2023 Board Resources

a scheme in which the sober home, treatment center, or other provider pays third parties a “finder’s fee” for each patient that enters treatment. Oftentimes, these payments accompany providers accused of billing for unnecessary procedures or substandard treatment. While legislative backdrop suggests a focus on substance abuse treatment, which could include toxicology/UDT lab testing, EKRA is not limited by its terms to such testing. Labs are defined by reference to the CLIA statute, 42 U.S.C. § 263a. This broad definition means that all laboratories, not just laboratories that perform toxicology screening, are arguably subject to EKRA. EKRA includes seven exceptions to the prohibition, plus an authority for the Attorney General to create additional exceptions through rulemaking (which the Attorney General has not exercised to date). We note that OIG is not authorized to issue rules on EKRA. Some of the EKRA statutory exceptions mirror a corresponding AKS exception, some are not contained in the AKS, and some are different from the AKS. EKRA’s preemption provision states that EKRA “shall not apply to conduct that is prohibited under” the AKS. 126 However, there is some ambiguity proffered by the industry as to whether conduct permitted by AKS is now prohibited by EKRA or not. 127 We anticipate that this point of ambiguity may eventually become subject to Attorney General rulemaking or, ultimately, judicial interpretation. EKRA’s employment exception is materially different from, and more restrictive than, the AKS employment safe harbor. Under EKRA, the employment exception protects payments to a bona fide employee that are not determined by and do not vary by the 1) number of individuals referred to a laboratory, 2) 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 laboratory. 128 EKRA contains the same personal services safe harbor as the AKS. In terms of marketing, there is a significant threshold question as to whether EKRA applies to marketing arrangements between businesses as opposed to marketing directly to patients. EKRA does not use the AKS term “arrange for or recommend,” which as discussed below, is the term OIG has interpreted to include marketing. Instead, EKRA uses, and does not define, the terms “in exchange for a person using” and “patronage.” At present, as EKRA is less than a year old, there are no regulations or interpretative guidance from the government on the meaning of these terms. As a result, and based on general statutory construction principles and available legislative intent, there may be a reasonable argument that EKRA was intended to apply only to direct-to-patient marketing activities and not business-to-business marketing activities. Alternatively, if EKRA is interpreted to apply to business-to-business marketing activities, it is reasonable to assume that the government would apply its longstanding AKS facts and circumstances analysis to these activities, absent regulations or guidance stating otherwise. primarily have affected private health insurance plans ........ The [Federal AKS] applies only to Federal health care programs; it does not apply to privately insured patients.” Letter from Barbara Pisaro Clark, Act. Asst. Sec'y for Leg., Secretary of HHS, to Committee on Energy and Commerce, United States House of Representatives (Sept. 12, 2017). 126 18 U.S.C. § 220(d). 127 American Clinical Laboratory Association Memo from Alston & Bird, at https://www.acla.com/acla-memo- regarding-anti-kickback-provisions-of-the-support-for-patients-and-communities-act-public-law-115-271/ 128 18 U.S.C. § 220(b)(2).