42658 Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Rules and Regulations 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 11, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.555 is amended by 

alphabetically adding ‘‘Artichoke, 

globe’’ to the table in paragraph (a) to 

read as follows: 

§ 180.555 Trifloxystrobin; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe ........................ 1.0 

* * * * * 

* * * * * 

[FR Doc. 2012–17630 Filed 7–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 156 

[CMS–9965–F] 

RIN 0938–AR36 

Patient Protection and Affordable Care 

Act; Data Collection To Support 

Standards Related to Essential Health 

Benefits; Recognition of Entities for 

the Accreditation of Qualified Health 

Plans 

AGENCY: Department of Health and 

Human Services. 

ACTION: Final rule. 

SUMMARY: This final rule establishes 

data collection standards necessary to 

implement aspects of section 1302 of 

the Patient Protection and Affordable 

Care Act (Affordable Care Act), which 

directs the Secretary of Health and 

Human Services to define essential 

health benefits. This final rule outlines 

the data on applicable plans to be 

collected from certain issuers to support 

the definition of essential health 

benefits. This final rule also establishes 

a process for the recognition of 

accrediting entities for purposes of 

certification of qualified health plans. 

DATES: Effective Date: These regulations 

are effective on August 20, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Adam Block at (410) 786–1698, for 

matters related to essential health 

benefits data collection. 

Deborah Greene at (301) 492–4293, for 

matters related to accreditation of 

qualified health plans. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Beginning in 2014, all nongrandfathered health plans in the 

individual and small group market, and 

other plans will cover the essential 

health benefits (EHB), as defined by the 

Secretary of Health and Human Services 

(the Secretary). The Affordable Care Act 

directs that the EHB reflect the scope of 

benefits covered by a typical employer 

plan and cover at least the following 10 

general categories of items and services: 

Ambulatory patient services; emergency 

services; hospitalization; maternity and 

newborn care; mental health and 

substance use disorder services, 

including behavioral health treatment; 

prescription drugs; rehabilitative and 

habilitative services and devices; 

laboratory services; preventive and 

wellness services and chronic disease 

management; and pediatric services, 

including oral and vision care. EHB will 

promote predictability for consumers 

who purchase coverage in these 

markets, facilitate comparison across 

health plans, and ensure that individual 

and small group subscribers have the 

same access to the same scope of 

benefits provided under a typical 

employer plan. 

This final rule includes data reporting 

standards for health plans that represent 

potential State-specific benchmark 

plans. Specifically, the final rule 

establishes that issuers of the largest 

three small group market products in 

each state report information on covered 

benefits. 

In addition, this rule establishes the 

first phase of a two-phased approach for 

recognizing accrediting entities to 

implement the standards established 

under the Affordable Care Act for 

qualified health plans (QHPs) to be 

accredited on the basis of local 

performance by an accrediting entity 

recognized by the Secretary on a 

timeline established by the Exchange 

and addresses some data sharing and 

performance requirements of the 

recognized accrediting entities. In phase 

one, the National Committee for Quality 

Assurance (NCQA) and URAC are 

recognized as accrediting entities on an 

interim basis. In phase two, a criteriabased review process will be adopted 

through future rulemaking. 

I. Background 

Section 2707 of the Public Health 

Service Act, as added by section 1201 of 

the Affordable Care Act, directs that, for 

plan years beginning on or after January 

1, 2014, health insurance issuers 

offering non-grandfathered plans in the 

individual or small group market ensure 

such coverage includes EHB as 

described in section 1302(a) of the 

Affordable Care Act. Section 1302 of the 

Affordable Care Act provides for the 

establishment of EHB, to be defined by 

the Secretary. The law also directs that 

EHB reflect the scope of benefits 

covered by a typical employer plan and 

cover at least the 10 general categories 

of items and services previously listed. 

Section 1302(b)(4) of the Affordable 

Care Act further establishes that the 

Secretary define EHB such that it: 

• Sets an appropriate balance among 

the 10 general categories; 

• Does not discriminate based on age, 

disability, or expected length of life; 

• Takes into account the health care 

needs of diverse segments of the 

population; and 

• Does not allow denials of essential 

benefits based on age, life expectancy, 

disability, or degree of medical 

dependency and quality of life. 

Section 1302(b)(4) of the Affordable 

Care Act further directs the Secretary to 


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1Available at: http://cciio.cms.gov/resources/ 

files/Files2/12162011/ 

essential_health_benefits_bulletin.pdf. 

consider the provision of emergency 

services and dental benefits when 

determining whether a particular health 

plan covers the EHB. Finally, sections 

1302(b)(4)(G) and (H) of the Affordable 

Care Act direct the Secretary to 

periodically review the EHB, report the 

findings of the review to the Congress 

and to the public, and update the EHB 

as needed. A bulletin on HHS’s 

intended benchmark approach to 

defining essential health benefits was 

made available for comment on 

December 16, 2011 (EHB Bulletin).1

Section 1311(c)(1)(D)(i) of the 

Affordable Care Act provides that in 

order to be certified as a QHP and 

operate in an Exchange, a health plan 

must be accredited by a recognized 

accrediting entity on a uniform timeline 

established by the applicable Exchange. 

In a separate rule titled ‘‘Patient 

Protection and Affordable Care Act; 

Establishment of Exchanges and 

Qualified Health Plans; Exchange 

Standards for Employers’’ (Exchange 

Rule) published in the March 27, 2012 

Federal Register (77 FR 18310), HHS 

finalized 45 CFR 156.275, specifying 

that a QHP issuer must be accredited by 

an entity recognized by HHS. 

II. Provisions of the Proposed 

Regulation and Analysis and Responses 

to Public Comments 

The Data Collection to Support 

Standards Related to Essential Health 

Benefits; Recognition of Entities for the 

Accreditation of Qualified Health Plans 

proposed rule was published in the 

Federal Register on June 5, 2012 and 

the comment period closed on July 5, 

2012 (77 FR 33133). In total, we 

received 80 public comments on the 

proposed regulation. 

We received numerous comments on 

the EHB data collection portion of the 

proposed rule. Commenters represented 

a variety of stakeholders, including 

issuers, states, consumer groups, and 

others interested parties. We received a 

number of comments in support of the 

proposed data collection, including the 

required submission of data on 

treatment limitations, prescription drug 

coverage, and other descriptive 

information for small group plans. 

Commenters also recommended 

specific uses of the data we proposed to 

collect, for example that consumers and 

states have access to the data. Several 

commenters urged HHS to use the data 

for specific purposes, such as to ensure 

that certain services are covered, that 

plans are not discriminatory, that 

prescription drug coverage is 

comparable to a typical employer plan 

and that benefit limits do not reduce 

actuarial value (AV). We note that the 

purpose of the data collection in this 

final rule is to collect benefit and 

coverage information from potential 

benchmark plans. Accordingly, we 

addressed comments on potential uses 

of the data collected to the extent that 

they are related to the development of 

benchmark plans. 

We received a number of comments 

that fall outside of the scope of this 

regulation, which is specific to data 

collection from certain issuers to 

support the definition of essential 

health benefits. Because we intend to 

publish additional rules on EHB 

standards in the future, we do not 

specifically address these comments in 

this final rule. 

We also received numerous comments 

on the proposed rule regarding 

recognition of accrediting entities. 

Commenters represented a diverse set of 

stakeholders including but not limited 

to accrediting entities, healthcare 

provider organizations, consumer 

groups, health plans, industry experts, 

and members of the public. The vast 

majority of commenters supported the 

recognition of NCQA and URAC for the 

accreditation of QHPs in the interim 

phase one and agreed with the proposed 

provisions that we outlined in the 

NPRM. We received a number of 

comments on the timeline, financial and 

operational requirements for 

accreditation, the Federally Facilitated 

Exchange (FFE), the broader quality 

requirements in the Affordable Care Act, 

network adequacy and access standards 

for QHPs, coordination of quality 

requirements inside and outside 

Exchanges, and Exchange requirements. 

We have not addressed such comments 

and others that are outside the scope of 

this final rule. HHS will be releasing 

future rulemaking and guidance on 

these other topics. Several commenters 

requested clarifications regarding the 

future recognition process for 

accrediting entities, clinical quality 

measures criteria, accreditation 

standards related to network adequacy 

and access, documentation and data 

sharing requirements. In this final rule, 

we have responded to comments 

submitted in response to the recognition 

of entities for the accreditation of QHPs 

within the scope of the proposal and 

this final rule. 

A. Collection of Essential Health 

Benefits Data (§ 156.120) 

1. Definitions 

Under § 156.120(a), we proposed 

definitions for terms that are used 

throughout the section. For the most 

part, the definitions presented in 

§ 156.120(a) were taken from existing 

regulations. 

We proposed 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 proposed that for the purposes of 

this data collection ‘‘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 note that 

a ‘‘portal plan’’ is collected as a unique 

combination of benefits, which may 

include optional benefits available for 

an additional premium (often referred to 

as ‘‘riders’’) as well as benefits that are 

legally considered riders but are not 

optional for consumers (‘‘mandatory 

riders’’), if those benefits are part of the 

most commonly purchased set of 

benefits within the product by 

enrollment. 

We proposed that ‘‘health insurance 

product’’ has the meaning given to the 

term at § 159.110 of this chapter, which 

is a package of benefits that an issuer 

offers that is reported to state regulators 

in an insurance filing. We proposed that 

‘‘small group market’’ has the meaning 

given to the term in § 155.20 of this 

chapter, which is the meaning in section 

1304(a)(3) of the Affordable Care Act. 

We also proposed that ‘‘State’’ has the 

meaning given at § 155.20. We noted 

that the Public Health Service Act 

definition of ‘‘State’’ that would apply 

to section 2707(a) is broader than the 

definition in section 1304 of the 

Affordable Care Act. 

We proposed that ‘‘treatment 

limitations’’ have the meaning found in 

§ 146.136 of this chapter, which 

includes both quantitative and 

nonquantitative limits on benefits. 

Examples of quantitative limits include 

limits based on the frequency of 

treatment, days of coverage, or other 

similar limits on the scope and duration 

of treatment. Examples of 

nonquantitative limits include prior 

authorization and step therapy 

requirements. In response to comments 


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received on this proposal, we are 

changing the definition of ‘‘treatment 

limitations’’ for the purpose of this final 

rule to include only quantitative limits. 

Additionally, throughout the 

proposed rule we referred to ‘‘issuers,’’ 

which is defined in previous 

rulemaking at 45 CFR 156.20. 

Comment: We received several 

comments on the treatment of riders, or 

optional benefits available for an 

additional premium, under proposed 

§ 156.120. Commenters requested that 

HHS clarify the treatment of riders with 

respect to EHB; specifically some 

commenters recommended that HHS 

collect information on riders made 

available as part of a plan and stated 

that benefits offered through riders be 

considered part of EHB. Another 

commenter expressed concern that the 

definition of ‘‘health insurance product’’ 

included in the final rule could make it 

difficult for issuers and states to identify 

the largest plan within that product as 

a benchmark option. 

