81 FR 47741 - Coverage for Contraceptive Services

DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF LABOR
Employee Benefits Security Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 141 (July 22, 2016)

Page Range		47741-47745
FR Document		2016-17242

This document is a request for information on whether there are alternative ways (other than those offered in current regulations) for eligible organizations that object to providing coverage for contraceptive services on religious grounds to obtain an accommodation, while still ensuring that women enrolled in the organizations' health plans have access to seamless coverage of the full range of Food and Drug Administration-approved contraceptives without cost sharing. This information is being solicited in light of the Supreme Court's opinion in Zubik v. Burwell, 136 S. Ct. 1557 (2016). The Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) invite public comments via this request for information.

Federal Register, Volume 81 Issue 141 (Friday, July 22, 2016)

[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Proposed Rules]
[Pages 47741-47745]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-17242]

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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 54

DEPARTMENT OF LABOR

Employee Benefits Security Administration

29 CFR Part 2590

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 147

[CMS-9931-NC]

Coverage for Contraceptive Services

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

ACTION: Request for information.

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SUMMARY: This document is a request for information on whether there
are alternative ways (other than those offered in current regulations)
for eligible organizations that object to providing coverage for
contraceptive services on religious grounds to obtain an accommodation,
while still ensuring that women enrolled in the organizations' health
plans have access to seamless coverage of the full range of Food and
Drug Administration-approved contraceptives without cost sharing. This
information is being solicited in light of the Supreme Court's opinion
in Zubik v. Burwell, 136 S. Ct. 1557 (2016). The Departments of Health
and Human Services (HHS), Labor, and the Treasury (collectively, the
Departments) invite public comments via this request for information.

DATES: Comments must be submitted on or before September 20, 2016.

ADDRESSES: In commenting, please refer to file code CMS-9931-NC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-9931-NC, P.O. Box 8010,
Baltimore, MD 21244-8010. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-9931-NC, 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:
David Mlawsky, Centers for Medicare & Medicaid Services (CMS),
Department of Health and Human Services, at (410) 786-1565.
Elizabeth Schumacher or Suzanne Adelman, Employee Benefits Security
Administration, Department of Labor, at (202) 693-8335.
Karen Levin, Internal Revenue Service, Department of the Treasury,
at (202) 317-6846.
Customer Service Information: Individuals interested in obtaining
information from the Department of Labor concerning employment-based
health coverage laws may call the EBSA Toll-Free Hotline at 1-866-444-
EBSA (3272) or visit the Department of Labor's Web site (http://www.dol.gov/ebsa). In addition, information from HHS on private health
insurance for consumers can be found on the CMS Web site
(www.cciio.cms.gov), and information on health reform can be found at
http://www.HealthCare.gov.

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: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.

I. Background

The Patient Protection and Affordable Care Act (Pub. L. 111-148)
was enacted on March 23, 2010. The Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) was enacted on March 30,
2010. These statutes are collectively known as the Affordable Care Act.
The Affordable Care Act reorganizes, amends, and adds to the provisions
of part A of title XXVII of the Public Health Service Act (PHS Act)
relating to group health plans and health insurance issuers in the
group and individual markets. The Affordable Care Act adds section
715(a)(1) to the Employee Retirement Income Security Act of 1974
(ERISA) and section 9815(a)(1) to the

[[Page 47742]]

