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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 understand commenters' concerns regarding providing consumers direct access to QHP quality data on the Exchange website where they are choosing a plan and these comments will help inform consumer testing and final guidance regarding display of quality rating information. We agree that health plan quality-related information should be provided to consumers in an easily understandable format and manner to support the comparison of plan options. We intend to provide details regarding display requirements in future technical guidance and will work with State Exchanges that do not have the technical capacity to display data directly on their websites during the initial implementation phase-in period.

Comment: Several commenters supported flexibility for States to display additional quality data and recommended that such data be collected and displayed consistently with the Federal measures. Other commenters expressed concern regarding States posting additional data because of the potential for conflicting measures to confuse consumers. They also expressed concern about consumer comprehension of displayed QRS data and allowing for approaches to meet diverse needs including regional, cultural, language, and demographic differences. One commenter suggested criteria for establishing governing principles for States choosing to display additional quality information, such as requiring States to only use NQF-endorsed measures or

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California that have implemented their own QHP quality ratings be used to inform quality reporting on the FFE.

Response: We maintain in the final rule that the Exchange must prominently display the Federal QRS rating information, as calculated by HHS, and results from the ESS for each QHP on its website. We believe that the Federal quality standards regarding QRS establishes a foundation for a uniform, national strategy for monitoring quality activities in the Exchanges with a core set of measures and standard approaches to health plan quality reporting. We also believe it is important that States have the opportunity to build on this uniform strategy with the display of additional measures that reflect local priorities. We anticipate issuing future guidance that will include standards for States who wish to exercise this flexibility. However, we clarify that HHS would not include any State-level data in calculations for the Federal QRS. HHS is currently conducting research and consumer testing regarding display of consumer-friendly information and terminology of health plan quality data and as we noted in the proposed rule, we intend to issue technical guidance including standardized display requirements in the near future.

We will work with States to prevent display of both Federal and State-level quality measure data in a manner that confuses consumers.

Comment: Many commenters supported a five-star display for QRS ratings that would ensure consistency across commercial and Medicare markets and increase enrollee familiarity with the rating systems. One commenter recommended that CMS report QHP summary ratings at half-star levels (for example, 3.5, 4.0, 4.5) to enable consumers to better distinguish between plans, similar to the Medicare Advantage and Part D ratings.

Response: As stated in the proposed rule, we intend to display star ratings that would be

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These comments regarding display requirements will inform the future technical guidance that we intend to issue in the near future. For more detailed information on the proposed QRS scoring specifications approach, including the proposed process of scoring QHPs and converting scores into ratings on a five-star scale, we refer commenters to the March 28, 2014, draft QRS Scoring Specifications document available at https://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/QRS-ScoringSpecification.pdf.

Comment: We also received a number of comments on quality measures for dental plans, sampling design and methodology for the ESS, quality rating and survey measure sets, QRS framework, process for selection of ESS vendors and quality reporting for QHPs offered outside the Exchange.

Response: We have not addressed such comments, and others that are not directly related to the proposed rule, because they are outside the scope of this rulemaking.

Summary of Regulatory Changes For the reasons described above, we are finalizing the provision as proposed.

b. Enrollee Satisfaction Survey System (§155.1405) In §155.1405, we proposed that the Exchange would prominently display results from the ESS on its website, in accordance with §155.205(b)(1)(iv), as calculated by HHS, and in a form and manner specified by HHS, starting in 2016. We also proposed that the display of the QRS information (which incorporates member experience data from the ESS) by an Exchange would meet the requirement of displaying the ESS information and satisfy the standard outlined in 45 CFR 155.205(b)(1)(iv). The standards for QHP issuers regarding the collection and submission

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Comment: The majority of commenters supported the proposed display requirement for Exchanges in §155.1405. Several commenters did not support the approach to provide State Exchanges the flexibility to make ESS beta test results publicly available in 2015 because these results are intended for process improvement and not official. Some commenters supported allowing all Exchanges to make the beta test information available in 2015 to identify best practices and provide access to information to support consumer choice. One commenter suggested requiring several criteria to be met prior to publicly presenting ESS 2015 beta test results.





Response: We agree that the purpose of the 2015 ESS beta test results is primarily for process improvement. However, we also believe that if reliable QHP-level assessment scores are available in the ESS beta test results, this information could provide important early feedback to Exchanges and consumers. We intend to provide State Exchanges and QHP issuers with the ESS beta test results with appropriate disclaimers including that beta test results are not finalized and are part of the survey development process. HHS would not require nor restrict a State Exchange from posting this information on its website but would encourage inclusion of appropriate disclaimers to inform the consumer about the limitations of the data (for example, the information reflects beta test results that are not finalized and are part of the survey development process). HHS does not plan on posting the 2015 ESS beta test results on the FFE website.

Comment: Many commenters urged HHS to have a uniform policy for ESS scoring calculations and for display and require that complete ESS results, by metal-tier level, be made publicly available on all Exchange websites for consumers, accessible to researchers and

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scores not used in the QRS because of concerns that the survey may not capture information regarding a QHP's quality that are applicable to areas that a health plan can directly influence.

Response: We intend to provide the HHS standardized, calculated full ESS results to State Exchanges and to display the results at the product-level on the FFE website and will provide further details regarding display of the data, to consumers, in future technical guidance.