Response: In response to these 

comments, we now use the term portal 

plan defined in § 159.110 for this 

identification in the final rule, which as 

described above may include riders. The 

issuers subject to this reporting 

requirement will submit the requested 

benefit data on the largest plan by 

enrollment within that product. By 

using the ‘‘portal plan’’ definition for 

this data collection, the largest plan by 

enrollment will be comprised of the 

most commonly purchased unique set of 

benefits, which may include riders. 

2. Required Information (§ 156.120(b)) 

In § 156.120(b), we proposed that 

certain issuers of applicable plans 

described in paragraph (c) of this 

section submit certain benefit and 

enrollment information to HHS. We 

stated that this information could be 

used by HHS and eventually states, 

Exchanges, and issuers to define, 

evaluate, and provide the EHB. 

First, at § 156.120(b)(1), we proposed 

that the relevant issuers would submit 

administrative data necessary to identify 

their health plan. Since an issuer may 

offer multiple similar plans within a 

product, this information is critical to 

the identification of a single, uniquely 

identified benchmark plan. 

At § 156.120(b)(2), we proposed that 

the relevant issuers would submit data 

and descriptive information on the 

plans identified in paragraph (d) in four 

areas. Additional detail describing the 

specific data elements that issuers 

would submit can be found in the 

revision of the currently approved 

Health Insurance Web Portal 

information collection request (ICR). 

The ICR is approved under OCN: 0938– 

1086, and is available to the public 

under a notice and comment period 

separate from the notice of proposed 

rulemaking. That notice and comment 

period is ongoing until August 5, 2012. 

Section 156.120(b)(2)(i) proposed that 

certain issuers submit information on 

covered health benefits in the applicable 

plans to be used to define certain 

benchmark plan options. 

In section 156.120(b)(2)(ii), we 

proposed to collect from issuers data on 

treatment limitations imposed on 

coverage, if applicable. For example, a 

quantitative scope and duration 

treatment limitation might limit a 

physical therapy benefit to 10 physical 

therapy visits per year. 

At § 156.120(b)(2)(iii), we proposed to 

collect data on drug coverage. This 

would include a list of covered drugs 

and whether each drug is subject to 

prior authorization and/or step therapy. 

In response to comments received on 

this proposal, we no longer intend to 

collect data on prior authorization and/ 

or step therapy for drug coverage. 

At § 156.120(b)(2)(iv) we proposed to 

collect plan enrollment data, which is 

discussed in more detail in the ‘‘Plans 

Impacted’’ section below. 

Comment: Many commenters 

requested that HHS collect data in 

addition to the elements listed in the 

proposed rule, such as data on 

exclusions, medical necessity, 

habilitative services, cost-sharing 

(including premiums and co-pays), 

additional drug data, additional data on 

treatment limits, and a more extensive 

list of benefits. 

Response: We believe the data 

collection proposed balances a minimal 

data collection burden on issuers while 

being sufficient to support the 

establishment of a potential benchmark 

for each state. Therefore, we are not 

requiring issuers to report any 

additional data elements in this final 

rule. 

Comment: Some commenters 

expressed concern with the data 

collection of treatment limitations, 

particularly with regard to 

nonquantitative treatment limits, stating 

that the data elements are related to 

product design as opposed to benefit 

coverage and that the data are not 

necessary to establish EHB standards. 

Others expressed concern with the 

collection of prescription drug 

formularies. 

Response: We believe that the data 

collection described in the proposed 

rule reflects the appropriate balance 

between the need to collect data that are 

sufficiently specific to establish 

benchmark plans while minimizing the 

burden on issuers. However, we agree 

with the commenters that the data on 

nonquantitative limits are not necessary 

for benchmark plan purposes and are 

therefore amending our definition of 

treatment limitations and data 

collection to include only quantitative 

limits. We encourage commenters to 

continue to submit comments on the 

PRA package associated with this rule. 

Comment: Two commenters 

expressed concern that the proposed 

data collection asks for information that 

is proprietary and confidential. 

Response: The data HHS intends to 

collect are part of the contract 

agreement between the issuer and 

enrollees in the plan and available to 

every enrollee. Therefore, we believe 

issuers will not experience adverse 

commercial effects as a result of 

reporting the data. 

Comment: Some commenters 

recommended that HHS leverage data 

already collected by states and by 

HealthCare.gov for purposes of 

establishing default benchmark plans 

and urged HHS to synchronize the 

collection of data described in the 

proposed rule with data collection to 

support HealthCare.gov. 

Response: The benefit data are 

consistent with the data collected to 

support HealthCare.gov. We believe it is 

necessary to collect additional 

information related to treatment 

limitations and drug coverage to 

establish the definition of essential 

health benefits. We also note that the 

data we intend to collect to establish 

potential benchmark plans are more 

recent and at a plan level. 

Comment: Several commenters 

requested that HHS clarify specific data 

elements of the proposed data 

collection, for example that HHS 

describe the level of specificity and 

establish the format for data submission. 

One commenter recommended that HHS 

modify the language in its data 

collection on drugs from ‘‘drug 

coverage’’ to ‘‘formulary’’ and urged 

HHS to ensure a flexible prescription 

drug benefit. 

Response: We refer commenters to the 

relevant parts of the PRA package 

associated with the NPRM and available 

at http://www.cms.gov/Regulations-and 

Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing-Items/CMS1247405.html. The 

PRA package includes additional 

information on the data HHS intends to 

collect with regard to treatment 

limitations, as well as a list of the data 

elements. 


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2Available at: http://cciio.cms.gov/resources/ 

files/largest-smgroup-products-7-2-2012.pdf.PDF. 

3Available at: http://cciio.cms.gov/resources/ 

files/largest-smgroup-products-7-2-2012.pdf.PDF. 

3. Issuers Who Will Report 

(§ 156.120(c)) 

Section 156.120(c) of the proposed 

regulation specified that these reporting 

requirements would apply only to 

certain issuers. Specifically, we 

proposed to collect data from the issuers 

in each state that offer the three largest 

health insurance products, by 

enrollment, in that state’s small group 

market. We proposed that enrollment 

data submitted to www.HealthCare.gov 

would be the source of product 

enrollment and therefore, the products 

eligible to be benchmarks based on 

enrollment (described in part 159 of this 

title) on March 31, 2012, the date set 

forth in the December 16, 2011 EHB 

bulletin. State data may vary from 

www.HealthCare.gov data, and we 

requested comment on whether states 

should be permitted to use an 

alternative data source for determining 

the enrollment in the small group 

market. We also solicited comment on 

whether closed block products or 

association products should be included 

as options in the selection of the largest 

three products. 

Under the approach outlined in the 

EHB bulletin, states would be permitted 

to select their own benchmark plans 

from a set of options. State submissions 

of these selections are information 

collections under the PRA. As part of 

the PRA package, we requested 

comment on the draft instructions for 

states to submit benefits for their 

selected benchmark plan. 

Comment: Several commenters made 

recommendations with respect to which 

plans should be available as benchmark 

plan options. Some commenters 

recommended that HHS exclude 

association plans and plans closed to 

new enrollment as benchmark plan 

options. In contrast, a few commenters 

stated that plans closed to new 

enrollment should be available as 

benchmark plan options. 

Response: As described in the EHB 

Bulletin, HHS intends to propose that 

EHB be defined in reference to one of 

four benchmark plan options. With 

respect to potential default benchmark 

plans, we refer commenters to the 

guidance published on July 2, 2012, 

titled ‘‘Essential Health Benefits: List of 

the Largest Three Small Group Products 

by State,’’ 2 which provides a state-bystate list of small group market products 

available for selection as benchmark 

plans. 

Comment: Several commenters 

expressed concern that HHS is only 

collecting data on the small group 

market benchmark options. 

Response: We note that this regulation 

is narrow in scope and collects data in 

order to establish potential default 

benchmark plans in each state. As stated 

in the EHB Bulletin, the default 

benchmark plan in each state is the 

largest small group market plan within 

the largest small group market product 

by enrollment, supplemented to reflect 

coverage in the 10 statutory benefit 

categories. 

Comment: Several commenters 

recommended that HHS consider 

additional data to establish EHB, such 

as national claims data or data from 

Medicaid. 

Response: Our proposed data 

collection from issuers is consistent 

with the benchmark approach described 

in the EHB bulletin, which uses a 

typical employer plan as a reference to 

define EHB. 

4. Plans Affected (§ 156.120(d)) 

In § 156.120(d), we proposed that 

issuers of the largest three products in 

each state provide information based on 

the plan with the highest enrollment 

within the product. For purposes of 

identifying the benchmark plan, we 

proposed to identify the plan following 

the definition of ‘‘portal plan’’ in 

§ 159.110 of this chapter. 

We stated in the proposed rule that 

issuers may use their own data to 

determine which plan within each 

product has the highest enrollment, 

although we expect that for many 

products, the benefits will be the same 

across plans within the product. We 

also specified that enrollment data 

should reflect a plan’s entire service 

area and to the extent possible should 

align with the timing of the 

www.HealthCare.gov data collection 

(reflecting enrollment as of March 31, 

2012). We requested comment on the 

necessity of plan-level specificity. 

Comment: Several commenters 

offered feedback on the enrollment data 

used to identify the plans eligible for 

benchmark consideration. Several 

comments supported the use of the 

HealthCare.gov for determining 

enrollment. Commenters also urged 

HHS to allow states to use their own 

enrollment data and recommended that 

if state enrollment data conflict with 

HealthCare.gov data, the state data 

should be considered. In contrast, one 

commenter recommended that if state 

enrollment data are permitted, states 

should be required to demonstrate that 

the state data are more accurate. 

Response: The guidance published on 

July 2, 2012, titled ‘‘Essential Health 

Benefits: List of the Largest Three Small 

Group Products by State,’’ 3 clarifies the 

small group market products that are 

available for benchmark plan 

consideration in each state. In 

developing this list, HHS worked with 

states to reconcile enrollment data from 

HealthCare.gov with state data when 

necessary. 

5. Reporting Requirements (§ 156.120(e)) 

Finally, § 156.120(e) proposed that 

issuers described in subparagraph (c) 

submit the information described in 

subparagraph (b) to HHS in a form and 

manner to be determined by HHS. We 

stated that we intend to make 

information on final state selections of 

benchmarks publicly available as soon 

as possible so that issuers can use it for 

benefit design and rate setting for 2014. 

We intend to publish the State-specific 

benchmarks for notice and comment 

and then finalize those benchmarks, as 

approved by the Secretary. We 

welcomed public comment on this 

approach. 

Comment: Several commenters 

requested additional guidance on the 

schedule for collecting data pursuant to 

this final rule. 

Response: We clarify in this final rule 

that the submission window for 

applicable issuers will open upon the 

effective date of this final regulation and 

remain open until September 4, 2012. 

Issuers will use the Health Insurance 

Oversight system to make these 

submissions. 

