Margulies

Ross Margulies

Partner
Washington, DC

I help my clients navigate a complex healthcare regulatory environment so they can remain informed, innovative and patient-focused.

An experienced healthcare attorney, Ross Margulies brings a proactive approach to client management, helping providers, payers, biopharmaceutical and medical device manufacturers, and other innovators navigate the federal and state healthcare legislative and regulatory landscape, including in the Medicare, Medicaid and 340B programs. He provides clients with expert strategic counseling on legislative, regulatory and administrative processes, including novel coverage and reimbursement matters.

Healthcare providers, payers, biopharmaceutical and medical device manufacturers, pharmacy benefit managers, agents/brokers, digital health companies and healthcare startups rely on Ross for expert strategic counseling on legislative, regulatory and administrative processes, including novel coverage and reimbursement matters before the Centers for Medicare & Medicaid Services. He has substantial experience in Medicare and Medicaid law, including advising clients on all facets of the Medicare Prescription Drug Benefit (Medicare Part D), the Medicare Advantage program (Medicare Part C), the 340B Drug Pricing Program and Medicaid managed care. He is a co-author of the firm's Medicaid & the Law blog, www.medicaidandthelaw.com, which highlights and explains current legal and policy issues in the Medicaid program. He represents his clients before the United States Congress in drafting Technical Assistance and legislative amendments, and before the Centers for Medicare & Medicaid Services (CMS) and other components of the U.S. Department of Health and Human Services (HHS) where he regularly achieves successful policy and regulatory changes on behalf of his clients.

In addition to managing the D.C. Office branch of the Foley Hoag Foundation, Ross provides regular pro-bono advice to healthcare organizations serving disadvantaged populations, including Community of Hope in Washington, D.C. and the Tennessee Justice Center in Nashville, TN. Ross is an Adjunct Professor of Law at Vanderbilt Law School where he teaches Medicare and Medicaid law.

Prior to joining Foley Hoag, Ross worked in a variety of public sector settings, including serving in the Office of the General Counsel (OGC) at the U.S. Department of Health and Human Services and at the Health Resources & Services Administration (HRSA). Ross also previously served as a Research Associate at the George Washington University Milken Institute School of Public Health where he focused on healthcare legal issues involving the Medicare and Medicaid programs. 

Education

  • George Washington University Law School, J.D., with honors, 2011
  • George Washington University School of Medicine and Health Sciences, M.P.H., 2011
  • McGill University, B.A., magna cum laude, 2007

Bar and Court Admissions

BAR ADMISSIONS
  • District of Columbia
  • Maryland
  • Tennessee

 

Languages

  • Hebrew

Experience

BIOPHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURERS

Ross provides strategic counseling for both emerging and mature life sciences companies with regard to coverage, coding, and reimbursement under the Medicare, Medicaid, and 340B programs. Representative experience includes:

  • Successfully represented multiple biopharmaceutical, medical device and diagnostic manufacturers in obtaining Medicare New Technology Add-On Payment (NTAP) designation for their novel therapies. Achieved multiple “firsts,” including the first NTAP for an orally administered therapy, the first NTAP for a diagnostic and the first Qualified Infectious Disease Product to receive NTAP conditional approval prior to FDA approval
  • Represented manufacturers with respect to their obligations under the 340B Drug Pricing Program, including in Alternative Dispute Resolution proceedings with providers
  • Drafted Technical Assistance (TA) for state and Federal legislative committees on behalf of multiple manufacturer clients, regularly incorporating amended legislative text to help achieve client goals
  • Implemented multiple manufacturer and non-profit led Patient Assistance Programs (PAPs), including requests for OIG Advisory Opinions, development of PAP Policies and Procedures and policy/regulatory oversight
  • Achieved multiple unique ICD-10 procedure and diagnosis codes on behalf of biopharmaceutical and medical device clients
  • Developed novel legal arguments and assembled compelling scientific evidence that successfully reversed an adverse Medicare policy decision affecting the coding and payment for a biotechnology product
  • Persuaded the Center for Medicaid and CHIP Services (CMCS) to issue a rare guidance document instructing state Medicaid agencies on their coverage obligation for a new, novel therapy
  • Collaborated with a biopharmaceutical manufacturer in its engagement with the US Pharmacopeia (USP) to develop a new category/class under the Medicare Model Guidelines
  • Advised a home hemodialysis manufacturer in its discussions with CMS and Medicare Administrative Contracts (MACs) after receiving the first-ever approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
  • Worked with the Center for Medicare and Medicaid Innovation (CMMI) on an innovative payment and service delivery model to improve quality of care for federal health care beneficiaries
  • Assisted manufacturers in negotiating multiple value-based agreements with payers, including State Medicaid agencies

