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[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Rules and Regulations]
[Pages 42658-42672]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17831]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 156

[CMS-9965-F]
RIN 0938-AR36

Patient Protection and Affordable Care Act; Data Collection To 
Support Standards Related to Essential Health Benefits; Recognition of 
Entities for the Accreditation of Qualified Health Plans

AGENCY: Department of Health and Human Services.

ACTION: Final rule.

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SUMMARY: This final rule establishes data collection standards 
necessary to implement aspects of section 1302 of the Patient 
Protection and Affordable Care Act (Affordable Care Act), which directs 
the Secretary of Health and Human Services to define essential health 
benefits. This final rule outlines the data on applicable plans to be 
collected from certain issuers to support the definition of essential 
health benefits. This final rule also establishes a process for the 
recognition of accrediting entities for purposes of certification of 
qualified health plans.

DATES: Effective Date: These regulations are effective on August 20, 
2012.

FOR FURTHER INFORMATION CONTACT:

Adam Block at (410) 786-1698, for matters related to essential health 
benefits data collection.
Deborah Greene at (301) 492-4293, for matters related to accreditation 
of qualified health plans.

SUPPLEMENTARY INFORMATION: 

Executive Summary

    Beginning in 2014, all non-grandfathered health plans in the 
individual and small group market, and other plans will cover the 
essential health benefits (EHB), as defined by the Secretary of Health 
and Human Services (the Secretary). The Affordable Care Act directs 
that the EHB reflect the scope of benefits covered by a typical 
employer plan and cover at least the following 10 general categories of 
items and services: Ambulatory patient services; emergency services; 
hospitalization; maternity and newborn care; mental health and 
substance use disorder services, including behavioral health treatment; 
prescription drugs; rehabilitative and habilitative services and 
devices; laboratory services; preventive and wellness services and 
chronic disease management; and pediatric services, including oral and 
vision care. EHB will promote predictability for consumers who purchase 
coverage in these markets, facilitate comparison across health plans, 
and ensure that individual and small group subscribers have the same 
access to the same scope of benefits provided under a typical employer 
plan.
    This final rule includes data reporting standards for health plans 
that represent potential State-specific benchmark plans. Specifically, 
the final rule establishes that issuers of the largest three small 
group market products in each state report information on covered 
benefits.
    In addition, this rule establishes the first phase of a two-phased 
approach for recognizing accrediting entities to implement the 
standards established under the Affordable Care Act for qualified 
health plans (QHPs) to be accredited on the basis of local performance 
by an accrediting entity recognized by the Secretary on a timeline 
established by the Exchange and addresses some data sharing and 
performance requirements of the recognized accrediting entities. In 
phase one, the National Committee for Quality Assurance (NCQA) and URAC 
are recognized as accrediting entities on an interim basis. In phase 
two, a criteria-based review process will be adopted through future 
rulemaking.

I. Background

    Section 2707 of the Public Health Service Act, as added by section 
1201 of the Affordable Care Act, directs that, for plan years beginning 
on or after January 1, 2014, health insurance issuers offering non-
grandfathered plans in the individual or small group market ensure such 
coverage includes EHB as described in section 1302(a) of the Affordable 
Care Act. Section 1302 of the Affordable Care Act provides for the 
establishment of EHB, to be defined by the Secretary. The law also 
directs that EHB reflect the scope of benefits covered by a typical 
employer plan and cover at least the 10 general categories of items and 
services previously listed. Section 1302(b)(4) of the Affordable Care 
Act further establishes that the Secretary define EHB such that it:
     Sets an appropriate balance among the 10 general 
categories;
     Does not discriminate based on age, disability, or 
expected length of life;
     Takes into account the health care needs of diverse 
segments of the population; and
     Does not allow denials of essential benefits based on age, 
life expectancy, disability, or degree of medical dependency and 
quality of life.
    Section 1302(b)(4) of the Affordable Care Act further directs the 
Secretary to

[[Page 42659]]

consider the provision of emergency services and dental benefits when 
determining whether a particular health plan covers the EHB. Finally, 
sections 1302(b)(4)(G) and (H) of the Affordable Care Act direct the 
Secretary to periodically review the EHB, report the findings of the 
review to the Congress and to the public, and update the EHB as needed. 
A bulletin on HHS's intended benchmark approach to defining essential 
health benefits was made available for comment on December 16, 2011 
(EHB Bulletin).\1\
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    \1\ Available at: http://cciio.cms.gov/resources/files/Files2/12162011/essential_health_benefits_bulletin.pdf.
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    Section 1311(c)(1)(D)(i) of the Affordable Care Act provides that 
in order to be certified as a QHP and operate in an Exchange, a health 
plan must be accredited by a recognized accrediting entity on a uniform 
timeline established by the applicable Exchange. In a separate rule 
titled ``Patient Protection and Affordable Care Act; Establishment of 
Exchanges and Qualified Health Plans; Exchange Standards for 
Employers'' (Exchange Rule) published in the March 27, 2012 Federal 
Register (77 FR 18310), HHS finalized 45 CFR 156.275, specifying that a 
QHP issuer must be accredited by an entity recognized by HHS.

II. Provisions of the Proposed Regulation and Analysis and Responses to 
Public Comments

    The Data Collection to Support Standards Related to Essential 
Health Benefits; Recognition of Entities for the Accreditation of 
Qualified Health Plans proposed rule was published in the Federal 
Register on June 5, 2012 and the comment period closed on July 5, 2012 
(77 FR 33133). In total, we received 80 public comments on the proposed 
regulation.
    We received numerous comments on the EHB data collection portion of 
the proposed rule. Commenters represented a variety of stakeholders, 
including issuers, states, consumer groups, and others interested 
parties. We received a number of comments in support of the proposed 
data collection, including the required submission of data on treatment 
limitations, prescription drug coverage, and other descriptive 
information for small group plans.
    Commenters also recommended specific uses of the data we proposed 
to collect, for example that consumers and states have access to the 
data. Several commenters urged HHS to use the data for specific 
purposes, such as to ensure that certain services are covered, that 
plans are not discriminatory, that prescription drug coverage is 
comparable to a typical employer plan and that benefit limits do not 
reduce actuarial value (AV). We note that the purpose of the data 
collection in this final rule is to collect benefit and coverage 
information from potential benchmark plans. Accordingly, we addressed 
comments on potential uses of the data collected to the extent that 
they are related to the development of benchmark plans.
    We received a number of comments that fall outside of the scope of 
this regulation, which is specific to data collection from certain 
issuers to support the definition of essential health benefits. Because 
we intend to publish additional rules on EHB standards in the future, 
we do not specifically address these comments in this final rule.
    We also received numerous comments on the proposed rule regarding 
recognition of accrediting entities. Commenters represented a diverse 
set of stakeholders including but not limited to accrediting entities, 
healthcare provider organizations, consumer groups, health plans, 
industry experts, and members of the public. The vast majority of 
commenters supported the recognition of NCQA and URAC for the 
accreditation of QHPs in the interim phase one and agreed with the 
proposed provisions that we outlined in the NPRM. We received a number 
of comments on the timeline, financial and operational requirements for 
accreditation, the Federally Facilitated Exchange (FFE), the broader 
quality requirements in the Affordable Care Act, network adequacy and 
access standards for QHPs, coordination of quality requirements inside 
and outside Exchanges, and Exchange requirements. We have not addressed 
such comments and others that are outside the scope of this final rule. 
HHS will be releasing future rulemaking and guidance on these other 
topics. Several commenters requested clarifications regarding the 
future recognition process for accrediting entities, clinical quality 
measures criteria, accreditation standards related to network adequacy 
and access, documentation and data sharing requirements. In this final 
rule, we have responded to comments submitted in response to the 
recognition of entities for the accreditation of QHPs within the scope 
of the proposal and this final rule.

A. Collection of Essential Health Benefits Data (Sec.  156.120)

1. Definitions
    Under Sec.  156.120(a), we proposed definitions for terms that are 
used throughout the section. For the most part, the definitions 
presented in Sec.  156.120(a) were taken from existing regulations.
    We proposed to define ``health benefits'' as ``benefits for medical 
care, as defined at Sec.  144.103 of this chapter, that may be 
delivered through the purchase of insurance or otherwise.'' This 
proposed definition is adapted from the definition of health benefits 
finalized in the Early Retiree Reinsurance Program regulation at 45 CFR 
149.2.
    We proposed that for the purposes of this data collection ``health 
plan'' has the meaning given to the term ``portal plan'' in Sec.  
159.110 of this chapter, which is the discrete pairing of a package of 
benefits and a particular cost sharing option (not including premium 
rates or premium quotes). We note that a ``portal plan'' is collected 
as a unique combination of benefits, which may include optional 
benefits available for an additional premium (often referred to as 
``riders'') as well as benefits that are legally considered riders but 
are not optional for consumers (``mandatory riders''), if those 
benefits are part of the most commonly purchased set of benefits within 
the product by enrollment.
    We proposed that ``health insurance product'' has the meaning given 
to the term at Sec.  159.110 of this chapter, which is a package of 
benefits that an issuer offers that is reported to state regulators in 
an insurance filing. We proposed that ``small group market'' has the 
meaning given to the term in Sec.  155.20 of this chapter, which is the 
meaning in section 1304(a)(3) of the Affordable Care Act. We also 
proposed that ``State'' has the meaning given at Sec.  155.20. We noted 
that the Public Health Service Act definition of ``State'' that would 
apply to section 2707(a) is broader than the definition in section 1304 
of the Affordable Care Act.
    We proposed that ``treatment limitations'' have the meaning found 
in Sec.  146.136 of this chapter, which includes both quantitative and 
nonquantitative limits on benefits. Examples of quantitative limits 
include limits based on the frequency of treatment, days of coverage, 
or other similar limits on the scope and duration of treatment. 
Examples of nonquantitative limits include prior authorization and step 
therapy requirements. In response to comments

