On March 30, 2020, the Secretary of Health and Human Services issued 18 “Blanket Waivers” protecting specifically described arrangements from sanctions under the federal physician self-referral prohibition (“Stark”) during the COVID-19 national emergency. For an arrangement to take advantage of a Blanket Waiver: (1) the remuneration must be direct (i.e., between entity and physician/physician organization/immediate family member); and (2) must be solely related to “COVID-19 Purposes,” which is defined, although broadly. The Blanket Waivers include:
- Remuneration from an entity to a physician that is above or below the fair market value for services personally performed by the physician to the entity.
- Rental charges paid by an entity to a physician that are below fair market value for the entity’s lease of office space from the physician.
- The referral by a physician in a group practice for medically necessary designated health services furnished by the group practice in a location that does not qualify as a “same building” or “centralized building” for purposes of 42 CFR 411.355(b)(2).
Shortly after, on April 3, 2020, the Office of Inspector General (“OIG”) issued a Policy Statement declaring it would not impose administrative sanctions under the federal anti-kickback statute (“Federal Anti-Kickback”) with respect to remuneration and arrangements protected under the Stark Blanket Waivers. With this enforcement discretion, parties don’t have to worry about conducting a separate analysis under Federal Anti-Kickback if they meet a Blanket Waiver.
Before parties run out to try to take advantage of these new Blanket Waivers, there still needs to be a cautious approach. First, both the Blanket Waivers and OIG discretion are temporary as they will expire upon termination of the COVID-19 national emergency. Therefore, parties should understand the short-term nature of these arrangements and have plans in place to unwind the transaction when the time comes. Second, the Secretary included the language “absent the government’s determination of fraud and abuse” leaving open the possibility that Blanket Waiver protection could be lost if not used in good faith. Finally, because Stark applies to physician self-referral arrangements, non-physicians looking to take advantage of the OIG’s enforcement discretion will be out of luck as the OIG’s policy is very specific in that it only applies to those arrangements covered by the Blanket Waivers and does not apply to any other arrangements that implicate the Federal Anti-Kickback. The OIG provided the examples where the policy would not apply as including direct financial relationships between pharmaceutical or device manufacturers and physicians, or between providers where there is no physician involved.
Should you have questions about the new Blanket Waivers or other regulatory compliance during COVID-19, email us at email@example.com.