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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules number of impacted consumers, an issuer or non-Federal governmental plans past history of substantiated complaints, the effect of the alleged violation on a consumer, the deterrent effect that knowledge of the investigation or examination may have on others who may consider committing similar violations, and other considerations that CMS deems appropriate.
HHS further proposes to revise 45
CFR 150.303a to add a new sentence to clarify that CMS may review any information it deems useful to determine if a violation of the PHS Act has occurred when undertaking an investigation or examination. HHS
proposes this change to more clearly describe current CMS procedures, which may include a review of applicable data and documentation, such as paid and denied claims, summary plan documents, summary of benefits and coverage, and notifications to enrollees, to assess whether the entity may be in violation of the PHS Act.
Additionally, HHS proposes a conforming amendment to paragraph a2 to capture a reference to reports from providers and facilitiesalong with reports from state insurance departments, the NAIC and other Federal and state agenciesas potential sources or types of information that could lead to an investigation or examination to ensure compliance with the applicable PHS Act requirements.
HHS proposes to remove and replace 45 CFR 150.303c, which currently states that a complaint may be directed to any CMS regional office. HHS
proposes this change because the CMS
regional offices no longer process complaints. Instead, CMS offers several methods for entities or individuals to submit complaints. These methods vary based on the type of coverage or plan in which an individual is enrolled and the substance of the complaint, and are described on CMSs public web pages.
For PHS Act complaints regarding nonFederal governmental plans, consumers can email PHIG@cms.hhs.gov. For complaints with respect to issuers, consumers in states that are directly enforcing the applicable PHS Act provision are referred to the state department of insurance; for states in which CMS is directly enforcing PHS
Act requirements, consumers can email MarketConduct@cms.hhs.gov. The list of current states in which CMS is directly enforcing one or more PHS Act provisions is available on the CMS
website at https www.cms.gov/CCIIO/
Programs-and-Initiatives/HealthInsurance-Market-Reforms/compliance.

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HHS proposes to remove the complaint provision that is currently in 45 CFR 150.303c, and replace it with a new provision specifying that CMS
may conduct random or targeted investigations and market conduct examinations of issuers and non-Federal governmental plans to ensure compliance with the PHS Act. HHS is proposing this regulation to codify another enforcement tool for CMS for situations where it is responsible for enforcement of the Federal market reform provisions. The proposal is also intended to codify in regulation the new statutory obligations established under the CAA for HHS to conduct certain specified audits and reviews. More specifically, section 2799A1a2Aii of the PHS Act directs HHS to conduct audits of a sample of claims data with respect to a year beginning with 2022
from not more than 25 group health plans and health insurance issuers offering group or individual health insurance coverage to verify compliance with the qualifying payment amount requirements described in section 2799A1 of the PHS Act, as enacted by the No Surprises Act. HHS expects states with primary enforcement authority with respect to section 2799A1 of the PHS Act will carry out enforcement activities to verify compliance with the qualifying payment amount requirements in section 2799A
1 of the PHS Act and 45 CFR 149.140
to the extent that the qualifying payment amount is used to determine the recognized amount for purposes of calculating cost sharing under section 2799A1. As noted in 45 CFR
149.140f, HHS intends to carry out these statutory provisions in states in which CMS is directly enforcing using the market conduct examination procedures described in 45 CFR
150.313, as proposed to be amended, when conducting random and targeted audits for compliance with the requirements for applying a qualifying payment amount.30 Additionally, section 203 of Title II of Division BB of the CAA amended section 2726a of the PHS Act to expressly require group health plans and health insurance issuers offering group or individual health insurance coverage 31 that provide both medical/surgical M/S
30 86

FR 36899 and 36979 July 13, 2021.
to section 2723b1 of the PHS Act, CMS enforces section 2726 of the PHS Act and other applicable provisions of Title XXVII of the PHS Act with respect to non-Federal governmental group health plans in all states and with respect to health insurance issuers selling products in the individual and fully insured group markets in states that elect not to enforce or fail to substantially enforce section 2726 of the PHS Act and other applicable provisions of Title XXVII of the PHS Act.
31 Pursuant
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benefits and mental health or substance use disorder MH/SUD benefits and that impose nonquantitative treatment limitations NQTLs on MH/SUD
benefits to perform, document, and make available upon request to HHS or the applicable state authority comparative analyses of the design and application of their NQTLs. PHS Act section 2726a8B, as added by section 203 of Title II of Division BB of the CAA further directs HHS to request, review, and report to Congress its findings regarding NQTL comparative analyses from group health plans and health insurance issuers each year. In order to satisfy the newly codified statutory obligations for HHS to conduct these specified audits and reviews under the CAA, CMS currently intends to focus random or targeted investigations under the new proposed 45 CFR 150.303c on ensuring compliance with i qualifying payment amount requirements described in section 2799A1 of the PHS Act, which was added by the No Surprises Act, and ii the NQTL comparative analysis requirements described in section 2726a8 of the PHS Act. CMS is committed to robust enforcement of these new requirements and ensuring compliance with other applicable PHS
Act provisions. HHS is of the view that this is a necessary and appropriate exercise of its enforcement and rulemaking authorities under sections 2723 and 2792 of the PHS Act, respectively. Further, HHS is of the view that having authority to conduct random or targeted investigations or examinations for all PHS Act provisions, including but not limited to qualifying payment amount requirements described in section 2799A1 of the PHS Act, which was added by the No Surprises Act and codified in regulations at 45 CFR
149.140, and the NQTL comparative analysis requirements described in section 2726a8 of the PHS Act, would create a more efficient and effective enforcement program in that CMS would be able to proactively ensure consumers are receiving the benefits to which they are entitled rather than having to wait to receive a complaint or other information indicating a potential PHS Act violation in situations where CMS is responsible for enforcement. For example, an investigation or examination by CMS of one responsible entity may identify a potential systematic error or issue that the agency suspects may impact similarly situated entities subject to CMSs enforcement authority. These proposed rules would provide CMS

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