[Federal Register Volume 77, Number 108 (Tuesday, June 5, 2012)]
[Proposed Rules]
[Pages 33133-33142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13489]



[[Page 33133]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 156

[CMS-9965-P]
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: Proposed rule.

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SUMMARY: This proposed rule would establish data collection standards 
necessary to implement aspects 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 proposed 
rule outlines the data on applicable plans to be collected from certain 
issuers to support the definition of essential health benefits. A 
bulletin on HHS' intended benchmark approach to defining essential 
health benefits was published for comment on December 16, 2011, and we 
intend to pursue comprehensive rulemaking on essential health benefits 
in the future. This proposed rule would also establish a process for 
the recognition of accrediting entities for purposes of certification 
of qualified health plans.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. Eastern Standard 
Time (EST) on July 5, 2012.

ADDRESSES: In commenting, please refer to file code CMS-9965-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-9965-P, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-9965-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:

a. For delivery in Washington, DC-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.

    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)

b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.

    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Adam Block at (301) 492-4392, 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:
    Submitting Comments: We welcome comments from the public on issues 
set forth in this proposed rule to assist us in fully considering 
issues and developing policies. Comments will be most useful if they 
are organized by the paragraph of the proposed rule to which they 
apply. You can assist us by referencing the file code CMS-9965-P, and 
the specific ``issue identifier'' that precedes the section on which 
you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Executive Summary

    Beginning in 2014, all non-grandfathered health plans in the 
individual and small group market, Medicaid benchmark and benchmark-
equivalent plans, and Basic Health Programs, where applicable, 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 ten 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.
    The Department of Health and Human Services (HHS) has provided the 
public with information about EHB in several phases:
     On December 16, 2011, HHS released a bulletin, following 
the report from the Department of Labor describing the scope of 
benefits covered under employer-sponsored coverage and an HHS 
commissioned study from the Institute of Medicine (IOM) that

[[Page 33134]]

recommended criteria and methods for determining and updating essential 
health benefits, outlining its intended regulatory approach for 
defining EHB. The bulletin considered an intended approach in which EHB 
would be defined by a benchmark plan selected by each State. This 
State-specific benchmark plan would serve as a reference plan, 
reflecting both the scope of services and any limits offered by a 
``typical employer plan'' in that State as required by section 
1302(b)(2)(A) of the Affordable Care Act. In the December 16, 2011, 
bulletin, we laid out four potential benchmark plan types for 2014 and 
2015. They are: (1) The largest plan by enrollment in any of the three 
largest small group insurance products in the State's small group 
market, (2) any of the largest three State employee health benefit 
plans by enrollment, (3) any of the largest three national Federal 
Employees Health Benefits Program plan options by enrollment, and (4) 
the largest insured commercial non-Medicaid health maintenance 
organization (HMO) operating in the State. We intend to propose these 
options in comprehensive rulemaking on EHB in the future. Health 
insurance issuers could adopt the scope of services and limits of the 
State benchmark, or vary it within defined parameters.
     On January 25, 2012, HHS released an illustrative list of 
the largest three small group market products by State.
     On February 17, 2012, HHS further clarified the approach 
described in the bulletin through a series of Frequently Asked 
Questions.
    This proposed rule includes data reporting standards for health 
plans that represent potential State-specific EHB benchmarks, as 
described in the bulletin released on December 16, 2011. Specifically, 
the proposed rule would establish that issuers of the largest three 
small group market products in each State must report information on 
covered benefits.
    In addition, this rule proposes 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. In phase one, the National Committee for 
Quality Assurance (NCQA) and URAC would be recognized as accrediting 
entities on an interim basis. In phase two, a criteria-based review 
process would be adopted through future rulemaking.

II. Background

A. Legislative Overview

    Section 1302 of the Affordable Care Act provides for the 
establishment of EHB, to be defined by the Secretary and included in 
QHPs offered through an Exchange. In addition, section 2707 of the 
Public Health Service Act, as added by section 1201 of the Affordable 
Care Act, directs that on and 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. The law also directs that EHB 
reflect the scope of benefits covered by a typical employer plan and 
cover at least the following ten 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. Section 1302(b)(4) of the Affordable Care Act establishes 
that the Secretary must define the EHB such that it:
     Sets an appropriate balance among the ten 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 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.
    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. 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.