[[Page 42660]]

received on this proposal, we are changing the definition of 
``treatment limitations'' for the purpose of this final rule to include 
only quantitative limits.
    Additionally, throughout the proposed rule we referred to 
``issuers,'' which is defined in previous rulemaking at 45 CFR 156.20.
    Comment: We received several comments on the treatment of riders, 
or optional benefits available for an additional premium, under 
proposed Sec.  156.120. Commenters requested that HHS clarify the 
treatment of riders with respect to EHB; specifically some commenters 
recommended that HHS collect information on riders made available as 
part of a plan and stated that benefits offered through riders be 
considered part of EHB. Another commenter expressed concern that the 
definition of ``health insurance product'' included in the final rule 
could make it difficult for issuers and states to identify the largest 
plan within that product as a benchmark option.
    Response: In response to these comments, we now use the term portal 
plan defined in Sec.  159.110 for this identification in the final 
rule, which as described above may include riders. The issuers subject 
to this reporting requirement will submit the requested benefit data on 
the largest plan by enrollment within that product. By using the 
``portal plan'' definition for this data collection, the largest plan 
by enrollment will be comprised of the most commonly purchased unique 
set of benefits, which may include riders.
2. Required Information (Sec.  156.120(b))
    In Sec.  156.120(b), we proposed that certain issuers of applicable 
plans described in paragraph (c) of this section submit certain benefit 
and enrollment information to HHS. We stated that this information 
could be used by HHS and eventually states, Exchanges, and issuers to 
define, evaluate, and provide the EHB.
    First, at Sec.  156.120(b)(1), we proposed that the relevant 
issuers would submit administrative data necessary to identify their 
health plan. Since an issuer may offer multiple similar plans within a 
product, this information is critical to the identification of a 
single, uniquely identified benchmark plan.
    At Sec.  156.120(b)(2), we proposed that the relevant issuers would 
submit data and descriptive information on the plans identified in 
paragraph (d) in four areas. Additional detail describing the specific 
data elements that issuers would submit can be found in the revision of 
the currently approved Health Insurance Web Portal information 
collection request (ICR). The ICR is approved under OCN: 0938-1086, and 
is available to the public under a notice and comment period separate 
from the notice of proposed rulemaking. That notice and comment period 
is ongoing until August 5, 2012. Section 156.120(b)(2)(i) proposed that 
certain issuers submit information on covered health benefits in the 
applicable plans to be used to define certain benchmark plan options.
    In section 156.120(b)(2)(ii), we proposed to collect from issuers 
data on treatment limitations imposed on coverage, if applicable. For 
example, a quantitative scope and duration treatment limitation might 
limit a physical therapy benefit to 10 physical therapy visits per 
year.
    At Sec.  156.120(b)(2)(iii), we proposed to collect data on drug 
coverage. This would include a list of covered drugs and whether each 
drug is subject to prior authorization and/or step therapy. In response 
to comments received on this proposal, we no longer intend to collect 
data on prior authorization and/or step therapy for drug coverage.
    At Sec.  156.120(b)(2)(iv) we proposed to collect plan enrollment 
data, which is discussed in more detail in the ``Plans Impacted'' 
section below.
    Comment: Many commenters requested that HHS collect data in 
addition to the elements listed in the proposed rule, such as data on 
exclusions, medical necessity, habilitative services, cost-sharing 
(including premiums and co-pays), additional drug data, additional data 
on treatment limits, and a more extensive list of benefits.
    Response: We believe the data collection proposed balances a 
minimal data collection burden on issuers while being sufficient to 
support the establishment of a potential benchmark for each state. 
Therefore, we are not requiring issuers to report any additional data 
elements in this final rule.
    Comment: Some commenters expressed concern with the data collection 
of treatment limitations, particularly with regard to nonquantitative 
treatment limits, stating that the data elements are related to product 
design as opposed to benefit coverage and that the data are not 
necessary to establish EHB standards. Others expressed concern with the 
collection of prescription drug formularies.
    Response: We believe that the data collection described in the 
proposed rule reflects the appropriate balance between the need to 
collect data that are sufficiently specific to establish benchmark 
plans while minimizing the burden on issuers. However, we agree with 
the commenters that the data on nonquantitative limits are not 
necessary for benchmark plan purposes and are therefore amending our 
definition of treatment limitations and data collection to include only 
quantitative limits. We encourage commenters to continue to submit 
comments on the PRA package associated with this rule.
    Comment: Two commenters expressed concern that the proposed data 
collection asks for information that is proprietary and confidential.
    Response: The data HHS intends to collect are part of the contract 
agreement between the issuer and enrollees in the plan and available to 
every enrollee. Therefore, we believe issuers will not experience 
adverse commercial effects as a result of reporting the data.
    Comment: Some commenters recommended that HHS leverage data already 
collected by states and by HealthCare.gov for purposes of establishing 
default benchmark plans and urged HHS to synchronize the collection of 
data described in the proposed rule with data collection to support 
HealthCare.gov.
    Response: The benefit data are consistent with the data collected 
to support HealthCare.gov. We believe it is necessary to collect 
additional information related to treatment limitations and drug 
coverage to establish the definition of essential health benefits. We 
also note that the data we intend to collect to establish potential 
benchmark plans are more recent and at a plan level.
    Comment: Several commenters requested that HHS clarify specific 
data elements of the proposed data collection, for example that HHS 
describe the level of specificity and establish the format for data 
submission. One commenter recommended that HHS modify the language in 
its data collection on drugs from ``drug coverage'' to ``formulary'' 
and urged HHS to ensure a flexible prescription drug benefit.
    Response: We refer commenters to the relevant parts of the PRA 
package associated with the NPRM and available at http://www.cms.gov/Regulations-and Guidance/Legislation/PaperworkReductionActof1995/PRA-
Listing-Items/CMS1247405.html. The PRA package includes additional 
information on the data HHS intends to collect with regard to treatment 
limitations, as well as a list of the data elements.

[[Page 42661]]

3. Issuers Who Will Report (Sec.  156.120(c))
    Section 156.120(c) of the proposed regulation specified that these 
reporting requirements would apply only to certain issuers. 
Specifically, we proposed to collect data from the issuers in each 
state that offer the three largest health insurance products, by 
enrollment, in that state's small group market. We proposed that 
enrollment data submitted to www.HealthCare.gov would be the source of 
product enrollment and therefore, the products eligible to be 
benchmarks based on enrollment (described in part 159 of this title) on 
March 31, 2012, the date set forth in the December 16, 2011 EHB 
bulletin. State data may vary from www.HealthCare.gov data, and we 
requested comment on whether states should be permitted to use an 
alternative data source for determining the enrollment in the small 
group market. We also solicited comment on whether closed block 
products or association products should be included as options in the 
selection of the largest three products.
    Under the approach outlined in the EHB bulletin, states would be 
permitted to select their own benchmark plans from a set of options. 
State submissions of these selections are information collections under 
the PRA. As part of the PRA package, we requested comment on the draft 
instructions for states to submit benefits for their selected benchmark 
plan.
    Comment: Several commenters made recommendations with respect to 
which plans should be available as benchmark plan options. Some 
commenters recommended that HHS exclude association plans and plans 
closed to new enrollment as benchmark plan options. In contrast, a few 
commenters stated that plans closed to new enrollment should be 
available as benchmark plan options.
    Response: As described in the EHB Bulletin, HHS intends to propose 
that EHB be defined in reference to one of four benchmark plan options. 
With respect to potential default benchmark plans, we refer commenters 
to the guidance published on July 2, 2012, titled ``Essential Health 
Benefits: List of the Largest Three Small Group Products by State,'' 
\2\ which provides a state-by-state list of small group market products 
available for selection as benchmark plans.
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    \2\ Available at: http://cciio.cms.gov/resources/files/largest-smgroup-products-7-2-2012.pdf.PDF.
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    Comment: Several commenters expressed concern that HHS is only 
collecting data on the small group market benchmark options.
    Response: We note that this regulation is narrow in scope and 
collects data in order to establish potential default benchmark plans 
in each state. As stated in the EHB Bulletin, the default benchmark 
plan in each state is the largest small group market plan within the 
largest small group market product by enrollment, supplemented to 
reflect coverage in the 10 statutory benefit categories.
    Comment: Several commenters recommended that HHS consider 
additional data to establish EHB, such as national claims data or data 
from Medicaid.
    Response: Our proposed data collection from issuers is consistent 
with the benchmark approach described in the EHB bulletin, which uses a 
typical employer plan as a reference to define EHB.
4. Plans Affected (Sec.  156.120(d))
    In Sec.  156.120(d), we proposed that issuers of the largest three 
products in each state provide information based on the plan with the 
highest enrollment within the product. For purposes of identifying the 
benchmark plan, we proposed to identify the plan following the 
definition of ``portal plan'' in Sec.  159.110 of this chapter.
    We stated in the proposed rule that issuers may use their own data 
to determine which plan within each product has the highest enrollment, 
although we expect that for many products, the benefits will be the 
same across plans within the product. We also specified that enrollment 
data should reflect a plan's entire service area and to the extent 
possible should align with the timing of the www.HealthCare.gov data 
collection (reflecting enrollment as of March 31, 2012). We requested 
comment on the necessity of plan-level specificity.
    Comment: Several commenters offered feedback on the enrollment data 
used to identify the plans eligible for benchmark consideration. 
Several comments supported the use of the HealthCare.gov for 
determining enrollment. Commenters also urged HHS to allow states to 
use their own enrollment data and recommended that if state enrollment 
data conflict with HealthCare.gov data, the state data should be 
considered. In contrast, one commenter recommended that if state 
enrollment data are permitted, states should be required to demonstrate 
that the state data are more accurate.
    Response: The guidance published on July 2, 2012, titled 
``Essential Health Benefits: List of the Largest Three Small Group 
Products by State,'' \3\ clarifies the small group market products that 
are available for benchmark plan consideration in each state. In 
developing this list, HHS worked with states to reconcile enrollment 
data from HealthCare.gov with state data when necessary.
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    \3\ Available at: http://cciio.cms.gov/resources/files/largest-smgroup-products-7-2-2012.pdf.PDF.
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5. Reporting Requirements (Sec.  156.120(e))
    Finally, Sec.  156.120(e) proposed that issuers described in 
subparagraph (c) submit the information described in subparagraph (b) 
to HHS in a form and manner to be determined by HHS. We stated that we 
intend to make information on final state selections of benchmarks 
publicly available as soon as possible so that issuers can use it for 
benefit design and rate setting for 2014. We intend to publish the 
State-specific benchmarks for notice and comment and then finalize 
those benchmarks, as approved by the Secretary. We welcomed public 
comment on this approach.
    Comment: Several commenters requested additional guidance on the 
schedule for collecting data pursuant to this final rule.
    Response: We clarify in this final rule that the submission window 
for applicable issuers will open upon the effective date of this final 
regulation and remain open until September 4, 2012. Issuers will use 
the Health Insurance Oversight system to make these submissions.
    Comment: Several commenters urged HHS to make the data collected 
pursuant to this final rule, including data on benefits, treatment 
limits, and prescription drugs, publicly available to all stakeholders. 
Several commenters urged HHS to release these data as soon as possible. 
In addition, some commenters recommended that HHS establish a federal 
oversight role in the evaluation and approval of state-specific EHB 
packages.
    Response: HHS intends to publish State-specific benchmarks for 
notice and comment.

