”3 minute read
- Media CoveragePaving the Way for Prevention Over the Counter3 minute read
- Media CoverageRichard Hughes Quoted in “An R.S.V. Shot for Infants Is in Short Supply. Here’s What to Know”4 minute read
- Media CoverageRichard Hughes Quoted in “Webinar Highlights Recommendations to Improve Disparities in CRC Screening”3 minute read
- Media CoverageRichard Hughes Quoted in “RSV Vaccines Aren’t Covered by Medicare for These Vulnerable Groups”2 minute read
- PublicationsCalifornia Enacts Statute That Furthers Efforts to Move Toward a Unified Health Care Financing System11 minute read
- Media CoverageRichard Hughes Quoted in “Opinion: It Shouldn’t Be So Hard for Older Adults to Receive the RSV Vaccine”2 minute read
- Media CoverageRichard Hughes Quoted in “New RSV Vaccines Aren’t Covered by Some Health Insurance Plans”3 minute read
- PublicationsAdditional Withdrawals of Long-Standing Guidance and Newly Proposed Merger Guidelines2 minute read
- PublicationsCMS Seeks Comment on Initial Guidance for the Part D Manufacturer Discount Program: Inflation Reduction Act Updates ...2 minute read
- PublicationsFalse Claims Act: Businesses Should Consider How to Document Their Interpretations3 minute read
- PublicationsCMS Issues an Information Collection Request for the Drug Price Negotiation Process: Inflation Reduction Act Updates ...3 minute read
- Media CoverageDelia Deschaine Quoted in “Abortion Pill Legal Fight Leaves FDA Grappling with Response”4 minute read
- Media CoverageGeorge Breen Quoted in “Landmark FCA Showdown Looking Like Defense Bar Letdown"2 minute read
- Media CoverageGeorge Breen Quoted in “Justices Appear Open to Whistleblowers’ Drug Fraud Arguments”2 minute read
- Media CoverageDelia Deschaine Quoted in “Employers Pause Plans to Make Abortion Pills Easier to Access”3 minute read
- Media CoverageDelia Deschaine Quoted in “Blue States Stockpile Abortion Pills Amid Legal Uncertainty”4 minute read
- PublicationsCMS’s Initial Guidance on Medicare Drug Price Negotiation Program Suggests Familiar Pharmacy Chargeback Process ...12 minute read
- Media CoverageDelia Deschaine Quoted in “Doctors Seek Clarity from FDA as States Stockpile Abortion Pills”2 minute read
- PublicationsCMS Issues an Information Collection Request on Negotiation Data Elements: Inflation Reduction Act Updates3 minute read
- PublicationsCMS Issues New Guidance on Medicare Drug Price Negotiation Program: Inflation Reduction Act Updates2 minute read
- PublicationsCMS Releases Its List of 27 Part B Rebatable Drugs for Q2 of 2023: Inflation Reduction Act Updates3 minute read
- BlogsComments to CMS Guidance on the Medicare Prescription Drug Inflation Rebate Program Due March 11, 202310 minute read
- PublicationsFDA Significantly Reforms Cosmetics Regulations for First Time in Over 80 Years11 minute read
- PublicationsBiden Administration Prioritizes Health Equity in Proposed Reforms to Medicare Managed Care33 minute read
- Media CoverageGeorge Breen Quoted in “Justices Ignite FCA Debate: Fairness vs. 'Invitation to Fraud'”3 minute read
- PublicationsCongressional Legislation Seeks to Ensure “Equitable Treatment” in the 340B Program2 minute read
- Media CoverageArena District Gains National Law Firm Tenant: Epstein Becker Green Moves into New Office Space in Columbus, Ohio ...2 minute read
- Media CoverageLaw360 Office Snapshot: Epstein Becker Green Opens New Columbus Spot3 minute read
- Firm AnnouncementsEpstein Becker Green Expands Columbus Office in New Arena District Location3 minute read
- Media CoverageRichard Hughes, Kala Shankle Featured in “Viewpoint: Pharmacists Need Standard Pathway to Bill for Paxlovid” ...2 minute read
- PublicationsPharmacists Can Now Prescribe Paxlovid, but Barriers Persist4 minute read
- PublicationsFTC Maintains Strong Opposition to COPAsAugust 25, 20222 minute read
- PublicationsMore Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act18 minute read
- Publications
Disorder in the Post-Roe World? . . . “It Is So Ordered” by the Dobbs Court
2 minute read - PublicationsCOVID-19 Vaccination and the Fetal Cell Line Conundrum for Employee Religious Objections10 minute read
- Media Coverage
Epstein Becker Green Expands “From Roe to Dobbs” Resource Center for Employers and Health Care / Life Sciences ...
1 minute read - Firm AnnouncementsLynn Shapiro Snyder Serves on the Nashville Health Care Council’s Board of Directors2 minute read
- PublicationsFDA Greenlights Pharmacists to Prescribe COVID-19 Drug Paxlovid13 minute read
- Media CoverageDelia Deschaine Quoted in “Can States Legally Ban FDA-Approved Abortion Pills?”2 minute read
- Media CoverageLynn Shapiro Snyder Continues Service on Nashville Health Care Council’s Board of Directors2 minute read
- PublicationsRecent Actions Highlight That Price Fixing Reaches Beyond Agreements on the Ultimate Price1 minute read
- PublicationsFTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector23 minute read
- Media CoverageDelia Deschaine Quoted in “What a Lawsuit in Mississippi Tells Us About the Future of Abortion Pills”4 minute read
- PublicationsFederal Trade Commission’s Focus on Pharmacy Benefit Managers2 minute read
- PublicationsCMS Finalizes Changes to Pharmacy DIR in Part D Starting with Contract Year 202414 minute read
- PublicationsFDA Releases Proposed Rule on National Standards for Drug Wholesaler Licensure18 minute read
- PublicationsThe $2 Trillion Build Back Better Act Passes the House, Bringing the Potential for a Significant Health Care Expansion ...4 minute read