B. Stakeholder Consultation and Input

    HHS has consulted with a wide range interested stakeholders on 
policies related to EHB. First, the Department of Labor issued a report 
on April 15, 2011, describing the scope of benefits offered under 
employer-sponsored coverage. Second, the IOM issued a consensus report 
on October 7, 2011, providing its recommendations for the process HHS 
should use to define EHB.
    Following the release of the IOM's recommendations, HHS held a 
number of listening sessions with consumers, providers, employers, 
health plans, and State representatives to gather public input. These 
sessions were held throughout the country.
    HHS also released several documents for public review and comment. 
On December 16, 2011, HHS released a bulletin outlining its intended 
regulatory approach to defining EHB. HHS received approximately 11,000 
comments in response to the bulletin. Commenters represented a wide 
variety of stakeholders, including health insurance issuers, consumers, 
health providers, States, employers, and Members of Congress. Among 
other topics, many commenters requested additional information on 
potential EHB benchmark plans, and urged HHS to publish the benefit 
designs of the selected benchmark plans as soon as possible. In 
particular, issuers emphasized that timely access to the benefits 
included in the benchmark is necessary to design health plans.
    HHS considered the comments received on the bulletin in developing 
the policies in this proposed rule. HHS will continue to review the 
comments on the bulletin as we develop future policy related to EHB.
    Regarding the recognition of accrediting entities, HHS received 
comments in response to the Exchange Rule. In addition, HHS conducted a 
review of the entities conducting health plan accreditation in the U.S. 
and found that substantially all issuers that have health plan 
accreditation are accredited by NCQA and/or URAC.\1\
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    \1\ See http://www.ncqa.org/tabid/135/Default.aspx. Accessed 
April 24, 2012. See also https://www.urac.org/accreditation/ 
Accessed April 24, 2012.
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C. Structure of the Proposed Rule

    The regulations outlined in this proposed rule would be codified in 
45 CFR part 156. The provision in part 156 outlines the standards for 
health insurance issuers with respect to

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participation in an Exchange, including the minimum certification 
requirements for QHPs. The provision in Sec.  156.120 proposes data 
collection from certain issuers of applicable plans to define benchmark 
options for EHB.
    Additional standards and guidance on the EHB package and phase two 
of the recognition of accrediting entities would be addressed in future 
rulemaking. Consistent standards related to the accrediting entities 
that would fulfill the accreditation requirements for multi-State plans 
would also be addressed in future rulemaking implementing section 1334 
of the Affordable Care Act promulgated by the U.S. Office of Personnel 
Management.