Comment: Several commenters urged 

HHS to make the data collected 

pursuant to this final rule, including 

data on benefits, treatment limits, and 

prescription drugs, publicly available to 

all stakeholders. Several commenters 

urged HHS to release these data as soon 

as possible. In addition, some 

commenters recommended that HHS 

establish a federal oversight role in the 

evaluation and approval of state-specific 

EHB packages. 

Response: HHS intends to publish 

State-specific benchmarks for notice and 

comment. 

B. Voluntary Data Collection From 

Stand-Alone Dental Plans 

Section 1302(b) of the Affordable Care 

Act outlines the ten statutory benefit 

categories, including pediatric oral care, 

which must be covered by applicable 

plans. Section 1302(b)(4)(F) allows 

QHPs in an Exchange in a state to 

choose not to offer coverage for 

pediatric oral services provided that a 

stand-alone dental benefit plan that 

covers pediatric oral services is offered 


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through the same Exchange. In order for 

QHPs to know whether their plan 

design must include pediatric oral 

services, issuers need to know if standalone dental plans would be offered 

through their Exchange. To facilitate 

and streamline the communication of 

this information, we proposed to collect, 

on a voluntary basis, information from 

likely stand-alone dental issuers to find 

out whether various Exchanges are 

likely to have stand-alone plans as 

options. 

Comment: One commenter expressed 

concern that the data collection from 

stand-alone dental plans described in 

the proposed rule would be voluntary, 

and recommended that HHS require 

QHPs to offer pediatric dental benefits 

unless there is confirmation that a 

stand-alone dental plan will be offered. 

Response: We appreciate the 

commenter’s concern and note that the 

goal of this data collection is to begin 

the process of identifying which issuers 

intend to offer stand-alone dental 

coverage in Exchanges. We believe that 

a requirement is not necessary and this 

voluntary collection was only proposed 

to facilitate the most efficient exchange 

of information between issuers. 

C. Accreditation of QHP Issuers 

(§ 156.275) 

1. Recognition of Accrediting Entity by 

HHS (§ 156.275(c)(1)) 

Section 1311(c)(1)(D)(i) of the 

Affordable Care Act directs a health 

plan to ‘‘be accredited with respect to 

local performance on clinical quality 

measures * * * by any entity 

recognized by the Secretary for the 

accreditation of health insurance issuers 

or plans (so long as any such entity has 

transparent and rigorous methodological 

and scoring criteria).’’ HHS has 

determined that recognizing entities 

through an interim phase one process is 

necessary to meet the timeline for 

Exchange QHP certification activities 

and may include the accreditation 

requirement, depending on the uniform 

timeline established by an Exchange. In 

the proposed rule, we stated that after 

a survey of the market, to HHS’s 

knowledge, only two entities that 

accredit health plans meet or plan to 

meet the statutory requirements this 

year. We proposed recognition of the 

National Committee for Quality 

Assurance (NCQA) and URAC on an 

interim basis for the purpose of 

accreditation of QHPs, subject to the 

conditions specified in paragraphs 

(c)(2), (c)(3), and (c)(4) of § 156.275 of 

the proposed rule. As such, we 

proposed for this recognition to be 

effective once these conditions are met, 

at which time HHS would provide 

notification in the Federal Register. We 

requested comment on whether or not 

there are other accrediting entities that 

meet or would meet the statutory 

requirements this year. 

In addition, we proposed certain data 

sharing and performance standards for 

the recognized accrediting entities. 

We are making a technical correction 

in this final rule to clarify that both 

NCQA and URAC currently meet certain 

statutory requirements for accreditation. 

At the time the proposed rule was 

published, we did not include the fact 

that URAC had already released its 

Health Plan Accreditation Program 

Version 7 effective January 3, 2012, 

which includes reporting on a CAHPS 

survey and a set of clinical performance 

measures which are statutorily required 

to be considered as part of accreditation. 

Here, we clarify that both entities have 

already issued health plan accreditation 

standards that meet the conditions for 

recognition as detailed in paragraphs 

(c)(2)(ii), (c)(2)(iv) and (c)(3) of this rule. 

Comment: The vast majority of 

commenters expressed support for 

recognizing NCQA and URAC in phase 

one of the process to recognize 

accrediting entities. Commenters agreed 

with provisions to identify these two 

entities in this interim phase and 

encouraged HHS to finalize its 

recognition of NCQA and URAC as soon 

as possible. 

Response: We intend to provide 

notification in the Federal Register to 

make this recognition effective once the 

documentation requirements in (c)(4) 

are satisfied. 

Comment: One commenter stated that 

the Accreditation Association for 

Ambulatory Health Care, Inc. (AAAHC) 

should be recognized as an accrediting 

entity for the purposes of QHP 

certification in addition to the NCQA 

and URAC in the phase one recognition 

process. The commenter contends that 

AAAHC meets the requirements for the 

phase one recognized accrediting 

entities. 

Response: Upon review of the 

AAAHC’s accreditation processes and 

standards, we believe that, currently, 

the AAAHC does not meet the statutory 

requirements necessary to be recognized 

for phase one. Our review indicates that 

the AAAHC does not currently score 

clinical quality and CAHPS data from 

health plans as part of accreditation in 

a standardized, comparable way across 

health plans using transparent and 

rigorous methodological and scoring 

criteria, as directed by section 

1311(c)(1)(D)(i) of the Affordable Care 

Act and 45 CFR156.275(c)(3), which is 

finalized in this rule. We believe that 

the methodology and scoring criteria for 

accreditation by recognized accrediting 

entities is a significant requirement that 

contributes to the strength and validity 

of the accreditation of QHPs. For these 

reasons, the statutory accreditation 

requirements for QHP issuers would not 

be met if AAAHC were recognized as an 

accrediting entity as part of the phase 

one recognition process. In the final 

rule, we are maintaining the proposed 

recognition of the NCQA and URAC in 

the interim phase one process of 

recognizing accrediting entities. We 

encourage entities that would like to be 

recognized as accrediting entities for the 

purposes of fulfilling the accreditation 

requirement for QHPs in the future to 

prepare and plan to apply for the phase 

two recognition process. We anticipate 

that the future recognition process will, 

at a minimum, require accreditation on 

local performance in the nine categories 

specified in 45 CFR 156.275(a)(1) and 

clinical measures that span a broad 

range of conditions and domains. 

Comment: Two commenters requested 

that CMS establish an accreditation 

recognition process that enables New 

York and other states with rigorous 

issuer regulation, state licensing and 

quality monitoring requirements to be 

recognized as accrediting entities in 

phase one such that accreditation by 

entities such as NCQA and URAC is 

unnecessary if QHP issuers are licensed 

in such states. The commenters state 

that the licensing and oversight 

processes and standards in New York 

exceed those of NCQA and URAC. 

Response: The standards described by 

commenters are currently for state 

licensing and oversight requirements 

and not for accreditation of health 

plans. However, the statute specifically 

directs that QHPs be accredited and that 

the Secretary recognize accrediting 

entities. In the final rule, we are 

maintaining the proposed recognition of 

the NCQA and URAC in the interim 

phase one process of recognizing 

accrediting entities. However, we will 

consider the role of states in the phase 

two recognition process for accrediting 

entities. 

Comment: One commenter requested 

a specific public deadline for URAC to 

obtain full approval as a recognized 

accrediting entity so that QHPs may 

confidently choose their accreditation 

provider and begin their accreditation 

process immediately. The commenter 

suggests that if URAC does not meet full 

approval for being a recognized 

accrediting entity by a specified 

deadline, that the accreditation 

requirement be delayed until sufficient 

accrediting entity choices are available. 


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Response: As noted, we have made a 

technical correction to the proposed 

rule to accurately state that URAC has 

already released its Health Plan 

Accreditation Program Version 7 which 

includes reporting on a CAHPS survey 

and a set of clinical performance 

measures. We intend to recognize both 

URAC and the NCQA as recognized 

accrediting entities for the interim phase 

one recognition process once both 

entities fulfill the documentation 

requirements finalized in 

§ 156.275(c)(4). 

Comment: One commenter requested 

clarification regarding which health 

plan accreditation program URAC is 

proposing because there are multiple 

materials referenced including Health 

Plan Accreditation Program 7.0, Health 

Insurance Exchange Version 7.1 and 

measures Version 1.3 

Response: We clarify that URAC’s 

publicly released Health Plan 

Accreditation Program Version 7 

includes the standards that meet the 

statutory requirements to be recognized 

as an accrediting entity of QHPs and has 

been effective since January 3, 2012. 

Comment: Several commenters 

expressed concern that NCQA or URAC 

accreditation is not the best measure of 

the quality and effectiveness of 

Consumer Operated and Oriented Plans 

(CO–OP). The commenters are 

concerned that the accreditation 

processes of NCQA and URAC do not 

adequately address many of the key 

goals established for CO–OPs under the 

Affordable Care Act, including member 

control, consumer focus and benefit 

delivery innovation. Commenters 

proposed that the accrediting entities 

modify their accreditation processes to 

include a focus on the unique nature of 

CO–OPs. 

Response: Pursuant to 45 CFR 

156.520(e)(2), CO–OPs must meet the 

same accreditation standards as other 

QHPs. We maintain, in this final rule, 

the recognition of accrediting entities 

for phase one. We will consider the 

unique goals established for all QHPs 

including CO–OP plans as we develop 

the requirements for the phase two 

recognition process. 

2. Phased Recognition Process for 

Accrediting Entities (§ 156.275(c)(1)) 

We proposed that the recognition as 

an approved entity for accreditation of 

QHPs is effective until it is rescinded or 

this interim phase one process is 

replaced by the process that we intend 

to identify in future rulemaking. We 

proposed for the future phase two 

recognition process to include an 

application procedure, standards for 

recognition, criteria-based review of 

applications, public participation, and 

public notice of the recognition for 

entities seeking to become a recognized 

accrediting entity. We welcomed 

comments to inform this future 

rulemaking. 

Comment: A few commenters stated 

that recognized accrediting entities’ 

accreditation processes should be 

equally rigorous, include comparable 

accreditation results and use consistent 

standards. One commenter urged CMS 

to establish standards as part of the 

phase two recognition process, then 

compare these standards with the phase 

two accrediting entities’ standards to 

recognize them as accrediting entities 

for the purposes of QHP accreditation. 

Response: We agree that recognized 

accrediting entities should have 

rigorous, comparable processes and 

standards. We will consider the 

commenter’s suggestion regarding use of 

a crosswalk to compare and ensure that 

each recognized accrediting entity meet 

the standards for the phase two 

recognition process. We will be 

establishing these standards in future 

rulemaking and will replace the phase 

one process codified in § 156.275(c)(1). 

Comment: One commenter requested 

clarification and public transparency of 

a timeline for moving from phase one to 

phase two of recognizing accrediting 

entities. The commenter questioned 

whether the proposed phases will align 

with the phased approach also being 

planned for new quality reporting and 

display requirements. The commenter 

recommended that HHS consider the 

different timelines across Exchanges for 

requiring accreditation of QHP issuers. 

