Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel, 20581-20597 [2013-07951]
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules
§ 488.13
Loss of accreditation.
§ 489.3
If an accrediting organization notifies
CMS that it is terminating a provider or
supplier due to non-compliance with its
CMS-approved accreditation
requirements, the state survey agency
will conduct a full review in a timely
manner.
■ 17. Section 488.28 is amended by
revising paragraph (a) to read as follows:
§ 488.28 Providers or suppliers, other than
SNFs and NFs, with deficiencies.
(a) If a provider or supplier is found
to be deficient in one or more of the
standards in the conditions of
participation, conditions for coverage,
or conditions for certification or
requirements, it may participate in, or
be covered under, the Medicare program
only if the provider or supplier has
submitted an acceptable plan of
correction for achieving compliance
within a reasonable period of time
acceptable to the Secretary. In the case
of an immediate jeopardy situation, the
Secretary may require a shorter time
period for achieving compliance.
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PART 489—PROVIDER AGREEMENTS
AND SUPPLIER APPROVAL
18. The authority citation for part 489
is revised to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395(hh).
19. Section 489.1 is amended by
revising paragraph (b) to read as follows:
■
§ 489.1
Statutory basis.
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(b) Although section 1866 of the Act
speaks only to providers and provider
agreements, the following rules in this
part also apply to the approval of
supplier entities that, for participation
in Medicare, are subject to a
determination by CMS on the basis of a
survey conducted by the state survey
agency or CMS surveyors; or, in lieu of
a state survey agency or CMS-conducted
survey, accreditation by an accrediting
organization whose program has CMS
approval in accordance with § 488.4 at
the time of the accreditation survey and
accreditation decision, in accordance
with the following:
(1) The effective date rules specified
in § 489.13.
(2) The requirements specified in
§ 489.53(a)(2), (13), and (18), related to
termination by CMS of participation in
Medicare.
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■ 20. Section 489.3 is amended by
revising the definition of ‘‘Immediate
jeopardy’’ to read as follows:
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Definitions.
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Immediate jeopardy means a situation
in which the provider’s or supplier’s
non-compliance with one or more
requirements, conditions of
participation, conditions for coverage,
or certification has caused, or is likely
to cause, serious injury, harm,
impairment, or death to a resident or
patient.
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■ 21. Section 489.53 is amended by—
■ A. Revising paragraphs (a)
introductory text, (a)(2), (a)(13).
■ B. Adding reserved paragraph (a)(17).
■ C. Adding paragraph (a)(18).
■ D. Revising paragraph (d)(2)(i)
introductory text.
The additions and revisions read as
follows:
§ 489.53
Termination by CMS.
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the violation poses immediate jeopardy
to the health or safety of individuals
who present themselves to the hospital
for emergency services, CMS—
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CMS–3255–P
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: November 15, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: March 13, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–07950 Filed 4–4–13; 8:45 am]
(a) Basis for termination of agreement.
CMS may terminate the agreement with
any provider if CMS finds that any of
the following failings is attributable to
that provider, and may, in addition to
the applicable requirements in this
chapter governing the termination of
agreements with suppliers, terminate
the agreement with any supplier to
which the failings in paragraphs (a)(2),
(a)(13), and (a)(18) of this section are
attributable:
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(2) The provider or supplier places
restrictions on the persons it will accept
for treatment and it fails either to
exempt Medicare beneficiaries from
those restrictions or to apply them to
Medicare beneficiaries the same as to all
other persons seeking care.
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(13) The provider or supplier refuses
to permit photocopying of any records
or other information by, or on behalf of,
CMS, as necessary to determine or
verify compliance with participation
requirements.
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(17) [Reserved]
(18) The provider or supplier fails to
grant immediate access upon a
reasonable request to a state survey
agency or other authorized entity for the
purpose of determining, in accordance
with § 488.3, whether the provider or
supplier meets the applicable
requirements, conditions of
participation, conditions for coverage or
conditions for certification.
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(d) * * *
(2) * * *
(i) Hospitals. If CMS finds that a
hospital is in violation of § 489.24 (a)
through (f), and CMS determines that
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BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 155
[CMS–9955–P]
RIN 0938–AR75
Patient Protection and Affordable Care
Act; Exchange Functions: Standards
for Navigators and Non-Navigator
Assistance Personnel
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Proposed rule.
AGENCY:
The proposed regulations
would create conflict-of-interest,
training and certification, and
meaningful access standards applicable
to Navigators and non-Navigator
assistance personnel in Federallyfacilitated Exchanges, including State
Partnership Exchanges, and to nonNavigator assistance personnel in Statebased Exchanges that are funded
through federal Exchange Establishment
grants. These proposed standards would
help ensure that Navigators and nonNavigator assistance personnel will be
fair and impartial and will be
appropriately trained, and that they will
provide services and information in a
manner that is accessible.
The proposed regulations would also
make two amendments to the existing
regulation for Navigators that would
apply to all Navigators in all Affordable
Insurance Exchanges (Exchanges),
including State-based Exchanges,
clarifying that any Navigator licensing,
certification, or other standards
SUMMARY:
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prescribed by the state or Exchange
must not prevent the application of the
provisions of title I of the Affordable
Care Act; and adding to the list of
entities ineligible to become Navigators,
those entities with relationships to
issuers of stop loss insurance, including
those who are compensated directly or
indirectly by issuers of stop loss
insurance in connection with
enrollment in Qualified Health Plans or
non-Qualified Health Plans. The
proposed regulations would also clarify
that the same ineligibility criteria that
apply to Navigators would also apply to
non-Navigator assistance personnel
providing services in any Federallyfacilitated Exchanges, including in State
Consumer Partnership Exchanges, and
to federally funded non-Navigator
assistance personnel in State-based
Exchanges.
To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on May 6, 2013.
ADDRESSES: In commenting, please refer
to file code CMS–9955–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–9955–P, P.O. Box 8010, Baltimore,
MD 21244–1850.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–9955–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following addresses prior to the close of
the comment period: a. For delivery in
Washington, DC—Centers for Medicare
& Medicaid Services, Department of
Health and Human Services, Room 445–
G, Hubert H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
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DATES:
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(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Joan
Matlack, (888) 393–2789.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland, 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone (800) 743–3951.
I. Background
A. Introduction
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 laws are collectively known
as the Affordable Care Act.
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Beginning on October 1, 2013,
individuals and small businesses will be
able to purchase private health
insurance through state-based
competitive marketplaces called
Affordable Insurance Exchanges
(Exchanges), also known as the Health
Insurance Marketplaces.
The Exchanges will provide
competitive marketplaces where
individuals and small employers can
compare available private health
insurance options on the basis of price,
quality, and other factors. The
Exchanges, which will offer coverage
that is effective beginning on January 1,
2014, will help enhance competition in
the health insurance market, improve
choice of affordable health insurance,
and give small businesses the same
purchasing power as large businesses.
Pursuant to sections 1311(b) and
1321(b) of the Affordable Care Act, each
state has the opportunity to establish an
Exchange that—(1) Facilitates the
purchase of insurance coverage by
qualified individuals through Qualified
Health Plans (QHPs); (2) assists
qualified employers in the enrollment of
their employees in QHPs; and (3) meets
other standards specified in the
Affordable Care Act. These are referred
to as State-Based Exchanges.
Section 1321(c)(1) of the Affordable
Care Act requires the Secretary of HHS
(‘‘Secretary’’) to establish and operate
Exchanges within states that either: (1)
do not elect to establish an Exchange, or
(2) as determined by the Secretary on or
before January 1, 2013, will not have an
Exchange operational by January 1,
2014. These HHS-operated Exchanges
are referred to as Federally-facilitated
Exchanges. The Secretary has also
explained through sub-regulatory
guidance that these Federally-facilitated
Exchanges may include State
Partnership Exchanges in which states
may assume significant responsibility
for key Exchange functions.1 Generally,
a State Partnership Exchange will take
one of two forms: a State Plan
Management Partnership Exchange, or a
State Consumer Partnership Exchange
(Consumer Partnership Exchange).
Consumers can receive assistance
from a variety of sources when seeking
access to health insurance coverage
through an Exchange. Sections
1311(d)(4)(K) and 1311(i) of the
Affordable Care Act, and the regulation
implementing those provisions, 45 CFR
1 See 77 FR 18310, 18325–26 (Mar. 27, 2012);
General Guidance on Federally-facilitated
Exchanges (May 16, 2012) at https://cciio.cms.gov/
resources/files/ffe-guidance-05–16–2012.pdf; and
Guidance on the State Partnership Exchange (Jan.
3, 2013) at https://cciio.cms.gov/resources/files/
partnership-guidance-01–03–2013.pdf.
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155.210, direct all Exchanges to award
grants to Navigators that will provide
fair and impartial information to
consumers about health insurance, the
Exchange, QHPs, and insurance
affordability programs including
premium tax credits, Medicaid and the
Children’s Health Insurance Program
(CHIP); and that will provide referrals to
consumer assistance programs (CAP)
and health insurance ombudsmen for
enrollees with grievances, complaints,
or questions about their health plan or
coverage. Navigators are an important
resource for all consumers, particularly
communities that are under-served by
and under-represented in the current
health insurance market. Navigators will
not make eligibility determinations and
will not select QHPs for consumers or
enroll applicants into QHPs, but will
help consumers through the eligibility
and enrollment process. The Exchange
regulations, at 45 CFR 155.400(a), state
that ‘‘[t]he Exchange must accept a QHP
selection from an applicant * * * and
must—(1) Notify the issuer of the
applicant’s selected QHP; and (2)
Transmit information necessary to
enable the QHP issuer to enroll the
applicant’’ (emphasis added).
Additionally, as articulated in 45 CFR
§ 155.310(d), the Exchange is
responsible for making eligibility
determinations. Taken together, these
regulations clearly mean that the
Exchange, not Navigators, must
determine eligibility and enroll
applicants into QHPs. Additionally, a
Navigator cannot make the decision for
an applicant as to which QHP to select.
That said, Navigators may play an
important role in facilitating a
consumer’s enrollment in a QHP by
providing fair, impartial, and accurate
information that assists consumers with
submitting the eligibility application,
clarifying the distinctions among QHPs,
and helping qualified individuals make
informed decisions during the health
plan selection process.
The Exchange regulations also
authorize Exchanges to perform certain
consumer service functions in addition
to the Navigator program. Federal
regulations at 45 CFR § 155.205(d) and
(e) provide that each Exchange must
conduct consumer assistance activities
as well as outreach and education
activities to educate consumers about
the Exchange and insurance
affordability programs to encourage
participation. The activities under
§ 155.205(d) and (e) include, but are not
limited to, the Navigator grant program.
Establishing a non-Navigator consumer
assistance program pursuant to
§ 155.205(d) and (e) will help ensure
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that the Exchange is providing outreach,
education, and assistance to as broad a
range of consumers as possible so that
all consumers can receive help when
accessing health insurance coverage
through an Exchange.
A program established to fulfill the
consumer assistance, education, and
outreach functions under § 155.205(d)
and (e) through in-person consumer
support, other than a Navigator
program, is referred to in the proposed
regulation and in this preamble as a
‘‘non-Navigator assistance program
authorized by § 155.205(d) and (e)’’ or
more simply as a ‘‘non-Navigator
assistance program.’’ In addition, we
refer to persons carrying out these
consumer assistance, education, and
outreach functions under § 155.205(d)
and (e) as ‘‘non-Navigator assistance
personnel carrying out consumer
assistance functions under § 155.205 (d)
and (e)’’ or ‘‘non-Navigator entities or
individuals authorized to carry out
consumer assistance functions under
§ 155.205 (d) and (e)’’ or more simply as
‘‘non-Navigator assistance personnel.’’
Non-Navigator assistance programs
include what have sometimes been
referred to as ‘‘in-person assistance
programs.’’ Similarly, non-Navigator
assistance personnel include what have
sometimes been referred to as ‘‘inperson assistance personnel.’’ Therefore,
when references are made in this
preamble or in the proposed regulation
to non-Navigator assistance programs or
non-Navigator assistance personnel,
those references also apply to in-person
assistance programs or in-person
assistance personnel, respectively.
State-based Exchanges may, but need
not, establish non-Navigator assistance
programs to provide consumer
assistance, education, and outreach
under § 155.205(d) and (e).
Additionally, as a condition of a state’s
participation in a Consumer Partnership
Exchange, the state will establish and
operate a non-Navigator assistance
program in a way that is consistent with
the policies and interpretations HHS
adopts for § 155.205(d) and (e) for the
Federally-facilitated Exchanges. This
does not affect the obligation of a
Consumer Partnership Exchange to
establish and operate a Navigator
program, however. HHS will have
responsibility for the inherently
governmental function of awarding
federal Navigator grants for the
Federally-facilitated Exchanges,
including State Partnership Exchanges.
Federally-facilitated Exchanges, other
than Consumer Partnership Exchanges,
do not anticipate including a nonNavigator assistance program.
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Section 1311(i)(6) prohibits
Exchanges from using section 1311(a)
grant funds to fund Navigator grants.
However, section 1311(a) grant funds
may be used to cover the Exchange’s
cost of administering the Navigator
program, including, for example, the
cost of Navigator training, grants
management, and oversight.
State-based Exchanges and state
partners in Consumer Partnership
Exchanges may use section 1311(a)
Exchange Establishment grants to fund
non-Navigator assistance programs
consistent with the following
discussion.
Together, section 1311(a)(4)(B) and
section 1311(d)(5)(A) provide that, as
long as grant funds under section
1311(a) are available to the state, a Statebased Exchange need not be selfsustaining during its initial year of
operation. Accordingly, as long as
section 1311(a) grant funds are available
to the state, a State-based Exchange may
not have sufficient funds independent
of section 1311(a) grant funds during its
initial year of operation to achieve all of
the goals of the Navigator program. As
a transitional policy in such
circumstances, a State-based Exchange
may use a non-Navigator assistance
program in its initial year of operation
to fill in any gaps in its Navigator
program and otherwise ensure that the
full range of services that its Navigator
program will provide in subsequent
years are provided during its initial year
of operation. As the State-based
Exchange becomes self-sustaining, the
roles of the non-Navigator assistance
program and the Navigator program may
change. We note that, after the Statebased Exchange becomes selfsustaining, the State-based Exchange
can choose to establish or continue a
non-Navigator assistance program, as a
supplement to its fully-funded
Navigator program. Similarly, a Statebased Exchange that is self-sustaining
from the outset, because section 1311(a)
grant funds are no longer available to
the state, can make a similar choice. In
both such circumstances, the nonNavigator assistance program would
have to be funded through some source
other than section 1311(a) grant funds.
Section 1311(a) grant funds are
available for non-Navigator assistance
programs in Consumer Partnership
Exchanges because the state has elected
to establish and operate outreach,
educational, and assistance activities to
assist in its transition to a State-based
Exchange, as a condition of its
participation in the Consumer
Partnership Exchange. Such activities
do not purport to, nor do they in fact,
supplant the obligation of the federal
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government to establish a Navigator
program. When a state partner in a
Consumer Partnership Exchange
transitions to a State-Based Exchange,
the discussion of State-Based Exchanges
above will apply.
While section 1311(i)(1) directs that
the Navigator program be a grant
program, State-based Exchanges and
state partners in a Consumer
Partnership Exchange have the
flexibility to build a non-Navigator
assistance program through contracts,
direct hiring, or grants, subject to state
law. Utilizing funding mechanisms
other than grants for non-Navigator
assistance programs may be particularly
important to ensure that State-based
Exchanges have enhanced flexibility to
utilize non-Navigator assistance
personnel to fill in any gaps in their
Navigator programs or to appropriately
supplement their Navigator program, as
described above, by, for example,
serving communities that may not be
reached by their Navigator program.
B. Legislative and Regulatory Overview
Section 1311 of the Affordable Care
Act generally establishes the creation of
Exchanges and outlines various
requirements and standards Exchanges
must satisfy. Specifically, pursuant to
sections 1311(b) and 1321(b) of the
Affordable Care Act, each state has the
opportunity to establish an Exchange.
Sections 1311(d)(4)(K) and 1311(i) of
the Affordable Care Act direct each
Exchange to establish a program under
which it awards grants to Navigators
who will carry out a list of required
duties. A final rule implementing
sections 1311(d)(4)(K) and 1311(i) of the
Affordable Care Act was published on
March 27, 2012 (77 FR 18310), and is
codified at 45 CFR § 155.210.
Section 1311(i)(3) of the Affordable
Care Act lists the duties Navigators must
perform. Section 155.210(e) interprets
these duties to include: maintaining
expertise in eligibility, enrollment, and
program specifications; conducting
public education activities to raise
awareness about the Exchange;
providing information and services in a
fair, accurate, and impartial manner,
including information that
acknowledges other health programs
such as Medicaid and CHIP; facilitating
selection of a QHP; providing referrals
for consumers with questions,
complaints, or grievances to any
applicable office of health insurance
consumer assistance or health insurance
ombudsman established under section
2793 of the Public Health Service Act
(PHS Act), or any other appropriate state
agency or agencies; providing
information in a culturally and
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linguistically appropriate manner,
including to persons with limited
English proficiency; and ensuring
accessibility and usability of Navigator
tools and functions for persons with
disabilities.
Section 1311(i)(4) directs the
Secretary to establish standards for
Navigators, including provisions to
ensure that any entity selected as a
Navigator is qualified, and licensed if
appropriate, to engage in the Navigator
activities required by the law and to
avoid conflicts of interest. 45 CFR
155.210(b)(1), which interprets this
provision, directs each Exchange to
‘‘develop and publicly disseminate
* * * [a] set of standards, to be met by
all entities and individuals awarded
Navigator grants, designed to prevent,
minimize and mitigate any conflicts of
interest, financial or otherwise, that may
exist for an entity or individuals to be
awarded a Navigator grant and to ensure
that all entities and individuals carrying
out Navigator functions have
appropriate integrity.’’ Additionally, 45
CFR 155.210(c)(1)(iv) provides that a
Navigator must not have a conflict of
interest during its term as Navigator. 45
CFR 155.210(b)(2) directs Exchanges to
develop and disseminate a set of
training standards, to be met by all
entities and individuals carrying out
Navigator functions, to ensure Navigator
expertise in the needs of underserved
and vulnerable populations; eligibility
and enrollment rules and procedures;
the range of QHP options and insurance
affordability programs; and privacy and
security requirements applicable to
personally identifiable information.
This proposal develops and
disseminates standards under
§ 155.210(b)(1) and (2) for the Federallyfacilitated Exchanges, including State
Partnership Exchanges, and for nonNavigator assistance personnel in Statebased Exchanges that are funded
through federal Exchange Establishment
grants. These standards could also be
used by State-based Exchanges at their
discretion for their Navigator programs
and for any non-Navigator assistance
programs not funded with 1311(a)
Exchange Establishment grants.
45 CFR 155.210(c)(1)(iii) also
interprets section 1311(i)(4), and directs
that entities or individuals must meet
any licensing, certification, or other
standards prescribed by the state or
Exchange, if applicable, in order to
receive a Navigator grant.
Section 1311(i)(4) of the Affordable
Care Act also specifies that under the
standards established by the Secretary,
Navigators shall not be health insurance
issuers or receive any consideration
directly or indirectly from any health
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insurance issuer in connection with the
enrollment of any qualified individuals
or employees of a qualified employer in
QHPs. 45 CFR § 155.210(d), which
interprets this provision, prohibits
Navigators from being health insurance
issuers. It also provides that Navigators
should not receive any compensation
directly or indirectly from health
insurance issuers in connection with the
enrollment of qualified individuals or
employees of a qualified employer,
whether that enrollment is in QHPs or
in non-QHPs. Section 155.210(d) further
clarifies that a Navigator must not be a
subsidiary of a health insurance issuer
or be an association that includes
members of, or lobbies on behalf of, the
insurance industry.
Section 1311(i)(5) of the Affordable
Care Act directs the Secretary to
develop standards to ensure that
information made available by
Navigators is fair, accurate, and
impartial.
Provisions of the Exchange
regulations, at 45 CFR 155.210(c)(2),
direct the Exchange to select at least two
different types of entities as Navigators,
one of which must be a community and
consumer-focused non-profit group.
Section 1321(a) of the Affordable Care
Act provides authority for the Secretary
to establish standards and regulations to
implement the statutory standards
related to Exchanges, QHPs, and other
components of title I of the Affordable
Care Act.
Section 1321(c)(1) of the Affordable
Care Act requires the Secretary to
establish and operate Exchanges within
states that either: (1) do not elect to
establish an Exchange, or (2) as
determined by the Secretary on or
before January 1, 2013, will not have an
Exchange operational by January 1,
2014. These HHS-operated Exchanges
are referred to as Federally-facilitated
Exchanges, and include State
Partnership Exchanges.
Section 1321(d) of the Affordable Care
Act states that nothing in title I of that
Act shall be construed to preempt any
state law that does not prevent the
application of the provisions of the title.
Title I of the Affordable Care Act
includes all provisions related to
Exchanges, including the Navigator
provisions.
Provisions of the Exchange
regulations, at 45 CFR 155.205(d), direct
Exchanges to have a consumer
assistance function that meets the
accessibility standards set forth in
§ 155.205(c). This consumer assistance
function includes the Navigator program
at section 1311(i) of the Affordable Care
Act and 45 CFR 155.210, but is not
limited to the Navigator program.
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45 CFR 155.205(e) directs Exchanges to
conduct outreach and education
activities that also meet the accessibility
standards in § 155.205(c), and to
educate consumers about the Exchange
and insurance affordability programs to
encourage participation. The
accessibility standards for § 155.205(d)
and (e), as detailed in § 155.205(c),
include a requirement that applicants
and enrollees be provided information
in plain language and in a manner that
is accessible and timely for persons with
disabilities and individuals with limited
English proficiency. Additionally, a
notice of proposed rulemaking
published on January 22, 2013 would
amend § 155.205(d) 2 to require any
individual providing consumer
assistance under § 155.205(d) to be
trained regarding QHP options,
insurance affordability programs,
eligibility, and benefits rules and
regulations governing all insurance
affordability programs operated in the
state, as implemented in the state, prior
to providing consumer assistance. Once
finalized, that rule will apply to and
require such training for non-Navigator
assistance personnel.
HHS has also published a proposed a
rule (78 FR 4594) that would create a
new section 45 CFR § 155.225,
proposing to require each Exchange to
certify staff and volunteers of Exchangedesignated organizations and
organizations designated by State
Medicaid and Children’s Health
Insurance Program agencies to serve as
certified application counselors in the
Exchange.
C. Overview of Proposed Rule
First, this proposed regulation would
amend § 155.210(c)(1)(iii) to clarify that
any Navigator licensing, certification, or
other standards prescribed by the state
or Exchange must not prevent the
application of the provisions of title I of
the Affordable Care Act. The proposed
rule would also amend § 155.210(d) to
clarify that a Navigator cannot be an
issuer of, or a subsidiary of an issuer of,
stop loss insurance, and cannot receive
any consideration, directly or indirectly,
from an issuer of stop loss insurance in
connection with the enrollment of any
individuals or employees in a QHP or a
non-QHP. These proposed amendments
to § 155.210 would be applicable to
Navigators in all Exchanges, including
2 See Notice of Proposed Rulemaking on Essential
Health Benefits in Alternative Benefit Plans,
Eligibility Notices, Fair Hearing and Appeal
Processes for Medicaid and Exchange Eligibility
Appeals and Other Provisions Related to Eligibility
and Enrollment for Exchanges, Medicaid and CHIP,
and Medicaid Premiums and Cost Sharing, 78 FR
4594, 4710 (Jan. 22, 2013).
