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[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Rules and Regulations]
[Pages 8668-8706]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3228]

[[Page 8667]]

Vol. 77

Tuesday,

No. 30

February 14, 2012

Part VII

Department of the Treasury

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Internal Revenue Service

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26 Parts 54 and 602

Department of Labor

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Employee Benefits Security Administration

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29 CFR Part 2590

Department of Health and Human Services

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45 CFR Part 147

 Summary of Benefits and Coverage and Uniform Glossary; Final Rule

Federal Register / Vol. 77 , No. 30 / Tuesday, February 14, 2012 / 
Rules and Regulations

[[Page 8668]]

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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 54 and 602

[TD 9575]
RIN 1545-BJ94

DEPARTMENT OF LABOR

Employee Benefits Security Administration

29 CFR Part 2590

RIN 1210-AB52

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[CMS-9982-F]

45 CFR Part 147

RIN 0938-AQ73

Summary of Benefits and Coverage and Uniform Glossary

AGENCIES: Internal Revenue Service, Department of the Treasury; 
Employee Benefits Security Administration, Department of Labor; Centers 
for Medicare & Medicaid Services, Department of Health and Human 
Services.

ACTION: Final rule.

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SUMMARY: This document contains final regulations regarding the summary 
of benefits and coverage and the uniform glossary for group health 
plans and health insurance coverage in the group and individual markets 
under the Patient Protection and Affordable Care Act. This document 
implements the disclosure requirements under section 2715 of the Public 
Health Service Act to help plans and individuals better understand 
their health coverage, as well as other coverage options. A guidance 
document published elsewhere in this issue of the Federal Register 
provides further guidance regarding compliance.

DATES: Effective date. These final regulations are effective April 16, 
2012.
    Applicability date. The requirements to provide an SBC, notice of 
modification, and uniform glossary under PHS Act section 2715 and these 
final regulations apply for disclosures to participants and 
beneficiaries who enroll or re-enroll in group health coverage through 
an open enrollment period (including re-enrollees and late enrollees) 
beginning on the first day of the first open enrollment period that 
begins on or after September 23, 2012. For disclosures to participants 
and beneficiaries who enroll in group health plan coverage other than 
through an open enrollment period (including individuals who are newly 
eligible for coverage and special enrollees), the requirements under 
PHS Act section 2715 and these final regulations apply beginning on the 
first day of the first plan year that begins on or after September 23, 
2012. For disclosures to plans, and to individuals and dependents in 
the individual market, these requirements are applicable to health 
insurance issuers beginning on September 23, 2012.

FOR FURTHER INFORMATION CONTACT: Amy Turner or Heather Raeburn, 
Employee Benefits Security Administration, Department of Labor, at 
(202) 693-8335; Karen Levin, Internal Revenue Service, Department of 
the Treasury, at (202) 622-6080; Jennifer Libster or Padma Shah, 
Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, at (301) 492-4222.

SUPPLEMENTARY INFORMATION:
    Customer Service Information: Individuals interested in obtaining 
information from the Department of Labor concerning employment-based 
health coverage laws may call the EBSA Toll-Free Hotline at 1-866-444-
EBSA (3272) or visit the Department of Labor's Web site (http://www.dol.gov/ebsa). In addition, information from HHS on private health 
insurance for consumers can be found on the Centers for Medicare & 
Medicaid Services (CMS) Web site (http://www.cms.hhs.gov/HealthInsReformforConsume/01_Overview.asp) and information on health 
reform can be found at http://www.healthcare.gov.

I. Executive Summary

A. Purpose of the Regulatory Action

1. Need for Regulatory Action
    Under section 2715 of the Public Health Service Act (PHS Act), as 
added by the Patient Protection and Affordable Care Act (Affordable 
Care Act), the Departments of Health and Human Services, Labor, and the 
Treasury (the Departments) are to develop standards for use by group 
health plans and health insurance issuers offering group or individual 
health insurance coverage in compiling and providing a summary of 
benefits and coverage (SBC) that ``accurately describes the benefits 
and coverage under the applicable plan or coverage.'' PHS Act section 
2715 also calls for the ``development of standards for the definitions 
of terms used in health insurance coverage.''
    This regulation establishes the standards required to be met under 
PHS Act section 2715. Among other things, these standards ensure this 
information is presented in clear language and in a uniform format that 
helps consumers to better understand their coverage and better compare 
coverage options. The current patchwork of non-uniform consumer 
disclosure requirements makes shopping for coverage inefficient, 
difficult, and time-consuming, particularly in the individual and small 
group market, but also in some large employer plans in which workers 
may be confused about the value of their health benefits as part of 
their total compensation. As a result of this confusion, health 
insurance issuers and employers may face less pressure to compete on 
price, benefits, and quality, contributing to inefficiency in the 
health insurance and labor markets.
    The statute is detailed but not self-implementing, contains 
ambiguities, and specifically requires the Departments to develop 
standards, consult with the National Association of Insurance 
Commissioners, and issue regulations. Therefore these consumer 
protections cannot be established without this regulation.
2. Legal Authority
    The substantive authority for this regulation is generally PHS Act 
section 2715, which is incorporated by reference into Employee 
Retirement Income Security Act (ERISA) section 715 and the Internal 
Revenue Code (Code) section 9815. PHS Act section 2792, ERISA section 
734, and Code section 9833 also provide rulemaking authority. (For a 
fuller discussion of the Departments' legal authority, see section V. 
of this preamble.)

B. Summary of the Major Provisions of This Regulatory Action

    Paragraph (a) of the final regulations implements the general 
disclosure requirement and sets forth the standards for who provides an 
SBC, to whom, and when. The regulations outline three different 
scenarios under which an SBC will be provided: (1) By a group health 
insurance issuer to a group health plan; (2) by a group health 
insurance issuer and a group health plan to participants and 
beneficiaries; and (3) by a health insurance issuer to individuals and 
dependents in the individual market. For each scenario, an SBC must be 
provided in several different circumstances, such as upon application 
for coverage, by the first day of coverage (if information in the SBC 
has changed), upon renewal or reissuance, and upon request. The final 
regulations also

[[Page 8669]]

include special rules to prevent unnecessary duplication in the 
provision of an SBC with respect to group health coverage and 
individual health insurance coverage.
    The final regulations set forth a list of requirements for the SBC 
that generally mirror those set forth in the statute. There are a total 
of 12 required content elements under the regulations, including 
uniform standard definitions of medical and health coverage terms, 
which will help consumers better understand their coverage; a 
description of the coverage including the cost sharing requirements 
such as deductibles, coinsurance, and co-payments; and information 
regarding any exceptions, reductions, or limitations under the 
coverage. The final regulations also require inclusion of coverage 
examples, which illustrate benefits provided under the plan or coverage 
for common benefits scenarios. In addition, the regulations specify 
requirements related to the appearance of the SBC, which generally must 
be presented in a uniform format, cannot exceed four double-sided pages 
in length, and must not include print smaller than 12-point font. These 
requirements are detailed further in a Notice published elsewhere in 
today's Federal Register providing additional guidance related to PHS 
Act section 2715 and these final regulations.
    PHS Act section 2715 and the final regulations also require that 
plans and issuers provide notice of modification in any of the terms of 
the plan or coverage involved that would affect the content of the SBC, 
that is not reflected in the most recently provided SBC, and that 
occurs other than in connection with a renewal or reissuance of 
coverage.
    Finally, the statute directs the Departments to develop standards 
for definitions for certain insurance-related and medical terms, as 
well as other terms that will help consumers understand and compare the 
terms of coverage and the extent of medical benefits (including any 
exceptions and limitations). Group health plans and health insurance 
issuers must provide the uniform glossary in the appearance specified 
by the Departments, so that the glossary is presented in a uniform 
format and uses terminology understandable by the average plan enrollee 
or individual covered under an individual policy. A guidance document 
published elsewhere in today's Federal Register provides further 
guidance with respect to the uniform glossary.
    The requirements to provide an SBC, notice of modification, and 
uniform glossary under PHS Act section 2715 and these final regulations 
apply for disclosures with respect to participants and beneficiaries 
who enroll or re-enroll in group health coverage through an open 
enrollment period (including re-enrollees and late enrollees), 
beginning on the first day of the first open enrollment period that 
begins on or after September 23, 2012. For disclosures to participants 
and beneficiaries who enroll in group health plan coverage other than 
through an open enrollment period (including individuals who are newly 
eligible for coverage and special enrollees), the requirements under 
PHS Act section 2715 and these final regulations apply beginning on the 
first day of the first plan year that begins on or after September 23, 
2012. For disclosures to plans, and to individuals and dependents in 
the individual market, these requirements apply to health insurance 
issuers beginning on September 23, 2012.

C. Costs and Benefits

    The direct benefits of these final regulations come from improved 
information, which will enable consumers, both individuals and 
employers, to better understand the coverage they have and make better 
coverage decisions, based on their preferences with respect to benefit 
design, level of financial protection, and cost. The Departments 
believe that such improvements will result in a more efficient, 
competitive market. These final regulations will also benefit consumers 
by reducing the time they spend searching for and compiling health plan 
and coverage information.
    Under the final regulations, group health plans and health 
insurance issuers will incur costs to compile and provide the summary 
of benefits and coverage and uniform glossary of health coverage and 
medical terms. The Departments estimate that the annualized cost may be 
around $73 million. As is common with regulations implementing new 
policies, there is considerable uncertainty arising from general data 
limitations and the degree to which economies of scale exist for 
disclosing this information. Nonetheless, the Departments believe that 
these final regulations lower overall administrative costs from the 
proposed regulations because of several policy changes, notably 
flexibility in the instructions for completing the SBC, the omission of 
premium (or cost of coverage) information from the SBC, the reduction 
in the number of coverage examples required from three to two, and 
provisions allowing greater flexibility for electronic disclosure.
    In accordance with Executive Orders 12866 and 13563, the 
Departments believe that the benefits of this regulatory action justify 
the costs.

II. Background

    The Patient Protection and Affordable Care Act, Pub. L. 111-148, 
was enacted on March 23, 2010; the Health Care and Education 
Reconciliation Act, Pub. L. 111-152, was enacted on March 30, 2010 
(these are collectively known as the ``Affordable Care Act''). The 
Affordable Care Act reorganizes, amends, and adds to the provisions of 
part A of title XXVII of the Public Health Service Act (PHS Act) 
relating to group health plans and health insurance issuers in the 
group and individual markets. The term ``group health plan'' includes 
both insured and self-insured group health plans.\1\ The Affordable 
Care Act adds section 715(a)(1) to the Employee Retirement Income 
Security Act (ERISA) and section 9815(a)(1) to the Internal Revenue 
Code (the Code) to incorporate the provisions of part A of title XXVII 
of the PHS Act into ERISA and the Code, and make them applicable to 
group health plans, and health insurance issuers providing health 
insurance coverage in connection with group health plans. The PHS Act 
sections incorporated by this reference are sections 2701 through 2728. 
PHS Act sections 2701 through 2719A are substantially new, though they 
incorporate some provisions of prior law. PHS Act sections 2722 through 
2728 are sections of prior law renumbered, with some, mostly minor, 
changes.
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    \1\ The term ``group health plan'' is used in title XXVII of the 
PHS Act, part 7 of ERISA, and chapter 100 of the Code, and is 
distinct from the term ``health plan,'' as used in other provisions 
of title I of the Affordable Care Act. The term ``health plan'' does 
not include self-insured group health plans.
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    Subtitles A and C of title I of the Affordable Care Act amend the 
requirements of title XXVII of the PHS Act (changes to which are 
incorporated into ERISA by section 715). The preemption provisions of 
ERISA section 731 and PHS Act section 2724 \2\ (implemented in 29 CFR 
2590.731(a) and 45 CFR 146.143(a)) apply so that the requirements of 
part 7 of ERISA and title XXVII of the PHS Act, as amended by the 
Affordable Care Act, are not to be ``construed to supersede any 
provision of State law which establishes, implements, or continues in 
effect any standard or requirement solely relating to health insurance 
issuers in connection with group or individual health insurance 
coverage except to the extent that such standard or

[[Page 8670]]

requirement prevents the application of a requirement'' of provisions 
added to the PHS Act by the Affordable Care Act. Accordingly, State 
laws with stricter health insurance issuer requirements than those 
imposed by the PHS Act will not be superseded by those provisions. 
(Preemption and State flexibility under PHS Act section 2715 are 
discussed more fully below under section III.D.)
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    \2\ Code section 9815 incorporates the preemption provisions of 
PHS Act section 2724. Prior to the Affordable Care Act, there were 
no express preemption provisions in chapter 100 of the Code.
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    The Departments of Health and Human Services (HHS), Labor, and the 
Treasury (the Departments) are taking a phased approach to issuing 
regulations implementing the revised PHS Act sections 2701 through 
2719A and related provisions of the Affordable Care Act. These final 
regulations are being published to implement the disclosure 
requirements under PHS Act section 2715. As discussed more fully below, 
a document containing further guidance for compliance is published 
elsewhere in this issue of the Federal Register.

III. Overview of the Final Regulations

A. Summary of Benefits and Coverage

1. In General
    Section 2715 of the PHS Act, added by the Affordable Care Act, 
directs the Departments to develop standards for use by a group health 
plan and a health insurance issuer offering group or individual health 
insurance coverage in compiling and providing a summary of benefits and 
coverage (SBC) that ``accurately describes the benefits and coverage 
under the applicable plan or coverage.'' PHS Act section 2715 also 
calls for the ``development of standards for the definitions of terms 
used in health insurance coverage.''
    The statute directs the Departments, in developing such standards, 
to ``consult with the National Association of Insurance Commissioners'' 
(referred to in this document as the ``NAIC''), ``a working group 
composed of representatives of health insurance-related consumer 
advocacy organizations, health insurance issuers, health care 
professionals, patient advocates including those representing 
individuals with limited English proficiency, and other qualified 
individuals.'' \3\ On July 29, 2011, the NAIC provided its final 
recommendations to the Departments regarding the SBC. On August 22, 
2011, the Departments published in the Federal Register proposed 
regulations (76 FR 52442) and an accompanying document with templates, 
instructions, and related materials (76 FR 52475) for implementing the 
disclosure provisions under PHS Act section 2715. The proposed 
regulations and accompanying document adhered to the recommendations of 
the NAIC. After consideration of all the comments received on the 
proposed regulations and accompanying document, the Departments are 
publishing these final regulations. In conjunction with these final 
regulations, the Departments are also publishing a guidance document 
elsewhere in this issue of the Federal Register that contains further 
guidance for compliance, including information on how to obtain the SBC 
template (with instructions and sample language for completing the 
template) and the uniform glossary. All of these items are displayed at 
www.dol.gov/ebsa/healthreform and www.cciio.cms.gov.
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    \3\ The NAIC convened a working group (NAIC working group) 
comprised of a diverse group of stakeholders. This working group met 
frequently each month for over one year while developing its 
recommendations. In developing its recommendations, the NAIC 
considered the results of various consumer testing sponsored by both 
insurance industry and consumer associations. Throughout the 
process, NAIC working group draft documents and meeting notes were 
displayed on the NAIC's Web site for public review, and several 
interested parties filed formal comments. In addition to 
participation from the NAIC working group members, conference calls 
and in-person meetings were open to other interested parties and 
individuals and provided an opportunity for non-member feedback. See 
www.naic.org/committees_b_consumer_information.htm.
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2. Providing the SBC
    Paragraph (a) of the final regulations implements the general 
disclosure requirement and sets forth the standards for who provides an 
SBC, to whom, and when. PHS Act section 2715 generally requires that an 
SBC be provided to applicants, enrollees, and policyholders or 
certificate holders. PHS Act section 2715(d)(3) places the 
responsibility to provide an SBC on ``(A) a health insurance issuer 
(including a group health plan that is not a self-insured plan) 
offering health insurance coverage within the United States; or (B) in 
the case of a self-insured group health plan, the plan sponsor or 
designated administrator of the plan (as such terms are defined in 
section 3(16) of ERISA).'' \4\ Accordingly, the final regulations 
interpret PHS Act section 2715 to apply to both group health plans and 
health insurance issuers offering group or individual health insurance 
coverage. In addition, consistent with the statute, the final 
regulations hold the plan administrator of a group health plan 
responsible for providing an SBC. Under the final regulations, the SBC 
must be provided in writing and free of charge.
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    \4\ ERISA section 3(16) defines an administrator as: (i) The 
person specifically designated by the terms of the instrument under 
which the plan is operated; (ii) if an administrator is not so 
designated, the plan sponsor; or (iii) in the case of a plan for 
which an administrator is not designated and plan sponsor cannot be 
identified, such other person as the Secretary of Labor may by 
regulation prescribe.
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    Several commenters argued that large group health plans or self-
insured group health plans should be exempt from the requirement to 
provide the SBC. Many of these commenters noted that such plans already 
provide a wealth of useful information, including a summary plan 
description and open season materials that accurately describe the plan 
and any coverage options. However, the statute includes no such 
exemption for large or self-insured plans. Moreover, the Departments 
believe that the SBC's uniform format and appearance requirements will 
allow individuals to easily compare coverage options across different 
types of plans and insurance products, including those offered through 
Affordable Insurance Exchanges (Exchanges) beginning in 2014.
    Several commenters asked whether the SBC is required to be provided 
with respect to all group health plans, including certain account-type 
arrangements such as health flexible spending arrangements (health 
FSAs) \5\, health reimbursement arrangements (HRAs) \6\, and health 
savings accounts (HSAs) \7\. An SBC need not be provided for plans, 
policies, or benefit packages that constitute excepted benefits. Thus, 
for example, an SBC need not be provided for stand-alone dental or 
vision plans or health FSAs if they constitute excepted benefits under 
the Departments' regulations.\8\ If benefits under a health FSA do not 
constitute excepted benefits, the health FSA is a group health plan 
generally subject to the SBC requirements. For a health FSA that does 
not meet the criteria for excepted benefits and that is integrated with 
other major medical coverage, the SBC is prepared for the other major 
medical coverage, and the effects of the health FSA can be denoted in 
the appropriate spaces on the SBC for deductibles, copayments, 
coinsurance, and benefits otherwise not covered by the major medical 
coverage. A stand-alone health FSA must satisfy the SBC requirements 
independently.
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    \5\ See Code section 106(c)(2).
    \6\ See IRS Notice 2002-45, 2002-2 C.B. 93.
    \7\ See Code section 223.
    \8\ See 26 CFR 54.9831-1(c), 29 CFR 2590.732(c), 45 CFR 
146.145(c).
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    An HRA is a group health plan. Benefits under an HRA generally do 
not constitute excepted benefits, and thus HRAs are generally subject 
to the SBC requirements. A stand-alone HRA generally must satisfy the 
SBC requirements (though many of the

[[Page 8671]]

limitations that apply under traditional fee-for-service or network 
plans do not apply under stand-alone HRAs). An HRA integrated with 
other major medical coverage need not separately satisfy the SBC 
requirements; the SBC is prepared for the other major medical coverage, 
and the effects of employer allocations to an account under the HRA can 
be denoted in the appropriate spaces on the SBC for deductibles, 
copayments, coinsurance, and benefits otherwise not covered by the 
other major medical coverage.
    HSAs generally are not group health plans and thus generally are 
not subject to the SBC requirements. Nevertheless, an SBC prepared for 
a high deductible health plan associated with an HSA can mention the 
effects of employer contributions to HSAs in the appropriate spaces on 
the SBC for deductibles, copayments, coinsurance, and benefits 
otherwise not covered by the high deductible health plan.
    There are three general scenarios under which an SBC will be 
provided: (1) By a group health insurance issuer to a group health 
plan; (2) by a group health insurance issuer and a group health plan to 
participants and beneficiaries; and (3) by a health insurance issuer to 
individuals and dependents in the individual market. In general, the 
proposed regulations directed that, in each of these scenarios, the SBC 
be provided when an employer or individual is comparing health coverage 
options, including prior to purchasing or enrolling in a particular 
plan or policy.
    Some commenters asserted that certain timing requirements in the 
proposed regulations could be administratively difficult for plans and 
issuers to meet under certain conditions, such as when negotiations of 
policy terms are ongoing less than 30 days before renewal, making the 
proposed timeframe for providing the SBC difficult or impossible to 
achieve. In response to public comments, the final regulations 
streamline and harmonize the rules for providing the SBC, while 
ensuring that individuals and employers have timely and complete 
information under all three scenarios in which an SBC might be 
provided. Moreover, in certain circumstances, the final regulations 
provide plans and issuers with additional time to provide the SBC. For 
example, under the proposed regulations, an SBC would have been 
required to be provided as soon as practicable following an application 
for health coverage or a request for an SBC, but in no event later than 
seven days following the application or request. For all three 
scenarios under which an SBC might be provided, the final regulations 
substitute a seven business day period for the seven calendar day 
period in the proposed regulations in each place it appeared.
    The Departments also received comments regarding issuance of an SBC 
at renewal or reissuance of coverage. The proposed regulations would 
have required that, if written application materials are required for 
renewal, the SBC must be provided no later than the date on which the 
materials are distributed. This requirement has been retained without 
change in the final regulations. In addition, upon an automatic renewal 
of coverage (that is, when written application materials are not 
required for renewal), the proposed regulations would have required a 
new SBC to be provided no later than 30 days prior to the first day of 
coverage under the new plan or policy year. The final regulations 
require that, in general, if renewal or reissuance of coverage is 
automatic, the SBC must be provided no later than 30 days prior to the 
first day of the new plan or policy year. However, with respect to 
insured coverage, in situations in which the SBC cannot be provided 
within this timeframe because, for instance, the issuer and the 
purchaser have not yet finalized the terms of coverage for the new 
policy year, the final regulations provide an exception. Under that 
circumstance, the SBC must be provided as soon as practicable, but in 
no event later than seven business days after the issuance of the 
policy, certificate, or contract of insurance (for simplicity, referred 
to collectively as a ``policy'' in the remainder of this preamble), or 
the receipt of written confirmation of intent to renew, whichever is 
earlier. The regulations provide this flexibility only when the terms 
of coverage are finalized in fewer than 30 days in advance of the new 
policy year; otherwise, the SBC must be provided upon automatic renewal 
no later than 30 days prior to the first day of coverage under the new 
plan or policy year.

a. Provision of the SBC by an Issuer to a Plan

    Paragraph (a)(1)(i) of the final regulations requires a health 
insurance issuer offering group health insurance coverage to provide an 
SBC to a group health plan (including, for this purpose, its sponsor) 
upon an application by the plan for health coverage. The SBC must be 
provided as soon as practicable following receipt of the application, 
but in no event later than seven business days following receipt of the 
application. If there is any change to the information required to be 
in the SBC before the first day of coverage, the issuer must update and 
provide a current SBC to the plan no later than the first day of 
coverage. If the information is unchanged, the SBC does not need to be 
provided again in connection with coverage for that plan year, except 
upon request. As noted later in this preamble, the final regulations, 
in contrast to the proposed regulations, do not include premium or cost 
of coverage information as a required element of the SBC. In many 
cases, the only change to the information the proposed regulations 
required to be in the SBC between application for coverage and the 
first day of coverage is the premium or cost of coverage information. 
Because these final regulations eliminate the requirement to include 
premium or cost of coverage information in the SBC, the Departments 
anticipate that the number of circumstances in which issuers will have 
to provide a second SBC will be significantly fewer under the final 
regulations than they would have been under the proposed regulations.

b. Provision of the SBC by a Plan or Issuer to Participants and 
Beneficiaries

    Under paragraph (a)(1)(ii) of the final regulations, a group health 
plan (including the plan administrator), and a health insurance issuer 
offering group health insurance coverage, must provide an SBC to a 
participant or beneficiary \9\ with respect to each benefit package 
offered by the plan or issuer for which the participant or beneficiary 
is eligible.\10\ Some commenters stated that SBCs should only be 
provided to participants, not beneficiaries, or that the SBC should 
only be provided to beneficiaries upon request. The

[[Page 8672]]

statutory language, which refers to ``applicants'' and ``enrollees,'' 
could be interpreted to support either interpretation. These final 
regulations retain the requirement that the SBC be provided to both 
participants and beneficiaries. However, as described below, the final 
regulations include an anti-duplication rule under which a single SBC 
may be provided to a family unless any beneficiaries are known to 
reside at a different address. Accordingly, separate SBCs need to be 
provided to beneficiaries only in limited circumstances.
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    \9\ ERISA section 3(7) defines a participant as: Any employee or 
former employee of an employer, or any member or former member of an 
employee organization, who is or may become eligible to receive a 
benefit of any type from an employee benefit plan which covers 
employees of such employers or members of such organization, or 
whose beneficiaries may be eligible to receive any such benefit. 
ERISA section 3(8) defines a beneficiary as: A person designated by 
a participant, or by the terms of an employee benefit plan, who is 
or may become entitled to a benefit thereunder.
    \10\ With respect to insured group health plan coverage, PHS Act 
section 2715 generally places the obligation to provide an SBC on 
both a plan and issuer. As discussed below, under section 
III.A.2.d., ``Special Rules to Prevent Unnecessary Duplication With 
Respect to Group Health Coverage'', if either the issuer or the plan 
provides the SBC, both will have satisfied their obligations. As 
they do with other notices required of both plans and issuers under 
Part 7 of ERISA, Title XXVII of the PHS Act, and Chapter 100 of the 
Code, the Departments expect plans and issuers to make contractual 
arrangements for sending SBCs. Accordingly, the remainder of this 
preamble generally refers to requirements for plans or issuers.
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    The SBC must be provided as part of any written application 
materials that are distributed by the plan or issuer for enrollment. If 
the plan does not distribute written application materials for 
enrollment, the SBC must be distributed no later than the first date 
the participant is eligible to enroll in coverage for the participant 
or any beneficiaries. If there is any change to the information 
required to be in the SBC between the application for coverage and the 
first day of coverage, the plan or issuer must update and provide a 
current SBC to a participant or beneficiary no later than the first day 
of coverage.
    Under the final regulations, the plan or issuer must also provide 
the SBC to special enrollees.\11\ The proposed regulations would have 
required that the SBC be provided within seven calendar days of a 
request for special enrollment. One commenter stated that special 
enrollees should not be distinguished from other enrollees with such 
expedited disclosure, particularly since they have already enrolled in 
coverage and are no longer comparing coverage options. The final rule 
provides that special enrollees must be provided the SBC no later than 
when a summary plan description is required to be provided under the 
timeframe set forth in ERISA section 104(b)(1)(A) and its implementing 
regulations, which is 90 days from enrollment. The revised timing 
requirement related to providing an SBC in connection with special 
enrollment is expected to reduce administrative costs for providing 
SBCs to these individuals, who have already chosen the plan, policy, or 
benefit package in which to enroll. To the extent individuals who are 
eligible for special enrollment and are contemplating their coverage 
options would like to receive SBCs earlier, they may always request an 
SBC with respect to any particular plan, policy, or benefit package and 
the SBC is required to be provided as soon as practicable, but in no 
event later than seven business days following receipt of the request 
(as discussed more fully below).
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    \11\ Regulations regarding special enrollment are available at 
26 CFR 54.9801-6, 29 CFR 2590.701-6, and 45 CFR 146.117.
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c. Provision of the SBC Upon Request in Group Health Coverage

    As discussed earlier in this preamble, a health insurance issuer 
offering group health insurance coverage must provide the SBC to a 
group health plan (and a plan or issuer must provide the SBC to a 
participant or beneficiary) upon request for an SBC or summary 
information about the health coverage, as soon as practicable, but in 
no event later than seven business days following receipt of the 
request. The Departments received several comments addressing the 
requirement to provide the SBC upon request. Many comments were 
supportive of this approach, especially with regards to participants 
and beneficiaries needing information about their coverage in the 
middle of a plan year after life changes. Other comments suggested that 
providing SBCs to employers and individuals who are only ``shopping'' 
for coverage and not yet enrolled is unnecessary and will require 
multiple SBCs to be provided as employers and individuals go through 
underwriting.
    The final regulations retain the requirement that the SBC be 
provided upon request to participants, beneficiaries and employers, 
including prior to submitting an application for coverage, because the 
SBC provides information that not only helps consumers understand their 
coverage, but also helps consumers compare coverage options prior to 
selecting coverage. The Departments believe it is essential for 
employers, participants, and beneficiaries to have this information to 
help make informed coverage decisions and believe that the 
modifications to the SBC template, including the removal of premium 
information, adequately addresses the concerns that health insurance 
issuers will have to provide multiple SBCs to employers and individuals 
prior to underwriting.
    Health insurance issuers offering individual market coverage must 
also provide the SBC to individuals upon request, to allow consumers 
reviewing coverage options the same ability to compare coverage options 
in the individual market, as well in the Exchanges and the group 
markets.

d. Special Rules to Prevent Unnecessary Duplication With Respect to 
Group Health Coverage

    The proposed regulations provided three rules to streamline 
provision of the SBC and prevent unnecessary duplication with respect 
to group health plan coverage. Paragraph (a)(1)(iii) of the final 
regulations retains these special rules, with some modifications. The 
first states that the requirement to provide an SBC generally will be 
considered satisfied for all entities if it is provided by any entity, 
so long as all timing and content requirements are satisfied. The 
second states that a single SBC may be provided to a participant and 
any beneficiaries at the participant's last known address. However, if 
a beneficiary's last known address is different than the participant's 
last known address, a separate SBC is required to be provided to the 
beneficiary at the beneficiary's last known address. Finally, under the 
special rule providing that SBCs are not required to be provided 
automatically upon renewal for benefit packages in which the 
participant or beneficiary is not enrolled, a plan or issuer generally 
has up to seven business days (rather than seven calendar days, as 
specified in the proposed regulation) to respond to a request to 
provide the SBC with respect to another benefit package for which the 
participant or beneficiary is eligible.
    Many commenters pointed out the potential duplication and confusion 
that can result with carve-out arrangements, which is generally when a 
plan or issuer contracts with an administrative service provider (such 
as a pharmacy benefit manager or managed behavioral health 
organization) to manage prescribed functions such as managed care and 
utilization review. Plans and issuers should coordinate with their 
service providers, and with each other, to ensure that the SBCs they 
provide are accurate.

e. Provision of the SBC by an Issuer Offering Individual Market 
Coverage

    Under these final regulations, the Secretary of HHS sets forth 
standards applicable to individual health insurance coverage about who 
provides an SBC, to whom, and when. The provisions of the final 
regulations for individual market coverage parallel the group market 
requirements described above, with only those changes necessary to 
reflect the differences between the two markets, and the provisions of 
the final regulations are intended to more clearly reflect the 
similarity between the two sets of rules.

