COVID-19 Prompts HHS to Issue Blanket Waivers of Federal Stark Law

In light of the COVID-19 pandemic, the Department of Health and Human Services, on March 30, issued nationwide blanket waivers of the federal Anti-kickback Statute (AKS) and physician self-referral law (Stark). The waivers are retroactive to March 1, 2020.

In a follow-up to that announcement, on April 3, the Department of Health and Human Services Office of Inspector General (OIG), issued a policy statement relating to the enforcement of the AKS that aligns with HHS’ blanket waiver decision.

In its notice, OIG said it will “exercise its enforcement discretion not to impose administrative sanctions under the federal anti-kickback statute for certain remuneration related to COVID-19 covered by the Blanket Waivers†issued by HHS. Its statement applies to conduct occurring on or after April 3 and will end on the same date at the blanket waivers do.

The waivers are designed to provide relief to the healthcare industry as it navigates a never-before-seen environment, giving providers flexibility and allowing them to be able to meet the needs of patients.

The waivers focus on the fair market value requirements and include instances in which compensation might be above or below fair market value such as: remuneration for services performed by a physician; rental charges for office space or equipment; interest rates on loans; the temporary expansion of facility capacity above the number of operating rooms, procedure rooms, and beds for which the hospital was licensed; among others. Click here for a complete list.

In addition, HHS lays out examples of activities that may fall within the scope of the waivers. Among them:

• Hospitals paying above previously contracted rates for services in particularly hazardous or challenging environments.
• Hospitals providing free medical office space to physicians whose patients don’t need inpatient care.
• To accommodate patient surge, a hospital rents office space or equipment from an independent physician practice at below fair market value or at no charge.
• An entity providing free telehealth equipment to a physician practice to care for patients who are in isolation.
• A hospital provides meals, comfort items (for example, a change of clothing), or onsite child care with a value greater than $36 per instance to medical staff physicians who spend long hours at the hospital during the COVID-19 outbreak.

The Centers for Medicare & Medicaid Services (CMS) provided additional examples for physicians and other practitioners related to the new waivers. Click here for those examples.

HHS noted that its waivers have no bearing on arrangements that implicate the federal anti-kickback statute that are not covered by the blanket waivers (e.g., this policy statement would not apply to direct financial relationships between pharmaceutical or device manufacturers and physicians or between providers where there is no physician involved). 

While these waivers provide welcome relief at a time when the healthcare industry is facing an unprecedented emergency situation, it is important to note that these arrangements are solely for a COVID-19 purpose and providers would be well-advised to make sure they remain in compliance with all laws and regulations.

The Health Care Offices of Anthony C. Vitale is well-versed in those laws and can assist you in evaluating whether your activities are in compliance. For more information contact us at  305-358-4500 or info@vitalehealthlaw.com