On February 17, 2021, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its FAQ’s concerning the COVID-19 public health emergency. In the update, OIG gave guidance on its enforcement discretion regarding administrative services provided to COVID-19 vaccination sites on a per-vaccine basis. It should be noted that this guidance is not an advisory opinion, is not binding on OIG, and does not constitute a waiver of any statutory or regulatory requirement, though it may be helpful when structuring these arrangements.
OIG addressed the question of whether a non-provider philanthropic entity could contract to provide administrative services to a healthcare provider relating to the operation of COVID-19 vaccination sites and be compensated on a per-vaccine basis. The entity would provide administrative services including arranging for the physical vaccination sites, data systems, online and web-based scheduling, site development and training, and reporting to state agencies. The healthcare provider would provide clinical staff, oversee administration of the vaccine, and bill third-party payors, including federal healthcare programs.
After billing for the vaccine administration, the healthcare provider would retain a certain amount per hour for compensation and to cover staffing costs. The remainder of the compensation would flow to the entity providing the administrative services. OIG specified that there would be no other arrangements between the entity, the healthcare provider, any beneficiary, or other person capable of arranging for referrals for items or services payable by a federal healthcare program.
In analyzing this arrangement, OIG noted that compensation methodologies that involve “per patient,” “per click,” “per order,” and similar methodologies in payment arrangements with parties in a position, directly or indirectly, to refer or recommend an item or service payable by a Federal health care program implicate the Federal anti-kickback statute. However, given the safeguards in place, and the unique circumstances of the COVID-19 public health emergency, OIG ultimately concluded that this hypothetical arrangement presented a “low risk of fraud and abuse under the Federal anti-kickback statute.”
The safeguards discussed by OIG are not altogether clear. OIG does not define “philanthropic entity” in this context or specify whether an entity organized as a for-profit corporation is included in the hypothetical. Further, the disapproval of other arrangements between the provider and the administrative entity, if interpreted broadly, likely limits the scope of any such arrangement within the context of a large business structure. Any per-volume compensation to an entity in a position to provide referrals carries risk. However, an entity looking to de-risk its COVID-19 vaccine operation may find helpful guidance in this FAQ.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in structuring business relationships and complying with federal law and regulations, including the anti-kickback statute. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or email@example.com.