Federal Register / Vol. 77, No. 108 / Tuesday, June 5, 2012 / Proposed Rules 33133 

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. 

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 nongrandfathered health plans in the 

individual and small group market, 

Medicaid benchmark and benchmarkequivalent 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 


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33134 Federal Register / Vol. 77, No. 108 / Tuesday, June 5, 2012 / Proposed Rules 

1See http://www.ncqa.org/tabid/135/ 

Default.aspx. Accessed April 24, 2012. See also 

https://www.urac.org/accreditation/ Accessed April 

24, 2012. 

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 nonMedicaid 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

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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Federal Register / Vol. 77, No. 108 / Tuesday, June 5, 2012 / Proposed Rules 33135 

2 45 CFR 147.140(a) defines grandfathered health 

coverage. 

3See ‘‘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. 

4See ‘‘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. 

participation in an Exchange, including 

the minimum certification requirements 

for QHPs. The provision in § 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 multiState 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 

§ 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 

§ 1301(a)(1)(B); Public Health Service 

Act § 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. 

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. 

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 (§ 156.120) 

1. Definitions 

Under § 156.120(a), we propose 

definitions for terms that are used 

throughout the section. For the most 

part, the definitions presented in 

§ 156.120(a) are taken from existing 

regulations. 

We propose to define ‘‘health 

benefits’’ as ‘‘benefits for medical care, 

as defined at § 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 § 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 § 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 § 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 § 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 

§ 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. 

Additionally, throughout this 

proposed rule we refer to ‘‘issuers’’ 

which is defined in previous 

rulemaking at 45 CFR 156.20. 

2. Required Information (§ 156.120(b)) 

In § 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 § 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 § 156.120(b)(2), we propose that 

the relevant issuers would submit data 

and descriptive information on the 


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33136 Federal Register / Vol. 77, No. 108 / Tuesday, June 5, 2012 / Proposed Rules 

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 § 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 § 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 

(§ 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 (§ 156.120(d)) 

In § 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 § 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 (§ 156.120(e)) 

Finally, § 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 standalone dental issuers can begin to submit 

this information. 

C. Accreditation of QHP Issuers 

(§ 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 § 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 

§ 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 


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Federal Register / Vol. 77, No. 108 / Tuesday, June 5, 2012 / Proposed Rules 33137 

5See http://www.ncqa.org/tabid/135/ 

Default.aspx. Accessed April 24, 2012. 

6URAC 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. 

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. 

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 § 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 § 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-qualitystrategy04302012a.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 § 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. 

In § 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 

§ 156.230(a). We solicit comments on 

this proposed requirement. 

In § 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 § 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 § 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 


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7The QHP issuer will provide the accrediting 

entity with this identifier. 

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 

§ 156.275(c)(2) and (3) would no longer 

be met. We are soliciting comments on 

these documentation requirements. 

As codified in § 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. 

• 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 (§ 156.120) 

Proposed § 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 

(§ 156.275) 

Proposed § 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 


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8Wage data in this section are taken from the 

Bureau of Labor Statistics available at http:// 

www.bls.gov/oes/current/oes_dc.htm. 

1 year for each of the accrediting entities 

at a cost of $110 for a total of $220.8

Proposed § 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 § 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 Federallyfacilitated 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 standalone 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: OIRA_submission@omb.eop.gov 

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 


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9According 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). 

10See ‘‘About NCQA,’’ NCQA Web site. Available 

at http://www.ncqa.org/tabid/675Default.aspx. 

11See ‘‘Frequently Asked Questions’’ URAC Web 

site. Available at: https://www.urac.org/about/ 

faqs.aspx#General. 

12According 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). 

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. 

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

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 


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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 § 156.120, to read as 

follows: 

Subpart B—Standards for Essential 

Health Benefits, Actuarial Value, and 

Cost Sharing 

§ 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 § 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 § 159.110 

of this chapter. 

Health plan has the meaning given to 

the term, ‘‘Portal Plan’’ in § 159.110 of 

this chapter. 

Small group market has the meaning 

given to the term in § 155.20 of this 

chapter. 

State has the meaning given to the 

term in § 155.20 of this chapter. 

Treatment limitations has the 

meaning given to the term in § 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 § 156.275 by adding 

paragraph (c) to read as follows: 

§ 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. 


wreier-aviles on DSK7SPTVN1PROD with PROPOSALS
33142 Federal Register / Vol. 77, No. 108 / Tuesday, June 5, 2012 / Proposed Rules 

(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 § 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 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R8–ES–2010–0049; 

4500030113] 

RIN 1018–AX89 

Endangered and Threatened Wildlife 

and Plants; 12-Month Petition Finding 

and Proposed Listing of 

Arctostaphylos franciscana as 

Endangered 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), announce the 

reopening of the public comment period 

on our September 8, 2011, combined 12- 

month petition finding and proposed 

rule to list Arctostaphylos franciscana 

(Franciscan manzanita) as endangered 

and designate critical habitat under the 

Endangered species Act of 1973, as 

amended (Act). In the proposed rule, we 

found that critical habitat was not 

determinable at the time because we did 

not have sufficient information on what 

physical and biological features would 

be essential to the conservation of the 

species, or what other areas outside the 

known occupied site may be essential 

for the conservation of the species. The 

Service seeks data and comments from 

the public on this proposed listing rule 

and whether the designation of critical 

habitat for the species is prudent and 

determinable. We are reopening the 

comment period to allow all interested 

parties an additional opportunity to 

comment on the proposed rule and to 

submit information on the status of the 

species. Comments previously 

submitted need not be resubmitted, as 

they will be fully considered in 

preparation of the final rule. 

DATES: We will accept comments 

received or postmarked on or before 

June 20, 2012. Comments submitted 

electronically using the Federal 

eRulemaking Portal (see ADDRESSES

section, below) must be received by 

11:59 p.m. Eastern Time on the closing 

date. 

ADDRESSES: Document availability: You 

may obtain copies of the proposed rule 

on the Internet at http:// 

www.regulations.gov at Docket Number 

FWS–R8–ES–2010–0049, or by mail 

from the Sacramento Fish and Wildlife 

Office (see FOR FURTHER INFORMATION

CONTACT). 

Comment submission: You may 

submit written comments by one of the 

following methods: 

(1) Electronically: Go to the Federal 

eRulemaking Portal: http:// 

www.regulations.gov. In the Search box, 

enter FWS–R8–ES–2010–0049, which is 

the docket number for this rulemaking. 

Then, on the left side of the screen, 

under the Document Type heading, 

click on the Proposed Rules link to 

locate this document and submit a 

comment. 

(2) By hard copy: Submit by U.S. mail 

or hand-delivery to: Public Comments 

Processing, Attn: FWS–R8–ES–2010– 

0049; Division of Policy and Directives 

Management; U.S. Fish and Wildlife 

Service; 4401 N. Fairfax Drive, MS 

2042–PDM; Arlington, VA 22203. 

We request that you send comments 

only by the methods described above. 

We will post all information received on 

http://www.regulations.gov. This 

generally means that we will post any 

personal information you provide us 

(see the Public Comments section below 

for more information). 

FOR FURTHER INFORMATION CONTACT: 

Karen Leyse, Listing Coordinator, 

Sacramento Fish and Wildlife Office, 

2800 Cottage Way, Room W–2605, 

Sacramento, CA 95825; by telephone at 

916–414–6600; or by facsimile at 

916–414–6712. If you use a 

telecommunications device for the deaf 

(TDD), please call the Federal 


wreier-aviles on DSK7SPTVN1PROD with PROPOSALS