Response: We intend to establish 

through future rulemaking the 

recognition process of accrediting 

entities to align with the timeframe of 

other quality reporting requirements, 

including establishing a quality rating 

system. We recognize that it is 

important to coordinate these 

requirements for effective quality 

reporting and minimal burden on 

issuers. We will consider commenters’ 

recommendations regarding the phase 

two recognition process as we develop 

future rulemaking. 

Comment: One commenter requested 

clarification that the recognized 

accrediting entities from phase one 

would need to go through the full 

application process proposed for phase 

two rather than be grandfathered into 

phase two recognition. 

Response: As we stated in the 

proposed rule, we maintain that the 

recognition of accrediting entities in 

phase one is effective until it is 

rescinded or this interim phase one 

process is replaced by the phase two 

process. We are clarifying that a phase 

one recognized accrediting entity must 

complete the application to be 

recognized for the phase two 

recognition process that we intend to 

identify in future rulemaking. We 

intend to propose in future rulemaking 

that the accreditation that is obtained 

from NCQA or URAC would be 

recognized for the purposes of QHP 

certification until this accreditation 

expired, regardless of whether NCQA or 

URAC continue to be recognized as 

accrediting entities in the future phase 

two recognition process. 

Comment: A few commenters 

requested HHS to clearly distinguish the 

broader quality requirements on 

Exchanges and health insurance issuers 

and stated that accreditation should not 

be considered a permanent substitute 

for such requirements. 

Response: We acknowledge that 

accreditation is not a substitute for the 

broader quality requirements included 

in the Affordable Care Act. We intend 

to issue rulemaking and welcome future 

public comment and stakeholder input 

regarding the quality requirements on 

Exchanges and health insurance issuers. 

Comment: One commenter 

recommended that HHS monitor fees 

that accrediting entities charge and to 

potentially place a limit on fees that 

may not be included in the medical loss 

ratio (MLR) calculation. The commenter 

recommended that the criteria for 

review in the phase two recognition 

process for accrediting entities include 

full transparency in pricing. 

Response: Accreditation user fees are 

part of the quality improvement 

component of MLR under 45 CFR 

158.150(b)(2)(i)(5). We believe more 

entities will apply to meet the standards 

that we will be issuing for the phase two 

recognition process for accrediting 

entities, increasing competition. 

3. Clinical Quality Measure Standards 

(§ 156.275(c)(2)(ii)) 

We proposed that the first condition 

of recognition is based on section 

1311(c)(1)(D)(i) of the Affordable Care 

Act, which requires accreditation on 

local performance in nine categories, 

which are codified in 45 CFR 

156.275(a)(1): 

• Clinical quality measures such as 

the Healthcare Effectiveness Data and 

Information Set (HEDIS); 

• Patient experience ratings on a 

standardized Consumer Assessment of 

Healthcare Providers and Systems 

(CAHPS) survey; 

• Consumer access; 

• Utilization management; 

• Quality Assurance; 

• Provider credentialing; 


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• Complaints and appeals; 

• Network adequacy and access; and 

• Patient information programs. 

We proposed 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 proposed that the clinical quality 

measure set must: 

• Span a breadth of conditions and 

domains, including, but not limited to, 

preventive care, mental health and 

substance abuse disorders, chronic care, 

and acute care; 

• Include measures that are 

applicable to adults and separate 

measures that are applicable to children; 

• Align with the priorities of the 

National Strategy for Quality 

Improvement in Health Care issued by 

the Secretary and submitted to Congress 

on March 12, 2011 (see http:// 

www.healthcare.gov/law/resources/ 

reports/quality03212011a.html) and the 

National Quality Strategy: 2012 Annual 

Progress Report released by HHS on 

April 30, 2012 (see http:// 

www.healthcare.gov/news/factsheets/ 

2012/04/national-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 Act of 1995 (NTTAA) and 

Office of Management and Budget 

(OMB) Circular A–119 (1998)) or, where 

appropriate endorsed measures are 

unavailable, are in common use for 

health plan quality measurement and 

meet health plan industry standards; 

and, 

• Be evidence based. 

We solicited comments on these 

standards for clinical quality measures, 

including whether additional standards 

for such measures should be included, 

the standards for using endorsed and 

non-endorsed measures, and whether 

HHS should require entities seeking 

recognition as accrediting entities to 

review specific clinical measures as part 

of accreditation and if so, which ones. 

Comment: One commenter 

recommended additional criteria for 

clinical quality measures to include 

domains such as outcomes and process 

apart from access and patient 

satisfaction, be risk-adjusted when 

appropriate, be scientifically sound and 

be periodically updated for use within 

the accreditation standards. A few 

commenters recommended prioritizing 

measures that are being used 

concurrently by public and private 

sector purchasers and payers. 

Commenters also suggested that HHS 

require accrediting entities to review 

health plan processes including 

marketing practices, member privacy, 

language access services and health plan 

efforts to reduce health care disparities 

and to provide culturally competent 

services. 

Response: Much of the recommended 

criteria for clinical quality measures are 

already current components of 

accreditation standards and processes of 

the accrediting entities being recognized 

in the interim phase one. In this final 

rule, we are maintaining the standards 

that we proposed for clinical quality 

measure sets but will consider the 

additional suggested criteria in future 

rulemaking on phase two. 

Comment: Several commenters 

expressed concern that clinical quality 

measure standards used by current 

accrediting entities and the CAHPS 

survey process do not include people 

with disabilities. Several commenters 

recommended that phase two 

recognition process requirements for 

recognized accrediting entities should 

include standards for clinical quality 

measures that address the needs of 

people with disabilities and that 

specifically address persons in need of 

habilitative and rehabilitative services 

and devices. Commenters suggested that 

the accreditation process should address 

habilitative and rehabilitative related 

quality measures, the evaluation of 

quality of life beyond that represented 

by the typical quality indicators and 

network adequacy. 

Response: As part of future 

rulemaking on the phase two 

recognition process, we will consider 

these standards. 

Comment: One commenter requested 

clarification regarding which CAHPS 

survey will be used to measure patient 

experience or whether a future CAHPS 

survey will be developed. The 

commenter opposed the use of 

instruments such as the CAHPS Surgical 

Care Survey and the Clinician/Group 

CAHPS as proposed measure tools and 

recommended inclusion of all types of 

providers such as advanced practice 

registered nurses and certified registered 

nurse anesthetists in any measurement 

tools developed to adequately capture 

the patient and caregiver experience. 

Response: We are finalizing the 

requirement that the recognized 

accrediting entities require accreditation 

on local performance in patient 

experience ratings on a standardized 

CAHPS survey. We are not specifying 

which CAHPS surveys that the 

recognized accrediting entities must use 

as part of accreditation but expect that 

the recognized accrediting entities will 

use health plan CAHPS surveys and will 

not use the surgical care and/or 

Clinician/Group CAHPS surveys. 

Comment: Several commenters 

expressed support that accreditation 

include, to the extent possible, measures 

that are already developed or endorsed 

by recognized consensus standards 

setting bodies. A few commenters stated 

that measures should be based on 

national standards such as National 

Quality Forum (NQF) endorsed 

measures. One commenter requested 

clarification regarding the language 

related to measures that are developed 

or adopted by a voluntary consensus 

standards setting body. This commenter 

recommended that CMS specify that 

measure sets used for QHP accreditation 

only include measures that are endorsed 

by the entity with a contract with the 

Secretary, which is currently only the 

National Quality Forum (NQF). 

Response: We agree that NQF plays a 

significant role in endorsing quality 

measures. However, we do not require 

clinical quality measures to either be 

endorsed by NQF or submitted for 

review to NQF since recognized 

accrediting entities may use a diverse 

measurement set. We maintain the 

criteria we proposed for the clinical 

quality measure set. We will consider 

the commenter’s recommendations as 

we set the measurement standards as 

part of the future rulemaking on phase 

two. 

Comment: One commenter suggested 

that the clinical quality measure 

requirements for recognized accrediting 

entities include measures that reflect 

patients’ and families’ perspectives and 

measures that advance primary care 

services and medical homes. 

Response: We believe that the patient 

perspective is captured by the 

requirement that accreditation include 

patient experience ratings on a 

standardized CAHPS survey in 45 CFR 

156.275(a)(1). We also maintain in this 

final rule that clinical quality measures 

be aligned with priorities of the 

National Strategy for Quality 

Improvement in Health Care (‘‘the 

National Strategy’’). The National 

Strategy includes as core principles, 

person-centeredness and family 

engagement, and strengthening primary 

care using models such as patientcentered medical homes. 

Comment: A few commenters 

recommended requiring independent 

auditing of results as an additional 


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criterion for clinical quality measures 

considered as part of accreditation to 

ensure the accuracy and comparability 

of results, to provide an important 

feedback loop for plans, and to instill 

support among all stakeholders. 

Response: While independent 

auditing of results could be an effective 

way to assure accuracy and 

comparability and provide useful 

verification information to issuers and 

stakeholders, we maintain in the final 

rule the criteria we proposed in 

§ 156.275(c)(2)(ii), which was based on 

diverse stakeholder input. 

Comment: One commenter suggested 

that the phase two recognition process 

should include clinical measures, such 

as those from Minnesota Community 

Measurement, which address health 

outcomes for patients rather than 

process measures concerning the kind of 

care or tests that patients receive. 

Another commenter suggested that HHS 

examine and consider adoption of the 

uSPEQ measurement tool, which 

incorporates both consumer and 

employee satisfaction as primary factors 

in assessing the success of a program 

and that has been used to evaluate 

programs from a consumer perspective. 

Response: Many of the quality 

measures currently used by the 

recognized accrediting entities address 

patients’ health outcomes and patient 

experience. We will consider clinical 

health outcomes measures from 

organizations such as the Minnesota 

Community Measurement and 

measurement tools such as uSPEQ when 

we propose rules on phase two. 

Comment: One commenter 

recommended that recognized 

accrediting entities require qualified 

health plans seeking accreditation to 

submit data on HIV quality measures to 

ensure that the care supported by 

qualified health plans can be effectively 

monitored and evaluated. The 

commenter suggested that, at a 

minimum, plans should be required to 

submit data for HIV measures proposed 

for Stage II Meaningful Use and to select 

from measures that are being used by 

Medicare, Medicaid and the HIV/AIDS 

Bureau. 

Response: The recognized accrediting 

entities do not currently use an HIVrelated quality measure in their 

accreditation scoring. However, there 

are such measures under development 

for accreditation standards. We 

maintain in the final rule that measures 

selected should be developed or 

adopted by a voluntary consensus 

standards setting body, appropriately 

endorsed whenever possible and span a 

breadth of conditions. We support the 

alignment of measures with existing 

public and private measurement 

initiatives and intend to consider other 

measures during rulemaking for phase 

two. 

Comment: One commenter endorsed 

HHS’s recognition of URAC as an 

accrediting entity largely because it 

supports data collection requirements 

URAC has already implemented to help 

ensure QHP issuers seeking 

accreditation are currently complying 

with the Paul Wellstone-Pete Domenici 

Mental Health Parity and Addiction 

Equity Act of 2008 (MHPAEA). The 

commenter encouraged HHS to require 

that as a condition of becoming a QHP 

accrediting entity, NCQA, as well as 

other possible future QHP accrediting 

entities, data collection of MHPAEA 

compliance as part of each QHP’s local 

performance in the nine categories, 

including utilization management. 