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Federally-facilitated Exchanges, State
Partnership Exchanges, and State-based
Exchanges.
Second, this proposed rule would add
a new provision at 45 CFR 155.215 that
would establish conflict-of-interest,
training, and accessibility standards
applicable to Navigators and nonNavigator assistance personnel in
Federally-facilitated Exchanges,
including State Partnership Exchanges.
We also propose that these standards
would apply to non-Navigator
assistance programs and personnel in
State-based Exchanges that are funded
through federal section 1311(a)
Exchange Establishment grants.
Proposed section 155.215(a) provides
details on the set of conflict-of-interest
standards applicable to these Navigators
and non-Navigator personnel. Proposed
§ 155.215(a)(2)(i) would also establish
that the non-Navigator assistance
personnel described above must comply
with the same set of conflict-of-interest
prohibitions that apply to Navigators
under § 155.210(d). Section 155.215(b)
proposes standards related to training,
certification, and recertification for
these Navigators and non-Navigator
personnel. These standards include
details about the requirement to be
certified, to register and receive training,
the content required for training, and
the requirement to receive a passing
score on all HHS-approved certification
examinations after training. Proposed
§ 155.215(c) and (d) would establish
standards for these Navigators and nonNavigator personnel to ensure
meaningful access to their services by
individuals with limited English
proficiency and people with disabilities.
The standards proposed at 155.215(c)
and (d) should be read together with all
other applicable standards issued by the
Secretary related to ensuring meaningful
access by individuals with limited
English proficiency and people with
disabilities.
State-based Exchanges would not be
required to use the standards proposed
in § 155.215 for their Navigators, or for
non-Navigator assistance programs not
funded through section 1311(a)
Exchange Establishment grants.
However, we believe that State-based
Exchanges may find the federal
standards to be useful models, and
could draw upon them as they develop
and disseminate conflict-of-interest and
training standards for Navigators
pursuant to § 155.210(b), or when
establishing standards for any nonNavigator assistance program that is
established by the State-based Exchange
that is not funded by federal 1311(a)
Exchange Establishment grants.
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In addition, while the conflict-ofinterest, training and meaningful access
standards that are now being proposed
would apply to the Navigators and nonNavigator assistance personnel
described above, we have not proposed
that the standards would also apply to
certified application counselors.
Certified application counselors have
been proposed as an additional source
of consumer assistance, required in
every Exchange, in a separate proposed
rule (78 FR 4594), but that rule has not
yet been finalized. We are, however,
requesting public comments regarding
whether all or some of the standards
being proposed for Navigators and nonNavigator assistance personnel in this
proposed regulation should also apply
to certified application counselors in the
event that every Exchange is required to
establish a certified application
counselor program after publication of a
final rule.
II. Provisions of the Proposed Rule
A. Navigator Program Standards
(Proposed Amendments to § 155.210)
The proposed rule contains two
amendments to specific provisions of
the existing Navigator regulation,
§ 155.210. These proposed amendments
would apply to Navigators in all
Exchanges, including Federallyfacilitated Exchanges, State Partnership
Exchanges and State-based Exchanges.
1. Entities and Individuals Eligible to be
a Navigator (Proposed Amendment to
§ 155.210(c)(1)(iii))
Section 155.210(c)(1)(iii),
implementing section 1311(i)(4) of the
Affordable Care Act, currently directs
that, to receive a Navigator grant, an
entity or individual must ‘‘meet any
licensing, certification or other
standards prescribed by the state or
Exchange, if applicable.’’ Section
1321(d) of the Affordable Care Act
provides that state laws that do not
prevent the application of the
provisions of title I of the Affordable
Care Act are not preempted.
The proposed rule would clarify that
any Navigator licensing, certification, or
other standards prescribed by the state
or Exchange should not prevent the
application of the provisions of title I of
the Affordable Care Act. Thus, for
example, as HHS has previously advised
(see 77 FR 18310 at 18331–32), a
requirement by a state or an Exchange
that Navigators be agents and brokers or
obtain errors and omissions coverage
would violate the requirement at
§ 155.210(c)(2) that at least two types of
entities must serve as Navigators,
because it would mean that only agents
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or brokers could be Navigators. In
addition, holding an agent or broker
license is neither necessary, nor by itself
sufficient, to perform the duties of a
Navigator, as these licenses generally do
not address areas in which Navigators
need expertise, including the public
coverage options that would be
available to some consumers. Similarly,
if a State or Exchange required all
Navigators to hold a producer license, or
if a producer license was required to
carry out any of the required Navigator
duties, this would also conflict with
§ 155.210(c)(2), because in that event, all
Navigators in the Exchange would be
licensed agents or brokers, as defined in
§ 155.20.
Therefore, we propose to amend
§ 155.210(c)(1)(iii) to clarify, consistent
with Affordable Care Act section
1321(d), that to receive a Navigator
grant, an entity or individual must meet
any licensing, certification or other
standard prescribed by the State or
Exchange, if applicable, as long as such
standards do not prevent the application
of the provisions of title I of the
Affordable Care Act. We solicit public
public comments on this proposed
amendment.
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
2. Prohibition on Navigator Conduct
(Proposed Amendment to § 155.210(d))
Under § 155.210(d), a Navigator may
not be a health insurance issuer; be a
subsidiary of a health insurance issuer;
be an association that includes members
of, or lobbies on behalf of, the insurance
industry; or receive any consideration,
directly or indirectly, from any health
insurance issuer in connection with the
enrollment of any individuals or
employees in a QHP or non-QHP. We
propose to amend section 155.210(d) to
further clarify that a Navigator must also
not be an issuer of stop loss insurance,
or a subsidiary of an issuer of stop loss
insurance, and must not receive any
consideration, directly or indirectly,
from any issuer of stop loss insurance in
connection with the enrollment of
individuals or employers in a QHP or
non-QHP.3
Section 1311(i)(3)(B) of the Affordable
Care Act directs that a Navigator must
distribute fair and impartial information
concerning enrollment in QHPs. Section
1311(i)(5) of the Affordable Care Act
further directs that the Secretary shall
3 HHS, jointly with the Departments of Labor and
the Treasury, issued a Request for Information
Regarding Stop Loss Insurance on May 1, 2012. See
77 FR 25788. In that Request for Information, we
explained that stop loss insurance is designed to
protect against health insurance claims that are
catastrophic or unpredictable in nature, and that it
provides coverage to self-insured group health
plans once a certain level of risk has been absorbed
by the plan.
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establish standards to ensure that
information made available by
Navigators is fair, accurate, and
impartial. In addition, section 1311(i)(4)
directs the Secretary to establish
standards to avoid conflicts of interest
by Navigators. Existing regulations at 45
CFR 155.210(c)(1)(iv) and (e)(2) also
direct that Navigators must not have a
conflict of interest during their term as
a Navigator, and must provide
information and services in a fair,
accurate, and impartial manner. Taken
together, these requirements indicate
that a Navigator should not have a
conflict of interest when presenting
information or providing the range of
coverage choices to individuals or small
employers who receive the Navigator’s
assistance. Similarly, the Navigator
must not have a personal interest in the
coverage choices made by individuals or
employers who receive the Navigator’s
assistance. More specifically, with
respect to the assistance offered by a
Navigator to a small employer, a
Navigator should not have a personal
interest in whether a small employer
chooses to self-insure its employees, or
chooses to enroll in fully-insured
coverage inside or outside the Exchange.
We believe that an issuer of stop loss
insurance, a subsidiary of an issuer of
stop loss insurance, or an individual or
entity receiving consideration from any
issuer of stop loss insurance in
connection with enrollment in a QHP or
non-QHP, would have conflicts of
interest prohibited by § 155.210(c)(1)(iv)
and such conflicts of interest would
compromise the ability of a Navigator to
provide information and services in a
fair, accurate, and impartial manner as
required by § 155.210(e)(2).
Navigators with a financial
relationship with an issuer of stop loss
insurance raise the same kinds of
concerns that would be present for a
Navigator with a relationship with a
health insurance issuer (or an entity
receiving consideration from a health
insurance issuer). Such Navigators
could have a financial incentive to
encourage small employers towards selffunding and might not present all
coverage options, including insured
options, to small employers in a fair,
accurate, and impartial manner. In
addition, such conflicts of interest might
interfere with a Navigator’s duty to
‘‘facilitate selection of a QHP,’’ as
required by § 155.210(e)(3).
The proposed amendments would
help ensure that Navigators provide any
small employers that request help from
a Navigator with information and
services in a fair, accurate, and impartial
manner, and that such information
facilitate small employers’ selection of
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QHPs in Small Business Health Options
(SHOP) Exchanges, if they choose to
enroll in such coverage. We solicit
public comments on this proposal.
B. Standards Applicable to Navigators
and Non-Navigator Assistance
Personnel Carrying Out Consumer
Assistance Functions Under
§§ 155.205(d) and (e) and 155.210 in a
Federally-Facilitated Exchange and to
Non-Navigator Assistance Personnel
Funded Through an Exchange
Establishment Grant (Proposed
§ 155.215)
1. Conflict-of-Interest Standards
(Proposed § 155.215(a))
The proposed regulation proposes
conflict-of-interest standards that are
substantially similar for both Navigators
and non-Navigator assistance personnel.
These proposed conflict-of-interest
standards would apply to all Navigators
and non-Navigator assistance personnel
in a Federally-facilitated Exchange
(including a State Partnership
Exchange), and to federally-funded nonNavigator assistance personnel in a
State-based Exchange.
The standards applicable to
Navigators interpret the requirements at
section 1311(i)(4) of the Affordable Care
Act and 45 CFR 155.210(c)(1)(iv) and
(d). In addition, these standards would
help ensure that Navigators provide
information in a fair, accurate, and
impartial manner, pursuant to
Affordable Care Act section 1311(i)(5)
and 45 CFR 155.210(e)(2). These
standards also follow from 45 CFR
155.210(b), which specifies that
Exchanges establish a set of conflict-ofinterest standards applicable to
Navigators in the Exchange.
We also believe that non-Navigator
assistance personnel who carry out
consumer outreach, assistance, and
education in Federally-facilitated
Exchanges, including State Partnership
Exchanges, and non-Navigator
assistance personnel in State-based
Exchanges that are funded through
Exchange Establishment grants should
be subject to conflict-of-interest
standards. To be helpful to the public,
we believe that services provided under
§ 155.205(d) and (e) should be carried
out in a fair, impartial, and unbiased
manner. Applying conflict-of-interest
standards to these non-Navigator
assistance personnel will therefore
ensure that they provide services
consistent with this interpretation of
§ 155.205,and will minimize confusion
in the marketplace. We solicit public
comments on applying the same
conflict-of-interest standards to both
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Navigators and non-Navigator assistance
personnel.
State-based Exchanges would not be
required to adopt the conflict-of-interest
standards proposed in § 155.215(a) for
their Navigators or for their nonNavigator assistance personnel that are
not funded through 1311(a) Exchange
Establishment grants. However, Statebased Exchanges may wish to consider
using the standards proposed in
§ 155.215 as models when developing
their own standards.
a. Conflict-of-Interest Standards for
Navigators (Proposed § 155.215(a)(1))
Section 1311(i)(4) of the Affordable
Care Act directs the Secretary to
establish standards for Navigators,
including provisions to avoid conflicts
of interest. Section 155.210(b)(1) directs
all Exchanges to develop and publicly
disseminate conflict-of-interest
standards for Navigators. The conflictof-interest standards proposed in
§ 155.215(a)(1) are intended to apply to
all Navigators in Federally-facilitated
Exchanges, including State Partnership
Exchanges.
Section 155.210(c)(1)(iv) prohibits
Navigators from having conflicts of
interest during their terms as
Navigators. In this context, we have
explained that having a conflict of
interest means having a private or
personal interest sufficient to influence,
or appear to influence, the objective
exercise of a Navigator’s official duties
(77 FR 18330–18331). In addition,
§ 155.210(d) directs that a Navigator
must not have certain relationships with
insurance issuers or the insurance
industry. Because any individual or
entity with the conflicts of interest
listed at § 155.210(d) would be barred
from participating as a Navigator, the
first proposed conflict-of-interest
standard, as set forth in proposed
§ 155.215(a)(1)(i), would require that a
Navigator entity, including a Navigator
grant applicant, submit to the Exchange
a written attestation that the Navigator
and its staff do not have any of these
prohibited conflicts of interest. This
disclosure to the Exchange will help to
ensure that Navigators comply with the
prohibitions on Navigator conduct set
forth in § 155.210(d), and that
individuals and entities who are
ineligible under § 155.210(d) do not
apply to the Exchange for grants to serve
as Navigators. We solicit public
comments on the proposal to require
Navigators to submit an attestation
regarding eligibility.
Proposed § 155.215(a)(1)(ii) would
direct that all Navigator entities submit
to the Exchange a written plan to remain
free of conflicts of interest during their
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term as a Navigator. This plan should
ensure that the Navigator grantee, and
all those individuals who serve as
Navigators under the direction of the
Navigator grantee, would fully comply
with the prohibitions in § 155.210(d),
and all other conflict-of-interest
requirements, as described below,
throughout the term of a Navigator
grant. This would be particularly
important for those Navigator entities
that may have a changing workforce,
and might thus utilize new or different
staff or employees during the term of a
Navigator grant. We solicit public
comments on the proposed requirement
to submit a written plan to remain free
of conflicts of interest, including
comments on the form of and content
for the plan.
Proposed § 155.215(a)(1)(iii) would
direct that all Navigators, both
individual Navigators and Navigator
entities, and their staff, provide
information to consumers about the full
range of QHP options and insurance
affordability programs such as premium
tax credits and cost sharing reductions
and Medicaid and CHIP, for which they
are eligible. This proposed requirement
would help ensure that consumers
receive all of the information they need
to make an informed enrollment
decision, and that the information they
receive is fair, as required by
§ 155.210(e)(2).
Lastly, the proposed conflict-ofinterest standards for Navigators include
the requirement at proposed
§ 155.215(a)(1)(iv) that certain conflicts
of interest, while not a bar to serving as
a Navigator, should be disclosed to the
Exchange and to each consumer
receiving application assistance (which
includes pre-enrollment and postenrollment services, but does not
include outreach and education
assistance), both by the Navigator
individual and the entity. In developing
the conflict-of-interest standards in the
proposed rule, we have been mindful
that every Navigator must ‘‘provide
information and services in a fair,
accurate and impartial manner’’ under
§ 155.210(e)(2). We have also been
mindful that each Exchange must
develop standards ‘‘designed to prevent,
minimize and mitigate any conflicts of
interest, financial or otherwise, that may
exist for an entity or individuals to be
awarded a Navigator grant and to ensure
that all entities and individuals carrying
out Navigator functions have
appropriate integrity,’’ § 155.210(b)(1).
The requirement that an Exchange
develop standards to minimize and
mitigate conflicts of interests suggests
that some conflicts of interest would not
be absolute bars to service as a
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Navigator, provided that the conflict of
interest would not ultimately prevent
the entity or individual from providing
information and services in a fair,
accurate, and impartial manner. Striking
this balance will allow for a robust pool
of Navigators, without sacrificing the
need to ensure that all Navigators have
the integrity, fairness, and impartiality
to carry out their duties appropriately.
Under the proposed rule, in order to
mitigate conflicts of interest, there are
three types of information that
Navigators should disclose to the
Exchange and to their consumers. First,
Navigator and all Navigator staff
members would be required to disclose
to the Exchange and to each consumer
who receives application assistance
from the Navigator entity or individual,
any lines of insurance business, other
than health insurance or stop loss
insurance, which the Navigator intends
to sell while serving as a Navigator.
Since Navigators must not sell health
insurance and as we also propose, must
not sell stop loss insurance, the
proposed requirement that Navigators
disclose ‘‘any lines of insurance
business’’ is not intended to apply to the
sale of health insurance or stop loss
insurance, since these are not conflicts
of interest that could be mitigated
through disclosure (see § 155.210(d)).
In addition, the proposed rule would
require disclosure of two other types of
indirect financial conflicts of interest.
Navigators and their staff members
would be required to disclose to the
Exchange and each consumer receiving
application assistance, any existing and
former employment relationships they
have had within the last five years with
any issuer of health insurance or stop
loss insurance, or subsidiaries of such
issuers. It is is intended that any
existing employment relationships
disclosed would be non-prohibited
relationships, because receipt of any
consideration directly or indirectly from
any health insurance issuer or issuer of
stop loss insurance in connection with
the enrollment of any individuals or
employees in a QHP or a non-QHP
would already be prohibited by
§ 155.210(d)(4). They must also disclose
any existing employment relationships
between any health insurance issuer or
stop-loss insurance issuer, or subsidiary
of such issuers, and the individual’s
spouse or domestic partner. Navigators
and their staff members would also be
required to disclose to the Exchange and
to each consumer receiving application
assistance any existing or anticipated
financial, business, or contractual
relationships with one or more issuers
of health insurance or stop loss
insurance or subsidiaries of such
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issuers. These types of conflict-ofinterest relationships with issuers of
health insurance or stop loss insurance
should be disclosed because these
relationships may confer benefits or
indirect financial gain that would
compromise a Navigator’s objectivity.
We solicit public comments on the
proposed requirement to disclose
certain types of potential financial
conflicts of interest.
Under existing regulations, a
Navigator must not act on behalf of
health insurance issuers, either as
agents or under appointment, since this
would violate the prohibition on
conflicts of interest in § 155.210(d)(1)
through (d)(3) and the prohibition at
§ 155.210(d)(4) on receiving
compensation from issuers in
connection with enrollment. However,
we note that agents and brokers have
traditionally assisted consumers in
obtaining health insurance. We
anticipate that agents and brokers will
continue to be an important source of
assistance for many consumers seeking
access to health insurance coverage
through an Exchange, including those
who own and/or are employed by small
businesses. The proposed conflict-ofinterest standards for Navigators would
permit agents and brokers to serve as
Navigators in an Exchange operated by
HHS, provided that the agent or broker
can satisfy the standards that will apply
to all Navigators in the Exchange. For
example, as stated above, all Navigators,
including agents and brokers serving as
Navigators, are prohibited from
receiving consideration, directly or
indirectly, from any health insurance
issuer in connection with the
enrollment of consumers into QHPs or
non-QHPs (§ 155.210(d)(4)), and we
interpret that provision to apply to the
receipt of trailer commissions. Under
the proposed amendments to
§ 155.210(d), the same prohibition
would apply to agents or brokers
receiving consideration from stop loss
insurance issuers. Agents and brokers
who sell other lines of insurance would
not be prohibited from receiving
consideration from the sale of those
other lines of insurance while serving as
Navigators, provided they complied
with the disclosure requirement.
If an entity or organization is awarded
a grant to be a Navigator, the entity as
a whole is considered to be a Navigator.
Therefore, the prohibition on receipt of
compensation from certain insurance
issuers in connection with the
enrollment of consumers into QHPs or
non-QHPs, would apply to the entire
organization and its entire staff. While
a Navigator could retain staff members
who serve as agents and brokers, those
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staff members—and the organization
itself—could not receive compensation
from health insurance or stop loss
insurance issuers for enrolling
individuals or employees in QHPs or
health insurance plans outside of the
Exchange. Such staff members,
however, could continue to be
compensated for selling other insurance
products (for example, auto, life, and
homeowners’ policies).
We solicit public comments on the
proposed conflict-of-interest standards
applicable to Navigators.
b. Conflict-of-Interest Standards for
Non-Navigator Assistance Personnel
Carrying Out Consumer Assistance
Functions Under § 155.205(d) and (e)
(Proposed § 155.215(a)(2))
Proposed § 155.215(a)(2) would
establish a set of parallel conflict-ofinterest standards that would apply in
Federally-facilitated Exchanges
(including State Partnership Exchanges)
to non-Navigator assistance personnel
carrying out consumer assistance
functions under 155.205(d) and (e), and
to federally-funded non-Navigator
assistance personnel in a State-Based
Exchange. As discussed above, we
believe the same conflict-of-interest
considerations that apply to Navigators
should also apply to these nonNavigator assistance personnel. With
respect to the requirement to submit a
mitigation plan under proposed
§ 155.215(a)(2)(iii), consistent with the
requirement that only a Navigator entity
(not individual staff) would be required
to submit the plan, the mitigation plan
would only be required on an
individual basis if the individual is not
working for an entity serving as nonNavigator assistance personnel.
In addition, the proposed rule would
direct that these non-Navigator
assistance personnel adhere to and
comply with the same restrictions on
participation and prohibitions on
conduct that apply to Navigators under
§ 155.210(d). Therefore, like Navigators,
individuals and entities performing
non-Navigator assistance functions
under § 155.205(d) and (e) must not
have any of the disqualifying conflicts
of interest arising from being an issuer
of health insurance or stop loss
insurance, a subsidiary of such an
issuer, or an association with members
that are issuers or that lobbies for health
insurance or stop loss issuers, or from
receiving compensation from an issuer
of health insurance or stop loss
insurance in connection with
enrollment in QHPs or non-QHPs. We
solicit public comments on the
application of these proposed standards
to non-Navigator assistance personnel.
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2. Training Standards for Navigators and
Non-Navigator Assistance Personnel
Carrying Out Consumer Assistance
Functions Under §§ 155.205(d) and (e)
and 155.210 (Proposed § 155.215(b))
Existing regulations at 45 CFR
155.210(b)(2) direct Exchanges to
develop and disseminate a set of
training standards, to be met by all
entities and individuals carrying out
Navigator functions. Under
§ 155.210(b)(2), the training standards
developed by the Exchange must ensure
Navigator expertise in eligibility and
enrollment rules and procedures, the
range of QHP options and insurance
affordability programs, the needs of
underserved and vulnerable
populations, and privacy and security
requirements applicable to personally
identifiable information. In addition, to
receive a Navigator grant,
§ 155.210(c)(1)(iii) directs that an entity
or individual must meet any licensing,
certification, or other standards
prescribed by the state or Exchange, if
applicable.
In addition, in the proposed rule
relating to Essential Health Benefits in
Alternative Benefit Plans, Eligibility
Notices, Fair Hearing and Appeal
Processes for Medicaid and Exchange
Eligibility Appeals and Other Provisions
Related to Eligibility and Enrollment for
Exchanges, Medicaid and CHIP, and
Medicaid Premiums and Cost Sharing,
published on January 22, 2013 (78 FR
4594, 4710), we proposed an
amendment to § 155.205(d) that would
require any individual providing
consumer assistance under that section,
including Navigators, to ‘‘be trained
regarding QHP options, insurance
affordability programs, eligibility, and
benefits rules and regulations governing
all insurance affordability programs
operated in the state, as implemented in
the state, prior to providing such
assistance.’’