B. Voluntary Data Collection From Stand-Alone Dental Plans

    Section 1302(b) of the Affordable Care Act outlines the ten 
statutory benefit categories, including pediatric oral care, which must 
be covered by applicable plans. Section 1302(b)(4)(F) allows QHPs in an 
Exchange in a state to choose not to offer coverage for pediatric oral 
services provided that a stand-alone dental benefit plan that covers 
pediatric oral services is offered

[[Page 42662]]

through the same Exchange. In order for QHPs to know whether their plan 
design must include pediatric oral services, issuers need to know if 
stand-alone dental plans would be offered through their Exchange. To 
facilitate and streamline the communication of this information, we 
proposed to collect, on a voluntary basis, information from likely 
stand-alone dental issuers to find out whether various Exchanges are 
likely to have stand-alone plans as options.
    Comment: One commenter expressed concern that the data collection 
from stand-alone dental plans described in the proposed rule would be 
voluntary, and recommended that HHS require QHPs to offer pediatric 
dental benefits unless there is confirmation that a stand-alone dental 
plan will be offered.
    Response: We appreciate the commenter's concern and note that the 
goal of this data collection is to begin the process of identifying 
which issuers intend to offer stand-alone dental coverage in Exchanges. 
We believe that a requirement is not necessary and this voluntary 
collection was only proposed to facilitate the most efficient exchange 
of information between issuers.

C. Accreditation of QHP Issuers (Sec.  156.275)

1. Recognition of Accrediting Entity by HHS (Sec.  156.275(c)(1))
    Section 1311(c)(1)(D)(i) of the Affordable Care Act directs a 
health plan to ``be accredited with respect to local performance on 
clinical quality measures * * * by any entity recognized by the 
Secretary for the accreditation of health insurance issuers or plans 
(so long as any such entity has transparent and rigorous methodological 
and scoring criteria).'' HHS has determined that recognizing entities 
through an interim phase one process is necessary to meet the timeline 
for Exchange QHP certification activities and may include the 
accreditation requirement, depending on the uniform timeline 
established by an Exchange. In the proposed rule, we stated that after 
a survey of the market, to HHS's knowledge, only two entities that 
accredit health plans meet or plan to meet the statutory requirements 
this year. We proposed recognition of the National Committee for 
Quality Assurance (NCQA) and URAC on an interim basis for the purpose 
of accreditation of QHPs, subject to the conditions specified in 
paragraphs (c)(2), (c)(3), and (c)(4) of Sec.  156.275 of the proposed 
rule. As such, we proposed for this recognition to be effective once 
these conditions are met, at which time HHS would provide notification 
in the Federal Register. We requested comment on whether or not there 
are other accrediting entities that meet or would meet the statutory 
requirements this year.
    In addition, we proposed certain data sharing and performance 
standards for the recognized accrediting entities.
    We are making a technical correction in this final rule to clarify 
that both NCQA and URAC currently meet certain statutory requirements 
for accreditation. At the time the proposed rule was published, we did 
not include the fact that URAC had already released its Health Plan 
Accreditation Program Version 7 effective January 3, 2012, which 
includes reporting on a CAHPS survey and a set of clinical performance 
measures which are statutorily required to be considered as part of 
accreditation. Here, we clarify that both entities have already issued 
health plan accreditation standards that meet the conditions for 
recognition as detailed in paragraphs (c)(2)(ii), (c)(2)(iv) and (c)(3) 
of this rule.
    Comment: The vast majority of commenters expressed support for 
recognizing NCQA and URAC in phase one of the process to recognize 
accrediting entities. Commenters agreed with provisions to identify 
these two entities in this interim phase and encouraged HHS to finalize 
its recognition of NCQA and URAC as soon as possible.
    Response: We intend to provide notification in the Federal Register 
to make this recognition effective once the documentation requirements 
in (c)(4) are satisfied.
    Comment: One commenter stated that the Accreditation Association 
for Ambulatory Health Care, Inc. (AAAHC) should be recognized as an 
accrediting entity for the purposes of QHP certification in addition to 
the NCQA and URAC in the phase one recognition process. The commenter 
contends that AAAHC meets the requirements for the phase one recognized 
accrediting entities.
    Response: Upon review of the AAAHC's accreditation processes and 
standards, we believe that, currently, the AAAHC does not meet the 
statutory requirements necessary to be recognized for phase one. Our 
review indicates that the AAAHC does not currently score clinical 
quality and CAHPS data from health plans as part of accreditation in a 
standardized, comparable way across health plans using transparent and 
rigorous methodological and scoring criteria, as directed by section 
1311(c)(1)(D)(i) of the Affordable Care Act and 45 CFR156.275(c)(3), 
which is finalized in this rule. We believe that the methodology and 
scoring criteria for accreditation by recognized accrediting entities 
is a significant requirement that contributes to the strength and 
validity of the accreditation of QHPs. For these reasons, the statutory 
accreditation requirements for QHP issuers would not be met if AAAHC 
were recognized as an accrediting entity as part of the phase one 
recognition process. In the final rule, we are maintaining the proposed 
recognition of the NCQA and URAC in the interim phase one process of 
recognizing accrediting entities. We encourage entities that would like 
to be recognized as accrediting entities for the purposes of fulfilling 
the accreditation requirement for QHPs in the future to prepare and 
plan to apply for the phase two recognition process. We anticipate that 
the future recognition process will, at a minimum, require 
accreditation on local performance in the nine categories specified in 
45 CFR 156.275(a)(1) and clinical measures that span a broad range of 
conditions and domains.
    Comment: Two commenters requested that CMS establish an 
accreditation recognition process that enables New York and other 
states with rigorous issuer regulation, state licensing and quality 
monitoring requirements to be recognized as accrediting entities in 
phase one such that accreditation by entities such as NCQA and URAC is 
unnecessary if QHP issuers are licensed in such states. The commenters 
state that the licensing and oversight processes and standards in New 
York exceed those of NCQA and URAC.
    Response: The standards described by commenters are currently for 
state licensing and oversight requirements and not for accreditation of 
health plans. However, the statute specifically directs that QHPs be 
accredited and that the Secretary recognize accrediting entities. In 
the final rule, we are maintaining the proposed recognition of the NCQA 
and URAC in the interim phase one process of recognizing accrediting 
entities. However, we will consider the role of states in the phase two 
recognition process for accrediting entities.
    Comment: One commenter requested a specific public deadline for 
URAC to obtain full approval as a recognized accrediting entity so that 
QHPs may confidently choose their accreditation provider and begin 
their accreditation process immediately. The commenter suggests that if 
URAC does not meet full approval for being a recognized accrediting 
entity by a specified deadline, that the accreditation requirement be 
delayed until sufficient accrediting entity choices are available.

[[Page 42663]]