Internal Revenue Code (Code) to incorporate the provisions of part A of
title XXVII of the PHS Act into ERISA and the Code, and to make those
provisions applicable to group health plans and health insurance
issuers providing health insurance coverage in connection with group
health plans. The sections of the PHS Act incorporated into ERISA and
the Code are sections 2701 through 2728.
Section 2713 of the PHS Act, as added by the Affordable Care Act
and incorporated into ERISA and the Code, requires that non-
grandfathered group health plans and health insurance issuers offering
non-grandfathered group or individual health insurance coverage provide
coverage of certain specified preventive services without cost sharing.
These preventive services include preventive care and screenings for
women provided for in comprehensive guidelines supported by the Health
Resources and Services Administration (HRSA). On August 1, 2011, the
Departments amended regulations to cover women's preventive services
provided for in HRSA guidelines,\1\ and HRSA adopted and released such
guidelines, which were based on recommendations of the independent
organization, the National Academy of Medicine (formerly Institute of
Medicine). The preventive services identified in the HRSA guidelines
include all Food and Drug Administration (FDA)-approved contraceptives,
sterilization procedures, and patient education and counseling for
women with reproductive capacity, as prescribed by a health care
provider (collectively, contraceptive services).\2\
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\1\ 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, 45 CFR 147.130.
\2\ The HRSA guidelines exclude services relating to a man's
reproductive capacity, such as vasectomies and condoms.
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The Departments issued regulations that provide an accommodation
for eligible organizations that object on religious grounds to
providing coverage for contraceptive services.\3\ Under the
accommodation, an eligible organization does not have to contract,
arrange, pay, or provide a referral for contraceptive coverage. At the
same time, the accommodation generally ensures that women enrolled in
the health plan established by the eligible organization, like women
enrolled in health plans maintained by other employers, receive
contraceptive coverage seamlessly--that is, through the same issuers or
third party administrators that provide or administer the rest of their
health coverage, and without financial, logistical, or administrative
obstacles.\4\ Minimizing such obstacles is essential to achieving the
purpose of the Affordable Care Act's preventive services provision,
which seeks to remove barriers to the use of preventive services and to
ensure that women receive full and equal health coverage appropriate to
their medical needs.
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\3\ 26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A, 45 CFR 147.131.
\4\ An accommodation is also available with respect to student
health insurance coverage arranged by eligible organizations that
are institutions of higher education. 45 CFR 147.131(f). For ease of
use, this RFI refers only to ``employers'' with religious objections
to the contraceptive-coverage requirement, but references to
employers with respect to insured group health plans should also be
considered to include institutions of higher education that are
eligible organizations with respect to student health insurance
coverage.
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Under the Departments' regulations, an eligible organization may
invoke the accommodation by self-certifying its eligibility using a
form provided by the Department of Labor, EBSA Form 700, and providing
the form to its health insurance issuer (to the extent it has an
insured plan) or third party administrator (to the extent it has a
self-insured plan).\5\ Alternatively, instead of sending the self-
certification form to its issuer or third party administrator, the
regulations allow an eligible organization to invoke the accommodation
by providing certain information to HHS, without using any particular
form.\6\
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\5\ The EBSA form 700 is available at: https://www.dol.gov/ebsa/pdf/preventiveserviceseligibleorganizationcertificationform.pdf
\6\ A model notice to HHS that eligible organizations may, but
are not required to, use is available at: http://www.cms.gov/cciio/resources/Regulations-and-Guidance/index.html#Prevention.
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In Zubik v. Burwell, 136 S. Ct. 1557 (2016), the Supreme Court
considered claims by a number of employers that, even with the
accommodation provided in the regulations, the contraceptive-coverage
requirement violates the Religious Freedom Restoration Act of 1993
(RFRA). Following oral argument, the Court requested supplemental
briefing from the parties. The Court's order noted that under the
existing regulations, an objecting employer with an insured plan that
seeks to invoke the accommodation by contacting its issuer must use a
form of notice provided by the government.\7\ The Court directed the
parties to file supplemental briefs addressing ``whether contraceptive
coverage could be provided to [the objecting employers'] employees,
through [the employers'] insurance companies, without any such
notice.'' \8\ After consideration of the supplemental briefing, the
Supreme Court vacated the judgments of the courts below and remanded
Zubik and several other cases raising parallel RFRA challenges to the
accommodation. 136 S. Ct. at 1560-1561. The Court emphasized that it
``expresse[d] no view on the merits of the cases'' and, in particular,
that it did not ``decide whether [the employers'] religious exercise
has been substantially burdened, whether the Government has a
compelling interest, or whether the current regulations are the least
restrictive means of serving that interest.'' Id. at 1560. The Court,
however, stated that in light of what it viewed as ``the substantial
clarification and refinement in the positions of the parties'' in their
supplemental briefs, the parties ``should be afforded an opportunity to
arrive at an approach going forward that accommodates [the objecting
employers'] religious exercise while at the same time ensuring that
women covered by [the employers'] health plans `receive full and equal
health coverage, including contraceptive coverage.''' Id. (citation
omitted).
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\7\ Zubik v. Burwell, Nos. 14-1418 et al., 2016 WL 1203818, at
*2 (Mar. 29, 2016).
\8\ Id.
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As the government explained in its briefs in Zubik, the Departments
continue to believe that the existing accommodation regulations are
consistent with RFRA for two independent reasons. First, as eight of
the nine courts of appeals to consider the issue have held, the
accommodation does not substantially burden objecting employers'
exercise of religion. Second, as some of those courts have also held,
the accommodation is the least restrictive means of furthering the
government's compelling interest in ensuring that women receive full
and equal health coverage, including contraceptive coverage.
Nevertheless, the Departments also are committed to respecting the
beliefs of religious employers that object to providing contraceptive
coverage, and the Departments have consistently sought to accommodate
religious objections to the contraceptive-coverage requirement even
where not required to do so by RFRA. Consistent with that approach, the
Departments are issuing this Request for Information (RFI) to
determine, as contemplated by the Supreme Court's opinion in Zubik,
whether modifications to the existing accommodation procedure could
resolve the objections asserted by the plaintiffs in the pending RFRA
cases while still ensuring that the affected women seamlessly receive
full and equal health coverage, including contraceptive coverage.
The Departments are using the RFI procedure because the issues
addressed in the supplemental briefing in Zubik affect a wide variety
of stakeholders,