Consistent with the existing
requirements in § 155.210(b)(2) and
§ 155.210(c)(1)(iii) and the proposed
requirements at 78 FR 4710, we now
propose a specific set of training
standards that would require up to 30
hours of training, including standards
for certification and recertification, for
all Navigators and non-Navigator
assistance personnel in Federallyfacilitated Exchanges, including State
Partnership Exchanges, and all federally
funded non-Navigator assistance
personnel in State-based Exchanges, to
ensure that these entities and
individuals can satisfy the duties and
obligations of serving as Navigators or
non-Navigator assistance personnel.
These proposed standards would be
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applicable to all Navigators and nonNavigator assistance personnel in
Federally-facilitated Exchanges,
including State Partnership Exchanges,
and to all federally funded nonNavigator assistance personnel in Statebased Exchanges, and can be used by
State-based Exchanges at their option
for their Navigator personnel and nonfederally funded non-Navigator
assistance personnel.
a. Certification and Recertification
Standards (Proposed § 155.215(b)(1))
Section 1311(i)(4) of the Affordable
Care Act directs the Secretary to
establish standards for Navigators,
including provisions to ensure that any
private or public entity that is selected
as a Navigator is qualified, and licensed
if appropriate, to engage in Navigator
activities and to avoid conflicts of
interest. Under existing regulations at 45
CFR 155.210(c)(1)(iii), Navigators must
meet any ‘‘licensing, certification or
other standards prescribed by the state
or Exchange, if applicable.’’ In addition,
we have previously proposed to amend
§ 155.205(d) to require that any
individual providing consumer
assistance under § 155.205(d) must be
trained regarding QHP options,
insurance affordability programs,
eligibility, and benefits rules and
regulations governing all insurance
affordability programs operated in the
state, as implemented in the state, prior
to providing such assistance (78 FR
4594).
We now propose in § 155.215(b)(1)
that all Navigators and non-Navigator
assistance personnel in a Federallyfacilitated Exchange or State Partnership
Exchange, and federally-funded nonNavigator assistance personnel in a
State-Based Exchange, register with the
Exchange and be certified by the
Exchange, and prior to certification,
complete an HHS-approved training
before carrying out any consumer
assistance functions in the Exchange.
We propose in § 155.215(b)(2) the topics
about which such Navigators and nonNavigator assistance personnel would
receive training prior to certification.
The proposed rule would also direct
that individuals and staff of Navigator
entities and non-Navigator assistance
entities receive a passing score on all
HHS-approved examinations in order to
serve as Navigators or non-Navigator
assistance personnel in a Federallyfacilitated Exchange, a State Partnership
Exchange, or as federally-funded nonNavigator assistance personnel in a
State-based Exchange.
The proposed recertification
requirement for Navigators and nonNavigator assistance personnel would
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ensure that they remain appropriately
trained to adequately serve consumers.
The rule also proposes that Navigators
and non-Navigator assistance personnel
should obtain continuing education and
be certified and/or recertified on at least
an annual basis.
We also propose that these
certification requirements would
specifically direct that all Navigators
and non-Navigator assistance personnel
be prepared to serve both the individual
Exchange and SHOP in a Federallyfacilitated Exchange. Section
1311(i)(2)(A) of the Affordable Care Act
directs that, to be eligible to receive a
Navigator grant, an entity must
demonstrate that it has existing
relationships, or could readily establish
relationships, with employers and
employees. In addition, section
1311(i)(2)(B) directs that the types of
entities that may be eligible for a
Navigator grant include resource
partners of the Small Business
Administration. We infer from these
standards that Navigators must be
prepared to serve the needs of small
businesses, and therefore will need to be
prepared to serve the needs of both the
individual Exchange and SHOP. We
also believe that non-Navigator
assistance personnel who carry out
consumer outreach, assistance, and
education in the Exchange and are paid
for by Federal funding should be
prepared to serve the needs of both the
individual Exchange and SHOP. In
order to be truly helpful and useful to
the public, we believe that services
provided under § 155.205(d) and (e)
should be available to all consumers,
including small businesses. Directing
non-Navigator assistance personnel in
Federally-facilitated Exchanges,
including State Partnership Exchanges,
and federally funded non-Navigator
assistance personnel in State-based
Exchanges to provide assistance to all
consumers will ensure that they provide
services consistent with this
interpretation of § 155.205.
Each Navigator and non-Navigator
assistance personnel should have the
ability to help any individual who
presents him or herself for assistance.
However, there may be some instances
where a Navigator, or non-Navigator
assistance personnel, does not have the
immediate capacity to help an
individual. In such cases, the Navigator
or non-Navigator assistance personnel
should be capable of providing
assistance in a timely manner but
should also refer consumers seeking
assistance to other Exchange resources,
such as the toll-free Exchange Call
Center, or to another Navigator or nonNavigator assistance personnel in the
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20589
same Exchange who might have better
capacity to serve that individual more
effectively.
We solicit public comments on these
proposed training and certification
standards, including the proposed
recertification standards.
b. Training Module Content Standards
(Proposed § 155.215(b)(2))
Each entity that serves as a Navigator,
and each individual that will carry out
Navigator functions under the terms of
a Navigator grant in a Federallyfacilitated Exchange or State Partnership
Exchange, must receive training to
perform all of the duties of a Navigator.
Although different Navigators may
perform these duties at different levels
of effort or focus, every Navigator must
be trained to perform all of the listed
duties in section 1311(i)(3) of the
Affordable Care Act and in § 155.210(e).
Therefore, in order to carry out a
Navigator’s duties to maintain expertise
in eligibility and facilitate selection of
QHPs, all Navigators will receive
training so that they are equipped with
the necessary information to help
consumers apply for coverage through
the Exchange, which will ultimately
result in an eligibility determination for
enrollment in a QHP and/or an
insurance affordability program. NonNavigator assistance personnel must
receive comparable training with
respect to their specific responsibilities.
In addition, Navigators and nonNavigator assistance personnel must
receive training on the privacy and
security requirements for the protection
of personally identifiable information,
including relevant state laws.
In addition to training designed to
help Navigators and non-Navigator
assistance personnel build expertise in
eligibility and facilitating selection of
QHPs, training for Navigators and nonNavigator assistance personnel should
prepare them to educate consumers
about the advanced payments of the
premium tax credit and cost-sharing
reductions and help them submit the
appropriate information to receive an
eligibility determination for insurance
affordability programs, including
advanced payments of the premium tax
credits and cost-sharing reductions. In
addition, Navigators should be trained
so that they will be prepared to fulfill
the duty at § 155.210(e)(2) to ‘‘provide
information and services in a fair,
accurate and impartial manner,’’
including the requirement that ‘‘such
information acknowledge other health
programs,’’ including Medicaid and
CHIP. Therefore, § 155.215(b)(2)
proposes a set of standards for the
content of the training module for
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Navigators and non-Navigator assistance
personnel in a Federally-facilitated
Exchange or State Partnership
Exchange, and for federally funded nonNavigator assistance personnel in a
State-based Exchange, to ensure that
they would be knowledgeable in these
areas, and fully prepared to assist
consumers.
The Exchange regulations, at 45 CFR
155.260(a), establish privacy and
security standards for Exchanges, and
§ 155.260(b) provides that Exchanges
must require Navigators and other nonExchange entities to abide by the same
or more stringent privacy and security
standards as a condition of contract or
agreement with such entities. Consistent
with these requirements, we propose
that the training for Navigators and nonNavigator assistance personnel must
include training designed to ensure that
they safeguard consumers’ sensitive
personal information including but not
limited to health information, income
and tax information, and Social Security
number.
Subsections 155.205(d) and (e) direct
Exchanges to conduct consumer
assistance, outreach, and education
activities, including Navigator
programs, in a way that meets the
standards set forth at § 155.205(c).
Section 155.205(c), in turn, directs
Exchanges to provide information to
applicants and enrollees in plain
language and in a manner that is
accessible and timely to individuals
living with disabilities and individuals
who are limited English proficient
(LEP). Additionally, § 155.210(e)(5)
directs Navigators to provide
information in a manner that is
culturally and linguistically appropriate
to the needs of the population served by
the Exchange, including individuals
with limited English proficiency, and to
ensure accessibility and usability of
Navigator tools and functions for
individuals with disabilities. We
interpret the foregoing provisions to
require all entities and individuals
carrying out activities authorized by §§
155.205(d) and (e) and155.210,
including Navigators and non-Navigator
assistance personnel, to be
knowledgeable about the special needs
of populations with limited English
proficiency and people with a full range
of disabilities, and how best to
communicate with and assist these
consumers. The rule therefore proposes
that the training for Navigators and nonNavigator assistance personnel would
include training designed to ensure that
they will be equipped to provide
culturally and linguistically appropriate
services and ensure physical and other
accessibility for people with disabilities.
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We solicit public comments on the
proposed requirement to receive
training regarding culturally and
linguistically appropriate services as
well as accessibility for people with
disabilities.
3. Providing Culturally and
Linguistically Appropriate Services
(CLAS Standards) (Proposed
§ 155.215(c))
Proposed § 155.215(c) and (d) detail
standards for the use and provision of
culturally and linguistically appropriate
tools and services as well as
requirements to ensure access by
individuals with disabilities who seek
assistance from Navigators and nonNavigator assistance personnel in
Federally-facilitated Exchanges,
including State Partnership Exchanges,
and from federally-funded nonNavigator assistance personnel in a
State-based Exchange.
Section 1311(i)(3)(E) of the Affordable
Care Act directs that Navigator entities
have a duty to provide information in a
manner that is culturally and
linguistically appropriate to the needs of
the population being served by the
Exchange or Exchanges. According to
the regulation implementing this
provision, Navigators must ‘‘provide
information in a manner that is
culturally and linguistically appropriate
to the needs of the population being
served by the Exchange, including
individuals with limited English
proficiency’’ (§ 155.210(e)(5)).
Additionally, all non-Navigator
assistance personnel must meet the
accessibility standards set forth at
§ 155.205(c).
Independent of these obligations,
certain Federal civil rights laws, such as
Title VI of the Civil Rights Act of 1964
and Section 504 of the Rehabilitation
Act of 1973, also apply to Navigators in
Federally-facilitated and State
Partnership Exchanges. These laws
would also apply to non-Navigator
assistance programs in State-based and
State Partnership Exchanges to the
extent such programs receive federal
financial assistance. These federal civil
rights laws impose nondiscrimination
obligations with respect to persons with
disabilities and that address the
communications needs of persons who
have limited English proficiency (LEP).
While the proposed training module
content standards discussed earlier in
this preamble include a requirement
that training include providing
culturally and linguistically appropriate
services, this proposed rule also
provides more specific standards for
ensuring meaningful access. These
proposed standards should be read
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together with all other applicable
standards issued by the Secretary
related to ensuring meaningful access by
individuals with limited English
proficiency.
The specific standards proposed in
§ 155.215(c) include that Navigators and
non-Navigator assistance personnel
develop, maintain, and regularly update
general knowledge about the racial,
ethnic, and cultural groups in their
service area, including the primary
languages spoken, and continue to use
this information. The proposed
requirements would also include that
such entities and individuals provide
consumers with information and
assistance in the consumer’s preferred
language, at no cost to the consumer,
which would include oral interpretation
of non-English languages and the
translation of written documents in nonEnglish languages when necessary to
ensure meaningful access. We also
propose that use of a consumer’s family
or friends as interpreters can satisfy the
requirement to provide linguistically
appropriate services only when
requested by the consumer as the
preferred alternative to an offer of other
interpretive services. We anticipate that
most Navigators and non-Navigator
assistance personnel would use readily
available telephonic interpretation
services and other effective low-cost
services in order to meet the
requirement to provide language access
to the consumers they serve, so that it
will not be costly or onerous.
In addition, § 155.215(c)(4) of the
proposed rule would require that nonNavigator assistance personnel provide
limited-English-proficiency consumers
with oral and written notices informing
them of their right to receive language
assistance services and how to obtain
such services. This requirement could
be satisfied using methods outlined in
existing § 155.205(c)(2), which allows
for the use of taglines in non-English
languages placed on documents or Web
sites to indicate the availability of
language services.
Section 155.215(c)(6) of the proposed
rule would also direct Navigator and
non-Navigator assistance personnel
entities to implement strategies to
recruit and promote a staff that is
representative of the demographic
characteristics, including primary
languages spoken, of the communities
in their service area.
4. Standards Ensuring Access by
Persons With Disabilities (Proposed
§ 155.215(d))
Section 155.210(e)(5) directs that an
entity serving as a Navigator has a duty
to ‘‘ensure accessibility and usability of
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Navigator tools and functions for
individuals with disabilities in
accordance with the Americans with
Disabilities Act and Section 504 of the
Rehabilitation Act.’’ Similarly,
§ 155.205(c) requires that persons
providing consumer assistance pursuant
to § 155.205(d) and (e) provide
individuals living with disabilities with
information that is accessible at no cost
to the individual, in accordance with
the Americans with Disabilities Act and
section 504 of the Rehabilitation Act.
Additionally, independent of these
obligations, certain Federal civil rights
laws, such as Title VI of the Civil Rights
Act of 1964 and Section 504 of the
Rehabilitation Act of 1973, also apply to
Navigators in Federally-facilitated and
State Partnership Exchanges. These laws
would also apply to non-Navigator
assistance programs in State-based and
State Partnership Exchanges to the
extent such programs receive federal
financial assistance. These federal civil
rights laws impose nondiscrimination
obligations with respect to persons with
disabilities and that address the
communications needs of persons who
have limited English proficiency (LEP).
In accordance with these
requirements, § 155.215(d)(2) of the
proposed rule would direct that
auxiliary aids and services for
individuals with disabilities be
provided at no cost where necessary for
effective communication. The proposal
specifies that the use of a consumer’s
family or friends as interpreters can
satisfy the requirement to provide
auxiliary aids and services only when
requested by the consumer as the
preferred alternative to an offer of other
auxiliary aids and services. In addition,
proposed section 155.215(d)(3) would
require Navigators and non-Navigator
assistance personnel in a Federallyfacilitated Exchange or State Partnership
Exchange, and federally-funded nonNavigator assistance personnel in a
State-based Exchange to provide
assistance to consumers in a location
and in a manner that is physically and
otherwise accessible to individuals with
disabilities. Proposed section
155.215(d)(1) would direct Navigators
and non-Navigator assistance personnel
to ensure that any consumer education
materials, Web sites, or other tools
utilized for consumer assistance
purposes are accessible to people with
disabilities.
Section 155.215(d)(4) of the proposed
rule would also require that legally
authorized representatives be permitted
to assist individuals with disabilities to
make informed decisions. Finally,
proposed § 155.215(d)(5) would direct
that individuals carrying out Navigator
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and non-Navigator assistance functions
have the ability to refer people with
disabilities to local, state, and federal
long-term services and supports
programs when appropriate. We seek
comment on this requirement.
These proposed standards should be
read together with all other applicable
standards issued by the Secretary
related to ensuring meaningful access by
people with disabilities.
5. Monitoring (Proposed § 155.215(e))
The proposed rule indicates that
Federally-facilitated Exchanges
(including State Partnership Exchanges)
will monitor compliance with the
standards described in § 155.215 and
with the requirements described in
§ 155.205(d) and (e) and 155.210. To the
extent possible, these Exchanges will
engage in monitoring whether
Navigators and non-Navigator assistance
personnel comply with those standards,
including, for example, reviewing
reports filed by Navigators and
reviewing the attestations and conflictof-interest plans required to be
submitted to the Exchange as proposed
in § 155.215(a)(1)(i) through (ii) and
(a)(2)(ii) through (iii) of the proposed
regulation; conducting discussions with
states in which Navigator grantees and
non-Navigator assistance personnel
exercise their functions; and reviewing
casework and complaints filed with the
Exchange or a relevant state. We solicit
comments on how monitoring for
federally-funded non-Navigator
assistance personnel in State-based
Exchanges should be conducted.
III. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (PRA) requires
that we solicit comment on the
following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
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20591
This proposed rule would establish
conflict-of-interest and training
standards, including standards for
certification and recertification, for
Navigators and non-Navigator assistance
personnel in an Exchange being
operated by HHS as a Federallyfacilitated Exchange or as a State
Partnership Exchange pursuant to HHS
authority under section 1321(c)(1) of the
Affordable Care Act and for nonNavigator assistance personnel in Statebased Exchanges that are funded
through federal Exchange Establishment
grants. The proposal requires that these
Navigators and non-Navigator assistance
personnel provide an attestation that
they are not ineligible individuals or
entities and submit a plan for mitigating
conflicts of interest, register with the
Exchange, receive training, be initially
certified, and receive subsequent
recertification with the Exchange.
Section III.A outlines information
collection requirements associated with
disclosure of conflicts of interest. These
disclosures include an attestation
regarding eligibility to be a Navigator or
non-Navigator assistance personnel; a
plan for mitigating conflicts of interest;
a requirement to provide information to
consumers about their coverage options;
and a requirement to disclose other
potential, non-prohibited, conflicts of
interest. Section III.B outlines
information collection requirements
associated with registration,
certification, and recertification
requirements. We are soliciting public
comments on each of these issues for
the following sections of the proposed
rule that contain information collection
requirements (ICRs).
For purposes of the information
collection requirements, Navigator
personnel and non-Navigator assistance
personnel are estimated to have a
professional wage of $20 per hour.4
Navigator and non-Navigator assistance
project leads are estimated to have a
professional wage of $29 per hour.5
Navigator senior executives are
estimated to have a professional wage of
$48 per hour.6 The average professional
wage for Navigator personnel, projects
4 These positions are estimated to be equivalent
to a GS–9 position with the Federal government.
See https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2012/general-schedule/
gs_h.pdf.
5 These positions are estimated to be equivalent
to a GS–12 position with the Federal government.
See https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2012/general-schedule/
gs_h.pdf.
6 These positions are estimated to be equivalent
to a GS–15 position with the Federal government.
See https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2012/general-schedule/
gs_h.pdf.
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leads, senior executives, and nonNavigator assistance personnel and
project leads is estimated to be $29.20
per hour.
At this time we are unable to estimate
the number of Navigator grantees and
applicants or the number of nonNavigator assistance personnel and
project leads; therefore the estimates
discussed below are on a per individual
basis. Additionally, we are unable to
estimate the number of consumers
expected to receive assistance from
Navigator grantees or non-Navigator
assistance personnel; therefore estimates
for disclosures to consumers discussed
below are on a per consumer basis. We
invite public comments on the number
of Navigator grantees or the number of
non-Navigator assistance personnel and
project leads expected, as well as the
number of consumers expected to
receive assistance.
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A. ICRs Regarding Disclosure of
Conflicts of Interest (Proposed
§ 155.215(a))
Pursuant to proposed
§ 155.215(a)(1)(i) & (iv) and (a)(2)(ii) &
(v), Navigator program grantees and
other entities and individuals providing
assistance under §§ 155.205(d) and (e)
would be required to disclose conflicts
of interest. This disclosure would
include an attestation that an individual
or entity is not an ineligible entity.
Additionally, pursuant to proposed
§ 155.215(a)(1)(ii) and (a)(2)(iii), a plan
for mitigating any conflicts of interest
would also be submitted. The cost
burden associated with the attestation
would apply to each Navigator entity
and applicant, and to each individual or
entity serving as non-Navigator
assistance personnel. The cost burden
associated with the plan for mitigating
any conflicts of interest will apply to
each Navigator program grantee and to
each individual or entity serving as nonNavigator assistance personnel.7 The
attestation and mitigation plan are onetime requirements.
We estimate it will take Navigator
personnel, project leads, senior
executives, non-Navigator assistance
personnel, and non-Navigator assistance
project leads 0.25 hours (15 minutes)
each to prepare and provide the
attestation that they are an eligible
entity. With a wage of $20 per hour for
Navigator and non-Navigator personnel,
$29 per hour for Navigator and nonNavigator project leads, and $48 per
hour for senior executives, we estimate
7 The mitigation plan is only required on an
individual basis if the individual is not working for
an entity serving as non-Navigator assistance
personnel.
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the cost burden per Navigator personnel
would be $5, per Navigator project lead
would be $7.25, per Navigator senior
executives would be $12, per nonNavigator assistance personnel would
be $5, and per non-Navigator assistance
personnel would be $7.25. The total
burden per person would be 0.25 hours
and $7.30 on average.
The plan for mitigating conflicts of
interest would be required on a per
entity basis; 8 therefore we assume for
Navigator program grantees, the senior
executive would be responsible for
developing and providing the plan for
mitigating conflicts of interest because
only one plan is required per grantee.
For purposes of the ICR we are
assuming burden and cost estimates
based on a non-Navigator assistance
project lead wage of $29 per hour.
We estimate that for a Navigator
program grantee it will take a senior
executive up to 5 hours to prepare and
provide a plan for mitigating conflicts of
interest and a non-Navigator assistance
project lead would also require up to 5
hours to prepare and provide a plan for
mitigating conflicts of interest. With a
wage of $48 per hour for senior
executives and $29 per hour for nonNavigator assistance project leads, we
estimate the total one-time annual cost
burden for a Navigator program grantee
would be $240, and for non-Navigator
assistance project leads would be $145.
Pursuant to proposed
§ 155.215(a)(1)(iii) and (a)(2)(iv),
Navigator program grantees and nonNavigator assistance personnel would
be required to provide information to
consumers about the full range of QHP
options and insurance affordability
programs for which they are eligible. We
assume that the total time to provide
this disclosure would be one hour per
disclosure. We assume for the Navigator
program grantee that the Navigator
personnel would prepare the disclosure
and the total burden estimated per
disclosure would be 1 hour at a cost of
$20. For non-Navigator assistance
personnel we estimate the total burden
per disclosure would be 1 hour for
preparing the disclosure at a cost of $20.
The total burden per disclosure would
be 1 hour and $20 on average.
Pursuant to proposed
§ 155.215(a)(1)(iv) and (a)(2)(v),
Navigator personnel, projects leads,
senior executives, non-Navigator
assistance personnel, and non-Navigator
assistance project leads would be
required to disclose the Exchange and to
consumers: any lines of insurance
business, not covered by the restrictions
on participation and prohibitions on
8 An
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conduct in § 155.210(d), which they
intend to sell while carrying out the
consumer assistance functions; any
existing and former employment
relationships within the last five years
with any health insurance issuers or
issuers of stop loss insurance or
subsidiaries of health insurance issuers
or issuers of stop loss insurance; any
existing employment relationships
between a spouse or domestic partner
and any health insurance issuers or
issuers of stop loss insurance or
subsidiaries of health insurance issuers
or issuers of stop loss insurance; and
any existing or anticipated financial,
business, or contractual relationships
with one or more health insurance
issuers or issuers of stop loss insurance,
or subsidiaries of health insurance
issuers or issuers of stop loss insurance.
We estimate the total time to prepare
this disclosure would be 0.16 hours (10
minutes). The total cost estimated for
preparing this disclosure per Navigator
personnel would be $3.20, per Navigator
project lead would be $4.64, per
Navigator senior executive would be
$7.68, per non-Navigator assistance
personnel would be $3.20, and per nonNavigator assistance project lead would
be $4.64. The total burden per person
would be 0.16 hours and $4.67 on
average.
