HHS issues blanket waivers of the Stark Law

On March 30, 2020, certain blanket waivers of the physician self-referral law (the “Stark Law”) as relates to COVID-19 were issued by the Secretary of the Department of Health and Human Services (HHS) under Section 1135 of the Social Security Act. These blanket waivers are effective retroactive to March 1, 2020.

Unless an exception is satisfied, the Stark Law generally prohibits a physician from making referrals for certain designated health services that are payable by Medicare to an entity with which the physician (or an immediate family member of the physician) has a financial relationship. The Stark Law also prohibits the filing of claims for services that are furnished pursuant to a prohibited referral. Following the outbreak of the COVID-19 pandemic, various professional associations contacted HHS and CMS requesting waivers related to the Stark Law in order for healthcare providers to more quickly respond to increasing medical needs.

Guidance regarding the blanket waivers can be found here: https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf, and sets forth details regarding the HHS waivers of section 1877(g) of the Act. For each blanket waiver, all conditions of the waiver must be satisfied in order for a provider to rely on the waiver. Providers are not required to notify HHS or CMS in advance of using any of the blanket waivers; however, if a blanket waiver is used, the provider must make its records regarding the use of such waivers available upon request.

The waivers only apply to relationship and referrals that are exclusively related to the “COVID-19 Purposes” which are defined to mean: 

• “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.”

The guidance sets forth in detail the referrals and related claims for which HHS is waiving sanctions. Some of the Stark Law exceptions to which the waivers relate include but not are not limited to: personal services arrangements, rental of office space/equipment, payments by a physician, non-monetary compensation, medical staff incidental benefits, and physician ownership/investment in hospitals. The blanket waivers also allow for referrals by a physician to an entity with which the physician (or immediate family member) has a compensation arrangement that does not meet the writing or signature requirement(s) of an applicable exception but satisfies the other requirements of the applicable exception. This would include, for example, a situation in which a physician and hospital have agreed upon the physician providing call coverage services, and the physician begins providing such services prior to the arrangement being documented in a writing signed by the parties.

Additional waivers include referrals by a physician in a group practice for services provided by the group practice to a patient outside of the practice location (e.g., patient’s home, assisted living facility); referrals by a physician to an entity with which the physician’s immediate family member has a financial relationship so long as the referred patient resides in a rural area; and enrollment of a physician-owned ASC in Medicare as a hospital in order to provide medically necessary care to patients during the outbreak, so long as certain requirements are met.

The issued guidance also includes a list of scenarios that would fall within in the scope of the blanket waivers. These examples are helpful in determining the scope of the waivers, and what HHS intended the waivers to cover. Some illustrative situations that are included in the guidance are: 

• A hospital paying physicians above a previously-agreed upon/contracted rate for the physicians to provide professional services for COVID-19 patients in hazardous or challenging environments.
•  A hospital renting space from a physician practice below fair market value to accommodate increased patient volumes.
•  A hospital providing meals, onsite childcare and other items with a value greater than $36 per instance to medical staff physicians who are spending increased hours on-site due to the COVID-19 pandemic.
•  A physician-owned hospital temporary increasing its inpatient bed count to accommodate increased patient volumes.

CMS has also advised that individual waivers of sanctions under section 1877(g) of the Act may be requested. The process for requesting waivers of sanctions can be found here: https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Spotlight.

Questions regarding the blanket waivers as well as requests for sanction waivers can be directed to [email protected].

The blanket waivers issued by HHS are expansive and – along with the prior waivers issued by CMS – demonstrate an intent to remove barriers that may delay or prevent the provision of care to patients. While the guidance states the Stark Law blanket waivers only apply to relationships and referrals that are exclusively related to the “COVID-19 Purposes,” it appears that HHS and CMS are taking a somewhat broad view of what constitutes a COVID-19 Purpose. For example, the relationship does not have to directly relate to the provision of services to COVID-19 units or patients, but can also apply to an increased need for services for all patients due to the increased burden on the system as a result of the pandemic. That being said, prior to proceeding under one of the blanket waivers, providers should closely review the relationship and ensure that the arrangement does relate to a COVID-19 Purpose. Additionally, by not requiring prior notice to or authorization by CMS, providers will be able to use these blanket waivers immediately to provide some relief to a strained healthcare delivery system, and to ensure patients are getting the care they need. While prior notice is not required, providers should keep detailed records regarding use of the waivers, and must be prepared to provide such records if requested.

Waller will provide updates as more details and guidance become available. For additional information, please contact any member of Waller’s Healthcare Regulatory Compliance practice.