To facilitate the provision of medical services related to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (“CMS”) and Department of Health and Human Services Office of the Inspector General (“OIG”) have issued waivers and other guidance concerning payments and referrals that may otherwise implicate the Anti-Kickback Statute (“AKS”) and the Physician Self-Referral Law (“Stark law”).
Broadly speaking, the AKS imposes criminal penalties for remuneration for referring a patient for services that may be covered by a federal healthcare program, and the Stark law imposes civil penalties on physicians who refer patients for federally payable services to entities in which they have some financial interest. For example, these laws may be implicated by a physician’s promotion of a telemedicine platform in which they’ve made an investment, since such promotion could result in referrals for federally paid services to an entity in which the physician has a financial interest.
The AKS and Stark law provide “safe harbors” or “exceptions” for particular arrangements. For example, such marketing arrangements may be structured to fall under the “bona fide employment relationship” or “personal service arrangement” exceptions to Stark law liability, or the “personal services and management contracts” AKS safe harbor. If a physician invested in the telemedicine platform enters into an employment relationship with the entity that owns the platform, then they may avoid liability if (among other statutory requirements) the physician’s remuneration is consistent with the fair market value for those services and is not determined in a manner that takes into account the volume or value of any referrals.
CMS is responsible for Stark law monitoring and enforcement, and on March 30, 2020, it issued a list of 18 blanket waivers for certain requirements for financial relationships and referrals related to the COVID-19 national emergency, retroactive to March 1. On April 3, the OIG issued a policy statement that for purposes of AKS enforcement, it also will not impose sanctions for remuneration covered by CMS blanket waivers 1 through 11. On April 21, CMS issued further explanatory guidance for application of the blanket waivers, clarifying that they are intended to waive specific requirements for certain exceptions to Stark law liability—such as the “bona fide employment relationship” exception—but that all non-waived requirements for a given exception must still be observed. Both the blanket waivers and OIG’s enforcement policy are intended to last only for the duration of the national emergency.
“Related to” COVID-19 is broadly defined in these documents to include, for example, shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak, which may include telemedicine services for patients observing social distancing but who are otherwise unaffected by the outbreak. As such, the waivers may be applicable to general telehealth arrangements, such as the example above.
For example, “blanket waiver” no. 1 excepts “[r]emuneration from an entity to a physician … that is above or below the fair market value for services personally performed … .” This waiver may cover arrangements in which a physician is paid more than fair market value for marketing and referral services like those described above, although other non-waived requirements must still be observed. As may be relevant to web-based telemedicine platforms, the blanket waivers still do not permit compensation based on the volume or value of referrals generated, so any “pay-per-click” or similar arrangements may still trigger liability under the Stark law and/or AKS.
The CMS and OIG encourage interested parties to contact them directly with questions concerning the application of the blanket waivers to specific compensation arrangements. CMS inquiries regarding application of the blanket waivers for Stark law purposes may be directed to 1877CallCenter@cms.hhs.gov, and OIG inquires for AKS purposes may be directed to OIGComplianceSuggestions@oig.hhs.gov. OIG also maintains a public repository of frequently asked questions regarding arrangements related to the COVID-19 emergency, including directions for obtaining an advisory opinion.