Response: We will consider the 

commenter’s suggestion to include data 

collection related to MHPAEA 

compliance when we develop standards 

for the phase two process for 

recognizing accrediting entities in future 

rulemaking. 

4. Product Type Level of Accreditation 

(§ 156.275(c)(2)(iii)) 

In § 156.275(c)(2)(iii), we proposed 

that recognized accrediting entities 

provide separate accreditation 

determinations for each product type 

offered by a QHP issuer in each 

Exchange (for example, Exchange HMO, 

Exchange point of service (POS) plans, 

and Exchange preferred provider 

organization (PPO) plans), based on data 

submitted by the issuer that are 

representative of the population of each 

QHP in that Exchange product type. We 

believe that the product type is the 

appropriate level for accreditation as it 

would balance capturing the QHP 

experience and enabling the reporting of 

valid and reliable performance 

measures. An issuer may offer multiple 

QHPs under the same product type, in 

the same Exchange, if the product type 

for that Exchange is accredited, each of 

the corresponding QHPs would be 

considered to be accredited. We 

solicited comments on the proposed 

level of accreditation. We also solicited 

comments on circumstances under 

which an exception should be made to 

the accreditation determination being 

made at the Exchange product type 

level. 

Comment: A few commenters 

opposed requiring accreditation at the 

Exchange product type level due to their 

belief that product type level 

accreditation is not current market 

practice and potential challenges of 

inadequate sample size if accreditation 

moves to more granular levels. Several 

commenters expressed support for 

product type level accreditation to 

facilitate comparisons based on quality 

and transparency. One commenter 

recommended that states should have 

the responsibility to dictate the product 

level requiring accreditation because 

implementation of federally-defined 

product types would disrupt states’ 

existing regulatory classifications and 

accreditation requirements for insurance 

products. 

Response: We maintain in the final 

rule that recognized accrediting entities 

provide separate accreditation 

determinations for each Exchange 

product type since QHP issuers must be 

accredited on the basis of local 

performance per § 156.275(a)(1). We 

believe that accreditation at the overall 

QHP issuer level would not adequately 

meet the requirement that QHP issuers 

be accredited on the basis of local 

performance. We believe that 

accreditation at the plan or metal-level 

would also be unreasonable because of 

the likely inadequate sample size for 

reliable performance data reporting. 

Comment: One commenter stated that 

although NCQA generally accredits by 

product type, which combines product 

line (that is, Commercial, Medicare, 

Medicaid or Exchange) with product 

(that is, HMO, POS or PPO), there are 

some exceptions. For example, with 

NCQA approval, issuers can combine 

HMO and PPO or POS and PPO (or all 

three) products for HEDIS reporting 

purposes or they can combine the same 

product across contiguous states for 

statistically valid HEDIS and CAHPS 

results. 

Response: We understand that there 

may be some necessary exceptions to 

product type level accreditation for 

methodological reasons. We maintain 

that recognized accrediting entities 

provide separate accreditation 

determinations for each QHP product 

type offered in an Exchange (for 

example, Exchange HMO or Exchange 

PPO). However, we agree that in some 

instances, such as when sample sizes 

are inadequate to provide statistically 

valid results at the Exchange product 

type level, an exception to Exchange 

product level accreditation would then 

be reasonable. In the final rule, we are 

modifying the requirement that 

recognized accrediting entities provide 

accreditation at the Exchange product 

type level to permit an exception when 

this Exchange product type level 

accreditation is not methodologically 

sound. In such cases, the recognized 

accrediting entity must demonstrate that 

the Exchange product type level 

accreditation is not methodologically 


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4Exchange Final Rule published in 77 FR 18310 

at 18412 (March 27, 2012). 

sound as a condition of the Exchange 

granting an exception such as 

authorizing Exchange product type 

combinations across contiguous states 

(for example, Exchange HMO in New 

York and Exchange HMO in New 

Jersey.) We encourage Exchanges to 

collaborate and consult with state 

Departments of Insurance and other 

state regulatory and licensing bodies in 

granting the exception. 

Comment: One commenter requested 

clarification on whether NCQA and 

URAC will be responsible for 

accrediting dental plans. The 

commenter suggested that designated 

accrediting entities use specific clinical 

quality measures developed by the 

Dental Quality Alliance (DQA) to 

accredit dental plans. 

Response: We are not currently 

requiring that recognized accrediting 

entities accredit stand-alone dental 

plans. The Exchange final rule specifies 

that to the extent that accreditation 

standards specific to stand-alone dental 

plans do not exist,4 then such plans 

would not be required to meet the 

accreditation timeline required by 45 

CFR 155.1045. 

Comment: A few commenters 

recommended allowing plans to meet 

Exchange-specific requirements as part 

of their current accreditation instead of 

undergoing a separate accreditation 

process solely for Exchanges. One 

commenter recommended that at a 

minimum, issuer-level accreditation on 

policies and procedures should apply 

across product types offered within 

Exchanges. 

Response: We agree with commenters 

and clarify our interpretation of this 

final rule that the recognized accrediting 

entities may review policies and 

procedures at the issuer level, provided 

that the same policies and procedures 

apply across an issuer’s product lines 

and product types. We maintain that the 

recognized accrediting entity must 

provide accreditation at the Exchange 

product type level but we do not require 

recognized accrediting entities to 

duplicate valid and applicable work or 

reviews conducted in connection with 

accreditations provided at a different 

level for the same issuer. 

5. Network Adequacy and Access in 

Accreditation Standards 

(§ 156.275(c)(2)(iv)) 

As part of our proposal that 

recognized accrediting entities include 

network adequacy and access in the 

accreditation standards, we proposed in 

subparagraph (c)(2)(iv) that the network 

adequacy and access standards outlined 

in section 1311(c)(1)(D) of the 

Affordable Care Act and 45 CFR 

156.275(a)(1)(viii) must, at a minimum, 

be consistent with the general 

requirements for network adequacy 

standards for QHP issuers codified in 

§ 156.230(a). We solicited comments on 

this proposed requirement. 

Comment: We received one comment 

that the current accreditation standards 

relating to network adequacy in use by 

NCQA are not fully consistent with the 

general requirements for network 

adequacy standards in § 156.230(a) 

because NCQA does not currently 

address the inclusion of essential 

community providers in their network 

adequacy assessment. However, in its 

comment on the proposed rule, NCQA 

stated willingness to work with CMS to 

address this in their accreditation 

standards in the future. 

Response: We acknowledge that 

NCQA does not currently capture 

information regarding essential 

community providers as part of its 

current accreditation standards. Because 

the direction to cover essential 

community providers is included as a 

separate provision defined in § 156.235, 

we are finalizing the rule for the phase 

one recognition process such that 

network adequacy and access 

accreditation standards must be 

consistent with § 156.230(a)(2) and 

§ 156.230(a)(3) only. A review of the 

inclusion of essential community 

providers as part of accreditation 

standards will not be required in the 

interim phase one recognition process. 

This change does not affect the QHP 

certification standard that QHPs 

demonstrate essential community 

provider network adequacy. We will 

consider proposing that accreditation 

standards be fully consistent with all 

general requirements of network 

adequacy in § 156.230(a) in future 

rulemaking on phase two. 

Comment: One commenter expressed 

concerns about making network 

adequacy a part of the accreditation 

process and stated that it should not be 

delegated to private accreditors. The 

commenter believes that this is 

inherently a regulatory function and 

should be retained by a regulatory body. 

One commenter recommends that HHS 

clearly specify and distinguish the 

network adequacy responsibilities of 

Exchanges, QHP issuers, and recognized 

accrediting entities to ensure that 

consumers’ access and rights are 

protected and information on provider 

networks is accurate. 

Response: Section 1311(c)(1)(D)(i) of 

the Affordable Care Act and 45 CFR 

156.275(c)(2)(iv) direct that recognized 

accrediting entities include network 

adequacy and access in the 

accreditation standards. We clarify in 

the final rule that for the phase one 

recognition process, network adequacy 

and access accreditation standards 

should be consistent with 

§ 156.230(a)(2) and § 156.230(a)(3), 

including maintaining a network that is 

sufficient in number and types of 

providers to assure that all services will 

be accessible without unreasonable 

delay and is consistent with the network 

adequacy provisions of section 2702(c) 

of the PHS Act. 

6. Methodological and Scoring Criteria 

Requirements (§ 156.275(c)(3)) 

In § 156.275(c)(3), we proposed that 

each recognized accrediting entity must 

use transparent and rigorous 

methodological and scoring criteria, as 

required by section 1311(c)(1)(D)(i) of 

the Affordable Care Act. We did not 

receive comments on this section and 

are finalizing the provisions as 

proposed. 

7. Documentation Requirements 

(§ 156.275(c)(4)) 

In § 156.275(c)(4), we proposed that 

each accrediting entity recognized by 

the Secretary, as a condition of gaining 

and maintaining recognition, provide to 

HHS its current accreditation processes 

to demonstrate that the entity meets the 

conditions described in §§ 156.275(c)(2) 

and 156.275(c)(3). Documentation 

should include accreditation standards 

and requirements, processes, and 

measure specifications for performance 

measures. We proposed that the initial 

submission of documentation be made 

at a time specified by HHS. We solicited 

comment on this timing requirement, 

specifically whether NCQA and URAC 

may only be recognized if this 

documentation is provided within a 

certain number of days of the final rule. 

Recognized accrediting entities must 

also submit any proposed changes or 

updates to the accreditation and 

measurement process with 60 days 

notice prior to implementation such that 

HHS has ample opportunity to review 

and comment on whether these changes 

or updates are significant enough to 

mean that the conditions in 

§§ 156.275(c)(2) and 156.275(c)(3) 

would no longer be met. We solicited 

comments on these documentation 

standards. 

Comment: One commenter 

recommended a timeframe of ninety 

days for submission of required 

documentation by accrediting entities. 

The accrediting entities being 

recognized in phase one stated no 

opposition to submitting documentation 


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5We expect the QHP issuer will provide the 

accrediting entity with the HIOS identifiers. 

within a timeframe specified by HHS; 

one commented that it would provide 

documentation at any time it is 

required. And we received numerous 

comments in support of the proposed 60 

day timeframe for changes and updates. 

Response: We only received one 

comment regarding a specific timeframe 

for documentation submission. We 

finalize in this rule that the 

documentation from recognized 

accrediting entities, due under 

§ 156.275(c)(4) be provided within 60 

days of the publication of this final rule. 

We believe that 60 days is a reasonable 

time for accrediting entities to submit 

their current accreditation processes, 

standards, and requirements. 

Comment: A few commenters 

requested clarification regarding 

providing notice on updates or changes 

to the accreditation and measurement 

process and providing health plans with 

adequate time to implement the 

proposed changes. We received 

numerous comments in support of the 

proposed 60 day timeframe for changes 

and updates. The commenters’ 

recommended that HHS clarify that 

issuers should be provided with a one 

year advance notice of changes in 

accreditation and measurement process. 

