Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies for a period of 60 days (subject to extension by the Secretary for successive 60-day periods) or for the duration of the COVID-19 national emergency (if earlier), except the waiver of the HIPAA Privacy Rule described below applies for only 72 hours following a hospital’s implementation of its disaster protocol.

The 1135 Waiver:

• Waives EMTALA sanctions for the direction or relocation of an individual to another location to receive medical screening pursuant to an appropriate state emergency preparedness plan or for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared Federal public health emergency for the COVID-19 pandemic.

• Waives the following HIPAA Privacy Rule regulations for 72 hours following the implementation by a hospital of its disaster protocol:

  • the requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory (as set forth in 45 C.F.R. § 164.510);

  • the requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. § 164.520); and

  • the patient’s right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. § 164.522).

• Waives requirements that physicians and other health care professionals hold licenses in the State in which they provide services, if they have an equivalent license from another State (and are not affirmatively barred from practice in that State or any State a part of which is included in the emergency area).

• Waives or modifies certain conditions of participation, certification requirements, program participation or similar requirements for health care providers (including hospitals), as deemed necessary by the Centers for Medicare and Medicaid Services (CMS) to ensure the availability of health care items and services in connection with the COVID-19 pandemic.

• Waives Stark Law sanctions as determined appropriate by CMS.

• Waives payment limitations under the Medicare Advantage Program related to direct payments to providers for services provided to enrollees.

• Modifies certain deadlines and timetables for the performance of required federal health care program activities, as determined by CMS.

In connection with this 1135 Waiver issued by HHS, CMS also issued blanket waivers of certain laws, rules and regulations, including without limitation:

• Waiver of the skilled nursing facility (SNF) 3-day hospital inpatient stay requirement for those patients who need to be transferred to a SNF as a result of the effect of a disaster or emergency.

• Waives requirements that, for purposes of Medicare and Medicaid, out-of-state providers be licensed in the state where they are providing services when they are licensed in another state.

• Allows acute care hospitals with distinct psychiatric units or inpatient rehabilitation units, to move patients from those units to acute care beds/units, and also allows acute care hospitals to move acute care patients to “excluded distinct part units” (e.g., to the psychiatric or IRF units), if appropriate for the care to be provided.

• Waives enrollment screening requirements addressing application fees, criminal background checks, and site visits.

• Establishes a toll-free hotline for non-certified Part B suppliers, physicians and nonphysician practitioners to enroll and receive temporary Medicare billing privileges, and expediting any pending or new applications for providers.

• Allows all licensed providers to render services outside of their state of enrollment.

• Postpones revalidation actions.

The CMS guidance also provides information on how states can request an 1135 Waiver of additional specific provisions under Medicare, Medicaid and CHIP.

The COVID-19 pandemic represents a dynamic challenge to the health care system, and as a result new guidance is being provided continuously. We will endeavor to provide updates as necessary to support our clients and their communities.