The Centers for Medicare & Medicaid Services (CMS) on March 30, 2020, issued blanket waivers of sanctions under the physician self-referral law (Stark Law), retroactive to March 1, 2020, in response to the COVID-19 pandemic (Stark Blanket Waiver). The Stark Blanket Waiver is one of a sweeping set of waivers that CMS issued as part of its COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (Emergency Declaration).
Stark Law prohibits 1) physicians from referring certain designated healthcare services (DHS) covered by Medicare to entities that have a "financial relationship" (including direct/indirect compensation and ownership arrangements) with the referring physician (or an immediate family member), and 2) DHS entities from billing Medicare for DHS rendered as a result of such referrals. There are a number of Stark Law exceptions; however, because Stark Law is a strict liability statute, all of the exceptions' requirements — many of which are highly specific and technical — must be squarely met. As such, Stark Law may limit the ability of DHS entities to enter into certain financial arrangements with physicians, as well as the ability of physicians to freely refer patients for DHS, particularly during emergency situations such as the COVID-19 pandemic.
CMS issued provider-specific guidance on how the waivers, including the Stark Blanket Waiver, will impact physicians and other clinicians. To note, the Stark Blanket Waiver would protect only remuneration and referrals that are related to a broad set of "COVID-19 Purposes," such as securing the services of physicians who "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[.]"
CMS provided the following illustrative examples of how the Stark Blanket Waiver will enable flexibility for physicians and DHS entities:
These examples are merely illustrative, and each arrangement should be carefully reviewed to ensure that the financial relationships and/or referrals are consistent with the Stark Blanket Waiver. Additionally, each arrangement should be reviewed to ensure that it does not run afoul of other applicable state and federal laws (including, specifically, applicable fraud, waste and abuse laws). Finally, although DHS entities and physician do not need to notify CMS to utilize the Stark Blanket Waiver, they "must make records relating to the use of the blanket waivers available to" CMS upon request.
As mentioned, the Emergency Declaration contains other sweeping waivers on specific Medicare requirements that may provide flexibility for hospitals, long-term care facilities and skilled/non-skilled nursing facilities, home health agencies, hospices, end-stage renal dialysis (ESRD) facilities, durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers, and other healthcare providers that are impacted by the COVID-19 pandemic. They include:
These examples are a part of more than 60 specific waivers and other changes announced in the Emergency Declaration that appear to be intended to allow flexibility for healthcare providers that are impacted by the COVID-19 pandemic. Healthcare providers, including DHS entities and physicians, should continue to monitor the CMS Coronavirus Waivers & Flexibilities website and other resources for any further developments in responding to the COVID-19 pandemic.
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