Loyola University Chicago School of Law, JD 2020
On October 24, President Trump signed a new bill aimed at combatting issues arising from the opioid epidemic. This bill, entitled the Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT” Act) is a combination of seventy bills that effect the healthcare industry. This act includes new and revised Medicaid and Medicare laws that relate to the opioid crisis through the expansion of substance use disorder services. However, this bill, primarily aimed to combat the opioid epidemic, contains key provisions that will affect healthcare providers. Healthcare providers should be especially mindful of this new Act, as there are new anti-kickback provisions that require compliance officers and departments to ensure that their healthcare entities are in compliance with this new law.
All-Payor Anti-Kickback Provisions
The SUPPORT Act creates a parallel kickback prohibition to the federal Anti-Kickback Statute (“AKS”) to attempt to “close the gap” that Congress felt was left open under federal AKS. This kickback reaches new healthcare entities that fall outside the scope of AKS. Through this prohibition, Congress sought to stop “patient brokering”, in which third parties recruit patients for facilities in order to get kickbacks from the facilities who received the referral. In particular, section 8122 of the new Act, the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), creates a new all-payor anti-kickback prohibition that specifically targets arrangements with certain healthcare entities, including recovery homes, laboratories, and clinical treatment facilities. Violations of the SUPPORT Act’s anti-kickback prohibition have steep penalties, with monetary fines of up to $200,000 dollars, and/or imprisonment of up to ten years for each occurrence. In addition to these new provisions, nine new statutory exceptions have also been introduced into law, some of which resemble or reference the federal AKS exceptions. These include certain disclosed discounts under a health care benefit program, certain payments to bona fide employees and independent contractors, payments for services and other federally qualified health center arrangements that meet the federal AKS safe harbor and exception requirements, and certain coinsurance and copayment waivers and discounts.
Differences between SUPPORT and the Federal Anti-Kickback Statute
Like AKS, the SUPPORT Act penalizes the offer, payment, solicitation, or remuneration to obtain referrals. However, unlike federal AKS, the new prohibition only applies to referrals to a “health care benefit program” which is defined as “any public or private plan or contract, effecting commerce, under which any medical benefit, item, or service is provided to any individual.” The federal AKS statute applies only to referrals reimbursed by federal health care programs, which means EKRA expands the prohibition to a broader variety of relationships and referrals than are currently covered under the federal AKS. These prohibitions apply specifically to the healthcare entities listed previously (recovery homes, laboratories, and clinical treatment facilities) and thus the scope only effects arrangements with these entities. However, the language of the statute does not specify the type of referral, meaning that it is not limited to only referrals relating to substance abuse or addiction treatment. The ambiguous language of the statute is concerning, as the Act may unintentionally police arrangements that have little to do with helping the population that Act intends to protect—patients with substance-abuse disorders. If Congress only sought to protect patients going to these healthcare entities for the purpose of opioid addiction and related substance-abuse disorders, there may be push back from the healthcare entities who are indirectly affected.
In addition to the difference in scope between federal AKS and EKRA, providers should also be mindful of the differences between the exceptions created in both laws. In particular, EKRA and AKS both contain exceptions to payment arrangements between bona fide employees and contractors, but EKRA’s exception applies to both employees and contractors, whereas AKS has a separate exception for each. Furthermore, EKRA requires that compensation for both employees and contractors not be determined through productivity-based markers, including the number of tests or procedures performed. Unlike EKRA, the practice of productivity or incentive-based compensation is permissible under AKS exceptions. This raises interesting questions about the way this Act will affect the quality and care of the patients at these entities. Healthcare providers, regardless of whether their services extend past substance abuse disorders, must be mindful of whether their arrangements will be affected by EKRA even if they are currently in compliance with federal and state anti-kickback laws.