[[Page 8673]]

For example, individuals and dependents in the individual market are 
comparable to group health plan participants and beneficiaries. 
Accordingly, an issuer offering individual health insurance coverage 
must provide an SBC to an individual or dependent upon receiving an 
application for any health insurance policy, as soon as practicable 
following receipt of the application, but in no event later than seven 
business days following receipt of the application. If there is any 
change in the information required to be in the SBC between the 
application for coverage and the first day of coverage, the issuer must 
update and provide a current SBC to an individual or dependent no later 
than the first day of coverage.\12\ Additionally, an issuer must 
provide the SBC to any individual or dependent upon request for an SBC 
or summary information about a health insurance product as soon as 
practicable, but in no event later than seven business days following 
the request. Similar to the group market, a request for an SBC or 
summary information includes a request made at any time, including 
prior to applying for coverage.
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    \12\ As noted elsewhere in this preamble, the final regulations, 
in contrast to the proposed regulations, do not include premium 
information as a required element of the SBC. Because, in many 
cases, the only change to the information required to be in the SBC 
before the first day of coverage is the premium, the Departments 
anticipate that the number of circumstances in which issuers will 
have to provide a second SBC before the first day of coverage will 
significantly decrease under the final regulation.
---------------------------------------------------------------------------

    The final regulations retain the individual market anti-duplication 
rule, similar to the group health coverage anti-duplication rule, for 
individual health insurance coverage that covers more than one 
individual (or an application for coverage that is being made for more 
than one individual). In that case, as under the proposed regulations, 
a single SBC may generally be provided to one address, unless any 
dependents are known to reside at a different address.
3. Content
    PHS Act section 2715(b)(3) generally provides that the SBC must 
include:
    a. Uniform definitions of standard insurance terms and medical 
terms so that consumers may compare health coverage and understand the 
terms of (or exceptions to) their coverage;
    b. A description of the coverage, including cost sharing, for each 
category of benefits identified by the Departments;
    c. The exceptions, reductions, and limitations on coverage;
    d. The cost-sharing provisions of the coverage, including 
deductible, coinsurance, and copayment obligations;
    e. The renewability and continuation of coverage provisions;
    f. A coverage facts label that includes examples to illustrate 
common benefits scenarios (including pregnancy and serious or chronic 
medical conditions) and related cost sharing based on recognized 
clinical practice guidelines;
    g. A statement about whether the plan provides minimum essential 
coverage as defined under section 5000A(f) of the Code, and whether the 
plan's or coverage's share of the total allowed costs of benefits 
provided under the plan or coverage meets applicable requirements;
    h. A statement that the SBC is only a summary and that the plan 
document, policy, or certificate of insurance should be consulted to 
determine the governing contractual provisions of the coverage; and
    i. A contact number to call with questions and an Internet web 
address where a copy of the actual individual coverage policy or group 
certificate of coverage can be reviewed and obtained.
    The proposed regulations generally mirrored the content elements 
set forth in the statute, with four additional elements recommended by 
the NAIC: (1) For plans and issuers that maintain one or more networks 
of providers, an Internet address (or similar contact information) for 
obtaining a list of the network providers; (2) for plans and issuers 
that maintain a prescription drug formulary, an Internet address where 
an individual may find more information about the prescription drug 
coverage under the plan or coverage; (3) an Internet address where an 
individual may review and obtain the uniform glossary; and (4) premiums 
(or cost of coverage for self-insured group health plans). The proposed 
regulations solicited comments on these additional four content 
elements. In addition, the proposed regulations solicited comments on 
whether the SBC should include a disclosure informing individuals of 
their right to receive a paper copy of the glossary upon request.
    These final regulations retain the first two proposed additional 
content elements without change, modify the third, and delete the 
fourth. The final regulations retain: (1) The inclusion of an Internet 
address (or other contact information) for obtaining a list of the 
network providers, and (2) the inclusion of an Internet address (or 
similar contact information) where an individual may find more 
information about the prescription drug coverage under the plan or 
coverage. The final regulations also retain the requirement of the 
inclusion of an Internet address where an individual may review and 
obtain the uniform glossary, with a modification. The Departments 
received several comments regarding the inclusion of information 
concerning the uniform glossary including a suggestion that individuals 
be informed of their right to request a paper copy of the uniform 
glossary. Commenters noted that the omission of such a disclosure would 
deny important information to some individuals who are most in need of 
this information. After review and consideration of the comments, the 
final regulations require information for obtaining copies of the 
uniform glossary, which includes an Internet address where an 
individual may review the uniform glossary, a contact phone number to 
obtain a paper copy of the uniform glossary, and a disclosure that 
paper copies of the uniform glossary are available. It is important to 
note that the definitions in the glossary are solely for the purpose of 
these regulations; they do not, for example, apply to Medicare coverage 
policy nor the Secretary of Health and Human Services' definition of 
essential health benefits.
    The final regulations do not require the SBC to include premium or 
cost of coverage information. The Departments received numerous 
comments on this issue. Comments supporting the inclusion of premium 
information stated that this information was essential for consumers to 
make meaningful coverage comparisons, and it was necessary for 
consumers to make coverage comparisons and understand their total 
financial exposure, as well as useful to encourage competition in the 
markets on both price and value. One comment stated that employees also 
need this information to know if the coverage offered by an employer 
meets the Affordable Care Act's affordability test,\13\ which 
determines the eligibility of employees for premium tax credits with 
respect to qualified health plans purchased on an Exchange.\14\ 
Comments opposing this additional content requirement stated that this 
requirement would be administratively burdensome in the group market, 
where health insurance issuers do not have information on employer 
contributions, and would not be able to provide

[[Page 8674]]

accurate cost of coverage information to employees. In addition, some 
comments noted that it would not be possible to provide an accurate 
premium estimate prior to medical underwriting. Some comments 
recommended that premium information be provided in a separate 
document, for example, a premium table.
---------------------------------------------------------------------------

    \13\ See Code section 36B(c)(2)(C)(i)(II), as added by section 
1401 of the Affordable Care Act.
    \14\ Providing information in the SBC for individuals relating 
to Exchanges and the premium tax credit is addressed in the document 
containing further compliance guidance that is published elsewhere 
in this issue of the Federal Register.
---------------------------------------------------------------------------

    After considering all of the comments, the final regulations do not 
require the SBC to include premium or cost of coverage information. The 
Departments understand that it is administratively and logistically 
complex to convey this information to individuals in an SBC in 
divergent circumstances in both the individual and group markets, 
including, for example, when premiums differ based on family size and 
when, in the group market, employer contributions impact cost of 
coverage. The Departments recognize that the inclusion of premium 
information in the SBC could result in numerous SBCs being required to 
be provided to individuals. However, if premium information is not 
required, only a single SBC might be necessary. The Departments believe 
that premium information can be more efficiently and effectively 
provided by means other than the SBC. For example, in the individual 
market, the Departments note that some of this information may be 
available through the Federal health care reform Web portal, 
HealthCare.gov,\15\ to individuals shopping for coverage. Furthermore, 
the Departments anticipate that premium information for qualified 
health plans will be made widely available through Exchanges for 
coverage effective beginning in 2014.
---------------------------------------------------------------------------

    \15\ Established pursuant to 45 CFR 159.120 (75 FR 24470).
---------------------------------------------------------------------------

    With respect to the uniform definitions required by the statute, 
the Departments proposed to follow the NAIC's recommended two-part 
approach, requiring provision of--(1) a uniform glossary, which 
includes definitions of health coverage terminology, to be provided in 
connection with the SBC, and (2) a ``Why this Matters'' column for the 
SBC template (with instructions for plans and issuers to use in 
completing the SBC template).\16\ The Departments retain this approach 
in the final regulations. The guidance document published elsewhere in 
today's Federal Register addresses comments received on the SBC and 
related materials (including the uniform glossary) and details the 
changes from the initial proposal.
---------------------------------------------------------------------------

    \16\ National Association of Insurance Commissioners, Consumer 
Information Working Group, December 17, 2010, Final Package of 
Attachments. Available at http://www.naic.org/documents/committees_b_consumer_information_ppaca_final_materials.pdf.
---------------------------------------------------------------------------

    The statute also directs that the SBC include a statement about 
whether a plan or coverage provides minimum essential coverage, as 
defined under section 5000A(f) of the Code, (minimum essential coverage 
statement) and whether the plan's or coverage's share of the total 
allowed costs of benefits provided under the plan or coverage meets 
applicable minimum value requirements (minimum value statement).\17\ 
However, this content is not relevant until other elements of the 
Affordable Care Act are implemented. Therefore, the final regulations 
require the minimum essential coverage and minimum value statements to 
be included in SBCs with respect to coverage beginning on or after 
January 1, 2014.\18\ Future guidance will address the minimum essential 
coverage and minimum value statements.
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    \17\ PHS Act section 2715(b)(3)(G) provides that this statement 
must indicate whether the plan or coverage (1) provides minimum 
essential coverage (as defined under section 5000A(f) of the Code) 
and (2) ensures that the plan's or coverage's share of the total 
allowed costs of benefits provided under the plan or coverage is not 
less than 60 percent of such costs. The minimum essential coverage 
and minimum value requirements are part of a larger set of health 
coverage reforms that take effect on January 1, 2014.
    \18\ In the Notice providing compliance guidance published 
separately in today's Federal Register, the Departments state that 
the SBC template (with instructions, samples, and a guide for 
coverage example calculations to be used in completing the SBC 
template) does not provide language to comply with these 
requirements because the Notice authorizes these documents only with 
respect to the first year of applicability. Information on the 
minimum essential coverage statement and the minimum value statement 
will be provided in future guidance.
---------------------------------------------------------------------------

    The statute also requires that an SBC contain a ``coverage facts 
label.'' For ease of reference, the proposed regulations used the term 
``coverage examples'' in place of the statutory term. The Departments 
received many comments regarding the coverage examples. Some comments 
supported the general approach in the proposed regulations and 
indicated that coverage examples would be a valuable comparison tool 
for consumers. Other comments expressed concerns that the coverage 
examples would cause confusion for consumers, as the examples do not 
represent the actual treatment plan for any particular individual, or 
might not represent the actual costs that an individual might incur for 
a similar cost of treatment. Some such comments urged the Departments 
to take a different approach to the coverage examples, such as 
providing an actual cost calculator. The Departments also received 
comments on the number of coverage examples that should be required, as 
well as which benefit scenarios should be included in the final 
regulations. Comments varied with regards to the number of recommended 
coverage examples, ranging from one to more than six.
    These final regulations retain the general approach to the coverage 
examples that was proposed.\19\ Consumer testing performed on behalf of 
the NAIC \20\ demonstrated that the coverage examples facilitated 
individuals' understanding of the benefits and limitations of a plan or 
policy and helped them make more informed choices about their options. 
Such testing also showed that individuals were able to comprehend that 
the examples were only illustrative. Additionally, while some plans 
provide very useful coverage calculators to their enrollees to help 
them make health care decisions, they are not uniform across all plans 
and most are not available to individuals prior to enrollment, making 
it difficult for individuals and employers to make coverage 
comparisons. Nonetheless, as discussed in the guidance document issued 
elsewhere in this issue of the Federal Register, the Departments are 
taking a phased approach to implementing the coverage examples and 
intend to consider additional feedback from consumer testing in the 
future.
---------------------------------------------------------------------------

    \19\ The Departments are making one technical change in these 
final regulations. The proposed regulations stated that the 
underlying benefits scenario for a coverage example must be based on 
recognized clinical practice guidelines ``available through'' the 
National Guideline Clearinghouse (NGC), Agency for Healthcare 
Research and Quality. The Departments believe that the proposed 
regulations would have inadvertently excluded recognized clinical 
practice guidelines available through other sources, such as the 
National Comprehensive Cancer Network. Accordingly, these final 
regulations provide that a benefits scenario must be based on 
recognized clinical guidelines ``as defined by'' the NGC. Currently, 
the NGC uses a definition set forth by the Institute of Medicine. 
The current definition of clinical practice guidelines adopted by 
NGC is available at http://www.guideline.gov/about/inclusion-criteria.aspx.
    \20\ A summary of the focus group testing done by America's 
Health Insurance Plans is available at: http://www.naic.org/documents/committees_b_consumer_information_101012_ahip_focus_group_summary.pdf, a summary of the focus group testing done 
by Consumers Union on the coverage examples is available at: http://prescriptionforchange.org/wordpress/wp-content/uploads/2011/08/A_New_Way_of_Comparing_Health_Insurance.pdf.
---------------------------------------------------------------------------

    To the extent a plan's terms that are required to be in the SBC 
template cannot reasonably be described in a manner consistent with the 
template and instructions, the plan or issuer must

[[Page 8675]]

accurately describe the relevant plan terms while using its best 
efforts to do so in a manner that is still consistent with the 
instructions and template format as reasonably possible. Such 
situations may occur, for example, if a plan provides a different 
structure for provider network tiers or drug tiers than is contemplated 
by the template and these instructions, if a plan provides different 
benefits based on facility type (such as hospital inpatient versus non-
hospital inpatient), in a case where the effects of a health FSA or an 
HRA are being described, or if a plan provides different cost sharing 
based on participation in a wellness program.
    Finally, the Departments solicited comments on whether any special 
rules are necessary to accommodate expatriate plans and received 
comments related to adjustments needed for expatriate plan coverage. 
Some commenters noted that PHS Act section 2715(d)(3) refers to a 
health insurance issuer ``offering health insurance coverage within the 
United States.'' \21\ Other commenters suggested that coverage 
information that is particularly important to expatriates (such as 
medical evacuation, repatriation benefits, and country-appropriate 
care) be exempt from the requirements under PHS Act section 2715. These 
final regulations include a special provision that provides that, in 
lieu of summarizing coverage for items and services provided outside 
the United States, a plan or issuer may provide an Internet address (or 
similar contact information) for obtaining information about benefits 
and coverage provided outside the United States. Also, to the extent 
the plan or policy provides coverage available within the United 
States, the plan or issuer is still required to provide an SBC in 
accordance with PHS Act section 2715 that accurately summarizes 
benefits and coverage available within the United States.
---------------------------------------------------------------------------

    \21\ The Departments note that, in the context of group health 
plan coverage, section 4(b)(4) of ERISA provides that a plan 
maintained outside the United States primarily for the benefit of 
persons substantially all of whom are nonresident aliens is exempt 
from ERISA title I, including ERISA section 715.
---------------------------------------------------------------------------

4. Appearance
    PHS Act section 2715 sets forth standards related to the appearance 
of the SBC. Specifically, the statute provides that the SBC is to be 
presented in a uniform format, utilizing terminology understandable by 
the average plan enrollee, that does not exceed four pages in length, 
and does not include print smaller than 12-point font. The final 
regulations retain the interpretation from the proposed regulations 
that the four-page limitation is four double-sided pages.\22\
---------------------------------------------------------------------------

    \22\ PHS Act section 2715(b)(1) does not prescribe whether the 
four pages are four single-sided pages or four double-sided pages. 
The SBC template transmitted by NAIC exceeded four single-sided 
pages. After considering the extent of statutorily-required content 
in PHS Act section 2715(b)(3), as well as the appearance and 
language requirements of PHS Act sections 2715(b)(1) and (2), the 
Departments are interpreting four pages to be four double-sided 
pages, in order to ensure that this information is presented in an 
understandable and meaningful way.
---------------------------------------------------------------------------

    The proposed regulations requested comments regarding the 
requirement to provide the SBC as a stand-alone document. Specifically, 
comments were requested about whether the SBC should be allowed to be 
included in a summary plan description (SPD) if it is intact and 
prominently displayed and the timing requirements for delivery of the 
SBC are met. The Departments received many comments in response to this 
request. Some comments opposed allowing the SBC to be included 
alongside or within an SPD, noting that SPDs tend to be lengthy 
documents and allowing this would be contrary to the purpose of 
requiring a short summary document. However, many comments supported 
this approach, indicating that permitting this option would reduce 
burdens and costs associated with printing and disseminating the SBC 
documents.
    Paragraph (a)(3) of these final regulations requires plans and 
issuers to provide the SBC in the form specified by the Secretaries in 
guidance and completed in accordance with the instructions for 
completing the SBC that are specified by the Secretaries in guidance. A 
guidance document published elsewhere in this issue of the Federal 
Register provides such guidance. The Notice specifies that SBCs 
provided in connection with group health plan coverage may be provided 
either as a stand-alone document or in combination with other summary 
materials (for example, an SPD), if the SBC information is intact and 
prominently displayed at the beginning of the materials (such as 
immediately after the Table of Contents in an SPD) and in accordance 
with the timing requirements for providing an SBC. For health insurance 
coverage offered in the individual market, the SBC must be provided as 
a stand-alone document, but HHS notes that it can be included in the 
same mailing as other plan materials. This guidance regarding 
appearance may be modified for years after the first year of 
applicability.
5. Form

a. Group Health Plan Coverage

    To facilitate faster and less burdensome disclosure of the SBC, and 
to be consistent with PHS Act section 2715(d)(2), which permits 
disclosure in either paper or electronic form, the proposed regulations 
set forth rules to permit greater use of electronic transmittal of the 
SBC. Those proposed regulations generally permitted issuers to provide 
the SBC to plans electronically (such as an email or Internet posting) 
if certain conditions were met, and required plans and issuers 
providing the SBC to participants and beneficiaries to comply with the 
Department of Labor's electronic disclosure safe harbor requirements at 
29 CFR 2520.104b-1(c). In all circumstances, the proposed regulations 
permitted plans and issuers to provide SBCs in paper form.
    Comments generally supported permitting provision of the SBC 
electronically; however, some comments also asked for more flexibility 
with regard to electronic provision to participants and beneficiaries. 
These comments generally requested the rule for provision to 
participants and beneficiaries mirror the rule for provision to plans, 
and suggested this change would reduce costs and burdens associated 
with delivery. Other comments raised concerns about decreased consumer 
protection if the rules for providing an electronic SBC are too 
flexible. Some commenters also asked to extend to the group market the 
option available to individual market issuers to provide information to 
HealthCare.gov to be in compliance with the requirement to provide the 
SBC upon request for information about coverage prior to submitting an 
application.
    After taking into account all of the comments, these final 
regulations generally retain the approach from the proposed regulations 
with respect to an SBC provided electronically by an issuer to a plan. 
For SBCs provided electronically by a plan or issuer to participants 
and beneficiaries, these final regulations make a distinction between a 
participant or beneficiary who is already covered under the group 
health plan, and a participant or beneficiary who is eligible for 
coverage but not enrolled in a group health plan. This distinction 
should provide new flexibility in some circumstances, while also 
ensuring adequate consumer protections where necessary. For 
participants and beneficiaries who are already covered under the group 
health plan, these final regulations permit

[[Page 8676]]

provision of the SBC electronically if the requirements of the 
Department of Labor's regulations at 29 CFR 2520.104b-1 are met. 
(Paragraph (c) of those regulations includes an electronic disclosure 
safe harbor.\23\) For participants and beneficiaries who are eligible 
for but not enrolled in coverage, these final regulations permit the 
SBC to be provided electronically if the format is readily accessible 
and a paper copy is provided free of charge upon request. Additionally, 
if the electronic form is an Internet posting, the plan or issuer must 
timely advise the individual in paper form (such as a postcard) or 
email that the documents are available on the Internet, provide the 
Internet address, and notify the individual that the documents are 
available in paper form upon request. The Departments note that the 
rules for participants and beneficiaries who are eligible for but not 
enrolled in coverage are substantially similar to the requirements for 
an issuer providing an electronic SBC to a plan. Finally, as in the 
proposed regulations, plans, and participants and beneficiaries (both 
covered, and eligible but not enrolled) have the right to receive an 
SBC in paper format, free of charge, upon request.
---------------------------------------------------------------------------

    \23\ On April 7, 2011, the Department of Labor published a 
Request for Information regarding electronic disclosure at 76 FR 
19285. In it, the Department of Labor stated that it is reviewing 
the use of electronic media by employee benefit plans to furnish 
information to participants and beneficiaries covered by employee 
benefit plans subject to ERISA. Because these regulations adopt the 
ERISA electronic disclosure rules by cross-reference, any changes 
that may be made to 29 CFR 2520.104b-1 in the future would also 
apply to the SBC.
---------------------------------------------------------------------------

b. Individual Health Insurance Coverage

    The Departments received several comments on the proposed 
regulations, which generally required paper delivery of the SBC and set 
forth certain circumstances in which electronic disclosure is 
permissible. Some comments recommended the SBC for individual market 
coverage be provided in paper form by default, unless the individual 
explicitly elects electronic delivery. These comments cautioned against 
assuming individuals have regular access to a computer or a requisite 
level of computer literacy simply because an individual submits a 
request online. Instead, they argued individuals should be able to 
specify the form in which they prefer to receive the SBC.
    Other comments recommended greater flexibility for electronic 
delivery to reduce the costs of compliance, including eliminating the 
requirement to acknowledge receipt of an SBC provided through 
electronic delivery methods. These comments urged the Departments to 
adopt broader standards that reflect the current state of technology. 
Specifically, they recommended extending the electronic delivery rules 
that apply to disclosure from the issuer to the plan in paragraph 
(a)(4)(i) of the final regulations, to disclosure in the individual 
market. Some comments also suggested that plans provide in their 
enrollment materials a notice of the individual's right to receive a 
paper copy of the SBC upon request, and a telephone number or other 
contact information for making such request.
    The Departments determined it is appropriate to amend the 
individual market standards in the proposed regulations related to the 
form and manner of delivery. Rather than specifying the circumstances 
making paper or electronic appropriate, these final regulations 
establish the general standard that an issuer offering individual 
health insurance coverage must provide the SBC in a manner that can 
reasonably be expected to provide actual notice regardless of the 
format. These final regulations provide several examples of methods of 
delivery that may satisfy this requirement. For instance, an issuer may 
reasonably expect an individual or dependent to receive actual notice 
if the issuer provides the SBC by email to an individual who has agreed 
to receive the SBC (or other electronic disclosures) by email from the 
issuer and who has provided an email address for that purpose. Or, if 
the SBC is posted on the Internet, an individual may reasonably be 
expected to receive actual notice if the issuer timely advises the 
individual in paper form (such as a postcard) that the documents are 
available on the Internet and includes the applicable Internet address.
    These final regulations substantially retain the safeguards for 
electronic disclosure in the proposed regulations. Under these final 
regulations, an issuer providing the SBC electronically must ensure 
that the format is readily accessible; the SBC is placed in a location 
that is prominent and readily accessible; the SBC is provided in an 
electronic form that is consistent with the appearance, content, and 
language requirements of these final regulations; and that the issuer 
notifies the individual or dependent that the SBC is available from the 
issuer in paper form without charge upon request. These final 
regulations remove the ``acknowledge receipt'' requirement. However, 
the regulations also require that the SBC be provided in an electronic 
form which can be electronically retained and printed. These final 
regulations provide standards for the form and manner of providing the 
SBC that balance the objective of protecting consumers by providing 
accessible information with the goal of simplifying information 
collection burdens on issuers.
    Finally, the final regulations clarify the provision that would 
deem health insurance issuers in the individual market to be in 
compliance with the requirement to provide the SBC to an individual 
requesting information about coverage prior to submitting an 
application if the issuer provides the information to HealthCare.gov. 
The final regulations clarify that a health insurance issuer offering 
individual health insurance coverage must provide all of the content 
required under paragraph (a)(2), as specified in guidance by the 
Secretary, to HealthCare.gov to be deemed compliant with the 
requirement to provide an SBC to an individual requesting summary 
information prior to submitting an application for coverage. The final 
regulations further clarify that any SBC furnished pursuant to a 
request for an SBC, at the time of application or subsequently, would 
be required to be provided in a form and manner consistent with the 
rules described above. The Departments determined that this provision 
is consistent with the standards for electronic disclosure and reduces 
the burden of providing an SBC to individuals shopping for individual 
health insurance coverage.
    The Departments received comments in support of this approach which 
stated HealthCare.gov provides useful summary information about health 
insurance products that are available to both individuals and small 
employers shopping for coverage and recommended the final regulations 
similarly extend the ``deemed compliance'' provision to the small group 
market. At this time, the Departments are reviewing comments requesting 
that the regulations extend the deemed compliance provision to the 
small group market and may issue future guidance on this issue.
6. Language
    PHS Act section 2715(b)(2) provides that standards shall ensure 
that the SBC ``is presented in a culturally and linguistically 
appropriate manner.'' The final regulations retain the approach of the 
proposed regulations and provide that, to satisfy the requirement to 
provide the SBC in a culturally and linguistically appropriate manner, 
a plan or issuer follows the rules for

