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Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Proposed Rules
access to health insurance coverage, consumers access to health care, or human life.
As noted earlier in this section of the preamble, the existing flexibility made available in the November 2020 IFC 136
for the COVID19 PHE will continue to apply. The Departments also clarify that, similar to the November 2020 IFC, this rule does not propose to allow states to waive 31 CFR 33.112a2 and 45 CFR 155.1312a2, which requires states to conduct a separate process for meaningful consultation with federallyrecognized tribes. The Departments note that tribal consultation is subject to separate requirements in accordance with Executive Order 13175,137 which mandates the establishment of regular and meaningful consultation and collaboration with tribal officials in the development of federal policies that have tribal implications.
In addition, the Departments clarify that a state cannot use this flexibility to request to eliminate public notice and participation procedures. Instead, this is a targeted proposal intended to extend the existing COVID19 PHE flexibilities to future emergent situations to remove potential barriers and allow both the federal government and states flexibility to respond to emergent situations as they unfold. It is limited to permitting states to request to modify, in part, certain otherwise applicable public notice and participation requirements.
Examples of the public notice and participation procedures that currently apply that, under this proposal, a state may seek to have waived or modified during a future emergent situation include the requirement that states notify the public and hold hearings prior to submitting an application, that the state hold more than one public hearing in more than one location, and that the Departments provide for public notice and comment after an application is determined to be complete. States may also seek to modify the state and/
or federal comment periods to be less than 30 days and to host public hearings virtually rather than in-person.
In addition, the Departments are of the view that these flexibilities are necessary to allow states flexibility to respond to rapid changes in the event of a future emergent situation and note that these proposals align with existing flexibilities available for public health programs that do not apply to section 1332 waivers. For example, when the 136 See
85 FR 71142, https
www.federalregister.gov/documents/2020/11/06/
2020-24332/additional-policy-and-regulatoryrevisions-in-response-to-the-covid-19-public-healthemergency.
137 See 85 FR 71142, 71178.

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President declares a disaster or emergency under the Stafford Act or the National Emergencies Act and the Secretary of HHS declares a PHE under section 319 of the Public Health Service Act, section 1135 of the Act allows the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and CHIP requirements to ensure: 1
Sufficient health care items and services are available to meet the needs of individuals enrolled in these programs in the emergency areas and time periods; and 2 providers who give such services in good faith can be reimbursed and exempted from sanctions absent any determination of fraud and abuse. However, section 1135
of the Act does not apply to or otherwise provide the Departments with authority to waive or modify requirements regarding section 1332
waivers when similar events cause similar impacts in the private health insurance markets. The proposed modifications to the Departments section 1332 waiver regulations outlined in this rule are designed to generally align with the section 1135
flexibilities, but would be available in broader circumstances than emergencies or disasters declared under the Stafford Act or the National Emergencies Act and public health emergencies declared under section 319 of the Public Health Service Act. The Departments are proposing to apply this flexibility to include other emergencies at the state or local level to allow states to better address all of the various emergent situations that may impact their state health insurance markets and residents access to coverage and care.
Consistent with the existing framework for state modification requests related to the COVID19 PHE, for a state request to modify the state or federal public notice requirements to expedite a decision on a proposed section 1332 waiver request during an emergent situation to be approved, the state must meet the requirements outlined in 31 CFR 33.118b and 45
CFR 155.1318b. Under this proposal, the Secretaries could approve a states request to modify the federal and/or state public notice procedures, in part, in future emergent situations if the state meets all of the following requirements:
The state requests a modification in the form and manner specified by the Secretaries.
The state acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the request for the modification for the section 1332
waiver, and the waiver application request, as applicable.

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The state details in its request for a modification, as applicable, the justification for the requested modification from the state public notice procedures, and the alternative public notice procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the states request for a modification.
The state details in its request for a modification, as applicable, the justification for the request and the alternative public notice procedures it requests to be implemented at the federal level.
The Departments also propose that the state, as applicable, implements the alternative public notice procedures at the state level if the states modification request is approved and, if required, amends the section 1332 waiver application to specify that it is the states intent to comply with those alternative public notice procedures in the states modification request. These are the same requirements that apply under the existing framework for state modification requests related to the COVID19 PHE and are currently captured in 31 CFR 33.118b1 through 4 and f and 45 CFR 155.1318b1
through 4 and f.138
Any state submitting a proposed section 1332 waiver application during a future emergent situation could submit a separate request to the Secretaries to modify, in part, certain otherwise applicable state and/or federal public notice and public participation requirements or could include such a request in its section 1332 waiver application request.
Consistent with the framework for COVID19 PHE state modification requests, the Secretaries review and consideration of a modification request for future emergent situations would vary based on the states circumstances, its modification request, and the complexity and breadth of the states proposed section 1332 waiver request.
For example, during the COVID19
PHE, many states prohibited in-person public gatherings or established stay-athome orders due to the public health 138 To effectuate the extension of these flexibilities to future emergent situations, the Departments propose to amend 31 CFR 33.118b3
and 45 CFR 155.1318b3 to replace the current reference to public health emergency with the emergent situation. This criterion otherwise remains the same.

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