B. ICRs Regarding Training and
Certification Standards (Proposed
§ 155.215(b))
1. Registration Prior to Training
Pursuant to proposed
§ 155.215(b)(1)(ii), Navigator personnel,
project leads, senior executives, nonNavigator assistance personnel, and
non-Navigator assistance project leads
would be required to register prior to
training. We assume that it will take
Navigator personnel, project leads,
senior executives, non-Navigator
assistance personnel, and non-Navigator
assistance project leads each 0.25 hours
(15 minutes) to register. With a wage of
$20 per hour for Navigator and nonNavigator assistance personnel, $29 for
Navigator and non-Navigator assistance
project leads, and $48 for senior
executives, we estimate the total cost
burden for Navigator personnel would
be $5, for Navigator project leads would
be $7.25, for Navigator senior executives
would be $12, for non-Navigator
assistance personnel would be $5, and
for non-Navigator assistance project
leads would be $7.25. The total burden
per person would be 0.25 hours and
$7.30 on average.
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2. Certification and Recertification
Pursuant to § 155.215(b)(1), Navigator
personnel, project leads, senior
executives, non-Navigator assistance
personnel, and non-Navigator assistance
project leads would be required to
complete a training program to obtain
certification consisting of up to 30 hours
of training including any approved
certification exams. There are
recordkeeping requirements associated
with the certification and recertification
provisions. Each person who receives
training would be expected to obtain
and maintain a record of certification.
Pursuant to § 155.215(b)(1)(iv),
Navigator personnel, project leads,
senior executives, non-Navigator
assistance personnel, and non-Navigator
assistance project leads who intend to
continue beyond their initial period of
performance would be required to be
recertified on an annual basis. Each
person who receives recertification
would be expected to obtain proof of
recertification and keep it on file. It is
estimated that the time burden
associated with maintaining proof of
certification or recertification would be
0.016 hours (1 minute); we assume
proof will be maintained through
electronic copies with minimal cost.
The total cost estimated for
maintaining proof of certification or
recertification per Navigator would be
$0.32; per Navigator project lead would
be $0.48; per Navigator senior executive
would be $0.75; per non-Navigator
assistance personnel would be $0.32,
and per non-Navigator assistance project
lead would be $0.48. In the initial year
the requirement will be to maintain
proof of initial certification; in
subsequent years the requirement will
be to maintain proof of recertification.
Because these requirements would be
the same time and cost burden we are
categorizing them as one annual burden.
The total annual burden estimated for
maintaining proof of certification or
recertification would be 0.016 hours and
$0.47 on average.
TABLE 1—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS, BY RESPONDENT
Hourly labor
cost of
reporting
($) **
Burden per
response
(hours)
Total labor
cost of
reporting
($)
Total capital/
maintenance
costs ($)
Proposed regulation section(s)
OMB control No.
Conflict of Interest Attestation § 155.215(a)(1)(i)
& (a)(2)(ii).
Conflict
of
Interest
Mitigation
Plan§ 155.215(a)(1)(ii) & (a)(2)(iii) Navigator
Senior Executive.
Non-Navigator Assistance Project Lead ...............
Conflict of Interest Disclosure of Coverage Options § 155.215(a)(1)(iii) & (a)(2)(iv).
Conflict of Interest Disclosure to Exchange and
Consumers § 155.215(a)(1)(iv) & (a)(2)(v).
Training Registration § 155.215(b)(1)(ii) ...............
Certification and Recertification § 155.215(b)(1) ..
0938–New ....................
0.25
29.20
7.30
0
0938–New ....................
5
48
240
0
5 ....................................
0938–New ....................
29
1
145
20
0
20
0
0938–New ....................
.16
29.20
4.67
0
0938–New ....................
0938–New ....................
0.25
0.016
29.20
29.20
7.30
0.47
0
0
Total ...............................................................
.......................................
........................
........................
424.27
0
** The hourly cost of $29.20 in certain rows is an average of the professional wages estimated for Navigator personnel, project leads, senior
executives, non-Navigator assistance personnel, and non-Navigator assistance project leads.
IV. Regulatory Impact Statement
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
A. Summary
HHS is publishing this proposed rule
to implement the protections intended
by Congress in the most economically
efficient manner possible. HHS has
examined the effects of this rule as
required by Executive Order 13563 (76
FR 3821, January 21, 2011), Executive
Order 12866 (58 FR 51735, September
1993, Regulatory Planning and Review),
the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4), Executive Order
13132 on Federalism, and the
Congressional Review Act (5 U.S.C.
804(2)).
B. Executive Orders 12866 and 13563
Executive Order 12866 directs
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
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economic, environmental, public health
and safety effects; distributive impacts;
and equity). Executive Order 13563 is
supplemental to and reaffirms the
principles, structures, and definitions
governing regulatory review as
established in Executive Order 12866.
OMB has determined that this proposed
rule is a ‘‘significant regulatory action’’
under Executive Order 12866.
Accordingly, OMB reviewed this
proposed rule.
1. Need for Regulatory Action
This proposed regulation would
establish conflict of interest, training
and certification, and meaningful access
standards applicable to Navigator
programs in Federally-facilitated
Exchanges, including State Partnership
Exchanges, non-Navigator assistance
programs in State Partnership
Exchanges, and non-Navigator
assistance programs in State-Based
Exchanges that are funded through
federal 1311(a) Exchange Establishment
grants. The proposed rule would require
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that these Navigators and non-Navigator
assistance personnel register with and
be certified by the Exchange. In
addition, the proposed rule would
establish standards for Navigators and
non-Navigator assistance personnel to
ensure meaningful access to their
services by individuals with limited
English proficiency and individuals
with disabilities.
The proposed rule also would amend
existing regulations to clarify that
Navigators must meet any licensing,
certification or other standards
prescribed by the State or Exchange, if
applicable, so long as such standards do
not prevent the application of the
provisions of title I of the Affordable
Care Act; add entities with relationships
with issuers of stop loss insurance,
including those who are compensated
directly or indirectly by issuers of stop
loss insurance in connection with
enrollment in QHPs or non-QHPs, to the
list of entities ineligible to become
Navigators; and clarify that the same
ineligibility criteria that apply to
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Navigators providing services in any
Federally-facilitated Exchange,
including State Partnership Exchanges,
would also apply to non-Navigator
assistance personnel providing
assistance in State Partnership
Exchanges and federally-funded nonNavigator assistance personnel in Statebased Exchanges.
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
2. Summary of Impacts
The proposed regulations would help
ensure that Navigators in Federallyfacilitated Exchanges, non-Navigator
assistance personnel in State
Partnership Exchanges, and federallyfunded non-Navigator assistance
personnel in State-based Exchanges will
be fair and impartial, will be
appropriately trained, and will provide
services and information in a manner
that is accessible to persons with
limited English proficiency and persons
with disabilities. The proposed rule
would also ensure that Navigators meet
any licensing, certification or other
standards prescribed by the State or
Exchange, if applicable, so long as such
standards do not prevent the application
of the provisions of title I of the
Affordable Care Act.
Navigators and non-Navigator
assistance personnel would incur costs
in order to comply with the provisions
of this proposed rule, which would be
covered by the Navigator grants and
other compensation provided by the
Exchange to non-Navigator assistance
personnel. HHS anticipates that the
impacts of the proposed rule would not
be economically significant.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
requires agencies that issue a regulation
to analyze options for regulatory relief
of small businesses if a 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’’). HHS uses as its measure of
significant economic impact on a
substantial number of small entities a
change in revenues of more than 3 to 5
percent.
HHS anticipates that the proposed
rule would not have a significant
economic impact on a substantial
number of small entities. Some of the
entities that act as Navigators and nonNavigator assistance personnel may be
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small entities and would incur costs to
comply with the provisions of this rule.
It should be noted that serving as a
Navigator or non-Navigator assistance
personnel is voluntary, and the cost
burden related to registering for
accounts, verification of registration,
initial online training and certification,
continuing education and
recertification, conflict of interest
notification, and providing assistance to
consumers would be covered by the
Navigator grants and other
compensation provided by the Exchange
to non-Navigator assistance personnel.
Due to lack of data, HHS is unable to
estimate how many small entities would
elect to serve as Navigators and nonNavigator assistance personnel. We
invite public comments on this issue.
The size threshold for ‘‘small’’
business established by the SBA is
currently $7 million in annual receipts
for insurance agencies and brokerages.9
As discussed earlier, we anticipate that
agents and brokers will continue to be
an important source of assistance for
many consumers seeking access to
health insurance coverage through an
Exchange, including those who own
and/or are employed by small
businesses. The proposed conflict of
interest standards for Navigators would
permit agents and brokers to serve as
Navigators in an Exchange operated by
HHS, provided that the agent or broker
can satisfy the standards that would
apply to all Navigators in the Exchange.
Additionally, we anticipate that agents
and brokers will also play a role in
educating consumers about Exchanges
and insurance affordability programs,
and in helping consumers receive
eligibility determinations, compare
plans, and enroll in coverage to the
extent permitted by a given state.
In addition, section 1102(b) of the
Social Security Act requires us to
prepare a regulatory impact analysis if
a rule may have a significant economic
impact on the operations of a substantial
number of small rural hospitals. This
analysis must conform to the provisions
of section 604 of the RFA. This
proposed rule would not affect small
rural hospitals. Therefore, the Secretary
has determined that this proposed rule
would not have a significant impact on
the operations of a substantial number
of small rural hospitals.
D. Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
9 ‘‘Table of Size Standards Matched To North
American Industry Classification System Codes,’’
effective January 7, 2013, U.S. Small Business
Administration, available at https://www.sba.gov.
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requires that agencies assess anticipated
costs and benefits before issuing any
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 2013, that threshold level is
approximately $141 million.
UMRA does not address the total cost
of a final rule. Rather, it focuses on
certain categories of cost, mainly those
‘‘Federal mandate’’ costs resulting
from—(1) imposing enforceable duties
on state, local, or tribal governments, or
on the private sector; or (2) increasing
the stringency of conditions in, or
decreasing the funding of, state, local, or
tribal governments under entitlement
programs.
This proposed rule does not mandate
expenditures by state governments,
local governments, tribal governments,
or the private sector, of $141 million.
The cost burden for Navigators and nonNavigator assistance personnel related
to registering for accounts, verification
of registration, initial online training
and certification, continuing education
and recertification and conflict of
interest notification would be covered
by the Navigator grants and other
compensation provided by the Exchange
to non-Navigator assistance personnel
and would not exceed the UMRA
threshold. As discussed previously in
the preamble, state-based Exchanges
and state partners in State Partnership
Exchanges may use section 1311(a)
Exchange Establishment grants to fund
non-Navigator assistance programs.
Section 1311(i)(6) prohibits Exchanges
from using section 1311(a) grant funds
to fund Navigator grants. Section
1311(a) grant funds, however, may be
used to cover the Exchange’s cost of
administering the Navigator program,
including, for example, the cost of
Navigator training, grants management,
and oversight.
E. Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a rule
that imposes substantial direct
requirement costs on state and local
governments or has federalism
implications.
The proposed rule would clarify that
any Navigator licensing, certification, or
other standards prescribed by the state
or Exchange should not prevent the
application of the provisions of title I of
the Affordable Care Act. An entity or
individual would be required to meet
any licensing, certification, or other
standards prescribed by the State or
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Exchange, if applicable, so long as such
standards do not prevent the application
of the provisions of title I of the
Affordable Care Act.
Throughout the process of developing
this proposed regulation, HHS has
attempted to balance the states’ interests
and Congress’ intent to provide uniform
minimum protections to consumers in
every state. By doing so, it is HHS’s
view that we 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
regulation, the Department certifies that
the Centers for Medicare & Medicaid
Services has complied with the
requirements of Executive Order 13132
for the proposed regulation in a
meaningful and timely manner.
F. Congressional Review Act
This proposed rule 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.
List of Subjects in 45 CFR Part 155
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Administrative practice and
procedure, Advertising, Brokers,
Conflict of interest, Consumer
protection, Grant programs-health,
Grants administration, Health care,
Health insurance, Health maintenance
organization (HMO), Health records,
Hospitals, Indians, Individuals with
disabilities, Loan programs-health,
Organization and functions
(Government agencies), Medicaid,
Public assistance programs, Reporting
and recordkeeping requirements, Safety,
State and local governments, Technical
assistance, Women, and Youth.
For the reasons stated in the
preamble, the Department of Health and
Human Services proposes to amend 45
CFR part 155 as set forth below:
PART 155—EXCHANGE
ESTABLISHMENT STANDARDS AND
OTHER RELATED STANDARDS
UNDER THE AFFORDABLE CARE ACT
1. The authority citation for part 155
continues to read as follows:
■
Authority: Title I of the Affordable Care
Act, sections 1301, 1302, 1303, 1304, 1311,
1312, 1313, 1321, 1322, 1331, 1334, 1402,
1411, 1412, 1413.
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2. Section 155.210 is amended by
revising paragraphs (c)(1)(iii), (d)(1),
(d)(2), and (d)(4) to read as follows:
■
§ 155.210
Navigator program standards.
*
*
*
*
*
(c) * * *
(1) * * *
(iii) Meet any licensing, certification
or other standards prescribed by the
State or Exchange, if applicable, so long
as such standards do not prevent the
application of the provisions of title I of
the Affordable Care Act;
*
*
*
*
*
(d) * * *
(1) Be a health insurance issuer or
issuer of stop loss insurance;
(2) Be a subsidiary of a health
insurance issuer or issuer of stop loss
insurance;
*
*
*
*
*
(4) Receive any consideration directly
or indirectly from any health insurance
issuer or issuer of stop loss insurance in
connection with the enrollment of any
individuals or employees in a QHP or a
non-QHP.
*
*
*
*
*
■ 3. Section 155.215 is added to read as
follows:
§ 155.215 Standards applicable to
Navigators and non-Navigator Assistance
Personnel carrying out consumer
assistance functions under §§ 155.205(d)
and (e) and 155.210 in a Federally-facilitated
Exchange and to non-Navigator Assistance
Personnel Funded Through an Exchange
Establishment Grant.
(a) Conflict-of-Interest Standards. The
following conflict-of-interest standards
apply in an Exchange operated by HHS
during the exercise of its authority
under 45 CFR 155.105(f) and to nonNavigator assistance personnel funded
through an Exchange Establishment
Grant under section 1311(a) of the
Affordable Care Act:
(1) Conflict-of-Interest Standards for
Navigators.
(i) All Navigator entities, including
Navigator grant applicants, must submit
to the Exchange a written attestation
that the Navigator, including the
Navigator’s staff:
(A) Is not a health insurance issuer or
issuer of stop loss insurance;
(B) Is not a subsidiary of a health
insurance issuer or issuer of stop loss
insurance;
(C) Is not an association that includes
members of, or lobbies on behalf of, the
insurance industry; and
(D) Will not receive any consideration
directly or indirectly from any health
insurance issuer or issuer of stop loss
insurance in connection with the
enrollment of any individuals or
employees in a QHP or non-QHP.
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Sfmt 4702
20595
(ii) All Navigator entities must submit
to the Exchange a written plan to remain
free of conflicts of interest during the
term as a Navigator.
(iii) All Navigator entities, including
the Navigator’s staff, must provide
information to consumers about the full
range of QHP options and insurance
affordability programs for which they
are eligible.
(iv) All Navigator entities, including
the Navigator’s staff, must disclose to
the Exchange and to each consumer
who receives application assistance
from the Navigator:
(A) Any lines of insurance business,
not covered by the restrictions on
participation and prohibitions on
conduct in § 155.210(d), which the
Navigator intends to sell while carrying
out the consumer assistance functions;
(B) Any existing employment
relationships, or any former
employment relationships within the
last 5 years, with any health insurance
issuers or issuers of stop loss insurance
or subsidiaries of health insurance
issuers or issuers of stop loss insurance,
including any existing employment
relationships between a spouse or
domestic partner and any health
insurance issuers or issuers of stop loss
insurance, or subsidiaries of health
insurance issuers or issuers of stop loss
insurance; and
(C) Any existing or anticipated
financial, business, or contractual
relationships with one or more health
insurance issuers or issuers of stop loss
insurance, or subsidiaries of health
insurance issuers or issuers of stop loss
insurance.
(2) Conflict-of-Interest Standards for
Non-Navigator Assistance Personnel
Carrying Out Consumer Assistance
Functions Under § 155.205(d) and (e).
All Non-Navigator entities or
individuals authorized to carry out
consumer assistance functions under
§ 155.205(d) and (e) must—
(i) Comply with the prohibitions on
Navigator conduct set forth at
§ 155.210(d).
(ii) Submit to the Exchange a written
attestation that the entity or individual:
(A) Is not a health insurance issuer or
issuer of stop loss insurance;
(B) Is not a subsidiary of a health
insurance issuer or issuer of stop loss
insurance;
(C) Is not an association that includes
members of, or lobbies on behalf of, the
insurance industry; and
(D) Will not receive any consideration
directly or indirectly from any health
insurance issuer or issuer of stop loss
insurance in connection with the
enrollment of any individuals or
employees in a QHP or non-QHP.
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(iii) Submit to the Exchange a written
plan to remain free of conflicts of
interest while carrying out consumer
assistance functions under § 155.205(d)
and (e).
(iv) Provide information to consumers
about the full range of QHP options and
insurance affordability programs for
which they are eligible.
(v) Disclose to the Exchange and to
each consumer who receives application
assistance from the entity or individual:
(A) Any lines of insurance business,
not covered by the restrictions on
participation and prohibitions on
conduct in § 155.210(d), which the
entity or individual intends to sell while
carrying out the consumer assistance
functions;
(B) Any existing employment
relationships, or any former
employment relationships within the
last five years, with any health
insurance issuers or issuers of stop loss
insurance, or subsidiaries of health
insurance issuers or issuers of stop loss
insurance, including any existing
employment relationships between a
spouse or domestic partner and any
health insurance issuers or issuers of
stop loss insurance, or subsidiaries of
health insurance issuers or issuers of
stop loss insurance; and
(C) Any existing or anticipated
financial, business, or contractual
relationships with one or more health
insurance issuers or issuers of stop loss
insurance, or subsidiaries of health
insurance issuers or issuers of stop loss
insurance.
(b) Training standards for Navigators
and Non-Navigator Assistance
Personnel carrying out consumer
assistance functions under
§§ 155.205(d) and (e) and 155.210. The
following training standards apply in an
Exchange operated by HHS during the
exercise of its authority under
§ 155.105(f), and to non-Navigator
assistance personnel funded through an
Exchange Establishment Grant under
section 1311(a) of the Affordable Care
Act.
(1) Certification and recertification
standards. All individuals or entities
who carry out consumer assistance
functions under §§ 155.205(d) and (e)
and 155.210, including Navigators, must
meet the following certification and
recertification requirements.
(i) Obtain certification by the
Exchange prior to carrying out any
consumer assistance functions under
§§ 155.205(d) and (e) or 155.210;
(ii) Register for and complete a HHSapproved training;
(iii) Following completion of the
HHS-approved training described in
paragraph (b)(1)(ii) of this section,
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complete and achieve a passing score on
all approved certification examinations
prior to carrying out any consumer
assistance functions under §§ 155.205(d)
and (e) or 155.210;
(iv) Obtain continuing education and
be certified and/or recertified on at least
an annual basis; and
(v) Be prepared to serve both the
individual Exchange and SHOP.
(2) Training module content
standards. All individuals who carry
out the consumer assistance functions
under §§ 155.205(d) and (e) and 155.210
must receive training in the following
subjects:
(i) QHPs (including the metal levels
described at § 156.140(b)), and how they
operate, including benefits covered,
payment processes, rights and processes
for appeals and grievances, and
contacting individual plans;
(ii) The range of insurance
affordability programs, including
Medicaid, the Children’s Health
Insurance Program (CHIP), and other
public programs;
(iii) The tax implications of
enrollment decisions;
(iv) Eligibility requirements for
premium tax credits and cost-sharing
reductions, and the impacts of premium
tax credits on the cost of premiums;
(v) Contact information for
appropriate federal, state, and local
agencies for consumers seeking
additional information about specific
coverage options not offered through the
Exchange;
(vi) Basic concepts about health
insurance and the Exchange; the
benefits of having health insurance and
enrolling through an Exchange; and the
individual responsibility to have health
insurance;
(vii) Eligibility and enrollment rules
and procedures, including how to
appeal an eligibility determination;
(viii) Providing culturally and
linguistically appropriate services;
(ix) Ensuring physical and other
accessibility for people with a full range
of disabilities;
(x) Understanding differences among
health plans;
(xi) Privacy and security standards
applicable under § 155.260 for handling
and safeguarding consumers’ personally
identifiable information;
(xii) Working effectively with
individuals with limited English
proficiency, people with a full range of
disabilities, and vulnerable, rural, and
underserved populations;
(xiii) Customer service standards;
(xiv) Outreach and education methods
and strategies; and
(xv) Applicable administrative rules,
processes and systems related to
Exchanges and QHPs.
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(c) Providing Culturally and
Linguistically Appropriate Services
(CLAS Standards). The following
standards will apply in an Exchange
operated by HHS during the exercise of
its authority under § 155.105(f) and to
non-Navigator assistance personnel
funded through an Exchange
Establishment Grant under section
1311(a) of the Affordable Care Act. To
ensure that information provided as part
of any consumer assistance functions
under §§ 155.205(d) and (e) or 155.210
is culturally and linguistically
appropriate to the needs of the
population being served, including
individuals with limited English
proficiency as required by
§§ 155.205(c)(2) and 155.210(e)(5), any
entity or individual carrying out these
functions must:
(1) Develop and maintain general
knowledge about the racial, ethnic, and
cultural groups in their service area,
including each group’s diverse cultural
health beliefs and practices, preferred
languages, health literacy, and other
needs;
(2) Collect and maintain updated
information to help understand the
composition of the communities in the
service area, including the primary
languages spoken;
(3) Provide consumers with
information and assistance in the
consumer’s preferred language, at no
cost to the consumer, including the
provision of oral interpretation of nonEnglish languages and the translation of
written documents in non-English
languages when necessary to ensure
meaningful access. Use of a consumer’s
family or friends as oral interpreters can
satisfy the requirement to provide
linguistically appropriate services only
when requested by the consumer as the
preferred alternative to an offer of other
interpretive services;
(4) Provide oral and written notice to
consumers with limited English
proficiency informing them of their
right to receive language assistance
services and how to obtain them;
(5) Receive ongoing education and
training in culturally and linguistically
appropriate service delivery; and
(6) Implement strategies to recruit,
support, and promote a staff that is
representative of the demographic
characteristics, including primary
languages spoken, of the communities
in their service area.
(d) Standards ensuring access by
persons with disabilities. The following
standards related to ensuring access by
people with disabilities will apply in an
Exchange operated by HHS during the
exercise of its authority under
§ 155.105(f), and to non-Navigator
E:\FR\FM\05APP1.SGM
05APP1
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
assistance personnel funded through an
Exchange Establishment Grant under
section 1311(a) of the Affordable Care
Act. Any entity or individual carrying
out any consumer assistance functions
under §§ 155.205(d) and (e) or 155.210,
and in accordance with § 155.205(c),
must:
(1) Ensure that any consumer
education materials, Web sites, or other
tools utilized for consumer assistance
purposes, are accessible to people with
disabilities, including those with
sensory impairments, such as visual or
hearing impairments, and those with
mental illness, addiction, and physical,
intellectual, and developmental
disabilities;
(2) Provide auxiliary aids and services
for individuals with disabilities, at no
cost, where necessary for effective
communication. Use of a consumer’s
family or friends as interpreters can
satisfy the requirement to provide
auxiliary aids and services only when
requested by the consumer as the
preferred alternative to an offer of other
auxiliary aids and services;
(3) Provide assistance to consumers in
a location and in a manner that is
physically and otherwise accessible to
individuals with disabilities;
(4) Ensure that legally authorized
representatives are permitted to assist
an individual with a disability to make
informed decisions;
(5) Acquire sufficient knowledge to
refer people with disabilities to local,
state, and federal long-term services and
supports programs when appropriate;
and
(6) Be able to work with all
individuals regardless of age, disability,
or culture, and seek advice or experts
when needed.