[[Page 8677]]

providing notices with respect to claims and appeals in a culturally 
and linguistically appropriate manner under PHS Act section 2719, and 
paragraph (e) of its implementing regulations.\24\ Note, nothing in 
these final regulations should be construed as limiting an individual's 
rights under Federal or State civil rights statutes, such as Title VI 
of the Civil Rights Act of 1964 (Title VI) which prohibits recipients 
of Federal financial assistance, including issuers participating in 
Medicare Advantage, from discriminating on the basis of race, color, or 
national origins. To ensure non-discrimination on the basis of national 
origin, recipients are required to take reasonable steps to ensure 
meaningful access to their programs and activities by limited English 
proficient persons. For more information, see, ``Guidance to Federal 
Financial Assistance Recipients Regarding Title VI Prohibition Against 
National Origin Discrimination Affecting Limited English Proficient 
Persons,'' available at http://www.hhs.gov/ocr/civilrights/resources/specialtopics/lep/policyguidancedocument.html. While the Departments 
received several comments regarding the thresholds set forth in the 
claims and appeals regulations, the Departments are not making any 
changes to those standards through these final regulations. Any changes 
suggested will be considered as part of future rulemakings related to 
the regulations under PHS Act section 2719, so that the two rules 
remain consistent.
---------------------------------------------------------------------------

    \24\ See 75 FR 43330 (July 23, 2010), as amended by 76 FR 37208 
(June 24, 2011).
---------------------------------------------------------------------------

B. Notice of Modification

    PHS Act section 2715(d)(4) directs that a group health plan or 
health insurance issuer offering group or individual health insurance 
coverage must provide notice of any material modification if it makes a 
material modification (as defined under ERISA section 102) in any of 
the terms of the plan or coverage involved that is not reflected in the 
most recently provided SBC. The comments generally supported the 
standards regarding the notice of modification in the proposed 
regulations, which are adopted as final regulations without change.
    However, some comments requested clarification concerning the 
requirement to provide a notice of modification. For example, several 
comments requested clarification on what changes in the terms of 
coverage would rise to the level of a material modification. For 
purposes of PHS Act section 2715, the proposed and final regulations 
interpret the statutory reference to the SBC to mean that only a 
material modification in the terms of the plan or coverage that would 
affect the content of the SBC; that is not reflected in the most 
recently provided SBC; and that occurs other than in connection with a 
renewal or reissuance of coverage would trigger the notice. In these 
circumstances, the notice would be required to be provided to enrollees 
(or, in the individual market, covered individuals) no later than 60 
days prior to the date on which such change will become effective. A 
material modification, within the meaning of section 102 of ERISA, 
includes any modification to the coverage offered under a plan or 
policy that, independently, or in conjunction with other 
contemporaneous modifications or changes, would be considered by an 
average plan participant (or in the case of individual market coverage, 
an average individual covered under a policy) to be an important change 
in covered benefits or other terms of coverage under the plan or 
policy.\25\ A material modification could be an enhancement of covered 
benefits or services or other more generous plan or policy terms. It 
includes, for example, coverage of previously excluded benefits or 
reduced cost-sharing. A material modification could also be a material 
reduction in covered services or benefits, as defined in 29 CFR 
2520.104b-3(d)(3) of the Department of Labor' regulations, or more 
stringent requirements for receipt of benefits. As a result, it also 
includes changes or modifications that reduce or eliminate benefits, 
increase cost-sharing, or impose a new referral requirement.\26\ 
(However, changes to the information in the SBC resulting from changes 
in the regulatory requirements for an SBC are not changes to the plan 
or policy requiring the mid-year provision of a notice of modification, 
unless specified in such new requirements.)
---------------------------------------------------------------------------

    \25\ See DOL Information Letter, Washington Star/Washington-
Baltimore Newspaper Guild to Munford Page Hall, II, Baker & McKenzie 
(February 8, 1985).
    \26\ See, e.g., Ward v. Maloney, 386 F.Supp.2d 607, 612 
(M.D.N.C. 2005), which discusses judicial interpretations of when an 
amendment is and is not a material modification.
---------------------------------------------------------------------------

    The Departments also received comments seeking clarification on 
when a notice of modification must be provided. Several comments 
suggested that this notice must also be provided for modifications 
effective for new plan or policy years. The final regulations require 
that this notice be provided only for changes other than in connection 
with a renewal or reissuance of coverage. At renewal, plans and issuers 
must provide an updated SBC in accordance with the requirements 
otherwise applicable to SBCs. PHS Act section 2715 and paragraph (b) of 
the final regulations specify the timing for providing a notice of 
modification in situations other than in connection with a renewal or 
reissuance of coverage. To the extent a plan or policy implements a 
mid-year change that is a material modification, that affects the 
content of the SBC, and that occurs other than in connection with a 
renewal or reissuance of coverage, the final regulations require a 
notice of modification to be provided 60 days in advance of the 
effective date of the change. Comments generally supported the 
flexibility provided in the proposed regulations, which permitted plans 
and issuers to either provide an updated SBC reflecting the 
modifications or provide a separate notice describing the material 
modifications. Plans and issuers continue to have this flexibility 
under these final regulations.
    For ERISA-covered group health plans subject to PHS Act section 
2715, this notice is required in advance of the timing requirements 
under the Department of Labor's regulations at 29 CFR 2520.104b-3 for 
providing a summary of material modification (SMM) (generally not later 
than 210 days after the close of the plan year in which the 
modification or change was adopted, or, in the case of a material 
reduction in covered services or benefits, not later than 60 days after 
the date of adoption of the modification or change). In situations 
where a complete notice is provided in a timely manner under PHS Act 
section 2715(d)(4), an ERISA-covered plan will also satisfy the 
requirement to provide an SMM under Part 1 of ERISA.

 C. Uniform Glossary

    Section 2715(g)(2) of the PHS Act directs the Departments to 
develop standards for definitions for at least the following insurance-
related terms: co-insurance, co-payment, deductible, excluded services, 
grievance and appeals, non-preferred provider, out-of-network co-
payments, out-of-pocket limit, preferred provider, premium, and UCR 
(usual, customary and reasonable) fees. Section 2715(g)(3) of the PHS 
Act directs the Departments to develop standards for definitions for at 
least the following medical terms: durable medical equipment, emergency 
medical transportation, emergency room care, home health care, hospice 
services, hospital outpatient care, hospitalization, physician 
services, prescription drug coverage, rehabilitation services, and 
skilled nursing care. Additionally, the statute directs the Departments 
to

[[Page 8678]]

develop standards for such other terms as will help consumers 
understand and compare the terms of coverage and the extent of medical 
benefits (including any exceptions and limitations).
    The final regulations adopt the approach of the proposed 
regulations with respect to the uniform glossary. This includes the 
adoption of the NAIC recommendation to include the following additional 
terms in the uniform glossary: Allowed amount, balance billing, 
complications of pregnancy, emergency medical condition, emergency 
services, habilitation services, health insurance, in-network co-
insurance, in-network co-payment, medically necessary, network, out-of-
network co-insurance, plan, preauthorization, prescription drugs, 
primary care physician, primary care provider, provider, reconstructive 
surgery, specialist, and urgent care.
    The Departments received a number of comments on the proposed 
uniform glossary. Several comments recommended that the final glossary 
include additional terms. In general, these comments recommended 
additional terms to provide consumers with additional information to 
help them better understand their coverage and the content of the SBC. 
These comments suggested the glossary include additional terms that may 
appear in the SBC and that may cause confusion, including specialty 
drugs, mental health services and behavioral health, cosmetic surgery, 
and preventive care. In addition, some commenters recommended including 
definitions for complex or potentially confusing insurance terms, 
including explanations of plan types (such as health maintenance 
organizations or ERISA plans) and terms such as actuarial value and 
cost-sharing. Other commenters warned against making the uniform 
glossary too long.
    Some commenters recommended modifications to certain definitions in 
the uniform glossary. For example, several comments recommended 
modification to the term ``medical necessity.'' In developing the final 
uniform glossary, the Departments were very cognizant of the consumer 
testing performed by the NAIC with respect to the uniform glossary 
included in the proposed regulations and the need to convey in concise, 
easy-to-understand language basic medical and coverage terms.\27\ 
Accordingly, very minor changes were made in the final uniform 
glossary, and it continues to include a disclaimer that the terms and 
definitions of terms in particular plans or policies may differ from 
those contained in the glossary, together with information on how to 
get a copy of the actual policy or plan document.
---------------------------------------------------------------------------

    \27\ A summary of the focus group testing done by America's 
Health Insurance Plans is available at: http://www.naic.org/documents/committees_b_consumer_information_101012_ahip_focus_group_summary.pdf, a summary of the focus group testing done 
by Consumers Union on the SBC template and the uniform glossary is 
available at: http://www.commonwealthfund.org/Publications/Issue-Briefs/2011/Feb/Making-Health-Insurance-Cost-Sharing-Clear.aspx.
---------------------------------------------------------------------------

    Some commenters requested flexibility to use their own, plan-
specific or policy-specific terms in the glossary. PHS Act section 
2715(g) is titled ``Development of Standard Definitions.'' The NAIC 
developed the uniform glossary to provide generalized, plain-English 
definitions for common coverage and medical terms. The document was 
intended to help consumers understand the basics of insurance. At the 
same time, the document specifically cautions that it is intended to be 
a general educational tool and that individual plan terms may differ 
(and refers consumers to the SBC for information on how to get an 
accurate description of their actual plan or policy terms). A guidance 
document published elsewhere in this issue of the Federal Register 
announces the availability of the final uniform glossary. The SBC may 
be used by plans and issuers to convey more accurate descriptions, 
where appropriate.
    Like the proposed regulations, the final regulations direct a plan 
or issuer to make the uniform glossary available upon request within 
seven business days. A plan or issuer satisfies this requirement by 
complying with the content requirement described in paragraph 
(a)(2)(i)(L) of the final regulations, which requires that the SBC 
include an Internet address where an individual may review and obtain 
the uniform glossary, a contact phone number to obtain a paper copy of 
the uniform glossary, and a disclosure that paper copies are available 
upon request. The Internet address may be a place where the document 
can be found on the plan's or issuer's Web site, or the Web site of 
either the Department of Labor or HHS. However, a plan or issuer must 
make a paper copy of the glossary available within seven business days 
upon request. Group health plans and health insurance issuers must 
provide the uniform glossary in the appearance specified by the 
Departments, so that the glossary is presented in a uniform format and 
uses terminology understandable by the average plan enrollee or 
individual covered under an individual policy.

D. Preemption

    Section 2715 of the PHS Act is incorporated into ERISA section 715, 
and Code section 9815, and is subject to the preemption provisions of 
ERISA section 731 and PHS Act section 2724 (implemented in 29 CFR 
2590.731(a) and 45 CFR 146.143(a)). Under these provisions, the 
requirements of part 7 of ERISA and part A of title XXVII of the PHS 
Act, as amended by the Affordable Care Act, are not to be ``construed 
to supersede any provision of State law which establishes, implements, 
or continues in effect any standard or requirement solely relating to 
health insurance issuers in connection with group or individual health 
insurance coverage except to the extent that such standard or 
requirement prevents the application of a requirement'' of part A of 
title XXVII of the PHS Act. Accordingly, State laws that impose 
requirements on health insurance issuers that are stricter than those 
imposed by the Affordable Care Act will not be superseded by the 
Affordable Care Act. Moreover, PHS Act section 2715(e) provides that 
the standards developed under PHS Act section 2715(a), ``shall preempt 
any related State standards that require [an SBC] that provides less 
information to consumers than that required to be provided under this 
section, as determined by the [Departments].'' Reading these two 
preemption provisions together, the final regulations do not prevent 
States from imposing separate, additional disclosure requirements on 
health insurance issuers.
    The Departments received several comments seeking clarification on 
the preemption of State disclosure standards. These comments indicate 
that many States have existing disclosure requirements that may be 
duplicative and noted consumers could be confused by multiple 
disclosures. These final regulations retain the preemption standard as 
stated in the proposed regulations. However, the Departments take note 
of the concerns about the potential for consumer confusion, and 
encourage States to take steps to harmonize existing State requirements 
with these Federal consumer disclosure requirements. The Departments 
will work with States to clarify the requirements, potential 
differences, and options.
    In addition, some comments requested clarification that States may 
not require the modification of the SBC or uniform glossary in their 
own disclosure standards. Comments stated that any State modifications 
to these

[[Page 8679]]

documents would defeat the purpose of having an SBC template and 
uniform glossary, and one comment requested that any State law 
modifications to these documents be preempted, and that any additional 
content required by State law be limited to an addendum to the SBC. If 
States require health insurance issuers to provide information not 
contained in the SBC or uniform glossary, then they may require issuers 
to provide that information only if it is provided in a document that 
is separate from the SBC. This separate document can, however, be 
provided at the same time as the SBC.

E. Failure To Provide

    PHS Act section 2715(f), incorporated into ERISA section 715 and 
Code section 9815, provides that a group health plan (including its 
administrator), and a health insurance issuer offering group or 
individual health insurance coverage, that ``willfully fails to provide 
the information required under this section shall be subject to a fine 
of not more than $1,000 for each such failure.'' In addition, under PHS 
Act section 2715(f), a separate fine may be imposed for each individual 
or entity for whom there is a failure to provide an SBC. Due to the 
different enforcement jurisdictions of the Departments, as well as 
their different underlying enforcement structures, the mechanisms for 
imposing the new penalty vary slightly, as discussed below.
1. Department of HHS
    Enforcement of Part A of Title XXVII of the PHS Act, including 
section 2715, is generally governed by PHS Act section 2723 and 
corresponding regulations at 45 CFR 150.101 et seq. Under those 
provisions, a State has the discretion to enforce the provisions 
against health insurance issuers in the first instance, and the 
Secretary of HHS only enforces a provision after the Secretary 
determines that a State has failed to substantially enforce the 
provision. If a State enforces a provision such as PHS Act section 
2715, it uses its own enforcement mechanisms. If the Secretary 
enforces, the statute provides for penalties of up to $100 per day for 
each affected individual.
    PHS Act section 2715(f) provides that an entity that willfully 
fails to provide the information required under PHS Act section 2715 
shall be subject to a fine of not more than $1,000 for each such 
failure. Such failure constitutes a separate offense with respect to 
each enrollee. This penalty can only be imposed by the Secretary.
    Paragraph (e) of the final regulations clarifies that States have 
primary enforcement authority over health insurance issuers for any 
violations, whether willful or not, using their own remedies and that 
PHS Act section 2715 does not limit the Secretary's authority to impose 
penalties for willful violations regardless of State enforcement. 
However, the Secretary intends to use enforcement discretion if the 
Secretary determines that the State is adequately addressing willful 
violations.
    The Secretary of HHS has direct enforcement authority for 
violations by non-Federal governmental plans, and will use the 
appropriate penalty for violations of section 2715, depending on 
whether the violation is willful. Paragraph (e) of the HHS final 
regulations cross references the enforcement regulations at 45 CFR 
150.101 et seq., and states that they relate to any failure, regardless 
of intent, by a health insurance issuer or non-Federal governmental 
plan, to comply with any requirement of PHS Act section 2715.
2. Departments of Labor and the Treasury
    The Department of Labor enforces the requirements of part 7 of 
ERISA with respect to ERISA-covered group health plans (generally, 
plans other than church plans or plans maintained by a governmental 
entity) and the Department of the Treasury enforces the requirements of 
chapter 100 of the Code with respect to group health plans maintained 
by an entity that is not a governmental entity. On April 21, 1999, 
pursuant to section 104 of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA), Public Law 104-191, the Secretaries 
entered into a memorandum of understanding \28\ that, among other 
things, established a mechanism for coordinating enforcement and 
avoiding duplication of effort for shared jurisdiction. The memorandum 
of understanding applies, as appropriate, to health legislation enacted 
after April 21, 1999 over which at least two of the Departments share 
jurisdiction, including PHS Act section 2715 as incorporated into ERISA 
and the Code. Therefore, in enforcing PHS Act section 2715, the 
Departments of Labor and the Treasury will coordinate to avoid 
duplication in the case of group health plans that are not church plans 
and that are not maintained by a governmental entity.
---------------------------------------------------------------------------

    \28\ See 64 FR 70164 (December 15, 1999).
---------------------------------------------------------------------------

a. Department of Labor

    The Department of Labor will issue separate regulations in the 
future describing the procedures for assessment of the civil fine 
provided under PHS Act section 2715(f) as incorporated by section 715 
of ERISA. In accordance with ERISA section 502(b)(3), 29 U.S.C. 
1132(b)(3), the Secretary of Labor is not authorized to assess this 
fine against a health insurance issuer.

b. Department of the Treasury

    If a group health plan (other than a plan maintained by a 
governmental entity) fails to comply with the requirements of chapter 
100 of the Code, an excise tax is imposed under section 4980D of the 
Code. The excise tax is generally $100 per day per individual for each 
day that the plan fails to comply with chapter 100 with respect to that 
individual. Numerous rules under section 4980D reduce the amount of the 
excise tax for failures due to reasonable cause and not to willful 
neglect. Special rules apply for church plans. Taxpayers subject to the 
excise tax under section 4980D are required to report the failures 
under chapter 100 and the amount of the excise tax on IRS Form 8928. 
See 26 CFR 54.4980D-1, 54.6011-2, and 54.6151-1.
    Section 2715(f) of the PHS Act subjects a plan sponsor or 
designated administrator to a fine of not more than $1,000 for each 
failure to provide an SBC. Unless and until future guidance provides 
otherwise, group health plans subject to chapter 100 of the Code should 
continue to report the excise tax of section 4980D on IRS Form 8928 
with respect to failures to comply with PHS Act section 2715. The 
Secretaries of Labor and the Treasury will coordinate to determine 
appropriate cases in which the fine of PHS Act section 2715(f) should 
be imposed on group health plans that are in the jurisdiction of both 
Departments.

F. Applicability

    PHS Act section 2715 provides that the requirement for group health 
plans and health insurance issuers to provide an SBC applies not later 
than 24 months after the date of enactment of the Affordable Care Act 
(which is March 23, 2012). PHS Act section 2715 also provides that 
group health plans and health insurance issuers shall provide the SBC 
pursuant to standards developed by the Departments. The proposed 
regulations proposed an applicability date beginning March 23, 2012. At 
the same time, the Departments invited comments generally, as well as

[[Page 8680]]

on a range of discrete issues, including the timing of the application 
of the SBC requirement. On November 17, 2011, the Departments issued 
guidance \29\ providing that, until final regulations are issued and 
applicable, plans and issuers are not required to comply with PHS Act 
section 2715.
---------------------------------------------------------------------------

    \29\ See FAQs About Affordable Care Act Implementation Part VII 
and Mental Health Parity Implementation, available at www.dol.gov/ebsa/faqs/faq-aca7.html and cciio.cms.gov/resources/factsheets/aca_implementation_faqs7.html.
---------------------------------------------------------------------------

    The Departments received numerous comments on the applicability 
date of the regulations. Several comments stated plans and issuers 
would need time to make changes to their systems and workflow processes 
and could not come into compliance by March 23, 2012 without incurring 
significant cost and administrative challenges. Some comments recommend 
delaying applicability for 12 months, noting that PHS Act section 2715 
contemplates that plans and issuers would have 12 months from the date 
the Secretary develops standards to begin providing the SBC, while 
others recommended delaying applicability for 18 to 24 months to allow 
sufficient time for group health plans to revise and coordinate service 
vendor agreements. Other comments stated the requirements should apply 
beginning with a plan's open enrollment period to avoid disruption 
during the plan year. Still others recommended phasing in the 
requirements by market segment, starting with the individual market 
initially and broadening over time to include the group market. These 
commenters emphasized the complexity in the group market of 
coordinating between the plan and the issuer (and perhaps across 
multiple issuers and/or service providers) and the greater need for 
standardized information in the individual market (where there are no 
other Federal requirements to provide summary information). Finally, 
some comments expressed support for the proposed March 23, 2012 
applicability date, arguing individuals and employers should receive 
the consumer protections of PHS Act section 2715 no later than the date 
intended by statute.
    Following review of the comments submitted on this issue and 
further consideration of the administrative and systems changes 
required to implement these requirements, the Departments have 
determined it would not be feasible to require plans and issuers to 
comply with the standards in the final regulations beginning March 23, 
2012 and have delayed the applicability date for six months from that 
which was proposed to provide sufficient time for plans and issuers to 
come into compliance with these provisions. The Departments agree that 
implementing these provisions to coincide with employers' typical open 
enrollment processes in the group market will reduce confusion for 
current enrollees who typically make enrollment decisions during annual 
open enrollment periods and will avoid unnecessary cost to group health 
plan sponsors of producing these materials off-cycle. The final 
regulations provide that the requirements to provide an SBC, notice of 
modification, and uniform glossary under PHS Act section 2715 and these 
final regulations apply for disclosures with respect to participants 
and beneficiaries who enroll or re-enroll in group health coverage 
through an open enrollment period (including re-enrollees and late 
enrollees), beginning on the first day of the first open enrollment 
period that begins on or after September 23, 2012. For administrative 
simplicity, with respect to disclosures to participants and 
beneficiaries who enroll in group health plan coverage other than 
through an open enrollment period (including individuals who are newly 
eligible for coverage and special enrollees), PHS Act section 2715 and 
these final regulations apply on the first day of the first plan year 
that begins on or after September 23, 2012. For disclosures to plans, 
and to individuals and dependents in the individual market, these 
requirements are applicable to health insurance issuers beginning 
September 23, 2012.

IV. Economic Impact and Paperwork Burden

A. Executive Orders 12866 and 13563--Department of Labor and Department 
of Health and Human Services

    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). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule has been designated a ``significant regulatory 
action'' under section 3(f) of Executive Order 12866. Accordingly, the 
rule has been reviewed by the Office of Management and Budget.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). As discussed below, the Departments have concluded that these 
final regulations would not have economic impacts of $100 million or 
more in any one year or otherwise meet the definition of an 
``economically significant rule'' under Executive Order 12866. 
Nonetheless, consistent with Executive Orders 12866 and 13563, the 
Departments have provided an assessment of the potential benefits and 
the costs associated with this final regulation.
    The Departments have updated the cost estimates from what was 
presented in the proposed regulations. Since publication of the 
proposed regulations, the Departments have continued to refine 
assumptions and estimates to take into account policy decisions made in 
the final regulations and to incorporate better data. The estimates 
presented in this rule are a result of those efforts and represent the 
Departments' best estimate. Discussion of the public comments and the 
updates to the Departments' estimates are included in the relevant 
sections of the impact analysis. While the Departments believe the 
estimates in these final regulations represent the Departments' best 
estimate, the Departments emphasize there is considerable uncertainty, 
as is common with regulations implementing new policies, and the 
discussion throughout the impact analysis reflects this.
1. Current Regulatory Framework
    Health plan sponsors and issuers do not currently uniformly 
disclose information to consumers about benefits and coverage in a 
simple and consistent way. ERISA-covered group health plans are 
required to describe important plan information concerning eligibility, 
benefits, and participant rights and responsibilities in a summary plan 
description (SPD). But as these documents have increased in size and 
complexity--for example, due to the insertion of more legalistic 
language that is designed to mitigate the employer's risk of 
litigation--they have become more difficult for participants and 
beneficiaries to understand.\30\ Indeed, a recent analysis of SPDs from 
40 employer health plans from across the United States (varying based 
on geography, firm size, and industry sector) found that, on average, 
SPDs are generally written at a first year college reading level (with 
readability ranging

[[Page 8681]]

from a 9th grade reading level to nearly a college graduate reading 
level).\31\ Moreover, the formats of existing SPDs are not 
standardized. For example, while these documents could be dozens of 
pages long, there is no requirement that they include an executive 
summary. Additionally, group health plans not covered by ERISA, such as 
plans sponsored by State and local governments, are not required to 
comply with such disclosure requirements.
---------------------------------------------------------------------------

    \30\ ERISA Advisory Council. Report of the Working Group on 
health and Welfare Benefit Plans' Communication. November 2005. 
Available at: http://www.dol.gov/ebsa/publications/AC_1105c_report.html.
    \31\ ``How Readable Are Summary Plan Descriptions For Health 
Care Plans?'' Employee Benefit Research Institute (EBRI) Notes. 
October 2006, Vol. 27, No. 10. Available at: http://www.ebri.org/pdf/notespdf/EBRI_Notes_10-20061.pdf.
---------------------------------------------------------------------------

    In the individual market, health insurance issuers are subject to 
various, diverse State disclosure laws. For example, States like 
Massachusetts,\32\ New York,\33\ Rhode Island,\34\ Utah \35\ and 
Vermont \36\ have established minimum standards for disclosure of 
health insurance information. However, even within such States, 
consumer disclosures vary widely with respect to their required 
content. Additionally, some State disclosure laws are limited to 
current enrollees, so that individuals shopping for coverage do not 
receive information about health insurance coverage options. Other 
State disclosure requirements only extend to managed care 
organizations, and not to other segments of the market.\37\
---------------------------------------------------------------------------

    \32\ M.G.L.A. 176Q Sec.  5 (2010).
    \33\ NY Ins. Law Sec.  3217-a (2010).
    \34\ Office of the Health Insurance Commissioner Regulation 5: 
Standards for Readability of Health Insurance Forms, State of Rhode 
Island and Providence Plantations, August 21, 2010.
    \35\ Utah Code Sec.  31A-22-613.5 (2010).
    \36\ Division of Health Care Administration, Rule 10.000: 
Quality Assurance Standards and Consumer Protections for Managed 
care Plans, State of Vermont, September 20, 1997.
    \37\ For example, New York requires Health Maintenance 
Organizations to provide to prospective members, as well as 
policyholders, information on cost-sharing, including out-of-network 
costs, limitations and exclusions on benefits, prior authorization 
requirements, and other disclosures such as appeal rights. NY Ins. 
Law section 3217-a (2010). Utah requires each insurer issuing a 
health benefit plan to provide all enrollees, prior to enrollment in 
the health benefit plan, written disclosure of restrictions or 
limitations on prescription drugs and biologics, coverage limits 
under the plan, and any limitation or exclusion of coverage. Utah 
Code section 31A-22-613.5 (2010). Rhode Island requires all health 
insurance forms to meet minimum readability standards. Office of the 
Health Insurance Commissioner Regulation 5: Standards for 
Readability of Health Insurance Forms, State of Rhode Island and 
Providence Plantations, August 21, 2010.
---------------------------------------------------------------------------

2. Need for Regulatory Action
    Congress added new PHS Act section 2715 through the Affordable Care 
Act to ensure that plans and issuers provide benefits and coverage 
information in a more uniform format that helps consumers to better 
understand their coverage and better compare coverage options. These 
final regulations are necessary to provide standards for a summary of 
benefits and coverage (SBC) and a uniform glossary of terms used in 
health coverage. This approach is consistent with Executive Order 
13563, which directs agencies to ``identify and consider regulatory 
approaches that reduce burdens and maintain flexibility and freedom of 
choice for the public. These approaches include * * * disclosure 
requirements as well as provision of information to the public in a 
form that is clear and intelligible.''
    The current patchwork of consumer disclosure requirements makes the 
process of shopping for coverage an inefficient, difficult, and time-
consuming task. Consumers incur significant search costs while trying 
to locate reliable cost, coverage and benefit data.\38\ Such search 
costs arise, in part, due to a lack of uniform information across the 
various coverage options, particularly in the individual and small 
group markets, but also in large employer plans. Although not directly 
comparable, in Medigap, a market with standardized benefits, the 
average per-beneficiary search cost was estimated at $72--far higher 
than in other insurance markets, such as auto insurance.\39\
---------------------------------------------------------------------------

