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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
with another enforcement tool to investigate whether these other entities have experienced the same error or issue without having to wait to receive a complaint or other information indicating a PHS Act violation to take action.
HHS also proposes a conforming amendment to the title for this section to also capture a reference to examinations and to remove the reference to a potential violation. This would align with the proposed amendments to 45 CFR 150.303, as outlined in this section of the preamble, to allow CMS to randomly select nonFederal governmental plans and issuers for investigation and market conduct examination to ensure compliance with applicable PHS Act requirements when CMS is responsible for enforcement, as well as the other amendments to 45 CFR
150.303 to specify that CMS may also undertake an examination based on information the agency receives that an issuer or non-Federal governmental plan may be failing to meet a PHS Act requirement.
HHS seeks comment on these proposed changes.
9. Notice to Responsible Entities 45
CFR 150.307
HHS proposes to revise several provisions in 45 CFR 150.307 regarding the notice that is sent to responsible entities when there is a potential violation, to reflect and clarify the current CMS enforcement procedures.
The proposed revisions are further intended to provide responsible entities additional information and clarity regarding CMSs authority and process for conducting investigations.32
Specifically, HHS proposes to replace the word investigation with information in the introductory text to align this section with the regulatory text in 45 CFR 150.303, which generally addresses information that may warrant an investigation or an examination. HHS
is also proposing to revise the introductory text to clarify that the notice would also be sent to initiate investigations of randomly selected nonFederal governmental plans and issuers under new proposed 45 CFR 150.303c.
The proposed revision to the introductory text also provides that CMS would also send this notice to the responsible entity or entities in situations where information received under 45 CFR 150.303a indicates a potential violation. HHS is also 32 HHS is not proposing to incorporate a reference to market conduct examinations in 45 CFR 150.307
due to the separate regulation, 45 CFR 150.313, that addresses and details CMSs authority and processes for conducting such examinations.

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proposing to remove the provision in 45
CFR 150.307a, which currently states that the notice describes the substance of the complaint or other information received, and to replace it with a new provision specifying that the notice describes the information received under 45 CFR 150.303 that gives rise to the investigation or notifies the responsible entity that it was selected by CMS for a random investigation under 45 CFR 150.303c. HHS is proposing this change to clarify that CMS does not provide personally identifiable information PII or PHI via a complaint without the complainants express consent. HHS also would not disclose confidential or other sensitive information protected from disclosure that may be included in the complaint.
However, the notice would include other information sufficient to explain the potential violations and provide the responsible entity an adequate opportunity to respond to the allegations, or to notify the responsible entity of its selection for, and the PHS
Act provisions that are the focus of, a random investigation under new proposed 45 CFR 150.303c.
Consistent with current text at 45 CFR
150.307b, CMS generally contacts the responsible entity once it reviews the information received under 45 CFR
150.303 and provides the responsible entity 30 days to respond with additional information, including documentation of compliance as described in 45 CFR 150.311. CMS also directs the responsible entity to submit any data or documentation that CMS
identifies as relevant and may use to assess whether the responsible entity is violating applicable PHS Act provisions.
However, there are circumstances in which CMS has determined it is not appropriate to provide the responsible entity 30 days to respond. Such circumstances include complaints involving urgent medical issues, allegations of fraud or abuse, and when CMS must complete the investigation within a specified time frame under the statute. Accordingly, CMS proposes to revise 45 CFR 150.307b to clarify that the notice provided under this section would direct the responsible entity to provide any documentation that CMS
identifies as relevant to the investigation, in addition to other documentation, such as documentation of compliance as described in 45 CFR
150.311, that in the responsible entitys view would aid CMS in evaluating the allegations and the entitys compliance with the PHS Act requirements identified in the notice. HHS further proposes to revise 45 CFR 150.307b
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such that CMS would provide the date by which the responsible entity must respond to the notice; the goal is to ensure the efficient administration of investigations. CMS anticipates generally providing 14 days for response. In circumstances that warrant a more rapid response, CMS anticipates providing at least 24 hours for response.
In circumstances that warrant additional time, such when CMS requests large amounts of data, CMS anticipates providing more than 14 days for response. HHS is not proposing any amendments to 45 CFR 150.307c and therefore would retain the requirement that the notice also inform the responsible entity that a civil money penalty may be assessed. Lastly, under the new proposed 45 CFR 150.307d, the notice would also inform responsible entities that CMS may require the responsible entity to take certain corrective actions as necessary to bring it into compliance with the applicable PHS Act requirements. HHS
believes it is necessary and appropriate to highlight, as part of this notice, that corrective actions may be required because, similar to the potential for a civil money penalty to be assessed, this is another potential outcome of an investigation.
HHS seeks comment on these proposed changes.
10. Request for Extension 45 CFR
150.309
HHS is proposing conforming amendments to revise 45 CFR 150.309
by removing the references to 30 days and clarifying that a responsible entity may request an extension when it cannot prepare a response or provide the requested information to CMS by the deadline provided in the notice under 45 CFR 150.307, and that failure to respond by the initial deadline provided in the notice or an extended deadline granted by CMS may result in CMSs imposition of a civil money penalty based upon the complaint or other information alleging or indicating a violation of PHS Act requirements. To align with proposed amendments to 45
CFR 150.313, HHS proposes to codify examples of what CMS would consider good cause, which include but are not limited to situations when a responsible entity indicates it has limited staffing resources to prepare a response, or when a responsible entity requests clarification from CMS regarding its request for information.
11. Responses to Allegations of Noncompliance 45 CFR 150.311
HHS proposes a conforming revision at 45 CFR 150.311e to add a reference
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