The Centers for Medicare & Medicaid Services (CMS) issued waivers and allowances that will affect risk management programs:

• CMS issued 18 blanket waivers of sanctions under the physician self-referral law, known as the Stark Law. CMS refers to the waivers as the Patients Over Paperwork initiative. These waivers allow hospitals and other healthcare providers more flexibility to respond to the pandemic. The Stark Law waivers are retroactive to March 1, 2020, and do not yet have an expiration date. (The full text of the waivers is available online at: https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf.)

CMS explained the waivers apply only to financial relationships and referrals that are solely related to COVID-19. They allow non-fair market value (FMV) compensation, in which hospitals can pay above or below FMV for equipment, office space, or physician services.

The waivers also allow physician-owned hospital capacity expansion. This means physician-owned hospitals can increase their number of licensed beds, operating rooms, and procedure rooms temporarily. CMS also said physician-owned ambulatory surgical centers can convert to hospitals to help address a surge in patients during the pandemic.

Hospitals may provide medical staff benefits such as daily meals, laundry service, or childcare services during the pandemic without running afoul of kickback prohibitions. CMS also will allow nonmonetary compensation such as continuing medical education on COVID-19 protocols, shelter when the physician must isolate, or meals for the family of a physician exposed to the virus. This compensation must not exceed the annual nonmonetary compensation cap.

CMS waived the writing requirement, allowing compensation for physicians without first obtaining all required documentation. CMS explained this could apply, for instance, when a physician provides personal protective equipment from his or her own office or surgical suite to use in the hospital.

• The Department of Health and Human Services Office of Inspector General (OIG) also issued a policy saying it will not impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for remuneration related to COVID-19. OIG previously issued voluntary safe harbors for activities that pose little risk of fraud, but then went further to state that it will exempt arrangements that do not satisfy the safe harbor requirements. However, they must meet one of the permissible forms of remuneration allowed under the Stark Law blanket waivers.

• CMS issued rule changes and temporary regulatory waivers applying to an expansion of the Medicare home health benefit to COVID-19 patients. It also issued waivers to the Medicare home health and hospice regulations.

• CMS announced temporary measures that will allow ambulatory surgery centers that have postponed elective and nonessential procedures during the pandemic to temporarily contract with a local healthcare system to provide hospital services. They also may bill as a hospital during the federal government’s emergency declaration.