    \38\ M. Susan Marquis et al., ``Consumer Decision Making in the 
Individual Health Insurance Market,'' 25 Health Affairs w.226, 
w.231-w.232 (May 2006). Available at: http://
content.healthaffairs.org/content/25/3/w226.full.pdf+html.
    \39\ Nicole Maestas et al., ``Price Variation in Markets with 
Homogenous Goods: The Case of Medigap,'' National Bureau of Economic 
Research (January 2009).
---------------------------------------------------------------------------

    In addition to individual consumers, employers, especially small 
business employers, also face a daunting search process when they shop 
for health coverage. A 2011 study of the commercial health insurance 
market found that many employers, especially small businesses, lack the 
necessary knowledge, sophistication, and information to efficiently 
choose appropriate health plans to purchase on behalf of their 
employees. This lack of knowledge, sophistication, and information 
requires health insurers to spend more money on marketing to target 
small business employers. Health insurers then pass the extra marketing 
costs on to employers in the form of higher premiums. The study 
determined that in 1997, this inefficiency cost consumers in the fully 
insured market $34.4 billion. Employers' lack of knowledge, 
sophistication, and information also produces incentives for health 
insurers to charge different prices for identical products to different 
customers, depending upon the customer's negotiating skills. This price 
variability causes 64 percent more turnover in plan membership, than 
would otherwise occur. High levels of turnover discourage health 
insurers from promoting healthy lifestyles and investing in the future 
health of their policyholders.\40\
---------------------------------------------------------------------------

    \40\ Cebul, Randall D., James B. Rebitzer, Lowell J. Taylor, and 
Mark E. Votruba. 2011. ``Unhealthy Insurance Markets: Search 
Frictions and the Cost and Quality of Health Insurance.'' American 
Economic Review, 101 (August 2011): 1842-1871.
---------------------------------------------------------------------------

    Given this difficulty in obtaining comparable information across 
and within health insurance markets, consumers may not always make 
informed purchase decisions that best meet the health and financial 
needs of themselves, their families, or their employees. Similarly, 
workers may overestimate or underestimate the value of employer-
sponsored health benefits, and thus their total compensation; and 
health insurance issuers and employers may face less pressure to 
compete on price, benefits, and quality, leading to inefficiency in the 
health insurance and labor markets.
    Furthermore, research suggests that many consumers do not 
understand how health coverage works. Oftentimes, contracts and benefit 
descriptions are written in technical language that requires a 
sophisticated level of literacy that many people do not have.\41\ One 
study found that consumers have particular difficulty understanding 
cost sharing and tend to underestimate their coverage for mental 
health, substance abuse and prescription drug benefits, while 
overestimating their coverage for long-term care.\42\
---------------------------------------------------------------------------

    \41\ For example, as discussed earlier, the average Summary Plan 
Description is written at a first-year college reading level. See 
Employee Benefit Research Institute, October 2006.
    \42\ D.W. Garnick, A.M. Hendricks, K.E. Thorpe, J.P. Newhouse, 
K. Donelan and R.J. Blendon. ``How well do Americans understand 
their health coverage?'' Health Affairs, 12(3). 1993:204-12. 
Available at: http://content.healthaffairs.org/content/12/3/204.full.pdf.
---------------------------------------------------------------------------

3. Summary of Impacts
    Table 1 below depicts an accounting statement summarizing the 
Departments' assessment of potential benefits, costs, and transfers 
associated with this regulatory action. The Departments have limited 
the period covered by the RIA to 2012-2013. Estimates are not provided 
for subsequent years, because there will be significant changes in the 
marketplace in 2014, including those related to the offering of new 
individual and small group plans through the Affordable

[[Page 8682]]

Insurance Exchanges, and new market reforms outside of the new 
Exchanges, and the wide-ranging scope of these changes makes it 
difficult to project results for 2014 and beyond.
    The direct benefits of these final regulations come from improved 
information, which will enable consumers, both individuals and 
employers, to better understand the coverage they have and allow 
consumers choosing coverage to more easily compare coverage options. As 
a result, consumers may make better coverage decisions, which more 
closely match their preferences with respect to benefit design, level 
of financial protection, and cost. The Departments believe that such 
improvements will result in a more efficient, competitive market. These 
final regulations would also benefit consumers by reducing the time 
they spend searching for and compiling health plan and coverage 
information.
    Under the final regulations, group health plans and health 
insurance issuers would incur costs to compile and provide the summary 
of benefits and coverage disclosures and a uniform glossary of health 
coverage and medical terms. The Departments estimate that the 
annualized cost may be around $73 million, although there is 
considerable uncertainty arising from general data limitations and the 
degree to which economies of scale exist for disclosing this 
information. The Departments' annualized cost estimates for the final 
regulation are higher than the estimated annualized cost of $50 
million, which was set forth in the proposed regulations, because, 
among other things, the Departments now have narrowed the cost estimate 
period from 2011-2013 to 2012-2013. This change reflects the fact that 
the Departments issued guidance on November 17, 2011 providing that, 
until final regulations are issued and applicable, plans and issuers 
are not required to comply with PHS Act section 2715, and the fact that 
these final regulations are being published in 2012.\43\ Nonetheless, 
these final regulations lower overall administrative costs compared to 
the proposed regulations because of several policy changes, notably the 
omission of premium or cost of coverage information from SBCs, the 
provision of only two coverage examples, and provisions allowing 
greater flexibility for electronic disclosures prior to enrollment in 
coverage.
---------------------------------------------------------------------------

    \43\ See FAQs About Affordable Care Act Implementation Part VII 
and Mental Health Parity Implementation, available at www.dol.gov/ebsa/faqs/faq-aca7.html and cciio.cms.gov/resources/factsheets/aca_implementation_faqs7.html.
---------------------------------------------------------------------------

    The Departments anticipate that the provisions of these final 
regulations will help consumers, including employers, make better 
health coverage choices and more easily understand their coverage. In 
accordance with Executive Orders 12866 and 13563, the Departments 
believe that the benefits of this regulatory action justify the costs.

                                            Table 1--Accounting Table
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Benefits:
Qualitative:
Improved information will enable consumers, including applicants, enrollees, and policyholders, to more easily
 and efficiently understand and compare coverage, and as a result, make better choices.
----------------------------------------------------------------------------------------------------------------
Costs                                                   Estimate     Year dollar   Discount rate          Period
                                                                                         percent         covered
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($ millions/year)..........             $73            2012               7       2012-2013
                                                              73            2012               3       2012-2013
----------------------------------------------------------------------------------------------------------------

4. Benefits
    In developing these final regulations, the Departments carefully 
considered their potential effects, including costs, benefits, and 
transfers. Because of data limitations, the Departments did not attempt 
to quantify expected benefits of these final regulations. Nonetheless, 
the Departments were able to identify several benefits, which are 
discussed below.
    These final regulations could generate significant economic and 
social welfare benefits to consumers. Under these final regulations, 
health insurance issuers and group health plans would provide clear and 
consistent information to consumers. Uniform disclosure is anticipated 
to benefit individuals shopping for, or enrolled in, group and 
individual health insurance coverage and group health plans. The direct 
benefits of these final regulations come from improved information, 
which will enable consumers to better understand the coverage they have 
and allow consumers choosing coverage to more easily compare options. 
As a result, consumers will make better coverage decisions, which more 
closely match their preferences with respect to benefit design, level 
of financial protection, and cost. The Departments believe that such 
improvements will result in a more efficient, competitive market.
    These final regulations would also benefit consumers by reducing 
the time they spend searching for and compiling health plan and 
coverage information. As stated above, consumers in the individual 
market, as well as consumers in some large employer-sponsored plans, 
have a number of coverage options and must make a choice using 
disclosures and tools that vary widely in content and format. A growing 
body of decision-making research suggests that the abundance and 
complexity of information can overwhelm consumers and create a 
significant non-price barrier to coverage.\44\ For example, a RAND 
study of California's individual market found that reducing barriers to 
information about health insurance products would lead to increases in 
purchase rates comparable to modest price subsidies.\45\ By ensuring 
consumers have access to readily available, concise, and understandable 
information about their coverage options, these final regulations could 
reduce consumers' cost of obtaining information and may increase health 
insurance purchase rates and satisfaction with the plan purchased.
---------------------------------------------------------------------------

    \44\ Judith H. Hibbard and Ellen Peters, ``Supporting Informed 
Consumer Health Care Decisions: Data Presentation Approaches that 
Facilitate the Use of Information in Choice,'' 24 Annu. Rev. Public 
Health 413, 416 (2003).
    \45\ M. Susan Marquis et al., ``Consumer Decision Making in the 
Individual Health Insurance Market,'' 25 Health Affairs w.226, 
w.231-w.232 (May 2006). Available at: http://
content.healthaffairs.org/content/25/3/w226.full.pdf+html.
---------------------------------------------------------------------------

    Furthermore, greater transparency in pricing and benefits 
information will allow consumers to make more informed purchasing 
decisions, resulting in cost-savings for some value-conscious consumers 
who today pay higher premiums because of imperfect

[[Page 8683]]

information about benefits.\46\ In particular, the use of coverage 
examples called for by these final regulations would better enable 
consumers to understand how key coverage provisions operate in the 
context of recognizable health care situations and more meaningfully 
compare the level of financial protection offered by a plan or 
coverage, resulting in potential cost-savings.\47\ \48\ The Departments 
therefore expect that uniform disclosures under these final regulations 
will enable consumers to derive more value from their health coverage 
and enhance the ability of plan sponsors, particularly small 
businesses, to purchase products that are appropriate to both their 
needs and the health and financial needs of their employees.
---------------------------------------------------------------------------

    \46\ A study of California's individual market found that 25 
percent of consumers chose products with premiums that were more 
than 30 percent higher than the median price for an actuarially 
equivalent product for a similar person. Melinda Beeuwkes Buntin et 
al., ``Trends and Variability In Individual Insurance Products,'' 
Health Affairs w3.449, w3.457 (2003), available at http://content.healthaffairs.org/content/early/2003/09/24/hlthaff.w3.449.citation.
    \47\ Shoshanna Sofaer et al., ``Helping Medicare Beneficiaries 
Choose Health Insurance: The Illness Episode Approach, 30 The 
Gerontologist 308-315 (1990).
    \48\ Michael Schoenbaum et al., ``Health Plan Choice and 
Information about Out-of-Pocket Costs: An Experimental Analysis,'' 
38 Inquiry 35-48 (Spring 2001).
---------------------------------------------------------------------------

    Finally, these final regulations are expected to facilitate 
consumers' ability to understand their coverage. As stated above, 
research suggests that consumers do not understand how coverage works 
or the terminology used in health insurance policies. Consequently, 
consumers may face unexpected medical expenses if they become seriously 
ill. They may also become confused by a coverage or payment decision 
made by their plan or issuer, leading to inefficiency in the operation 
of employee benefit plans and health insurance coverage. By making it 
easier for consumers to understand the key features of their coverage, 
these final regulations would enhance consumers' ability to use their 
coverage. Additionally, the uniform format will make it easier for 
consumers who change jobs or insurance coverage to see how their new 
plan or coverage benefits are similar to and different from their 
previous coverage.
5. Costs
    Section 2715 of the PHS Act and these final regulations direct 
group health plans and health insurance issuers to compile and provide 
an SBC and a uniform glossary of health coverage and medical terms. The 
Departments have attempted to quantify one-time start-up costs as well 
as maintenance costs associated with these requirements. However, there 
is considerable uncertainty arising from general data limitations and 
the degree to which economies of scale can be realized to reduce costs 
for issuers and third party administrators (TPAs).
    In the proposed regulations, the Departments estimated total 
administrative costs to be $25 million in 2011, $73 million in 2012, 
and $58 million in 2013. The Departments now estimate that issuers and 
TPAs will incur approximately $90 million in one-time costs and 
maintenance costs in 2012, and $55 in maintenance costs in 2013. These 
costs and the methodology used to estimate them are discussed below, 
and presented in Tables 2-6 below.

General Assumptions

    In order to assess the potential administrative costs relating to 
these final regulations, the Departments consulted with several 
industry experts, including individuals at large health insurance 
issuers and representing a TPA association, individuals who formerly 
worked at health insurance companies, and insurance market researchers, 
to gain insight into the tasks and level of resources required. The 
discussions focused on estimating the costs that would be start-up 
versus maintenance, and determining which functions or departments of 
an insurance company or TPA would be involved in implementing the 
provision. In addition, we reviewed the analyses of other Affordable 
Care Act regulations that impose new requirements on health insurance 
issuers and TPAs, to determine appropriate work levels and categories 
for this regulation. Particularly, we analyzed the Medical Loss Ratio 
(MLR) interim final rule (75 FR 74918). Based on these discussions, the 
Departments estimate that there will be two categories of principal 
costs associated with the standards in these final regulations: one-
time start-up costs and ongoing maintenance costs. The one-time start-
up costs include costs to develop teams to review the new standards and 
costs to implement workflow and process changes, particularly the 
development of information technology (IT) systems interfaces that 
would generate SBC disclosures through data housed in a number of 
different systems. The maintenance costs include costs to maintain and 
update IT systems in compliance with the final standards; to produce, 
review, distribute, and update the SBC disclosures; to produce and 
distribute notices of modifications; and to provide the glossary in 
paper form upon request.
    With respect to the individual market, issuers are responsible for 
generating, reviewing, updating, and distributing SBCs. With respect to 
employer-sponsored coverage, the Departments assume that fully-insured 
plans will rely on health insurance issuers, and self-insured plans 
will rely on TPAs, to perform these functions. Some commenters stated 
that some employers internally prepare plan materials and do not rely 
on TPAs. While the Departments acknowledge that some plans may 
internally prepare the SBC disclosures, the Departments do not have 
sufficient data to develop separate estimates for such plans. 
Therefore, the Departments continue to make this simplifying assumption 
because most plans appear to rely on issuers and TPAs for the purpose 
of administrative duties such as enrollment and claims processing.\49\ 
Thus, the Departments have used health insurance issuers and TPAs as 
the units of analysis for the purposes of estimating administrative 
costs in this regulatory impact analysis.
---------------------------------------------------------------------------

    \49\ See, for example, the Department of Labor's March 2011 
report to Congress on self-insured health plans, available at http://www.dol.gov/ebsa/pdf/ACAReportToCongress032811.pdf.
---------------------------------------------------------------------------

    As discussed in the MLR interim final rule, the Departments 
estimate there are about 440 firms offering comprehensive coverage in 
the individual, small, or large group markets, and 75 million covered 
lives therein.\50\ The number of covered lives includes individuals in 
the individual market as well as those in insured group health plans.
---------------------------------------------------------------------------

    \50\ The NAIC data actually indicate 442 issuers and 74,830,101 
covered lives. But the Departments have limited these values to only 
two significant figures given general data uncertainty. For example, 
the NAIC data do not include issuers regulated by California's 
Department of Managed Health Care (DMHC) as well as small, single-
State issuers that are not required by State regulators to submit 
NAIC annual financial statements.
---------------------------------------------------------------------------

    With respect to the self-insured market, the Departments estimate 
there are 77 million individuals in self-insured ERISA-covered plans 
and approximately 14 million individuals in self-insured non-Federal 
governmental plans.\51\ The Departments note that, according to 2007 
Economic Census data, there are 2,243 TPAs providing administrative 
services for health and/or welfare funds. However, there is some 
uncertainty as to whether all of those TPAs serve self-insured plans; 
many

[[Page 8684]]

issuers, for example, have subsidiary lines of business through 
administrative services only (ASO) contracts through which they perform 
third-party administrative functions for self-insured plans.\52\ Based 
on conversations with a national TPA association, the Departments 
assume that about one-third of the total number of TPAs, or about 748 
TPAs, are relevant for purposes of this analysis. However, given the 
considerable overlap between issuers and TPAs, the Departments 
recognize there may be fewer affected TPAs, so these estimates should 
be considered an upper bound of burden estimates.
---------------------------------------------------------------------------

    \51\ U.S. Department of Labor, EBSA calculations using the March 
2009 Current Population Survey Annual Social and Economic Supplement 
and the 2009 Medical Expenditure Panel Survey; see also interim 
final rule for internal claims and appeals and external review 
processes (75 FR 43330, 43345).
    \52\ See, for example, the Department of Labor's March 2011 
report to Congress on self-insured health plans, available at http://www.dol.gov/ebsa/pdf/ACAReportToCongress032811.pdf.
---------------------------------------------------------------------------

    Because the SBC disclosures are closely related to disclosures that 
issuers and TPAs provide today as a part of their normal operations 
(for example, covered benefits and cost sharing), the Departments 
estimate that the incremental costs of compiling and providing such 
readily available information in the final, standardized format is 
estimated to be modest.\53\ The regulated community has taken exception 
to this assumption, and it has stated in written comments, and 
discussions with the Departments, that information will need to be 
pulled from multiple sources. However, an opposite conclusion appears 
to have been reached by a November 2011 survey related to the regulated 
community's preparedness for SBCs. Particularly, the survey noted that 
existing communications practices and technology would allow affected 
entities to be in compliance even by the statutory compliance date of 
March 23, 2012.\54\ The results of this survey are also consistent with 
comments indicating that timely compliance is feasible.
---------------------------------------------------------------------------

    \53\ For example, issuers in the individual and small group 
markets already report some of the SBC information to HHS for 
display in the plan finder on the HealthCare.gov Web site. Issuers 
have been reporting data to HHS since May 2010 and have refreshed 
that data on a quarterly basis. These reporting entities have 
demonstrated that they have the capacity to report information on 
plan benefit design. See http://finder.healthcare.gov/. Further, 
ERISA-covered plans already report some of the SBC information in 
summary plan descriptions (SPDs).
    \54\ See December 13, 2011 news release for HighRoads Pulse 
Study, available at http://newsroom.highroads.com/hr-compliance-connection/highroads-study-shows-employers-will-not-eliminate-benefits-coverage-due-to-health-care-reform. Among other things, the 
study's author noted, ``SBCs have not caused a great concern among 
organizations. * * * This is partly a reflection of current 
communications practices--many employers are already providing a 
level of communication close to that required by the SBC 
regulations--and partly a reflection of HR departments embracing 
technology. By using automation to leverage existing data, they are 
better able to respond to required changes. That will enable timely 
compliance once the new deadline is determined.''
---------------------------------------------------------------------------

    The per-issuer or per-TPA cost will largely be determined by size 
(based on annual premium revenues) and current practices--most 
importantly, whether the issuer or TPA maintains a robust information 
technology infrastructure, including a plan benefits design database. 
Moreover, with regard to issuers, administrative costs may be related 
to the number of markets in which a company operates (that is, 
individual, small group, or large group market); the number of policies 
it offers; and the number of States and licensed entities through which 
it offers coverage.
    To account for variations among issuers, the Departments classify 
them by size as small, medium, and large issuers based on 2009 premium 
revenue for individual, small group, and large group comprehensive 
coverage.\55\ Consistent with the assumptions that were used in the MLR 
interim final rule, small issuers are defined as those earning up to 
$50 million in annual premium revenue; medium issuers as those earning 
between $50 million and $1 billion in annual premium revenue; and large 
issuers as those earning more than $1 billion in annual premium 
revenue. Based on these assumptions, the Departments estimate there are 
140 small, 230 medium, and 70 large issuers.
---------------------------------------------------------------------------

    \55\ The premium revenue data come from the 2009 NAIC financial 
statements, also known as ``Blanks,'' where insurers report 
information about their various lines of business.
---------------------------------------------------------------------------

    To account for variations among TPAs, the Departments applied the 
proportions of small, medium, and large issuers to the estimated 750 
TPAs. The Departments acknowledge that issuers and TPAs are different 
and may not have the same size variation. Nonetheless, given general 
data limitations, the Departments have adopted this methodology, and, 
on its basis, estimate that there are 240 small, 390 medium, and 120 
large TPAs. Table 2 below summarizes the estimated number of issuers 
and TPAs.

               Table 2--Issuer and TPA Size Classification
------------------------------------------------------------------------
                                              Small    Medium     Large
------------------------------------------------------------------------
Issuers...................................       140       230        70
TPAs......................................       240       390       120
------------------------------------------------------------------------

Staffing Assumptions

    Table 5 below summarizes the Departments' staffing assumptions, 
including the estimated number of hours for each task for a small, 
medium, or large issuer/TPA as well as the percentage of time that 
different professionals devote to each task. The following assumptions 
are based on the best information available to the Departments at this 
time. Particularly, the following series of assumptions are based on 
conversations with industry experts, the Departments' understanding of 
the regulated community, and previous analysis in the MLR interim final 
rule.

IT Systems and Workflow Process Changes

    In the proposed regulations, the Departments estimated that it 
would take a large issuer/TPA about 960 hours to implement IT systems 
and workflow process changes, based on discussions with a large issuer. 
These final regulations incorporate policy changes designed to reduce 
administrative burden. The Departments estimate that the administrative 
burden to implement IT systems and workflow process changes would be 
reduced, at least, by about 10 percent.\56\ Accordingly, the 
Departments are reducing the 960 hours time burden downward, by 10 
percent, to 864 hours. The Departments continue to assume that IT 
systems and workflow process changes would be implemented only by IT 
professionals. Furthermore, the Departments continue to assume that a 
medium issuer/TPA would need about 75 percent of a large issuer's/TPA's 
time, and a small issuer would need about 50 percent of a large 
issuer's/TPA's time, to implement IT systems and workflow process 
changes. These estimates are based on the assumption that medium and 
smaller issuers and TPA's have fewer products/clients that need to come 
into compliance.
---------------------------------------------------------------------------

    \56\ A 10 percent is a conservative estimate of the reduction in 
administrative burden. A national association of insurance companies 
informed the Departments that premium information alone may account 
for 10 percent of compliance costs. Given that the omission of 
premium information from SBCs is one of several policy changes in 
these final regulations, we conclude that there could be, at a 
minimum, a 10 percent reduction in administrative burden.
---------------------------------------------------------------------------

    In the proposed regulations, the Departments estimated that it 
would take a large issuer/TPA about 160 hours to develop teams to 
analyze the new standards in relation to their current workflow 
processes. These final regulations incorporate policy changes designed 
to reduce administrative

[[Page 8685]]

burden. The Departments estimate that the administrative burden to 
develop teams would be reduced by about 10 percent. Accordingly, the 
Departments are revising the 160 hours time burden downward, by 10 
percent, to 144 hours. The Departments continue to assume teams would 
be comprised of IT professionals (45 percent), benefits/sales 
professionals (50 percent), and attorneys (5 percent), based on 
technical analysis presented in the MLR interim final rule. The 
Departments also continue to scale down the burden for medium and small 
issuers/TPAs by assuming the same relative proportion as above (that 
is, 75 percent and 50 percent, respectively).
    In the proposed regulations, the Departments assumed that, in 2013, 
each issuer/TPA would incur a separate maintenance cost to maintain IT 
systems and address changes in regulatory provisions. The Departments 
assumed the maintenance cost would equal 15% of the total one-time 
burden noted above (for example, the Departments assumed it will take a 
large issuer 15% of 1008 hours, or 151 hours). The Departments further 
assumed that the teams to implement the maintenance tasks would be 
comprised of IT professionals (55%), benefits/sales professionals 
(40%), and attorneys (5%). The Departments maintain these assumptions 
in these final regulations.
    The Departments continue to assume that the one-time and 
maintenance costs to implement IT systems changes and address 
regulatory requirements would be split between the costs to produce 
SBCs and the costs to produce the coverage examples (CEs).

Production and Review of SBCs and CEs

    In the proposed regulations, the Departments estimated that each 
issuer/TPA would need 3 hours to produce, and 1 hour to review, SBCs 
(not including CEs) for all products. Some commenters thought this time 
burden was an underestimate. However, these commenters did not provide 
data that could allow the Departments to adjust their estimates. 
Accordingly, in these final regulations, the Departments are retaining 
their original estimates. The Departments also continue to assume that 
the 3 hours needed to produce SBCs would be equally divided between IT 
professionals and benefits/sales professionals. The Departments also 
continue to assume that the 1 hour needed to review SBCs would be 
equally divided between financial managers for benefits/sales 
professionals and attorneys, based on previous analyses related to the 
MLR regulation.
    In the proposed regulations, the Departments estimated it would 
take each issuer/TPA about 90 hours to produce, and about 30 hours to 
review, CEs related to three benefits scenarios for all applicable 
products, based on the MLR regulation. However, under the guidance 
document published elsewhere in this issue of the Federal Register, 
issuers and TPAs will need to produce a CE related to only two benefits 
scenarios in 2012 and 2013. Accordingly, in these final regulations, 
the Departments are adjusting the time burden downward by one-third. 
The Departments now estimate that each issuer/TPA would need about 60 
hours to produce, and about 20 hours to review, two CEs for all 
products. The Departments continue to assume that the 60 hours to 
produce the two CEs would be equally divided between IT professionals 
and benefits/sales professionals. The Departments also continue to 
assume that the 20 hours to review the two CEs would be equally divided 
between financial managers and attorneys.
    For each individual who receives the SBC in paper form, the 
Departments estimate that printing and distributing the paper 
disclosures would take clerical staff about 1 minute (0.02 hours) in 
the group markets and about 2 minutes (0.03 hours) in the individual 
market. The Departments assume that the individual market has lower 
economies of scale and, thus, increased distribution costs.

