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.