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About Rebecca
Rebecca Merrill is a health care regulatory and operations attorney who advises providers, suppliers, health systems, research institutions and life sciences organizations on complex compliance, enforcement and business matters.
She partners closely with legal, compliance and operational teams, as well as senior leadership and boards, to navigate evolving regulatory requirements, manage enterprise risk and support strategic initiatives. She brings a practical, detail-oriented approach to addressing both day-to-day compliance needs and high-stakes regulatory challenges in fast-paced, highly regulated environments.
Rebecca’s practice includes:
- Reimbursement Strategies & Compliance: Advising on health care regulatory matters, including Medicare and Medicaid reimbursement, enrollment, licensure, credentialing and scope of practice requirements.
- Compliance Counsel: Counseling clients on health care regulatory compliance, including the Stark Law and Anti-Kickback Statute and their state law counterparts, state fee splitting and corporate practice of medicine restrictions, and HIPAA/HITECH privacy, data sharing and cybersecurity matters. Developing program guidance, conducting targeted and enterprise-level compliance program assessments; drafting and revising compliance program policies, procedures, forms, templates, communications and work plans; and providing compliance education to providers, leadership, boards and board committees.
- Investigations and Enforcement: Advising on investigations and defense of False Claims Act, overpayment and other enforcement matters, including intake, investigation, audits (exploratory probes and statistically valid retrospective audits), interim preventive actions, guidance, drafting, execution and implementation, as applicable, of program integrity communications, voluntary returns and disclosures, federal and state settlement agreements and corporate integrity agreements.
- Clinical Research: Advising on clinical research contracting, operations, regulatory compliance and research misconduct matters, including:
- Research Contracting: Regulatory review, strategy, drafting and negotiation of clinical research agreements, including master clinical trial agreements, site feasibility agreements, research consortium and collaboration agreements, confidentiality agreements, data and material transfer agreements.
- Operations: Counseling clients on research program development, compliance work plans, use of artificial intelligence in clinical research operations, data and material repositories and research privacy and confidentiality.
- Regulatory Compliance: Advising on human subjects protection, informed consent, conflicts of interest, conflicts of commitment, fraud and abuse and other regulatory challenges.
- Research Misconduct: Advising on internal reviews, audits, investigations and defense of research non-compliance and research misconduct matters, including reporting to the Office of Research Integrity (ORI) and responding to subpoenas and civil investigative demands.
- Transactions: Consulting on transactional strategy, drafting and negotiating definitive transaction documents, and overseeing and executing regulatory aspects of transactions, including due diligence and representation and warranty coverage, as well as advising on broader corporate and contracting matters, including drafting and negotiating professional services and independent contractor agreements, management, vendor, equipment and supply agreements, physician and advanced practice provider employment agreements, recruitment agreements and other health care and commercial agreements.
Rebecca brings prior experience from two global law firms and a national health insurance company, as well as a Master of Health Administration and prior experience in project management. Her skills as a strategic advisor and efficient problem solver make her a go-to resource for navigating complex health care compliance and transactional matters.