Labor Cost Assumptions

    Table 7 below presents the Departments' hourly labor cost 
assumptions (stated in 2012 dollars) for each staff category based on 
Bureau of Labor Statistics (BLS) data. The Departments use mean hourly 
wage estimates from the BLS May 2010 National Occupational Employment 
and Wage Estimates (accessed at http://www.bls.gov/oes/current/oes_nat.htm#00-0000) for computer systems analysts (Occupation Code 15-
1121), insurance underwriters (Occupation Code 13-2053), financial 
managers (Occupation Code 23-1011), executive secretaries and 
administrative assistants (Occupation Code 43-6011), and attorneys 
(Occupation Code 23-1011) as the basis for estimating labor costs for 
2012 through 2013 and adjust the hourly wage rate to include a 33 
percent fringe benefit estimate for private sector employees.\57\
---------------------------------------------------------------------------

    \57\ See the Technical Appendix to the MLR interim final rule, 
available at http://cciio.cms.gov.
---------------------------------------------------------------------------

Distribution Assumptions

    The Departments make the following assumptions regarding the 
distribution of the SBC disclosures (including CEs).\58\ These 
assumptions are based on the best information available to the 
Departments at this time. Particularly, the following series of 
assumptions are based on conversations with industry experts, the 
Departments' understanding of the regulated community, and previous 
analysis in the MLR interim final rule. The distribution assumptions 
are as follows:
---------------------------------------------------------------------------

    \58\ Although CEs are an integral component of SBCs, the costs 
associated with CEs are different from the rest of the SBC, and, 
thus, are separately calculated within this analysis.
---------------------------------------------------------------------------

     The SBCs would be limited to one per household for family 
members located at the same residence. According to one large issuer, 
there are 2.2 covered lives per family.
     The number of individuals who would receive an SBC before 
enrolling in the plan or coverage equals 20 percent of the number of 
enrollees at any point during the course of a year.\59\
---------------------------------------------------------------------------

    \59\ Based on this assumption, the Departments make the 
following estimate. Prior to enrollment in a given year, 180,000 
individuals would receive SBCs from small issuers or TPAs; 3,700,000 
individuals would receive SBCs from medium issuers or TPAs; 
11,000,000 individuals would receive SBCs from large issuers or 
TPAs.
---------------------------------------------------------------------------

     In 2012 and 2013, respectively, about 2.5 percent and 5 
percent of covered individuals who receive a paper SBC would receive a 
paper glossary from issuers and TPAs. The Departments assume that the 
burden and cost of providing paper glossaries would be proportional to 
the burden and cost of providing papers SBCs, excluding coverage 
examples. The Departments also assume that individuals who do not 
request a paper copy of the glossary will access it electronically 
using the Internet address provided in the SBC. These assumptions, 
presented here in these final regulations, have not changed from the 
proposed regulations.
     In 2013, about 2 percent of covered individuals would 
receive a notice of modifications.\60\ Further, the burden

[[Page 8686]]

and cost of providing such notices would be proportional to the 
combined burden and cost of providing the SBCs, including CEs. In 2012, 
the first year of implementation, the number of notices of 
modifications would be negligible.
---------------------------------------------------------------------------

    \60\ ERISA section 104(b) requires ERISA-covered plans to 
furnish participants and beneficiaries with a Summary of Material 
Modifications (SMM) no later than 210 days after the end of the plan 
year in which the material change was adopted or in the case of a 
material reduction in covered services or benefits, no later than 60 
days after adoption of the modification or change. As part of its 
analysis for the Department of Labor's SPD/SMM regulations (29 CFR 
2520.104b-3), the Department estimated that about 20 percent of 
health plans would need to distribute SMM in a given year due to 
plan amendments. However, almost all of these modifications occur 
between plan years--not during a plan year; therefore, the 
modifications would be required to be disclosed in a SBC that is 
distributed upon renewal of coverage. The Departments, thus, expect 
that only two percent of plans will need to issue a notice of 
modification in the middle of a plan year, because mid-year changes 
that would result in an update to the SBC are very rare, based on 
the Department of Labor's experience with ERISA plans. For purposes 
of simplification, the Departments extend this assumption to the 
individual market as well.
---------------------------------------------------------------------------

     In the proposed regulations, the Departments estimated 
that electronic distribution would account for 38 percent of all 
disclosures in the group market and 70 percent of all disclosures in 
the individual market. The estimate for the group market was based on 
the methodology used to analyze the cost burden for the Department of 
Labor's claims procedure regulation (OMB Control Number 1210-0053).\61\
---------------------------------------------------------------------------

    \61\ See the ERISA e-disclosure rule at 29 CFR 2520.104b-1.
---------------------------------------------------------------------------

     In these final regulations, the Departments are revising 
upward their estimate of electronic distribution in the group market to 
50 percent for pre-enrollment disclosures. This upward revision is 
justified, because, for participants and beneficiaries who are eligible 
but not enrolled for coverage, these final regulations permit the SBC 
to be provided electronically if the format is readily accessible and a 
paper copy is provided free of charge upon request.
     The estimate for the group market remains the same for 
post-enrollment disclosures. The estimate for the individual market 
also remains the same, and is based on statistics set forth by the 
National Telecommunications and Information Administration, which 
indicate that 30 percent of Americans do not use the Internet.\62\
---------------------------------------------------------------------------

    \62\ U.S. Department of Commerce, National Telecommunications 
and Information Administration, Digital Nation (February 2010), 
available at http://www.ntia.doc.gov/reports/2010/NTIA_internet_use_report_Feb2010.pdf.
---------------------------------------------------------------------------

     SBC disclosures would be distributed with usual marketing 
and enrollment materials, thus, costs to mail the documents will be 
negligible. However, paper glossaries and notices of modifications 
would require mailing and supply costs as follows: $0.45 postage cost 
per mailing and $0.05 supply cost per mailing. The postage costs have 
increased by $0.01 from the $0.44, as set forth in the proposed 
regulations, to reflect new first-class postage rates effective January 
22, 2012.
     Printing costs $0.03 per side of a page. The Departments 
estimate that it would cost $0.18 to print a complete SBC (which is six 
sides of a page based on the length of the NAIC sample completed SBC) 
and $0.12 to print the uniform glossary (which is four sides of a page, 
based on the length of the NAIC recommended uniform glossary). This 
cost burden is in addition to the time it would take clerical staff to 
print and distribute the SBC or glossary.

Cost Estimate

    The Tables below present costs and burden hours for issuers and 
TPAs associated with the final disclosure requirements of PHS Act 
section 2715. Tables 3-4 contain cost estimates for 2012 and 2013, 
derived from the labor hours presented in Table 5 and the hourly rate 
estimates presented in Table 6, as well as estimates of non-labor 
costs. Labor hour estimates were developed for each one-time and 
maintenance task associated with analyzing requirements, developing IT 
systems, and producing SBCs (that include CEs).

                    Table 3--2012 Hour Burden, Equivalent Cost, and Cost Burden--2012 Dollars
----------------------------------------------------------------------------------------------------------------
                                     Number of
                                     affected       Hour burden     Equivalent      Cost burden      Number of
                                     entities                          cost         (non-labor)     disclosures
----------------------------------------------------------------------------------------------------------------
SBC Requirements--Issuers.......             440         570,000     $21,000,000      $2,700,000         570,000
SBC Requirements--TPAs..........             750         760,000      30,000,000       3,600,000          60,000
Coverage Example Requirements--              440         193,000      10,500,000       1,400,000         193,000
 Issuers........................
Coverage Example Requirements--              750         330,000      17,900,000       1,800,000         330,000
 TPAs...........................
Glossary Requests--Issuers......             440          10,000         310,000         350,000          10,000
Glossary Requests--TPAs.........             750          12,000         380,000         460,000          12,000
                                 -------------------------------------------------------------------------------
    Subtotal....................  ..............       1,900,000      80,000,000      10,000,000       1,900,000
                                 -------------------------------------------------------------------------------
        Total 2012 Costs........  ..............  ..............      90,000,000  ..............  ..............
----------------------------------------------------------------------------------------------------------------

                    Table 4--2013 Hour Burden, Equivalent Cost, and Cost Burden--2012 Dollars
----------------------------------------------------------------------------------------------------------------
                                     Number of
                                     affected       Hour burden     Equivalent      Cost burden      Number of
                                     entities                          cost         (non-labor)     disclosures
----------------------------------------------------------------------------------------------------------------
SBC Requirements--Issuers.......             440         430,000     $14,000,000      $2,700,000      41,000,000
SBC Requirements--TPAs..........             750         540,000      18,000,000       3,600,000      49,000,000
Coverage Example Requirements--              440          59,000       3,300,000       1,400,000      41,000,000
 Issuers........................
Coverage Example Requirements--              750         100,000       5,600,000       1,800,000      49,000,000
 TPAs...........................
Notice of Material                           440           8,900         290,000         310,000         820,000
 Modifications--Issuers.........
Notice of Material                           750          11,000         380,000         400,000         990,000
 Modifications--TPAs............
Glossary Requests--Issuers......             440          20,000         630,000         710,000       1,100,000
Glossary Requests--TPAs.........             750          25,000         760,000         920,000       1,500,000
                                 -------------------------------------------------------------------------------
    Subtotal....................  ..............       1,200,000      43,000,000      12,000,000      94,000,000
                                 -------------------------------------------------------------------------------
        Total 2013 Costs........  ..............  ..............      55,000,000  ..............  ..............
----------------------------------------------------------------------------------------------------------------

[[Page 8687]]

                 Table 5--Estimated Staffing Hours for Small, Medium, and Large Issuers and TPAs
----------------------------------------------------------------------------------------------------------------
                                                                                       Hours
                                                    Percent of   -----------------------------------------------
            Staffing hour assumptions              hours by task  Small  issuer/  Medium  issuer/ Large  issuer/
                                                                        TPA             TPA             TPA
----------------------------------------------------------------------------------------------------------------
IT Development and Workflow Process Change:
    One-Time Develop Teams/Analyze Requirements   ..............           72             108             144
     (IT, underwriting/sales)...................
    IT Professionals Benefits/Sales.............              45           32              49              65
    Professionals...............................              50           36              54              72
    Attorneys...................................               5            4               5               7
    Implementing Systems Changes (IT and          ..............          432             648             864
     workflow)..................................
    IT Professionals............................             100          432             648             864
Maintenance:
    Updating to Address Changes in Requirements.  ..............           76             113             151
    IT Professionals............................              55           42              62              83
    Benefits/Sales Professionals................              40           30              45              60
    Attorneys...................................               5            4               6               8
SBC Requirement (maintenance):
    Producing SBCs..............................  ..............            3               3               3
    IT Professionals............................              50            1.5             1.5             1.5
    Benefits/Sales Professionals................              50            1.5             1.5             1.5
    Internal Review of SBCs.....................  ..............            1               1               1
    Financial Managers--Benefits/Sales                        50            0.5             0.5             0.5
     Professionals..............................
    Attorneys...................................              50            0.5             0.5             0.5
Producing and Distributing Paper Version of SBCs
 (Group Markets):
    Clerical Staff..............................             100            0.02            0.02            0.02
Producing and Distributing Paper Version of SBCs
 (Individual Market):
    Clerical Staff..............................             100            0.03            0.03            0.03
CE Requirement (maintenance):
    Producing CEs...............................  ..............           60              60              60
    IT Professionals............................              50           30              30              30
    Benefits/Sales Professionals................              50           30              30              30
    Internal Review of CEs......................  ..............           20              20              20
    Financial Managers--Benefits/Sales                        50           10              10              10
     Professionals..............................
    Attorneys...................................              50           10              10              10
----------------------------------------------------------------------------------------------------------------

       Table 6--Estimated Loaded Hourly Wages for Staff Categories
------------------------------------------------------------------------
                                                          Loaded  hourly
         Staff category                  BLS Code           wage  (2012
                                                             dollars)
------------------------------------------------------------------------
IT Professionals...............  Computer Systems                 $54.52
                                  Analysts (Occupation
                                  Code 15-1121).
Financial Professionals--        Insurance Underwriters            43.76
 Benefits/Sales.                  (Occupation Code 13-
                                  2053).
Financial Manager..............  Financial Managers                78.50
                                  (Occupation Code 11-
                                  3031).
Attorneys......................  Lawyers (Occupation               86.86
                                  Code 23-1011).
Clerical Staff.................  Executive Secretaries             30.78
                                  and Administrative
                                  Assistants (Occupation
                                  Code 43-6011).
------------------------------------------------------------------------

    The Departments received many comments stating that the preliminary 
cost analysis underestimated the one-time start-up costs as well as 
maintenance costs. For example, one commenter did a survey of its 
members (hereinafter ``regulated community survey''), wherein 36 member 
companies responded to questions regarding implementation and 
maintenance costs. The commenter extrapolated the survey results to all 
enrollees with coverage in the United States. Accordingly, the 
commenter projected that one-time implementation costs would be $188 
million and maintenance costs would be $194 million per year. The 
commenter stated that a significant cost driver was the March 23, 2012 
deadline to switch from current benefit descriptions to the new uniform 
SBCs. Accordingly, the commenter estimated that there could be a 
savings of 23 percent with an 18-month extension of the implementation 
timeline. The commenter also stated that additional factors affecting 
costs were, among other things, the proposed regulations' requirement 
to provide premium information; the number and complexity of coverage 
examples; the renewal process and timeframe to provide SBCs; the number 
of variations of SBCs to be delivered to each applicant or enrollee; 
paper delivery of SBCs to most group enrollees; and insufficient 
flexibility in the SBC template. As discussed elsewhere in this 
preamble, the Departments have taken steps to ease administrative 
burden related to most of these factors, and therefore believe that 
these estimates do not reflect the policies in the final rule.
    Because the regulated community survey, as well other commenters' 
cost estimates, did not provide specific, detailed cost information, it 
is difficult for the Department to acquire more than a general 
understanding of the differences between the Departments' cost 
estimates and the commenters' cost estimates. Accordingly, the 
Departments continue to believe that there is considerable uncertainty 
arising from general data limitations and the degree to which economies 
of scale are achievable.
    Even if the Departments were to utilize the regulated community 
survey, or other commenters' cost estimates, it

[[Page 8688]]

would be necessary for the Departments to discount those projected 
costs to account for policy changes in these final regulations. 
Particularly, these final regulations now omit premium or cost of 
coverage information from SBCs, provide for only two coverage examples, 
and allow greater flexibility for electronic disclosures prior to 
enrollment in coverage.
6. Regulatory Alternatives
    Several provisions in these final regulations involved policy 
choices. A first policy choice involved the applicability date of these 
final regulations. The Departments received many comments indicating 
that the proposed March 23, 2012 applicability date was not practical 
for compliance. Accordingly, in these final regulations, the 
Departments are delaying the applicability of these provisions by six 
months to provide plans and issuers additional time to comply. As 
discussed elsewhere in this preamble, for disclosures to plans, and to 
individuals and dependents in the individual market, these final 
regulations apply to health insurance issuers beginning September 23, 
2012. Similarly, for the group market, for disclosures with respect to 
participants and beneficiaries who enroll or re-enroll through an open 
enrollment period (including re-enrollees and late enrollees), these 
final regulations apply beginning on the first day of the first open 
enrollment period that begins on or after September 23, 2012. For 
disclosures with respect to participants and beneficiaries who enroll 
other than through an open enrollment period (including individuals who 
are newly eligible for coverage and special enrollees), these final 
regulations apply on the first day of the first plan year that begins 
on or after September 23, 2012. This approach to implementation should 
lessen administrative burden on the regulated community.
    A second policy choice involved whether to include premium or cost 
of coverage information in the SBC. The Departments received many 
comments that expressed concerns about the complexity of conveying such 
information in both the individual and group markets. As noted above in 
the preamble to these final regulations, the Departments believe that 
premium information can be more efficiently and effectively provided in 
documentation other than the SBC. Therefore, the Departments are not 
requiring plans and issuers to include premium or cost of coverage 
information in the SBC. Accordingly, this policy choice should also 
lessen administrative burden on the regulated community.
    A third policy choice involved the number of coverage examples that 
plans issuers must provide in the SBC. The Departments received a 
number of comments about the potential cost and burden associated with 
providing coverage examples. To address these concerns, the guidance 
document published elsewhere in this issue of the Federal Register 
clarifies that for the first year of applicability, the SBC will 
include only two coverage examples--having a baby (normal delivery) and 
routine maintenance of well-controlled type 2 diabetes. Additional 
coverage examples will be added in later years. This policy choice 
should also lessen administrative burden on the regulated community.
    A fourth policy choice involved determining how to minimize the 
burden of providing the SBC to individuals shopping for health 
insurance coverage. The Departments recognize it may be difficult for 
issuers to provide accurate information about the terms of coverage 
prior to underwriting. Accordingly, these final regulations provide 
that if individual health insurance issuers provide the information 
required by these final regulations and as specified in guidance 
published by the Secretary to the HHS Secretary's Web portal 
(HealthCare.gov), as established by 45 CFR 159.120, then they will be 
deemed to have satisfied the requirement to provide an SBC to 
individuals who request summary information about coverage prior to 
submitting an application. The Departments determined this approach 
promotes regulatory efficiency, minimizing the administrative burden on 
health insurance issuers without significantly lessening the 
protections under PHS Act section 2715.
    A fifth policy choice related to electronic distribution of SBCs. 
The Departments received comments about the electronic transmission of 
SBCs to participants and beneficiaries in the group market. 
Specifically, some comments requested that plans and issuers be 
permitted to provide SBCs to participants and beneficiaries in a manner 
other than those set forth by the Department of Labor's electronic 
disclosure safe harbor requirements at 29 CFR 2520.104b-1(c). These 
final regulations retain the proposed requirements, but make a 
distinction between a participant or beneficiary who is already covered 
under the group health plan, and a participant or beneficiary who is 
eligible for coverage but not enrolled in a group health plan. This 
distinction should provide new flexibility in some circumstances, while 
also ensuring adequate consumer protections where necessary, and will 
help reduce the burden of providing the SBC to participants and 
beneficiaries prior to enrollment.
    A sixth policy choice related to whether, in the case of covered 
individuals residing at the same address, one SBC would satisfy the 
disclosure requirement with respect to all such individuals, or whether 
multiple SBCs would be required to be provided. Under these final 
regulations, a single SBC may be provided to a family unless any 
individuals are known to reside at a different address. Separate SBCs 
will therefore need to be provided only in limited circumstances.
    A seventh policy choice related to how many SBCs a participant or 
beneficiary would automatically receive from a group health plan at 
renewal. The final regulations would further limit burden by requiring 
a plan or issuer to provide, at renewal, a new SBC for only the benefit 
package in which a participant or beneficiary is enrolled. That is, if 
the plan offers multiple benefits packages, an SBC is not required for 
each benefit package offered under the group health plan, which the 
Departments believe would otherwise create an undue burden during open 
season. Participants and beneficiaries would be able to receive upon 
request an SBC for any benefits package for which they are eligible. 
The Departments believe this balanced approach addresses the needs of 
plans, issuers, and consumers, at renewal.
    An eighth policy choice related to the interpretation of the PHS 
Act section 2715(d)(4), which requires notice of any material 
modification in any of the terms of the plan or coverage that is not 
reflected in the most recently provided SBC. The Departments note that 
a material modification, within the meaning of section 102 of ERISA and 
its implementing regulations at 29 CFR 2520.104b-3, is broadly defined 
to include any modification to the coverage offered under the plan or 
policy, that independently, or in conjunction with other 
contemporaneous modifications or changes, would be considered by the 
average plan participant to be an important change in covered benefits 
or other terms of coverage under the plan or policy. The final 
regulations interpret this provision as requiring notice only for a 
material modification that would affect the content of the SBC; that is 
not reflected in the most recently provided SBC; and that occurs other 
than in connection with renewal or reissuance of coverage (that is, a 
mid-plan or

[[Page 8689]]

policy-year change). This approach is consistent with the language of 
PHS Act section 2715(d)(4) and is more narrowly focused on what we 
interpret to be the purpose of that provision.

B. Regulatory Flexibility Act--Department of Labor and Department of 
Health and Human Services

    The Regulatory Flexibility Act (RFA) requires agencies that issue a 
regulation to analyze options for regulatory relief of small businesses 
if a final rule has a significant 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 nonprofit 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.'') The Departments use as their measure 
of significant economic impact on a substantial number of small 
entities a change in revenues of more than 3 to 5 percent.
    As discussed in the Web Portal interim final rule (75 FR 24481), 
HHS examined the health insurance industry in depth in the Regulatory 
Impact Analysis that HHS prepared for the final rule on establishment 
of the Medicare Advantage program (69 FR 46866, August 3, 2004). In 
that analysis, HHS determined that there were few if any insurance 
firms underwriting comprehensive health insurance policies (in 
contrast, for example, to travel insurance policies or dental discount 
policies) that fell below the size thresholds for ``small'' business 
established by the SBA. Currently, the SBA size threshold is $7 million 
in annual receipts for both health insurers (North American Industry 
Classification System, or NAICS, Code 524114) and TPAs (NAICS Code 
524292).
    Additionally, as discussed in the Medical Loss Ratio interim final 
rule (75 FR 74918), HHS 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, HHS used total Accident and Health (A&H) earned premiums as a 
proxy for annual receipts. HHS estimated that there were 28 small 
entities with less than $7 million in A&H earned premiums offering 
individual or group comprehensive major medical coverage; however, this 
estimate may overstate the actual number of small health insurance 
issuers offering such coverage, since it does not include receipts from 
these companies' other lines of business. These 28 small entities 
represent about 6.4 percent of the approximately 440 health insurers 
that are accounted for in this RIA. Based on this calculation, the 
Departments assume that there are an equal percentage of TPAs that are 
small entities. That is, 48 small entities represent about 6.4 percent 
of the approximately 750 TPAs that are accounted for in this RIA.
    The Departments estimate that issuers and TPAs earning less than 
$50 million in annual premium revenue, including the 76 small entities 
mentioned above, would incur costs of approximately $33,000 and $10,000 
per issuer/TPA in 2012 and 2013, respectively. Numbers of this 
magnitude do not approach the amounts necessary to be considered a 
``significant economic impact'' on firms with revenues in the order of 
millions of dollars. Additionally, as discussed earlier, the 
Departments believe that these estimates overstate the number of small 
entities that will be affected by the requirements in this final 
regulation, as well as the relative impact of these requirements on 
these entities, because the Departments have based their analysis on 
the affected entities' total A&H earned premiums (rather than their 
total annual receipts). Accordingly, the Departments have determined 
and certify that these final regulations will not have a significant 
economic impact on a substantial number of small entities, and that a 
regulatory flexibility analysis is not required.

C. Special Analyses--Department of the Treasury

    For purposes of the Department of the Treasury it has been 
determined that this Treasury decision is not a significant regulatory 
action as defined in Executive Order 12866. Therefore, a regulatory 
assessment is not required. It has also been determined that section 
553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does 
not apply to these final regulations. It is hereby certified that the 
collections of information contained in this Treasury decision will not 
have a significant impact on a substantial number of small entities. 
Accordingly, a regulatory flexibility analysis under the Regulatory 
Flexibility Act (5 U.S.C. chapter 6) is not required. Section 54.9815-
2715 of the final regulations requires both group health insurance 
issuers and group health plans to distribute an SBC and notice of any 
material modifications to the plan that affect the information required 
in the SBC. Under these final regulations, if a health insurance issuer 
satisfies the obligations to distribute an SBC and a notice of 
modifications, those obligations are satisfied not just for the issuer 
but also for the group health plan. For group health plans maintained 
by small entities, it is anticipated that the health insurance issuer 
will satisfy these obligations for both the plan and the issuer in 
almost all cases. For this reason, these information collection 
requirements will not impose a significant impact on a substantial 
number of small entities. Pursuant to section 7805(f) of the Code, the 
notice of proposed rulemaking preceding these regulations was submitted 
to the Chief Counsel for Advocacy of the Small Business Administration 
for comment on its impact on small business.

D. Unfunded Mandates Reform Act--Department of Labor and Department of 
Health and Human Services

    Section 202 of the Unfunded Mandates Reform Act (UMRA) of 1995 that 
agencies assess anticipated costs and benefits before issuing any final 
rule that includes a Federal mandate that could result in expenditure 
in any one year by State, local or Tribal governments, in the 
aggregate, or by the private sector, of $100 million in 1995 dollars 
updated annually for inflation. In 2011, that threshold level is 
approximately $136 million. These final regulations include no mandates 
on State, local, or Tribal governments. These final regulations include 
directions to produce standardized consumer disclosures that will 
affect private sector firms (for example, health insurance issuers 
offering coverage in the individual and group markets, and third-party 
administrators providing administrative services to group health 
plans), but we conclude that these costs will not exceed the $136 
million threshold. Thus, we conclude that these final regulations do 
not impose an unfunded mandate on State, local or Tribal governments or 
the private sector. Regardless, consistent with policy embodied in 
UMRA, this notice of final rulemaking has been designed to be the least 
burdensome alternative for State, local and Tribal governments, and the 
private sector while achieving the objectives of the Affordable Care 
Act.

E. Paperwork Reduction Act

1. Department of Labor and Department of the Treasury
    Section 2715 of the PHS Act directs the Departments, in 
consultation with the National Association of Insurance Commissioners 
(NAIC) and a working group comprised of stakeholders, to

[[Page 8690]]

``develop standards for use by a group health plan and a health 
insurance issuer in compiling and providing to applicants, enrollees, 
and policyholders and certificate holders a summary of benefits and 
coverage explanation that accurately describes the benefits and 
coverage under the applicable plan or coverage.'' For disclosures to 
plans, and to individuals and dependents in the individual market, 
these final regulations apply to health insurance issuers beginning 
September 23, 2012. Similarly, for the group market, for disclosures 
with respect to participants and beneficiaries who enroll or re-enroll 
through an open enrollment period (including re-enrollees and late 
enrollees), these final regulations apply beginning on the first day of 
the first open enrollment period that begins on or after September 23, 
2012. For disclosures with respect to participants and beneficiaries 
who enroll other than through an open enrollment period (including 
individuals who are newly eligible for coverage and special enrollees), 
these final regulations apply on the first day of the first plan year 
that begins on or after September 23, 2012.
    To implement this provision, collection of information requirements 
relate to the provision of the following:
     Summary of benefits and coverage.
     Coverage examples (as components of each SBC).
     A uniform glossary of health coverage and medical terms 
(uniform glossary).
     Notice of modifications.

A copy of the ICR may be obtained by contacting the PRA addressee: G. 
Christopher Cosby, Office of Policy and Research, U.S. Department of 
Labor, Employee Benefits Security Administration, 200 Constitution 
Avenue NW., Room N-5718, Washington, DC 20210. Telephone: (202) 693-
8410; Fax: (202) 219-4745. These are not toll-free numbers. Email: 
ebsa.opr@dol.gov. ICRs submitted to OMB also are available at 
reginfo.gov (http://www.reginfo.gov/public/do/PRAMain).
    The Departments estimate 858 respondents each year from 2012-2013. 
This estimate reflects approximately 220 issuers offering comprehensive 
major medical coverage in the small and large group markets, and 
approximately 638 third-party administrators (TPAs).\63\
---------------------------------------------------------------------------

    \63\ The Departments estimate that there are 440 issuers and 750 
TPAs. Because the Department of Labor and the Department of the 
Treasury share the hour and cost burden for issuers and TPAs with 
the Department of Health and Human Services, the burden to produce 
the SBCs including Coverage Examples for group health plans is 
calculated using half the number of issuers (220) and 85 percent of 
the TPAs (638). While the group health plans could prepare their own 
SBCs, the Departments assume that SBCs would be prepared by service 
providers, i.e., issuers and TPAs.
---------------------------------------------------------------------------

    To account for variation in firm size, the Departments estimate a 
weighted burden on the basis of issuer's 2009 total earned premiums for 
comprehensive major medical coverage.\64\ The Departments define small 
issuers as those with total earned premiums less than $50 million; 
medium issuers as those with total earned premiums between $50 million 
and $999 million; and large issuers as those with total earned premiums 
of $1 billion or more. Accordingly, the Departments estimate 
approximately 70 small, 115 medium, and 35 large issuers. Similarly, 
the Departments estimate approximately 204 small, 332 medium, and 102 
large TPAs.
---------------------------------------------------------------------------

    \64\ The premium revenue data come from the 2009 NAIC financial 
statements, also known as ``Blanks,'' where insurers report 
information about their various lines of business.
---------------------------------------------------------------------------

2012 Burden Estimate

    In 2012, the Departments estimate a one-time administrative burden 
of about 620,000 hours with an equivalent cost of about $34,000,000 
across the industry to prepare for the provisions of these final 
regulations. This calculation is made assuming issuers and TPAs will 
need to implement two principal tasks: (1) develop teams to analyze 
current workflow processes against the new rules and (2) make 
appropriate changes to IT systems and processes. With respect to task 
(1), the Departments estimate about 88,000 burden hours with an 
equivalent cost of about $4,500,000. The Departments calculate these 
estimates as follows: \65\
---------------------------------------------------------------------------

    \65\ For the purposes of these and other estimates in this 
section IV.E, the Departments again use the assumptions outlined 
above in section IV.A.5.