III. Provisions of the Proposed Regulation

    Beginning in 2014, individuals and small businesses would be able 
to purchase private health insurance through competitive marketplaces 
called Affordable Insurance Exchanges (Exchanges). Exchanges would 
facilitate the purchase of insurance coverage by qualified individuals 
from QHPs and assist qualified employers in the enrollment of their 
employees into QHPs. See Affordable Care Act Sec.  1311(b).
    Beginning in 2014, non-grandfathered health insurance plans offered 
in the individual or small group market would offer EHB. See Affordable 
Care Act Sec.  1301(a)(1)(B); Public Health Service Act Sec.  
2707(a).\2\ Section 1302(b) of the Affordable Care Act directs the 
Secretary to define EHB in a way that includes at least the ten general 
categories of benefits described in the statute, and that is equal in 
scope to the benefits provided under a typical employer plan. Section 
1321(a)(1) authorizes the Secretary to issue regulations setting 
standards for meeting the requirements of title I of the Affordable 
Care Act, including section 1302, as the Secretary determines 
appropriate.
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    \2\ 45 CFR 147.140(a) defines grandfathered health coverage.
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    The bulletin outlining HHS' intended regulatory approach stated 
that we are considering an approach whereby EHB would be defined by a 
benchmark plan selected by each State.\3\ The selected benchmark plan 
would serve as a reference plan, reflecting both the scope of benefits 
and any limits contained in the plan, as required by section 
1302(b)(2)(A) of the Affordable Care Act. If a State does not exercise 
the option to select a benchmark health plan, we intend to propose in 
future rulemaking that the default benchmark plan for that State would 
be the largest plan by enrollment in the largest product in the State's 
small group market. Under this approach, the specific set of benchmark 
benefits defined using the data collected in 2012 would apply for plan 
years 2014 and 2015.\4\ We intend to revisit this approach for plan 
years starting in 2016 and would provide additional information through 
subsequent rulemaking.
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    \3\ See ``Essential Health Benefits Bulletin,'' Center for 
Consumer Information and Insurance Oversight. December 16, 2011. 
Available at: http://cciio.cms.gov/resources/files/Files2/12162011/essential_health_benefits_bulletin.pdf.
    \4\ See ``Frequently Asked Questions on Essential Health 
Benefits Bulletin,'' Center for Consumer Information and Insurance 
Oversight. February 17, 2012. Available at: http://cciio.cms.gov/resources/files/Files2/02172012/ehb-faq-508.pdf.
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    The purpose of this proposed rule is to collect sufficient 
information on potential benchmark plans' benefits to enable plans 
seeking to offer coverage in the individual or small group market in 
2014 to know what benefits will be included in the EHB benchmark. This 
proposed rule would add new regulation text at 45 CFR 156.120.
    Finally, to implement the accreditation provisions of the 
Affordable Care Act relating to QHPs, we are proposing the first phase 
of a two-phased approach for recognizing accrediting entities. In this 
rule, we propose to recognize, on an interim basis, those entities that 
best meet the requirements stipulated in section 1311(c)(1)(D)(i) of 
the Affordable Care Act. In phase two, we currently plan to adopt, 
through future rulemaking, a recognition process that includes an 
application procedure, standards for recognition, a criteria-based 
review of applications, public participation, and public notice of the 
recognition. At this time, we have determined that recognizing entities 
through the phase one process outlined above is necessary to meet the 
timeline for Exchange QHP certification activities which must commence 
in early 2013. Exchanges may include the accreditation requirements as 
early as 2013 certification, for the 2014 plan year.

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

1. Definitions
    Under Sec.  156.120(a), we propose definitions for terms that are 
used throughout the section. For the most part, the definitions 
presented in Sec.  156.120(a) are taken from existing regulations.
    We propose 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 propose that ``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 propose 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 propose 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 
propose that ``State'' has the meaning given at Sec.  155.20. We note 
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 propose that ``treatment limitations'' have the meaning found in 
Sec.  146.136 of this chapter, which includes both quantitative and 
non-quantitative 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 non-quantitative limits include prior authorization and 
step therapy requirements.
    Additionally, throughout this proposed rule we refer to ``issuers'' 
which is defined in previous rulemaking at 45 CFR 156.20.
2. Required Information (Sec.  156.120(b))
    In Sec.  156.120(b), this rule proposes that certain issuers of 
applicable plans described in paragraph (c) of this section submit 
certain benefit and enrollment information to HHS. This information 
would 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 propose 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 propose that the relevant issuers would 
submit data and descriptive information on the

