Deborah Kantar Gardner
Deborah Kantar Gardner is a Boston-based partner in Ropes & Gray’s health care practice. Her practice focuses on Medicare and Medicaid payment, compliance and enforcement matters, including administrative and judicial litigation in connection with Medicare and Medicaid reimbursement. Recently, she has been helping clients navigate the impact of the COVID-19 pandemic, including assisting providers with obtaining and understanding the federal financial relief available through the Federal Emergency Management Agency (FEMA), the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), and the Small Business Administration funding programs. Deborah’s clients include hospitals and health systems, health plans/managed care organizations, clinical diagnostic laboratories, pharmacies, behavioral health providers, dialysis providers, physician practice management companies, therapy practices, durable medical equipment suppliers and medical device companies.
Deborah defends health care entities in connection with federal and state civil False Claims Act, consumer protection, drug pricing and other program integrity investigations, as well as with internal reviews involving billing and coding or regulatory compliance. She represents clients in connection with federal health care program and commercial payor disputes, including administrative and judicial appeals associated with payments and cost report issues, licensure, and billing revocations, and voluntary self-disclosures. She represents hospitals in connection with EMTALA matters, CMS enrollment, decertification and ACGME matters, HRSA and manufacturer 340B audits, and managed care contracting.
Deborah counsels clients, including managed care organizations, on compliance with federal health care program authorities, including regulatory compliance, telehealth, billing, coding and risk adjustment matters, and federal and state fraud and abuse laws.
False Claims Act, Medicare, Medicaid and Consumer Protection Investigations
- Conducted and assisted in the resolution of an investigation into a residential service provider jointly conducted by the New York Attorney General’s Medicaid Fraud Control Unit and the United States Attorneys’ Office for the Southern District of New York.
- Successfully defended a major New York health system in connection with a False Claims Act investigation brought by the United States Attorneys’ Office for the Southern District of New York.
- Successfully represented two major health systems in connection with False Claims Act investigations brought by the U.S. Department of Justice and the United States Attorneys’ Office for the Southern District of Florida into the Medicare coverage of implantable cardioverter defibrillators.
- Successfully represented a New York hospital in connection with a Medicare program integrity audit of the medical necessity and inpatient admission for certain cardiac procedures.
- Successfully represented several hospitals in challenges to Medicare and Medicaid program integrity and Recovery Audit Contractor audits.
- Successfully represented a national pharmacy in a Massachusetts Attorney General investigation into prescription drug pricing.
- Successfully represented Academic Medical Center in connection with an ACGME investigation into graduate medical education matters.
- Successfully represented a dialysis company in connection with a CMS enforcement action.
- Represents DME supplier in connection with state investigation into Medicaid pricing.
- Successfully represented health plan in connection with a Medicare rebate dispute.
Administrative and Judicial Litigation
- Successfully represented many hospitals in reimbursement appeals at the Provider Reimbursement Review Board and in the federal district and circuit courts.
- Successfully represented health care entities in numerous Administrative Law Judge and Medicare Appeals Council appeals involving, among other things, issues of medical necessity and/or inpatient status, billing revocations, Medicaid and Medicare payment disputes.
- Successfully represented major children’s hospital in connection with a commercial payor dispute.
- Successfully represented numerous hospitals and a dialysis provider in Medicare certification challenges.
- Successfully represented a national radiology group in connection with an appeal of a billing revocation.
- Regularly assists diagnostic laboratories in connection with Medicare payment suspensions, Medicare program integrity audits, and commercial payor disputes.
- Successfully represented a medical device company in connection with state licensing appeals and commercial payor issues.
Regulatory Compliance and Payment Matters
- Successfully represented many hospitals in connection with Medicare termination proceedings and System Improvement Agreement negotiations.
- Advises health care entities on Medicare and Medicaid coverage and payment issues, including medical necessity, billing and coding, provider-based status, physician supervision, incident-to, bundled payment models, outlier payments, therapy and lab billing, and the implications of regulatory changes.
- Counsels health care entities on compliance with Medicare and Medicaid authorities, including , survey and certification, charges and co-payments, reporting and returning overpayments, and self-disclosures.
- Counsels health care entities regarding compliance with state drug pricing laws.