                                                     Task 1--Analyze Current Workflow and New Rules
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small issuer/TPA          Medium issuer/TPA         Large issuer/TPA
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52           32       $1,800           49       $2,600           65       $3,500
Benefits/Sales Professionals.................................        43.76           36        1,600           54        2,400           72        3,200
Attorneys....................................................        86.86            4          310            5          500            7          630
                                                              ------------------------------------------------------------------------------------------
    Total per issuer/TPA.....................................  ...........           72        3,700          108        5,500          144        7,300
                                                              ------------------------------------------------------------------------------------------
        Total for all issuers/TPAs...........................  ...........       20,000    1,000,000       48,000    2,500,000       20,000    1,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    With respect to task (2), the Departments estimate about 530,000 
burden hours with an equivalent cost of about $29,000,000. The 
Departments calculate these estimates as follows:

                                                                   Task 2--IT Changes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small issuer/TPA          Medium issuer/TPA         Large issuer/TPA
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52          432      $24,000          648      $35,000          864      $47,000
                                                              ------------------------------------------------------------------------------------------

[[Page 8691]]

 
    Total per issuer/TPA.....................................  ...........          432       24,000          648       35,000          864       47,000
                                                              ------------------------------------------------------------------------------------------
        Total for all issuers/TPAs...........................  ...........      120,000    6,600,000      290,000   16,000,000      120,000    6,400,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In addition to the one-time administrative costs mentioned above, 
the Departments assume that plans and issuers will incur additional 
administrative burden. With regard to this administrative burden, the 
estimated hour and cost burden for the collections of information in 
2012 are as follows:
     The Departments estimate that there will be about 
77,000,000 SBCs.
     The Departments assume 50 percent of the total number of 
SBCs would be sent electronically prior to enrollment, and 38 percent 
would be sent electronically after enrollment, in the small and large 
group markets. Accordingly, the Departments estimate that about 
31,000,000 SBCs would be electronically distributed, and about 
46,000,000 SBCs would be distributed in paper form. The Departments 
assume there are costs only for paper disclosures, but no costs for 
electronic disclosures.
    Task 3: SBCs--The estimated hour burden for preparing the SBCs is 
about 780,000 hours with an equivalent cost of about $24,000,000, and a 
cost burden of about $5,500,000. The Departments calculate these 
estimates as follows:

                                                       Task 3: Equivalent Costs for Producing SBCs
                                                               [Except coverage examples]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small issuer/TPA          Medium issuer/TPA         Large issuer/TPA
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52          1.5          $82          1.5          $82          1.5          $82
Benefits/Sales Professionals.................................        43.76          1.5           66          1.5           66          1.5           66
Financial Managers...........................................        78.50          0.5           39          0.5           39          0.5           39
Attorneys....................................................        86.86          0.5           43          0.5           43          0.5           43
                                                              ------------------------------------------------------------------------------------------
    Total per issuer/TPA.....................................  ...........            4          230            4          230            4          230
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers/TPAs...............................  ...........        1,100       63,000        1,800      100,000          500       32,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                     Task 3: Equivalent Costs for Distributing SBCs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Hourly wage                     Total number of                        Total
                                                                           rate        Hours per SBC         SBCs         Total hours    equivalent cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clerical staff.....................................................          $30.78            0.017       46,000,000          780,000      $24,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                      Task 3: Cost Burden for Printing SBCs
----------------------------------------------------------------------------------------------------------------
                                                                                Total number of     Total cost
                                                                Cost per SBCs         SBCs            burden
----------------------------------------------------------------------------------------------------------------
Printing Costs...............................................           $0.12       46,000,000       $5,500,000
----------------------------------------------------------------------------------------------------------------

    Task 4: Two Coverage Examples--The estimated hour burden for 
producing and printing coverage examples is about 69,000 hours with an 
equivalent cost of about $4 million, and a cost burden of about 
$2,800,000. The Departments calculate these estimates as follows:

                                                Task 4: Equivalent Costs for Producing Coverage Examples
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small issuer/TPA          Medium issuer/TPA         Large issuer/TPA
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52           30       $1,640           30       $1,640           30       $1,640
Benefits/Sales Professionals.................................        43.76           30        1,310           30        1,310           30        1,310
Financial Managers...........................................        78.50           10          780           10          780           10          780
Attorneys....................................................        86.86           10          870           10          870           10          870
                                                              ------------------------------------------------------------------------------------------

[[Page 8692]]

 
    Total per issuer/TPA.....................................  ...........           80        4,600           80        4,600           80        4,600
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers/TPAs...............................  ...........       21,900    1,260,000       36,000    2,100,000       11,000      630,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

                               Task 4: Cost Burden for Printing Coverage Examples
----------------------------------------------------------------------------------------------------------------
                                                                Printing cost    Total CE sets      Total cost
                                                                  per CE set        printed           burden
----------------------------------------------------------------------------------------------------------------
Printing Costs...............................................           $0.06       46,000,000       $2,800,000
----------------------------------------------------------------------------------------------------------------

    Task 5: Glossary Requests--The Departments assume that, in 2012, 
issuers and TPAs will begin responding to glossary requests from 
covered individuals, and that 2.5 percent of covered individuals, who 
receive paper SBCs, will request glossaries in paper form. The 
Departments estimate that the hour and cost burden of providing the 
notices to be 2.5 percent of the hour and cost burden of distributing 
paper SBCs, plus an additional cost burden of $0.50 for each glossary 
(including $0.45 for first-class postage and $0.05 for supply costs). 
Accordingly, in 2012, the Departments estimate an hour burden of about 
24,000 hours with an equivalent cost of about $740,000 and a cost 
burden of about $740,000 associated with about 1,200,000 glossary 
requests.
    The total 2012 burden estimate is about 1,500,000 hours with an 
equivalent cost of about $63,000,000 and cost burden of about 
$9,000,000.

2013 Burden Estimate

    Task 1: SBCs--The number of disclosures is assumed to remain 
constant at about 77,000,000. Accordingly, in 2013, the Departments 
again estimate a burden of about 780,000 hours with an equivalent cost 
of about $5,500,000 and a cost burden of about $24,000,000 for 
preparing and distributing SBCs.
    Task 2: Two Coverage Examples--The Departments again estimate about 
69,000 hours with an equivalent cost of about $4,000,000 and a cost 
burden of about $2,800,000 for producing and printing coverage 
examples.
    Task 3: Notices of Modifications--The Departments assume that, in 
2013, issuers and TPAs would send notices of modifications to covered 
individuals, and that two percent of covered individuals would receive 
such notice. The Departments estimate that the hour and cost burden of 
providing the notices to be two percent of the combined hour and cost 
burden of providing the SBCs including the coverage examples, plus an 
additional cost burden of $0.50 for each paper notice (including $0.45 
for first-class postage and $0.05 for supply costs). Accordingly, in 
2013, the Departments estimate an hour burden of about 17,000 hours 
with an equivalent cost of $570,000 and a cost burden of about $630,000 
associated with preparing and distributing about 1,500,000 notices of 
modification. [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/
PREAMB][SUPLINF][HED]*[/HED]?>
    Task 4: Glossary Requests--The Departments assume that, in 2013, 
issuers and TPAs will again respond to glossary requests from covered 
individuals, and that five percent of covered individuals, who receive 
paper SBCs, will request glossaries in paper form. The Departments 
estimate that the burden and cost of providing the glossaries to be 
five percent of the hour and cost burden of distributing paper SBCs, 
plus an additional cost burden for $0.50 for each glossary (including 
$0.45 for first-class postage and $0.05 for supply costs). Accordingly, 
in 2013, the Departments estimate an hour burden of about 39,000 hours 
with an equivalent cost of about $1,200,000 and a cost burden of about 
$1,400,000 associated with 2,300,000 glossary requests.
    Task 5: Maintenance Administrative Costs--In 2013, the Departments 
assume that issuers and TPAs will need to make updates to address 
changes in standards, and, thus, incur 15 percent of the one-time 
administrative burden. Accordingly, the estimated hour burden is about 
93,000 hours, with an equivalent cost of about $4,800,000. The 
Departments calculate these estimates as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small Issuer/TPA          Medium Issuer/TPA         Large Issuer/TPA
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52           42       $2,300           62       $3,400           83       $4,500
Benefits/Sales Professionals.................................        43.76           30        1,300           45        2,000           60        2,600
Attorneys....................................................        86.86            4          350            6          520            8          690
                                                              ------------------------------------------------------------------------------------------
    Total per issuer/TPA.....................................  ...........           76        4,000          113        5,900          151        7,800
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers/TPAs...............................  ...........       21,000    1,100,000       51,000    2,600,000       21,000    1,100,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total 2013 burden estimate is about 1,000,000 hours with an 
equivalent cost of nearly $35,000,000 and a cost burden of $10,000,000.
    Estimates are not provided for subsequent years, because there will 
be significant changes in the marketplace in 2014, including those 
related to the offering of new individual and small group plans through 
the Affordable Insurance Exchanges, and new market reforms outside of 
the new Exchanges, and the wide-ranging scope of these

[[Page 8693]]

changes makes it difficult to project results for 2014 and beyond.
    The Departments note that persons are not required to respond to, 
and generally are not subject to any penalty for failing to comply 
with, an ICR unless the ICR has a valid OMB control number.
    The 2012-2013 paperwork burden estimates are summarized as follows:
    Type of Review: New collection.
    Agencies: Employee Benefits Security Administration, Department of 
Labor; Internal Revenue Service, U.S. Department of the Treasury.
    Title: Affordable Care Act Uniform Explanation of Coverage 
Documents
    OMB Number: 1210-0147; 1545-2229.
    Affected Public: Business or other for profit; not-for-profit 
institutions.
    Total Respondents: 858.
    Total Responses: 79,500,000.
    Frequency of Response: On-going.
    Estimated Total Annual Burden Hours (two year average): 620,000 
hours (Employee Benefits Security Administration); 620,000 hours 
(Internal Revenue Service).
    Estimated Total Annual Cost Burden (two year average): $4,800,000 
(Employee Benefits Security Administration); $4,800,000 (Internal 
Revenue Service).
2. Department of Health and Human Services

ICRs Related to the Summary of Benefits and Uniform Glossary (45 CFR 
147.200)

    The Department estimates 333 respondents each year from 2012-2013. 
This estimate reflects the approximately 220 issuers offering 
comprehensive major medical coverage in the individual market and to 
fully-insured non-federal governmental plans, and 113 TPAs acting as 
service providers for self-insured non-federal governmental plans.\66\
---------------------------------------------------------------------------

    \66\ The Department estimates that there are 440 issuers and 750 
TPAs. Because the Department shares the hour and cost burden for 
issuers with the Department of Labor and the Department of the 
Treasury, the burden to produce the SBCs including coverage examples 
for non-federal governmental plans and issuers in the individual 
market is calculated using half the number of issuers (221) and 15% 
of TPAs (113). While non-federal governmental plans could prepare 
their own SBCs, the Department assumes that SBCs would be prepared 
by service providers, i.e., issuers and TPAs.
---------------------------------------------------------------------------

    To account for variation in firm size, the Department estimates a 
weighted burden on the basis of issuers' 2009 total earned premiums for 
comprehensive major medical coverage.\67\ The Department defines small 
issuers as those with total earned premiums less than $50 million; 
medium issuers as those with total earned premiums between $50 million 
and $999 million; and large issuers as those with total earned premiums 
of $1 billion or more. Accordingly, the Department estimates 
approximately 70 small, 115 medium, and 35 large issuers. Similarly, 
the Department estimates approximately 36 small, 59 medium, and 18 
large TPAs.
---------------------------------------------------------------------------

    \67\ The premium revenue data come from the 2009 NAIC financial 
statements, also known as ``Blanks,'' where insurers report 
information about their various lines of business
---------------------------------------------------------------------------

2012 Burden Estimate

    In 2012, the Department estimates a one-time administrative burden 
of about 230,000 hours with an equivalent cost of about $13,000,000 
across the industry to prepare for the provisions of these final 
regulations. This calculation is made assuming issuers and TPAs will 
need to implement two principal tasks: (1) develop teams to analyze 
current workflow processes against the new standards and (2) make 
appropriate changes to IT systems and processes.
    With respect to task (1), the Department estimates about 34,000 
burden hours with an equivalent cost of about $1,800,000. The 
Department calculates these estimates as follows:\68\
---------------------------------------------------------------------------

    \68\ For the purposes of these and other estimates in this 
section IV.E, the Department again use the assumptions outlined 
above in section IV.A.5.

                                                     Task 1: Analyze Current Workflow and New Rules
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small Issuer/TPA          Medium Issuer/TPA         Large Issuer/TPA
                                                               Hourly Wage -----------------------------------------------------------------------------
                                                                   Rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         Cost        Hours         Cost        Hours         Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52           32       $1,800           49       $2,600           65       $3,500
Benefits/Sales Professionals.................................        43.76           36        1,600           54        2,400           72        3,200
Attorneys....................................................        86.86            4          310            5          500            7          600
                                                              ------------------------------------------------------------------------------------------
    Total per issuer/TPA.....................................  ...........           72        3,700          108        6,000          144        7,000
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers/TPAs...............................  ...........        7,600      390,000       19,000    1,000,000        7,600      370,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    With respect to task (2), the Department estimates about 200,000 
burden hours with an equivalent cost of about $11,000,000. The 
Department calculates these estimates as follows:

                                                                   Task 2: IT Changes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small Issuer/TPA          Medium Issuer/TPA         Large Issuer/TPA
                                                               Hourly Wage -----------------------------------------------------------------------------
                                                                   Rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         Cost        Hours         Cost        Hours         Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52          432      $24,000          648      $35,000          864      $50,000
                                                              ------------------------------------------------------------------------------------------
    Total per issuer/TPA.....................................  ...........          432       24,000          648       35,000          864       50,000
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers/TPAs...............................  ...........       46,000    2,500,000      110,000    6,100,000       46,000    2,700,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 8694]]

    In addition to the one-time administrative costs mentioned above, 
the Department assumes that plans and issuers will incur additional 
administrative burden. With regard to this administrative burden, the 
estimated hour and cost burden for the collections of information in 
2012 are as follows:
     The Department estimates that there will be about 
13,000,000 SBCs.
     The Department assumes 50 percent of the total number of 
SBCs would be sent electronically prior to enrollment, and 38 percent 
would be sent electronically after enrollment, in the small and large 
group markets. The Department further assumes 70 percent of SBCs would 
be sent electronically in the individual market. Accordingly, the 
Department estimates that about 7,100,000 disclosures would be 
electronically distributed, and about 6,200,000 disclosures would be 
distributed in paper form. The Department assumes there are costs only 
for paper disclosures, but no costs for electronic disclosures
    Task 3: SBCs--The estimated hour burden is about 130,000 hours with 
an equivalent cost of about $4,200,000, and a cost burden of about 
$740,000. The Department calculates these estimates as follows:

                                         Task 3--Equivalent Costs for Producing SBCs (Except Coverage Examples)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Small Issuer              Medium Issuer             Large Issuer
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52          1.5          $82          1.5          $82          1.5          $82
Benefits/Sales Professionals.................................        43.76          1.5           66          1.5           66          1.5           66
Financial Managers...........................................        78.50          0.5           39          0.5           39          0.5           39
Attorneys....................................................        86.86          0.5           43          0.5           43          0.5           43
                                                              ------------------------------------------------------------------------------------------
    Total per issuer.........................................  ...........            4          230            4          230            4          230
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers....................................  ...........          420       24,000          700       40,000          210       12,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

                  Task 3--Equivalent Costs for Distributing SBCs (Including Coverage Examples)
----------------------------------------------------------------------------------------------------------------
                                                                              Total                     Total
                                                 Hourly wage   Hours per    number of   Total hours   equivalent
                                                     rate         SBC          SBCs                      cost
----------------------------------------------------------------------------------------------------------------
Clerical Staff, Individual Market..............       $30.78        0.033    1,700,000       56,000   $1,700,000
Clerical Staff, Group Market...................        30.78        0.017    4,500,000       77,000    2,400,000
                                                ----------------------------------------------------------------
    Total......................................  ...........  ...........    6,200,000      130,000    4,100,000
----------------------------------------------------------------------------------------------------------------

                        Task 3--Cost Burden for Printing SBCs (Except Coverage Examples)
----------------------------------------------------------------------------------------------------------------
                                                                 Cost per SBC      Total SBCs      Cost burden
----------------------------------------------------------------------------------------------------------------
Printing Costs...............................................           $0.12        6,200,000         $740,000
----------------------------------------------------------------------------------------------------------------

    Task 4: Two Coverage Examples--The estimated hour burden for 
producing and printing coverage examples is about 27,000 hours with an 
equivalent cost of about $1,500,000, and a cost burden of about 
$370,000. The Department calculates these estimates as follows:

                                                Task 4--Equivalent Costs for Producing Coverage Examples
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small Issuer/TPA          Medium Issuer/TPA         Large Issuer/TPA
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52           30       $1,640           30       $1,640           30       $1,640
Benefits/Sales Professionals.................................        43.76           30        1,310           30        1,310           30        1,310
Financial Managers...........................................        78.50           10          780           10          780           10          780
Attorneys....................................................        86.86           10          870           10          870           10          870
                                                              ------------------------------------------------------------------------------------------
    Total per issuer/TPA.....................................  ...........           80        4,600           80        4,600           80        4,600
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers/TPAs...............................  ...........        8,500      490,000       14,000      800,000        4,200      240,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 8695]]

                               Task 4--Cost Burden for Printing Coverage Examples
----------------------------------------------------------------------------------------------------------------
                                                                Printing cost    Total CE sets      Total cost
                                                                  per CE set        printed           burden
----------------------------------------------------------------------------------------------------------------
Printing Costs...............................................           $0.06        6,200,000         $370,000
----------------------------------------------------------------------------------------------------------------

    Task 5: Glossary Requests--The Department assumes that, in 2012, 
issuers and TPAs will begin responding to glossary requests from 
covered individuals, and that 2.5 percent of covered individuals, who 
receive paper SBCs, will request glossaries in paper form. The 
Department assumes that the hour and cost burden of providing the 
glossaries to be 2.5 percent of the hour and cost burden of 
distributing paper SBCs, plus an additional cost burden of $0.50 for 
each glossary (including $0.45 for first-class postage and $0.05 for 
supply costs). Accordingly, in 2012, the Department estimates an hour 
burden of about 2,700 hours with an equivalent cost of about $82,000 
and a cost burden of about $99,000 associated with about 160,000 
glossary requests.
    The total 2012 burden estimate is about 390,000 hours, or 1,200 
hours per respondent, with an equivalent cost of about $19,000,000, or 
$57,000 per respondent, and cost burden of about $1,200,000, or $3,600 
per respondent.

2013 Burden Estimate

    Task 1: SBCs--The number of disclosures is assumed to remain 
constant at 13,000,000. Thus, in 2013, the Department again estimates 
an hour burden of about 130,000 hours with an equivalent cost of about 
$4,200,000 and cost burden of about $740,000.
    Task 2: Two Coverage Examples--The Department again estimates an 
hour burden of about 27,000 hours with an equivalent cost of about 
$1,500,000 and cost burden of about $370,000 for producing and printing 
coverage examples.
    Task 3: Notices of Modifications--The Department assumes that, in 
2013, issuers will begin sending notices of modifications to covered 
individuals, and that two percent of covered individuals would receive 
such notice. The Department estimates that the hour and cost burden of 
providing the notices to be two percent of the combined hour and cost 
burden of providing the SBCs including the coverage examples, plus an 
additional cost burden of $0.50 for each paper notice (including $0.45 
for first-class postage and $0.05 for supply costs). Accordingly, in 
2013, the Department estimates an hour burden of about 3,100 hours with 
an equivalent cost of about $118,000 and a cost burden of about $22,000 
associated with about 260,000 notices of modification.
    Task 4: Glossary Requests--The Department assumes that, in 2013, 
issuers and TPAs will again respond to glossary requests from covered 
individuals, and that five percent of covered individuals, who receive 
paper SBCs, will request glossaries in paper form. The Department 
estimates that the hour and cost burden of providing the glossaries to 
be 5 percent of the hour and cost burden of distributing paper SBCs, 
plus an additional cost burden of $0.50 for each glossary (including 
$0.45 for first-class postage and $0.05 for supply costs). Accordingly, 
in 2013, the Department estimates an hour burden of about 5,300 hours 
with an equivalent cost of $160,000 and a cost burden of about $190,000 
associated with 310,000 glossary requests.
    Task 5: Maintenance Administrative Costs--In 2013, the Department 
assumes that issuers and TPAs will need to make updates to address 
changes in standards, and, thus, incur 15 percent of the one-time 
administrative burden. Accordingly, the estimated hour burden is about 
36,000 hours with an equivalent cost of about $1,800,000. The 
Department calculates these estimates as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Small issuer/TPA          Medium issuer/TPA         Large issuer/TPA
                                                               Hourly wage -----------------------------------------------------------------------------
                                                                   rate                   Equivalent                Equivalent                Equivalent
                                                                               Hours         cost        Hours         cost        Hours         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
IT Professionals.............................................       $54.52           42       $2,300           62       $3,400           83       $4,500
Benefits/Sales Professionals.................................        43.76           30        1,300           45        2,000           60        2,600
Attorneys....................................................        86.86            4          350            6          520            8          690
                                                              ------------------------------------------------------------------------------------------
    Total per issuer/TPA.....................................  ...........           76        4,000          113        5,900          151        7,800
                                                              ------------------------------------------------------------------------------------------
    Total for all issuers/TPAs...............................  ...........        8,100      420,000       20,000    1,000,000        8,000      410,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total 2013 burden estimate is about 200,000 hours, or about 600 
hours per respondent, with an equivalent cost of about $7,800,000, or 
$23,000 per respondent, and cost burden of about $1,400,000, or $4,200 
per respondent.
    Estimates are not provided for subsequent years, because there will 
be significant changes in the marketplace in 2014, including those 
related to the offering of new individual and small group plans through 
the Affordable Insurance Exchanges, and new market reforms outside of 
the new Exchanges, and the wide-ranging scope of these changes makes it 
difficult to project results for 2014 and beyond.
    The Department notes that persons are not required to respond to, 
and generally are not subject to any penalty for failing to comply 
with, an ICR unless the ICR has a valid OMB control number.
    The 2012-2013 paperwork burden estimates are summarized as follows:
    Type of Review: New collection (Request for a new OMB Control 
Number).
    Agency: Department of Health and Human Services.
    Title: Affordable Care Act Uniform Explanation of Coverage 
Documents
    CMS Identifier (OMB Control Number): CMS-10407 (0938-1146).
    Affected Public: Business; State, Local, or Tribal Governments.
    Total Respondents: 333.
    Total Responses: 13,000,000.
    Frequency of Response: On-going.
    Estimated Total Annual Burden Hours (two year average): 300,000 
hours.
    Estimated Total Annual Cost Burden (two year average): $1,300,000.

[[Page 8696]]

ICRs Related to Deemed Compliance Reporting (45 CFR 
147.200(a)(4)(iii)(C))

    Under 45 CFR 147.200(a)(4)(iii)(C), if individual health insurance 
issuers provide information required by these final regulations to the 
HHS Secretary's Web portal (HealthCare.gov), as established by 45 CFR 
159.120, then they will be deemed to have satisfied the requirement to 
provide an SBC to individuals who request information about coverage 
prior to submitting an application for coverage. Individual health 
insurance issuers already provide most SBC content elements to 
HealthCare.gov, except for five data elements related to patient 
responsibility for each coverage example: deductibles, co-payments, co-
insurance, limits or exclusions, and the total of all four cost-sharing 
amounts.
    Accordingly, the additional burden associated with the requirements 
under Sec.  147.200(a)(4)(iii)(C) is the time and effort it would take 
each of the 220 issuers in the individual market to enter the five 
additional data elements into an Excel spreadsheet. We estimate that it 
will take these issuers about 110 hours, at a total estimated cost of 
about $3,300, for each coverage example. For two coverage examples, the 
burden and cost would be about 220 hours at a cost of about $6,600.
    In deriving these figures, we used the following hourly labor rates 
and estimated the time to complete each task: $ 30.78/hr and 0.5 hr/
issuer for clerical staff to enter data into an Excel spreadsheet, or 
about $15 per respondent per coverage example.
    This information collection requirement reflects the clarification 
in these final regulations that issuers must provide all content 
required in the SBC, including the information necessary for coverage 
examples, to Healthcare.gov to be deemed compliant. The aforementioned 
burden estimates will be submitted for OMB review and approval as a 
revision to the information collection request currently approved under 
OMB control number 0938-1086.
    To obtain copies of the supporting statement and any related forms 
for the final paperwork collections referenced above, access CMS' Web 
site at http://www.cms.gov/PaperworkReductionActof1995/PRAL/list.asp#TopOfPage or email your request, including your address, phone 
number, OMB number, and CMS document identifier, to 
Paperwork@cms.hhs.gov, or call the Reports Clearance Office at 410-786-
1326.

F. Federalism Statement--Department of Labor and Department of Health 
and Human Services

    Executive Order 13132 outlines fundamental principles of 
federalism, and requires the adherence to specific criteria by Federal 
agencies in the process of their formulation and implementation of 
policies that have ``substantial direct effects'' on the States, the 
relationship between the national government and States, or on the 
distribution of power and responsibilities among the various levels of 
government. Federal agencies promulgating regulations that have 
federalism implications must consult with State and local officials and 
describe the extent of their consultation and the nature of the 
concerns of State and local officials in the preamble to the 
regulation.
    In the Departments' view, these final rules have federalism 
implications, because it would have direct effects on the States, the 
relationship between national governments and States, or on the 
distribution of power and responsibilities among various levels of 
government relating to the disclosure of health insurance coverage 
information to consumers. Under these final rules, all group health 
plans and health insurance issuers offering group or individual health 
insurance coverage, including self-funded non-federal governmental 
plans as defined in section 2791 of the PHS Act, would be required to 
follow uniform standards for compiling and providing a summary of 
benefits and coverage to consumers. Such Federal standards developed 
under PHS Act section 2715(a) would preempt any related State standards 
that require a summary of benefits and coverage that provides less 
information to consumers than that required to be provided under PHS 
Act section 2715(a).
    In general, through section 514, ERISA supersedes State laws to the 
extent that they relate to any covered employee benefit plan, and 
preserves State laws that regulate insurance, banking, or securities. 
While ERISA prohibits States from regulating a plan as an insurance or 
investment company or bank, the preemption provisions of section 731 of 
ERISA and section 2724 of the PHS Act (implemented in 29 CFR 
2590.731(a) and 45 CFR 146.143(a)) apply so that the HIPAA requirements 
(including those of the Affordable Care Act) are not to be ``construed 
to supersede any provision of State law which establishes, implements, 
or continues in effect any standard or requirement solely relating to 
health insurance issuers in connection with group health insurance 
coverage except to the extent that such standard or requirement 
prevents the application of a requirement'' of a Federal standard. The 
conference report accompanying HIPAA indicates that this is intended to 
be the ``narrowest'' preemption of State laws (See House Conf. Rep. No. 
104-736, at 205, reprinted in 1996 U.S. Code Cong. & Admin. News 2018). 
States may continue to apply State law requirements except to the 
extent that such requirements prevent the application of the Affordable 
Care Act requirements that are the subject of this rulemaking. 
Accordingly, States have significant latitude to impose requirements on 
health insurance issuers that are more restrictive than the Federal 
law. However, under these final rules, a State would not be allowed to 
impose a requirement that modifies the summary of benefits and coverage 
required to be provided under PHS Act section 2715(a), because it would 
prevent the application of this final rule's uniform disclosure 
requirement.
    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, the 
Departments have engaged in efforts to consult with and work 
cooperatively with affected States, including consulting with, and 
attending conferences of, the National Association of Insurance 
Commissioners and consulting with State insurance officials on an 
individual basis. It is expected that the Departments will act in a 
similar fashion in enforcing the Affordable Care Act, including the 
provisions of section 2715 of the PHS Act. Throughout the process of 
developing these final regulations, to the extent feasible within the 
specific preemption provisions of HIPAA as it applies to the Affordable 
Care Act, the Departments have attempted to balance the States' 
interests in regulating health insurance issuers, and Congress' intent 
to provide uniform minimum protections to consumers in every State. By 
doing so, it is the Departments' view that they have complied with the 
requirements of Executive Order 13132.
    Pursuant to the requirements set forth in section 8(a) of Executive 
Order 13132, and by the signatures affixed to this final rule, the 
Departments certify that the Employee Benefits Security Administration 
and the Centers for Medicare & Medicaid Services have complied with the 
requirements of Executive Order 13132 for the attached final rule in a 
meaningful and timely manner.

