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We Help Laboratories Manage the Unique Compliance Obligations and Operational Risks They Face Daily
Our healthcare lawyers work with laboratories across the country to help them effectively manage risk, meet compliance obligations, and grow their businesses. While laboratories face many of the same risks and challenges as other healthcare providers, they also face unique laws and regulatory challenges. Overcoming these challenges requires specific expertise and practical insights gained from repeated interactions with our clients and regulators.
Our Services for Laboratories
We have extensive experience advising and representing laboratories across the country in all aspects of their operations. This includes assisting with matters such as:
Fraud and Abuse
Laboratories, lab executives, and others targeted with allegations of fraud and abuse can face substantial civil or criminal penalties. Our lawyers have significant experience successfully representing laboratories and other clients in audits and investigations conducted by HHS OIG and other private, state, and federal entities.
Regulatory Compliance
Laboratories must take several proactive steps to meet their regulatory compliance obligations. As outlined in the Model Compliance Plan for Clinical Laboratories published by the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG), at a minimum, a laboratory’s compliance program should address:
- Standards of Conduct
- Medical Necessity
- Billing
- Reliance on Standing Orders
- Compliance with OIG Fraud Alerts
- Marketing
- Pricing
- Records Retention
- Compliance as an Element of Performance
Our lawyers work closely with our laboratory clients to help develop and implement regulatory compliance programs designed specifically to help avoid recoupments and other penalties in the event of an external audit or investigation.
Transactions
We draft and negotiate all types of transactions for our laboratory clients, like reference agreements, marketing agreements, and purchase and sale transactions. When considering these relationships, it is imperative that laboratories give due consideration to the restrictions imposed by laws, including the Anti-Kickback Statute, Stark Law, and the Eliminating Kickbacks in Recovery Act (EKRA).
Payor Issues
Whether due to audits or day-to-day challenges, laboratories frequently encounter payor issues. Whether your laboratory is struggling to secure payment, facing an audit, or facing recoupment demands, our healthcare lawyers can help.
Licensure and Accreditation
Laboratories are subject to various licensing requirements, and obtaining accreditation from an approved national accrediting organization can afford significant benefits with regard to Medicare billing and other areas. Therefore, we help our clients understand their obligations, explore their options, and take the necessary steps to secure licensure and accreditation.
Genetic Testing Laboratory Compliance
Law enforcement has targeted its enforcement efforts toward genetic laboratories and persons who service them. As a result, laboratories that provide genetic testing services face must redouble their compliance efforts, including relationships with marketers and telemedicine providers: obligations and enforcement risks above and beyond those that apply across the board. With particular experience in the areas of cardiovascular genetic testing (CGT), genetic cancer screening (CGX), pharmacogenomics (PGX) screening, and other forms of genetic testing, we can help laboratories navigate this complex area.
Toxicology Laboratory Compliance
We have particular experience advising and representing toxicology laboratories. This subsector of industry exploded when laboratory tests were introduced into addiction treatment services. Toxicology labs also face heightened compliance obligations, and questions concerning these laboratories’ billing compliance efforts can quickly expand into full-fledged healthcare fraud investigations. We work alongside our clients to help them establish and maintain compliance and to help them withstand scrutiny from state and federal authorities when necessary.
Schedule a Confidential Consultation at Silverman Bain, LLP
For more information about our experience working with laboratories or to inquire about engaging our services, please contact us today to speak with a healthcare lawyer at Silverman Bain, LLP in confidence.