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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 would be made available to the public under a 
notice and comment period separate from this notice of proposed 
rulemaking. Section 156.120(b)(2)(i) proposes that certain issuers 
submit information on covered health benefits in the applicable plans. 
This information is needed to define certain benchmark plan options.
    Section 156.120(b)(2)(ii) proposes to collect from issuers data on 
any 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 propose to collect data on drug 
coverage. This would include a list of covered drugs and information on 
whether each drug is subject to prior authorization and/or step 
therapy.
    At Sec.  156.120(b)(2)(iv) we propose to collect plan enrollment 
data, which is discussed in more detail in the ``Plans Impacted'' 
section below.
    We are soliciting comment on other data elements that may be 
necessary to ensure that health plans offer EHB.
3. Issuers Required to Report (Sec.  156.120(c))
    Section 156.120(c) of this proposed regulation specifies that these 
reporting requirements would apply only to certain issuers. 
Specifically, we propose 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 propose 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 bulletin. State data may vary from 
www.HealthCare.gov data, and we request comment on whether States 
should be permitted to use an alternative data source for determining 
the enrollment in the small group market. We are also soliciting 
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 December 16, 2011 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 noted below, we seek comment on the draft 
instructions for States to submit benefits for their selected benchmark 
plan.
4. Plans Impacted (Sec.  156.120(d))
    In Sec.  156.120(d), we propose 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 identify the plan following the definition of 
``portal plan'' in Sec.  159.110 of this chapter.
    Issuers may use their own data to determine which plan within each 
product has the highest enrollment, although we expect for many 
products, the benefits will be the same across plans within the 
product. 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 seek comment on the necessity of plan-level specificity.
5. Reporting Requirements (Sec.  156.120(e))
    Finally, Sec.  156.120(e) proposes 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 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 welcome public comment on this approach. See 
below for more information on how to comment on the data collection, in 
addition to the draft approach to how and when plans should submit the 
data.

B. Voluntary Data Collection From Stand-Alone Dental Plans

    Beginning in 2014, QHPs and other non-grandfathered health 
insurance plans in the individual and small group market will offer the 
EHB. Section 1302(b) of the Affordable Care Act outlines the ten 
statutory benefit categories, including pediatric oral care, which must 
be included by those 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 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 propose 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. Therefore, we are requesting that issuers 
that intend to offer stand-alone dental plans in any Exchange notify 
HHS of their intent to participate. We intend to provide further 
guidance that explains the format and date by which stand-alone dental 
issuers can begin to submit this information.

C. Accreditation of QHP Issuers (Sec.  156.275)

    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).'' At this time, HHS has determined that 
recognizing entities through an interim phase one process is necessary 
to meet the timeline for Exchange QHP certification activities, which 
must commence in early 2013 and may include the accreditation 
requirement, depending on the uniform timeline established by an 
Exchange. 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 propose 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) through (4) of Sec.  156.275 of this 
proposed rule. We propose for this recognition to be effective once 
these conditions are met, at which time HHS would provide notification 
in the Federal Register. This 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 Sec.  156.275(c)(1)(ii) in future rulemaking. We intend for 
the future recognition process to include an application procedure, 
standards for recognition, a criteria-based review of applications, 
public participation, and public notice of the recognition for entities 
seeking to become a recognized accrediting entity. We solicit comments 
to inform this future rulemaking. We request comment

[[Page 33137]]

on whether or not there are other accrediting entities that meet or 
would meet the statutory requirements this year.
    We propose recognition of NCQA and URAC as accrediting entities 
because our review indicates that these accrediting entities currently 
issue or plan to issue health plan accreditation that meets the 
conditions for recognition as detailed in paragraphs (c)(2) through (4) 
of this proposed rule. The majority of people currently enrolled in 
private health plans are in health plans accredited by these two 
entities.\5\ We solicit comment on our proposal to recognize 
accrediting entities on this basis and whether or not there are other 
entities that accredit health plans that meet the requirements of 
section 1311(c)(1)(D)(i) of the Affordable Care Act.
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    \5\ See http://www.ncqa.org/tabid/135/Default.aspx. Accessed 
April 24, 2012.
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    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;
     Complaints and appeals;
     Network adequacy and access; and
     Patient information programs.
    In Sec.  156.275(c)(2)(ii) through (iv), we propose requirements to 
interpret and further implement the statutory accreditation 
requirements. We solicit comments on each of these three additional 
provisions.
    We propose 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 propose 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 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,
     Be evidence based.
    We solicit 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.
    We are aware that URAC does not currently include clinical quality 
measures or patient experience ratings on a CAHPS survey in its 
accreditation standards for health plans. Based on URAC's recent press 
release and whitepaper,\6\ URAC plans to release the Health Plan 
Accreditation Program 7.0, which includes reporting on a CAHPS survey 
and a set of clinical performance measures, and would allow for the 
flexibility to add additional clinical measure requirements specified 
for Exchanges. Because our proposal is to recognize NCQA and URAC on 
the condition that accreditation be provided consistent with Sec.  
156.275(c)(2), recognition of URAC would depend on URAC's 
implementation of this plan and our review and approval of its new 
accreditation measures.
---------------------------------------------------------------------------

