We are a leading healthcare provider specializing in diagnostic and clinical laboratory services. Our mission is to improve patient outcomes by delivering accurate, timely, and comprehensive diagnostic information. We are committed to maintaining the highest standards of compliance and integrity in all aspects of our operations. As part of our continued growth and dedication to excellence, we are seeking a highly experienced Senior Healthcare Compliance Attorney with a strong focus on medical laboratory compliance to join our legal team.
Position Overview:
The Senior Healthcare Compliance Attorney will play a pivotal role in ensuring that our medical laboratory operations are conducted in strict accordance with all applicable federal, state, and local laws, regulations, and industry standards. This position requires a seasoned attorney with extensive experience in healthcare compliance, particularly in the context of clinical and diagnostic laboratories. The ideal candidate will have a deep understanding of the regulatory environment governing medical laboratories, including but not limited to the Clinical Laboratory Improvement Amendments (CLIA), Health Insurance Portability and Accountability Act (HIPAA), the Stark Law, Anti-Kickback Statute (AKS), False Claims Act (FCA), and related state laws.
Key Responsibilities:
Regulatory Compliance:
Provide expert legal advice and guidance on all matters related to healthcare compliance, with a primary focus on medical laboratory operations.
Ensure that the company's laboratory practices comply with all relevant federal and state regulations, including CLIA, HIPAA, Stark Law, AKS, and FCA.
Monitor and interpret changes in relevant laws and regulations, and advise the company on the potential impact of such changes on operations.
Develop and implement compliance policies and procedures that align with legal requirements and industry best practices.
Conduct regular audits and assessments of laboratory operations to identify potential compliance risks and areas for improvement.
Collaborate with the laboratory management team to address any identified compliance issues and implement corrective actions.
Legal Research and Analysis:
Conduct thorough legal research on complex regulatory issues related to medical laboratory operations.
Analyze and interpret statutes, regulations, and case law to provide accurate and timely legal advice to the company.
Prepare detailed legal memoranda and reports to communicate findings and recommendations to the executive team and other stakeholders.
Stay informed of emerging trends and developments in healthcare compliance and laboratory regulations, and proactively advise the company on potential opportunities or risks.
Contract Review and Negotiation:
Review, draft, and negotiate a wide range of contracts related to laboratory services, including vendor agreements, service contracts, and business associate agreements (BAAs).
Ensure that all contracts comply with applicable laws and regulations and align with the company's compliance policies.
Advise the business development and procurement teams on legal risks and mitigation strategies in contract negotiations.
Collaborate with external legal counsel, as necessary, to ensure that complex or high-risk contracts are thoroughly reviewed and negotiated.
Compliance Training and Education:
Develop and deliver comprehensive compliance training programs for laboratory staff, management, and other relevant personnel.
Educate employees on key compliance topics, including CLIA requirements, HIPAA privacy and security rules, Stark Law, AKS, and FCA.
Create and maintain training materials, including presentations, manuals, and online resources, to support ongoing compliance education.
Monitor the effectiveness of training programs and make recommendations for improvements based on feedback and audit results.
Risk Management:
Identify and assess potential legal and compliance risks related to laboratory operations and develop strategies to mitigate those risks.
Work closely with the risk management team to implement risk mitigation plans and monitor their effectiveness.
Assist in the investigation and resolution of compliance-related incidents, including breaches of HIPAA, CLIA non-compliance, and potential violations of the Stark Law, AKS, or FCA.
Provide legal support in responding to government inquiries, audits, and investigations related to laboratory compliance.
Policy Development and Implementation:
Lead the development and implementation of company-wide compliance policies and procedures specific to laboratory operations.
Ensure that policies are regularly reviewed and updated to reflect changes in laws, regulations, and industry standards.
Collaborate with cross-functional teams, including laboratory operations, IT, and HR, to ensure seamless integration of compliance policies into daily operations.
Monitor compliance with company policies and take corrective action as necessary to address any violations.
Internal Investigations and Enforcement:
Conduct internal investigations related to suspected compliance violations, including but not limited to improper billing practices, HIPAA breaches, and laboratory test reporting issues.
Prepare investigation reports and present findings to the General Counsel, Chief Compliance Officer, and other senior management.
Develop and implement corrective action plans to address any identified compliance issues.
Work with HR and management to enforce disciplinary measures for compliance violations, as appropriate.
External Relations and Advocacy:
Serve as the company's primary legal representative in interactions with regulatory agencies, including the Centers for Medicare & Medicaid Services (CMS), Office for Civil Rights (OCR), and state health departments.
Advocate on behalf of the company in regulatory proceedings, audits, and enforcement actions related to laboratory compliance.
Build and maintain relationships with industry associations, regulatory bodies, and other external stakeholders to stay informed of developments in laboratory compliance.
Represent the company in external forums, such as industry conferences, workshops, and legal seminars, to share expertise and stay updated on best practices.
Litigation Management:
Provide legal oversight and support for any litigation related to laboratory compliance, including defense against government enforcement actions, whistleblower lawsuits, and civil litigation.
Work with external counsel to develop litigation strategies and manage the litigation process, including discovery, motions, and settlement negotiations.
Ensure that all litigation is conducted in a manner that protects the company's interests and complies with legal and ethical standards.
Ethics and Integrity:
Promote a culture of ethics and integrity within the company by modeling ethical behavior and reinforcing the importance of compliance.
Provide guidance to employees at all levels on ethical issues and dilemmas related to laboratory operations.
Ensure that the company's compliance program includes robust mechanisms for reporting and addressing ethical concerns, including anonymous reporting channels and protections against retaliation.
Qualifications:
- Education: Juris Doctor (JD) degree from an accredited law school.
- Bar Admission: Must be a member in good standing of the bar in at least one U.S. state, with the ability to be admitted to practice in New York if not already admitted.
- Experience: A minimum of 5 years of legal experience in healthcare compliance, with a strong preference for experience in medical laboratory compliance.
- Regulatory Knowledge: In-depth knowledge of federal and state healthcare regulations, including CLIA, HIPAA, Stark Law, AKS, and FCA.
- Contract Expertise: Proven experience in reviewing, drafting, and negotiating healthcare-related contracts, including vendor agreements and BAAs.
- Investigative Skills: Strong experience in conducting internal investigations related to compliance violations and preparing detailed investigation reports.
- Communication: Excellent written and verbal communication skills, with the ability to clearly articulate complex legal concepts to non-legal stakeholders.
- Analytical Skills: Strong analytical and problem-solving skills, with the ability to assess legal risks and develop practical solutions.
- Leadership: Demonstrated ability to lead cross-functional teams and collaborate effectively with colleagues at all levels of the organization.
- Ethical Integrity: A strong commitment to ethical behavior and a proven track record of promoting compliance and integrity within an organization.
Preferred Qualifications:
- Healthcare Compliance Certification: Certification in healthcare compliance (CHC) or related credentials are strongly preferred.
- Medical Laboratory Experience: Direct experience working in or providing legal counsel to clinical or diagnostic laboratories.
- Government Relations: Experience interacting with federal and state regulatory agencies, including CMS and OCR, on compliance matters.
- Litigation Experience: Experience managing litigation related to healthcare compliance, particularly in the laboratory setting.
- Technology Proficiency: Familiarity with legal research tools, compliance software, and electronic health records (EHR) systems.
Benefits:
Competitive salary and bonus structure
Professional development opportunities
Collaborative and supportive work environment
