The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT). This new law will go into effect in October.
One specific point to note with this law is the fact that it extends beyond physicians. EKRA also includes laboratories as defined under CLIA [42 U.S.C. 263a]:
[A] facility for the biological, microbiological, serological, chemical, immune-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
What is the purpose of EKRA? Lawmakers designed EKRA as another tool to fight against kickbacks in the medical field. It is supposed to encourage physicians and other medical professionals to provide quality care for the patient and further eliminate financial incentives.
However, critics have voiced concern that the law could have unintended consequences.
What types of unintended consequences? The medical field is attempting to move towards collaborative care. Having laws that punish medical professionals, including those who own and operate diagnostic and clinical laboratories, for working together may thwart this effort. As a result of this new law, labs are wise to review their billing policies and make changes as needed to avoid allegations of a violation.
How will the government enforce EKRA? As recently discussed during a Dark Daily Webinar focusing on how to better serve labs and pathology groups, although the law is federal, enforcement will likely extend beyond federal agencies. Two prime examples: whistleblowers and public as well as private insurance providers. Whistleblower laws will continue to allow employees and workers to expose potential wrongdoing within their organizations and payors will be able to assert a violation as a reason for nonpayment.
What happens if the government establishes a violation? Penalties are harsh. Each individual violation can result in a $200,000 fine, 10 years imprisonment as well as personal exposure for those who serve as board members or officers within a business or organization accused of a violation.