    Response: As noted, we have made a technical correction to the 
proposed rule to accurately state that URAC has already released its 
Health Plan Accreditation Program Version 7 which includes reporting on 
a CAHPS survey and a set of clinical performance measures. We intend to 
recognize both URAC and the NCQA as recognized accrediting entities for 
the interim phase one recognition process once both entities fulfill 
the documentation requirements finalized in Sec.  156.275(c)(4).
    Comment: One commenter requested clarification regarding which 
health plan accreditation program URAC is proposing because there are 
multiple materials referenced including Health Plan Accreditation 
Program 7.0, Health Insurance Exchange Version 7.1 and measures Version 
1.3
    Response: We clarify that URAC's publicly released Health Plan 
Accreditation Program Version 7 includes the standards that meet the 
statutory requirements to be recognized as an accrediting entity of 
QHPs and has been effective since January 3, 2012.
    Comment: Several commenters expressed concern that NCQA or URAC 
accreditation is not the best measure of the quality and effectiveness 
of Consumer Operated and Oriented Plans (CO-OP). The commenters are 
concerned that the accreditation processes of NCQA and URAC do not 
adequately address many of the key goals established for CO-OPs under 
the Affordable Care Act, including member control, consumer focus and 
benefit delivery innovation. Commenters proposed that the accrediting 
entities modify their accreditation processes to include a focus on the 
unique nature of CO-OPs.
    Response: Pursuant to 45 CFR 156.520(e)(2), CO-OPs must meet the 
same accreditation standards as other QHPs. We maintain, in this final 
rule, the recognition of accrediting entities for phase one. We will 
consider the unique goals established for all QHPs including CO-OP 
plans as we develop the requirements for the phase two recognition 
process.
2. Phased Recognition Process for Accrediting Entities (Sec.  
156.275(c)(1))
    We proposed that the recognition as an approved entity for 
accreditation of QHPs is effective until it is rescinded or this 
interim phase one process is replaced by the process that we intend to 
identify in future rulemaking. We proposed for the future phase two 
recognition process to include an application procedure, standards for 
recognition, criteria-based review of applications, public 
participation, and public notice of the recognition for entities 
seeking to become a recognized accrediting entity. We welcomed comments 
to inform this future rulemaking.
    Comment: A few commenters stated that recognized accrediting 
entities' accreditation processes should be equally rigorous, include 
comparable accreditation results and use consistent standards. One 
commenter urged CMS to establish standards as part of the phase two 
recognition process, then compare these standards with the phase two 
accrediting entities' standards to recognize them as accrediting 
entities for the purposes of QHP accreditation.
    Response: We agree that recognized accrediting entities should have 
rigorous, comparable processes and standards. We will consider the 
commenter's suggestion regarding use of a crosswalk to compare and 
ensure that each recognized accrediting entity meet the standards for 
the phase two recognition process. We will be establishing these 
standards in future rulemaking and will replace the phase one process 
codified in Sec.  156.275(c)(1).
    Comment: One commenter requested clarification and public 
transparency of a timeline for moving from phase one to phase two of 
recognizing accrediting entities. The commenter questioned whether the 
proposed phases will align with the phased approach also being planned 
for new quality reporting and display requirements. The commenter 
recommended that HHS consider the different timelines across Exchanges 
for requiring accreditation of QHP issuers.
    Response: We intend to establish through future rulemaking the 
recognition process of accrediting entities to align with the timeframe 
of other quality reporting requirements, including establishing a 
quality rating system. We recognize that it is important to coordinate 
these requirements for effective quality reporting and minimal burden 
on issuers. We will consider commenters' recommendations regarding the 
phase two recognition process as we develop future rulemaking.
    Comment: One commenter requested clarification that the recognized 
accrediting entities from phase one would need to go through the full 
application process proposed for phase two rather than be grandfathered 
into phase two recognition.
    Response: As we stated in the proposed rule, we maintain that the 
recognition of accrediting entities in phase one is effective until it 
is rescinded or this interim phase one process is replaced by the phase 
two process. We are clarifying that a phase one recognized accrediting 
entity must complete the application to be recognized for the phase two 
recognition process that we intend to identify in future rulemaking. We 
intend to propose in future rulemaking that the accreditation that is 
obtained from NCQA or URAC would be recognized for the purposes of QHP 
certification until this accreditation expired, regardless of whether 
NCQA or URAC continue to be recognized as accrediting entities in the 
future phase two recognition process.
    Comment: A few commenters requested HHS to clearly distinguish the 
broader quality requirements on Exchanges and health insurance issuers 
and stated that accreditation should not be considered a permanent 
substitute for such requirements.
    Response: We acknowledge that accreditation is not a substitute for 
the broader quality requirements included in the Affordable Care Act. 
We intend to issue rulemaking and welcome future public comment and 
stakeholder input regarding the quality requirements on Exchanges and 
health insurance issuers.
    Comment: One commenter recommended that HHS monitor fees that 
accrediting entities charge and to potentially place a limit on fees 
that may not be included in the medical loss ratio (MLR) calculation. 
The commenter recommended that the criteria for review in the phase two 
recognition process for accrediting entities include full transparency 
in pricing.
    Response: Accreditation user fees are part of the quality 
improvement component of MLR under 45 CFR 158.150(b)(2)(i)(5). We 
believe more entities will apply to meet the standards that we will be 
issuing for the phase two recognition process for accrediting entities, 
increasing competition.
3. Clinical Quality Measure Standards (Sec.  156.275(c)(2)(ii))
    We proposed that the first condition of recognition is based on 
section 1311(c)(1)(D)(i) of the Affordable Care Act, which requires 
accreditation on local performance in nine categories, which are 
codified in 45 CFR 156.275(a)(1):
     Clinical quality measures such as the Healthcare 
Effectiveness Data and Information Set (HEDIS);
     Patient experience ratings on a standardized Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) survey;
     Consumer access;
     Utilization management;
     Quality Assurance;
     Provider credentialing;

[[Page 42664]]

     Complaints and appeals;
     Network adequacy and access; and
     Patient information programs.
    We proposed in Sec.  156.275(c)(2)(ii) that the clinical quality 
measures meet certain criteria in order for the accreditation to meet 
the requirements outlined in section 1311(c)(1)(D) of the Affordable 
Care Act and 45 CFR 156.275(a)(1)(i). These criteria were chosen based 
on stakeholder input and to ensure that the clinical quality measures 
used in accreditation are applicable to the Exchange enrollee 
population.
    We proposed that the clinical quality measure set must:
     Span a breadth of conditions and domains, including, but 
not limited to, preventive care, mental health and substance abuse 
disorders, chronic care, and acute care;
     Include measures that are applicable to adults and 
separate measures that are applicable to children;
     Align with the priorities of the National Strategy for 
Quality Improvement in Health Care issued by the Secretary and 
submitted to Congress on March 12, 2011 (see http://www.healthcare.gov/law/resources/reports/quality03212011a.html) and the National Quality 
Strategy: 2012 Annual Progress Report released by HHS on April 30, 2012 
(see http://www.healthcare.gov/news/factsheets/2012/04/national-quality-strategy04302012a.html);
     Only include measures that are either developed or adopted 
by a voluntary consensus standards setting body (such as those 
described in the National Technology and Transfer Advancement Act of 
1995 (NTTAA) and Office of Management and Budget (OMB) Circular A-119 
(1998)) or, where appropriate endorsed measures are unavailable, are in 
common use for health plan quality measurement and meet health plan 
industry standards; and,
     Be evidence based.
    We solicited comments on these standards for clinical quality 
measures, including whether additional standards for such measures 
should be included, the standards for using endorsed and non-endorsed 
measures, and whether HHS should require entities seeking recognition 
as accrediting entities to review specific clinical measures as part of 
accreditation and if so, which ones.
    Comment: One commenter recommended additional criteria for clinical 
quality measures to include domains such as outcomes and process apart 
from access and patient satisfaction, be risk-adjusted when 
appropriate, be scientifically sound and be periodically updated for 
use within the accreditation standards. A few commenters recommended 
prioritizing measures that are being used concurrently by public and 
private sector purchasers and payers. Commenters also suggested that 
HHS require accrediting entities to review health plan processes 
including marketing practices, member privacy, language access services 
and health plan efforts to reduce health care disparities and to 
provide culturally competent services.
    Response: Much of the recommended criteria for clinical quality 
measures are already current components of accreditation standards and 
processes of the accrediting entities being recognized in the interim 
phase one. In this final rule, we are maintaining the standards that we 
proposed for clinical quality measure sets but will consider the 
additional suggested criteria in future rulemaking on phase two.
    Comment: Several commenters expressed concern that clinical quality 
measure standards used by current accrediting entities and the CAHPS 
survey process do not include people with disabilities. Several 
commenters recommended that phase two recognition process requirements 
for recognized accrediting entities should include standards for 
clinical quality measures that address the needs of people with 
disabilities and that specifically address persons in need of 
habilitative and rehabilitative services and devices. Commenters 
suggested that the accreditation process should address habilitative 
and rehabilitative related quality measures, the evaluation of quality 
of life beyond that represented by the typical quality indicators and 
network adequacy.
    Response: As part of future rulemaking on the phase two recognition 
process, we will consider these standards.
    Comment: One commenter requested clarification regarding which 
CAHPS survey will be used to measure patient experience or whether a 
future CAHPS survey will be developed. The commenter opposed the use of 
instruments such as the CAHPS Surgical Care Survey and the Clinician/
Group CAHPS as proposed measure tools and recommended inclusion of all 
types of providers such as advanced practice registered nurses and 
certified registered nurse anesthetists in any measurement tools 
developed to adequately capture the patient and caregiver experience.
    Response: We are finalizing the requirement that the recognized 
accrediting entities require accreditation on local performance in 
patient experience ratings on a standardized CAHPS survey. We are not 
specifying which CAHPS surveys that the recognized accrediting entities 
must use as part of accreditation but expect that the recognized 
accrediting entities will use health plan CAHPS surveys and will not 
use the surgical care and/or Clinician/Group CAHPS surveys.
    Comment: Several commenters expressed support that accreditation 
include, to the extent possible, measures that are already developed or 
endorsed by recognized consensus standards setting bodies. A few 
commenters stated that measures should be based on national standards 
such as National Quality Forum (NQF) endorsed measures. One commenter 
requested clarification regarding the language related to measures that 
are developed or adopted by a voluntary consensus standards setting 
body. This commenter recommended that CMS specify that measure sets 
used for QHP accreditation only include measures that are endorsed by 
the entity with a contract with the Secretary, which is currently only 
the National Quality Forum (NQF).
    Response: We agree that NQF plays a significant role in endorsing 
quality measures. However, we do not require clinical quality measures 
to either be endorsed by NQF or submitted for review to NQF since 
recognized accrediting entities may use a diverse measurement set. We 
maintain the criteria we proposed for the clinical quality measure set. 
We will consider the commenter's recommendations as we set the 
measurement standards as part of the future rulemaking on phase two.
    Comment: One commenter suggested that the clinical quality measure 
requirements for recognized accrediting entities include measures that 
reflect patients' and families' perspectives and measures that advance 
primary care services and medical homes.
    Response: We believe that the patient perspective is captured by 
the requirement that accreditation include patient experience ratings 
on a standardized CAHPS survey in 45 CFR 156.275(a)(1). We also 
maintain in this final rule that clinical quality measures be aligned 
with priorities of the National Strategy for Quality Improvement in 
Health Care (``the National Strategy''). The National Strategy includes 
as core principles, person-centeredness and family engagement, and 
strengthening primary care using models such as patient-centered 
medical homes.
    Comment: A few commenters recommended requiring independent 
auditing of results as an additional

