Senior Counsel, Healthcare

The Position:

We are seeking an experienced, highly motivated athlete Healthcare Senior Counsel to join our legal team at Veracyte. The ideal candidate will have a background in healthcare law, with experience in the life sciences industry across a range of topics including regulatory and healthcare and corporate compliance, billing, reimbursement matters, healthcare fraud and abuse laws, and government affairs and policy. This individual will play a critical role in ensuring that Veracyte navigates complex legal and regulatory issues within the healthcare industry, helping us maintain compliance and drive innovation in our diagnostic solutions. This position is fully remote, with some travel required, allowing flexibility in work location within the U.S. 

Key Responsibilities 

• Healthcare Regulatory Compliance: Advise on federal, state, and international healthcare laws, including FDA and IVDR regulations, HIPAA, CLIA, and other regulatory requirements relevant to molecular diagnostics. Ensure compliance with applicable healthcare standards and regulations. 

• Billing and Reimbursement Compliance: Advise on legal issues or manage external expert counsel on topics related to reimbursement for diagnostic services, including working with government and private payers. Ensure that billing practices and reimbursement strategies comply with applicable laws, including Medicare, Medicaid, and private payer regulations. 

• FCA, Anti-Kickback Statute, and Stark Law Compliance: Provide guidance and ensure compliance with key healthcare laws, including the False Claims Act (FCA), Anti-Kickback Statute, and Stark Law. Advise on matters related to potential violations of these statutes, and help establish preventive compliance measures. 

• Investigations: Assist internal and external counsel in internal investigations related to healthcare fraud, potential violations of federal healthcare regulations, or suspected compliance misconduct.  

• Corporate Compliance and Integrity: Collaborate with legal, compliance, and business colleagues to ensure corporate compliance and integrity across the organization. Advise on the development, implementation, and monitoring of compliance programs and ethical standards. Support the company’s efforts to maintain a strong culture of integrity and adherence to all applicable laws and regulations. 

• Government Affairs and Policy: Advise and support Veracyte on healthcare policy and government affairs matters, including analyzing proposed federal and state legislation, regulations, and policies that may impact the company’s operations.  

• Contract Review and Negotiation: Review, draft, and negotiate contracts with healthcare providers, third-party payers, clinical laboratories, research institutions, and other partners. Ensure that contracts are compliant with legal and regulatory standards. 

• Industry Trends and Legal Research: Stay current on developments in healthcare law, regulations, and industry trends, and provide strategic advice to the company on these matters. 

• Juris Doctor (JD) degree from an accredited law school.
• Active bar membership in good standing in at least one state jurisdiction. 
• Minimum of 8 years of experience in healthcare law, with a focus on regulatory compliance, billing and reimbursement, contract law, and government affairs. Experience in law firms or government is required; in-house experience is a plus. 
• In-depth understanding of the FDA’s regulatory framework for diagnostics, clinical laboratory regulations (e.g., CLIA), Diagnostic Billing – private and public payers, False Claims Act, Anti-Kickback Statute, and Stark Law. 
• Experience working with and advising life sciences companies, particularly in diagnostics or biotechnology. 
• Experience with Diagnostics Reimbursement 
• Strong interpersonal and communication skills, with the ability to work collaboratively across teams. 
• Ability to manage multiple projects simultaneously and work in a fast-paced, dynamic environment. 
• Can work in an environment striving for excellence while also balancing appropriate risk tolerance- have a bias for action through thoughtfulness.  
• Be a good human! 

Preferred Qualifications 

• Experience with healthcare reimbursement issues, including CMS and private payer contracting. 
• Familiarity with international healthcare regulations (e.g., EU Medical Device Regulation or IVD Regulation). 
• Familiarity with government affairs and policy.  
• Previous in-house counsel experience with a biotechnology or diagnostics company. 

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