PAYERS AND PHARMACY BENEFIT MANAGERS (PBMs)

Ross advises health plans and PBMs on all aspects of compliance and strategy with respect to the Medicare Prescription Drug (Part D) and Medicare Advantage (Part C) programs, as well as Federal and state rules and regulations regarding Medicaid fee-for-service and Medicare managed care. Representative experience includes:

  • Led policy and regulatory responses on behalf of multiple PBM clients in the face of multiple regulatory threats, including the constantly changing rules regarding rebates, benefit design, formulary requirements, pharmacy access standards, the exceptions and appeals process and questions of state law preemption. Developed novel legal arguments to challenge these policy proposals
  • Represented payers and PBMs in negotiations with the Centers for Medicare and Medicaid Services (CMS), the Office of Management and Budget (OMB), and on Capitol Hill
  • Provided advice to health plans in implementing new Transparency in Coverage requirements under the No Surprises Act
  • Successfully challenged the application of state anti-competitive “anti-PBM” laws on ERISA and Part D pre-emption grounds
  • Developed a consensus-led framework for a trade organization on pharmacy quality measures in the Medicare Advantage and Part D programs
  • Helped a Medicare Advantage plan secure designation by a state Medicaid agency and CMS as a dual-eligible special needs plan (Dual SNP)
  • Received CMS approval for a novel novation request involving a complex transaction consisting of multiple large Medicare Advantage organizations
  • Led efforts to received CMS approval for a new Primarily Health-Related Supplemental Benefit for a Medicare Advantage organization

HEALTHCARE PROVIDERS AND HOSPITALS

Providers looking to successfully navigate the complex web of state and Federal regulatory requirements look to Ross for a variety of legal needs. Representative experience includes:

  • Advised hospitals and hospital-based entities on CMS site-neutrality policies, including compliance with the Medicare program’s “provider-based” billing requirements
  • Represented multiple Federally Qualified Health Centers (FQHCs) before HHS and the Health Resources and Services Administration on issues related to coverage and reimbursement
  • Convinced CMS and a state Medicaid agency that a residential treatment facility was not an institution for mental disease (IMD), thereby allowing Medicaid payment for inpatient hospital services provided at the facility to continue uninterrupted
  • Assisted hospitals in remaining compliant with EMTALA program rules represent hospitals in EMTALA investigations by the Department of Health and Human Services Office of Inspector General
  • Provided compliance assistance to providers with respect to Federal and state anti-kickback laws, as well as the Physician Self-Referral Law (Stark law)

OTHER REPRESENTATIVE EXPERIENCE

  • Represented multiple digital health companies, including leaders in the prescription digital therapeutics (PDT) space, in various strategic partnerships and financing transactions, and with respect to coverage, coding and reimbursement issues
  • Advised multiple health insurance agents and brokers, including web-brokers, with respect to the sale of Medicare Advantage and Part D plans pursuant to the Medicare Marketing Guidelines, as well as the sale of qualified health plans on the Exchanges created by the Patient Protection and Affordable Care Act

Publications

  • The History of Rebates in the Drug Supply Chain and HHS’ Proposed Rule to Change Safe Harbor Protection for Manufacturer Rebates, Foley Hoag White Paper, Ross Margulies and Thomas Barker and Erik Schulwolf (March 2019)
  • As Republicans Rethink Medicaid, Rethink What Is ‘Health Care’, Huffington Post, Ross Margulies and Ruth Ann Norton (June 5, 2017) 
  • Assessing and Addressing Legal Barriers to the Clinical Integration of Community Health Centers and other Community Providers, Ross Margulies (July 2011)
  • Tax-Exempt Hospitals and the Patient Protection and Affordable Care Act: Implications for Public Health Policy and Practice, Public Health Reports. Volume 126 (March–April 2011)
  • Rosenbaum S., Margulies R., Shah P. The HHS Departmental Appeals Board: Its Role in Shaping Medicaid Policy and an Overview of Recent Rulings. Kaiser Family Foundation (2010)
  • Lopez N., Margulies R., Rosenbaum S. Analysis of the extent to which State Medicaid Agencies have relayed the recent H1N1 CMS missive to Medicaid providers, Ready or Not? Trust for America’s Health (2009)
  • Rosenbaum S., Cartwright-Smith L., Margulies R., Wood S., Mauery R. An Analysis of the Implications of the Stupak/Pitts Amendment for Coverage of Medically Indicated Abortions. (Nov 16, 2009)
FOLEY HOAG ALERTS & UPDATES
  • Details on OSHA, CMS Vaccination Rules Released November 5, 2021
  • Biden Administration Announces Sweeping New COVID-19 Vaccination Requirements for Private Employers and Health Care Facilities September 10, 2021
  • Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care Providers November 25, 2020
  • Summary of Supreme Court Oral Arguments in California v. Texas November 12, 2020
  • The Health Care Priorities of the Biden-Harris Administration and Post-Election Outlook for the 117th Congress November 11, 2020
  • Frequently Asked Questions: CARES Act Phase 3 Provider Relief Fund General Distribution October 17, 2020
IN THE MEDIA
  • “Importance of PBMs in Health Care Costs,” The Pharmacy Benefit with JC Scott (March 22, 2022)
  • “Exploring the Impact of the Robinson-Patman Act: Historical Insights and Future Considerations,” The Pharmacy Benefit with JC Scott (May 11, 2021)

