Laboratories Beware of EKRA

On October 24, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was signed into law (the Act’s text is available here).  The SUPPORT Act includes a number of provisions to address the ongoing opioid crisis, such as expanding the use of telehealth services for the treatment of Medicare beneficiaries with substance abuse disorders and increasing the number of health care providers that can prescribe or dispense medications that treat opioid use disorders.

Buried within the 250 page SUPPORT Act is Section 8122, the “Eliminating Kickback in Recovery Act of 2018” (“EKRA”) (codified as 18 U.S.C. § 220).  Although there is limited legislative history for this section, it appears that EKRA was initially intended to prohibit recovery homes and clinical treatment facilities from engaging in “patient brokering,” a practice where third parties recruit individuals with substance abuse disorders for these facilities in exchange for kickbacks.  However, the addition of laboratories to EKRA, seemingly at the last minute, makes this section of the SUPPORT Act much more expansive.

Under EKRA, it is a federal crime to knowingly and willfully:

1. solicit or receive 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; or
2. pay or offer 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
   • in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory.

Violations of EKRA may result in fines of no more than $200,000, imprisonment of no more than 10 years, or both, for each occurrence.

Although the language used in EKRA is similar to the language in the Federal Health Care Program Anti-Kickback Statute (the “Federal AKS”) (42 U.S.C. § 1320a-7b(b)), there are some important differences to be aware of.

First, EKRA applies to all health care benefit program business, including private payors, while the Federal AKS applies only to items and services paid for by federal health care programs.

Second, even though the SUPPORT Act focuses on substance abuse treatment, EKRA applies to all laboratory testing, regardless of whether the laboratory tests are related to substance abuse.

Third, like the Federal AKS, EKRA includes exceptions for certain arrangements (e.g., discounts, personal services and management contracts).  However, some of EKRA’s exceptions are different than the Federal AKS exceptions.  For example, EKRA includes an exception for patient copay and coinsurance waivers and discounts that differs from Federal AKS guidance regarding such waivers and discounts.  More importantly, EKRA’s exception for remuneration paid to employees is narrower than that the Federal AKS employment exception.  The Federal AKS employment safe harbor (42 C.F.R. § 1001.952(i)), protects payments, including volume-based commissions, paid to bona fide employees.  EKRA protects payments made to bona fide employees and independent contractors as long as the payment is not based on the number of individuals referred, the number of tests performed, or the amount billed to or received from a health care benefit program from the individuals referred.  In other words, even though volume-based commissions may be paid to employees under the Federal AKS, under EKRA, a laboratory that pays volume-based commissions to its employees risks enforcement.

EKRA became effective when the SUPPORT Act was signed into law on October 24, 2018, but federal regulations and guidance have not yet been issued, so there are still outstanding questions about EKRA’s impact.  One significant question is the extent to which certain aspects of EKRA are preempted by other laws, including the Federal AKS.  As drafted, EKRA says that it does “not apply to conduct that is prohibited under [the Federal AKS].”  This somewhat confusing language seems to prevent prosecution of conduct involving federal health care programs under both EKRA and the Federal AKS.  However, conversely, this appears to permit prosecution under EKRA of conduct permitted under the Federal AKS (e.g., a laboratory that provides volume-based commissions protected by the Federal AKS to employees, could be prosecuted under EKRA for providing those commissions).

We will continue to monitor developments related to EKRA but encourage laboratories to evaluate how this new law impacts their current business practices.