    \6\ URAC Health Plan Accreditation for Health Insurance 
Exchanges: A Symbol of Excellence, Quality, and Value available at: 
https://www.urac.org/Whitepaper/Value.pdf, accessed March 2, 2012.
---------------------------------------------------------------------------

    In Sec.  156.275(c)(2)(iii), we propose 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), and Exchange PPO), based on data 
submitted by the issuer that is 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, but if the product type 
for that Exchange is accredited, each of the corresponding QHPs would 
be considered to be accredited. We solicit comments on the proposed 
level of accreditation. We also solicit comments on circumstances under 
which an exception should be made to the accreditation determination 
being made at the Exchange product type level.
    As part of our proposal that recognized accrediting entities 
include network adequacy and access in the accreditation standards, we 
propose 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 solicit comments on this proposed 
requirement.
    In Sec.  156.275(c)(3), we propose that each recognized accrediting 
entity must use transparent and rigorous methodological and scoring 
criteria. This requirement is taken from section 1311(c)(1)(D)(i) of 
the Affordable Care Act.
    In Sec.  156.275(c)(4), we propose 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.  
156.275(c)(2) and (3). Documentation should include accreditation 
standards and requirements, processes, and measure specifications for 
performance measures. We propose that the initial submission of 
documentation be made at a time specified by HHS. We solicit comment on 
this timing requirement, specifically whether NCQA and URAC may only be 
recognized if this required 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

[[Page 33138]]

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.  156.275(c)(2) and (3) would 
no longer be met. We are soliciting comments on these documentation 
requirements.
    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 
with this requirement, we propose 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 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,\7\ and unique accreditation identifier(s) of 
the QHP issuer.
---------------------------------------------------------------------------

    \7\ The QHP issuer will provide the accrediting entity with this 
identifier.
---------------------------------------------------------------------------

     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, 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).
    We solicit comment, including whether fewer or more categories of 
information should be required for HHS to continue recognition of these 
entities.
    Our proposal would permit Exchanges to arrange additional data 
sharing agreements with the recognized accrediting entities if they 
choose to require additional information, such as information on the 
QHP issuer's policies and procedures. We are soliciting comments on 
these data sharing requirements. We solicit comment whether to 
incorporate a requirement that recognized accrediting entities must 
provide this additional information upon request from an Exchange.

IV. Collection of Information Requirements

A. Legislative Requirement for Solicitation of Comments

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we 
solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):

B. Requirements in Regulation Text

1. ICRs Regarding Collection of Essential Health Benefits Data (Sec.  
156.120)
    Proposed Sec.  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. This information would have to be 
submitted to HHS in a form and manner determined by HHS. The burden 
associated with meeting this requirement includes the time and effort 
needed by the issuer to compile the benefit coverage information and 
submit the information to HHS in a form and manner determined by HHS. 
Adding the limit data collection needed to establish EHB benchmarks to 
the benefit data already collected and updated on a regular basis would 
maximize issuers' ability to leverage current business systems and 
processes. We estimate that it would take 4 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. The 
data elements on which issuers would report are listed in the ICR 
released concurrently with this notice of proposed rulemaking. Issuers 
would provide HHS with the data collection requirements through an 
online tool that we would make available to them.
2. ICRs Regarding Data Collection From Recognized Accrediting Entities 
(Sec.  156.275)
    Proposed Sec.  156.275(c)(4) requires recognized accrediting 
entities to submit documentation to HHS as a condition of gaining and 
maintaining recognition. This documentation includes accreditation 
standards and requirements, processes, and measure specifications for 
performance measures. The burden associated with meeting this 
requirement is for an analyst level employee at the recognized 
accrediting entity to compile the documentation and electronically 
transmit it to HHS. It is assumed that these accreditation standards 
and requirements, processes, and measure specifications for performance 
measures would not be changed more than once per year. We estimate 2 
burden hours in