[[Page 42665]]

criterion for clinical quality measures considered as part of 
accreditation to ensure the accuracy and comparability of results, to 
provide an important feedback loop for plans, and to instill support 
among all stakeholders.
    Response: While independent auditing of results could be an 
effective way to assure accuracy and comparability and provide useful 
verification information to issuers and stakeholders, we maintain in 
the final rule the criteria we proposed in Sec.  156.275(c)(2)(ii), 
which was based on diverse stakeholder input.
    Comment: One commenter suggested that the phase two recognition 
process should include clinical measures, such as those from Minnesota 
Community Measurement, which address health outcomes for patients 
rather than process measures concerning the kind of care or tests that 
patients receive. Another commenter suggested that HHS examine and 
consider adoption of the uSPEQ measurement tool, which incorporates 
both consumer and employee satisfaction as primary factors in assessing 
the success of a program and that has been used to evaluate programs 
from a consumer perspective.
    Response: Many of the quality measures currently used by the 
recognized accrediting entities address patients' health outcomes and 
patient experience. We will consider clinical health outcomes measures 
from organizations such as the Minnesota Community Measurement and 
measurement tools such as uSPEQ when we propose rules on phase two.
    Comment: One commenter recommended that recognized accrediting 
entities require qualified health plans seeking accreditation to submit 
data on HIV quality measures to ensure that the care supported by 
qualified health plans can be effectively monitored and evaluated. The 
commenter suggested that, at a minimum, plans should be required to 
submit data for HIV measures proposed for Stage II Meaningful Use and 
to select from measures that are being used by Medicare, Medicaid and 
the HIV/AIDS Bureau.
    Response: The recognized accrediting entities do not currently use 
an HIV-related quality measure in their accreditation scoring. However, 
there are such measures under development for accreditation standards. 
We maintain in the final rule that measures selected should be 
developed or adopted by a voluntary consensus standards setting body, 
appropriately endorsed whenever possible and span a breadth of 
conditions. We support the alignment of measures with existing public 
and private measurement initiatives and intend to consider other 
measures during rulemaking for phase two.
    Comment: One commenter endorsed HHS's recognition of URAC as an 
accrediting entity largely because it supports data collection 
requirements URAC has already implemented to help ensure QHP issuers 
seeking accreditation are currently complying with the Paul Wellstone-
Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 
(MHPAEA). The commenter encouraged HHS to require that as a condition 
of becoming a QHP accrediting entity, NCQA, as well as other possible 
future QHP accrediting entities, data collection of MHPAEA compliance 
as part of each QHP's local performance in the nine categories, 
including utilization management.
    Response: We will consider the commenter's suggestion to include 
data collection related to MHPAEA compliance when we develop standards 
for the phase two process for recognizing accrediting entities in 
future rulemaking.
4. Product Type Level of Accreditation (Sec.  156.275(c)(2)(iii))
    In Sec.  156.275(c)(2)(iii), we proposed that recognized 
accrediting entities provide separate accreditation determinations for 
each product type offered by a QHP issuer in each Exchange (for 
example, Exchange HMO, Exchange point of service (POS) plans, and 
Exchange preferred provider organization (PPO) plans), based on data 
submitted by the issuer that are representative of the population of 
each QHP in that Exchange product type. We believe that the product 
type is the appropriate level for accreditation as it would balance 
capturing the QHP experience and enabling the reporting of valid and 
reliable performance measures. An issuer may offer multiple QHPs under 
the same product type, in the same Exchange, if the product type for 
that Exchange is accredited, each of the corresponding QHPs would be 
considered to be accredited. We solicited comments on the proposed 
level of accreditation. We also solicited comments on circumstances 
under which an exception should be made to the accreditation 
determination being made at the Exchange product type level.
    Comment: A few commenters opposed requiring accreditation at the 
Exchange product type level due to their belief that product type level 
accreditation is not current market practice and potential challenges 
of inadequate sample size if accreditation moves to more granular 
levels. Several commenters expressed support for product type level 
accreditation to facilitate comparisons based on quality and 
transparency. One commenter recommended that states should have the 
responsibility to dictate the product level requiring accreditation 
because implementation of federally-defined product types would disrupt 
states' existing regulatory classifications and accreditation 
requirements for insurance products.
    Response: We maintain in the final rule that recognized accrediting 
entities provide separate accreditation determinations for each 
Exchange product type since QHP issuers must be accredited on the basis 
of local performance per Sec.  156.275(a)(1). We believe that 
accreditation at the overall QHP issuer level would not adequately meet 
the requirement that QHP issuers be accredited on the basis of local 
performance. We believe that accreditation at the plan or metal-level 
would also be unreasonable because of the likely inadequate sample size 
for reliable performance data reporting.
    Comment: One commenter stated that although NCQA generally 
accredits by product type, which combines product line (that is, 
Commercial, Medicare, Medicaid or Exchange) with product (that is, HMO, 
POS or PPO), there are some exceptions. For example, with NCQA 
approval, issuers can combine HMO and PPO or POS and PPO (or all three) 
products for HEDIS reporting purposes or they can combine the same 
product across contiguous states for statistically valid HEDIS and 
CAHPS results.
    Response: We understand that there may be some necessary exceptions 
to product type level accreditation for methodological reasons. We 
maintain that recognized accrediting entities provide separate 
accreditation determinations for each QHP product type offered in an 
Exchange (for example, Exchange HMO or Exchange PPO). However, we agree 
that in some instances, such as when sample sizes are inadequate to 
provide statistically valid results at the Exchange product type level, 
an exception to Exchange product level accreditation would then be 
reasonable. In the final rule, we are modifying the requirement that 
recognized accrediting entities provide accreditation at the Exchange 
product type level to permit an exception when this Exchange product 
type level accreditation is not methodologically sound. In such cases, 
the recognized accrediting entity must demonstrate that the Exchange 
product type level accreditation is not methodologically

[[Page 42666]]

sound as a condition of the Exchange granting an exception such as 
authorizing Exchange product type combinations across contiguous states 
(for example, Exchange HMO in New York and Exchange HMO in New Jersey.) 
We encourage Exchanges to collaborate and consult with state 
Departments of Insurance and other state regulatory and licensing 
bodies in granting the exception.
    Comment: One commenter requested clarification on whether NCQA and 
URAC will be responsible for accrediting dental plans. The commenter 
suggested that designated accrediting entities use specific clinical 
quality measures developed by the Dental Quality Alliance (DQA) to 
accredit dental plans.
    Response: We are not currently requiring that recognized 
accrediting entities accredit stand-alone dental plans. The Exchange 
final rule specifies that to the extent that accreditation standards 
specific to stand-alone dental plans do not exist,\4\ then such plans 
would not be required to meet the accreditation timeline required by 45 
CFR 155.1045.
---------------------------------------------------------------------------

    \4\ Exchange Final Rule published in 77 FR 18310 at 18412 (March 
27, 2012).
---------------------------------------------------------------------------

    Comment: A few commenters recommended allowing plans to meet 
Exchange-specific requirements as part of their current accreditation 
instead of undergoing a separate accreditation process solely for 
Exchanges. One commenter recommended that at a minimum, issuer-level 
accreditation on policies and procedures should apply across product 
types offered within Exchanges.
    Response: We agree with commenters and clarify our interpretation 
of this final rule that the recognized accrediting entities may review 
policies and procedures at the issuer level, provided that the same 
policies and procedures apply across an issuer's product lines and 
product types. We maintain that the recognized accrediting entity must 
provide accreditation at the Exchange product type level but we do not 
require recognized accrediting entities to duplicate valid and 
applicable work or reviews conducted in connection with accreditations 
provided at a different level for the same issuer.
5. Network Adequacy and Access in Accreditation Standards (Sec.  
156.275(c)(2)(iv))
    As part of our proposal that recognized accrediting entities 
include network adequacy and access in the accreditation standards, we 
proposed in subparagraph (c)(2)(iv) that the network adequacy and 
access standards outlined in section 1311(c)(1)(D) of the Affordable 
Care Act and 45 CFR 156.275(a)(1)(viii) must, at a minimum, be 
consistent with the general requirements for network adequacy standards 
for QHP issuers codified in Sec.  156.230(a). We solicited comments on 
this proposed requirement.
    Comment: We received one comment that the current accreditation 
standards relating to network adequacy in use by NCQA are not fully 
consistent with the general requirements for network adequacy standards 
in Sec.  156.230(a) because NCQA does not currently address the 
inclusion of essential community providers in their network adequacy 
assessment. However, in its comment on the proposed rule, NCQA stated 
willingness to work with CMS to address this in their accreditation 
standards in the future.
    Response: We acknowledge that NCQA does not currently capture 
information regarding essential community providers as part of its 
current accreditation standards. Because the direction to cover 
essential community providers is included as a separate provision 
defined in Sec.  156.235, we are finalizing the rule for the phase one 
recognition process such that network adequacy and access accreditation 
standards must be consistent with Sec.  156.230(a)(2) and Sec.  
156.230(a)(3) only. A review of the inclusion of essential community 
providers as part of accreditation standards will not be required in 
the interim phase one recognition process. This change does not affect 
the QHP certification standard that QHPs demonstrate essential 
community provider network adequacy. We will consider proposing that 
accreditation standards be fully consistent with all general 
requirements of network adequacy in Sec.  156.230(a) in future 
rulemaking on phase two.
    Comment: One commenter expressed concerns about making network 
adequacy a part of the accreditation process and stated that it should 
not be delegated to private accreditors. The commenter believes that 
this is inherently a regulatory function and should be retained by a 
regulatory body. One commenter recommends that HHS clearly specify and 
distinguish the network adequacy responsibilities of Exchanges, QHP 
issuers, and recognized accrediting entities to ensure that consumers' 
access and rights are protected and information on provider networks is 
accurate.
    Response: Section 1311(c)(1)(D)(i) of the Affordable Care Act and 
45 CFR 156.275(c)(2)(iv) direct that recognized accrediting entities 
include network adequacy and access in the accreditation standards. We 
clarify in the final rule that for the phase one recognition process, 
network adequacy and access accreditation standards should be 
consistent with Sec.  156.230(a)(2) and Sec.  156.230(a)(3), including 
maintaining a network that is sufficient in number and types of 
providers to assure that all services will be accessible without 
unreasonable delay and is consistent with the network adequacy 
provisions of section 2702(c) of the PHS Act.
6. Methodological and Scoring Criteria Requirements (Sec.  
156.275(c)(3))
    In Sec.  156.275(c)(3), we proposed that each recognized 
accrediting entity must use transparent and rigorous methodological and 
scoring criteria, as required by section 1311(c)(1)(D)(i) of the 
Affordable Care Act. We did not receive comments on this section and 
are finalizing the provisions as proposed.
7. Documentation Requirements (Sec.  156.275(c)(4))
    In Sec.  156.275(c)(4), we proposed that each accrediting entity 
recognized by the Secretary, as a condition of gaining and maintaining 
recognition, provide to HHS its current accreditation processes to 
demonstrate that the entity meets the conditions described in 
Sec. Sec.  156.275(c)(2) and 156.275(c)(3). Documentation should 
include accreditation standards and requirements, processes, and 
measure specifications for performance measures. We proposed that the 
initial submission of documentation be made at a time specified by HHS. 
We solicited comment on this timing requirement, specifically whether 
NCQA and URAC may only be recognized if this documentation is provided 
within a certain number of days of the final rule. Recognized 
accrediting entities must also submit any proposed changes or updates 
to the accreditation and measurement process with 60 days notice prior 
to implementation such that HHS has ample opportunity to review and 
comment on whether these changes or updates are significant enough to 
mean that the conditions in Sec. Sec.  156.275(c)(2) and 156.275(c)(3) 
would no longer be met. We solicited comments on these documentation 
standards.
    Comment: One commenter recommended a timeframe of ninety days for 
submission of required documentation by accrediting entities. The 
accrediting entities being recognized in phase one stated no opposition 
to submitting documentation

