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«Department of Health and Human Services has submitted this rule to the Office of the Federal Register. The official version of the rule will be ...»

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We are not finalizing this section of the proposed rule at this time. We will consider finalizing the proposal in the future, and will address comments received on the proposal at that time. In the interim, stakeholders and others can rely on the published October 31, 2013 guidance.

Summary of Regulatory Changes We are not finalizing the provision proposed in §156.602(e) of the proposed rule at this time.

b. Requirements for Recognition as Minimum Essential Coverage for Types of Coverage Not Otherwise Designated Minimum Essential Coverage in the Statute or This Subpart (§156.604) We proposed a technical correction in §156.604 to clarify that health insurance issuers and plan administrators, in addition to sponsors of coverage and government agencies, may apply to HHS on behalf of a plan or coverage for recognition as minimum essential coverage.

Summary of Regulatory Changes We received no comments on this proposal and are finalizing the provision as proposed.

4. Subpart I—Enforcement Remedies in Federally-Facilitated Exchanges a. Available Remedies; Scope (§156.800) In §156.800(d), we proposed that HHS may consult and share information about QHP issuers with other Federal and State regulatory and enforcement entities to the extent that the

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consultation and information is necessary for HHS to determine whether an enforcement remedy under subpart I is appropriate.

Comment: We received multiple comments in support of our proposed regulation, including comments that requested we consider expanding this authority to include sharing information about QHP issuers to other State and Federal regulatory and enforcement entities that may need this information for their oversight purposes.

Response: Because we intend to share information about QHP issuers used for oversight and enforcement activities with other State and Federal regulatory and enforcement entities, and such entities have legitimate oversight and enforcement purposes for using such information, we agree that it is not necessary or appropriate for us to limit the ways in which such entities could use the information we would be sharing in a manner that would prohibit legitimate oversight and enforcement activities. We are finalizing the regulation accordingly.

Summary of Regulatory Changes We are finalizing §156.800(d) as proposed, with the modification of removing “to the extent that the consultation and information is necessary for HHS to determine whether an enforcement remedy under subpart I is appropriate” and replacing it with “to the extent that the consultation and information is necessary for purposes of State or Federal oversight activities.” b. Bases and Process for Imposing Civil Money Penalties in Federally-Facilitated Exchanges (§156.805) We did not receive comments on the proposed addition of §156.805(d)(3) and are finalizing the provision as proposed.

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We proposed adding §156.806 to explain that HHS will provide a written notice to the issuer, to include a description of the potential violation, a 30-day period for the QHP issuer to respond and to provide additional information to refute an alleged violation.

Comment: Some commenters requested that we permit extensions to the 30-day period for QHP issuers to respond and to provide additional information to refute an alleged violation.

One of these commenters also requested that we allow QHP issuers to have 60 days, rather than the proposed 30 days, to respond and provide additional information.

Response: We believe that 30 days provides QHP issuers with sufficient opportunity to respond and provide additional information to refute an alleged violation. Additionally, a QHP issuer that fails to act within the 30-day period will have an opportunity to request a hearing under Subpart J of 45 CFR Part 156. The QHP issuer will have the opportunity present its arguments and supporting documents at the time of the hearing.

Summary of Regulatory Changes We are finalizing the provisions proposed in §156.806 of the proposed rule without modification.

d. Bases and Process for Decertification of a QHP Offered by an Issuer Through a FederallyFacilitated Exchange (§156.810) In §156.810, we proposed several modifications to better align our bases for decertification, including bases for expedited decertifications, with regulatory provisions which have been finalized and to clarify certain regulatory text. We proposed rewording paragraph (a)(6) to clarify that the certification criteria means the standards under subpart C of this part. We also proposed in §156.810(d) that the FFE will be able to pursue an expedited decertification for

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violation of State or Federal law relating to internal claims and appeals and external review processes are bases for decertification under this paragraph. We proposed aligning the standards set forth under subparts K and M with the bases for decertification. We proposed adding a paragraph (12) to reflect that HHS may decertify a QHP if the QHP issuer substantially fails to meet the requirements related to the cases forwarded to QHP issuers under Subpart K, and adding a paragraph (13) to reflect that HHS may decertify a QHP if the QHP issuer substantially fails to meet the requirements in Subpart M.





Comment: We received general comments supporting our modifications to §156.810, including the inclusion of §156.810(a)(6) as a basis for expedited decertification and clarification that HHS may pursue decertifications for violations of applicable standards under Subpart C of 45 CFR Part 156. In addition, we received comments requesting that HHS not include violations of the provisions set forth under Subparts K and M as bases for decertification because the commenters indicated that not all of the provisions proposed under these Subparts have been finalized. One of the commenters requested that we extend the good faith policy adopted for 2014 until all provisions under these Subparts have been finalized.

Response: We recognize that there may be instances in which new regulations proposed under Subparts K or M have not yet been finalized. In such instances, HHS would not enforce these regulations until they have been finalized absent a separate authority to enforce these regulations. In the meantime, there are provisions set forth under Subparts K and M that have

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to include those provisions in §156.810 is appropriate.37 In the 2015 Letter to Issuers, we stated that we did not intend to extend the 2014 good faith compliance safe harbor.

Comment: One commenter requested that we expressly limit expedited decertifications to violations that put QHP enrollees' ability to access necessary medical items or services at risk or substantially compromise the operation of the Exchange.