One commenter recommended that 

regulations should permit accrediting 

entities to address any errors found in 

technical specifications within a shorter 

timeframe. One commenter 

recommended that HHS seek input from 

affected stakeholders to determine 

whether any proposed changes are 

significant enough to mean that the 

conditions in §§ 156.275(c)(2) and 

156.275(c)(3) would no longer be met. 

The commenter also requested 

clarification regarding HHS’s 

turnaround time to review and comment 

on accrediting entities’ planned changes 

and updates. 

Response: In the rule, we finalize this 

standard to state that recognized 

accrediting entities submit to HHS any 

proposed changes or updates to the 

accreditation and measurement process 

with 60 days prior to public notice. HHS 

does not intend to interfere with current 

practices of accrediting entities to 

provide advance notice to health plans 

and agree with commenters that health 

plans should have adequate time to 

implement any proposed changes. We 

also agree with the commenter’s 

recommendation that accrediting 

entities should correct any errors to 

technical specifications within a shorter 

time period. We clarify that recognized 

accrediting entities do not have to 

provide advance notice to CMS of nonsubstantive error corrections. We intend 

to seek diverse stakeholder input if 

conditions in §§ 156.275(c)(2) and 

156.275(c)(2) are no longer met. We 

intend to be expeditious during our 

review of any changes and updates of 

accreditation and measurement process. 

8. Authorization of Data Sharing by 

Accrediting Entities to the Exchange 

and HHS (§ 156.275(a)(2)) 

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, we proposed that when 

authorized by an accredited QHP issuer, 

recognized accrediting entities provide 

the following accreditation survey data 

elements to the Exchange in which the 

issuer plans to operate one or more 

QHPs: 

• The name, address, Health 

Insurance Oversight System (HIOS) 

issuer identifier,5 and unique 

accreditation identifier(s) of the QHP 

issuer. 

• The QHP issuer’s accredited 

product line(s) (that is, Commercial, 

Medicaid, Exchange) and type(s) which 

have been released; 

• For each of the QHP issuer’s 

accredited product type(s), HIOS 

product identifier (if applicable); 

accreditation status, survey type or level 

(if applicable); accreditation score; 

expiration date of accreditation; and 

clinical quality measure results and 

adult and child CAHPS measure survey 

results (and corresponding expiration 

dates of these data) at the level specified 

by the Exchange (for example, QHP 

product or plan level). 

Such disclosure was proposed to 

occur on the following occasions: 

during the annual certification period or 

as changes occur to these data 

throughout the coverage year. We 

solicited comment, including whether 

fewer or more categories of information 

should be included. 

The proposed rule would permit 

Exchanges to arrange additional data 

sharing agreements with the recognized 

accrediting entities if they choose, such 

as information on the QHP issuer’s 

policies and procedures. We solicited 

comments as to whether recognized 

accrediting entities must provide this 

additional information upon request 

from an Exchange. 

Comment: Several commenters 

recommended that recognized 

accrediting entities provide the 

Exchange a copy of the most recent 

accreditation survey for each accredited 

product as well as any corrective action 

plans and summaries of findings or 

other similar written comments or 

analysis that is provided to each insurer 

by the accrediting entities. A few 

commenters expressed concern 

regarding the release of proprietary 

health plan data and data containing 

sensitive personal health information. 

The commenters recommended that 

data sharing should be limited to quality 

measures and CAHPS survey results 

that will be displayed and not include 

the full accreditation survey or 

additional information that would 

undermine the accreditation process. 

One commenter requested that data be 

shared with state quality improvement 

organizations for additional oversight. 

Response: 45 CFR 156.275(a)(2) 

directs QHP issuers to authorize the 

accrediting entity to release to the 

Exchanges survey-related information 

such as corrective action plans or 

summaries of findings. However, we 

maintain in the final rule that the 

recognized accrediting entity provide 

data through data sharing agreements to 

an Exchange. We interpret this 

regulation to permit an Exchange the 

flexibility, through data sharing 

agreements, to request additional 

information or to engage in data sharing 

with another entity, such as a state 

quality improvement organization. We 

did not propose the requirement in this 

rule that recognized accrediting entities 

share additional data not identified in 

§ 156.275(a)(2) or § 156.275(c)(5) with 

Exchanges. We agree with the 

commenters’ recommendations that this 

qualitative information may provide 

useful insight to an Exchange. We are 

modifying the data sharing requirements 

between the recognized accrediting 

entities and Exchanges to expressly 

exclude personally identifiable data. 

Comment: One commenter requested 

more information regarding the process 

for recognized accrediting entities to 

provide data to Exchanges. 

Response: We will be working closely 

with the recognized accrediting entities 

to further clarify the process including 

definitions of data elements. 

Comment: One commenter requested 

clarification on whether accreditation 

data must be provided on non-Exchange 

products during early years of the 

Exchange and whether a recognized 

accrediting entity can collect 

authorizations from issuers to release 

data elements to an Exchange. 

Response: Because it will take time 

for QHP product type specific 

accreditation to be available, consistent 

with the proposed rule, recognized 

accrediting entities will provide 

accreditation data from a QHP issuer’s 

existing accreditation on non-Exchange 


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6Available at: http://www.cms.gov/Regulationsand-Guidance/Legislation/ 

PaperworkReductionActof1995/PRA-Listing-Items/ 

CMS1247405.html. 

7Available at: http://www.cms.gov/Regulationsand-Guidance/Legislation/ 

PaperworkReductionActof1995/PRA-Listing-Items/ 

cms-10435.html. 

products (for example, commercial and 

Medicaid) if these data are requested by 

an Exchange, once the QHP issuer 

authorizes the release of these data. As 

codified in § 156.275(a)(2), QHP issuers 

will authorize the release of their 

accreditation survey data as part of QHP 

certification. 

Comment: One commenter requested 

clarification regarding what clinical 

quality and CAHPS measure results data 

must be reported (for example, 

numerators and denominators only or 

more detailed data like member-level 

survey results). 

Response: The clinical quality 

measure results and adult and child 

CAHPS measure survey results specified 

in the final rule refer to only those 

measure results attained through a QHP 

issuer’s accreditation from a recognized 

accrediting entity. To allow Exchanges 

the flexibility to specify the level of 

detail that is appropriate and reasonable 

for the QHPs, we are not further 

defining the level of reporting of these 

data for each Exchange. 

Comment: One commenter requested 

clarification regarding what is meant by 

providing clinical or CAHPS data at the 

level specified by the Exchange. The 

commenter stated that there should be 

sufficient numbers for valid data 

collection by issuers, but not necessarily 

at the metal (Bronze, Silver, Gold or 

Platinum) level. 

Response: We recognize that adequate 

sample size for valid data collection is 

a critical element of accreditation. We 

maintain that Exchanges should have 

the flexibility to request clinical and 

CAHPS data at the QHP product or plan 

level if there are adequate sample sizes 

to capture the QHP experience and 

enable reporting of valid and reliable 

performance measures. 

Comment: One commenter 

recommended that CMS collect 

accrediting entity data on plan 

performance and scoring information of 

network adequacy requirements to 

support CMS’ network adequacy review 

and to minimize documentation 

requirements. 

Response: We agree that these data 

could support the Exchange in the 

review of network adequacy standards 

as part of QHP certification; however, at 

this time, we are not requiring 

recognized accrediting entities to 

provide accreditation survey data 

elements relating to network adequacy 

requirements, that are in excess of the 

disclosure required under 

§ 156.275(a)(2), to the Exchange. 

III. Provisions of the Final Regulations 

This final rule incorporates the 

provisions of the proposed rule with 

some substantive modifications, along 

with additional non-substantive changes 

to improve clarity, not noted here. 

Those provisions of the final rule that 

differ from the proposed rule are as 

follows: 

Changes to § 156.120(a) 

• Changes the definition of treatment 

limitations to include only quantitative 

limits, which also removes the 

requirement to provide data on 

nonquantitative limits for purposes of 

this final rule. 

Changes to § 156.120(e) 

• Establishes a submission deadline 

for applicable issuers. Issuer 

submissions are due on September 4, 

2012. 

Changes to § 156.275(c)(2)(iii) 

• Establishes exception authority to 

the product type level accreditation 

requirement when the product type 

level of accreditation is not 

methodologically sound. In such cases, 

the recognized accrediting entity must 

demonstrate that the Exchange product 

type level accreditation is not 

methodologically sound as a condition 

of the Exchange granting an exception to 

authorize accreditation at an aggregated 

level. 

Changes to § 156.275(c)(2)(iv) 

• Removes inclusion of essential 

community providers under the 

network adequacy standards for 

accreditation. 

• Maintains that network adequacy 

standards for accreditation be, at a 

minimum, consistent with general 

requirements for network adequacy for 

QHP issuers codified in § 156.230(a)(2) 

and (a)(3). 

Changes to § 156.275(c)(4)(i) 

• Establishes timeframe of within 60 

days of publication of the final rule that 

an accrediting entity must provide 

current accreditation standards and 

requirements, processes, and measure 

specifications for performance measures 

to demonstrate that each entity meets 

the conditions specified. 

Changes to § 156.275(c)(4)(ii) 

• Clarifies that recognized accrediting 

entities must provide to HHS any 

proposed changes or updates to 

accreditation standards, processes and 

measure specifications for performance 

measures with 60 days prior to public 

notification. 

Changes to § 156.275(c)(5) 

• Adds an exception to protect 

personally identifiable information. 

IV. Collection of Information 

Requirements 

As part of the proposed rule, and in 

accordance with the Paperwork 

Reduction Act, we sought comment on 

the information collection requests 

(ICRs) associated with the proposed 

rule. This included the of EHB data 

(§ 156.120) information collections. We 

received some comments on this 

section, which are discussed below. As 

described above, we finalize § 156.120 

as it was proposed, with the addition of 

a deadline for the reporting requirement 

in § 156.120(e). On June 5, 2012, we 

issued a 60-day Federal Register notice 

(77 FR 33221) seeking comments on the 

revision to the information collection 

request (ICR), ‘‘Health Care Reform 

Insurance Web Portal Requirements.’’ 6

In the proposed rule and the June 5, 

2012 60-day Federal Register Notice, we 

also sought comment on ICRs that are 

not discussed in the regulations text 

contained in this document, including 

the state selection of a benchmark and 

the voluntary data collection from 

standalone dental plans. We received 

some comments related to these ICRs, 

which we will consider before 

submitting the ICR to the Office of 

Management and Budget for review and 

approval. We plan to finalize the ICR on 

benchmark data collection and standalone dental separately from the other 

portions of the ‘‘Health Care Reform 

Insurance Web Portal Requirements’’ 

ICR. The comment period for this 

package remains open through August 

5, 2012, and we encourage interested 

parties to submit comments. 

