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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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Response: We acknowledge that in the initial years of QRS implementation, some QHP issuers may incur additional costs and burden for data validation since the QRS measure stewards may not be aligned with their chosen accrediting entity. However, we believe that the majority of QHP issuers offering coverage through the Exchanges in the initial years already have established relationships with HEDIS (Healthcare Effectiveness Data and Information Set) compliance auditors such that there should be minimal overall costs and burdens to the health care system. We refer commenters to the relevant estimated burden and costs in the Marketplace Quality Standards PRA package that is associated with the NPRM and available at http://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. We believe that aligning QRS measure validation requirements with the existing processes of the measure stewards provides consistency to ensure that valid and appropriate data are used to calculate quality rating information for public reporting. HHS anticipates refining the QRS over time as we gain experience about measures that are the most appropriate to the Exchange and approaches to quality measurement and health plan reporting evolve. As the QRS matures, we intend to consider changes to measures as well as ways to minimize the burden of QRS data collection, validation and submission. In addition, we are exploring ways to further streamline and align the accreditation standards with the quality reporting requirements to reduce duplicative and overlapping requirements.

Comment: Several commenters requested clarification of the data validation process and suggested alignment and coordination with the measure stewards so that there would not be multiple, independent audit requirements. They did not support having independent third party

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One commenter expressed concern regarding combining the HEDIS and CAHPS® validation processes causing issues with coordination with vendors and unnecessary burden.

Response: We clarify that we intend to direct QHP issuers to follow the data validation process of the QRS measure stewards. We do not intend to combine data validation processes for HEDIS and CAHPS® or ESS measure data; however, we clarify that, consistent with § 156.1125(b)(2), the survey sample data that the QHP issuer will need to provide to their contracted ESS vendor would need to be validated in a form and manner specified by HHS. We anticipate directing QHP issuers to use an independent third party to perform this validation. We intend to allow issuers to use the same third party validator used for QRS measures for validating the ESS survey sample, similar to the HEDIS CAHPS® process. We anticipate releasing technical guidance in 2014 to provide further details regarding data validation, finalized measures and measure specifications. We agree with commenters and believe that it is important to align and coordinate with existing data validation and submission requirements.

Comment: Several commenters requested that if HHS uses proprietary measures related to one accrediting entity, that HHS require that those data sets and quality measures be made freely available to all QHP issuers and to recognized accrediting entities to avoid imposing additional regulatory costs on those issuers seeking accreditation through the other entities. Some commenters requested consideration of allowing reporting of either HEDIS or quality measure data from the other two accrediting entities.

Response: We understand commenters' concerns regarding the need to make information on the QRS measure data sets available to all QHP issuers. We intend to provide details including QRS quality measure specifications (which will include details on the underlying

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organization may use the QRS measure specifications to report its performance without charge, and health plans may share their results. However, to designate the results as HEDIS data, the results must have been audited by an NCQA-Certified HEDIS Auditor. A successful audit ensures reliability and comparability of results for measures that are designated as HEDIS. We believe that requiring submission of a standard set of QRS quality measures, validated in a consistent manner as specified by the measure stewards, for all QHP issuers is critical to the goals of the QRS including the ability to provide reliable, comparable, and uniform quality data to consumers regardless of the Exchange. In addition, we considered non-HEDIS health plan quality measures during the measure selection process. However, based on the measure selection and measure set evaluation criteria, that were developed using the National Quality Forum (NQF) Measure Evaluation Criteria and the Measures Application Partnership (MAP) Measure-Selection Criteria (which factored in importance, performance gap, reliability and validity, feasibility and alignment) the majority of proposed measures to be included in the QRS for the initial years are HEDIS measures. As noted in the proposed rule, after considering public comments and review of the measures outlined in the November 19, 2013 Federal Register Notice with Comment38 on the QRS framework (QRS Notice), we intend to finalize the quality measures and anticipate publishing the finalized 2015 QRS measure set in the near future on a HHS website. We anticipate greater availability over time of more robust, data-driven clinical quality measures specified for health plans and which provide meaningful information regarding changes in a patient’s health outcome and intend to continue to seek feedback regarding evolution of the QRS. In addition, we are exploring ways to further streamline and align the

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accreditation standards with the quality reporting requirements to reduce duplication and minimize the burden of QRS data collection, validation and submission.

Comment: One commenter requested that the QHP rating information be accessible in an easy electronic format and that the rating methodology be released to issuers at the same time as the scores are released to allow issuers to estimate their own ratings.

Response: We agree and clarify that the QRS and ESS information will be easy to access in an electronic format. We intend to minimize burden by providing QRS and ESS information to issuers in an electronic format such as through Electronic File Transfers so that the vast majority of stakeholders would be able to easily download and view the data. Further we clarify that the 2015 beta test QRS scoring specifications and technical guidance which will include the ESS scoring methodology, would be released in 2014, in advance of the release of scores, to provide issuers ample time to estimate ratings if they so choose.

Comment: Many commenters suggested revisions to the QRS measure set. Some commenters urged CMS to incorporate all CAHPS® measures from the ESS into the QRS and not just a subset.

Response: As we noted earlier in the rule, we appreciate comments related to the QRS measure set, as well as the ESS measures, and they will inform future modifications and evolution of Exchange quality reporting; however, these comments are outside the scope of this rulemaking.