[[Page 8697]]

G. Congressional Review Act

    This regulation is subject to the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.), which specifies that before a rule can 
take effect, the Federal agency promulgating the rule shall submit to 
each House of the Congress and to the Comptroller General a report 
containing a copy of the rule along with other specified information, 
and has been transmitted to Congress and the Comptroller General for 
review.

V. Statutory Authority

    The Department of the Treasury regulations are adopted pursuant to 
the authority contained in sections 7805 and 9833 of the Code.
    The Department of Labor regulations are adopted pursuant to the 
authority contained in 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 
1181-1183, 1181 note, 1185, 1185a, 1185b, 1185d, 1191, 1191a, 1191b, 
and 1191c; sec. 101(g), Public Law104-191, 110 Stat. 1936; sec. 401(b), 
Public Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), 
Public Law 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), 
Public Law 111-148, 124 Stat. 119, as amended by Public Law 111-152, 
124 Stat. 1029; Secretary of Labor's Order 3-2010, 75 FR 55354 
(September 10, 2010).
    The Department of Health and Human Services regulations are adopted 
pursuant to the authority contained in sections 2701 through 2763, 
2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-
91, and 300gg-92), as amended.

List of Subjects

26 CFR Part 54

    Excise taxes, Health care, Health insurance, Pensions, Reporting 
and recordkeeping requirements.

29 CFR Part 2590

    Continuation coverage, Disclosure, Employee benefit plans, Group 
health plans, Health care, Health insurance, Medical child support, 
Reporting and recordkeeping requirements.

45 CFR Part 147

    Health care, Health insurance, Reporting and recordkeeping 
requirements, and State regulation of health insurance.

Steven T. Miller,
Deputy Commissioner for Services and Enforcement, Internal Revenue 
Service.
    Approved: February 7, 2012.
Emily S. McMahon,
Acting Assistant Secretary of the Treasury (Tax Policy).
    Signed this 7th day of February, 2012.
Phyllis C. Borzi,
Assistant Secretary, Employee Benefits Security Administration, 
Department of Labor.
    Dated: February 6, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: February 6, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.

Department of the Treasury

Internal Revenue Service

26 CFR Chapter 1

    Accordingly, the Internal Revenue Service amends 26 CFR parts 54 
and 602 as follows:

PART 54--PENSION EXCISE TAXES

0
Paragraph 1. The authority citation for Part 54 is amended by adding an 
entry for Sec.  54.9815-2715 in numerical order to read in part as 
follows:

    Authority: 26 U.S.C. 7805. * * *

    Section 54.9815-2715 also issued under 26 U.S.C. 9833.

0
Par. 2. Section 54.9815-2715 is added to read as follows:

Sec.  54.9815-2715  Summary of benefits and coverage and uniform 
glossary.

    (a) Summary of benefits and coverage--(1) In general. A group 
health plan (and its administrator as defined in section 3(16)(A) of 
ERISA), and a health insurance issuer offering group health insurance 
coverage, is required to provide a written summary of benefits and 
coverage (SBC) for each benefit package without charge to entities and 
individuals described in this paragraph (a)(1) in accordance with the 
rules of this section.
    (i) SBC provided by a group health insurance issuer to a group 
health plan--(A) Upon application. A health insurance issuer offering 
group health insurance coverage must provide the SBC to a group health 
plan (or its sponsor) upon application for health coverage, as soon as 
practicable following receipt of the application, but in no event later 
than seven business days following receipt of the application.
    (B) By first day of coverage (if there are changes). If there is 
any change in the information required to be in the SBC that was 
provided upon application and before the first day of coverage, the 
issuer must update and provide a current SBC to the plan (or its 
sponsor) no later than the first day of coverage.
    (C) Upon renewal. If the issuer renews or reissues the policy, 
certificate, or contract of insurance (for example, for a succeeding 
policy year), the issuer must provide a new SBC as follows:
    (1) If written application is required (in either paper or 
electronic form) for renewal or reissuance, the SBC must be provided no 
later than the date the written application materials are distributed.
    (2) If renewal or reissuance is automatic, the SBC must be provided 
no later than 30 days prior to the first day of the new plan or policy 
year; however, with respect to an insured plan, if the policy, 
certificate, or contract of insurance has not been issued or renewed 
before such 30-day period, the SBC must be provided as soon as 
practicable but in no event later than seven business days after 
issuance of the new policy, certificate, or contract of insurance, or 
the receipt of written confirmation of intent to renew, whichever is 
earlier.
    (D) Upon request. If a group health plan (or its sponsor) requests 
an SBC or summary information about a health insurance product from a 
health insurance issuer offering group health insurance coverage, an 
SBC must be provided as soon as practicable, but in no event later than 
seven business days following receipt of the request.
    (ii) SBC provided by a group health insurance issuer and a group 
health plan to participants and beneficiaries--(A) In general. A group 
health plan (including its administrator, as defined under section 
3(16) of ERISA), and a health insurance issuer offering group health 
insurance coverage, must provide an SBC to a participant or beneficiary 
(as defined under sections 3(7) and 3(8) of ERISA), and consistent with 
paragraph (a)(1)(iii) of this section, with respect to each benefit 
package offered by the plan or issuer for which the participant or 
beneficiary is eligible.
    (B) Upon application. The SBC must be provided as part of any 
written application materials that are distributed by the plan or 
issuer for enrollment. If the plan or issuer does not distribute 
written application materials for enrollment, the SBC must be 
distributed no later than the first date on which the participant is 
eligible to

[[Page 8698]]

enroll in coverage for the participant or any beneficiaries.
    (C) By first day of coverage (if there are changes). If there is 
any change to the information required to be in the SBC that was 
provided upon application and before the first day of coverage, the 
plan or issuer must update and provide a current SBC to a participant 
or beneficiary no later than the first day of coverage.
    (D) Special enrollees. The plan or issuer must provide the SBC to 
special enrollees (as described in Sec.  54.9801-6) no later than the 
date by which a summary plan description is required to be provided 
under the timeframe set forth in ERISA section 104(b)(1)(A) and its 
implementing regulations, which is 90 days from enrollment.
    (E) Upon renewal. If the plan or issuer requires participants or 
beneficiaries to renew in order to maintain coverage (for example, for 
a succeeding plan year), the plan or issuer must provide a new SBC when 
the coverage is renewed, as follows:
    (1) If written application is required for renewal (in either paper 
or electronic form), the SBC must be provided no later than the date on 
which the written application materials are distributed.
    (2) If renewal is automatic, the SBC must be provided no later than 
30 days prior to the first day of the new plan or policy year; however, 
with respect to an insured plan, if the policy, certificate, or 
contract of insurance has not been issued or renewed before such 30-day 
period, the SBC must be provided as soon as practicable but in no event 
later than seven business days after issuance of the new policy, 
certificate, or contract of insurance, or the receipt of written 
confirmation of intent to renew, whichever is earlier.
    (F) Upon request. A plan or issuer must provide the SBC to 
participants or beneficiaries upon request for an SBC or summary 
information about the health coverage, as soon as practicable, but in 
no event later than seven business days following receipt of the 
request.
    (iii) Special rules to prevent unnecessary duplication with respect 
to group health coverage--(A) An entity required to provide an SBC 
under this paragraph (a)(1) with respect to an individual satisfies 
that requirement if another party provides the SBC, but only to the 
extent that the SBC is timely and complete in accordance with the other 
rules of this section. Therefore, for example, in the case of a group 
health plan funded through an insurance policy, the plan satisfies the 
requirement to provide an SBC with respect to an individual if the 
issuer provides a timely and complete SBC to the individual.
    (B) If a single SBC is provided to a participant and any 
beneficiaries at the participant's last known address, then the 
requirement to provide the SBC to the participant and any beneficiaries 
is generally satisfied. However, if a beneficiary's last known address 
is different than the participant's last known address, a separate SBC 
is required to be provided to the beneficiary at the beneficiary's last 
known address.
    (C) With respect to a group health plan that offers multiple 
benefit packages, the plan or issuer is required to provide a new SBC 
automatically upon renewal only with respect to the benefit package in 
which a participant or beneficiary is enrolled; SBCs are not required 
to be provided automatically upon renewal with respect to benefit 
packages in which the participant or beneficiary is not enrolled. 
However, if a participant or beneficiary requests an SBC with respect 
to another benefit package (or more than one other benefit package) for 
which the participant or beneficiary is eligible, the SBC (or SBCs, in 
the case of a request for SBCs relating to more than one benefit 
package) must be provided upon request as soon as practicable, but in 
no event later than seven business days following receipt of the 
request.
    (2) Content--(i) In general. Subject to paragraph (a)(2)(iii) of 
this section, the SBC must include the following:
    (A) Uniform definitions of standard insurance terms and medical 
terms so that consumers may compare health coverage and understand the 
terms of (or exceptions to) their coverage, in accordance with guidance 
as specified by the Secretary;
    (B) A description of the coverage, including cost sharing, for each 
category of benefits identified by the Secretary in guidance;
    (C) The exceptions, reductions, and limitations of the coverage;
    (D) The cost-sharing provisions of the coverage, including 
deductible, coinsurance, and copayment obligations;
    (E) The renewability and continuation of coverage provisions;
    (F) Coverage examples, in accordance with paragraph (a)(2)(ii) of 
this section;
    (G) With respect to coverage beginning on or after January 1, 2014, 
a statement about whether the plan or coverage provides minimum 
essential coverage as defined under section 5000A(f) and whether the 
plan's or coverage's share of the total allowed costs of benefits 
provided under the plan or coverage meets applicable requirements;
    (H) A statement that the SBC is only a summary and that the plan 
document, policy, certificate, or contract of insurance should be 
consulted to determine the governing contractual provisions of the 
coverage;
    (I) Contact information for questions and obtaining a copy of the 
plan document or the insurance policy, certificate, or contract of 
insurance (such as a telephone number for customer service and an 
Internet address for obtaining a copy of the plan document or the 
insurance policy, certificate, or contract of insurance);
    (J) For plans and issuers that maintain one or more networks of 
providers, an Internet address (or similar contact information) for 
obtaining a list of network providers;
    (K) For plans and issuers that use a formulary in providing 
prescription drug coverage, an Internet address (or similar contact 
information) for obtaining information on prescription drug coverage; 
and
    (L) An Internet address for obtaining the uniform glossary, as 
described in paragraph (c) of this section, as well as a contact phone 
number to obtain a paper copy of the uniform glossary, and a disclosure 
that paper copies are available.
    (ii) Coverage examples. The SBC must include coverage examples 
specified by the Secretary in guidance that illustrate benefits 
provided under the plan or coverage for common benefits scenarios 
(including pregnancy and serious or chronic medical conditions) in 
accordance with this paragraph (a)(2)(ii).
    (A) Number of examples. The Secretary may identify up to six 
coverage examples that may be required in an SBC.
    (B) Benefits scenarios. For purposes of this paragraph (a)(2)(ii), 
a benefits scenario is a hypothetical situation, consisting of a sample 
treatment plan for a specified medical condition during a specific 
period of time, based on recognized clinical practice guidelines as 
defined by the National Guideline Clearinghouse, Agency for Healthcare 
Research and Quality. The Secretary will specify, in guidance, the 
assumptions, including the relevant items and services and 
reimbursement information, for each claim in the benefits scenario.
    (C) Illustration of benefit provided. For purposes of this 
paragraph (a)(2)(ii), to illustrate benefits provided under the plan or 
coverage for a particular benefits scenario, a plan or issuer simulates 
claims processing in accordance with

[[Page 8699]]

guidance issued by the Secretary to generate an estimate of what an 
individual might expect to pay under the plan, policy, or benefit 
package. The illustration of benefits provided will take into account 
any cost sharing, excluded benefits, and other limitations on coverage, 
as specified by the Secretary in guidance.
    (iii) Coverage provided outside the United States. In lieu of 
summarizing coverage for items and services provided outside the United 
States, a plan or issuer may provide an Internet address (or similar 
contact information) for obtaining information about benefits and 
coverage provided outside the United States. In any case, the plan or 
issuer must provide an SBC in accordance with this section that 
accurately summarizes benefits and coverage available under the plan or 
coverage within the United States.
    (3) Appearance. A group health plan and a health insurance issuer 
must provide an SBC in the form, and in accordance with the 
instructions for completing the SBC, that are specified by the 
Secretary in guidance. The SBC must be presented in a uniform format, 
use terminology understandable by the average plan enrollee, not exceed 
four double-sided pages in length, and not include print smaller than 
12-point font.
    (4) Form--(i) An SBC provided by an issuer offering group health 
insurance coverage to a plan (or its sponsor), may be provided in paper 
form. Alternatively, the SBC may be provided electronically (such as by 
email or an Internet posting) if the following three conditions are 
satisfied--
    (A) The format is readily accessible by the plan (or its sponsor);
    (B) The SBC is provided in paper form free of charge upon request; 
and
    (C) If the electronic form is an Internet posting, the issuer 
timely advises the plan (or its sponsor) in paper form or email that 
the documents are available on the Internet and provides the Internet 
address.
    (ii) An SBC provided by a group health plan or health insurance 
issuer to a participant or beneficiary may be provided in paper form. 
Alternatively, the SBC may be provided electronically (such as by email 
or an Internet posting) if the requirements of this paragraph 
(a)(4)(ii) are met.
    (A) With respect to participants and beneficiaries covered under 
the plan, the SBC may be provided electronically if the requirements of 
29 CFR 2520.104b-1 are met.
    (B) With respect to participants and beneficiaries who are eligible 
but not enrolled for coverage, the SBC may be provided electronically 
if--
    (1) The format is readily accessible;
    (2) The SBC is provided in paper form free of charge upon request; 
and
    (3) In a case in which the electronic form is an Internet posting, 
the plan or issuer timely notifies the individual in paper form (such 
as a postcard) or email that the documents are available on the 
Internet, provides the Internet address, and notifies the individual 
that the documents are available in paper form upon request.
    (5) Language. A group health plan or health insurance issuer must 
provide the SBC in a culturally and linguistically appropriate manner. 
For purposes of this paragraph (a)(5), a plan or issuer is considered 
to provide the SBC in a culturally and linguistically appropriate 
manner if the thresholds and standards of Sec.  54.9815-2719T(e) are 
met as applied to the SBC.
    (b) Notice of modification. If a group health plan, or health 
insurance issuer offering group health insurance coverage, makes any 
material modification (as defined under section 102 of ERISA) in any of 
the terms of the plan or coverage that would affect the content of the 
SBC, that is not reflected in the most recently provided SBC, and that 
occurs other than in connection with a renewal or reissuance of 
coverage, the plan or issuer must provide notice of the modification to 
enrollees not later than 60 days prior to the date on which the 
modification will become effective. The notice of modification must be 
provided in a form that is consistent with paragraph (a)(4) of this 
section.
    (c) Uniform glossary--(1) In general. A group health plan, and a 
health insurance issuer offering group health insurance coverage, must 
make available to participants and beneficiaries the uniform glossary 
described in paragraph (c)(2) of this section in accordance with the 
appearance and the form and manner requirements of paragraphs (c)(3) 
and (4) of this section.
    (2) Health-coverage-related terms and medical terms. The uniform 
glossary must provide uniform definitions, specified by the Secretary 
in guidance, of the following health-coverage-related terms and medical 
terms:
    (i) Allowed amount, appeal, balance billing, co-insurance, 
complications of pregnancy, co-payment, deductible, durable medical 
equipment, emergency medical condition, emergency medical 
transportation, emergency room care, emergency services, excluded 
services, grievance, habilitation services, health insurance, home 
health care, hospice services, hospitalization, hospital outpatient 
care, in-network co-insurance, in-network co-payment, medically 
necessary, network, non-preferred provider, out-of-network co-
insurance, out-of-network co-payment, out-of-pocket limit, physician 
services, plan, preauthorization, preferred provider, premium, 
prescription drug coverage, prescription drugs, primary care physician, 
primary care provider, provider, reconstructive surgery, rehabilitation 
services, skilled nursing care, specialist, usual customary and 
reasonable (UCR), and urgent care; and
    (ii) Such other terms as the Secretary determines are important to 
define so that individuals and employers may compare and understand the 
terms of coverage and medical benefits (including any exceptions to 
those benefits), as specified in guidance.
    (3) Appearance. A group health plan, and a health insurance issuer, 
must provide the uniform glossary with the appearance specified by the 
Secretary in guidance to ensure the uniform glossary is presented in a 
uniform format and uses terminology understandable by the average plan 
enrollee.
    (4) Form and manner. A plan or issuer must make the uniform 
glossary described in this paragraph (c) available upon request, in 
either paper or electronic form (as requested), within seven business 
days after receipt of the request.
    (d) Preemption. State laws that require a health insurance issuer 
to provide an SBC that supplies less information than required under 
paragraph (a) of this section are preempted.
    (e) Failure to provide. A group health plan or health insurance 
issuer that willfully fails to provide information required under this 
section to a participant or beneficiary is subject to a fine of not 
more than $1,000 for each such failure. A failure with respect to each 
participant or beneficiary constitutes a separate offense for purposes 
of this paragraph (e).
    (f) Effective/Applicability date--(1) This section is applicable to 
group health plans and group health insurance issuers in accordance 
with this paragraph (f). (See Sec.  54.9815-1251T(d), providing that 
this section applies to grandfathered health plans.)
    (i) For disclosures with respect to participants and beneficiaries 
who enroll or re-enroll through an open enrollment period (including 
re-enrollees and late enrollees), this section applies beginning on the 
first day of the first open enrollment period that begins on or after 
September 23, 2012; and
    (ii) For disclosures with respect to participants and beneficiaries 
who

[[Page 8700]]

enroll in coverage other than through an open enrollment period 
(including individuals who are newly eligible for coverage and special 
enrollees), this section applies beginning on the first day of the 
first plan year that begins on or after September 23, 2012.
    (2) For disclosures with respect to plans, this section is 
applicable to health insurance issuers beginning September 23, 2012.

PART 602--OMB CONTROL NUMBERS UNDER THE PAPERWORK REDUCTION ACT

0
Par. 3. The authority citation for part 602 continues to read in part 
as follows:

    Authority:  26 U.S.C. 7805. * * *

0
Par. 4. Section 602.101(b) is amended by adding the following entry in 
numerical order to the table to read as follows:

Sec.  602.101  OMB Control numbers.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                            Current OMB
   CFR part or section where identified and described       control No.
------------------------------------------------------------------------
 
                                * * * * *
54.9815-2715............................................       1545-2229
 
                                * * * * *
------------------------------------------------------------------------

Department of Labor

Employee Benefits Security Administration

29 CFR Chapter XXV

    For the reasons stated in the preamble, the Employee Benefits 
Security Administration amends 29 CFR part 2590 as follows:

PART 2590--RULES AND REGULATIONS FOR GROUP HEALTH PLANS

0
1. The authority citation for part 2590 continues to read as follows:

    Authority:  29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-
1183, 1181 note, 1185, 1185a, 1185b, 1185d, 1191, 1191a, 1191b, and 
1191c; sec. 101(g), Pub. L. 104-191, 110 Stat. 1936; sec. 401(b), 
Pub. L. 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), 
Pub. L. 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. 
L. 111-148, 124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 
1029; Secretary of Labor's Order 3-2010, 75 FR 55354 (September 10, 
2010).

Subpart C--Other Requirements

0
2. Section 2590.715-2715 is added to subpart C to read as follows:

Sec.  2590.715-2715  Summary of benefits and coverage and uniform 
glossary.

    (a) Summary of benefits and coverage--(1) In general. A group 
health plan (and its administrator as defined in section 3(16)(A) of 
ERISA), and a health insurance issuer offering group health insurance 
coverage, is required to provide a written summary of benefits and 
coverage (SBC) for each benefit package without charge to entities and 
individuals described in this paragraph (a)(1) in accordance with the 
rules of this section.
    (i) SBC provided by a group health insurance issuer to a group 
health plan--(A) Upon application. A health insurance issuer offering 
group health insurance coverage must provide the SBC to a group health 
plan (or its sponsor) upon application for health coverage, as soon as 
practicable following receipt of the application, but in no event later 
than seven business days following receipt of the application.
    (B) By first day of coverage (if there are changes). If there is 
any change in the information required to be in the SBC that was 
provided upon application and before the first day of coverage, the 
issuer must update and provide a current SBC to the plan (or its 
sponsor) no later than the first day of coverage.
    (C) Upon renewal. If the issuer renews or reissues the policy, 
certificate, or contract of insurance (for example, for a succeeding 
policy year), the issuer must provide a new SBC as follows:
    (1) If written application is required (in either paper or 
electronic form) for renewal or reissuance, the SBC must be provided no 
later than the date the written application materials are distributed.
    (2) If renewal or reissuance is automatic, the SBC must be provided 
no later than 30 days prior to the first day of the new plan or policy 
year; however, with respect to an insured plan, if the policy, 
certificate, or contract of insurance has not been issued or renewed 
before such 30-day period, the SBC must be provided as soon as 
practicable but in no event later than seven business days after 
issuance of the new policy, certificate, or contract of insurance, or 
the receipt of written confirmation of intent to renew, whichever is 
earlier.
    (D) Upon request. If a group health plan (or its sponsor) requests 
an SBC or summary information about a health insurance product from a 
health insurance issuer offering group health insurance coverage, an 
SBC must be provided as soon as practicable, but in no event later than 
seven business days following receipt of the request.
    (ii) SBC provided by a group health insurance issuer and a group 
health plan to participants and beneficiaries--(A) In general. A group 
health plan (including its administrator, as defined under section 
3(16) of ERISA), and a health insurance issuer offering group health 
insurance coverage, must provide an SBC to a participant or beneficiary 
(as defined under sections 3(7) and 3(8) of ERISA), and consistent with 
paragraph (a)(1)(iii) of this section, with respect to each benefit 
package offered by the plan or issuer for which the participant or 
beneficiary is eligible.
    (B) Upon application. The SBC must be provided as part of any 
written application materials that are distributed by the plan or 
issuer for enrollment. If the plan or issuer does not distribute 
written application materials for enrollment, the SBC must be 
distributed no later than the first date on which the participant is 
eligible to enroll in coverage for the participant or any 
beneficiaries.
    (C) By first day of coverage (if there are changes). If there is 
any change to the information required to be in the SBC that was 
provided upon application and before the first day of coverage, the 
plan or issuer must update and provide a current SBC to a participant 
or beneficiary no later than the first day of coverage.
    (D) Special enrollees. The plan or issuer must provide the SBC to 
special enrollees (as described in Sec.  2590.701-6 of this Part) no 
later than the date by which a summary plan description is required to 
be provided under the timeframe set forth in ERISA section 104(b)(1)(A) 
and its implementing regulations, which is 90 days from enrollment.
    (E) Upon renewal. If the plan or issuer requires participants or 
beneficiaries to renew in order to maintain coverage (for example, for 
a succeeding plan year), the plan or issuer must provide a new SBC when 
the coverage is renewed, as follows:
    (1) If written application is required for renewal (in either paper 
or electronic form), the SBC must be provided no later than the date on 
which the written application materials are distributed.
    (2) If renewal is automatic, the SBC must be provided no later than 
30 days prior to the first day of the new plan or policy year; however, 
with respect to an insured plan, if the policy, certificate, or 
contract of insurance has not been issued or renewed before such 30-day 
period, the SBC must be provided as soon as practicable but in no event 
later than seven business days after issuance of the new policy, 
certificate, or contract of insurance, or the receipt of written

[[Page 8701]]

confirmation of intent to renew, whichever is earlier.
    (F) Upon request. A plan or issuer must provide the SBC to 
participants or beneficiaries upon request for an SBC or summary 
information about the health coverage, as soon as practicable, but in 
no event later than seven business days following receipt of the 
request.
    (iii) Special rules to prevent unnecessary duplication with respect 
to group health coverage--(A) An entity required to provide an SBC 
under this paragraph (a)(1) with respect to an individual satisfies 
that requirement if another party provides the SBC, but only to the 
extent that the SBC is timely and complete in accordance with the other 
rules of this section. Therefore, for example, in the case of a group 
health plan funded through an insurance policy, the plan satisfies the 
requirement to provide an SBC with respect to an individual if the 
issuer provides a timely and complete SBC to the individual.
    (B) If a single SBC is provided to a participant and any 
beneficiaries at the participant's last known address, then the 
requirement to provide the SBC to the participant and any beneficiaries 
is generally satisfied. However, if a beneficiary's last known address 
is different than the participant's last known address, a separate SBC 
is required to be provided to the beneficiary at the beneficiary's last 
known address.
    (C) With respect to a group health plan that offers multiple 
benefit packages, the plan or issuer is required to provide a new SBC 
automatically upon renewal only with respect to the benefit package in 
which a participant or beneficiary is enrolled; SBCs are not required 
to be provided automatically upon renewal with respect to benefit 
packages in which the participant or beneficiary is not enrolled. 
However, if a participant or beneficiary requests an SBC with respect 
to another benefit package (or more than one other benefit package) for 
which the participant or beneficiary is eligible, the SBC (or SBCs, in 
the case of a request for SBCs relating to more than one benefit 
package) must be provided upon request as soon as practicable, but in 
no event later than seven business days following receipt of the 
request.
    (2) Content--(i) In general. Subject to paragraph (a)(2)(iii) of 
this section, the SBC must include the following:
    (A) Uniform definitions of standard insurance terms and medical 
terms so that consumers may compare health coverage and understand the 
terms of (or exceptions to) their coverage, in accordance with guidance 
as specified by the Secretary;
    (B) A description of the coverage, including cost sharing, for each 
category of benefits identified by the Secretary in guidance;
    (C) The exceptions, reductions, and limitations of the coverage;
    (D) The cost-sharing provisions of the coverage, including 
deductible, coinsurance, and copayment obligations;
    (E) The renewability and continuation of coverage provisions;
    (F) Coverage examples, in accordance with paragraph (a)(2)(ii) of 
this section;
    (G) With respect to coverage beginning on or after January 1, 2014, 
a statement about whether the plan or coverage provides minimum 
essential coverage as defined under section 5000A(f) of the Internal 
Revenue Code and whether the plan's or coverage's share of the total 
allowed costs of benefits provided under the plan or coverage meets 
applicable requirements;
    (H) A statement that the SBC is only a summary and that the plan 
document, policy, certificate, or contract of insurance should be 
consulted to determine the governing contractual provisions of the 
coverage;
    (I) Contact information for questions and obtaining a copy of the 
plan document or the insurance policy, certificate, or contract of 
insurance (such as a telephone number for customer service and an 
Internet address for obtaining a copy of the plan document or the 
insurance policy, certificate, or contract of insurance);
    (J) For plans and issuers that maintain one or more networks of 
providers, an Internet address (or similar contact information) for 
obtaining a list of network providers;
    (K) For plans and issuers that use a formulary in providing 
prescription drug coverage, an Internet address (or similar contact 
information) for obtaining information on prescription drug coverage; 
and
    (L) An Internet address for obtaining the uniform glossary, as 
described in paragraph (c) of this section, as well as a contact phone 
number to obtain a paper copy of the uniform glossary, and a disclosure 
that paper copies are available.
    (ii) Coverage examples. The SBC must include coverage examples 
specified by the Secretary in guidance that illustrate benefits 
provided under the plan or coverage for common benefits scenarios 
(including pregnancy and serious or chronic medical conditions) in 
accordance with this paragraph (a)(2)(ii).
    (A) Number of examples. The Secretary may identify up to six 
coverage examples that may be required in an SBC.
    (B) Benefits scenarios. For purposes of this paragraph (a)(2)(ii), 
a benefits scenario is a hypothetical situation, consisting of a sample 
treatment plan for a specified medical condition during a specific 
period of time, based on recognized clinical practice guidelines as 
defined by the National Guideline Clearinghouse, Agency for Healthcare 
Research and Quality. The Secretary will specify, in guidance, the 
assumptions, including the relevant items and services and 
reimbursement information, for each claim in the benefits scenario.
    (C) Illustration of benefit provided. For purposes of this 
paragraph (a)(2)(ii), to illustrate benefits provided under the plan or 
coverage for a particular benefits scenario, a plan or issuer simulates 
claims processing in accordance with guidance issued by the Secretary 
to generate an estimate of what an individual might expect to pay under 
the plan, policy, or benefit package. The illustration of benefits 
provided will take into account any cost sharing, excluded benefits, 
and other limitations on coverage, as specified by the Secretary in 
guidance.
    (iii) Coverage provided outside the United States. In lieu of 
summarizing coverage for items and services provided outside the United 
States, a plan or issuer may provide an Internet address (or similar 
contact information) for obtaining information about benefits and 
coverage provided outside the United States. In any case, the plan or 
issuer must provide an SBC in accordance with this section that 
accurately summarizes benefits and coverage available under the plan or 
coverage within the United States.
    (3) Appearance. A group health plan and a health insurance issuer 
must provide an SBC in the form, and in accordance with the 
instructions for completing the SBC, that are specified by the 
Secretary in guidance. The SBC must be presented in a uniform format, 
use terminology understandable by the average plan enrollee, not exceed 
four double-sided pages in length, and not include print smaller than 
12-point font.
    (4) Form--(i) An SBC provided by an issuer offering group health 
insurance coverage to a plan (or its sponsor), may be provided in paper 
form. Alternatively, the SBC may be provided electronically (such as by 
email or an Internet posting) if the following three conditions are 
satisfied--
    (A) The format is readily accessible by the plan (or its sponsor);