In the proposed rule, we also sought 

comment on ICRs for recognized 

accrediting entities (§ 156.275). We did 

not receive comments on the accrediting 

entities ICRs described in the proposed 

rule. As described above, although we 

made some changes to § 156.275 in this 

final rule, the ICRs are unchanged. We 

also issued a 60-day Federal Register 

notice seeking comments on these 

ICRs.7 That comment period closes on 

August 1, 2012, and we encourage 

interested parties to submit comments. 

Following close of the 60-day comment 

period, we will submit the accrediting 

entities ICR to OMB for approval. 

What follows is a discussion of 

comments received on the ICRs related 

to the EHB data (§ 156.120). 


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Section 156.120 states that issuers 

that offer the three largest health 

insurance products by enrollment in 

each state’s small group market, as 

determined by HHS based on data 

submitted in accordance with part 159 

of this title for March 31, 2012, must 

provide the data described in paragraph 

(b) for the health plan with the highest 

enrollment within that product. This 

data collection mirrors the benefit data 

fields currently collected under the 

Health Insurance Web Portal PRA 

package (OCN: 0938–1086) and also 

includes: The administrative data 

necessary to identify the health plan, 

data on covered benefits, any treatment 

limitations on those benefits, data on 

drug coverage, and enrollment. 

We estimate that it will take four 

hours for a health insurance issuer to 

meet this reporting requirement, 

including data collection, submission, 

and validation. This estimate is based 

on current industry surveys collected to 

monitor the burden of submission of 

similar data in the Medicare Advantage 

and Prescription Drug Programs. Given 

that the three health insurance issuers 

with the largest products by enrollment 

in each state (including the District of 

Columbia) would submit this 

information, the total burden is 

estimated to be 612 hours. We anticipate 

that the reporting requirement would 

require four hours for one employee at 

a cost of $77.00 an hour, based on the 

hourly cost reported by industry in 

responses to a CMS survey of Medicare 

Advantage and Prescription Drug 

Programs which requires employees 

with similar technical expertise, for a 

total cost of $308.00 a year per issuer. 

The total number of respondents 

required to report would be 153, the 

largest three issuers/products in each 

state and the District of Columbia by 

enrollment, for a total burden of 

$47,124. Issuers would provide HHS 

with the data collection requirements 

through an online tool that we would 

make available to them. 

Comment: We received some 

comments expressing concern that 

HHS’s burden estimates related to the 

proposed data collection were too low. 

Response: We appreciate these 

concerns, but for the reasons discussed 

above, believe that our estimates 

accurately reflect the burden of 

reporting. 

Comment: One commenter 

recommended that HHS avoid 

collection of an ‘‘other’’ benefit category 

because the category is somewhat 

ambiguous. 

Response: HHS included the ‘‘other’’ 

category to allow for full reporting of the 

benefits, including benefits that do not 

fall into the set of categories provided 

under HealthCare.gov. 

V. Regulatory Impact Analysis 

We have examined the impact of this 

final rule as required by Executive 

Order 12866 on Regulatory Planning 

and Review (September 30, 1993) and 

Executive Order 13563 on Improving 

Regulation and Regulatory Review 

(January 18, 2011). Executive Orders 

12866 and 13563 direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any one year). 

It is HHS’s belief that this rule does 

not reach this economic threshold and 

thus is not considered a major rule. This 

rule consists of a data collection from a 

limited number of health insurance 

issuers and a data submission by two 

accrediting entities to HHS. Because of 

the very limited scope of this final rule, 

we do not anticipate that there would be 

any costs associated with this 

rulemaking in addition to those costs, as 

outlined below. We derived the costs 

outlined below from the labor costs as 

outlined in the Collection of 

Information section above. The data 

collection from issuers only applies to 

the issuers of the three largest products 

by enrollment in each state’s small 

group market, which would result in a 

minor economic burden to an estimated 

153 issuers, at a total cost across all 

issuers of $47,124. Additionally, the 

PRA package that accompanied the 

proposed rule requested that issuers that 

wish to offer stand-alone dental plans in 

an Exchange notify HHS of their intent 

to participate. We estimate that 20 

dental issuers would voluntarily 

respond, at a total cost across all 

responding issuers of $770. The two 

entities which we are recognizing as 

accrediting entities already meet most of 

the conditions for phase one of the 

recognition process, and we anticipate 

that any required changes to their 

accreditation processes would be minor 

and result economic burden that we 

have estimated at $48,625. 

VI. Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) (RFA) requires 

agencies to prepare an initial regulatory 

flexibility analysis to describe the 

impact of the proposed rule on small 

entities, unless the head of the agency 

can certify that the rule would not have 

a significant economic impact on a 

substantial number of small entities. 

The RFA generally defines a ‘‘small 

entity’’ as—(1) A proprietary firm 

meeting the size standards of the Small 

Business Administration (SBA); (2) a 

not-for-profit organization that is not 

dominant in its field; or (3) a small 

government jurisdiction with a 

population of less than 50,000. States 

and individuals are not included in the 

definition of ‘‘small entity.’’ HHS uses 

as its measure of significant economic 

impact on a substantial number of small 

entities a change in revenues of more 

than 3 percent. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses, if a proposed rule has a 

significant impact on a substantial 

number of small entities. For purposes 

of the RFA, small entities include small 

businesses, nonprofit organizations, and 

small government jurisdictions. Small 

businesses are those with sizes below 

thresholds established by the Small 

Business Administration (SBA). 

As discussed above, this final rule is 

necessary to implement certain 

standards related to the establishment of 

essential health benefits and recognition 

of accrediting entities as authorized by 

the Affordable Care Act. Specifically, 

this rule outlines collecting data from 

issuers that offer the three largest small 

group products in each state and from 

NCQA and URAC, which are the phase 

one recognized accrediting entities. For 

the purposes of the regulatory flexibility 

analysis, we expect the following types 

of entities to be affected by this final 

rule—(1) QHP issuers (2) and NCQA 

and URAC. 

As discussed in the Medical Loss 

Ratio interim final rule (75 FR 74918), 

few, if any, issuers are small enough to 

fall below the size thresholds for small 

business established by the SBA. In that 

rule, we used a data set created from 

2009 National Association of Insurance 

Commissioners (NAIC) Health and Life 

Blank annual financial statement data to 

develop an updated estimate of the 

number of small entities that offer 

comprehensive major medical coverage 

in the individual and group markets. 

For purposes of that analysis, the 

Department used total Accident and 

Health earned premiums as a proxy for 

annual receipts. We estimated that there 

are 28 small entities with less than $7 

million in accident and health earned 

premiums offering individual or group 

comprehensive major medical coverage. 

However, this estimate may overstate 

the actual number of small health 

insurance issuers offering such 

coverage, since it does not include 


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8According 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). 

9See ‘‘About NCQA,’’ NCQA Web site. Available 

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

10See ‘‘Frequently Asked Questions’’ URAC Web 

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

faqs.aspx#General. 

11According 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). 

receipts from these companies’ other 

lines of business.8 We further estimate 

that any issuers that would be 

considered small businesses are likely 

to be subsidiaries of larger issuers that 

are not small businesses. 

This rule also directs two accrediting 

entities, NCQA and URAC, to submit 

documentation to HHS. The RFA, as 

noted previously, considers a non-profit 

entity that is not dominant in its field 

to be a small entity. We selected both 

NCQA and URAC because they are the 

two most dominant actors in the field of 

health plan accreditation. NCQA is a 

not-for-profit entity that has been in 

existence since 1990 and is widely 

recognized as a national leader in 

developing health care performance 

measures and quality standards. NCQA 

has accredited health plans covering 

over 70 percent of all Americans.9

URAC is also a not-for-profit entity that 

was formed over 20 years ago. URAC 

accredits plans in every state and, 

according to its Web site, is the largest 

accrediting body for health care.10

Finally, based on their dominant role in 

accrediting health plans, we believe that 

NCQA and URAC are both likely to have 

total annual receipts exceeding the 

Small Business Administration size 

standard.11

Based on the foregoing, we are not 

preparing an analysis for the RFA 

because we have determined, and the 

Secretary certifies, that this final rule 

would not have a significant economic 

impact on a substantial number of small 

entities. 

VII. Unfunded Mandates 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

requires that agencies assess anticipated 

costs and benefits and take certain other 

actions before issuing a final rule that 

includes any Federal mandate that may 

result in expenditures in any one year 

by a state, local, or tribal governments, 

in the aggregate, or by the private sector, 

of $100 million in 1995 dollars, updated 

annually for inflation. In 2012, that 

threshold is approximately $139 

million. UMRA does not address the 

total cost of a rule. Rather, it focuses on 

certain categories of costs, mainly those 

‘‘Federal mandate’’ costs resulting from: 

(1) Imposing enforceable duties on state, 

local, or Tribal governments, or on the 

private sector; or (2) increasing the 

stringency of conditions in, or 

decreasing the funding of, state, local, or 

tribal governments under entitlement 

programs. 

This final rule does not place any 

financial mandates on state, local, or 

Tribal governments. This rule 

authorizes a narrow data collection from 

an estimated 153 issuers, and the only 

costs associated with this reporting are 

labor costs, which we anticipate to total 

$47,124, which is significantly less than 

the threshold of $139 million. States 

may, at their option, select a benchmark 

plan and submit this information to 

HHS. We anticipate that it would take 

each state five hours of labor to 

complete and submit this information 

and that the per hour labor cost would 

be similar to that for the issuer data 

submission, which is $77 per hour. We 

cannot reasonably anticipate how many 

states will respond. However, assuming 

for the sake of argument that all states 

respond, the total cost would still be 

under $20,000, which is well below the 

$139 million threshold. The rule also 

sets standards for two accrediting 

entities to submit documentation to 

HHS as specified in the rule. We expect 

the cost to the two accrediting entities 

to be $48,898. 

VIII. Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

costs on state and local governments, 

preempts state law, or otherwise has 

Federalism implications. This final 

regulation, as it relates to the 

recognition of accrediting entities, does 

not impose any costs on state or local 

governments. However, this regulation 

includes reporting requirements if a 

state selects a benchmark plan. 

In compliance with the requirement 

of Executive Order 13132 that agencies 

examine closely any policies that may 

have Federalism implications or limit 

the policy making discretion of the 

states, HHS has engaged in efforts to 

consult with and work cooperatively 

with affected states, including 

participating in conference calls with 

and attending conferences of the 

National Association of Insurance 

Commissioners (NAIC), and consulting 

with state insurance officials on an 

individual basis. We believe that this 

final rule does not impose substantial 

direct costs on state and local 

governments, preempt state law, or 

otherwise have federalism implications. 

We note that states that choose to select 

a benchmark plan would be required to 

submit their benchmark plan selection 

to HHS, and provide information on the 

benchmark plan in the same format that 

is used by issuers. However, we 

anticipate that the administrative costs 

related to this requirement are likely to 

be minimal because the states are likely 

to obtain this information from the 

issuers. 

Pursuant to the requirements set forth 

in section 8(a) of Executive Order 

13132, and by the signatures affixed to 

this regulation, the Department of 

Health and Human Services certifies 

that CMS has complied with the 

requirements of Executive Order 13132 

for the attached regulation in a 

meaningful and timely manner. 

