Enacted in October 2018 as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), the Eliminating Kickbacks in Recovery Act (EKRA) was designed to prevent patient brokering and other forms of healthcare fraud in the substance abuse treatment industry. While originally intended to address issues in addiction treatment facilities, EKRA also applies to clinical diagnostic laboratories.
The Basics of EKRA
But what exactly does EKRA entail for clinical diagnostic labs? Essentially, EKRA prohibits any form of payment or other remuneration in exchange for patient referrals for services covered by a federal health care program or in exchange for the purchasing, leasing, or ordering of healthcare items or services reimbursable by a federal health care program. This includes Medicare, Medicaid, and other government-funded health programs.
Potential EKRA Violations in Clinical Diagnostic Labs
While EKRA was primarily aimed at addiction treatment centers, it has far-reaching implications for clinical diagnostic labs as well. Some common scenarios in which EKRA violations may occur in these settings include:
- Offering kickbacks in exchange for patient referrals for lab testing
- Accepting kickbacks in exchange for ordering specific lab tests
- Providing or receiving remuneration to induce the referral of specimens for lab testing
The Consequences of EKRA Violations
The penalties for EKRA violations can be severe, including hefty fines, potential loss of federal funding, and even criminal charges. Violations of EKRA can result in fines of up to $200,000 per violation, as well as imprisonment for up to 10 years for each offense. Additionally, individuals found guilty of violating EKRA may be excluded from participating in federal health care programs, effectively putting them out of business.
Detecting EKRA Violations in Clinical Diagnostic Labs
Given the serious consequences of EKRA violations, it is essential for clinical diagnostic labs to be vigilant in detecting and preventing potential violations. Some ways in which EKRA violations may be detected in these settings include:
Internal Audits
Regular internal audits can help identify any irregularities or red flags that may indicate potential EKRA violations. These audits should include a review of financial records, billing practices, and referral patterns to ensure compliance with EKRA regulations.
Training and Education
Proper training and education of staff members can help prevent EKRA violations before they occur. Employees should be made aware of the implications of EKRA and the consequences of non-compliance, as well as the importance of following established protocols and guidelines.
Whistleblower Reports
In some cases, EKRA violations may be brought to light through whistleblower reports. Employees or other individuals with knowledge of potential violations may choose to report them to the appropriate authorities, prompting an investigation into the matter.
Government Investigations
Government agencies such as the Department of Health and Human Services (HHS) and the Office of Inspector General (OIG) may conduct investigations into potential EKRA violations in clinical diagnostic labs. These investigations may be triggered by complaints, audits, or other sources of information.
Conclusion
While EKRA violations in clinical diagnostic labs may not be as common as in other healthcare settings, the consequences of non-compliance can be severe. By staying informed about EKRA regulations, conducting regular audits, and providing proper training to staff members, clinical diagnostic labs can help prevent potential violations and ensure compliance with federal laws.
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