[[Page 8702]]

    (B) The SBC is provided in paper form free of charge upon request; 
and
    (C) If the electronic form is an Internet posting, the issuer 
timely advises the plan (or its sponsor) in paper form or email that 
the documents are available on the Internet and provides the Internet 
address.
    (ii) An SBC provided by a group health plan or health insurance 
issuer to a participant or beneficiary may be provided in paper form. 
Alternatively, the SBC may be provided electronically (such as by email 
or an Internet posting) if the requirements of this paragraph 
(a)(4)(ii) are met.
    (A) With respect to participants and beneficiaries covered under 
the plan, the SBC may be provided electronically if the requirements of 
29 CFR 2520.104b-1 are met.
    (B) With respect to participants and beneficiaries who are eligible 
but not enrolled for coverage, the SBC may be provided electronically 
if:
    (1) The format is readily accessible;
    (2) The SBC is provided in paper form free of charge upon request; 
and
    (3) In a case in which the electronic form is an Internet posting, 
the plan or issuer timely notifies the individual in paper form (such 
as a postcard) or email that the documents are available on the 
Internet, provides the Internet address, and notifies the individual 
that the documents are available in paper form upon request.
    (5) Language. A group health plan or health insurance issuer must 
provide the SBC in a culturally and linguistically appropriate manner. 
For purposes of this paragraph (a)(5), a plan or issuer is considered 
to provide the SBC in a culturally and linguistically appropriate 
manner if the thresholds and standards of Sec.  2590.715-2719(e) of 
this Part are met as applied to the SBC.
    (b) Notice of modification. If a group health plan, or health 
insurance issuer offering group health insurance coverage, makes any 
material modification (as defined under section 102 of ERISA) in any of 
the terms of the plan or coverage that would affect the content of the 
SBC, that is not reflected in the most recently provided SBC, and that 
occurs other than in connection with a renewal or reissuance of 
coverage, the plan or issuer must provide notice of the modification to 
enrollees not later than 60 days prior to the date on which the 
modification will become effective. The notice of modification must be 
provided in a form that is consistent with paragraph (a)(4) of this 
section.
    (c) Uniform glossary--(1) In general. A group health plan, and a 
health insurance issuer offering group health insurance coverage, must 
make available to participants and beneficiaries the uniform glossary 
described in paragraph (c)(2) of this section in accordance with the 
appearance and form and manner requirements of paragraphs (c)(3) and 
(4) of this section.
    (2) Health-coverage-related terms and medical terms. The uniform 
glossary must provide uniform definitions, specified by the Secretary 
in guidance, of the following health-coverage-related terms and medical 
terms:
    (i) Allowed amount, appeal, balance billing, co-insurance, 
complications of pregnancy, co-payment, deductible, durable medical 
equipment, emergency medical condition, emergency medical 
transportation, emergency room care, emergency services, excluded 
services, grievance, habilitation services, health insurance, home 
health care, hospice services, hospitalization, hospital outpatient 
care, in-network co-insurance, in-network co-payment, medically 
necessary, network, non-preferred provider, out-of-network co-
insurance, out-of-network co-payment, out-of-pocket limit, physician 
services, plan, preauthorization, preferred provider, premium, 
prescription drug coverage, prescription drugs, primary care physician, 
primary care provider, provider, reconstructive surgery, rehabilitation 
services, skilled nursing care, specialist, usual customary and 
reasonable (UCR), and urgent care; and
    (ii) Such other terms as the Secretary determines are important to 
define so that individuals and employers may compare and understand the 
terms of coverage and medical benefits (including any exceptions to 
those benefits), as specified in guidance.
    (3) Appearance. A group health plan, and a health insurance issuer, 
must provide the uniform glossary with the appearance specified by the 
Secretary in guidance to ensure the uniform glossary is presented in a 
uniform format and uses terminology understandable by the average plan 
enrollee.
    (4) Form and manner. A plan or issuer must make the uniform 
glossary described in this paragraph (c) available upon request, in 
either paper or electronic form (as requested), within seven business 
days after receipt of the request.
    (d) Preemption. See Sec.  2590.731 of this part. In addition, State 
laws that require a health insurance issuer to provide an SBC that 
supplies less information than required under paragraph (a) of this 
section are preempted.
    (e) Failure to provide. A group health plan that willfully fails to 
provide information required under this section to a participant or 
beneficiary is subject to a fine of not more than $1,000 for each such 
failure. A failure with respect to each participant or beneficiary 
constitutes a separate offense for purposes of this paragraph (e).
    (f) Applicability date--(1) This section is applicable to group 
health plans and group health insurance issuers in accordance with this 
paragraph (f). (See Sec.  2590.715-1251(d), providing that this section 
applies to grandfathered health plans.)
    (i) For disclosures with respect to participants and beneficiaries 
who enroll or re-enroll through an open enrollment period (including 
re-enrollees and late enrollees), this section applies beginning on the 
first day of the first open enrollment period that begins on or after 
September 23, 2012; and
    (ii) For disclosures with respect to participants and beneficiaries 
who enroll in coverage other than through an open enrollment period 
(including individuals who are newly eligible for coverage and special 
enrollees), this section applies beginning on the first day of the 
first plan year that begins on or after September 23, 2012.
    (2) For disclosures with respect to plans, this section is 
applicable to health insurance issuers beginning September 23, 2012.

Department of Health and Human Services

45 CFR Subtitle A

    For the reasons stated in the preamble, the Department of Health 
and Human Services amends 45 CFR part 147 as follows:

PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND 
INDIVIDUAL HEALTH INSURANCE MARKETS

0
2. The authority citation for part 147 continues to read as follows:

    Authority: Sections 2701 through 2763, 2791, and 2792 of the 
Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-
91, and 300gg-92), as amended.

0
3. Add Sec.  147.200 to read as follows:

Sec.  147.200  Summary of benefits and coverage and uniform glossary.

    (a) Summary of benefits and coverage- (1) In general. A group 
health plan (and its administrator as defined in section 3(16)(A) of 
ERISA), and a health insurance issuer offering group or individual 
health insurance coverage, is required to provide a written summary of 
benefits and coverage (SBC) for each benefit package without charge to

[[Page 8703]]

entities and individuals described in this paragraph (a)(1) in 
accordance with the rules of this section.
    (i) SBC provided by a group health insurance issuer to a group 
health plan--(A) Upon application. A health insurance issuer offering 
group health insurance coverage must provide the SBC to a group health 
plan (or its sponsor) upon application for health coverage, as soon as 
practicable following receipt of the application, but in no event later 
than seven business days following receipt of the application.
    (B) By first day of coverage (if there are changes). If there is 
any change in the information required to be in the SBC that was 
provided upon application and before the first day of coverage, the 
issuer must update and provide a current SBC to the plan (or its 
sponsor) no later than the first day of coverage.
    (C) Upon renewal. If the issuer renews or reissues the policy, 
certificate, or contract of insurance (for example, for a succeeding 
policy year), the issuer must provide a new SBC as follows:
    (1) If written application is required (in either paper or 
electronic form) for renewal or reissuance, the SBC must be provided no 
later than the date the written application materials are distributed.
    (2) If renewal or reissuance is automatic, the SBC must be provided 
no later than 30 days prior to the first day of the new plan or policy 
year; however, with respect to an insured plan, if the policy, 
certificate, or contract of insurance has not been issued or renewed 
before such 30-day period, the SBC must be provided as soon as 
practicable but in no event later than seven business days after 
issuance of the new policy, certificate, or contract of insurance, or 
the receipt of written confirmation of intent to renew, whichever is 
earlier.
    (D) Upon request. If a group health plan (or its sponsor) requests 
an SBC or summary information about a health insurance product from a 
health insurance issuer offering group health insurance coverage, an 
SBC must be provided as soon as practicable, but in no event later than 
seven business days following receipt of the request.
    (ii) SBC provided by a group health insurance issuer and a group 
health plan to participants and beneficiaries--(A) In general. A group 
health plan (including its administrator, as defined under section 
3(16) of ERISA), and a health insurance issuer offering group health 
insurance coverage, must provide an SBC to a participant or beneficiary 
(as defined under sections 3(7) and 3(8) of ERISA), and consistent with 
paragraph (a)(1)(iii) of this section, with respect to each benefit 
package offered by the plan or issuer for which the participant or 
beneficiary is eligible.
    (B) Upon application. The SBC must be provided as part of any 
written application materials that are distributed by the plan or 
issuer for enrollment. If the plan or issuer does not distribute 
written application materials for enrollment, the SBC must be 
distributed no later than the first date on which the participant is 
eligible to enroll in coverage for the participant or any 
beneficiaries.
    (C) By first day of coverage (if there are changes). If there is 
any change to the information required to be in the SBC that was 
provided upon application and before the first day of coverage, the 
plan or issuer must update and provide a current SBC to a participant 
or beneficiary no later than the first day of coverage.
    (D) Special enrollees. The plan or issuer must provide the SBC to 
special enrollees (as described in 45 CFR 146.117) no later than the 
date by which a summary plan description is required to be provided 
under the timeframe set forth in ERISA section 104(b)(1)(A) and its 
implementing regulations, which is 90 days from enrollment.
    (E) Upon renewal. If the plan or issuer requires participants or 
beneficiaries to renew in order to maintain coverage (for example, for 
a succeeding plan year), the plan or issuer must provide a new SBC when 
the coverage is renewed, as follows:
    (1) If written application is required for renewal (in either paper 
or electronic form), the SBC must be provided no later than the date on 
which the written application materials are distributed.
    (2) If renewal is automatic, the SBC must be provided no later than 
30 days prior to the first day of the new plan or policy year; however, 
with respect to an insured plan, if the policy, certificate, or 
contract of insurance has not been issued or renewed before such 30-day 
period, the SBC must be provided as soon as practicable but in no event 
later than seven business days after issuance of the new policy, 
certificate, or contract of insurance, or the receipt of written 
confirmation of intent to renew, whichever is earlier.
    (F) Upon request. A plan or issuer must provide the SBC to 
participants or beneficiaries upon request for an SBC or summary 
information about the health coverage, as soon as practicable, but in 
no event later than seven business days following receipt of the 
request.
    (iii) Special rules to prevent unnecessary duplication with respect 
to group health coverage--(A) An entity required to provide an SBC 
under this paragraph (a)(1) with respect to an individual satisfies 
that requirement if another party provides the SBC, but only to the 
extent that the SBC is timely and complete in accordance with the other 
rules of this section. Therefore, for example, in the case of a group 
health plan funded through an insurance policy, the plan satisfies the 
requirement to provide an SBC with respect to an individual if the 
issuer provides a timely and complete SBC to the individual.
    (B) If a single SBC is provided to a participant and any 
beneficiaries at the participant's last known address then the 
requirement to provide the SBC to the participant and any beneficiaries 
is generally satisfied. However, if a beneficiary's last known address 
is different than the participant's last known address, a separate SBC 
is required to be provided to the beneficiary at the beneficiary's last 
known address.
    (C) With respect to a group health plan that offers multiple 
benefit packages, the plan or issuer is required to provide a new SBC 
automatically upon renewal only with respect to the benefit package in 
which a participant or beneficiary is enrolled; SBCs are not required 
to be provided automatically upon renewal with respect to benefit 
packages in which the participant or beneficiary is not enrolled. 
However, if a participant or beneficiary requests an SBC with respect 
to another benefit package (or more than one other benefit package) for 
which the participant or beneficiary is eligible, the SBC (or SBCs, in 
the case of a request for SBCs relating to more than one benefit 
package) must be provided upon request as soon as practicable, but in 
no event later than seven business days following receipt of the 
request.
    (iv) SBC provided by a health insurance issuer offering individual 
health insurance coverage--(A) Upon application. A health insurance 
issuer offering individual health insurance coverage must provide an 
SBC to an individual covered under the policy (including every 
dependent) upon receiving an application for any health insurance 
policy, as soon as practicable following receipt of the application, 
but in no event later than seven business days following receipt of the 
application.
    (B) By first day of coverage (if there are changes). If there is 
any change in the information required to be in the SBC that was 
provided upon application and before the first day of coverage, the 
issuer must update and provide a

[[Page 8704]]

current SBC to the individual no later than the first day of coverage.
    (C) Upon renewal. The issuer must provide the SBC to policyholders 
annually at renewal. The SBC must reflect any modified policy terms 
that would be effective on the first day of the new policy year. The 
SBC must be provided as follows:
    (1) If written application is required (in either paper or 
electronic form) for renewal or reissuance, the SBC must be provided no 
later than the date on which the written application materials are 
distributed.
    (2) If renewal or reissuance is automatic, the SBC must be provided 
no later than 30 days prior to the first day of the new policy year; 
however, if the policy, certificate, or contract of insurance has not 
been issued or renewed before such 30-day period, the SBC must be 
provided as soon as practicable but in no event later than seven 
business days after issuance of the new policy, certificate, or 
contract of insurance, or the receipt of written confirmation of intent 
to renew, whichever is earlier.
    (D) Upon request. A health insurance issuer offering individual 
health insurance coverage must provide an SBC to any individual or 
dependent anytime an individual requests an SBC or summary information 
about a health insurance product as soon as practicable, but in no 
event later than seven business days following receipt of the request. 
For purposes of this paragraph (a)(1)(iv)(D), a request for an SBC or 
summary information about a health insurance product includes a request 
made both before and after an individual submits an application for 
coverage.
    (v) Special rule to prevent unnecessary duplication with respect to 
individual health insurance coverage. If a single SBC is provided to an 
individual and any dependents at the individual's last known address, 
then the requirement to provide the SBC to the individual and any 
dependents is generally satisfied. However, if a dependent's last known 
address is different than the individual's last known address, a 
separate SBC is required to be provided to the dependent at the 
dependents' last known address.
    (2) Content--(i) In general. Subject to paragraph (a)(2)(iii) of 
this section, the SBC must include the following:
    (A) Uniform definitions of standard insurance terms and medical 
terms so that consumers may compare health coverage and understand the 
terms of (or exceptions to) their coverage, in accordance with guidance 
as specified by the Secretary;
    (B) A description of the coverage, including cost sharing, for each 
category of benefits identified by the Secretary in guidance;
    (C) The exceptions, reductions, and limitations of the coverage;
    (D) The cost-sharing provisions of the coverage, including 
deductible, coinsurance, and copayment obligations;
    (E) The renewability and continuation of coverage provisions;
    (F) Coverage examples, in accordance with paragraph (a)(2)(ii) of 
this section;
    (G) With respect to coverage beginning on or after January 1, 2014, 
a statement about whether the plan or coverage provides minimum 
essential coverage as defined under section 5000A(f) of the Internal 
Revenue Code and whether the plan's or coverage's share of the total 
allowed costs of benefits provided under the plan or coverage meets 
applicable requirements;
    (H) A statement that the SBC is only a summary and that the plan 
document, policy, certificate, or contract of insurance should be 
consulted to determine the governing contractual provisions of the 
coverage;
    (I) Contact information for questions and obtaining a copy of the 
plan document or the insurance policy, certificate, or contract of 
insurance (such as a telephone number for customer service and an 
Internet address for obtaining a copy of the plan document or the 
insurance policy, certificate, or contract of insurance);
    (J) For plans and issuers that maintain one or more networks of 
providers, an Internet address (or similar contact information) for 
obtaining a list of network providers;
    (K) For plans and issuers that use a formulary in providing 
prescription drug coverage, an Internet address (or similar contact 
information) for obtaining information on prescription drug coverage; 
and
    (L) An Internet address for obtaining the uniform glossary, as 
described in paragraph (c) of this section, as well as a contact phone 
number to obtain a paper copy of the uniform glossary, and a disclosure 
that paper copies are available.
    (ii) Coverage examples. The SBC must include coverage examples 
specified by the Secretary in guidance that illustrate benefits 
provided under the plan or coverage for common benefits scenarios 
(including pregnancy and serious or chronic medical conditions) in 
accordance with this paragraph (a)(2)(ii).
    (A) Number of examples. The Secretary may identify up to six 
coverage examples that may be required in an SBC.
    (B) Benefits scenarios. For purposes of this paragraph (a)(2)(ii), 
a benefits scenario is a hypothetical situation, consisting of a sample 
treatment plan for a specified medical condition during a specific 
period of time, based on recognized clinical practice guidelines as 
defined by the National Guideline Clearinghouse, Agency for Healthcare 
Research and Quality. The Secretary will specify, in guidance, the 
assumptions, including the relevant items and services and 
reimbursement information, for each claim in the benefits scenario.
    (C) Illustration of benefit provided. For purposes of this 
paragraph (a)(2)(ii), to illustrate benefits provided under the plan or 
coverage for a particular benefits scenario, a plan or issuer simulates 
claims processing in accordance with guidance issued by the Secretary 
to generate an estimate of what an individual might expect to pay under 
the plan, policy, or benefit package. The illustration of benefits 
provided will take into account any cost sharing, excluded benefits, 
and other limitations on coverage, as specified by the Secretary in 
guidance.
    (iii) Coverage provided outside the United States. In lieu of 
summarizing coverage for items and services provided outside the United 
States, a plan or issuer may provide an Internet address (or similar 
contact information) for obtaining information about benefits and 
coverage provided outside the United States. In any case, the plan or 
issuer must provide an SBC in accordance with this section that 
accurately summarizes benefits and coverage available under the plan or 
coverage within the United States.
    (3) Appearance. A group health plan and a health insurance issuer 
must provide an SBC in the form, and in accordance with the 
instructions for completing the SBC, that are specified by the 
Secretary in guidance. The SBC must be presented in a uniform format, 
use terminology understandable by the average plan enrollee (or, in the 
case of individual market coverage, the average individual covered 
under a health insurance policy), not exceed four double-sided pages in 
length, and not include print smaller than 12-point font. A health 
insurance issuer offering individual health insurance coverage must 
provide the SBC as a stand-alone document.
    (4) Form--(i) An SBC provided by an issuer offering group health 
insurance coverage to a plan (or its sponsor), may

[[Page 8705]]

be provided in paper form. Alternatively, the SBC may be provided 
electronically (such as by email or an Internet posting) if the 
following three conditions are satisfied--
    (A) The format is readily accessible by the plan (or its sponsor);
    (B) The SBC is provided in paper form free of charge upon request; 
and
    (C) If the electronic form is an Internet posting, the issuer 
timely advises the plan (or its sponsor) in paper form or email that 
the documents are available on the Internet and provides the Internet 
address.
    (ii) An SBC provided by a group health plan or health insurance 
issuer to a participant or beneficiary may be provided in paper form. 
Alternatively, for non-Federal governmental plans, the SBC may be 
provided electronically if the plan conforms to either the substance of 
the ERISA provisions at 29 CFR 2590.715-2715(a)(4)(ii), or the 
provisions governing electronic disclosure for individual health 
insurance issuers set forth in paragraph (a)(4)(iii) of this section.
    (iii) An issuer offering individual health insurance coverage must 
provide an SBC in a manner that can reasonably be expected to provide 
actual notice in paper or electronic form.
    (A) An issuer satisfies the requirements of this paragraph 
(a)(4)(iii) if the issuer:
    (1) Hand-delivers a printed copy of the SBC to the individual or 
dependent;
    (2) Mails a printed copy of the SBC to the mailing address provided 
to the issuer by the individual or dependent;
    (3) Provides the SBC by email after obtaining the individual's or 
dependent's agreement to receive the SBC or other electronic 
disclosures by email;
    (4) Posts the SBC on the Internet and advises the individual or 
dependent in paper or electronic form, in a manner compliant with 
paragraphs (a)(4)(iii)(A)(1) through (3), that the SBC is available on 
the Internet and includes the applicable Internet address; or
    (5) Provides the SBC by any other method that can reasonably be 
expected to provide actual notice.
    (B) An SBC may not be provided electronically unless:
    (1) The format is readily accessible;
    (2) The SBC is placed in a location that is prominent and readily 
accessible;
    (3) The SBC is provided in an electronic form which can be 
electronically retained and printed;
    (4) The SBC is consistent with the appearance, content, and 
language requirements of this section;
    (5) The issuer notifies the individual or dependent that the SBC is 
available in paper form without charge upon request and provides it 
upon request.
    (C) Deemed compliance. A health insurance issuer offering 
individual health insurance coverage that provides the content required 
under paragraph (a)(2) of this section, as specified in guidance 
published by the Secretary, to the federal health reform Web portal 
described in 45 CFR 159.120 will be deemed to satisfy the requirements 
of paragraph (a)(1)(iv)(D) of this section with respect to a request 
for summary information about a health insurance product made prior to 
an application for coverage. However, nothing in this paragraph should 
be construed as otherwise limiting such issuer's obligations under this 
section.
    (5) Language. A group health plan or health insurance issuer must 
provide the SBC in a culturally and linguistically appropriate manner. 
For purposes of this paragraph (a)(5), a plan or issuer is considered 
to provide the SBC in a culturally and linguistically appropriate 
manner if the thresholds and standards of Sec.  147.136(e) of this 
chapter are met as applied to the SBC.
    (b) Notice of modification. If a group health plan, or health 
insurance issuer offering group or individual health insurance 
coverage, makes any material modification (as defined under section 102 
of ERISA) in any of the terms of the plan or coverage that would affect 
the content of the SBC, that is not reflected in the most recently 
provided SBC, and that occurs other than in connection with a renewal 
or reissuance of coverage, the plan or issuer must provide notice of 
the modification to enrollees (or, in the case of individual market 
coverage, an individual covered under a health insurance policy) not 
later than 60 days prior to the date on which the modification will 
become effective. The notice of modification must be provided in a form 
that is consistent with paragraph (a)(4) of this section.
    (c) Uniform glossary--(1) In general. A group health plan, and a 
health insurance issuer offering group health insurance coverage, must 
make available to participants and beneficiaries, and a health 
insurance issuer offering individual health insurance coverage must 
make available to applicants, policyholders, and covered dependents, 
the uniform glossary described in paragraph (c)(2) of this section in 
accordance with the appearance and form and manner requirements of 
paragraphs (c)(3) and (4) of this section.
    (2) Health-coverage-related terms and medical terms. The uniform 
glossary must provide uniform definitions, specified by the Secretary 
in guidance, of the following health-coverage-related terms and medical 
terms:
    (i) Allowed amount, appeal, balance billing, co-insurance, 
complications of pregnancy, co-payment, deductible, durable medical 
equipment, emergency medical condition, emergency medical 
transportation, emergency room care, emergency services, excluded 
services, grievance, habilitation services, health insurance, home 
health care, hospice services, hospitalization, hospital outpatient 
care, in-network co-insurance, in-network co-payment, medically 
necessary, network, non-preferred provider, out-of-network co-
insurance, out-of-network co-payment, out-of-pocket limit, physician 
services, plan, preauthorization, preferred provider, premium, 
prescription drug coverage, prescription drugs, primary care physician, 
primary care provider, provider, reconstructive surgery, rehabilitation 
services, skilled nursing care, specialist, usual customary and 
reasonable (UCR), and urgent care; and
    (ii) Such other terms as the Secretary determines are important to 
define so that individuals and employers may compare and understand the 
terms of coverage and medical benefits (including any exceptions to 
those benefits), as specified in guidance.
    (3) Appearance. A group health plan, and a health insurance issuer, 
must provide the uniform glossary with the appearance specified by the 
Secretary in guidance to ensure the uniform glossary is presented in a 
uniform format and uses terminology understandable by the average plan 
enrollee (or, in the case of individual market coverage, an average 
individual covered under a health insurance policy).
    (4) Form and manner. A plan or issuer must make the uniform 
glossary described in this paragraph (c) available upon request, in 
either paper or electronic form (as requested), within seven business 
days after receipt of the request.
    (d) Preemption. For purposes of this section, the provisions of 
section 2724 of the PHS Act continue to apply with respect to 
preemption of State law. In addition, State laws that require a health 
insurance issuer to provide an SBC that supplies less information than 
required under paragraph (a) of this section are preempted.
    (e) Failure to provide. A health insurance issuer or a non-federal 
governmental health plan that willfully fails to provide information 
required under this section is subject to a fine of not more than 
$1,000 for each such failure. A failure with respect to each covered 
individual constitutes a

[[Page 8706]]

separate offense for purposes of this paragraph (e). HHS will enforce 
these provisions in a manner consistent with 45 CFR 150.101 through 
150.465.
    (f) Applicability date--(1) This section is applicable to group 
health plans and group health insurance issuers in accordance with this 
paragraph (f). (See Sec.  147.140(d), providing that this section 
applies to grandfathered health plans.)
    (i) For disclosures with respect to participants and beneficiaries 
who enroll or re-enroll through an open enrollment period (including 
re-enrollees and late enrollees), this section applies beginning on the 
first day of the first open enrollment period that begins on or after 
September 23, 2012; and
    (ii) For disclosures with respect to participants and beneficiaries 
who enroll in coverage other than through an open enrollment period 
(including individuals who are newly eligible for coverage and special 
enrollees), this section applies beginning on the first day of the 
first plan year that begins on or after September 23, 2012.
    (2) For disclosures with respect to plans, and to individuals and 
dependents in the individual market, this section is applicable to 
health insurance issuers beginning September 23, 2012.

[FR Doc. 2012-3228 Filed 2-9-12; 11:15 am]
BILLING CODE P
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