(e) Monitoring. Any Exchange
operated by HHS during the exercise of
its authority under § 155.105(f) will
monitor compliance with the standards
in this section and the requirements of
§§ 155.205(d) and (e) and 155.210.
Dated: March 13, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: March 25, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2013–07951 Filed 4–3–13; 11:15 am]
BILLING CODE 4120–01–P
VerDate Mar<15>2010
16:26 Apr 04, 2013
Jkt 229001
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 575
[Docket No. NHTSA–2012–0180]
New Car Assessment Program (NCAP)
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Request for comments.
AGENCY:
The U.S. New Car Assessment
Program (NCAP) provides comparative
information on the safety of new
vehicles to assist consumers with
vehicle purchasing decisions and
encourage motor vehicle manufacturers
to make safety improvements. To
maintain the relevance and effectiveness
of NCAP, NHTSA has periodically
updated the program, most recently in
model year 2011.
In response to the rapid development
of vehicle safety technologies, especially
in the area of crash avoidance, the
agency is once again requesting public
comments in order to help identify the
potential areas for improvement to the
program that have the greatest potential
for producing safety benefits. This
notice lists and describes potential areas
of study for improving NCAP. The
agency will use the comments it
receives to aid it in developing a notice
proposing near term upgrades to NCAP.
The agency will also use the comments
received in response to this notice to
help it in developing a draft 5-year plan
for the NCAP program outlining
research that the agency plans to
conduct as well as longer term upgrades
it intends to pursue making to NCAP.
DATES: You should submit your
comments early enough to ensure that
Docket Management receives them no
later than July 5, 2013.
ADDRESSES: Comments should refer to
the docket number above and be
submitted by one of the following
methods:
• Federal Rulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Mail: Docket Management Facility,
U.S. Department of Transportation, 1200
New Jersey Avenue SE., West Building
Ground Floor, Room W12–140,
Washington, DC 20590–0001.
• Hand Delivery: 1200 New Jersey
Avenue SE., West Building Ground
Floor, Room W12–140, Washington, DC,
between 9 a.m. and 5 p.m. ET, Monday
through Friday, except Federal
Holidays.
SUMMARY:
PO 00000
Frm 00102
Fmt 4702
Sfmt 4702
20597
• Instructions: For detailed
instructions on submitting comments
and additional information on the
rulemaking process, see the Public
Participation heading of the
SUPPLEMENTARY INFORMATION section of
this document. Note that all comments
received will be posted without change
to https://www.regulations.gov, including
any personal information provided.
• Privacy Act: Anyone is able to
search the electronic form of all
comments received into any of our
dockets by the name of the individual
submitting the comment (or signing the
comment, if submitted on behalf of an
association, business, labor union, etc.).
You may review DOT’s complete
Privacy Act Statement in the Federal
Register published on April 11, 2000
(65 FR 19477–78). For access to the
docket to read background documents
or comments received, go to https://
www.regulations.gov or the street
address listed above. Follow the online
instructions for accessing the dockets.
FOR FURTHER INFORMATION CONTACT: For
crashworthiness issues, you may contact
Ms. Jennifer N. Dang, Division Chief,
New Car Assessment Program, Office of
Crashworthiness Standards (Telephone:
202–493–0598). For crash avoidance
and advanced technology issues, you
may contact, Mr. Clarke Harper, Crash
Avoidance NCAP Coordinator
(Telephone: 202–366–1810). For legal
issues, you may contact Mr. Steve
Wood, Office of Chief Counsel
(Telephone: 202–366–2992). You may
send mail to any of these officials at the
National Highway Traffic Safety
Administration, 1200 New Jersey
Avenue SE., NVS–100, West Building,
Washington, DC 20590–0001.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Background
III. Comments Requested
IV. Subject Areas Under Consideration for
Possible Inclusion or Refinement
a. Crash Avoidance and Post-Crash
Technology Areas Under Consideration
i. Warning Technologies
1. Blind Spot Detection
2. Advanced Lighting
ii. Intervention Technologies
1. Lane Departure Prevention
2. Crash Imminent Braking (CIB) and
Dynamic Brake Support (DBS)
3. Automatic Pedestrian Detection and
Braking (Frontal and Rearward)
iii. Crash Notification Technologies
b. Crashworthiness Areas Under
Consideration
i. Rear Seat Occupants
ii. Silver Car Rating System for Older
Occupants
iii. Pedestrian Protection
E:\FR\FM\05APP1.SGM
05APP1
Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Proposed Rules]
[Pages 20581-20597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07951]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 155
[CMS-9955-P]
RIN 0938-AR75
Patient Protection and Affordable Care Act; Exchange Functions:
Standards for Navigators and Non-Navigator Assistance Personnel
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The proposed regulations would create conflict-of-interest,
training and certification, and meaningful access standards applicable
to Navigators and non-Navigator assistance personnel in Federally-
facilitated Exchanges, including State Partnership Exchanges, and to
non-Navigator assistance personnel in State-based Exchanges that are
funded through federal Exchange Establishment grants. These proposed
standards would help ensure that Navigators and non-Navigator
assistance personnel will be fair and impartial and will be
appropriately trained, and that they will provide services and
information in a manner that is accessible.
The proposed regulations would also make two amendments to the
existing regulation for Navigators that would apply to all Navigators
in all Affordable Insurance Exchanges (Exchanges), including State-
based Exchanges, clarifying that any Navigator licensing,
certification, or other standards
[[Page 20582]]
prescribed by the state or Exchange must not prevent the application of
the provisions of title I of the Affordable Care Act; and adding to the
list of entities ineligible to become Navigators, those entities with
relationships to issuers of stop loss insurance, including those who
are compensated directly or indirectly by issuers of stop loss
insurance in connection with enrollment in Qualified Health Plans or
non-Qualified Health Plans. The proposed regulations would also clarify
that the same ineligibility criteria that apply to Navigators would
also apply to non-Navigator assistance personnel providing services in
any Federally-facilitated Exchanges, including in State Consumer
Partnership Exchanges, and to federally funded non-Navigator assistance
personnel in State-based Exchanges.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on May 6, 2013.
ADDRESSES: In commenting, please refer to file code CMS-9955-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-9955-P, P.O. Box 8010,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-9955-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period: a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Room 445-G, Hubert H. Humphrey Building, 200
Independence Avenue, SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Joan Matlack, (888) 393-2789.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: https://www.regulations.gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland, 21244, Monday through Friday of each week from
8:30 a.m. to 4 p.m. To schedule an appointment to view public comments,
phone (800) 743-3951.
I. Background
A. Introduction
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 laws are collectively known as the Affordable Care Act.
Beginning on October 1, 2013, individuals and small businesses will
be able to purchase private health insurance through state-based
competitive marketplaces called Affordable Insurance Exchanges
(Exchanges), also known as the Health Insurance Marketplaces.
The Exchanges will provide competitive marketplaces where
individuals and small employers can compare available private health
insurance options on the basis of price, quality, and other factors.
The Exchanges, which will offer coverage that is effective beginning on
January 1, 2014, will help enhance competition in the health insurance
market, improve choice of affordable health insurance, and give small
businesses the same purchasing power as large businesses.
Pursuant to sections 1311(b) and 1321(b) of the Affordable Care
Act, each state has the opportunity to establish an Exchange that--(1)
Facilitates the purchase of insurance coverage by qualified individuals
through Qualified Health Plans (QHPs); (2) assists qualified employers
in the enrollment of their employees in QHPs; and (3) meets other
standards specified in the Affordable Care Act. These are referred to
as State-Based Exchanges.
Section 1321(c)(1) of the Affordable Care Act requires the
Secretary of HHS (``Secretary'') to establish and operate Exchanges
within states that either: (1) do not elect to establish an Exchange,
or (2) as determined by the Secretary on or before January 1, 2013,
will not have an Exchange operational by January 1, 2014. These HHS-
operated Exchanges are referred to as Federally-facilitated Exchanges.
The Secretary has also explained through sub-regulatory guidance that
these Federally-facilitated Exchanges may include State Partnership
Exchanges in which states may assume significant responsibility for key
Exchange functions.\1\ Generally, a State Partnership Exchange will
take one of two forms: a State Plan Management Partnership Exchange, or
a State Consumer Partnership Exchange (Consumer Partnership Exchange).
---------------------------------------------------------------------------
\1\ See 77 FR 18310, 18325-26 (Mar. 27, 2012); General Guidance
on Federally-facilitated Exchanges (May 16, 2012) at https://cciio.cms.gov/resources/files/ffe-guidance-05-16-2012.pdf; and
Guidance on the State Partnership Exchange (Jan. 3, 2013) at https://cciio.cms.gov/resources/files/partnership-guidance-01-03-2013.pdf.
---------------------------------------------------------------------------
Consumers can receive assistance from a variety of sources when
seeking access to health insurance coverage through an Exchange.
Sections 1311(d)(4)(K) and 1311(i) of the Affordable Care Act, and the
regulation implementing those provisions, 45 CFR
[[Page 20583]]
155.210, direct all Exchanges to award grants to Navigators that will
provide fair and impartial information to consumers about health
insurance, the Exchange, QHPs, and insurance affordability programs
including premium tax credits, Medicaid and the Children's Health
Insurance Program (CHIP); and that will provide referrals to consumer
assistance programs (CAP) and health insurance ombudsmen for enrollees
with grievances, complaints, or questions about their health plan or
coverage. Navigators are an important resource for all consumers,
particularly communities that are under-served by and under-represented
in the current health insurance market. Navigators will not make
eligibility determinations and will not select QHPs for consumers or
enroll applicants into QHPs, but will help consumers through the
eligibility and enrollment process. The Exchange regulations, at 45 CFR
155.400(a), state that ``[t]he Exchange must accept a QHP selection
from an applicant * * * and must--(1) Notify the issuer of the
applicant's selected QHP; and (2) Transmit information necessary to
enable the QHP issuer to enroll the applicant'' (emphasis added).
Additionally, as articulated in 45 CFR Sec. 155.310(d), the Exchange
is responsible for making eligibility determinations. Taken together,
these regulations clearly mean that the Exchange, not Navigators, must
determine eligibility and enroll applicants into QHPs. Additionally, a
Navigator cannot make the decision for an applicant as to which QHP to
select. That said, Navigators may play an important role in
facilitating a consumer's enrollment in a QHP by providing fair,
impartial, and accurate information that assists consumers with
submitting the eligibility application, clarifying the distinctions
among QHPs, and helping qualified individuals make informed decisions
during the health plan selection process.
The Exchange regulations also authorize Exchanges to perform
certain consumer service functions in addition to the Navigator
program. Federal regulations at 45 CFR Sec. 155.205(d) and (e) provide
that each Exchange must conduct consumer assistance activities as well
as outreach and education activities to educate consumers about the
Exchange and insurance affordability programs to encourage
participation. The activities under Sec. 155.205(d) and (e) include,
but are not limited to, the Navigator grant program. Establishing a
non-Navigator consumer assistance program pursuant to Sec. 155.205(d)
and (e) will help ensure that the Exchange is providing outreach,
education, and assistance to as broad a range of consumers as possible
so that all consumers can receive help when accessing health insurance
coverage through an Exchange.
A program established to fulfill the consumer assistance,
education, and outreach functions under Sec. 155.205(d) and (e)
through in-person consumer support, other than a Navigator program, is
referred to in the proposed regulation and in this preamble as a ``non-
Navigator assistance program authorized by Sec. 155.205(d) and (e)''
or more simply as a ``non-Navigator assistance program.'' In addition,
we refer to persons carrying out these consumer assistance, education,
and outreach functions under Sec. 155.205(d) and (e) as ``non-
Navigator assistance personnel carrying out consumer assistance
functions under Sec. 155.205 (d) and (e)'' or ``non-Navigator entities
or individuals authorized to carry out consumer assistance functions
under Sec. 155.205 (d) and (e)'' or more simply as ``non-Navigator
assistance personnel.'' Non-Navigator assistance programs include what
have sometimes been referred to as ``in-person assistance programs.''
Similarly, non-Navigator assistance personnel include what have
sometimes been referred to as ``in-person assistance personnel.''
Therefore, when references are made in this preamble or in the proposed
regulation to non-Navigator assistance programs or non-Navigator
assistance personnel, those references also apply to in-person
assistance programs or in-person assistance personnel, respectively.
State-based Exchanges may, but need not, establish non-Navigator
assistance programs to provide consumer assistance, education, and
outreach under Sec. 155.205(d) and (e). Additionally, as a condition
of a state's participation in a Consumer Partnership Exchange, the
state will establish and operate a non-Navigator assistance program in
a way that is consistent with the policies and interpretations HHS
adopts for Sec. 155.205(d) and (e) for the Federally-facilitated
Exchanges. This does not affect the obligation of a Consumer
Partnership Exchange to establish and operate a Navigator program,
however. HHS will have responsibility for the inherently governmental
function of awarding federal Navigator grants for the Federally-
facilitated Exchanges, including State Partnership Exchanges.
Federally-facilitated Exchanges, other than Consumer Partnership
Exchanges, do not anticipate including a non-Navigator assistance
program.
Section 1311(i)(6) prohibits Exchanges from using section 1311(a)
grant funds to fund Navigator grants. However, section 1311(a) grant
funds may be used to cover the Exchange's cost of administering the
Navigator program, including, for example, the cost of Navigator
training, grants management, and oversight.
State-based Exchanges and state partners in Consumer Partnership
Exchanges may use section 1311(a) Exchange Establishment grants to fund
non-Navigator assistance programs consistent with the following
discussion.
Together, section 1311(a)(4)(B) and section 1311(d)(5)(A) provide
that, as long as grant funds under section 1311(a) are available to the
state, a State-based Exchange need not be self-sustaining during its
initial year of operation. Accordingly, as long as section 1311(a)
grant funds are available to the state, a State-based Exchange may not
have sufficient funds independent of section 1311(a) grant funds during
its initial year of operation to achieve all of the goals of the
Navigator program. As a transitional policy in such circumstances, a
State-based Exchange may use a non-Navigator assistance program in its
initial year of operation to fill in any gaps in its Navigator program
and otherwise ensure that the full range of services that its Navigator
program will provide in subsequent years are provided during its
initial year of operation. As the State-based Exchange becomes self-
sustaining, the roles of the non-Navigator assistance program and the
Navigator program may change. We note that, after the State-based
Exchange becomes self-sustaining, the State-based Exchange can choose
to establish or continue a non-Navigator assistance program, as a
supplement to its fully-funded Navigator program. Similarly, a State-
based Exchange that is self-sustaining from the outset, because section
1311(a) grant funds are no longer available to the state, can make a
similar choice. In both such circumstances, the non-Navigator
assistance program would have to be funded through some source other
than section 1311(a) grant funds.
Section 1311(a) grant funds are available for non-Navigator
assistance programs in Consumer Partnership Exchanges because the state
has elected to establish and operate outreach, educational, and
assistance activities to assist in its transition to a State-based
Exchange, as a condition of its participation in the Consumer
Partnership Exchange. Such activities do not purport to, nor do they in
fact, supplant the obligation of the federal
[[Page 20584]]
government to establish a Navigator program. When a state partner in a
Consumer Partnership Exchange transitions to a State-Based Exchange,
the discussion of State-Based Exchanges above will apply.
While section 1311(i)(1) directs that the Navigator program be a
grant program, State-based Exchanges and state partners in a Consumer
Partnership Exchange have the flexibility to build a non-Navigator
assistance program through contracts, direct hiring, or grants, subject
to state law. Utilizing funding mechanisms other than grants for non-
Navigator assistance programs may be particularly important to ensure
that State-based Exchanges have enhanced flexibility to utilize non-
Navigator assistance personnel to fill in any gaps in their Navigator
programs or to appropriately supplement their Navigator program, as
described above, by, for example, serving communities that may not be
reached by their Navigator program.
B. Legislative and Regulatory Overview
Section 1311 of the Affordable Care Act generally establishes the
creation of Exchanges and outlines various requirements and standards
Exchanges must satisfy. Specifically, pursuant to sections 1311(b) and
1321(b) of the Affordable Care Act, each state has the opportunity to
establish an Exchange.
Sections 1311(d)(4)(K) and 1311(i) of the Affordable Care Act
direct each Exchange to establish a program under which it awards
grants to Navigators who will carry out a list of required duties. A
final rule implementing sections 1311(d)(4)(K) and 1311(i) of the
Affordable Care Act was published on March 27, 2012 (77 FR 18310), and
is codified at 45 CFR Sec. 155.210.
Section 1311(i)(3) of the Affordable Care Act lists the duties
Navigators must perform. Section 155.210(e) interprets these duties to
include: maintaining expertise in eligibility, enrollment, and program
specifications; conducting public education activities to raise
awareness about the Exchange; providing information and services in a
fair, accurate, and impartial manner, including information that
acknowledges other health programs such as Medicaid and CHIP;
facilitating selection of a QHP; providing referrals for consumers with
questions, complaints, or grievances to any applicable office of health
insurance consumer assistance or health insurance ombudsman established
under section 2793 of the Public Health Service Act (PHS Act), or any
other appropriate state agency or agencies; providing information in a
culturally and linguistically appropriate manner, including to persons
with limited English proficiency; and ensuring accessibility and
usability of Navigator tools and functions for persons with
disabilities.
Section 1311(i)(4) directs the Secretary to establish standards for
Navigators, including provisions to ensure that any entity selected as
a Navigator is qualified, and licensed if appropriate, to engage in the
Navigator activities required by the law and to avoid conflicts of
interest. 45 CFR 155.210(b)(1), which interprets this provision,
directs each Exchange to ``develop and publicly disseminate * * * [a]
set of standards, to be met by all entities and individuals awarded
Navigator grants, designed to prevent, minimize and mitigate any
conflicts of interest, financial or otherwise, that may exist for an
entity or individuals to be awarded a Navigator grant and to ensure
that all entities and individuals carrying out Navigator functions have
appropriate integrity.'' Additionally, 45 CFR 155.210(c)(1)(iv)
provides that a Navigator must not have a conflict of interest during
its term as Navigator. 45 CFR 155.210(b)(2) directs Exchanges to
develop and disseminate a set of training standards, to be met by all
entities and individuals carrying out Navigator functions, to ensure
Navigator expertise in the needs of underserved and vulnerable
populations; eligibility and enrollment rules and procedures; the range
of QHP options and insurance affordability programs; and privacy and
security requirements applicable to personally identifiable
information. This proposal develops and disseminates standards under
Sec. 155.210(b)(1) and (2) for the Federally-facilitated Exchanges,
including State Partnership Exchanges, and for non-Navigator assistance
personnel in State-based Exchanges that are funded through federal
Exchange Establishment grants. These standards could also be used by
State-based Exchanges at their discretion for their Navigator programs
and for any non-Navigator assistance programs not funded with 1311(a)
Exchange Establishment grants.
45 CFR 155.210(c)(1)(iii) also interprets section 1311(i)(4), and
directs that entities or individuals must meet any licensing,
certification, or other standards prescribed by the state or Exchange,
if applicable, in order to receive a Navigator grant.
Section 1311(i)(4) of the Affordable Care Act also specifies that
under the standards established by the Secretary, Navigators shall not
be health insurance issuers or receive any consideration directly or
indirectly from any health insurance issuer in connection with the
enrollment of any qualified individuals or employees of a qualified
employer in QHPs. 45 CFR Sec. 155.210(d), which interprets this
provision, prohibits Navigators from being health insurance issuers. It
also provides that Navigators should not receive any compensation
directly or indirectly from health insurance issuers in connection with
the enrollment of qualified individuals or employees of a qualified
employer, whether that enrollment is in QHPs or in non-QHPs. Section
155.210(d) further clarifies that a Navigator must not be a subsidiary
of a health insurance issuer or be an association that includes members
of, or lobbies on behalf of, the insurance industry.
Section 1311(i)(5) of the Affordable Care Act directs the Secretary
to develop standards to ensure that information made available by
Navigators is fair, accurate, and impartial.
Provisions of the Exchange regulations, at 45 CFR 155.210(c)(2),
direct the Exchange to select at least two different types of entities
as Navigators, one of which must be a community and consumer-focused
non-profit group.
Section 1321(a) of the Affordable Care Act provides authority for
the Secretary to establish standards and regulations to implement the
statutory standards related to Exchanges, QHPs, and other components of
title I of the Affordable Care Act.
Section 1321(c)(1) of the Affordable Care Act requires the
Secretary to establish and operate Exchanges within states that either:
(1) do not elect to establish an Exchange, or (2) as determined by the
Secretary on or before January 1, 2013, will not have an Exchange
operational by January 1, 2014. These HHS-operated Exchanges are
referred to as Federally-facilitated Exchanges, and include State
Partnership Exchanges.
Section 1321(d) of the Affordable Care Act states that nothing in
title I of that Act shall be construed to preempt any state law that
does not prevent the application of the provisions of the title. Title
I of the Affordable Care Act includes all provisions related to
Exchanges, including the Navigator provisions.
Provisions of the Exchange regulations, at 45 CFR 155.205(d),
direct Exchanges to have a consumer assistance function that meets the
accessibility standards set forth in Sec. 155.205(c). This consumer
assistance function includes the Navigator program at section 1311(i)
of the Affordable Care Act and 45 CFR 155.210, but is not limited to
the Navigator program.
[[Page 20585]]
45 CFR 155.205(e) directs Exchanges to conduct outreach and education
activities that also meet the accessibility standards in Sec.
155.205(c), and to educate consumers about the Exchange and insurance
affordability programs to encourage participation. The accessibility
standards for Sec. 155.205(d) and (e), as detailed in Sec.
155.205(c), include a requirement that applicants and enrollees be
provided information in plain language and in a manner that is
accessible and timely for persons with disabilities and individuals
with limited English proficiency. Additionally, a notice of proposed
rulemaking published on January 22, 2013 would amend Sec. 155.205(d)
\2\ to require any individual providing consumer assistance under Sec.
155.205(d) to be trained regarding QHP options, insurance affordability
programs, eligibility, and benefits rules and regulations governing all
insurance affordability programs operated in the state, as implemented
in the state, prior to providing consumer assistance. Once finalized,
that rule will apply to and require such training for non-Navigator
assistance personnel.
---------------------------------------------------------------------------
\2\ See Notice of Proposed Rulemaking on Essential Health
Benefits in Alternative Benefit Plans, Eligibility Notices, Fair
Hearing and Appeal Processes for Medicaid and Exchange Eligibility
Appeals and Other Provisions Related to Eligibility and Enrollment
for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost
Sharing, 78 FR 4594, 4710 (Jan. 22, 2013).
