Eliminating Kickbacks in the Recovery Act is more commonly known as EKRA. It is included in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, more commonly in the sense of the SUPPORT Act. Both were passed on October 24th, 2018. EKRA is similar to the Anti-Kickback Statute and the Physician Self-Referral Law, also known as Stark’s Law, which preceded it, in the sense these laws prohibit monetary gain for patient referrals. Yet, there are some important distinctions as well.
There are times when healthcare providers or health care professionals do not use best practice, an example of which has been written about. Such instances could explain why laws like EKRA, the Anti-Kickback Statute, and Stark’s Law are passed. However, this article focuses on what you should know about EKRA.
How do you Comply with EKRA?
EKRA requirements require full comprehension to ensure compliance is adhered to by healthcare providers. It contains a wide range of prohibited acts, so the familiarity with what they are and how each healthcare professional construes them is vital. This means healthcare professionals must address EKRA compliance as distinct from the compliance resultant from both the Anti-Kickback Statute and Physician Self-Referral Law.
Existing anti-kickback policies and procedures can be expanded to include EKRA. For those without them, conducting a risk assessment for identifying such risks is imperative. But so is also understanding the ramifications for noncompliance. What may be considered high risk for a healthcare provider may not be as equally high risk for healthcare professionals. This means that EKRA is not the same for everyone but instead varies according to what the individual is doing. This means there are no standard means of compliance, although there will be expected standards to meet, for which detailed proof must be documented.
What does EKRA Apply to?
Patient referrals to Clinical Treatment Facilities, Laboratories, Recovery Homes, and such.
EKRA applies to referral transactions involving all three of these places. This means soliciting, making an offer of, accepting, and being in receipt of remuneration in this regard is illegal. All forms of healthcare providers and professionals involved therein can thus face penalties for noncompliance.
Remuneration Paid with Funds received from All Payers.
EKRA covers every service that a health care benefit program provides, unlike Stark’s Law and the Anti-Kickback Statute. For the purposes of defining what a health care benefit program is, EKRA refers to 18 US Code, Sub Section 24(b), which states the term:
“any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”
This basically covers payments concerning patients who have private health insurance as well as those with a governmental health care program.
What does EKRA Prohibit?
1.Soliciting or receiving remuneration of any kind in exchange for a patient referral to a clinical treatment facility, laboratory, or recovery home.
2.Paying or offering remuneration of any kind to induce a patient referral to a clinical treatment facility, laboratory, or recovery home.
3.Paying or offering remuneration of any kind in exchange for a patient referral to a clinical treatment facility, laboratory, or recovery home.
EKRA has fewer exemptions in comparison to the Anti-Kickback Law. The latter has eleven statutes and twenty-eight regulatory safe harbors. A safe haven is a rule that exonerates legal responsibility due to actions or statements made that were genuinely believed to be correct. EKRA, in contrast, only has seven, which are:
Alternative Payment Models
Bona Fide Employee Compensation
Copay Waivers
Disclosed Price Discounts
Federally Qualified Health Centers
Medicare Part D Discounts
Personal Services
Although there are provisions in EKRA to allow extra exceptions by regulation, there have yet to be any.
What happens if EKRA is Contravened?
Being a criminal statute, if EKRA is contravened, then illegal activity has been found to have caused this. There are substantial punishments, more grievous than for the Anti-Kickback Statute if this is proven. This can consist of fines and/or imprisonment. There can be more than one culpable party, and if each party is therefore found guilty of violating EKRA, they can all expect to receive a punishment. The maximum penalty can be £200,000 and 10 years in jail for each violation.
The first prosecution under EKRA involved kickbacks accepted by a Kentucky substance abuse clinic office manager from a toxicology lab chief executive officer. This was over a period of approximately eight months between 2018 – 2019. After changing her version of events, she eventually pled guilty to making false statements and attempting to tamper with records. The office manager was eventually charged in 2020 to five months of imprisonment with five months of home detention. She also received a $55,000 fine.
To be found guilty, it must be proven that an unlawful payment or offer was either made or received, both knowingly and willfully. In addition, providers could also face a civil liability lawsuit if criminal action is deemed unjustified by prosecutors. If this transpires, then all the providers will be at risk of a civil liability lawsuit under the False Claims Act. This will particularly apply if they are found to have engaged in prohibited referral-related transactions involving government health care benefit programs, like Medicare. However, physicians could face the same lawsuit for contravening the Stark Law if they have been found to participate in prohibited self-referrals involving clinical treatment facilities, laboratories, or recovery homes.
It may initially appear daunting or even overwhelming, ensuring EKRA is adhered to. But since its implementation, there have been several successful prosecutions, which have shaken the healthcare industry up. Therefore, keeping abreast of any changes will potentially avoid any fines and or imprisonment. Documenting proof in this regard will further support you and provide your healthcare staff and organization with guidelines to avoid disrepute. More importantly, you will ensure your patients are treated equally fairly.