Eve M. Brunts
Partner
Eve Brunts assists a diverse array of health care clients with compliance, clinical research, reimbursement, and other regulatory matters.
Eve regularly advises pharmaceutical and medical device companies and health care providers on issues such as federal and state fraud and abuse laws; compliance best practices; coverage, claims and payment requirements for a variety of services; government regulation of clinical research; reimbursement for health care services in clinical trials; and federal and state laws regulating manufacturer interactions with providers.
Eve works with corporate colleagues on corporate transactions and government enforcement colleagues on government investigations when those matters involve the health care industry by providing compliance, reimbursement and other regulatory advice.
Experience
- Compliance Advice: Eve routinely works with compliance officers and in-house counsel from pharmaceutical and medical device companies as well as health care providers to identify and address compliance concerns by providing advice on substantive legal issues, industry better practices and processes for resolving compliance concerns.
- Compliance Assessments: Eve has conducted compliance assessments for pharmaceutical and medical device companies and health care providers to evaluate existing compliance policies, procedures and forms and worked with the clients to revise and update existing policies, procedures and forms. Eve provides assistance and practical advice tailored to the needs of a wide range of clients, including emerging companies developing and implementing new compliance programs to established companies with mature compliance programs seeking to keep pace with evolving industry better practices.
- Clinical Research: Eve has worked with pharmaceutical and medical device companies and research institutions to develop policies, procedures and forms for the conduct and funding of clinical research, including policies related to billing third party payers for clinical trial services. Eve has worked with a number of research sponsors to negotiate and implement arrangements with clinical research organizations. Eve frequently assists research sponsors and clinical sites on the development and negotiation of clinical trial agreements. Over a decade ago, Eve provided regulatory advice to a pharmaceutical manufacturer in connection with the development of the first-ever randomized clinical trial under an investigational new drug application that manages study participation entirely using electronic tools. More recently, Eve has assisted with the negotiation of agreements and advised on compliance with regulatory requirements for national clinical trials conducted virtually.
- Government Investigations: Eve has assisted colleagues in the government enforcement group in the defense of pharmaceutical and medical device companies and health care providers under government investigation by providing advice on fraud and abuse laws as well as Medicare and Medicaid coverage and reimbursement requirements.
- Government and Private Payer Reimbursement: Eve has helped health care providers and pharmaceutical and medical device companies decipher complex coverage, coding and payment policies of government health care programs to ensure appropriate billing or to understand a product’s reimbursement potential.
Publications
- Co-author, “Compliance Considerations For Pharma Co. Testing Programs,” Law360 (June 7, 2021)
- Co-author, “Billing for Clinical Trial Services: General Overview,” AHLA Institutional Review Boards: A Primer (December 2018)
- Co-author, “Value-Based Challenges And Opportunities For Pharma Companies,” Law360 (July 12, 2017)
- Co-author, “Clinical Research: Hospital Coverage Coding and Payment,” BNA Compliance Guide (2016)
- Co-author, “HIPAA Final Rule Clarifies Major Research Issues,” Bloomberg BNA’s Medical Research Law & Policy Report (February 6, 2013)
- Co-author, “Clinical Research,” Health Law Handbook (2012)
- Co-author, “The International Clinical Trials Roadmap: Steering Clear of Legal and Practical Roadblocks,” Journal of Health & Life Sciences Law (2012)
- Co-author, “Regulation of Industry-Sponsored Clinical Trials,” The Fundamentals of Life Sciences Law: Drugs, Devices and Biotech (2014)
- Co-author, “Payment for Clinical Trials and Payment-Related Compliance Issues,” 2 BNA Med. Research L & Pol’y Rep. 384 (2003)
Presentations
- “Interactions with Patients,” Virtual 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress (November 4, 2021)
- “Clinical Trial Services: Coverage and Payment,” FDANews (April 8, 2020)
- “Drug Pricing Reform: Rhetoric and Reality,” American Conference Institute Rx Drug Pricing Forum (October 16, 2019)
- “Protecting the Crown Jewels: Securing Confidential Information in Modern Research Collaborations,” NACUA (November 14-16, 2018)
- “Value-Based Health Care: Contracting Opportunities and Challenges for the Pharmaceutical Industry,” BIO General Counsel’s Committee Forum (April 12, 2018)
- “Answering the Call from Volume-Based Contracts to Value-Based Contracts,” American Conference Institute (January 22 – 24, 2018)
- “Challenges and Opportunities for the Pharmaceutical Industry”, Ropes & Gray VBHC Teleconference Series (June 7, 2017)
- “Integrated Delivery Networks: Legal, Contractual and Operational Challenges for Value-Based Contracting,” American Conference Institute (January 26 – 27, 2017)
- “Federal Sunshine (Open Payments) Law,” MAGI (October 25, 2016)
- “Research Collaborations: Intersection of Academia and Industry,” Strafford Webinars (July 28, 2016)
- “Patient Support Programs Pharmaceutical Compliance Forum,” (April 14, 2016)
- “U.S. Selected Insights: Medtech Commercialization,” Australian U.S. Business Week (February 23, 2016)
