[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\
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\6\ Available at: http://www.cms.gov/Regulations-and-Guidance/
Legislation/PaperworkReductionActof1995/PRA-Listing-Items/
CMS1247405.html.
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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.
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\7\ Available at: http://www.cms.gov/Regulations-and-Guidance/
Legislation/PaperworkReductionActof1995/PRA-Listing-Items/cms-
10435.html.
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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.
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\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).
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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\
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\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