Managing Counsel, Healthcare Regulatory and Compliance

Job Responsibilities

• Provide subject-matter expertise on state and federal healthcare fraud and abuse laws applicable to clinical laboratories, including the Anti-Kickback Statute, Physician Self-Referral Law (“Stark”), False Claims Act, Eliminating Kickbacks in Recovery Act (“EKRA”), Civil Monetary Penalties Law, and Medicare and Medicaid billing regulations.
• Review and advise on healthcare regulatory and compliance risks for a range of diagnostics-related business arrangements, including reference laboratory agreements, management services agreements, leases, specimen collection agreements, group purchasing organization arrangements, healthcare professional consulting and clinical advisory board agreements, co-marketing arrangements, and other commercial arrangements with referral sources.
• Collaborate with Law Department attorneys and contract professionals to review, draft, and negotiate compliance-sensitive contract provisions in commercial agreements.
• Serve as a trusted legal advisor to sales, operations, revenue cycle management, contracts, corporate development, payor solutions, and other stakeholders and functional areas supporting the diagnostics business.
• Partner with Law Department transactional attorneys and outside counsel to support healthcare regulatory and compliance-related due diligence on diagnostics acquisitions, proposing and implementing solutions that advance both compliance and business objectives.
• Partner with personnel in Corporate Compliance to develop, enhance, and implement policies, procedures, and training that are aligned to applicable healthcare laws and regulations.
• Assist in responding to government inquiries, audits, subpoenas, or investigations, coordinating closely with Law Department attorneys and outside counsel when necessary.
• Provide legal oversight for internal investigations involving potential fraud and abuse-related compliance issues, advising on potential corrective actions or government self-disclosures, as appropriate.
• Stay current on regulatory developments, HHS OIG advisory opinions, enforcement trends, DOJ/HHS OIG settlements, CMS policy updates, and state laws affecting the clinical laboratory industry.
• Advise leadership on healthcare regulatory and compliance trends and prepare briefing materials or presentations for executive stakeholders.

Minimum Qualifications

• Juris Doctor (JD) degree from an American Bar Association (ABA) approved law school.
• Attorney license to practice law within U.S.
• 8 or more years of legal experience at a law firm or in-house setting advising healthcare providers and organizations on complex fraud and abuse, regulatory, and compliance matters.
• 5 or more years of Legal experience with state and federal healthcare fraud and abuse laws, including the Anti-Kickback Statute, Physician Self-Referral Law (“Stark”), False Claims Act, Eliminating Kickbacks in Recovery Act (“EKRA”), Civil Monetary Penalties Law, and Medicare and Medicaid billing regulations.

Preferred Qualifications

• 5 or more years of experience advising clients on legal and healthcare regulatory issues in the clinical laboratory and/or diagnostics industry.