Clinical laboratories are concerned with numerous regulatory issues when it comes to compliance, but with the recent passage of the SUPPORT Act, not only is there one more law but this one has left laboratories scratching their heads as to what it means.
In an effort to combat the opioid crisis, President Trump signed into effect the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” (“SUPPORT Act”) on October 24, 2018. Included within the SUPPORT Act is legislation known as the “Eliminating Kickbacks in Recovery Act of 2018” which makes it a criminal offense to:
(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—(A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or (B) in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory.
While the new legislation looks very similar to the Federal Anti-Kickback law, there are significant differences. First, and most important, the new law applies to services covered not only by traditional Federal Programs (i.e. Medicare, Medicaid, Tricare, etc.), but also extends to commercial payors exposing a significant number of arrangements to increased scrutiny. Second, while there are “exceptions” to the new law the exceptions do not exactly track the existing Federal Anti-Kickback safe harbors. The most notable discrepancy involves compensation arrangements with employees where historically there were no issues with specific compensation methodologies. However, under the new law, compensation to employees cannot be determined by nor vary by: “(1) the number of individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (2) the number of tests or procedures performed; or (3) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory.”
Where the SUPPORT Act has left laboratories is in a state of limbo as they struggle to understand the interplay between it and the Federal Anti-Kickback. To date, there have been no proposed regulations interpreting the SUPPORT Act’s exceptions or the interplay between it and the Federal Anti-Kickback. The Attorney General is responsible for preparing the regulations, doing so “in consultation with the Secretary of Health and Human Services.” Therefore, we do not have clear guidance as to which law a laboratory should look to for compliance purposes, if not both. Regardless, it is imperative that all laboratories understand the impact of the SUPPORT Act on their operations and arrangements and begin assessing whether changes, if any, are necessary for compliance.
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