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HHS has also published a proposed a rule (78 FR 4594) that would
create a new section 45 CFR Sec. 155.225, proposing to require each
Exchange to certify staff and volunteers of Exchange-designated
organizations and organizations designated by State Medicaid and
Children's Health Insurance Program agencies to serve as certified
application counselors in the Exchange.
C. Overview of Proposed Rule
First, this proposed regulation would amend Sec.
155.210(c)(1)(iii) to clarify that any Navigator licensing,
certification, or other standards prescribed by the state or Exchange
must not prevent the application of the provisions of title I of the
Affordable Care Act. The proposed rule would also amend Sec.
155.210(d) to clarify that a Navigator cannot be an issuer of, or a
subsidiary of an issuer of, stop loss insurance, and cannot receive any
consideration, directly or indirectly, from an issuer of stop loss
insurance in connection with the enrollment of any individuals or
employees in a QHP or a non-QHP. These proposed amendments to Sec.
155.210 would be applicable to Navigators in all Exchanges, including
Federally-facilitated Exchanges, State Partnership Exchanges, and
State-based Exchanges.
Second, this proposed rule would add a new provision at 45 CFR
155.215 that would establish conflict-of-interest, training, and
accessibility standards applicable to Navigators and non-Navigator
assistance personnel in Federally-facilitated Exchanges, including
State Partnership Exchanges. We also propose that these standards would
apply to non-Navigator assistance programs and personnel in State-based
Exchanges that are funded through federal section 1311(a) Exchange
Establishment grants.
Proposed section 155.215(a) provides details on the set of
conflict-of-interest standards applicable to these Navigators and non-
Navigator personnel. Proposed Sec. 155.215(a)(2)(i) would also
establish that the non-Navigator assistance personnel described above
must comply with the same set of conflict-of-interest prohibitions that
apply to Navigators under Sec. 155.210(d). Section 155.215(b) proposes
standards related to training, certification, and recertification for
these Navigators and non-Navigator personnel. These standards include
details about the requirement to be certified, to register and receive
training, the content required for training, and the requirement to
receive a passing score on all HHS-approved certification examinations
after training. Proposed Sec. 155.215(c) and (d) would establish
standards for these Navigators and non-Navigator personnel to ensure
meaningful access to their services by individuals with limited English
proficiency and people with disabilities. The standards proposed at
155.215(c) and (d) should be read together with all other applicable
standards issued by the Secretary related to ensuring meaningful access
by individuals with limited English proficiency and people with
disabilities.
State-based Exchanges would not be required to use the standards
proposed in Sec. 155.215 for their Navigators, or for non-Navigator
assistance programs not funded through section 1311(a) Exchange
Establishment grants. However, we believe that State-based Exchanges
may find the federal standards to be useful models, and could draw upon
them as they develop and disseminate conflict-of-interest and training
standards for Navigators pursuant to Sec. 155.210(b), or when
establishing standards for any non-Navigator assistance program that is
established by the State-based Exchange that is not funded by federal
1311(a) Exchange Establishment grants.
In addition, while the conflict-of-interest, training and
meaningful access standards that are now being proposed would apply to
the Navigators and non-Navigator assistance personnel described above,
we have not proposed that the standards would also apply to certified
application counselors. Certified application counselors have been
proposed as an additional source of consumer assistance, required in
every Exchange, in a separate proposed rule (78 FR 4594), but that rule
has not yet been finalized. We are, however, requesting public comments
regarding whether all or some of the standards being proposed for
Navigators and non-Navigator assistance personnel in this proposed
regulation should also apply to certified application counselors in the
event that every Exchange is required to establish a certified
application counselor program after publication of a final rule.
II. Provisions of the Proposed Rule
A. Navigator Program Standards (Proposed Amendments to Sec. 155.210)
The proposed rule contains two amendments to specific provisions of
the existing Navigator regulation, Sec. 155.210. These proposed
amendments would apply to Navigators in all Exchanges, including
Federally-facilitated Exchanges, State Partnership Exchanges and State-
based Exchanges.
1. Entities and Individuals Eligible to be a Navigator (Proposed
Amendment to Sec. 155.210(c)(1)(iii))
Section 155.210(c)(1)(iii), implementing section 1311(i)(4) of the
Affordable Care Act, currently directs that, to receive a Navigator
grant, an entity or individual must ``meet any licensing, certification
or other standards prescribed by the state or Exchange, if
applicable.'' Section 1321(d) of the Affordable Care Act provides that
state laws that do not prevent the application of the provisions of
title I of the Affordable Care Act are not preempted.
The proposed rule would clarify that any Navigator licensing,
certification, or other standards prescribed by the state or Exchange
should not prevent the application of the provisions of title I of the
Affordable Care Act. Thus, for example, as HHS has previously advised
(see 77 FR 18310 at 18331-32), a requirement by a state or an Exchange
that Navigators be agents and brokers or obtain errors and omissions
coverage would violate the requirement at Sec. 155.210(c)(2) that at
least two types of entities must serve as Navigators, because it would
mean that only agents
[[Page 20586]]
or brokers could be Navigators. In addition, holding an agent or broker
license is neither necessary, nor by itself sufficient, to perform the
duties of a Navigator, as these licenses generally do not address areas
in which Navigators need expertise, including the public coverage
options that would be available to some consumers. Similarly, if a
State or Exchange required all Navigators to hold a producer license,
or if a producer license was required to carry out any of the required
Navigator duties, this would also conflict with Sec. 155.210(c)(2),
because in that event, all Navigators in the Exchange would be licensed
agents or brokers, as defined in Sec. 155.20.
Therefore, we propose to amend Sec. 155.210(c)(1)(iii) to clarify,
consistent with Affordable Care Act section 1321(d), that to receive a
Navigator grant, an entity or individual must meet any licensing,
certification or other standard prescribed by the State or Exchange, if
applicable, as long as such standards do not prevent the application of
the provisions of title I of the Affordable Care Act. We solicit public
public comments on this proposed amendment.
2. Prohibition on Navigator Conduct (Proposed Amendment to Sec.
155.210(d))
Under Sec. 155.210(d), a Navigator may not be a health insurance
issuer; be a subsidiary of a health insurance issuer; be an association
that includes members of, or lobbies on behalf of, the insurance
industry; or receive any consideration, directly or indirectly, from
any health insurance issuer in connection with the enrollment of any
individuals or employees in a QHP or non-QHP. We propose to amend
section 155.210(d) to further clarify that a Navigator must also not be
an issuer of stop loss insurance, or a subsidiary of an issuer of stop
loss insurance, and must not receive any consideration, directly or
indirectly, from any issuer of stop loss insurance in connection with
the enrollment of individuals or employers in a QHP or non-QHP.\3\
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\3\ HHS, jointly with the Departments of Labor and the Treasury,
issued a Request for Information Regarding Stop Loss Insurance on
May 1, 2012. See 77 FR 25788. In that Request for Information, we
explained that stop loss insurance is designed to protect against
health insurance claims that are catastrophic or unpredictable in
nature, and that it provides coverage to self-insured group health
plans once a certain level of risk has been absorbed by the plan.
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Section 1311(i)(3)(B) of the Affordable Care Act directs that a
Navigator must distribute fair and impartial information concerning
enrollment in QHPs. Section 1311(i)(5) of the Affordable Care Act
further directs that the Secretary shall establish standards to ensure
that information made available by Navigators is fair, accurate, and
impartial. In addition, section 1311(i)(4) directs the Secretary to
establish standards to avoid conflicts of interest by Navigators.
Existing regulations at 45 CFR 155.210(c)(1)(iv) and (e)(2) also direct
that Navigators must not have a conflict of interest during their term
as a Navigator, and must provide information and services in a fair,
accurate, and impartial manner. Taken together, these requirements
indicate that a Navigator should not have a conflict of interest when
presenting information or providing the range of coverage choices to
individuals or small employers who receive the Navigator's assistance.
Similarly, the Navigator must not have a personal interest in the
coverage choices made by individuals or employers who receive the
Navigator's assistance. More specifically, with respect to the
assistance offered by a Navigator to a small employer, a Navigator
should not have a personal interest in whether a small employer chooses
to self-insure its employees, or chooses to enroll in fully-insured
coverage inside or outside the Exchange.
We believe that an issuer of stop loss insurance, a subsidiary of
an issuer of stop loss insurance, or an individual or entity receiving
consideration from any issuer of stop loss insurance in connection with
enrollment in a QHP or non-QHP, would have conflicts of interest
prohibited by Sec. 155.210(c)(1)(iv) and such conflicts of interest
would compromise the ability of a Navigator to provide information and
services in a fair, accurate, and impartial manner as required by Sec.
155.210(e)(2).
Navigators with a financial relationship with an issuer of stop
loss insurance raise the same kinds of concerns that would be present
for a Navigator with a relationship with a health insurance issuer (or
an entity receiving consideration from a health insurance issuer). Such
Navigators could have a financial incentive to encourage small
employers towards self-funding and might not present all coverage
options, including insured options, to small employers in a fair,
accurate, and impartial manner. In addition, such conflicts of interest
might interfere with a Navigator's duty to ``facilitate selection of a
QHP,'' as required by Sec. 155.210(e)(3).
The proposed amendments would help ensure that Navigators provide
any small employers that request help from a Navigator with information
and services in a fair, accurate, and impartial manner, and that such
information facilitate small employers' selection of QHPs in Small
Business Health Options (SHOP) Exchanges, if they choose to enroll in
such coverage. We solicit public comments on this proposal.
B. Standards Applicable to Navigators and Non-Navigator Assistance
Personnel Carrying Out Consumer Assistance Functions Under Sec. Sec.
155.205(d) and (e) and 155.210 in a Federally-Facilitated Exchange and
to Non-Navigator Assistance Personnel Funded Through an Exchange
Establishment Grant (Proposed Sec. 155.215)
1. Conflict-of-Interest Standards (Proposed Sec. 155.215(a))
The proposed regulation proposes conflict-of-interest standards
that are substantially similar for both Navigators and non-Navigator
assistance personnel. These proposed conflict-of-interest standards
would apply to all Navigators and non-Navigator assistance personnel in
a Federally-facilitated Exchange (including a State Partnership
Exchange), and to federally-funded non-Navigator assistance personnel
in a State-based Exchange.
The standards applicable to Navigators interpret the requirements
at section 1311(i)(4) of the Affordable Care Act and 45 CFR
155.210(c)(1)(iv) and (d). In addition, these standards would help
ensure that Navigators provide information in a fair, accurate, and
impartial manner, pursuant to Affordable Care Act section 1311(i)(5)
and 45 CFR 155.210(e)(2). These standards also follow from 45 CFR
155.210(b), which specifies that Exchanges establish a set of conflict-
of-interest standards applicable to Navigators in the Exchange.
We also believe that non-Navigator assistance personnel who carry
out consumer outreach, assistance, and education in Federally-
facilitated Exchanges, including State Partnership Exchanges, and non-
Navigator assistance personnel in State-based Exchanges that are funded
through Exchange Establishment grants should be subject to conflict-of-
interest standards. To be helpful to the public, we believe that
services provided under Sec. 155.205(d) and (e) should be carried out
in a fair, impartial, and unbiased manner. Applying conflict-of-
interest standards to these non-Navigator assistance personnel will
therefore ensure that they provide services consistent with this
interpretation of Sec. 155.205,and will minimize confusion in the
marketplace. We solicit public comments on applying the same conflict-
of-interest standards to both
[[Page 20587]]
Navigators and non-Navigator assistance personnel.
State-based Exchanges would not be required to adopt the conflict-
of-interest standards proposed in Sec. 155.215(a) for their Navigators
or for their non-Navigator assistance personnel that are not funded
through 1311(a) Exchange Establishment grants. However, State-based
Exchanges may wish to consider using the standards proposed in Sec.
155.215 as models when developing their own standards.
a. Conflict-of-Interest Standards for Navigators (Proposed Sec.
155.215(a)(1))
Section 1311(i)(4) of the Affordable Care Act directs the Secretary
to establish standards for Navigators, including provisions to avoid
conflicts of interest. Section 155.210(b)(1) directs all Exchanges to
develop and publicly disseminate conflict-of-interest standards for
Navigators. The conflict-of-interest standards proposed in Sec.
155.215(a)(1) are intended to apply to all Navigators in Federally-
facilitated Exchanges, including State Partnership Exchanges.
Section 155.210(c)(1)(iv) prohibits Navigators from having
conflicts of interest during their terms as Navigators. In this
context, we have explained that having a conflict of interest means
having a private or personal interest sufficient to influence, or
appear to influence, the objective exercise of a Navigator's official
duties (77 FR 18330-18331). In addition, Sec. 155.210(d) directs that
a Navigator must not have certain relationships with insurance issuers
or the insurance industry. Because any individual or entity with the
conflicts of interest listed at Sec. 155.210(d) would be barred from
participating as a Navigator, the first proposed conflict-of-interest
standard, as set forth in proposed Sec. 155.215(a)(1)(i), would
require that a Navigator entity, including a Navigator grant applicant,
submit to the Exchange a written attestation that the Navigator and its
staff do not have any of these prohibited conflicts of interest. This
disclosure to the Exchange will help to ensure that Navigators comply
with the prohibitions on Navigator conduct set forth in Sec.
155.210(d), and that individuals and entities who are ineligible under
Sec. 155.210(d) do not apply to the Exchange for grants to serve as
Navigators. We solicit public comments on the proposal to require
Navigators to submit an attestation regarding eligibility.
Proposed Sec. 155.215(a)(1)(ii) would direct that all Navigator
entities submit to the Exchange a written plan to remain free of
conflicts of interest during their term as a Navigator. This plan
should ensure that the Navigator grantee, and all those individuals who
serve as Navigators under the direction of the Navigator grantee, would
fully comply with the prohibitions in Sec. 155.210(d), and all other
conflict-of-interest requirements, as described below, throughout the
term of a Navigator grant. This would be particularly important for
those Navigator entities that may have a changing workforce, and might
thus utilize new or different staff or employees during the term of a
Navigator grant. We solicit public comments on the proposed requirement
to submit a written plan to remain free of conflicts of interest,
including comments on the form of and content for the plan.
Proposed Sec. 155.215(a)(1)(iii) would direct that all Navigators,
both individual Navigators and Navigator entities, and their staff,
provide information to consumers about the full range of QHP options
and insurance affordability programs such as premium tax credits and
cost sharing reductions and Medicaid and CHIP, for which they are
eligible. This proposed requirement would help ensure that consumers
receive all of the information they need to make an informed enrollment
decision, and that the information they receive is fair, as required by
Sec. 155.210(e)(2).
Lastly, the proposed conflict-of-interest standards for Navigators
include the requirement at proposed Sec. 155.215(a)(1)(iv) that
certain conflicts of interest, while not a bar to serving as a
Navigator, should be disclosed to the Exchange and to each consumer
receiving application assistance (which includes pre-enrollment and
post-enrollment services, but does not include outreach and education
assistance), both by the Navigator individual and the entity. In
developing the conflict-of-interest standards in the proposed rule, we
have been mindful that every Navigator must ``provide information and
services in a fair, accurate and impartial manner'' under Sec.
155.210(e)(2). We have also been mindful that each Exchange must
develop standards ``designed to prevent, minimize and mitigate any
conflicts of interest, financial or otherwise, that may exist for an
entity or individuals to be awarded a Navigator grant and to ensure
that all entities and individuals carrying out Navigator functions have
appropriate integrity,'' Sec. 155.210(b)(1). The requirement that an
Exchange develop standards to minimize and mitigate conflicts of
interests suggests that some conflicts of interest would not be
absolute bars to service as a Navigator, provided that the conflict of
interest would not ultimately prevent the entity or individual from
providing information and services in a fair, accurate, and impartial
manner. Striking this balance will allow for a robust pool of
Navigators, without sacrificing the need to ensure that all Navigators
have the integrity, fairness, and impartiality to carry out their
duties appropriately.
Under the proposed rule, in order to mitigate conflicts of
interest, there are three types of information that Navigators should
disclose to the Exchange and to their consumers. First, Navigator and
all Navigator staff members would be required to disclose to the
Exchange and to each consumer who receives application assistance from
the Navigator entity or individual, any lines of insurance business,
other than health insurance or stop loss insurance, which the Navigator
intends to sell while serving as a Navigator. Since Navigators must not
sell health insurance and as we also propose, must not sell stop loss
insurance, the proposed requirement that Navigators disclose ``any
lines of insurance business'' is not intended to apply to the sale of
health insurance or stop loss insurance, since these are not conflicts
of interest that could be mitigated through disclosure (see Sec.
155.210(d)).
In addition, the proposed rule would require disclosure of two
other types of indirect financial conflicts of interest. Navigators and
their staff members would be required to disclose to the Exchange and
each consumer receiving application assistance, any existing and former
employment relationships they have had within the last five years with
any issuer of health insurance or stop loss insurance, or subsidiaries
of such issuers. It is is intended that any existing employment
relationships disclosed would be non-prohibited relationships, because
receipt of any consideration directly or indirectly from any health
insurance issuer or issuer of stop loss insurance in connection with
the enrollment of any individuals or employees in a QHP or a non-QHP
would already be prohibited by Sec. 155.210(d)(4). They must also
disclose any existing employment relationships between any health
insurance issuer or stop-loss insurance issuer, or subsidiary of such
issuers, and the individual's spouse or domestic partner. Navigators
and their staff members would also be required to disclose to the
Exchange and to each consumer receiving application assistance any
existing or anticipated financial, business, or contractual
relationships with one or more issuers of health insurance or stop loss
insurance or subsidiaries of such
[[Page 20588]]
issuers. These types of conflict-of-interest relationships with issuers
of health insurance or stop loss insurance should be disclosed because
these relationships may confer benefits or indirect financial gain that
would compromise a Navigator's objectivity. We solicit public comments
on the proposed requirement to disclose certain types of potential
financial conflicts of interest.
Under existing regulations, a Navigator must not act on behalf of
health insurance issuers, either as agents or under appointment, since
this would violate the prohibition on conflicts of interest in Sec.
155.210(d)(1) through (d)(3) and the prohibition at Sec. 155.210(d)(4)
on receiving compensation from issuers in connection with enrollment.
However, we note that agents and brokers have traditionally assisted
consumers in obtaining health insurance. We anticipate that agents and
brokers will continue to be an important source of assistance for many
consumers seeking access to health insurance coverage through an
Exchange, including those who own and/or are employed by small
businesses. The proposed conflict-of-interest standards for Navigators
would permit agents and brokers to serve as Navigators in an Exchange
operated by HHS, provided that the agent or broker can satisfy the
standards that will apply to all Navigators in the Exchange. For
example, as stated above, all Navigators, including agents and brokers
serving as Navigators, are prohibited from receiving consideration,
directly or indirectly, from any health insurance issuer in connection
with the enrollment of consumers into QHPs or non-QHPs (Sec.
155.210(d)(4)), and we interpret that provision to apply to the receipt
of trailer commissions. Under the proposed amendments to Sec.
155.210(d), the same prohibition would apply to agents or brokers
receiving consideration from stop loss insurance issuers. Agents and
brokers who sell other lines of insurance would not be prohibited from
receiving consideration from the sale of those other lines of insurance
while serving as Navigators, provided they complied with the disclosure
requirement.
If an entity or organization is awarded a grant to be a Navigator,
the entity as a whole is considered to be a Navigator. Therefore, the
prohibition on receipt of compensation from certain insurance issuers
in connection with the enrollment of consumers into QHPs or non-QHPs,
would apply to the entire organization and its entire staff. While a
Navigator could retain staff members who serve as agents and brokers,
those staff members--and the organization itself--could not receive
compensation from health insurance or stop loss insurance issuers for
enrolling individuals or employees in QHPs or health insurance plans
outside of the Exchange. Such staff members, however, could continue to
be compensated for selling other insurance products (for example, auto,
life, and homeowners' policies).
We solicit public comments on the proposed conflict-of-interest
standards applicable to Navigators.
b. Conflict-of-Interest Standards for Non-Navigator Assistance
Personnel Carrying Out Consumer Assistance Functions Under Sec.
155.205(d) and (e) (Proposed Sec. 155.215(a)(2))
Proposed Sec. 155.215(a)(2) would establish a set of parallel
conflict-of-interest standards that would apply in Federally-
facilitated Exchanges (including State Partnership Exchanges) to non-
Navigator assistance personnel carrying out consumer assistance
functions under 155.205(d) and (e), and to federally-funded non-
Navigator assistance personnel in a State-Based Exchange. As discussed
above, we believe the same conflict-of-interest considerations that
apply to Navigators should also apply to these non-Navigator assistance
personnel. With respect to the requirement to submit a mitigation plan
under proposed Sec. 155.215(a)(2)(iii), consistent with the
requirement that only a Navigator entity (not individual staff) would
be required to submit the plan, the mitigation plan would only be
required on an individual basis if the individual is not working for an
entity serving as non-Navigator assistance personnel.
In addition, the proposed rule would direct that these non-
Navigator assistance personnel adhere to and comply with the same
restrictions on participation and prohibitions on conduct that apply to
Navigators under Sec. 155.210(d). Therefore, like Navigators,
individuals and entities performing non-Navigator assistance functions
under Sec. 155.205(d) and (e) must not have any of the disqualifying
conflicts of interest arising from being an issuer of health insurance
or stop loss insurance, a subsidiary of such an issuer, or an
association with members that are issuers or that lobbies for health
insurance or stop loss issuers, or from receiving compensation from an
issuer of health insurance or stop loss insurance in connection with
enrollment in QHPs or non-QHPs. We solicit public comments on the
application of these proposed standards to non-Navigator assistance
personnel.
2. Training Standards for Navigators and Non-Navigator Assistance
Personnel Carrying Out Consumer Assistance Functions Under Sec. Sec.
155.205(d) and (e) and 155.210 (Proposed Sec. 155.215(b))
Existing regulations at 45 CFR 155.210(b)(2) direct Exchanges to
develop and disseminate a set of training standards, to be met by all
entities and individuals carrying out Navigator functions. Under Sec.
155.210(b)(2), the training standards developed by the Exchange must
ensure Navigator expertise in eligibility and enrollment rules and
procedures, the range of QHP options and insurance affordability
programs, the needs of underserved and vulnerable populations, and
privacy and security requirements applicable to personally identifiable
information. In addition, to receive a Navigator grant, Sec.
155.210(c)(1)(iii) directs that an entity or individual must meet any
licensing, certification, or other standards prescribed by the state or
Exchange, if applicable.
In addition, in the proposed rule relating to Essential Health
Benefits in Alternative Benefit Plans, Eligibility Notices, Fair
Hearing and Appeal Processes for Medicaid and Exchange Eligibility
Appeals and Other Provisions Related to Eligibility and Enrollment for
Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing,
published on January 22, 2013 (78 FR 4594, 4710), we proposed an
amendment to Sec. 155.205(d) that would require any individual
providing consumer assistance under that section, including Navigators,
to ``be trained regarding QHP options, insurance affordability
programs, eligibility, and benefits rules and regulations governing all
insurance affordability programs operated in the state, as implemented
in the state, prior to providing such assistance.''
