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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
the COVID19 public health emergency.29 HHS seeks comment on whether the approach taken in this proposed rule presents challenges with respect to providers or facilities furnishing telehealth services.
HHS also proposes to make a technical correction to the title of subpart B to reflect that this subpart would apply to multiple PHS Act requirements rather than only one requirement. HHS proposes to revise the title of subpart B by changing requirement to requirements as the term should have been plural.
4. Circumstances Requiring CMS
Enforcement 45 CFR 150.203
HHS proposes to make technical corrections to the introductory language at 45 CFR 150.203 to reflect that this section would apply to multiple PHS
Act requirements rather than only one requirement. HHS is not proposing further amendments because HHS
would interpret and apply the current language outlining the circumstances requiring CMS enforcement, which generally refers to states, to situations involving providers and facilities in the same manner in which it applies to health insurance issuers in situations where the applicable state authority fails to substantially enforce applicable PHS Act requirements.
5. Sources of Information Triggering an Investigation of State Enforcement 45
CFR 150.205
Section 150.205d provides that if information regarding the status of state enforcement of PHS Act requirements comes from state governors and commissioners of insurance, such information may trigger a CMS
investigation of whether a state is failing to substantially enforce these requirements. Because governors, commissioners, and other applicable state insurance agency or entity leaders may not have oversight or enforcement authority over providers and facilities, information regarding state enforcement of PHS Act requirements with respect to providers and facilities may instead come from the state departments of health or other state agencies with that authority. Additionally, some states have officials distinct from the 29 See, for example, Center for Connected Health Policy. Cross-State Licensing. Available at: https
www.cchpca.org/topic/cross-state-licensingprofessional-requirements/ last accessed August 8, 2021; and Federation of State Medical Boards. U.S.
States and Territories Modifying Requirements for Telehealth in Response to COVID19. July 28, 2021. Available at: https www.fsmb.org/
siteassets/advocacy/pdf/states-waiving-licensurerequirements-for-telehealth-in-response-to-covid19.pdf.

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commissioners of insurance who are responsible for regulating health maintenance organizations HMOs.
Therefore, HHS proposes to amend 45
CFR 150.205d to add a reference to officials responsible for regulating HMOs, directors of public health or any other state department, agency, or board with applicable oversight authority over entities subject to PHS Act requirements to the list of state officials who may be the source of information triggering an investigation. Proposed amendments to 45 CFR 150.205e2 would correct a typographical error which incorrectly referenced in 45 CFR 148.120 instead of 45 CFR 148.210.
6. Notice to the State 45 CFR 150.211
Under these proposed rules, in determining whether a state is failing to substantially enforce PHS Act requirements that apply to providers and facilities, CMS would use the processes and standards already established with respect to state enforcement of applicable PHS Act requirements with respect to health insurance issuers in 45 CFR 150.205
through 150.221. CMS is of the view that these processes can largely also apply to state enforcement of the new PHS Act requirements applicable to providers and facilities without change.
However, the current regulatory language at 45 CFR 150.211 specifies that if there is a reasonable question regarding state enforcement, CMS will send a notice to the governor or chief executive officer of the state, the insurance commissioner or chief insurance regulatory official, or the official responsible for regulating HMOs. Those individuals may not be the appropriate recipients if there is a reasonable question regarding state enforcement of PHS Act requirements that apply to providers or facilities.
Therefore, HHS proposes to amend 45
CFR 150.211 to add paragraph d specifying that a notice of possible failure to substantially enforce PHS Act requirements in such circumstances would be sent to the relevant state official responsible for regulating providers and facilities and to make conforming changes to paragraph b to reflect that notices would be sent to the insurance commissioner or chief insurance regulatory official when there is a reasonable question regarding state enforcement of PHS Act requirements that apply to health insurance issuers.
Paragraph c would be retained, which provides that such notices would be sent to the state official responsible for regulating HMOs, if different from the official listed in paragraph b, when the alleged failure involves HMOs.

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7. Transition to State Enforcement 45
CFR 150.221
HHS proposes to make conforming amendments to 45 CFR 150.221a2 to provide that the discussions between CMS and state officials regarding transition to state enforcement would include instructions to providers and facilities, rather than instructions only to issuers. HHS also proposes to amend 45 CFR 150.221b to similarly add references to providers and facilities to make clear that CMS may also negotiate a process to ensure that, to the extent practicable, and as permitted by law, its records documenting compliance and other relevant areas of CMSs enforcement operations are made available for incorporation into the records of the applicable state authority responsible for oversight and enforcement of providers and facilities.
These proposed changes would capture a reference to the new PHS Act requirements enacted in the CAA
applicable to providers and facilities to ensure the regulation includes situations where a transition back to state enforcement of applicable Federal requirements over such entities is appropriate. HHS also proposes to replace the language about making CMS
enforcement records available to states by removing the language about incorporation into the records of the State regulatory authority that would assume enforcement to more generally refer to making such records available to the State regulatory authority.
8. Basis for Initiating an Investigation 45 CFR 150.303
Currently, 45 CFR 150.303 provides that if CMS receives information that an issuer or non-Federal governmental plan may be failing to meet a PHS Act requirement, then an investigation may be warranted. HHS proposes to revise 45
CFR 150.303a to specify that CMS may undertake either an investigation or a market conduct examination, rather than only an investigation, within its discretion based on this information.
This proposed revision would align 45
CFR 150.303a with the regulatory text in 45 CFR 150.313b, which provides that CMS may initiate a market conduct examination when, based on the information described in 45 CFR
150.303, it finds evidence that a specific entity may be in violation of the PHS
Act.
When determining whether to undertake an investigation or examination, CMS would consider a number of different factors, including the facts and circumstances surrounding the potential violation, the potential
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