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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules respect to non-Federal governmental plans in all states.
When CMS is responsible for enforcement with respect to issuers and non-Federal governmental plans, enforcement tools CMS uses in accordance with 45 CFR 150.301
through 150.347, include policy form review, complaint-driven investigations, and market conduct examinations. CMS
also has authority to impose civil money penalties against health insurance issuers in a state in which CMS is directly enforcing the PHS Act, and against non-Federal governmental plan sponsors in all states that fail to comply with applicable PHS Act requirements.28
The CAA adds additional PHS Act requirements that apply to group health plans, including non-Federal governmental plans, health insurance issuers, providers, including providers of air ambulance services providers, and health care facilities facilities.
CMS would enforce these provisions to the extent they apply to non-Federal governmental plans in all states and to issuers in states where CMS directly enforces in the aforementioned manner.
With respect to enforcement of the requirements applicable to providers and facilities, the CAA largely mirrors the current issuer enforcement structure: Namely, states are the primary enforcers, with CMS only enforcing if a state fails to substantially enforce, and these proposed rules reflect this structure. However, the provisions of section 106a of the No Surprises Act that apply to providers of air ambulance services are enforced directly by CMS.
The CAA and these proposed rules would require CMS to follow the process set forth in section 1128A of the SSA to impose civil money penalties on providers or facilities for noncompliance with provisions of Part E of Title XXVII of the PHS Act and on providers of air ambulance services for non-compliance with the requirement to submit data under section 106a of the No Surprises Act. The applicable state authority involved in oversight and enforcement of providers and facilities would likely be different in most, if not all, states from the applicable state authority responsible for oversight and enforcement over health insurance issuers.
HHS proposes to make conforming amendments to existing regulations in subparts A, B, and D and to add a new subpart E to 45 CFR part 150 to provide for CMS direct enforcement when a state is not substantially enforcing PHS
28 See section 2723b of the PHS Act. Also see 45 CFR 150.301 through 150.347.

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Act requirements pertaining to providers and facilities and when a provider of air ambulance services fails to submit data required under section 106e of the No Surprises Act. HHS also proposes to amend existing regulations to add references to 45 CFR part 149, which implements these PHS Act requirements and to which the enforcement regulations in 45 CFR part 150 would also apply. Additionally, HHS proposes revising subpart C of 45
CFR part 150 to align these provisions with industry standards and clarify the existing CMS enforcement procedures, and equip CMS with additional tools to fulfill its enforcement responsibilities under the PHS Act.
HHS proposes revising the title of 45
CFR part 150 to reflect the extension of CMSs enforcement authority to providers and facilities in states that are not substantially enforcing the requirements in Part E of Title XXVII of the PHS Act and to providers of air ambulance services for purposes of the data submission requirements under section 106e of the No Surprises Act.
1. Basis and Scope 45 CFR 150.101
HHS proposes to add to 45 CFR
150.101a, which captures the basis of 45 CFR part 150, references to section 2799B4 of the PHS Act, which subjects providers and facilities to the enforcement provisions of the PHS Act that HHS proposes to implement in 45
CFR part 150, and section 106e of the No Surprises Act, which subjects providers of air ambulance services to civil money penalties for failure to comply with data reporting requirements. HHS also proposes to make conforming edits to expand the scope of 45 CFR part 150 in 45 CFR
150.101b, including to specifically outline the enforcement framework that HHS proposes to implement under subpart E of 45 CFR part 150. This includes proposed amendments to 45
CFR 150.101b2 to add a reference to 45 CFR part 149 to expand the scope of the framework applicable to enforcement over health insurance issuers. In addition, HHS proposes to add a new paragraph b3 to capture the scope of the framework applicable to enforcement over providers and facilities.
2. Definitions 45 CFR 150.103
HHS proposes to amend 45 CFR
150.103 to revise the introductory text to add a reference to 45 CFR part 149
and to add definitions related to enforcement against providers and facilities. Specifically, HHS proposes to define the term facility for purposes of 45 CFR part 150 to mean a health care
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facility, an emergency department of a hospital, and an independent freestanding emergency department, as those terms are defined in 45 CFR
149.30, and any other facility subject to the requirements in Part E of Title XXVII of the PHS Act. HHS also proposes to define the term provider for purposes of 45 CFR part 150 to mean a physician or other health care provider, as that term is defined in 45
CFR 149.30, as well as a provider of air ambulance services, as that term is defined in 45 CFR 149.30. These combined definitions would make 45
CFR part 150 easier to read and understand, as the enforcement procedures outlined in 45 CFR part 150
apply to all the aforementioned parties separately defined in 45 CFR 149.30.
HHS also proposes to make conforming amendments to add references to 45
CFR part 149 to the definition of individual health insurance policy or individual policy and the definition of PHS Act requirements. HHS seeks comment on these proposals.
3. State Enforcement 45 CFR 150.201
Under 45 CFR 150.201, states have primary enforcement authority over health insurance issuers with respect to PHS Act requirements, unless the state notifies CMS that it has not enacted legislation to enforce or that it is not otherwise enforcing PHS Act requirements or the state fails to substantially enforce the PHS Act requirements that apply to issuers, in which case CMS would enforce those requirements. These proposed rules would make a conforming amendment at 45 CFR 150.201 to specify that states also have primary enforcement authority over providers and facilities that furnishes items or services to individuals in the state, unless the state notifies CMS that it has not enacted legislation to enforce or that it is not otherwise enforcing PHS Act requirements or the state fails to substantially enforce the PHS Act requirements that apply to providers and facilities, in which case CMS would enforce these requirements. Under this proposed rule, a state would be the primary enforcer of the PHS Act requirements against providers or facilities that furnish services via telehealth to individuals located in the state, even in circumstances where the provider or facility is located in a different state. While many states require licensure of out-of-state telehealth providers furnishing care to individuals within the state, HHS
understands that this is not always true, and that many states have relaxed licensure requirements in response to
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