Federal Register - September 16, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
by CMS in any of the following circumstances:
26. Section 150.205 is amended by revising paragraphs d and e2 to read as follows:
150.205 Sources of information triggering an investigation of State enforcement.
d Information from the governors;
commissioners of insurance, or chief insurance regulatory officials, or officials responsible for regulating health maintenance organizations HMOs of the various States; and directors of public health or any other State department, agency, or board of the various States with applicable oversight authority regarding the status of their enforcement of PHS Act requirements.
e
2 Not pre-empted as provided in 146.143 relating to group market provisions and 148.210 relating to individual market requirements on the basis that they prevent the application of a PHS Act requirement.
27. Section 150.211 is amended by revising paragraph b and adding paragraph d to read as follows:
150.211
Notice to the State.
b If the alleged failure involves a health insurance issuer, the insurance commissioner or chief insurance regulatory official.
d If the alleged failure involves a provider or facility, the official responsible for regulating such provider or facility, if different from the officials listed in paragraphs b and c of this section.
28. Section 150.221 is amended by revising paragraphs a2 and b to read as follows:
150.221
Transition to State enforcement.
a
2 Instructions to issuers, providers, and facilities, as applicable.
b CMS may also negotiate a process to ensure that, to the extent practicable, as permitted by law, and as applicable, its records documenting issuer, provider, and facility compliance and other relevant areas of CMSs enforcement operations are made available to the State regulatory authority that will assume enforcement responsibility.
29. Section 150.303 is amended by revising the section heading and
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paragraphs a introductory text, a2, and c to read as follows:
150.303 Basis for initiating an investigation or examination.
a Information. Any information that indicates that any issuer may be failing to meet the PHS Act requirements or that any group health plan that is a nonFederal governmental plan may be failing to meet an applicable PHS Act requirement, may warrant an investigation or market conduct examination at CMSs discretion. An investigation or examination may include a review of any information CMS identifies as relevant to determine if a violation of the PHS Act has occurred. CMS may consider, but is not limited to considering, the following sources or types of information to determine if an investigation or market conduct examination is warranted:
2 Reports from providers and facilities, State insurance departments, the National Association of Insurance Commissioners, and other Federal and State agencies.
c Random and targeted investigations and market conduct examinations. CMS may conduct random or targeted investigations or market conduct examinations to ensure that health insurance issuers offering health insurance coverage in the individual or group markets, and nonFederal governmental plans, are in compliance with applicable PHS Act requirements.
30. Section 150.307 is amended by revising the introductory text and paragraphs a and b and adding paragraph d to read as follows:
150.307
Notice to responsible entities.
If information received under 150.303a indicates a potential violation, or if CMS selects an issuer or non-Federal governmental plan for investigation under 150.303c, CMS
provides written notice to the responsible entity or entities identified under 150.305. The notice does the following:
a Describes the information received under 150.303a that gave rise to the investigation, or notifies the responsible entity that it was selected by CMS for investigation under 150.303c and identifies the PHS Act requirements that are the focus of the investigation, as applicable.
b Provides the date by which the responsible entity or entities must respond and provide any documentation CMS identifies as relevant for purposes of an
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investigation, and by which the responsible entity or entities can provide additional information, including documentation of compliance as described in 150.311, that, in the responsible entitys view, will aid CMS
in evaluating the entitys compliance with the PHS Act requirements identified in the notice.
d States that CMS may require a plan of corrective action.
31. Section 150.309 is revised to read as follows:
150.309
Request for extension.
In circumstances in which an entity cannot prepare a response to CMS or provide the requested information by the deadline provided in the notice under 150.307, the entity may submit a written request for an extension from CMS detailing the reason for the extension request and showing good cause. Examples of what CMS would consider good cause include, but are not limited to, 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. If CMS grants the extension, the responsible entity must respond to the notice within the time frame specified in CMSs letter granting the extension of time. Failure to respond within the initial deadline provided in the notice, or within any extended time frame, 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.
32. Section 150.311 is amended by revising paragraph e to read as follows:
150.311 Responses to allegations of noncompliance.
e Documentation of the entitys issuance of conforming policies, certificates of insurance, plan documents, or amendments to policyholders or certificate holders before the issuance of the notice to the responsible entity or entities described in 150.307 or 150.313e.
33. Section 150.313 is amended by revising paragraphs b, c, and e and adding paragraphs f, g, h, and i to read as follows:
150.313
Market conduct examinations.
b General. If, based on the information described in 150.303a, CMS finds evidence that a responsible entity may be in violation of a PHS Act
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