As noted in the proposed rule, we believe that by displaying the QRS information (which incorporates member experience data from the ESS), an Exchange would meet the requirement, during the initial years of implementation, of displaying the ESS information and satisfy the standards outlined in 45 CFR 155.205(b)(1)(iv) and 45 CFR 155.1405. Therefore, State Exchanges will have the flexibility, in the initial years, to decide whether to display the full ESS results, as calculated by HHS. In the initial years, we believe that display of ESS results should align with the QRS and be presented at the product-level. We anticipate using the metal level data, as reported to HHS, to inform ESS implementation in future years and will re-examine the possibility of displaying the ESS results at a more granular level following an analysis of the 2015 beta test results. We believe that the ESS will provide valuable information regarding QHPs offered on Exchanges to consumers since it is largely based on the industry standard CAHPS® 5.0 Health Plan Survey that assesses commercial and Medicaid health plans. In addition, we are considering different ways to make QHP quality data, including ESS results, publicly available and accessible to consumers in a meaningful way.

Comment: A few commenters urged HHS to require State Exchanges to have a plan preview period for review of the ESS results. Some commenters requested that HHS provide

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One commenter urged HHS to offer a three month plan preview period for QRS and ESS results at a different time than review of quality ratings for Medicare Advantage plans.

Response: We appreciate the comments in support of HHS imposing a requirement on State Exchanges to have a plan preview period for review of the QRS and ESS results and may consider adopting this approach in future rulemaking. We note that some State Exchanges already have instituted a plan preview process for issuers to have the opportunity to review and correct data provided for display on Exchange websites. HHS also intends to host a plan preview period of QRS and ESS data for all QHP issuers participating in all Exchanges. We intend to balance alignment of data collection, submission, and plan preview timeframes for the QRS and ESS with existing processes, with the goal of minimal burden to issuers and State Exchanges.

Summary of Regulatory Changes We are finalizing this provision as proposed.

H. Part 156—Health Insurance Issuer Standards under the Affordable Care Act, Including Standards Related to Exchanges

1. Subpart B – Essential Health Benefits Package a. Prescription Drug Benefits (§156.122) Section 156.122(c) requires issuers that provide EHB to have procedures in place that allow an enrollee to request and gain access to clinically appropriate drugs not covered by the plan. In the proposed rule, we sought comment on amending the sought comment on amending the formulary exceptions standards under §156.122(c) to require that these processes can be expedited when necessary based on exigent circumstances, such as when an enrollee is suffering

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formulary drug. We considered, for example, whether issuers should be required to render decisions regarding formulary exceptions requests within 24 hours following the issuers’ receipt of the exceptions requests, as suggested in the “2014 Letter to Issuers on Federally-facilitated and State Partnership Exchanges”(2014 Letter to Issuers).31 As clarification, the prescription drug standard in §156.122(a)(1) was not intended to discourage issuers from offering clinically appropriate drugs to enrollees, including combination drugs. We sought comment on what specific standards would be appropriate for defining this expedited exceptions process, and on all other aspects of this proposal.

Comment: Some commenters supported the proposal to add additional parameters in regulation for the exceptions process and had recommendations regarding the parameters, including the timing of the reviews and the need for expedited reviews due to exigent circumstances. Many commenters supported a general 72-hour review timeframe and a 24-hour review timeframe due to exigency when the life or immediate health of the insured is at stake.

Several of these commenters recommended other standards in use today, such as the standards in the Medicare Part D program or Department of Labor standards for coverage determinations, and supported greater uniformity. Of those commenters who supported greater uniformity, the majority of commenters favored a process similar to that in Medicare Part D. Conversely, some commenters did not support any additional regulatory standards regarding the exceptions process. These commenters cited the timing of the rulemaking, potential for conflicting State law, desire for flexibility in prescription drug management practices, and desire for a better understanding of drug access issues.

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Response: We have heard from several stakeholders about enrollee difficulty in accessing, understanding, and using issuers’ exception processes under §156.122(c), since there is currently no requirement for uniformity across plans. Based on comments regarding the need for a uniform standard, we are finalizing standards for a health plan’s exceptions process that includes a process for exigent circumstances. Specifically, we are modifying §156.122(c) to include a policy that allows an enrollee (or enrollee’s designee) or the enrollee’s prescribing physician (or other prescriber) to request an expedited exceptions process based on exigent circumstances that are defined as when an enrollee is suffering from a health condition that may seriously jeopardize the enrollee's life, health, or ability to regain maximum function or when an enrollee is undergoing a current course of treatment using a non-formulary drug. We are also finalizing a requirement that issuers must provide a decision on an exception request based on exigent circumstances and notify the enrollee (and the prescribing physician or other prescriber as appropriate) of the determination no later than 24 hours after receiving the request. We believe that this policy will better ensure enrollee access to critical medications in a timely manner.

These provisions are effective for the 2015 plan year.

Comment: Commenters asked for clarification on operational considerations for implementing any specific exceptions process requirements, including a definition of “exigent,” when any timeframes begin, how long the enrollee has access to the medication if granted an exception, and if the enrollee is required to have access to the drug throughout the review processes.

Response: The timeframe for expedited (24-hour) review begins when the issuer or its designee receives an exception request based on exigent circumstances. An enrollee or the

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