[[Page 33139]]

1 year for each of the accrediting entities at a cost of $110 for a 
total of $220.\8\
---------------------------------------------------------------------------

    \8\ Wage data in this section are taken from the Bureau of Labor 
Statistics available at http://www.bls.gov/oes/current/oes_dc.htm.
---------------------------------------------------------------------------

    Proposed Sec.  156.275(c)(5) also requires recognized accrediting 
entities to share accreditation survey data with the Exchange once the 
release of these data have been authorized by the QHP issuer. To comply 
with this information collection, the recognized accrediting entities 
would need to collect the Health Insurance Oversight System (HIOS) 
issuer identification from each issuer offering an Exchange QHP and 
seeking accreditation from the recognized accrediting entity. We 
estimate that the burden associated with meeting this requirement would 
be in revising the contract language with the issuer and then inputting 
the HIOS issuer identification into the accrediting entities' database 
once the HIOS issuer ID has been provided by the issuer. To fulfill 
this requirement, we are estimating approximately 17 hours of work for 
an analyst at each accrediting entity with the vast majority of that 
time used to input the data. The cost burden associated with this 
requirement is estimated to be $940. Second, the accrediting entity 
would need to organize its accreditation data elements specified in 
proposed Sec.  156.275(c)(5) to match the data template provided by 
each Exchange. We are assuming 51 State-based Exchanges and we are 
assuming that this will require five hours of labor per Exchange for a 
total of 255 burden hours for an operations analyst at each accrediting 
entity. The cost burden associated with this is $14,025. Third, each 
accrediting entity would need to supply the data elements to each 
Exchange once per month as these data are updated. We are estimating 
that this process would take one hour per Exchange each month for a 
total hour burden of 612 hours and a cost burden of $33,660 per year.
    In total, the hour burden for each accrediting entity is 884 hours 
and the total cost burden per accrediting entity is $48,625. For both 
of the accrediting entities, the hour burden is 1772 and the cost 
burden is $97,470.

C. Additional Information Collection Requirements

    This proposed rule imposes collection of information requirements 
as outlined in the regulation text and specified above. However, this 
proposed rule also makes reference to several associated information 
collection requirements that are not discussed in the regulations text 
contained in this document. The following is a discussion of these 
requirements.
1. State Selection of Benchmark Plan
    We request that States indicate to HHS their benchmark plan 
selection and provide information on this plan in the format that 
issuers are required to use, which leverages the current data 
collection for the Health Insurance Web Portal, as described above at 
the same time CMS collects benefit information from the three largest 
small group market plan issuers in each State. However, if a State 
selects as its benchmark one of the three largest small group market 
benchmark options, for which HHS proposes to collect data to establish 
default benchmarks, the State may choose to rely on the issuer 
submission and provide HHS with only the name of the plan and other 
necessary identifying information. If the State relies solely on issuer 
data, HHS would review the data to ensure benefits in all ten 
categories, required by statute are offered. We further note that 
States may voluntarily provide information on State benefit mandates. 
We estimate that it would take each State that selects a benchmark five 
hours to make a benchmark determination, compile the data, and submit 
the information in the required format to HHS. If a State selects one 
of the top three small group market plans and chooses to identify its 
selection by name only, we believe the burden would be less than five 
hours. At this time we do not have any way to accurately estimate how 
many States would opt to select a benchmark. We will accept comments on 
this issue.
2. Data Collection from Stand-Alone Dental Plans
    We request that issuers that intend to offer stand-alone dental 
plans in any State Exchange or in the Federally-facilitated Exchange 
voluntarily notify HHS of their intent to participate. This collection, 
which would also be a revision of the Health Insurance Web Portal PRA 
package (OCN: 0938-1086), includes data on whether the issuer intends 
to offer stand-alone coverage, the anticipated Exchange market in which 
coverage would be offered, and the State and service area in which the 
issuer intends to offer coverage in the Exchange.
    The burden associated with this voluntary submission includes the 
time and effort needed by the issuer to report on whether it intends to 
offer stand-alone dental coverage. We estimate that it would take 0.5 
hours for a health insurance issuer to submit this information. We 
estimate that approximately 20 issuers would respond to this data 
collection. Therefore, the total burden is estimated to be 10 hours. We 
anticipate that the reporting would require one employee at a cost of 
$77.00 an hour for a total cost of $38.50 a year per issuer. The total 
number of respondents is estimated to be approximately 20, for a total 
burden of $770.
    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this proposed rule; or
    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget,