Comment: Several commenters supported the proposed approach for product-level reporting for the QRS in the initial years because more granular reporting would not be feasible due to potential sample size issues. One commenter urged CMS to clarify what it means by

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Many commenters recommended collection and reporting for the QRS at the metal tier level because consumer experience will be different for plans at different metal levels and this information is critical for enrollees' ability to make informed decisions about a particular plan.

Response: Although we acknowledge that consumer experience and characteristics may be different for QHPs at different metal levels, we believe that it is necessary, in the initial years of implementation, to provide a balanced approach regarding the level of data collection and public display for the QRS and ESS. We believe that there are fewer potential sample size issues with ESS reporting versus QRS reporting based on the populations eligible to participate in the ESS (that is, most measures include the entire enrollee population) and the limitations of eligible populations for the majority of QRS clinical quality measures (that is, most measures do not include the entire patient population, rather a subset of the population for which a clinical action is being measured). We also believe it is important to align the initial reporting of QRS information with the product-level requirements for QHP accreditation requirements. While we are maintaining the requirement that ESS data be submitted at the metal tier level, we anticipate aligning the public display of the ESS results with the QRS at the product-level for consistency across the quality measures and associated accreditation standards. We will re-examine the possibility of displaying the ESS results at a more granular level following an analysis of the 2015 beta test results. HHS is currently researching implementation of a process to collect data in a way that would allow us to assess the feasibility of level of coverage (for example, platinum, gold, silver, bronze, and catastrophic) reporting for the QRS as Exchange s mature and QHP enrollment grows. We maintain in the final rule that a QHP issuer must submit data at the level that will be specified by HHS but reiterate that the level of data submission may not align with

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greater flexibility regarding calculating scores based on different factors including adequate sample sizes and reliable measurement data.

Comment: Many commenters urged HHS to review and monitor the content of marketing materials as part of ongoing compliance reviews. Some commenters did not support the proposed marketing provision without accompanying HHS guidelines and a review process for marketing materials.

Response: We are finalizing the marketing provisions for the QRS and ESS, in §156.1120 and §156.1125 respectively, as proposed. We believe that it is important to set initial guidelines regarding referencing the QRS ratings and ESS results in issuer marketing materials for its respective QHPs and will be issuing future technical guidance that provides details regarding use and display of QRS and ESS results in issuer marketing materials. We note that we will consider effective and streamlined approaches of reviewing marketing materials as QHP issuer monitoring and oversight activities evolve in future years. As we stated in the Exchange final rule, States have significant experience with, and existing infrastructure to support monitoring and oversight of health plan marketing activities. We encourage a streamlined approach of incorporating review of a QHP issuer’s marketing materials referencing quality ratings and ESS results as part of an Exchange’s monitoring and oversight activities.

Comment: Some commenters supported the proposal to allow data collection based on combined populations if the plan offerings are the same inside and outside the Exchange to enhance sample size and reliability of data. Several commenters did not support the proposed approach because of potential differences that may be reflected in quality, confusion for consumers and skewed QRS results. One commenter noted that some issuers may only offer

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offered outside the Exchange. Commenters urged HHS to reconsider the proposed approach and consider alternatives such as comparison within a peer group.

Response: We agree with commenters regarding potential differences in enrollee characteristics of QHPs offered inside and outside the Exchange that may impact QRS and ESS results. We believe that it is important for the reliability and validity of the QRS to have adequate sample sizes and have the appropriate enrollee data to reflect meaningful information and differences regarding QHP quality to consumers selecting plans in the Exchange. During the 2015 beta testing period, we will not use data from QHPs outside the Exchange. We will assess the impact that this approach has on quality ratings in the beta test and will consider the feasibility of alternative approaches to ensure appropriate sample size and reliability of data. We anticipate issuing future guidance on whether plan offerings outside the Exchange that would be considered the same as one that is certified as a QHP and offered through the Exchange, as defined in § 153.500, can be included in the QRS and ESS.

Comment: Several commenters supported alignment of accreditation standards with QRS, ESS and QIS reporting. One commenter supported continued use of HEDIS and CAHPS® measures to ensure alignment with accrediting entities.

Response: We agree with commenters and note that to minimize burden and costs, it is important that alignment of QHP accreditation standards and quality reporting in the Exchanges be achieved as much as possible. We are considering updating standards for recognized accrediting entities and QHP accreditation in the near future and will solicit comment at that time regarding the potential of deeming QHP issuers and recognized accrediting entities in compliance with the accreditation requirements related to clinical quality measures and patient

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robust, evidence-based measures including HEDIS, CAHPS® and other measures that reflect the National Quality Strategy priorities.

Comment: Many commenters supported the proposed timeframes of QRS and ESS implementation including 2015 beta testing and public reporting during the 2016 open enrollment period for the 2017 coverage year. A few commenters urged HHS to finalize the QRS measures and measure specifications to provide to issuers by May 2014 at the latest so that issuers would have sufficient time to collect and submit data in time for beta testing. A few commenters expressed concern that consumers would have to wait until the 2016 open enrollment period to access quality rating information. And some commenters requested further delay for implementation because of the disproportionate financial and staff burden on new and smaller plans.



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