[[Page 42667]]

within a timeframe specified by HHS; one commented that it would 
provide documentation at any time it is required. And we received 
numerous comments in support of the proposed 60 day timeframe for 
changes and updates.
    Response: We only received one comment regarding a specific 
timeframe for documentation submission. We finalize in this rule that 
the documentation from recognized accrediting entities, due under Sec.  
156.275(c)(4) be provided within 60 days of the publication of this 
final rule. We believe that 60 days is a reasonable time for 
accrediting entities to submit their current accreditation processes, 
standards, and requirements.
    Comment: A few commenters requested clarification regarding 
providing notice on updates or changes to the accreditation and 
measurement process and providing health plans with adequate time to 
implement the proposed changes. We received numerous comments in 
support of the proposed 60 day timeframe for changes and updates. The 
commenters' recommended that HHS clarify that issuers should be 
provided with a one year advance notice of changes in accreditation and 
measurement process. One commenter recommended that regulations should 
permit accrediting entities to address any errors found in technical 
specifications within a shorter timeframe. One commenter recommended 
that HHS seek input from affected stakeholders to determine whether any 
proposed changes are significant enough to mean that the conditions in 
Sec. Sec.  156.275(c)(2) and 156.275(c)(3) would no longer be met. The 
commenter also requested clarification regarding HHS's turnaround time 
to review and comment on accrediting entities' planned changes and 
updates.
    Response: In the rule, we finalize this standard to state that 
recognized accrediting entities submit to HHS any proposed changes or 
updates to the accreditation and measurement process with 60 days prior 
to public notice. HHS does not intend to interfere with current 
practices of accrediting entities to provide advance notice to health 
plans and agree with commenters that health plans should have adequate 
time to implement any proposed changes. We also agree with the 
commenter's recommendation that accrediting entities should correct any 
errors to technical specifications within a shorter time period. We 
clarify that recognized accrediting entities do not have to provide 
advance notice to CMS of non-substantive error corrections. We intend 
to seek diverse stakeholder input if conditions in Sec. Sec.  
156.275(c)(2) and 156.275(c)(2) are no longer met. We intend to be 
expeditious during our review of any changes and updates of 
accreditation and measurement process.
8. Authorization of Data Sharing by Accrediting Entities to the 
Exchange and HHS (Sec.  156.275(a)(2))
    As codified in Sec.  156.275(a)(2), a QHP issuer must authorize the 
accrediting entity that accredits its QHPs to release to the Exchange 
and HHS certain materials related to QHP accreditation. In accordance, 
we proposed that when authorized by an accredited QHP issuer, 
recognized accrediting entities provide the following accreditation 
survey data elements to the Exchange in which the issuer plans to 
operate one or more QHPs:
     The name, address, Health Insurance Oversight System 
(HIOS) issuer identifier,\5\ and unique accreditation identifier(s) of 
the QHP issuer.
---------------------------------------------------------------------------

    \5\ We expect the QHP issuer will provide the accrediting entity 
with the HIOS identifiers.
---------------------------------------------------------------------------

     The QHP issuer's accredited product line(s) (that is, 
Commercial, Medicaid, Exchange) and type(s) which have been released;
     For each of the QHP issuer's accredited product type(s), 
HIOS product identifier (if applicable); accreditation status, survey 
type or level (if applicable); accreditation score; expiration date of 
accreditation; and clinical quality measure results and adult and child 
CAHPS measure survey results (and corresponding expiration dates of 
these data) at the level specified by the Exchange (for example, QHP 
product or plan level).
    Such disclosure was proposed to occur on the following occasions: 
during the annual certification period or as changes occur to these 
data throughout the coverage year. We solicited comment, including 
whether fewer or more categories of information should be included.
    The proposed rule would permit Exchanges to arrange additional data 
sharing agreements with the recognized accrediting entities if they 
choose, such as information on the QHP issuer's policies and 
procedures. We solicited comments as to whether recognized accrediting 
entities must provide this additional information upon request from an 
Exchange.
    Comment: Several commenters recommended that recognized accrediting 
entities provide the Exchange a copy of the most recent accreditation 
survey for each accredited product as well as any corrective action 
plans and summaries of findings or other similar written comments or 
analysis that is provided to each insurer by the accrediting entities. 
A few commenters expressed concern regarding the release of proprietary 
health plan data and data containing sensitive personal health 
information. The commenters recommended that data sharing should be 
limited to quality measures and CAHPS survey results that will be 
displayed and not include the full accreditation survey or additional 
information that would undermine the accreditation process. One 
commenter requested that data be shared with state quality improvement 
organizations for additional oversight.
    Response: 45 CFR 156.275(a)(2) directs QHP issuers to authorize the 
accrediting entity to release to the Exchanges survey-related 
information such as corrective action plans or summaries of findings. 
However, we maintain in the final rule that the recognized accrediting 
entity provide data through data sharing agreements to an Exchange. We 
interpret this regulation to permit an Exchange the flexibility, 
through data sharing agreements, to request additional information or 
to engage in data sharing with another entity, such as a state quality 
improvement organization. We did not propose the requirement in this 
rule that recognized accrediting entities share additional data not 
identified in Sec.  156.275(a)(2) or Sec.  156.275(c)(5) with 
Exchanges. We agree with the commenters' recommendations that this 
qualitative information may provide useful insight to an Exchange. We 
are modifying the data sharing requirements between the recognized 
accrediting entities and Exchanges to expressly exclude personally 
identifiable data.
    Comment: One commenter requested more information regarding the 
process for recognized accrediting entities to provide data to 
Exchanges.
    Response: We will be working closely with the recognized 
accrediting entities to further clarify the process including 
definitions of data elements.
    Comment: One commenter requested clarification on whether 
accreditation data must be provided on non-Exchange products during 
early years of the Exchange and whether a recognized accrediting entity 
can collect authorizations from issuers to release data elements to an 
Exchange.
    Response: Because it will take time for QHP product type specific 
accreditation to be available, consistent with the proposed rule, 
recognized accrediting entities will provide accreditation data from a 
QHP issuer's existing accreditation on non-Exchange

[[Page 42668]]

products (for example, commercial and Medicaid) if these data are 
requested by an Exchange, once the QHP issuer authorizes the release of 
these data. As codified in Sec.  156.275(a)(2), QHP issuers will 
authorize the release of their accreditation survey data as part of QHP 
certification.
    Comment: One commenter requested clarification regarding what 
clinical quality and CAHPS measure results data must be reported (for 
example, numerators and denominators only or more detailed data like 
member-level survey results).
    Response: The clinical quality measure results and adult and child 
CAHPS measure survey results specified in the final rule refer to only 
those measure results attained through a QHP issuer's accreditation 
from a recognized accrediting entity. To allow Exchanges the 
flexibility to specify the level of detail that is appropriate and 
reasonable for the QHPs, we are not further defining the level of 
reporting of these data for each Exchange.
    Comment: One commenter requested clarification regarding what is 
meant by providing clinical or CAHPS data at the level specified by the 
Exchange. The commenter stated that there should be sufficient numbers 
for valid data collection by issuers, but not necessarily at the metal 
(Bronze, Silver, Gold or Platinum) level.
    Response: We recognize that adequate sample size for valid data 
collection is a critical element of accreditation. We maintain that 
Exchanges should have the flexibility to request clinical and CAHPS 
data at the QHP product or plan level if there are adequate sample 
sizes to capture the QHP experience and enable reporting of valid and 
reliable performance measures.
    Comment: One commenter recommended that CMS collect accrediting 
entity data on plan performance and scoring information of network 
adequacy requirements to support CMS' network adequacy review and to 
minimize documentation requirements.
    Response: We agree that these data could support the Exchange in 
the review of network adequacy standards as part of QHP certification; 
however, at this time, we are not requiring recognized accrediting 
entities to provide accreditation survey data elements relating to 
network adequacy requirements, that are in excess of the disclosure 
required under Sec.  156.275(a)(2), to the Exchange.

III. Provisions of the Final Regulations

    This final rule incorporates the provisions of the proposed rule 
with some substantive modifications, along with additional non-
substantive changes to improve clarity, not noted here. Those 
provisions of the final rule that differ from the proposed rule are as 
follows:

Changes to Sec.  156.120(a)

     Changes the definition of treatment limitations to include 
only quantitative limits, which also removes the requirement to provide 
data on nonquantitative limits for purposes of this final rule.

Changes to Sec.  156.120(e)

     Establishes a submission deadline for applicable issuers. 
Issuer submissions are due on September 4, 2012.

Changes to Sec.  156.275(c)(2)(iii)

     Establishes exception authority to the product type level 
accreditation requirement when the product type level of accreditation 
is not methodologically sound. In such cases, the recognized 
accrediting entity must demonstrate that the Exchange product type 
level accreditation is not methodologically sound as a condition of the 
Exchange granting an exception to authorize accreditation at an 
aggregated level.

Changes to Sec.  156.275(c)(2)(iv)

     Removes inclusion of essential community providers under 
the network adequacy standards for accreditation.
     Maintains that network adequacy standards for 
accreditation be, at a minimum, consistent with general requirements 
for network adequacy for QHP issuers codified in Sec.  156.230(a)(2) 
and (a)(3).

Changes to Sec.  156.275(c)(4)(i)

     Establishes timeframe of within 60 days of publication of 
the final rule that an accrediting entity must provide current 
accreditation standards and requirements, processes, and measure 
specifications for performance measures to demonstrate that each entity 
meets the conditions specified.

Changes to Sec.  156.275(c)(4)(ii)

     Clarifies that recognized accrediting entities must 
provide to HHS any proposed changes or updates to accreditation 
standards, processes and measure specifications for performance 
measures with 60 days prior to public notification.

Changes to Sec.  156.275(c)(5)

     Adds an exception to protect personally identifiable 
information.