Attention: CMS Desk Officer, [CMS-9965-P]
Fax: (202) 395-6974; or
Email: [email protected]

V. Regulatory Impact Analysis

    We have examined the impact of this 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 1 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 proposed 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 Information Collection 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. The PRA 
package that accompanies this proposed rule requests that issuers that

[[Page 33140]]

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 proposing to recognize as 
accrediting entities already meet most of the conditions for 
recognition, 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 proposed 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 proposes collecting data 
from issuers that offer the three largest small group products in each 
state and from NCQA and URAC, which are the Phase I recognized 
accrediting entities. For the purposes of the regulatory flexibility 
analysis, we expect the following types of entities to be affected by 
this proposed 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 receipts from these companies' 
other lines of business.\9\ 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.
---------------------------------------------------------------------------

    \9\ According to the Small Business Administration size 
standards, entities with average annual receipts of $7 million or 
less would be considered small entities for North American Industry 
Classification System (NAICS) Code 524114 (Direct Health and Medical 
Insurance Carriers) (for more information, see ``Table of Size 
Standards Matched To North American Industry Classification System 
Codes,'' effective March 26, 2012, U.S. Small Business 
Administration, available at http://www.sba.gov).
---------------------------------------------------------------------------

    This proposed rule also requires 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.\10\ 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.\11\ 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.\12\
---------------------------------------------------------------------------

    \10\ See ``About NCQA,'' NCQA Web site. Available at http://www.ncqa.org/tabid/675Default.aspx.
    \11\ See ``Frequently Asked Questions'' URAC Web site. Available 
at: https://www.urac.org/about/faqs.aspx#General.
    \12\ 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 
proposed 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 proposed rule (and subsequent 
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 proposed 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 would 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 
proposes to have two

[[Page 33141]]

accrediting entities 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 proposed rule (and subsequent 
final rule) that imposes substantial direct costs on State and local 
governments, preempts State law, or otherwise has Federalism 
implications. This proposed regulation, as it relates to the 
recognition of accrediting entities, does not impose any costs on State 
or local governments. However, this proposed 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 proposed 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 
proposed 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 proposes to amend 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

    1. The authority citation for part 156 continues 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).

    2. Amend part 156 by adding subpart B, consisting of Sec.  156.120, 
to read as follows:

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, that 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 has the meaning given to the term in Sec.  
146.136 of this chapter.
    (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 impacted. 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.
    3. Amend Sec.  156.275 by adding paragraph (c) to read as follows:


Sec.  156.275  Accreditation of QHP issuers.

* * * * *
    (c)(1) Recognition of accrediting entity by HHS. (i) Effective upon 
completion of conditions listed in paragraphs (c)(2) through (4) of 
this section, at which time HHS will notify the public in the Federal 
Register that 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. 
Such recognition is effective until rescinded or recognition is 
required to be made by the process identified in paragraph (c)(1)(ii) 
of this section.
    (ii) [Reserved]
    (2)(i) Scope of accreditation. Subject to paragraphs (c)(2)(ii) 
through (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.

[[Page 33142]]

    (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.
    (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).
    (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 (3) of this 
section to HHS at a time period specified by HHS.
    (ii) Recognized accrediting entities must provide any proposed 
changes or updates to the accreditation standards and requirements, 
processes, and measure specifications for performance measures with 60 
days notice prior to implementation.
    (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 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
    (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: May 23, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: May 23, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-13489 Filed 6-1-12; 11:15 am]
BILLING CODE 4120-01-P