Consistent with the existing requirements in Sec. 155.210(b)(2)
and Sec. 155.210(c)(1)(iii) and the proposed requirements at 78 FR
4710, we now propose a specific set of training standards that would
require up to 30 hours of training, including standards for
certification and recertification, for all Navigators and non-Navigator
assistance personnel in Federally-facilitated Exchanges, including
State Partnership Exchanges, and all federally funded non-Navigator
assistance personnel in State-based Exchanges, to ensure that these
entities and individuals can satisfy the duties and obligations of
serving as Navigators or non-Navigator assistance personnel. These
proposed standards would be
[[Page 20589]]
applicable to all Navigators and non-Navigator assistance personnel in
Federally-facilitated Exchanges, including State Partnership Exchanges,
and to all federally funded non-Navigator assistance personnel in
State-based Exchanges, and can be used by State-based Exchanges at
their option for their Navigator personnel and non-federally funded
non-Navigator assistance personnel.
a. Certification and Recertification Standards (Proposed Sec.
155.215(b)(1))
Section 1311(i)(4) of the Affordable Care Act directs the Secretary
to establish standards for Navigators, including provisions to ensure
that any private or public entity that is selected as a Navigator is
qualified, and licensed if appropriate, to engage in Navigator
activities and to avoid conflicts of interest. Under existing
regulations at 45 CFR 155.210(c)(1)(iii), Navigators must meet any
``licensing, certification or other standards prescribed by the state
or Exchange, if applicable.'' In addition, we have previously proposed
to amend Sec. 155.205(d) to require that any individual providing
consumer assistance under Sec. 155.205(d) must be trained regarding
QHP options, insurance affordability programs, eligibility, and
benefits rules and regulations governing all insurance affordability
programs operated in the state, as implemented in the state, prior to
providing such assistance (78 FR 4594).
We now propose in Sec. 155.215(b)(1) that all Navigators and non-
Navigator assistance personnel in a Federally-facilitated Exchange or
State Partnership Exchange, and federally-funded non-Navigator
assistance personnel in a State-Based Exchange, register with the
Exchange and be certified by the Exchange, and prior to certification,
complete an HHS-approved training before carrying out any consumer
assistance functions in the Exchange. We propose in Sec. 155.215(b)(2)
the topics about which such Navigators and non-Navigator assistance
personnel would receive training prior to certification. The proposed
rule would also direct that individuals and staff of Navigator entities
and non-Navigator assistance entities receive a passing score on all
HHS-approved examinations in order to serve as Navigators or non-
Navigator assistance personnel in a Federally-facilitated Exchange, a
State Partnership Exchange, or as federally-funded non-Navigator
assistance personnel in a State-based Exchange.
The proposed recertification requirement for Navigators and non-
Navigator assistance personnel would ensure that they remain
appropriately trained to adequately serve consumers. The rule also
proposes that Navigators and non-Navigator assistance personnel should
obtain continuing education and be certified and/or recertified on at
least an annual basis.
We also propose that these certification requirements would
specifically direct that all Navigators and non-Navigator assistance
personnel be prepared to serve both the individual Exchange and SHOP in
a Federally-facilitated Exchange. Section 1311(i)(2)(A) of the
Affordable Care Act directs that, to be eligible to receive a Navigator
grant, an entity must demonstrate that it has existing relationships,
or could readily establish relationships, with employers and employees.
In addition, section 1311(i)(2)(B) directs that the types of entities
that may be eligible for a Navigator grant include resource partners of
the Small Business Administration. We infer from these standards that
Navigators must be prepared to serve the needs of small businesses, and
therefore will need to be prepared to serve the needs of both the
individual Exchange and SHOP. We also believe that non-Navigator
assistance personnel who carry out consumer outreach, assistance, and
education in the Exchange and are paid for by Federal funding should be
prepared to serve the needs of both the individual Exchange and SHOP.
In order to be truly helpful and useful to the public, we believe that
services provided under Sec. 155.205(d) and (e) should be available to
all consumers, including small businesses. Directing non-Navigator
assistance personnel in Federally-facilitated Exchanges, including
State Partnership Exchanges, and federally funded non-Navigator
assistance personnel in State-based Exchanges to provide assistance to
all consumers will ensure that they provide services consistent with
this interpretation of Sec. 155.205.
Each Navigator and non-Navigator assistance personnel should have
the ability to help any individual who presents him or herself for
assistance. However, there may be some instances where a Navigator, or
non-Navigator assistance personnel, does not have the immediate
capacity to help an individual. In such cases, the Navigator or non-
Navigator assistance personnel should be capable of providing
assistance in a timely manner but should also refer consumers seeking
assistance to other Exchange resources, such as the toll-free Exchange
Call Center, or to another Navigator or non-Navigator assistance
personnel in the same Exchange who might have better capacity to serve
that individual more effectively.
We solicit public comments on these proposed training and
certification standards, including the proposed recertification
standards.
b. Training Module Content Standards (Proposed Sec. 155.215(b)(2))
Each entity that serves as a Navigator, and each individual that
will carry out Navigator functions under the terms of a Navigator grant
in a Federally-facilitated Exchange or State Partnership Exchange, must
receive training to perform all of the duties of a Navigator. Although
different Navigators may perform these duties at different levels of
effort or focus, every Navigator must be trained to perform all of the
listed duties in section 1311(i)(3) of the Affordable Care Act and in
Sec. 155.210(e). Therefore, in order to carry out a Navigator's duties
to maintain expertise in eligibility and facilitate selection of QHPs,
all Navigators will receive training so that they are equipped with the
necessary information to help consumers apply for coverage through the
Exchange, which will ultimately result in an eligibility determination
for enrollment in a QHP and/or an insurance affordability program. Non-
Navigator assistance personnel must receive comparable training with
respect to their specific responsibilities. In addition, Navigators and
non-Navigator assistance personnel must receive training on the privacy
and security requirements for the protection of personally identifiable
information, including relevant state laws.
In addition to training designed to help Navigators and non-
Navigator assistance personnel build expertise in eligibility and
facilitating selection of QHPs, training for Navigators and non-
Navigator assistance personnel should prepare them to educate consumers
about the advanced payments of the premium tax credit and cost-sharing
reductions and help them submit the appropriate information to receive
an eligibility determination for insurance affordability programs,
including advanced payments of the premium tax credits and cost-sharing
reductions. In addition, Navigators should be trained so that they will
be prepared to fulfill the duty at Sec. 155.210(e)(2) to ``provide
information and services in a fair, accurate and impartial manner,''
including the requirement that ``such information acknowledge other
health programs,'' including Medicaid and CHIP. Therefore, Sec.
155.215(b)(2) proposes a set of standards for the content of the
training module for
[[Page 20590]]
Navigators and non-Navigator assistance personnel in a Federally-
facilitated Exchange or State Partnership Exchange, and for federally
funded non-Navigator assistance personnel in a State-based Exchange, to
ensure that they would be knowledgeable in these areas, and fully
prepared to assist consumers.
The Exchange regulations, at 45 CFR 155.260(a), establish privacy
and security standards for Exchanges, and Sec. 155.260(b) provides
that Exchanges must require Navigators and other non-Exchange entities
to abide by the same or more stringent privacy and security standards
as a condition of contract or agreement with such entities. Consistent
with these requirements, we propose that the training for Navigators
and non-Navigator assistance personnel must include training designed
to ensure that they safeguard consumers' sensitive personal information
including but not limited to health information, income and tax
information, and Social Security number.
Subsections 155.205(d) and (e) direct Exchanges to conduct consumer
assistance, outreach, and education activities, including Navigator
programs, in a way that meets the standards set forth at Sec.
155.205(c). Section 155.205(c), in turn, directs Exchanges to provide
information to applicants and enrollees in plain language and in a
manner that is accessible and timely to individuals living with
disabilities and individuals who are limited English proficient (LEP).
Additionally, Sec. 155.210(e)(5) directs Navigators to provide
information in a manner that is culturally and linguistically
appropriate to the needs of the population served by the Exchange,
including individuals with limited English proficiency, and to ensure
accessibility and usability of Navigator tools and functions for
individuals with disabilities. We interpret the foregoing provisions to
require all entities and individuals carrying out activities authorized
by Sec. Sec. 155.205(d) and (e) and155.210, including Navigators and
non-Navigator assistance personnel, to be knowledgeable about the
special needs of populations with limited English proficiency and
people with a full range of disabilities, and how best to communicate
with and assist these consumers. The rule therefore proposes that the
training for Navigators and non-Navigator assistance personnel would
include training designed to ensure that they will be equipped to
provide culturally and linguistically appropriate services and ensure
physical and other accessibility for people with disabilities. We
solicit public comments on the proposed requirement to receive training
regarding culturally and linguistically appropriate services as well as
accessibility for people with disabilities.
3. Providing Culturally and Linguistically Appropriate Services (CLAS
Standards) (Proposed Sec. 155.215(c))
Proposed Sec. 155.215(c) and (d) detail standards for the use and
provision of culturally and linguistically appropriate tools and
services as well as requirements to ensure access by individuals with
disabilities who seek assistance from Navigators and non-Navigator
assistance personnel in Federally-facilitated Exchanges, including
State Partnership Exchanges, and from federally-funded non-Navigator
assistance personnel in a State-based Exchange.
Section 1311(i)(3)(E) of the Affordable Care Act directs that
Navigator entities have a duty to provide information in a manner that
is culturally and linguistically appropriate to the needs of the
population being served by the Exchange or Exchanges. According to the
regulation implementing this provision, Navigators must ``provide
information in a manner that is culturally and linguistically
appropriate to the needs of the population being served by the
Exchange, including individuals with limited English proficiency''
(Sec. 155.210(e)(5)). Additionally, all non-Navigator assistance
personnel must meet the accessibility standards set forth at Sec.
155.205(c).
Independent of these obligations, certain Federal civil rights
laws, such as Title VI of the Civil Rights Act of 1964 and Section 504
of the Rehabilitation Act of 1973, also apply to Navigators in
Federally-facilitated and State Partnership Exchanges. These laws would
also apply to non-Navigator assistance programs in State-based and
State Partnership Exchanges to the extent such programs receive federal
financial assistance. These federal civil rights laws impose
nondiscrimination obligations with respect to persons with disabilities
and that address the communications needs of persons who have limited
English proficiency (LEP).
While the proposed training module content standards discussed
earlier in this preamble include a requirement that training include
providing culturally and linguistically appropriate services, this
proposed rule also provides more specific standards for ensuring
meaningful access. These proposed standards should be read together
with all other applicable standards issued by the Secretary related to
ensuring meaningful access by individuals with limited English
proficiency.
The specific standards proposed in Sec. 155.215(c) include that
Navigators and non-Navigator assistance personnel develop, maintain,
and regularly update general knowledge about the racial, ethnic, and
cultural groups in their service area, including the primary languages
spoken, and continue to use this information. The proposed requirements
would also include that such entities and individuals provide consumers
with information and assistance in the consumer's preferred language,
at no cost to the consumer, which would include oral interpretation of
non-English languages and the translation of written documents in non-
English languages when necessary to ensure meaningful access. We also
propose that use of a consumer's family or friends as interpreters can
satisfy the requirement to provide linguistically appropriate services
only when requested by the consumer as the preferred alternative to an
offer of other interpretive services. We anticipate that most
Navigators and non-Navigator assistance personnel would use readily
available telephonic interpretation services and other effective low-
cost services in order to meet the requirement to provide language
access to the consumers they serve, so that it will not be costly or
onerous.
In addition, Sec. 155.215(c)(4) of the proposed rule would require
that non-Navigator assistance personnel provide limited-English-
proficiency consumers with oral and written notices informing them of
their right to receive language assistance services and how to obtain
such services. This requirement could be satisfied using methods
outlined in existing Sec. 155.205(c)(2), which allows for the use of
taglines in non-English languages placed on documents or Web sites to
indicate the availability of language services.
Section 155.215(c)(6) of the proposed rule would also direct
Navigator and non-Navigator assistance personnel entities to implement
strategies to recruit and promote a staff that is representative of the
demographic characteristics, including primary languages spoken, of the
communities in their service area.
4. Standards Ensuring Access by Persons With Disabilities (Proposed
Sec. 155.215(d))
Section 155.210(e)(5) directs that an entity serving as a Navigator
has a duty to ``ensure accessibility and usability of
[[Page 20591]]
Navigator tools and functions for individuals with disabilities in
accordance with the Americans with Disabilities Act and Section 504 of
the Rehabilitation Act.'' Similarly, Sec. 155.205(c) requires that
persons providing consumer assistance pursuant to Sec. 155.205(d) and
(e) provide individuals living with disabilities with information that
is accessible at no cost to the individual, in accordance with the
Americans with Disabilities Act and section 504 of the Rehabilitation
Act.
Additionally, independent of these obligations, certain Federal
civil rights laws, such as Title VI of the Civil Rights Act of 1964 and
Section 504 of the Rehabilitation Act of 1973, also apply to Navigators
in Federally-facilitated and State Partnership Exchanges. These laws
would also apply to non-Navigator assistance programs in State-based
and State Partnership Exchanges to the extent such programs receive
federal financial assistance. These federal civil rights laws impose
nondiscrimination obligations with respect to persons with disabilities
and that address the communications needs of persons who have limited
English proficiency (LEP).
In accordance with these requirements, Sec. 155.215(d)(2) of the
proposed rule would direct that auxiliary aids and services for
individuals with disabilities be provided at no cost where necessary
for effective communication. The proposal specifies that the use of a
consumer's family or friends as interpreters can satisfy the
requirement to provide auxiliary aids and services only when requested
by the consumer as the preferred alternative to an offer of other
auxiliary aids and services. In addition, proposed section
155.215(d)(3) would require Navigators and non-Navigator assistance
personnel in a Federally-facilitated Exchange or State Partnership
Exchange, and federally-funded non-Navigator assistance personnel in a
State-based Exchange to provide assistance to consumers in a location
and in a manner that is physically and otherwise accessible to
individuals with disabilities. Proposed section 155.215(d)(1) would
direct Navigators and non-Navigator assistance personnel to ensure that
any consumer education materials, Web sites, or other tools utilized
for consumer assistance purposes are accessible to people with
disabilities.
Section 155.215(d)(4) of the proposed rule would also require that
legally authorized representatives be permitted to assist individuals
with disabilities to make informed decisions. Finally, proposed Sec.
155.215(d)(5) would direct that individuals carrying out Navigator and
non-Navigator assistance functions have the ability to refer people
with disabilities to local, state, and federal long-term services and
supports programs when appropriate. We seek comment on this
requirement.
These proposed standards should be read together with all other
applicable standards issued by the Secretary related to ensuring
meaningful access by people with disabilities.
5. Monitoring (Proposed Sec. 155.215(e))
The proposed rule indicates that Federally-facilitated Exchanges
(including State Partnership Exchanges) will monitor compliance with
the standards described in Sec. 155.215 and with the requirements
described in Sec. 155.205(d) and (e) and 155.210. To the extent
possible, these Exchanges will engage in monitoring whether Navigators
and non-Navigator assistance personnel comply with those standards,
including, for example, reviewing reports filed by Navigators and
reviewing the attestations and conflict-of-interest plans required to
be submitted to the Exchange as proposed in Sec. 155.215(a)(1)(i)
through (ii) and (a)(2)(ii) through (iii) of the proposed regulation;
conducting discussions with states in which Navigator grantees and non-
Navigator assistance personnel exercise their functions; and reviewing
casework and complaints filed with the Exchange or a relevant state. We
solicit comments on how monitoring for federally-funded non-Navigator
assistance personnel in State-based Exchanges should be conducted.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 (PRA) requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
This proposed rule would establish conflict-of-interest and
training standards, including standards for certification and
recertification, for Navigators and non-Navigator assistance personnel
in an Exchange being operated by HHS as a Federally-facilitated
Exchange or as a State Partnership Exchange pursuant to HHS authority
under section 1321(c)(1) of the Affordable Care Act and for non-
Navigator assistance personnel in State-based Exchanges that are funded
through federal Exchange Establishment grants. The proposal requires
that these Navigators and non-Navigator assistance personnel provide an
attestation that they are not ineligible individuals or entities and
submit a plan for mitigating conflicts of interest, register with the
Exchange, receive training, be initially certified, and receive
subsequent recertification with the Exchange.
Section III.A outlines information collection requirements
associated with disclosure of conflicts of interest. These disclosures
include an attestation regarding eligibility to be a Navigator or non-
Navigator assistance personnel; a plan for mitigating conflicts of
interest; a requirement to provide information to consumers about their
coverage options; and a requirement to disclose other potential, non-
prohibited, conflicts of interest. Section III.B outlines information
collection requirements associated with registration, certification,
and recertification requirements. We are soliciting public comments on
each of these issues for the following sections of the proposed rule
that contain information collection requirements (ICRs).
For purposes of the information collection requirements, Navigator
personnel and non-Navigator assistance personnel are estimated to have
a professional wage of $20 per hour.\4\ Navigator and non-Navigator
assistance project leads are estimated to have a professional wage of
$29 per hour.\5\ Navigator senior executives are estimated to have a
professional wage of $48 per hour.\6\ The average professional wage for
Navigator personnel, projects
[[Page 20592]]
leads, senior executives, and non-Navigator assistance personnel and
project leads is estimated to be $29.20 per hour.
---------------------------------------------------------------------------
\4\ These positions are estimated to be equivalent to a GS-9
position with the Federal government. See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2012/general-schedule/gs_h.pdf.
\5\ These positions are estimated to be equivalent to a GS-12
position with the Federal government. See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2012/general-schedule/gs_h.pdf.
\6\ These positions are estimated to be equivalent to a GS-15
position with the Federal government. See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2012/general-schedule/gs_h.pdf.
---------------------------------------------------------------------------
At this time we are unable to estimate the number of Navigator
grantees and applicants or the number of non-Navigator assistance
personnel and project leads; therefore the estimates discussed below
are on a per individual basis. Additionally, we are unable to estimate
the number of consumers expected to receive assistance from Navigator
grantees or non-Navigator assistance personnel; therefore estimates for
disclosures to consumers discussed below are on a per consumer basis.
We invite public comments on the number of Navigator grantees or the
number of non-Navigator assistance personnel and project leads
expected, as well as the number of consumers expected to receive
assistance.
A. ICRs Regarding Disclosure of Conflicts of Interest (Proposed Sec.
155.215(a))
Pursuant to proposed Sec. 155.215(a)(1)(i) & (iv) and (a)(2)(ii) &
(v), Navigator program grantees and other entities and individuals
providing assistance under Sec. Sec. 155.205(d) and (e) would be
required to disclose conflicts of interest. This disclosure would
include an attestation that an individual or entity is not an
ineligible entity. Additionally, pursuant to proposed Sec.
155.215(a)(1)(ii) and (a)(2)(iii), a plan for mitigating any conflicts
of interest would also be submitted. The cost burden associated with
the attestation would apply to each Navigator entity and applicant, and
to each individual or entity serving as non-Navigator assistance
personnel. The cost burden associated with the plan for mitigating any
conflicts of interest will apply to each Navigator program grantee and
to each individual or entity serving as non-Navigator assistance
personnel.\7\ The attestation and mitigation plan are one-time
requirements.
---------------------------------------------------------------------------
\7\ The mitigation plan is only required on an individual basis
if the individual is not working for an entity serving as non-
Navigator assistance personnel.
---------------------------------------------------------------------------
We estimate it will take Navigator personnel, project leads, senior
executives, non-Navigator assistance personnel, and non-Navigator
assistance project leads 0.25 hours (15 minutes) each to prepare and
provide the attestation that they are an eligible entity. With a wage
of $20 per hour for Navigator and non-Navigator personnel, $29 per hour
for Navigator and non-Navigator project leads, and $48 per hour for
senior executives, we estimate the cost burden per Navigator personnel
would be $5, per Navigator project lead would be $7.25, per Navigator
senior executives would be $12, per non-Navigator assistance personnel
would be $5, and per non-Navigator assistance personnel would be $7.25.
The total burden per person would be 0.25 hours and $7.30 on average.
The plan for mitigating conflicts of interest would be required on
a per entity basis; \8\ therefore we assume for Navigator program
grantees, the senior executive would be responsible for developing and
providing the plan for mitigating conflicts of interest because only
one plan is required per grantee. For purposes of the ICR we are
assuming burden and cost estimates based on a non-Navigator assistance
project lead wage of $29 per hour.
---------------------------------------------------------------------------
\8\ An individual could be serving as an entity.
---------------------------------------------------------------------------
We estimate that for a Navigator program grantee it will take a
senior executive up to 5 hours to prepare and provide a plan for
mitigating conflicts of interest and a non-Navigator assistance project
lead would also require up to 5 hours to prepare and provide a plan for
mitigating conflicts of interest. With a wage of $48 per hour for
senior executives and $29 per hour for non-Navigator assistance project
leads, we estimate the total one-time annual cost burden for a
Navigator program grantee would be $240, and for non-Navigator
assistance project leads would be $145.
Pursuant to proposed Sec. 155.215(a)(1)(iii) and (a)(2)(iv),
Navigator program grantees and non-Navigator assistance personnel would
be required to provide information to consumers about the full range of
QHP options and insurance affordability programs for which they are
eligible. We assume that the total time to provide this disclosure
would be one hour per disclosure. We assume for the Navigator program
grantee that the Navigator personnel would prepare the disclosure and
the total burden estimated per disclosure would be 1 hour at a cost of
$20. For non-Navigator assistance personnel we estimate the total
burden per disclosure would be 1 hour for preparing the disclosure at a
cost of $20. The total burden per disclosure would be 1 hour and $20 on
average.
Pursuant to proposed Sec. 155.215(a)(1)(iv) and (a)(2)(v),
Navigator personnel, projects leads, senior executives, non-Navigator
assistance personnel, and non-Navigator assistance project leads would
be required to disclose the Exchange and to consumers: any lines of
insurance business, not covered by the restrictions on participation
and prohibitions on conduct in Sec. 155.210(d), which they intend to
sell while carrying out the consumer assistance functions; any existing
and former employment relationships within the last five years with any
health insurance issuers or issuers of stop loss insurance or
subsidiaries of health insurance issuers or issuers of stop loss
insurance; any existing employment relationships between a spouse or
domestic partner and any health insurance issuers or issuers of stop
loss insurance or subsidiaries of health insurance issuers or issuers
of stop loss insurance; and any existing or anticipated financial,
business, or contractual relationships with one or more health
insurance issuers or issuers of stop loss insurance, or subsidiaries of
health insurance issuers or issuers of stop loss insurance. We estimate
the total time to prepare this disclosure would be 0.16 hours (10
minutes). The total cost estimated for preparing this disclosure per
Navigator personnel would be $3.20, per Navigator project lead would be
$4.64, per Navigator senior executive would be $7.68, per non-Navigator
assistance personnel would be $3.20, and per non-Navigator assistance
project lead would be $4.64. The total burden per person would be 0.16
hours and $4.67 on average.
B. ICRs Regarding Training and Certification Standards (Proposed Sec.
155.215(b))
1. Registration Prior to Training
Pursuant to proposed Sec. 155.215(b)(1)(ii), Navigator personnel,
project leads, senior executives, non-Navigator assistance personnel,
and non-Navigator assistance project leads would be required to
register prior to training. We assume that it will take Navigator
personnel, project leads, senior executives, non-Navigator assistance
personnel, and non-Navigator assistance project leads each 0.25 hours
(15 minutes) to register. With a wage of $20 per hour for Navigator and
non-Navigator assistance personnel, $29 for Navigator and non-Navigator
assistance project leads, and $48 for senior executives, we estimate
the total cost burden for Navigator personnel would be $5, for
Navigator project leads would be $7.25, for Navigator senior executives
would be $12, for non-Navigator assistance personnel would be $5, and
for non-Navigator assistance project leads would be $7.25. The total
burden per person would be 0.25 hours and $7.30 on average.
