Understanding The Effects Of Ekra On Clinical Laboratories
Enacted as part of the SUPPORT for Patients and Communities Act in 2018, the Eliminating Kickbacks in Recovery Act (EKRA) has significant implications for Healthcare Providers, including clinical laboratories. EKRA was designed to combat the opioid crisis by prohibiting kickbacks related to patient referrals to recovery homes, clinical treatment facilities, and laboratories. In this article, we will delve into what EKRA is, how it affects clinical laboratories, and what steps laboratories can take to ensure compliance.
What is EKRA?
EKRA is a federal law that prohibits the exchange of anything of value in return for patient referrals to recovery homes, clinical treatment facilities, and laboratories. This includes kickbacks, bribes, rebates, or any form of payment that could influence patient referrals. EKRA applies to all Healthcare Providers, including clinical laboratories, and carries significant penalties for non-compliance.
How Does EKRA Affect Clinical Laboratories?
For clinical laboratories, EKRA means that they must be vigilant in ensuring that all patient referrals are based on medical necessity and not influenced by kickbacks or other forms of payment. Failure to comply with EKRA can result in criminal prosecution, civil penalties, and exclusion from federal healthcare programs.
Key Provisions of EKRA for Clinical Laboratories
- Criminal penalties for violations of EKRA, including fines of up to $200,000 and imprisonment for up to 10 years.
- Civil monetary penalties for Healthcare Providers found to be in violation of EKRA, with fines of up to $100,000 per violation.
- Exclusion from federal healthcare programs, such as Medicare and Medicaid, for Healthcare Providers found to be in violation of EKRA.
Exceptions to EKRA for Clinical Laboratories
While EKRA imposes strict penalties for violations, there are certain exceptions for clinical laboratories that are compliant with federal healthcare laws. These exceptions include:
- Payments made by an employer to an employee for services rendered.
- Payments made by a facility to an independent contractor for services rendered.
- Discounts provided by a clinical laboratory to a health plan.
Ensuring Compliance with EKRA
Given the severe penalties for non-compliance, it is essential for clinical laboratories to take steps to ensure compliance with EKRA. Some key measures that laboratories can take include:
Implementing Compliance Programs
Establishing and maintaining a compliance program that includes policies and procedures for preventing violations of EKRA, as well as regular training for staff on compliance requirements.
Conducting Regular Audits
Performing regular audits of referral practices to ensure that all patient referrals are based on medical necessity and not influenced by kickbacks or other forms of payment.
Seeking Legal Counsel
Consulting with legal counsel to ensure that all business practices are in compliance with EKRA and other federal healthcare laws.
Conclusion
Overall, EKRA has significant implications for clinical laboratories, as it prohibits the exchange of anything of value in return for patient referrals. To ensure compliance with EKRA, laboratories must implement compliance programs, conduct regular audits, and seek legal counsel when needed. By adhering to the provisions of EKRA, clinical laboratories can avoid the severe penalties associated with non-compliance and continue to provide quality healthcare services to their patients.
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