List of Subjects in 45 CFR Part 156 

Administrative practice and 

procedure, Advertising, Advisory 

Committees, Brokers, Conflict of 

interest, Consumer protection, Grant 

programs—health, Grants 

administration, Health care, Health 

insurance, Health maintenance 

organization (HMO), Health records, 

Hospitals, Indians, Individuals with 

disabilities, Loan programs—health, 

Organization and functions 

(Government agencies), Medicaid, 

Public assistance programs, Reporting 

and recordkeeping requirements, Safety, 

State and local governments, Sunshine 

Act, Technical assistance, Women, and 

Youth. 

For the reasons set forth in the 

preamble, the Department of Health and 

Human Services amends 45 CFR subtitle 

A, subchapter B, as set forth below: 

PART 156—HEALTH INSURANCE 

ISSUER STANDARDS UNDER THE 

AFFORDABLE CARE ACT, INCLUDING 

STANDARDS RELATED TO 

EXCHANGES 

■ 1. The authority citation for part 156 

is revised to read as follows: 

Authority: Title I of the Affordable Care 

Act, Sections 1301–1304, 1311–1312, 1321, 

1322, 1324, 1334, 1341–1343, and 1401– 

1402, Pub. L. 111–148, 124 Stat. 119 (42 

U.S.C. 18042). 

■ 2. Add subpart B to part 156 to read 

as follows: 


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Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Rules and Regulations 42671 

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, which 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 include limits 

on benefits based on the frequency of 

treatment, number of visits, days of 

coverage, or other similar limits on the 

scope or duration of treatment. 

Treatment limitations include only 

quantitative treatment limitations. A 

permanent exclusion of all benefits for 

a particular condition or disorder, 

however, is not a treatment limitation. 

(b) Required information. The issuers 

described in paragraph (c) of this 

section must provide the following 

information for the health plans 

described in paragraph (d) of this 

section in accordance with the 

standards in paragraph (e) of this 

section: 

(1) Administrative data necessary to 

identify the health plan; 

(2) Data and descriptive information 

for each plan on the following items: 

(i) All health benefits in the plan; 

(ii) Treatment limitations; 

(iii) Drug coverage; and 

(iv) Enrollment; 

(c) Issuers required to report. The 

issuers that offer the three largest health 

insurance products by enrollment, as of 

March 31, 2012 (enrollment is 

determined by HHS based on data 

submitted in accordance with part 159 

of this title) in each state’s small group 

market must provide the information in 

paragraph (b) of this section. 

(d) Plans affected. The issuers 

described in paragraph (c) of this 

section must provide the information 

described in paragraph (b) of this 

section for the health plan with the 

highest enrollment (as determined by 

the issuer) within the products 

described in paragraph (c) of this 

section. 

(e) Reporting requirement. To ensure 

consistency in reporting, an issuer 

described in paragraph (c) of this 

section must submit, in a form and 

manner to be determined by HHS, the 

information described in paragraph (b) 

of this section to HHS no later than 

September 4, 2012. 

■ 3. Amend § 156.275 by adding 

paragraph (c) to read as follows: 

§ 156.275 Accreditation of QHP issuers. 

* * * * * 

(c) Accreditation—(1) Recognition of 

accrediting entity by HHS. Effective 

upon completion of conditions listed in 

paragraphs (c)(2), (c)(3), and (c)(4) of 

this section, at which time HHS will 

notify the public in the Federal 

Register, the National Committee for 

Quality Assurance (NCQA) and URAC 

are recognized as accrediting entities by 

the Secretary of HHS to provide 

accreditation of QHPs meeting the 

requirement of this section. 

(2)(i) Scope of accreditation. Subject 

to paragraphs (c)(2)(ii), (iii), and (iv) of 

this section, recognized accrediting 

entities must provide accreditation 

within the categories identified in 

paragraphs (a)(1) of this section. 

(ii) Clinical quality measures. 

Recognized accrediting entities must 

include a clinical quality measure set in 

their accreditation standards for health 

plans that: 

(A) Spans a breadth of conditions and 

domains, including, but not limited to, 

preventive care, mental health and 

substance abuse disorders, chronic care, 

and acute care. 

(B) Includes measures that are 

applicable to adults and measures that 

are applicable to children. 

(C) Aligns with the priorities of the 

National Strategy for Quality 

Improvement in Health Care issued by 

the Secretary of HHS and submitted to 

Congress on March 12, 2011; 

(D) Only includes measures that are 

either developed or adopted by a 

voluntary consensus standards setting 

body (such as those described in the 

National Technology and Transfer 

Advancement of Act of 1995 (NTTAA) 

and Office of Management and Budget 

(OMB) Circular A–119 (1998)) or, where 

appropriate endorsed measures are 

unavailable, are in common use for 

health plan quality measurement and 

meet health plan industry standards; 

and 

(E) Is evidence-based. 

(iii) Level of accreditation. Recognized 

accrediting entities must provide 

accreditation at the Exchange product 

type level unless the product type level 

of accreditation is not methodologically 

sound. In such cases, the recognized 

accrediting entity must demonstrate that 

the Exchange product type level 

accreditation is not methodologically 

sound as a condition of the Exchange 

granting an exception to authorize 

accreditation at an aggregated level. 

(iv) Network adequacy. The network 

adequacy standards for accreditation 

used by the recognized accrediting 

entities must, at a minimum, be 

consistent with the general 

requirements for network adequacy for 

QHP issuers codified in § 156.230(a)(2) 

and (a)(3). 

(3) Methodological and scoring 

criteria for accreditation. Recognized 

accrediting entities must use transparent 

and rigorous methodological and 

scoring criteria. 

(4) Documentation. An accrediting 

entity must provide the following 

documentation: 

(i) To be recognized, an accrediting 

entity must provide current 

accreditation standards and 

requirements, processes, and measure 

specifications for performance measures 

to demonstrate that each entity meets 

the conditions described in paragraphs 

(c)(2), and (c)(3) of this section to HHS 

within 60 days of the publication date 

of this final rule. 

(ii) Recognized accrediting entities 

must provide to HHS any proposed 

changes or updates to the accreditation 

standards and requirements, processes, 

and measure specifications for 

performance measures with 60 days 

notice prior to public notification. 

(5) Data sharing requirements 

between the recognized accrediting 

entities and Exchanges. When 

authorized by an accredited QHP issuer 

pursuant to paragraph (a)(2) of this 

section, recognized accrediting entities 

must provide the following QHP issuer’s 

accreditation survey data elements to 

the Exchange, other than personally 

identifiable information (as described in 

OMB Memorandum M–07–16), in 

which the issuer plans to operate one or 

more QHPs during the annual 

certification period or as changes occur 

to these data throughout the coverage 

year—the name, address, Health 

Insurance Oversight System (HIOS) 

issuer identifier, and unique 

accreditation identifier(s) of the QHP 

issuer and its accredited product line(s) 

and type(s) which have been released; 

and for each accredited product type: 

(i) HIOS product identifier (if 

applicable); 

(ii) Accreditation status, survey type, 

or level (if applicable); 

(iii) Accreditation score; 

(iv) Expiration date of accreditation; 

and 


tkelley on DSK3SPTVN1PROD with RULES
42672 Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Rules and Regulations 

(v) Clinical quality measure results 

and adult and child CAHPS measure 

survey results (and corresponding 

expiration dates of these data) at the 

level specified by the Exchange. 

Dated: July 16, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: July 16, 2012. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2012–17831 Filed 7–18–12; 4:15 pm] 

BILLING CODE 4120–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 12–115; DA 12–1084] 

Radio Broadcasting Services; 

Alberton, MT; Crystal Falls, MI; Saint 

Paul, AR; and Waitsburg, WA 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Audio Division, on its 

own motion, deletes four vacant 

allotments in various communities in 

Arkansas, Michigan, Montana, and 

Washington. These vacant allotments 

have been auctioned through our 

competitive bidding process, and are 

considered unsold permits that were 

included in Auction 93. We are deleting 

these vacant allotments from the FM 

Table, because there were no bona fide 

expressions of interest filed to retain 

these four vacant allotments. Deletion of 

these allotments may create other 

opportunities in nearby communities for 

new FM allotments or upgrades of 

existing stations. We conclude that the 

deletion of these vacant allotments 

could promote a more effective and 

efficient use of the FM broadcast 

spectrum. See Supplementary 

Information, supra. 

DATES: Effective August 20, 2012. 

ADDRESSES: Secretary, Federal 

Communications Commission, 445 12th 

Street SW., Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: 

Rolanda F. Smith, Media Bureau, (202) 

418–2700. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 12–115, 

adopted July 5, 2012, and released July 

6, 2012. The full text of this 

Commission decision is available for 

inspection and copying during normal 

business hours in the FCC’s Reference 

Information Center at Portals II, CY– 

A257, 445 Twelfth Street SW., 

Washington, DC 20554. This document 

may also be purchased from the 

Commission’s duplicating contractors, 

Best Copy and Printing, Inc., 445 12th 

Street SW., Room CY–B402, 

Washington, DC 20554, telephone 

1–800–378–3160 or via email www.

BCPIWEB.com. This document does not 

contain proposed information collection 

requirements subject to the Paperwork 

Reduction Act of 1995, Public Law 104– 

13. The Commission will not send a 

copy of this Report and Order pursuant 

to the Congressional Review Act, see 5 

U.S.C. 801(a)(1)(A), because the adopted 

rules are rules of particular 

applicability. 

The allotment of Channel 287A at 

Saint Paul, Arkansas is not currently 

listed in the FM Table of Allotments. 

Channel 287A at Saint Paul, Arkansas 

was allotted in MM Docket No. 97–34. 

See Saint Paul, Arkansas, 62 FR 65765, 

published December 16, 1997. Cumulus 

Licensing, LLC, permittee of Station 

DWYAK–FM, Channel 287A, Saint 

Paul, Arkansas received a construction 

permit to operate the station on Channel 

287A at Saint Paul, Arkansas. However, 

the Audio Division subsequently 

cancelled the construction permit (File 

No. BNPH–20041230ADG), rendering 

Channel 287A at Saint Paul, Arkansas a 

vacant allotment. 

List of Subjects in 47 CFR Part 73 

Radio, Radio broadcasting. 

Federal Communications Commission. 

Nazifa Sawez, 

Assistant Chief, Audio Division, Media 

Bureau. 

For the reasons discussed in the 

preamble, the Federal Communications 

Commission amends 47 CFR part 73 as 

follows: 

PART 73—RADIO BROADCAST 

SERVICES 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 47 U.S.C. 154, 303, 334, 336 and 

339. 

§ 73.202 [Amended] 

■ 2. Amend § 73.202(b) Table of FM 

Allotments as follows: 

■ a. Remove Crystal Falls, under 

Michigan, Channel 280C2. 

■ b. Remove Alberton, under Montana, 

Channel 288C3. 

■ c. Remove Waitsburg, under 

Washington, Channel 272A. 

[FR Doc. 2012–17785 Filed 7–19–12; 8:45 am] 

BILLING CODE 6712–01–P 


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