IV. Collection of Information Requirements

    As part of the proposed rule, and in accordance with the Paperwork 
Reduction Act, we sought comment on the information collection requests 
(ICRs) associated with the proposed rule. This included the of EHB data 
(Sec.  156.120) information collections. We received some comments on 
this section, which are discussed below. As described above, we 
finalize Sec.  156.120 as it was proposed, with the addition of a 
deadline for the reporting requirement in Sec.  156.120(e). On June 5, 
2012, we issued a 60-day Federal Register notice (77 FR 33221) seeking 
comments on the revision to the information collection request (ICR), 
``Health Care Reform Insurance Web Portal Requirements.'' \6\
---------------------------------------------------------------------------

    \6\ Available at: http://www.cms.gov/Regulations-and-Guidance/
Legislation/PaperworkReductionActof1995/PRA-Listing-Items/
CMS1247405.html.
---------------------------------------------------------------------------

    In the proposed rule and the June 5, 2012 60-day Federal Register 
Notice, we also sought comment on ICRs that are not discussed in the 
regulations text contained in this document, including the state 
selection of a benchmark and the voluntary data collection from 
standalone dental plans. We received some comments related to these 
ICRs, which we will consider before submitting the ICR to the Office of 
Management and Budget for review and approval. We plan to finalize the 
ICR on benchmark data collection and stand-alone dental separately from 
the other portions of the ``Health Care Reform Insurance Web Portal 
Requirements'' ICR. The comment period for this package remains open 
through August 5, 2012, and we encourage interested parties to submit 
comments.
    In the proposed rule, we also sought comment on ICRs for recognized 
accrediting entities (Sec.  156.275). We did not receive comments on 
the accrediting entities ICRs described in the proposed rule. As 
described above, although we made some changes to Sec.  156.275 in this 
final rule, the ICRs are unchanged. We also issued a 60-day Federal 
Register notice seeking comments on these ICRs.\7\ That comment period 
closes on August 1, 2012, and we encourage interested parties to submit 
comments. Following close of the 60-day comment period, we will submit 
the accrediting entities ICR to OMB for approval.
---------------------------------------------------------------------------

    \7\ Available at: http://www.cms.gov/Regulations-and-Guidance/
Legislation/PaperworkReductionActof1995/PRA-Listing-Items/cms-
10435.html.
---------------------------------------------------------------------------

    What follows is a discussion of comments received on the ICRs 
related to the EHB data (Sec.  156.120).

[[Page 42669]]

    Section 156.120 states that issuers that offer the three largest 
health insurance products by enrollment in each state's small group 
market, as determined by HHS based on data submitted in accordance with 
part 159 of this title for March 31, 2012, must provide the data 
described in paragraph (b) for the health plan with the highest 
enrollment within that product. This data collection mirrors the 
benefit data fields currently collected under the Health Insurance Web 
Portal PRA package (OCN: 0938-1086) and also includes: The 
administrative data necessary to identify the health plan, data on 
covered benefits, any treatment limitations on those benefits, data on 
drug coverage, and enrollment.
    We estimate that it will take four hours for a health insurance 
issuer to meet this reporting requirement, including data collection, 
submission, and validation. This estimate is based on current industry 
surveys collected to monitor the burden of submission of similar data 
in the Medicare Advantage and Prescription Drug Programs. Given that 
the three health insurance issuers with the largest products by 
enrollment in each state (including the District of Columbia) would 
submit this information, the total burden is estimated to be 612 hours. 
We anticipate that the reporting requirement would require four hours 
for one employee at a cost of $77.00 an hour, based on the hourly cost 
reported by industry in responses to a CMS survey of Medicare Advantage 
and Prescription Drug Programs which requires employees with similar 
technical expertise, for a total cost of $308.00 a year per issuer. The 
total number of respondents required to report would be 153, the 
largest three issuers/products in each state and the District of 
Columbia by enrollment, for a total burden of $47,124. Issuers would 
provide HHS with the data collection requirements through an online 
tool that we would make available to them.
    Comment: We received some comments expressing concern that HHS's 
burden estimates related to the proposed data collection were too low.
    Response: We appreciate these concerns, but for the reasons 
discussed above, believe that our estimates accurately reflect the 
burden of reporting.
    Comment: One commenter recommended that HHS avoid collection of an 
``other'' benefit category because the category is somewhat ambiguous.
    Response: HHS included the ``other'' category to allow for full 
reporting of the benefits, including benefits that do not fall into the 
set of categories provided under HealthCare.gov.

V. Regulatory Impact Analysis

    We have examined the impact of this final rule as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993) and Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011). Executive Orders 12866 and 13563 direct 
agencies to assess all costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, distributive impacts, 
and equity). A regulatory impact analysis (RIA) must be prepared for 
major rules with economically significant effects ($100 million or more 
in any one year).
    It is HHS's belief that this rule does not reach this economic 
threshold and thus is not considered a major rule. This rule consists 
of a data collection from a limited number of health insurance issuers 
and a data submission by two accrediting entities to HHS. Because of 
the very limited scope of this final rule, we do not anticipate that 
there would be any costs associated with this rulemaking in addition to 
those costs, as outlined below. We derived the costs outlined below 
from the labor costs as outlined in the Collection of Information 
section above. The data collection from issuers only applies to the 
issuers of the three largest products by enrollment in each state's 
small group market, which would result in a minor economic burden to an 
estimated 153 issuers, at a total cost across all issuers of $47,124. 
Additionally, the PRA package that accompanied the proposed rule 
requested that issuers that wish to offer stand-alone dental plans in 
an Exchange notify HHS of their intent to participate. We estimate that 
20 dental issuers would voluntarily respond, at a total cost across all 
responding issuers of $770. The two entities which we are recognizing 
as accrediting entities already meet most of the conditions for phase 
one of the recognition process, and we anticipate that any required 
changes to their accreditation processes would be minor and result 
economic burden that we have estimated at $48,625.

VI. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) 
requires agencies to prepare an initial regulatory flexibility analysis 
to describe the impact of the proposed rule on small entities, unless 
the head of the agency can certify that the rule would not have a 
significant economic impact on a substantial number of small entities. 
The RFA generally defines a ``small entity'' as--(1) A proprietary firm 
meeting the size standards of the Small Business Administration (SBA); 
(2) a not-for-profit organization that is not dominant in its field; or 
(3) a small government jurisdiction with a population of less than 
50,000. States and individuals are not included in the definition of 
``small entity.'' HHS uses as its measure of significant economic 
impact on a substantial number of small entities a change in revenues 
of more than 3 percent.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses, if a proposed rule has a significant impact on a 
substantial number of small entities. For purposes of the RFA, small 
entities include small businesses, nonprofit organizations, and small 
government jurisdictions. Small businesses are those with sizes below 
thresholds established by the Small Business Administration (SBA).
    As discussed above, this final rule is necessary to implement 
certain standards related to the establishment of essential health 
benefits and recognition of accrediting entities as authorized by the 
Affordable Care Act. Specifically, this rule outlines collecting data 
from issuers that offer the three largest small group products in each 
state and from NCQA and URAC, which are the phase one recognized 
accrediting entities. For the purposes of the regulatory flexibility 
analysis, we expect the following types of entities to be affected by 
this final rule--(1) QHP issuers (2) and NCQA and URAC.
    As discussed in the Medical Loss Ratio interim final rule (75 FR 
74918), few, if any, issuers are small enough to fall below the size 
thresholds for small business established by the SBA. In that rule, we 
used a data set created from 2009 National Association of Insurance 
Commissioners (NAIC) Health and Life Blank annual financial statement 
data to develop an updated estimate of the number of small entities 
that offer comprehensive major medical coverage in the individual and 
group markets. For purposes of that analysis, the Department used total 
Accident and Health earned premiums as a proxy for annual receipts. We 
estimated that there are 28 small entities with less than $7 million in 
accident and health earned premiums offering individual or group 
comprehensive major medical coverage. However, this estimate may 
overstate the actual number of small health insurance issuers offering 
such coverage, since it does not include

[[Page 42670]]

receipts from these companies' other lines of business.\8\ We further 
estimate that any issuers that would be considered small businesses are 
likely to be subsidiaries of larger issuers that are not small 
businesses.
---------------------------------------------------------------------------

    \8\ According to the Small Business Administration size 
standards, entities with average annual receipts of $7 million or 
less would be considered small entities for North American Industry 
Classification System (NAICS) Code 524114 (Direct Health and Medical 
Insurance Carriers) (for more information, see ``Table of Size 
Standards Matched To North American Industry Classification System 
Codes,'' effective March 26, 2012, U.S. Small Business 
Administration, available at http://www.sba.gov).
---------------------------------------------------------------------------

    This rule also directs two accrediting entities, NCQA and URAC, to 
submit documentation to HHS. The RFA, as noted previously, considers a 
non-profit entity that is not dominant in its field to be a small 
entity. We selected both NCQA and URAC because they are the two most 
dominant actors in the field of health plan accreditation. NCQA is a 
not-for-profit entity that has been in existence since 1990 and is 
widely recognized as a national leader in developing health care 
performance measures and quality standards. NCQA has accredited health 
plans covering over 70 percent of all Americans.\9\ URAC is also a not-
for-profit entity that was formed over 20 years ago. URAC accredits 
plans in every state and, according to its Web site, is the largest 
accrediting body for health care.\10\ Finally, based on their dominant 
role in accrediting health plans, we believe that NCQA and URAC are 
both likely to have total annual receipts exceeding the Small Business 
Administration size standard.\11\
---------------------------------------------------------------------------

    \9\ See ``About NCQA,'' NCQA Web site. Available at http://www.ncqa.org/tabid/675Default.aspx.
    \10\ See ``Frequently Asked Questions'' URAC Web site. Available 
at: https://www.urac.org/about/faqs.aspx#General.
    \11\ According to the Small Business Administration size 
standards, entities with average annual receipts of $7 million or 
less would be considered small entities for North American Industry 
Classification System (NAICS) Code 524298 (All Other Insurance 
Related Activities) (for more information, see ``Table of Size 
Standards Matched To North American Industry Classification System 
Codes,'' effective March 26, 2012, U.S. Small Business 
Administration, available at http://www.sba.gov).
---------------------------------------------------------------------------

    Based on the foregoing, we are not preparing an analysis for the 
RFA because we have determined, and the Secretary certifies, that this 
final rule would not have a significant economic impact on a 
substantial number of small entities.

