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.
Experience
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.
- Represents health care organization in connection with United States Department of Justice, United States Attorneys’ Offices and the Center for Medicare & Medicaid Services investigations into billing and coding practices.
- Represents health care organization in connection with United States Attorneys’ Office’s investigation into provision of health risk assessments.
- 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.
- Successfully represented 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.
- Advises Medicare managed care organizations and vendors to Medicare managed care organizations in connection with Medicare risk adjustment practices.
- 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.