[[Page 20593]]
2. Certification and Recertification
Pursuant to Sec. 155.215(b)(1), Navigator personnel, project
leads, senior executives, non-Navigator assistance personnel, and non-
Navigator assistance project leads would be required to complete a
training program to obtain certification consisting of up to 30 hours
of training including any approved certification exams. There are
recordkeeping requirements associated with the certification and
recertification provisions. Each person who receives training would be
expected to obtain and maintain a record of certification. Pursuant to
Sec. 155.215(b)(1)(iv), Navigator personnel, project leads, senior
executives, non-Navigator assistance personnel, and non-Navigator
assistance project leads who intend to continue beyond their initial
period of performance would be required to be recertified on an annual
basis. Each person who receives recertification would be expected to
obtain proof of recertification and keep it on file. It is estimated
that the time burden associated with maintaining proof of certification
or recertification would be 0.016 hours (1 minute); we assume proof
will be maintained through electronic copies with minimal cost.
The total cost estimated for maintaining proof of certification or
recertification per Navigator would be $0.32; per Navigator project
lead would be $0.48; per Navigator senior executive would be $0.75; per
non-Navigator assistance personnel would be $0.32, and per non-
Navigator assistance project lead would be $0.48. In the initial year
the requirement will be to maintain proof of initial certification; in
subsequent years the requirement will be to maintain proof of
recertification. Because these requirements would be the same time and
cost burden we are categorizing them as one annual burden. The total
annual burden estimated for maintaining proof of certification or
recertification would be 0.016 hours and $0.47 on average.
Table 1--Annual Recordkeeping and Reporting Requirements, by Respondent
----------------------------------------------------------------------------------------------------------------
Hourly labor
Burden per cost of Total labor Total capital/
Proposed regulation section(s) OMB control No. response reporting ($) cost of maintenance
(hours) ** reporting ($) costs ($)
----------------------------------------------------------------------------------------------------------------
Conflict of Interest 0938-New........ 0.25 29.20 7.30 0
Attestation Sec.
155.215(a)(1)(i) & (a)(2)(ii).
Conflict of Interest 0938-New........ 5 48 240 0
Mitigation PlanSec.
155.215(a)(1)(ii) &
(a)(2)(iii) Navigator Senior
Executive.
Non-Navigator Assistance 5............... 29 145 0
Project Lead.
Conflict of Interest 0938-New........ 1 20 20 0
Disclosure of Coverage
Options Sec.
155.215(a)(1)(iii) &
(a)(2)(iv).
Conflict of Interest 0938-New........ .16 29.20 4.67 0
Disclosure to Exchange and
Consumers Sec.
155.215(a)(1)(iv) & (a)(2)(v).
Training Registration Sec. 0938-New........ 0.25 29.20 7.30 0
155.215(b)(1)(ii).
Certification and 0938-New........ 0.016 29.20 0.47 0
Recertification Sec.
155.215(b)(1).
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. 424.27 0
----------------------------------------------------------------------------------------------------------------
** The hourly cost of $29.20 in certain rows is an average of the professional wages estimated for Navigator
personnel, project leads, senior executives, non-Navigator assistance personnel, and non-Navigator assistance
project leads.
IV. Regulatory Impact Statement
A. Summary
HHS is publishing this proposed rule to implement the protections
intended by Congress in the most economically efficient manner
possible. HHS has examined the effects of this rule as required by
Executive Order 13563 (76 FR 3821, January 21, 2011), Executive Order
12866 (58 FR 51735, September 1993, Regulatory Planning and Review),
the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-
354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4),
Executive Order 13132 on Federalism, and the Congressional Review Act
(5 U.S.C. 804(2)).
B. Executive Orders 12866 and 13563
Executive Order 12866 directs 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 is
supplemental to and reaffirms the principles, structures, and
definitions governing regulatory review as established in Executive
Order 12866. OMB has determined that this proposed rule is a
``significant regulatory action'' under Executive Order 12866.
Accordingly, OMB reviewed this proposed rule.
1. Need for Regulatory Action
This proposed regulation would establish conflict of interest,
training and certification, and meaningful access standards applicable
to Navigator programs in Federally-facilitated Exchanges, including
State Partnership Exchanges, non-Navigator assistance programs in State
Partnership Exchanges, and non-Navigator assistance programs in State-
Based Exchanges that are funded through federal 1311(a) Exchange
Establishment grants. The proposed rule would require that these
Navigators and non-Navigator assistance personnel register with and be
certified by the Exchange. In addition, the proposed rule would
establish standards for Navigators and non-Navigator assistance
personnel to ensure meaningful access to their services by individuals
with limited English proficiency and individuals with disabilities.
The proposed rule also would amend existing regulations to clarify
that Navigators must meet any licensing, certification or other
standards prescribed by the State or Exchange, if applicable, so long
as such standards do not prevent the application of the provisions of
title I of the Affordable Care Act; add entities with relationships
with issuers of stop loss insurance, including those who are
compensated directly or indirectly by issuers of stop loss insurance in
connection with enrollment in QHPs or non-QHPs, to the list of entities
ineligible to become Navigators; and clarify that the same
ineligibility criteria that apply to
[[Page 20594]]
Navigators providing services in any Federally-facilitated Exchange,
including State Partnership Exchanges, would also apply to non-
Navigator assistance personnel providing assistance in State
Partnership Exchanges and federally-funded non-Navigator assistance
personnel in State-based Exchanges.
2. Summary of Impacts
The proposed regulations would help ensure that Navigators in
Federally-facilitated Exchanges, non-Navigator assistance personnel in
State Partnership Exchanges, and federally-funded non-Navigator
assistance personnel in State-based Exchanges will be fair and
impartial, will be appropriately trained, and will provide services and
information in a manner that is accessible to persons with limited
English proficiency and persons with disabilities. The proposed rule
would also ensure that Navigators meet any licensing, certification or
other standards prescribed by the State or Exchange, if applicable, so
long as such standards do not prevent the application of the provisions
of title I of the Affordable Care Act.
Navigators and non-Navigator assistance personnel would incur costs
in order to comply with the provisions of this proposed rule, which
would be covered by the Navigator grants and other compensation
provided by the Exchange to non-Navigator assistance personnel. HHS
anticipates that the impacts of the proposed rule would not be
economically significant.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) requires agencies that issue a
regulation to analyze options for regulatory relief of small businesses
if a 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''). HHS uses as its measure of significant
economic impact on a substantial number of small entities a change in
revenues of more than 3 to 5 percent.
HHS anticipates that the proposed rule would not have a significant
economic impact on a substantial number of small entities. Some of the
entities that act as Navigators and non-Navigator assistance personnel
may be small entities and would incur costs to comply with the
provisions of this rule. It should be noted that serving as a Navigator
or non-Navigator assistance personnel is voluntary, and the cost burden
related to registering for accounts, verification of registration,
initial online training and certification, continuing education and
recertification, conflict of interest notification, and providing
assistance to consumers would be covered by the Navigator grants and
other compensation provided by the Exchange to non-Navigator assistance
personnel. Due to lack of data, HHS is unable to estimate how many
small entities would elect to serve as Navigators and non-Navigator
assistance personnel. We invite public comments on this issue.
The size threshold for ``small'' business established by the SBA is
currently $7 million in annual receipts for insurance agencies and
brokerages.\9\ As discussed earlier, we anticipate that agents and
brokers will continue to be an important source of assistance for many
consumers seeking access to health insurance coverage through an
Exchange, including those who own and/or are employed by small
businesses. The proposed conflict of interest standards for Navigators
would permit agents and brokers to serve as Navigators in an Exchange
operated by HHS, provided that the agent or broker can satisfy the
standards that would apply to all Navigators in the Exchange.
Additionally, we anticipate that agents and brokers will also play a
role in educating consumers about Exchanges and insurance affordability
programs, and in helping consumers receive eligibility determinations,
compare plans, and enroll in coverage to the extent permitted by a
given state.
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\9\ ``Table of Size Standards Matched To North American Industry
Classification System Codes,'' effective January 7, 2013, U.S. Small
Business Administration, available at https://www.sba.gov.
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In addition, section 1102(b) of the Social Security Act requires us
to prepare a regulatory impact analysis if a rule may have a
significant economic impact on the operations of a substantial number
of small rural hospitals. This analysis must conform to the provisions
of section 604 of the RFA. This proposed rule would not affect small
rural hospitals. Therefore, the Secretary has determined that this
proposed rule would not have a significant impact on the operations of
a substantial number of small rural hospitals.
D. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits before
issuing any 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 2013, that threshold level
is approximately $141 million.
UMRA does not address the total cost of a final rule. Rather, it
focuses on certain categories of cost, mainly those ``Federal mandate''
costs resulting from--(1) imposing enforceable duties on state, local,
or tribal governments, or on the private sector; or (2) increasing the
stringency of conditions in, or decreasing the funding of, state,
local, or tribal governments under entitlement programs.
This proposed rule does not mandate expenditures by state
governments, local governments, tribal governments, or the private
sector, of $141 million. The cost burden for Navigators and non-
Navigator assistance personnel related to registering for accounts,
verification of registration, initial online training and
certification, continuing education and recertification and conflict of
interest notification would be covered by the Navigator grants and
other compensation provided by the Exchange to non-Navigator assistance
personnel and would not exceed the UMRA threshold. As discussed
previously in the preamble, state-based Exchanges and state partners in
State Partnership Exchanges may use section 1311(a) Exchange
Establishment grants to fund non-Navigator assistance programs. Section
1311(i)(6) prohibits Exchanges from using section 1311(a) grant funds
to fund Navigator grants. Section 1311(a) grant funds, however, may be
used to cover the Exchange's cost of administering the Navigator
program, including, for example, the cost of Navigator training, grants
management, and oversight.
E. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that imposes substantial
direct requirement costs on state and local governments or has
federalism implications.
The proposed rule would clarify that any Navigator licensing,
certification, or other standards prescribed by the state or Exchange
should not prevent the application of the provisions of title I of the
Affordable Care Act. An entity or individual would be required to meet
any licensing, certification, or other standards prescribed by the
State or
[[Page 20595]]
Exchange, if applicable, so long as such standards do not prevent the
application of the provisions of title I of the Affordable Care Act.
Throughout the process of developing this proposed regulation, HHS
has attempted to balance the states' interests and Congress' intent to
provide uniform minimum protections to consumers in every state. By
doing so, it is HHS's view that we 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 regulation, the Department certifies that the Centers for Medicare
& Medicaid Services has complied with the requirements of Executive
Order 13132 for the proposed regulation in a meaningful and timely
manner.
F. Congressional Review Act
This proposed rule is subject to the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. Sec. 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.
List of Subjects in 45 CFR Part 155
Administrative practice and procedure, Advertising, Brokers,
Conflict of interest, Consumer protection, Grant programs-health,
Grants administration, Health care, Health insurance, Health
maintenance organization (HMO), Health records, Hospitals, Indians,
Individuals with disabilities, Loan programs-health, Organization and
functions (Government agencies), Medicaid, Public assistance programs,
Reporting and recordkeeping requirements, Safety, State and local
governments, Technical assistance, Women, and Youth.
For the reasons stated in the preamble, the Department of Health
and Human Services proposes to amend 45 CFR part 155 as set forth
below:
PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED
STANDARDS UNDER THE AFFORDABLE CARE ACT
0
1. The authority citation for part 155 continues to read as follows:
Authority: Title I of the Affordable Care Act, sections 1301,
1302, 1303, 1304, 1311, 1312, 1313, 1321, 1322, 1331, 1334, 1402,
1411, 1412, 1413.
0
2. Section 155.210 is amended by revising paragraphs (c)(1)(iii),
(d)(1), (d)(2), and (d)(4) to read as follows:
Sec. 155.210 Navigator program standards.
* * * * *
(c) * * *
(1) * * *
(iii) Meet any licensing, certification or other standards
prescribed by the State or Exchange, if applicable, so long as such
standards do not prevent the application of the provisions of title I
of the Affordable Care Act;
* * * * *
(d) * * *
(1) Be a health insurance issuer or issuer of stop loss insurance;
(2) Be a subsidiary of a health insurance issuer or issuer of stop
loss insurance;
* * * * *
(4) Receive any consideration directly or indirectly from any
health insurance issuer or issuer of stop loss insurance in connection
with the enrollment of any individuals or employees in a QHP or a non-
QHP.
* * * * *
0
3. Section 155.215 is added to read as follows:
Sec. 155.215 Standards applicable to Navigators and non-Navigator
Assistance Personnel carrying out consumer assistance functions under
Sec. Sec. 155.205(d) and (e) and 155.210 in a Federally-facilitated
Exchange and to non-Navigator Assistance Personnel Funded Through an
Exchange Establishment Grant.
(a) Conflict-of-Interest Standards. The following conflict-of-
interest standards apply in an Exchange operated by HHS during the
exercise of its authority under 45 CFR 155.105(f) and to non-Navigator
assistance personnel funded through an Exchange Establishment Grant
under section 1311(a) of the Affordable Care Act:
(1) Conflict-of-Interest Standards for Navigators.
(i) All Navigator entities, including Navigator grant applicants,
must submit to the Exchange a written attestation that the Navigator,
including the Navigator's staff:
(A) Is not a health insurance issuer or issuer of stop loss
insurance;
(B) Is not a subsidiary of a health insurance issuer or issuer of
stop loss insurance;
(C) Is not an association that includes members of, or lobbies on
behalf of, the insurance industry; and
(D) Will not receive any consideration directly or indirectly from
any health insurance issuer or issuer of stop loss insurance in
connection with the enrollment of any individuals or employees in a QHP
or non-QHP.
(ii) All Navigator entities must submit to the Exchange a written
plan to remain free of conflicts of interest during the term as a
Navigator.
(iii) All Navigator entities, including the Navigator's staff, must
provide information to consumers about the full range of QHP options
and insurance affordability programs for which they are eligible.
(iv) All Navigator entities, including the Navigator's staff, must
disclose to the Exchange and to each consumer who receives application
assistance from the Navigator:
(A) Any lines of insurance business, not covered by the
restrictions on participation and prohibitions on conduct in Sec.
155.210(d), which the Navigator intends to sell while carrying out the
consumer assistance functions;
(B) Any existing employment relationships, or any former employment
relationships within the last 5 years, with any health insurance
issuers or issuers of stop loss insurance or subsidiaries of health
insurance issuers or issuers of stop loss insurance, including any
existing employment relationships between a spouse or domestic partner
and any health insurance issuers or issuers of stop loss insurance, or
subsidiaries of health insurance issuers or issuers of stop loss
insurance; and
(C) Any existing or anticipated financial, business, or contractual
relationships with one or more health insurance issuers or issuers of
stop loss insurance, or subsidiaries of health insurance issuers or
issuers of stop loss insurance.
(2) Conflict-of-Interest Standards for Non-Navigator Assistance
Personnel Carrying Out Consumer Assistance Functions Under Sec.
155.205(d) and (e). All Non-Navigator entities or individuals
authorized to carry out consumer assistance functions under Sec.
155.205(d) and (e) must--
(i) Comply with the prohibitions on Navigator conduct set forth at
Sec. 155.210(d).
(ii) Submit to the Exchange a written attestation that the entity
or individual:
(A) Is not a health insurance issuer or issuer of stop loss
insurance;
(B) Is not a subsidiary of a health insurance issuer or issuer of
stop loss insurance;
(C) Is not an association that includes members of, or lobbies on
behalf of, the insurance industry; and
(D) Will not receive any consideration directly or indirectly from
any health insurance issuer or issuer of stop loss insurance in
connection with the enrollment of any individuals or employees in a QHP
or non-QHP.
[[Page 20596]]
(iii) Submit to the Exchange a written plan to remain free of
conflicts of interest while carrying out consumer assistance functions
under Sec. 155.205(d) and (e).
(iv) Provide information to consumers about the full range of QHP
options and insurance affordability programs for which they are
eligible.
(v) Disclose to the Exchange and to each consumer who receives
application assistance from the entity or individual:
(A) Any lines of insurance business, not covered by the
restrictions on participation and prohibitions on conduct in Sec.
155.210(d), which the entity or individual intends to sell while
carrying out the consumer assistance functions;
(B) Any existing employment relationships, or any former employment
relationships within the last five years, with any health insurance
issuers or issuers of stop loss insurance, or subsidiaries of health
insurance issuers or issuers of stop loss insurance, including any
existing employment relationships between a spouse or domestic partner
and any health insurance issuers or issuers of stop loss insurance, or
subsidiaries of health insurance issuers or issuers of stop loss
insurance; and
(C) Any existing or anticipated financial, business, or contractual
relationships with one or more health insurance issuers or issuers of
stop loss insurance, or subsidiaries of health insurance issuers or
issuers of stop loss insurance.
(b) Training standards for Navigators and Non-Navigator Assistance
Personnel carrying out consumer assistance functions under Sec. Sec.
155.205(d) and (e) and 155.210. The following training standards apply
in an Exchange operated by HHS during the exercise of its authority
under Sec. 155.105(f), and to non-Navigator assistance personnel
funded through an Exchange Establishment Grant under section 1311(a) of
the Affordable Care Act.
(1) Certification and recertification standards. All individuals or
entities who carry out consumer assistance functions under Sec. Sec.
155.205(d) and (e) and 155.210, including Navigators, must meet the
following certification and recertification requirements.
(i) Obtain certification by the Exchange prior to carrying out any
consumer assistance functions under Sec. Sec. 155.205(d) and (e) or
155.210;
(ii) Register for and complete a HHS-approved training;
(iii) Following completion of the HHS-approved training described
in paragraph (b)(1)(ii) of this section, complete and achieve a passing
score on all approved certification examinations prior to carrying out
any consumer assistance functions under Sec. Sec. 155.205(d) and (e)
or 155.210;
(iv) Obtain continuing education and be certified and/or
recertified on at least an annual basis; and
(v) Be prepared to serve both the individual Exchange and SHOP.
(2) Training module content standards. All individuals who carry
out the consumer assistance functions under Sec. Sec. 155.205(d) and
(e) and 155.210 must receive training in the following subjects:
(i) QHPs (including the metal levels described at Sec.
156.140(b)), and how they operate, including benefits covered, payment
processes, rights and processes for appeals and grievances, and
contacting individual plans;
(ii) The range of insurance affordability programs, including
Medicaid, the Children's Health Insurance Program (CHIP), and other
public programs;
(iii) The tax implications of enrollment decisions;
(iv) Eligibility requirements for premium tax credits and cost-
sharing reductions, and the impacts of premium tax credits on the cost
of premiums;
(v) Contact information for appropriate federal, state, and local
agencies for consumers seeking additional information about specific
coverage options not offered through the Exchange;
(vi) Basic concepts about health insurance and the Exchange; the
benefits of having health insurance and enrolling through an Exchange;
and the individual responsibility to have health insurance;
(vii) Eligibility and enrollment rules and procedures, including
how to appeal an eligibility determination;
(viii) Providing culturally and linguistically appropriate
services;
(ix) Ensuring physical and other accessibility for people with a
full range of disabilities;
(x) Understanding differences among health plans;
(xi) Privacy and security standards applicable under Sec. 155.260
for handling and safeguarding consumers' personally identifiable
information;
(xii) Working effectively with individuals with limited English
proficiency, people with a full range of disabilities, and vulnerable,
rural, and underserved populations;
(xiii) Customer service standards;
(xiv) Outreach and education methods and strategies; and
(xv) Applicable administrative rules, processes and systems related
to Exchanges and QHPs.
(c) Providing Culturally and Linguistically Appropriate Services
(CLAS Standards). The following standards will apply in an Exchange
operated by HHS during the exercise of its authority under Sec.
155.105(f) and to non-Navigator assistance personnel funded through an
Exchange Establishment Grant under section 1311(a) of the Affordable
Care Act. To ensure that information provided as part of any consumer
assistance functions under Sec. Sec. 155.205(d) and (e) or 155.210 is
culturally and linguistically appropriate to the needs of the
population being served, including individuals with limited English
proficiency as required by Sec. Sec. 155.205(c)(2) and 155.210(e)(5),
any entity or individual carrying out these functions must:
(1) Develop and maintain general knowledge about the racial,
ethnic, and cultural groups in their service area, including each
group's diverse cultural health beliefs and practices, preferred
languages, health literacy, and other needs;
(2) Collect and maintain updated information to help understand the
composition of the communities in the service area, including the
primary languages spoken;
(3) Provide consumers with information and assistance in the
consumer's preferred language, at no cost to the consumer, including
the provision of oral interpretation of non-English languages and the
translation of written documents in non-English languages when
necessary to ensure meaningful access. Use of a consumer's family or
friends as oral interpreters can satisfy the requirement to provide
linguistically appropriate services only when requested by the consumer
as the preferred alternative to an offer of other interpretive
services;
(4) Provide oral and written notice to consumers with limited
English proficiency informing them of their right to receive language
assistance services and how to obtain them;
(5) Receive ongoing education and training in culturally and
linguistically appropriate service delivery; and
(6) Implement strategies to recruit, support, and promote a staff
that is representative of the demographic characteristics, including
primary languages spoken, of the communities in their service area.
(d) Standards ensuring access by persons with disabilities. The
following standards related to ensuring access by people with
disabilities will apply in an Exchange operated by HHS during the
exercise of its authority under Sec. 155.105(f), and to non-Navigator
[[Page 20597]]
assistance personnel funded through an Exchange Establishment Grant
under section 1311(a) of the Affordable Care Act. Any entity or
individual carrying out any consumer assistance functions under
Sec. Sec. 155.205(d) and (e) or 155.210, and in accordance with Sec.
155.205(c), must:
(1) Ensure that any consumer education materials, Web sites, or
other tools utilized for consumer assistance purposes, are accessible
to people with disabilities, including those with sensory impairments,
such as visual or hearing impairments, and those with mental illness,
addiction, and physical, intellectual, and developmental disabilities;
(2) Provide auxiliary aids and services for individuals with
disabilities, at no cost, where necessary for effective communication.
Use of a consumer's family or friends as interpreters can satisfy the
requirement to provide auxiliary aids and services only when requested
by the consumer as the preferred alternative to an offer of other
auxiliary aids and services;
(3) Provide assistance to consumers in a location and in a manner
that is physically and otherwise accessible to individuals with
disabilities;
(4) Ensure that legally authorized representatives are permitted to
assist an individual with a disability to make informed decisions;
(5) Acquire sufficient knowledge to refer people with disabilities
to local, state, and federal long-term services and supports programs
when appropriate; and
(6) Be able to work with all individuals regardless of age,
disability, or culture, and seek advice or experts when needed.
(e) Monitoring. Any Exchange operated by HHS during the exercise of
its authority under Sec. 155.105(f) will monitor compliance with the
standards in this section and the requirements of Sec. Sec. 155.205(d)
and (e) and 155.210.
Dated: March 13, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: March 25, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2013-07951 Filed 4-3-13; 11:15 am]
BILLING CODE 4120-01-P