On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced additional blanket waivers and temporary rule changes designed to assist the health care system in coping with patient surges due to the novel coronavirus disease (COVID-19). As part of these “sweeping” regulatory changes, CMS, among other things, is now allowing hospitals to provide services outside of their hospital buildings in an effort to increase hospital capacity through what CMS has dubbed “Hospitals Without Walls.” CMS also issued eighteen unprecedented blanket waivers of sanctions under section 1877(g) of the Social Security Act, better known as the physician self-referral law (Stark Law), which afford hospitals, and other health care providers, greater flexibility to effectively respond to the COVID outbreak in the United States. CMS has dubbed these flexibilities “Patients Over Paperwork.” This article provides a high-level summary of the Stark Law waivers available to hospitals. Be sure to check Health Care Law Today for an in-depth analysis of the Stark Law Waivers.
Under existing federal rules, hospitals must provide inpatient services within the walls of the hospital in order to bill Medicare for those services. The new temporary emergency rules, however, allow hospitals to transfer patients to other facilities—including ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories—while still receiving payment for hospital services from Medicare. Under the temporary rules, hospitals that transfer patients to outside facilities must take care “to continue to exercise sufficient control and responsibility over the use of hospital resources in treating patients regardless of whether that treatment occurs in the hospital or outside the hospital under arrangements.”
CMS also announced the following rule changes and waivers—retroactively effective March 1, 2020 through the duration of the COVID-19 public health emergency—which aim to allow greater flexibility in the provision of medical services outside of a hospital facility:
In addition to the above waivers, CMS issued unprecedented waivers of sanctions under the Stark Law for referrals and claims related to the COVID-19 outbreak (collectively, the Stark Law Waivers or Waivers). As a result, hospitals now have increased flexibilities to provide certain items and services in response to the COVID-19 without fear of sanctions for noncompliance with certain Stark Law regulations. The Stark Law Waivers are retroactive to March 1, 2020 and apply for the duration of the national emergency, subject to a limited extension. This section highlights some of the Waivers available to hospitals. For an in-depth analysis of the full scope and applicability of the Stark Law Waivers, we recommend reading our previous blog post on the temporary blanket waivers issued by CMS.
Under the Stark Law Waivers, which apply only to financial relationships and referrals that are solely related to “COVID-19 Purposes” (as defined by CMS), hospitals have greater flexibility to provide certain medical items and services during the COVID-19 public health emergency, such as:
In its announcement of the Stark Law Waivers, CMS provided nearly twenty examples of remuneration, referrals or conduct that would likely be covered by such waivers. Prior to entering into any arrangement, we recommend reviewing these examples and consulting a member of the Foley health care team to ensure such conduct is covered by one of the available Waivers.
For more information, please contact your Foley relationship partner or the Foley colleagues listed below. For additional web-based resources available to assist you in monitoring the spread of the coronavirus on a global basis, you may wish to visit the websites of the CDC and the World Health Organization.
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