Foley Hoag Publications

Honors & Involvement

HONORS
  • High Honor, 2020-2021 Capital Pro Bono Honor Roll  
  • ABA-BNA Award For Excellence in the Study of Health Law
INVOLVEMENT
  • Adjunct Professor of Law, Vanderbilt Law School
  • American Health Lawyers Association, Member
  • Health Care Compliance Association, Member
  • DC Bar Association
  • Tennessee Bar Association

Speaking Engagements

  • "Navigating U.S. Coverage and Reimbursement for Digital Therapeutics," Korea Health Industry Development Institute (KHIDI) USA's DTx Strategy Forum for Korean Digital Healthcare (September 2022)
  • “Understanding the Reimbursement Landscape for Prescription Digital Therapeutics,” BIO International Convention (June 2022)
  • "The New Technology Add-on Payment (NTAP) Program: What Life Sciences Companies Should Know About Medicare's Time-Limited Program," Foley Hoag Webinar (March 2022)
  • “Transforming Digital Health: How Providers and DTx Companies Can Utilize RPM and RTM Codes to Improve Care,” Foley Hoag Webinar (December 2021) 
  • “Understanding the Biden Administration’s Vaccination Rules,” Foley Hoag Webinar (November 2021) 
  • “The Changing Face of the Medicaid Program: A Review of Recent Trends in State Medicaid Waivers,” AHLA Virtual Institute on Medicare and Medicaid Payment Issues (March 2021)
  •  “Health Care Policy in the Courts,” Foley Hoag Webinar (March 2021)
  • “Biden’s First 100 Days On Healthcare Part I and II,” Biopharma Congress 2020 (December 2020)
  • “Regulatory Issues Roundup,” AMCP Webinar (November 2020)  
  • “Medicare and Medicaid Legal Issues and Developments,” AHLA Virtual Health Plan Law and Compliance Institute (November 2020) 
  • “Public Health and Social Services Emergency Fund: Compliance Best Practices; Avoiding Liability Missteps,“ Foley Hoag Webinar (April 2020)  
  • “Drug Pricing Reforms: The Impossible, Possible and Probable," AHLA’s Institute for Health Plan Law and Compliance Institute (November 2019)
  • “Deep Dive I: Perspectives on State and Federal Medicaid Policies,“ American Society of Gene & Cell Therapy Policy Summit (November 2019) 
  • “The Times They Are a-Changin’ – A Look at Congressional Efforts to Reform the Medicare and Medicaid Prescription Drug Programs,”  AMCP Nexus 2019 (October 2019)   
  • "Keynote Legal Perspective: The Drug Pricing Landscape – A Survey of Current and Future Legal and Regulatory Reforms," 11th Annual Managed Markets and Account Management Strategies Conference (September 2019)  
  • “Assess Potential for Changes to Pharmaceutical Pricing, Discounting, and Reimbursement for the Future,” 2019 CBI 7th Annual Reimbursement and Access (August 2019) 
  • "Navigate the Legal Underpinnings of Patent Assistance and Gain Insight on OIG Oversight," PAP2019 (March 2019)
  • "Medicare and Medicaid Reimbursement Issues for New Emerging Technologies: Spotlight on CAR-T and Other Cell and Gene Therapies," AHLA Annual Institute on Medicare and Medicaid Payment Issues Conference (March 2019)