2024-2025 Global AI Trends Guide
Helen R. Trilling
Senior Counsel Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Chambers"Helen Trilling is praised by clients for being outstanding in providing practical guidance on a very timely basis."
Widely recognized as a problem solver, Helen Trilling combines deep industry knowledge with an understanding of government enforcement interests to help health care clients design competitive business strategies. Working at the forefront of clinical and health care reform developments, Helen helps manufacturers and providers assess market opportunities and structure attractive customer offerings while managing compliance risk.
Long before most health care companies had "fraud and abuse" concerns on their radar, Helen was helping clients develop compliance programs, and counseling them on anti-kickback, self-referral and false claims risks. As innovation spurs development of new products and services, whether in personalized medicine, companion diagnostics and lab-developed tests, biologics and specialty pharmacies, shared risk plans, health care IT, mobile diagnostic and treatment, or other new technologies, Helen's clients rely on her to help identify and evaluate risk in proposed offerings, design mitigation strategies or alternatives, and advocate for regulatory or legislative change where needed.
Helen's vast client base and depth of experience allow her to help clients benchmark against industry norms and evolving expectations of regulators and enforcement officials. Helen also regularly counsels clients on Medicare/Medicaid coverage, reimbursement, and billing, and has experience dealing with a wide variety of other federal and state regulatory issues in health care.
Helen's legal career includes stints at the Department of Health and Human Services (DHHS) and in the private sector. Perennially highly ranked by peers and clients, health care companies seek Helen out for her broad knowledge of the health care industry and regulatory environment, useful insight, and practical advice.
Chambers"Helen Trilling is praised by clients for being outstanding in providing practical guidance on a very timely basis."
Representative experience
Negotiated and assisted clients in implementing Corporate Integrity Agreements in each decade since the earliest imposed in the 1990s.
Assisted biotech company crafting innovative pricing strategy to meet commercial goals and comply with anti-kickback, false claims and pricing laws.
Obtained OIG Advisory Opinions where useful in support of client programs, and Special Fraud Alerts where needed to create a level playing field.
Assisted healthcare IT companies in design of compliant EHR and e-prescribing systems that may include some manufacturer-sponsored features.
Handled hospital internal investigation and first voluntary anti-kickback law disclosure to the DHHS Office of Inspector General.
Regularly furnishes regulatory insight key to defending healthcare investigations, supporting declinations or mitigating settlement penalties.
Regularly works with clients to close compliance program gaps, update policies, develop employee training, and establish monitoring and audit plans.
Regularly helps structure consultant contracts, education/research grants, charitable contributions, business courtesies, patient assistance programs.
Credentials
Education
- J.D., Harvard Law School, 1976
- A.B., Radcliffe College, magna cum laude, 1973
Bar admissions and qualifications
- District of Columbia
- Massachusetts (inactive)
Court admissions
- Supreme Judicial Court of Massachusetts
- U.S. Court of Appeals, District of Columbia Circuit
- U.S. Court of Appeals, Tenth Circuit
- U.S. District Court, District of Columbia
- U.S. District Court, District of Massachusetts
- U.S. Supreme Court
Memberships
- Board Member, Women in Law Empowerment Forum
- Member, American Health Lawyers Association
Recognition
News
Press releases
14 February 2022
Press releases
27 December 2021