Eve M. Brunts
Eve Brunts assists a diverse array of health care clients with reimbursement, clinical research, regulatory and compliance matters.
Eve regularly advises health care providers, pharmaceutical and medical device manufacturers, and managed care organizations on issues such as Medicare and Medicaid coverage, claims and payment requirements for a variety of services; government regulation and funding of clinical research; reimbursement for health care services in clinical trials; managed care contracting and state managed care laws; federal and state fraud and abuse laws; and federal and state laws regulating manufacturer interactions with providers.
Eve works with corporate partners on corporate transactions and government enforcement partners on government investigations when those matters involve the health care industry by providing regulatory and reimbursement advice.
- Clinical Research: Eve has worked with pharmaceutical and medical device manufacturers 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 provided federal and state 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.
- Compliance Advice: Eve routinely works with compliance officers and in-house counsel from health care providers as well as pharmaceutical and medical device manufacturers 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 manufacturers 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 recently assisted a system of medical device companies to develop and implement a health care code of conduct and related policies and to train their personnel on the policies.
- Government Investigations: Eve has assisted colleagues in the government enforcement group in the defense of pharmaceutical and medical device manufacturers and health care providers under government investigation by providing advice on Medicare and Medicaid coverage and reimbursement of drugs (including obligations under the Medicaid drug rebate program), devices and other services.
- Government and Private Payer Reimbursement: Eve has helped health care providers and pharmaceutical and medical device manufacturers decipher complex coverage, coding and payment policies of government health care programs to ensure appropriate billing or to understand a product’s reimbursement potential.
- Eve Brunts and Alison Fethke, “Value-Based Challenges And Opportunities For Pharma Companies,” Law360 (July 12, 2017)
- Eve Brunts, Eva Johnson and Katherine Sullivan, “Clinical Research: Hospital Coverage Coding and Payment,” BNA Compliance Guide (2016)
- Eve Brunts, Mark Barnes and Sara Ferranti, “HIPAA Final Rule Clarifies Major Research Issues,” Bloomberg BNA’s Medical Research Law & Policy Report (February 6, 2013)
- Eve Brunts and Clinton Hermes, “Clinical Research,” Health Law Handbook (2012)
- Eve Brunts, Clinton Hermes and Andrew Rusczek, “The International Clinical Trials Roadmap: Steering Clear of Legal and Practical Roadblocks,” Journal of Health & Life Sciences Law (2012)
- Eve Brunts, Clinton Hermes and Heather Pierce, “Regulation of Industry-Sponsored Clinical Trials,” The Fundamentals of Life Sciences Law: Drugs, Devices and Biotech (2014)
- Eve Brunts and Nancy Rice, “Payment for Clinical Trials and Payment-Related Compliance Issues,” 2 BNA Med. Research L & Pol’y Rep. 384 (2003)
- “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)