James C. Sherlock

I provide here an update on the status of waivers of federal health care laws in response to the COVID-19 crisis. All of the source materials are official government websites.

On March 13, President Trump declared a public health emergency under the authority vested in him by the Constitution and the laws of the United States of America, including the National Emergencies Act.

Under that proclamation, the Secretary of HHS has exercised the authority under section 1135 of the SSA to temporarily waive or modify certain requirements of the Medicare, Medicaid, and State Children’s Health Insurance programs and of the Health Insurance Portability and Accountability Act Privacy Rule throughout the duration of the public health emergency declared in response to the COVID‑19 outbreak.

On March 13, Secretary Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver,” which applies nationwide, took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.

The declaration waived or modified the following requirements:

• Certain conditions of participation, certification requirements, program participation or similar requirements for individual health care providers or types of health care providers, including as applicable, a hospital or other provider of services, a physician or other health care practitioner or professional, a health care facility, or a supplier of health care items or services, and pre-approval requirements.
• Requirements that physicians or 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).
• Sanctions under section 1867 of the the Emergency Medical Treatment and Labor Act, or EMTALA 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.
• Sanctions under section 1877(g) (relating to limitations on physician referral) under such conditions and in such circumstances as the Centers for Medicare & Medicaid Services determines appropriate.
• Limitations on payments under section 1851(i) of the Act for health care items and services furnished to individuals enrolled in a Medicare Advantage plan by health care professionals or facilities not included in the plan’s network.

The Secretary also waived sanctions and penalties arising from noncompliance with the following provisions of the HIPAA privacy regulations:  (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; (b) the requirement to distribute a notice of privacy practices; and (c) the patient’s right to request privacy restrictions or confidential communications; but in each case, only with respect to hospitals in the designated geographic area that have hospital disaster protocols in operation during the time the waiver is in effect.

He additionally modified deadlines and timetables and for the performance of required activities, but 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 enrolled 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 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.

The waivers described above are not effective with respect to any action taken thereunder that discriminates among individuals on the basis of their source of payment or their ability to pay.

The Secretary has encouraged states and territories to assess their needs and request additional available flexibilities. This waiver process is used frequently. This is the 15th time since September 2018. Virginia was last granted waivers on September 12, 2018 as a result of Hurricane Florence.

So far in March, CMS has approved two states for waivers in addition to those granted in the blanket waivers.  Those states are Florida, on March 16 and Washington on March 19. All Section 1135 approval letters will be posted^[1] here as they are issued.

A search of the dedicated Medicaid wesite^[2], virginia.gov and Bing returned no information on a Virginia request for such waivers.  One is certainly in the process of being developed, submitted or approved. What is being requested and the status of that request are excellent topics for the Governor and the Secretary of Health and Human Resources to address to the public.

^[1]https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/federal-disaster-resources/index.html^[2]

ibid.