The Blanket Waivers that the Center of Medicare and Medicaid services issued under the Stark Law apply only to financial relationships and referrals that are related to the national emergency that is the COVID-19 outbreak in the United States.
Any remuneration described in the Blanket Waivers must be directly between the entity and: (1) the physician or the physician organization in whose shoes the physician stands under 42 CFR 411.354(c); or (2) the immediate family member of the physician.
The remuneration and referrals described in the Blanket Waivers must be solely related to COVID-19 Purposes.
For purposes of the Blanket Waivers, COVID-19 Purposes are:
- Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID-19;
- Securing the services of physicians and other health care practitioners and professionals to furnish medically necessary patient care services, including services not related to the diagnosis and treatment of COVID-19 in response to the COVID-19 outbreak in the United States;
- Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
- Expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
- Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak in the United States; or
- Addressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community.
If one of the above purposes is not present, an arrangement cannot rely on the Blanket Waivers for compliance with the Stark Law. The arrangement might still be perfectly legal, but the waivers will not be available to permit the provider to short-circuit the usual contract compliance process for Stark Law compensation and other financial relationships.
