The US Department of Health and Human Services (“HHS”) recently announced that it will issue blanket waivers of the Stark Law for healthcare providers to allow them the flexibility they need to ensure that sufficient health care items and services are available to meet patient needs during the COVID-19 pandemic. In addition, the HHS Office of Inspector General (“OIG”) announced that it will “exercise its enforcement discretion” in applying Anti-Kickback Statute sanctions for the activities related to those blanket waivers.05
HHS notes a number of activities will be exempt from sanctions, absent a determination of fraud or abuse, including the following:
Remuneration from an entity to a physician that is above or below the fair market value (“FMV”) for services personally performed by the physician.
Rental charges paid by an entity to a physician that are below FMV for the entity’s lease of office space or equipment from the physician.
Remuneration from an entity to a physician that is below FMV for items or services purchased by the entity from the physician.
Rental charges paid by a physician to an entity that are below FMV for the physician’s lease of office space or equipment from the entity.
Remuneration from a physician to an entity that is below FMV for the use of the entity’s premises, or for items or services purchased by the physician from the entity.
Remuneration from a hospital to a physician in the form of medical staff incidental benefits.
Remuneration from an entity to a physician in the form of nonmonetary compensation.
Remuneration from an entity to a physician, or vice versa, resulting from a loan with an interest rate below FMV or on terms that are otherwise unavailable from a lender.
Various activities relating to referrals by physician owners of a hospital that relate to expanding facility capacity, and other referrals by physicians.
The complete list of exempt activities, as well as examples, can be found here.
HHS noted that parties utilizing the blanket waivers should develop and maintain records in a timely manner relating to the use of the blanket waivers, and must make those documents available to the Secretary upon request. However, it is not necessary to submit any documentation or notice to the Secretary or the Centers for Medicare and Medicaid Services (“CMS”) in advance. The waivers apply retroactively to March 1, 2020.
Following, this policy announcement, the HHS OIG issued a statement indicating that it would not impose administrative sanctions under the Federal Anti-Kickback Statute for certain remuneration covered by the blanket waivers. HHS OIG noted that they implemented this policy to “ensure[] that health care providers have the regulatory flexibility necessary to respond adequately to COVID-19 concerns.” The HHS OIG policy applies to conduct occurring on or after April 3, 2020.