VII. Unfunded Mandates

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
requires that agencies assess anticipated costs and benefits and take 
certain other actions before issuing a final rule that includes any 
Federal mandate that may result in expenditures in any one year by a 
state, local, or tribal governments, in the aggregate, or by the 
private sector, of $100 million in 1995 dollars, updated annually for 
inflation. In 2012, that threshold is approximately $139 million. UMRA 
does not address the total cost of a rule. Rather, it focuses on 
certain categories of costs, mainly those ``Federal mandate'' costs 
resulting from: (1) Imposing enforceable duties on state, local, or 
Tribal governments, or on the private sector; or (2) increasing the 
stringency of conditions in, or decreasing the funding of, state, 
local, or tribal governments under entitlement programs.
    This final rule does not place any financial mandates on state, 
local, or Tribal governments. This rule authorizes a narrow data 
collection from an estimated 153 issuers, and the only costs associated 
with this reporting are labor costs, which we anticipate to total 
$47,124, which is significantly less than the threshold of $139 
million. States may, at their option, select a benchmark plan and 
submit this information to HHS. We anticipate that it would take each 
state five hours of labor to complete and submit this information and 
that the per hour labor cost would be similar to that for the issuer 
data submission, which is $77 per hour. We cannot reasonably anticipate 
how many states will respond. However, assuming for the sake of 
argument that all states respond, the total cost would still be under 
$20,000, which is well below the $139 million threshold. The rule also 
sets standards for two accrediting entities to submit documentation to 
HHS as specified in the rule. We expect the cost to the two accrediting 
entities to be $48,898.

VIII. Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct costs on state and local governments, preempts state 
law, or otherwise has Federalism implications. This final regulation, 
as it relates to the recognition of accrediting entities, does not 
impose any costs on state or local governments. However, this 
regulation includes reporting requirements if a state selects a 
benchmark plan.
    In compliance with the requirement of Executive Order 13132 that 
agencies examine closely any policies that may have Federalism 
implications or limit the policy making discretion of the states, HHS 
has engaged in efforts to consult with and work cooperatively with 
affected states, including participating in conference calls with and 
attending conferences of the National Association of Insurance 
Commissioners (NAIC), and consulting with state insurance officials on 
an individual basis. We believe that this final rule does not impose 
substantial direct costs on state and local governments, preempt state 
law, or otherwise have federalism implications. We note that states 
that choose to select a benchmark plan would be required to submit 
their benchmark plan selection to HHS, and provide information on the 
benchmark plan in the same format that is used by issuers. However, we 
anticipate that the administrative costs related to this requirement 
are likely to be minimal because the states are likely to obtain this 
information from the issuers.
    Pursuant to the requirements set forth in section 8(a) of Executive 
Order 13132, and by the signatures affixed to this regulation, the 
Department of Health and Human Services certifies that CMS has complied 
with the requirements of Executive Order 13132 for the attached 
regulation in a meaningful and timely manner.

List of Subjects in 45 CFR Part 156

    Administrative practice and procedure, Advertising, Advisory 
Committees, Brokers, Conflict of interest, Consumer protection, Grant 
programs--health, Grants administration, Health care, Health insurance, 
Health maintenance organization (HMO), Health records, Hospitals, 
Indians, Individuals with disabilities, Loan programs--health, 
Organization and functions (Government agencies), Medicaid, Public 
assistance programs, Reporting and recordkeeping requirements, Safety, 
State and local governments, Sunshine Act, Technical assistance, Women, 
and Youth.
    For the reasons set forth in the preamble, the Department of Health 
and Human Services amends 45 CFR subtitle A, subchapter B, as set forth 
below:

PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE 
CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES

0
1. The authority citation for part 156 is revised to read as follows:

    Authority:  Title I of the Affordable Care Act, Sections 1301-
1304, 1311-1312, 1321, 1322, 1324, 1334, 1341-1343, and 1401-1402, 
Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18042).

0
2. Add subpart B to part 156 to read as follows:

[[Page 42671]]

Subpart B--Standards for Essential Health Benefits, Actuarial 
Value, and Cost Sharing

Sec.  156.120  Collection of data from certain issuers to define 
essential health benefits.

    (a) Definitions. The following definitions apply to this section, 
unless the context indicates otherwise:
    Health benefits means benefits for medical care, as defined at 
Sec.  144.103 of this chapter, which may be delivered through the 
purchase of insurance or otherwise.
    Health insurance product has the meaning given to the term in Sec.  
159.110 of this chapter.
    Health plan has the meaning given to the term, ``Portal Plan'' in 
Sec.  159.110 of this chapter.
    Small group market has the meaning given to the term in Sec.  
155.20 of this chapter.
    State has the meaning given to the term in Sec.  155.20 of this 
chapter.
    Treatment limitations include limits on benefits based on the 
frequency of treatment, number of visits, days of coverage, or other 
similar limits on the scope or duration of treatment. Treatment 
limitations include only quantitative treatment limitations. A 
permanent exclusion of all benefits for a particular condition or 
disorder, however, is not a treatment limitation.
    (b) Required information. The issuers described in paragraph (c) of 
this section must provide the following information for the health 
plans described in paragraph (d) of this section in accordance with the 
standards in paragraph (e) of this section:
    (1) Administrative data necessary to identify the health plan;
    (2) Data and descriptive information for each plan on the following 
items:
    (i) All health benefits in the plan;
    (ii) Treatment limitations;
    (iii) Drug coverage; and
    (iv) Enrollment;
    (c) Issuers required to report. The issuers that offer the three 
largest health insurance products by enrollment, as of March 31, 2012 
(enrollment is determined by HHS based on data submitted in accordance 
with part 159 of this title) in each state's small group market must 
provide the information in paragraph (b) of this section.
    (d) Plans affected. The issuers described in paragraph (c) of this 
section must provide the information described in paragraph (b) of this 
section for the health plan with the highest enrollment (as determined 
by the issuer) within the products described in paragraph (c) of this 
section.
    (e) Reporting requirement. To ensure consistency in reporting, an 
issuer described in paragraph (c) of this section must submit, in a 
form and manner to be determined by HHS, the information described in 
paragraph (b) of this section to HHS no later than September 4, 2012.

0
3. Amend Sec.  156.275 by adding paragraph (c) to read as follows:

Sec.  156.275  Accreditation of QHP issuers.

* * * * *
    (c) Accreditation--(1) Recognition of accrediting entity by HHS. 
Effective upon completion of conditions listed in paragraphs (c)(2), 
(c)(3), and (c)(4) of this section, at which time HHS will notify the 
public in the Federal Register, the National Committee for Quality 
Assurance (NCQA) and URAC are recognized as accrediting entities by the 
Secretary of HHS to provide accreditation of QHPs meeting the 
requirement of this section.
    (2)(i) Scope of accreditation. Subject to paragraphs (c)(2)(ii), 
(iii), and (iv) of this section, recognized accrediting entities must 
provide accreditation within the categories identified in paragraphs 
(a)(1) of this section.
    (ii) Clinical quality measures. Recognized accrediting entities 
must include a clinical quality measure set in their accreditation 
standards for health plans that:
    (A) Spans a breadth of conditions and domains, including, but not 
limited to, preventive care, mental health and substance abuse 
disorders, chronic care, and acute care.
    (B) Includes measures that are applicable to adults and measures 
that are applicable to children.
    (C) Aligns with the priorities of the National Strategy for Quality 
Improvement in Health Care issued by the Secretary of HHS and submitted 
to Congress on March 12, 2011;
    (D) Only includes measures that are either developed or adopted by 
a voluntary consensus standards setting body (such as those described 
in the National Technology and Transfer Advancement of Act of 1995 
(NTTAA) and Office of Management and Budget (OMB) Circular A-119 
(1998)) or, where appropriate endorsed measures are unavailable, are in 
common use for health plan quality measurement and meet health plan 
industry standards; and
    (E) Is evidence-based.
    (iii) Level of accreditation. Recognized accrediting entities must 
provide accreditation at the Exchange product type level unless the 
product type level of accreditation is not methodologically sound. In 
such cases, the recognized accrediting entity must demonstrate that the 
Exchange product type level accreditation is not methodologically sound 
as a condition of the Exchange granting an exception to authorize 
accreditation at an aggregated level.
    (iv) Network adequacy. The network adequacy standards for 
accreditation used by the recognized accrediting entities must, at a 
minimum, be consistent with the general requirements for network 
adequacy for QHP issuers codified in Sec.  156.230(a)(2) and (a)(3).
    (3) Methodological and scoring criteria for accreditation. 
Recognized accrediting entities must use transparent and rigorous 
methodological and scoring criteria.
    (4) Documentation. An accrediting entity must provide the following 
documentation:
    (i) To be recognized, an accrediting entity must provide current 
accreditation standards and requirements, processes, and measure 
specifications for performance measures to demonstrate that each entity 
meets the conditions described in paragraphs (c)(2), and (c)(3) of this 
section to HHS within 60 days of the publication date of this final 
rule.
    (ii) Recognized accrediting entities must provide to HHS any 
proposed changes or updates to the accreditation standards and 
requirements, processes, and measure specifications for performance 
measures with 60 days notice prior to public notification.
    (5) Data sharing requirements between the recognized accrediting 
entities and Exchanges. When authorized by an accredited QHP issuer 
pursuant to paragraph (a)(2) of this section, recognized accrediting 
entities must provide the following QHP issuer's accreditation survey 
data elements to the Exchange, other than personally identifiable 
information (as described in OMB Memorandum M-07-16), in which the 
issuer plans to operate one or more QHPs during the annual 
certification period or as changes occur to these data throughout the 
coverage year--the name, address, Health Insurance Oversight System 
(HIOS) issuer identifier, and unique accreditation identifier(s) of the 
QHP issuer and its accredited product line(s) and type(s) which have 
been released; and for each accredited product type:
    (i) HIOS product identifier (if applicable);
    (ii) Accreditation status, survey type, or level (if applicable);
    (iii) Accreditation score;
    (iv) Expiration date of accreditation; and

[[Page 42672]]

    (v) Clinical quality measure results and adult and child CAHPS 
measure survey results (and corresponding expiration dates of these 
data) at the level specified by the Exchange.

    Dated: July 16, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.

    Approved: July 16, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-17831 Filed 7-18-12; 4:15 pm]
BILLING CODE 4120-01-P
```