Response: We believe there may a few rare situations in which expedited decertifications may be necessary, but which may not be resulting from violations that put QHP enrollees' ability to access necessary medical items or services at risk or substantially compromise the operation of the Exchange. For example, if a QHP issuer loses its ability offer a QHP based on an applicable State law or State action, HHS would need a mechanism to remove the QHP from the Exchange expeditiously. Recognizing that such possibility should be rare, but possible, we decline to limit expedited decertifications as requested, and finalize this section as proposed.

Summary of Regulatory Changes We are finalizing the provisions proposed in §156.810 of the proposed rule, correcting only the numbering of the added provisions in paragraph (a).

5. Subpart L—Quality Standards a. Establishment of Standards for HHS-Approved Enrollee Satisfaction Survey Vendors for Use by QHP Issuers in Exchanges (§156.1105) We proposed to amend §156.1105 to include monitoring and appeals processes for HHSapproved ESS vendors that would apply for plan years beginning 2015. In paragraph (d), we proposed that HHS will monitor HHS-approved ESS vendors to ensure ongoing compliance

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with the application and approval standards in paragraphs (a) and (b). Further, we proposed that if HHS determines that an approved vendor is non-compliant with the standards outlined in paragraph (b), they may be removed from the approved list described in paragraph (c) and/or the submitted survey results may be ineligible to be included for ESS results. Lastly, we proposed in paragraph (e) an appeals process for an ESS vendor that submits an application to HHS for approval, as described in paragraph (a), and is not approved. Specifically, we proposed that an ESS vendor may appeal HHS’s decision by notifying HHS in writing within 15 days of the notification of not being approved by HHS and submitting additional documentation demonstrating how the vendor meets the standards in paragraph (b). HHS would review the submitted documentation and make a final approval determination within 30 days from receipt of the additional documentation. An ESS vendor that becomes approved via the appeals process would be included in the approved list, described in paragraph (c).

Comment: Many commenters supported the provisions in §156.1105 relating to the monitoring and appeals processes for ESS vendors. Several commenters requested clarification how, if HHS determines survey results ineligible to be included in ESS results because of a noncompliant vendor, the affected QHP's global quality rating would be calculated and displayed.

Commenters urged HHS to minimize such circumstances when results would not be published and to have adequate disclaimers explaining the reason for ESS results that are unavailable. A few commenters urged HHS to add a hold harmless provision to mitigate the harm on compliant QHPs who should not be penalized due to vendor behavior and to have alternative processes in such circumstances such as permit use of prior year’s scores.

Response: We clarify that, if HHS determines an ESS vendor to be non-compliant with

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HHS would designate those ESS measures that are included in the QRS as not being available for the current reporting year. Similar to the business relationships that issuers have with survey vendors to administer other CAHPS®-like surveys for other products (for example, Medicare Advantage), we expect issuers to work closely with their contracted vendors to mitigate harm on compliant QHPs. In such circumstances, we will work with affected QHP issuers and ESS vendors and consider approaches so that having unavailable ESS data is minimized (that is, opportunity to re-administer the survey using a compliant vendor). These standards and processes have been informed by our experience with the Medicare CAHPS® survey vendor program, under which it has been a rare occurrence for a vendor to be found non-complaint and its survey results deemed ineligible. We maintain and finalize the standards in 156.1105 as proposed.

Summary of Regulatory Changes We are finalizing the provisions proposed in §156.1105 of the proposed rule without modification.

b. Quality Rating System (§156.1120) In §156.1120, we proposed standards for QHP issuers offering coverage on Exchanges to collect and report the necessary information to implement the QRS pursuant to section 1311(c)(3) of the Affordable Care Act. In paragraph (a), we proposed data submission requirements for a QHP issuer for the information necessary to calculate the quality ratings for coverage offered on Exchanges under the QRS, and in §156.1120(b), we proposed to direct a QHP issuer to annually submit data necessary to calculate the QHP’s quality ratings to HHS and the Exchange, on a timeline and in a standardized form and manner specified by HHS. In

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each QHP that has been offered in an Exchange for at least one year. In paragraph (a)(2), we proposed to direct a QHP issuer to submit data that has been validated in a form and manner specified by HHS.

In paragraph (a)(3), we proposed that a QHP issuer must include information in its data submission only for those QHP enrollees at the reporting level specified by HHS that is necessary to calculate the quality ratings.

We noted that multi-State plans, as defined in §155.1000(a), are subject to reporting QRS data for calculation of quality ratings by HHS, as described in paragraph (a). The U.S. Office of Personnel Management (OPM) will provide guidance on quality reporting to issuers with whom it holds multi-State plan contracts.

Lastly, in paragraph (c), we proposed that an issuer may reference its QHP’s quality rating information in its marketing materials, in a manner specified by HHS. Similarly, in the subsequent section 156.1125 regarding the ESS, we proposed a similar marketing standard in §156.1125(c) that a QHP issuer may reference the ESS results for its QHPs in its marketing materials, in a manner specified by HHS.

Comment: Many commenters expressed concern that the proposed data validation process provides an unfair advantage to NCQA, would lead to NCQA having a monopoly and eliminate competition among accrediting entities. Commenters also noted that the proposed approach could disadvantage those issuers seeking accreditation from the other two recognized accrediting entities. Some commenters stated that some issuers may incur additional fees for services already purchased by URAC which may increase consumer premiums and affect their

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