- “Patient Support Programs Part 1: Getting Closer to the Patient,” Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress (October 22, 2015)
- “The Common Rule NPRM: Most Critical Issues,” Ropes & Gray Webinar (September 15, 2015)
- “Sharing Data and Specimens with Industry: Legal and Ethical Considerations,” Current Issues in Technology Transfer, Ropes & Gray (May 8, 2015)
- “Data Falsification: Legal Framework and Indicia of Concern,” FDLI (December 9, 2014)
- “New Trends in the Use of Fair Market Value Concepts,” PCF Disclosure, Transparency, and Aggregate Spend Conference (February 6, 2014)
- “Medicare Secondary Payer Rules: Clinical Trials,” Strafford Webinar (October 29, 2013)
- “Clinical Trial Agreements” Impact of Recent Legal Developments,” Society of Research Administrators International (August 7, 2013)
- “Clinical Research Collaborations, Academic Medical Centers and Community Providers, Opportunities and Challenges,” Ropes & Gray Webinar (June 11, 2013)
- “Medicare’s Secondary Payor Rule (B476),” MAGI East (May 7, 2013)
- “New Federal Payment Sunshine Rule: Implications for Manufacturers and Providers,” Strafford Publications (April 2, 2013)
- “Brave New World: Current Issues in AMC Relationships with Industry,” American Health Lawyers Association, 2013 Academic Medical Centers Program (January 24, 2013)
- “Selling Medical Devices in U.S. with a Human Sales Force: What will get a Company (and Management) in Trouble with the Law,” MDMA Compliance Conference (November 14, 2012)
- “U.S. Disclosure: Implementation Update,” Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (November 5, 2012)
- “Medicare Secondary Payer Rules: Clinical Trials,” Strafford Webinar (August 8, 2012)
- “Understanding the Nuances of Medicare Secondary Payer Rules Arising Out of Clinical Trials,” American Conference Institute Clinical Trials (July 18, 2012)
- “Co-Pay Assistance Program Litigation,” American Conference Institute In-House Counsel Forum on Prescription Drug Pricing (June 28, 2012)
- “Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges,” AHLA/FDLI Intersecting Worlds of Drug, Device, Biologics and Health Law (May 22, 2012)
- “Federal Payment for Sunshine Law: Implications for Manufacturers and Providers,” Strafford Webinar (December 6, 2011)
- “Resolving Challenging Issues in Clinical Trial Agreements,” PRIM&R, Advancing Ethical Research Conference (December 4, 2011)
- “Federal Sunshine Law: What You Need to Know Before January 1, 2012,” MassMEDIC (November 8, 2011)
- “Practical Approaches to Implementing an Aggregate Spend Program,” Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (November 2, 2011)
- “Into the Abyss: Subject Injury and Indemnification,” MAGI West 2011 (October 26, 2011)
- “Current Concerns in Clinical Research,” American Health Lawyers Association 2011 Annual Meeting (June, 2011)
- “Clinical Trials Disclosure and Reporting Compliance: State Laws,” Strafford Legal Webinar (March 31, 2011)
- “Fraud and Abuse Concerns in Clinical Trials,” American Conference Institute Fraud & Abuse Conference (March 30, 2011)
- “Compliance Issues in Research-Related Relationships with Health Care Professionals,” Pharmaceutical Compliance Forum: Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (October 21, 2010)
- “Word to the Wise: Recent OIG Settlements,” MAGI Clinical Research Conference (May 23, 2010)
- “Understanding Current Policies for Medicare Reimbursement of Clinical Trial Costs,” ACI Clinical Trials (February 24, 2010)
- “Key Compliance Issues in the Era of Oversight,” MDMA Annual Meeting (June 3, 2009)
- “Provider-Industry Relations: A Brave New World,” Health Care Financial Management Association, Massachusetts-Rhode Island Chapter, Compliance Update (December 12, 2008)
- “Third Party Payor Billing: Implementation Issues,” American Conference Institute Clinical Trials (February 26, 2008)
- “The Mechanics of Prescription Drug Pricing Rebate and Discount Systems, Rx Drug Pricing Boot Camp,” American Conference Institute (November 15, 2007)
- “Tips, Traps, and Trends in Informed Consent and Secondary Research: Secondary Research,” ACI Clinical Trials (September 26, 2007)
- “Overcoming Legal and Practical Constraints to Clinical Site and Subject Recruitment,” American Conference Institute Clinical Trials (July 16-17, 2007)
- “Clinical Trials Update,” Life Sciences Institute American Health Lawyers Association (April, 2007)
- “Coordination of Benefits Dilemma: Solving the Medicare Part B/Part D Conundrum,” ACI Prescription Drug Pricing (March 15-16, 2007)
- “Government Pricing Fundamentals,” Prescription Drug Pricing 101 & 102, (February 22-23, 2007)
- “Medicare and Medicaid Rules on Research Billing,” ExL Pharma: Clinical Trial Billing under Medicare (February 12, 2007)
- “The Mechanics of Prescription Drug Pricing and Rebate Systems,” Rx Drug Pricing Boot Camp, American Conference Institute (November 16 and 17, 2006)
- “Emerging Fraud and Abuse Compliance Issues for Device Manufacturers: The Year in Review,” Medical Device Manufacturers Association (May 18, 2005)
- “Managing Relationships: Manufacturers, Institutional Providers and their Affiliated Practitioners,” American Health Lawyers Association, Pharmaceutical and Device Law Institute (March 2005)
- “New OIG Compliance Guidance for Hospitals,” Healthcare Financial Management Association (December 17, 2004)
- “Biomedical Research Compliance Update,” Greater New York Hospital Association (March 16, 2004)
Education
- JD, Yale Law School, 1995
- BA, magna cum laude, Yale University, 1992
- LLM, Cambridge University, 1997
Admissions / Qualifications
Qualifications
- Massachusetts, 1996
Awards
- The Best Lawyers in America (2023)
- Boston Magazine “Top Lawyers” (2021)
- LMG Life Sciences Star (2012-2018)
- Chambers USA: America's Leading Lawyers for Business (2006-2022)