- Counsels dialysis companies in connection with regulatory compliance and reimbursement matters.
- Represents Medicare and Medicaid Managed Care Organizations in connection with commercial disputes, regulatory compliance , and contracting.
- Advises clients on compliance risk assessments, programs and policies.
- Advises clients in connection with 340B issues, including HRSA and manufacturer audits of 340B programs, and use of 340B grant program revenue.
- Co-author, “Surveying Drug Pricing Reform: The Latest State Activity,” Law360 (November 24, 2020)
- Co-author, “The Challenges Facing Trump's Drug Pricing Order,” Law360 (September 25, 2020)
- Co-author, “How To Determine Eligibility for HHS Emergency Funds,” Law360 (April 24, 2020)
- Co-author, “States Lead The Way On Drug Pricing Reform,” Law360 (February 12, 2020)
- Co-author, “The Trump Administration's Latest Drug Pricing Initiatives,” Law360 (January 14, 2019)
- Co-author, “New CMS Rules Reinforce Trend Away From Traditional Care,” Law360 (November 29, 2018)
- Quoted, “Medicare Overpayments Decline, but Some Problem Areas Remain,” Bloomberg BNA’s Health Care Daily (November 30, 2017)
- Co-author, “Future MACRA Concerns For Hospitals And Health Systems,” Law360 (November, 22, 2017)
- Quoted, “Healthcare reform can create confusion over compliance for providers,” Healthcare Dive (February 7, 2017)
- Co-author, “Taming the ‘Wild West’: Enforcement Trends and Reimbursement Issues Facing Independent Clinical Laboratories,” Bloomberg BNA Health Law Reporter (April 14, 2016)
- Co-author, “Laboratory Phlebotomists in Physician Offices? States Increasingly Saying ‘No,’” Bloomberg BNA’s G2 Intelligence (February 2014)
- Presenter, “What’s Happening (and What’s Likely to Happen) on Drug Pricing?” Ropes & gray Teleconference (December 2019)
- Presenter, “Navigating Telehealth - Understanding the Legal and Regulatory Framework Applicable to the Provision of Digital Health Services,” IPMI Healthcare Law & Compliance Institute (March 4, 2019)
- Presenter, “New Federal All-Payor Anti-Kickback Provisions: What Providers Should Know and Should Be Thinking About Now,” (December 18, 2018)
- Presenter, “Location, Location, Location: Opportunities and Challenges of Co-Located Hospital Facilities,” Health Care Law & Compliance Institute (March 5, 2018)
- Presenter, “Is Your EHR Getting You in Hot Water?” Greater New York Hospital Association (April 17, 2017)
- Speaker, “Winners and Losers in the Provider Sector in the Movement to Value-Based Health Care,” Ropes & Gray Teleconference (April 2017)
- Presenter, “The Federal False Claims Act post-Escobar: Compliance Priorities Following Universal Health Services v. Escobar,” Healthcare Financial Management Association (December 9, 2016)
- Presenter, “Avoiding Regulatory Scrutiny and Getting Paid: Compliance and Reimbursement in Challenging Time,” G2 Intelligence: Lab Institute 2016 (October 27, 2016)
- Presenter, “Escobar and the Implied False Certification Doctrine: Compliance Priorities Following Escobar,” Greater New York Hospital Association (September 15, 2016)
- Presenter, “Overpayments, Short Stays and Outpatient Reimbursement: Addressing Major Changes to CMS Rules in 2016,” Massachusetts Hospital Association (March 2016)
- Presenter, “Compliance in the Wake of the ACA,” Suffolk Law Panel (November 2013)
- Presenter, “In the Wake of the WakeMed Settlement: Strategic Considerations for Compliance and Response to Enforcement Action,” Ropes & Gray, LLP Teleconference (February 28, 2013)
- Presenter, “Legal and Compliance Update, Reimbursement, Billing and Coding,” Healthcare Financial Management Association (December 2012)
- Presenter, “Healthcare Beyond the Crossroads: Healthcare Reform after the Supreme Court Ruling: Follow-up Report,” Ropes & Gray LLP Teleconference (October 2012)
- JD, University of Pennsylvania Law School, 1989
- AB (American History and Literature), cum laude, Harvard College, 1985