EKRA Compliance, Law & Regulations for 2023
The Eliminating Kickbacks in Recovery Act (EKRA) significantly expands the federal government’s oversight of referral fees (and other forms of “remuneration”) in the health care sector. Applying to recovery homes, clinical treatment facilities, laboratories, and other providers, the EKRA imposes completely new prohibitions that did not exist under prior law.
In 2018, Congress enacted the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (SUPPORT Act) in direct response to the nation’s ongoing opioid crisis. While much of the SUPPORT Act focuses on issues that are specific to the crisis, it also contains a broad set of prohibitions pertaining to compensation paid in relation to patient referrals.
These prohibitions appear in the Eliminating Kickbacks in Recovery Act (EKRA), which was signed into law as part of the SUPPORT Act’s legislative package. The EKRA contains sweeping provisions, and notably – unlike the Anti-Kickback Statute – the EKRA statute does not solely apply to referral compensation paid out of Medicare, Medicaid and other government program-reimbursed funds. The EKRA’s prohibitions apply regardless of payor, and they apply to items and services both related and unrelated to opioid substance abuse treatment.
What is the Eliminating Kickbacks in Recovery Act (EKRA)?
The EKRA statute, codified in 18 U.S.C. Section 220, is a federal statute that prohibits any and all transactions (and any and all attempts to engage in transactions) involving the payment of compensation for patient referrals to recovery homes, clinical treatment facilities, and laboratories. Under federal law, these entities are defined as follows:
- Recovery Home – “[A] shared living environment that is, or purports to be, free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders.”
- Clinical Treatment Facility – “[A] medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”
- Laboratory – “[A] facility for the . . . 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.”
The EKRA’s prohibitions apply to services covered under any “health care benefit program.” This is important, and it distinguishes the EKRA from other federal laws such as the Anti-Kickback Statute and Stark Law that only apply to specified government health care benefit programs. Under the EKRA, entities and individuals that offer, pay, solicit, or accept unlawful compensation can face prosecution regardless of the payor – public or private – from which the funds are originally derived. This is made clear in 18 U.S.C. Section 24(b), which is referenced in the EKRA and defines a “health care benefit program” as, “any public or private plan or contract . . . under which any medical benefit, item, or service is provided to any individual . . . .”
The EKRA contains three specific prohibitions, all of which carry the same potential penalties. Federal prosecutors can pursue charges under the EKRA against anyone who:
- “[S]olicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory;”
- “[P]ays or offers any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind . . . to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory;” or,
- “[P]ays or offers any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind . . . in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory.”
5 Key Compliance Considerations Under the EKRA Laws
The EKRA creates substantial compliance burdens; and, as discussed in the FAQs below, the consequences of non-compliance can be severe. With this in mind, here are five key considerations regarding EKRA compliance:
1. The EKRA Applies to All Types of Health Care Providers and Professionals
While the EKRA specifically references recovery homes, clinical treatment facilities, and laboratories, these are not the only types of providers that need to comply. Other health care providers and professionals that refer patients to these facilities (and which may solicit or receive compensation for referrals) must establish EKRA compliance policies and procedures as well.
2. The EKRA Applies to All Forms of Remuneration
Similar to the Anti-Kickback Statute and Stark Law, the EKRA prohibits all forms of “remuneration” paid in connection with patient referrals. The statute specifically prohibits any, “kickback, bribe, or rebate,” but any other form of monetary or non-monetary compensation would be considered in violation of the EKRA as well.
3. Anti-Kickback Statute and Stark Law Compliance Policies are Insufficient to Address the EKRA
Due to the differences between the EKRA and the Anti-Kickback Statute and Stark Law, providers’ pre-existing compliance policies and procedures will be insufficient to address their compliance obligations under the EKRA. In order to cover the full scope of the EKRA’s prohibitions (including its application to services reimbursed by both public and private payors), providers must adopt policies and procedures that specifically address the language of the EKRA.
4. All Personnel Need to Receive Information and/or Training Regarding EKRA Compliance
Since any offer, payment, solicitation, or acceptance of prohibited remuneration can trigger liability under the EKRA, recovery homes, clinical treatment facilities, laboratories, and other providers must ensure that all personnel are aware of the statute’s prohibitions. This means that once policies and procedures have been adopted, it will be necessary to adequately disseminate these policies and procedures and provide appropriate training.
5. There are Seven Exceptions to the EKRA’s Prohibitions and the Potential for More
While the EKRA broadly prohibits the payment of referral fees and other forms of compensation as discussed above, the statute contains seven express exceptions, and it allows for additional exceptions to be adopted by regulation. Under the EKRA, the following are not considered unlawful forms of remuneration:
- Disclosed price discounts
- Non-volume-based compensation to bona fide employees
- Medicare Part D drug discounts
- Compensation for qualifying personal services
- Copay waivers
- Remuneration paid to Federally Qualified Health Centers
- Remuneration paid pursuant to “alternative payment models” and other approved payment arrangements
FAQs: Health Care Provider Compliance Under the EKRA Law
Q: What are the penalties for non-compliance with the EKRA?
Appearing in Title 18 of the U.S. Code, the EKRA is a criminal statute. Violations of the EKRA can carry fines of up to $200,000 and up to 10 years of federal imprisonment.
Q: Is it possible to face civil (instead of criminal) prosecution under the EKRA?
In certain circumstances, it is possible that a violation of the EKRA could lead to civil prosecution under the False Claims Act. If the violation involves a government health care benefit program, and if prosecutors do not believe that they have sufficient evidence to prove criminal culpability under the EKRA, it is possible that providers could face civil False Claims Act liability.
Q: What do recovery homes, clinical treatment facilities, and laboratories need to do in order to comply with the EKRA?
In order to establish EKRA compliance, recovery homes, clinical treatment facilities, and laboratories must ensure that they have adequate policies and procedures in place, and they must ensure that all personnel are familiar with the statute’s prohibitions as well as the risks of non-compliance. These facilities will also need to monitor for compliance on an ongoing basis, and they will need to promptly address any potential violations committed by their personnel.
Q: What do other health care providers and professionals need to do in order to comply with the EKRA?
For other health care providers and professionals, the steps for ensuring EKRA compliance are largely the same. Both initial and ongoing compliance efforts are necessary, and providers and professionals must have protocols for preventing, identifying, and remedying EKRA compliance failures.
Q: What can providers do to ensure that their utilization of disclosed price discounts and other EKRA exceptions do not lead to prosecution?
When relying on statutory or regulatory exceptions under the EKRA, clear and comprehensive documentation is critical to demonstrating compliance. In the event that an audit or investigation leads to questions about a specific practice or transaction, being able to provide documentation to show that the provider or facility has specifically acknowledged and addressed the EKRA’s prohibitions can be highly effective in preventing further inquiry and mitigating the risk of facing unwarranted allegations.
Speak with a Health Care Compliance Lawyer Familiar with EKRA Laws at Oberheiden P.C.
At Oberheiden P.C., we represent health care providers and professionals nationwide in all aspects of federal health care law compliance. If you need to speak with an attorney about adopting and implementing EKRA compliance policies and procedures, we encourage you to schedule a complimentary needs assessment. To schedule an appointment at your convenience, please call 888-680-1745 or contact us online today.