“Eliminating Kick-Backs and Recovery Act of 2018” (EKRA) is a part of a group of laws recently passed by Congress to expand the law enforcement spectrum available to fight the opioid epidemic. EKRA is part of approximately 70 separate actions referred to as the SUPPORT Act, i.e. Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients in Communities Act.

EKRA adds a new Anti-Kickback rule to the existing healthcare fraud enforcement spectrum. It expands the Anti-Kickback scope to all healthcare programs, rather than just the classic federal programs (Medicare, Medicaid and TriCare), and essentially eliminates Safe Harbor protection by statutorily narrowing the available protections.

EKRA states that “whoever” (which is an unlimited category not limited to just providers or doctors, such as the Stark Act) with respect to a “healthcare benefit program” (which is defined as any healthcare program that affects interstate commerce):

• Solicits or receives remuneration in return for referring a patient or patron to a recovery home, clinical treatment facility or laboratory, or
• Pays or offers any remuneration directly or indirectly to induce referrals of an individual to a recovery home, clinical treatment facility or laboratory or in exchange for any individual using such services

Shall be fined not more than $200,000, imprisoned not more than 10 years, or both for each occurrence.

The only exceptions, which thereby eliminates the application of other Safe Harbors, is that the act shall not apply to

1. A discount or other reduction in price obtained by a provider or other entity under a healthcare program if the reduction is properly disclosed and appropriately reflected in cost or charges.

2. A payment made by an employer to an employee or an independent contractor (who have “bonafide” relationships with the employers) if the payment is not determined by or does not vary by

• The number of individuals referred to a particular recovery home, clinical treatment facility or laboratory,
• The number of tests or procedures performed, or
• The amount billed to or receipt from the healthcare benefit program from the individuals referred to a particular recovery home, clinical treatment facility or laboratory.

3. Bonafide drug discounts.

4. Payments made as compensation for services under the personal services and management contract Safe Harbor provisions of 42 CFR 1001.952(d).

5. Waivers or discounts defined in 42 CFR 1001.952(h)(5) or other co-insurance or co-payments of the healthcare program.