HHS Issues National Emergency Health Care Waivers

Responding to the Coronavirus public health emergency, the Secretary of Health and Human Services (HHS) has waived certain requirements of the Medicare, Medicaid and Children’s Health Insurance Program (CHIP), including requirements relating to the Stark Self-Referral Law (“Stark”), the HIPAA privacy regulations and the Emergency Medical Treatment and Labor Act (EMTALA). This action was taken on March 13 pursuant to Section 1135(b) of the Social Security Act, which authorizes such waivers when the President declares a national emergency and the HHS Secretary declares a public health emergency pursuant to Section 319 of the Public Health Services Act.

• Secretary Alex Azar has waived these provisions “only to the extent necessary, as determined by the Centers for Medicare & Medicaid Services, to ensure that sufficient health care items and services are available to meet the needs of individuals in the Medicare, Medicaid and CHIP programs and to ensure that health care providers that furnish such items and services in good faith, but are unable to comply with one or more of these requirements as a result of the consequences of the [COVID-19] pandemic, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse.” While certain of the waivers are blanket in nature, others are to be granted on a case-by-case basis. The waivers pertinent to Stark, HIPAA and EMTALA are of the latter variety.
• Sanctions under Stark (42 U.S.C. § 1395nn) will be waived “under such conditions and in such circumstances as the Centers for Medicare & Medicaid Services determines appropriate.”
• Sanctions and penalties arising from noncompliance with the HIPAA privacy regulations will be waived where such noncompliance relates to “(a) 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); (b) the requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. § 164.520); and (c) the patient’s right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. § 164.522).” In each case, however, the waiver will only apply to “hospitals in the designated geographic area that have hospital disaster protocols in operation during the time the waiver is in effect.”
• Sanctions under EMTALA will be waived under circumstances involving “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 Coronavirus public health emergency.

A waiver of EMTALA or HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay.

The waivers are retroactive to March 1, nationwide, and typically end no later than the termination of the emergency period, or 60 days from the date the waiver or modification is first published unless extended by notice for additional periods of up to 60 days, up to the end of the emergency period. HIPAA waivers are limited to a 72-hour period beginning upon implementation of a hospital disaster protocol, and waiver of EMTALA requirements for emergencies that involve a pandemic disease last until the termination of the pandemic-related public health emergency. The 1135 waiver authority applies only to federal requirements and does not apply to state requirements for licensure or conditions of participation.

Those interested in obtaining waivers under any of these provisions that are not among those that have been designated blanket waivers should seek authorization from either the State Survey Agency (for example, the New York State Department of Health) or CMS Regional Office. Such request may be transmitted by email or by phone. Those requesting a waiver will be expected to provide “information on your facility and justification for requesting the waiver” after which “CMS will review and validate the 1135 waiver requests utilizing a cross-regional Waiver Validation Team” in order to “ensure they are justified and supportable.”