[[Page 47743]]

including many who are not parties to the cases that were before the
Supreme Court. Other employers also have brought RFRA challenges to the
accommodation, and their views may differ from the views held by the
employers in Zubik and the consolidated cases. In addition, any change
to the accommodation could have implications for the rights and
obligations of issuers, third party administrators, and women enrolled
in health plans established by objecting employers. RFIs are commonly
used to solicit public comments on potential rulemaking in a
transparent and open way. Information gathered through this RFI will be
used to determine whether changes to the current regulations should be
made and, if so, to inform the nature of those changes. The Departments
welcome comments from all stakeholders. A principal purpose of this RFI
is to determine whether there are modifications to the accommodation
that would be available under current law and that could resolve the
RFRA claims raised by organizations that object to the existing
accommodation on religious grounds. The Departments invite all such
organizations to submit comments, and request that their submissions
include specific responses to the questions posed below.\9\
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\9\ Consistent with the Supreme Court's decision in Zubik, the
Departments seek to determine whether changes to the existing
accommodation could resolve the pending RFRA claims brought by
objecting employers. The Supreme Court separately specified that,
while the RFRA litigation remains pending, ``the Government may not
impose taxes or penalties on [the plaintiffs] for failure to provide
the . . . notice'' required under the existing accommodation
regulations. Zubik, 136 S. Ct. at 1561. At the same time, the Court
also emphasized that ``[n]othing in [its] opinion, or in the
opinions or orders of the courts below, is to affect the ability of
the Government to ensure that women covered by [plaintiffs'] health
plans `obtain, without cost, the full range of FDA approved
contraceptives.''' Id. at 1560-1561 (quoting Wheaton College v.
Burwell, 134 S. Ct. 2806, 2807 (2014)). As such, those interim
matters are not within the scope of this RFI.
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II. Solicitation of Comments

A. Notification to Issuers Without Self-Certification

In its request for supplemental briefing in Zubik, the Supreme
Court asked the parties to address whether and how ``contraceptive
coverage may be obtained by [objecting employers'] employees through
[the employers'] insurance companies, but in a way that does not
require any involvement of [the employers] beyond their own decision to
provide health insurance without contraceptive coverage to their
employees.'' \10\ In particular, the Court posited ``a situation in
which [objecting employers] would contract to provide health insurance
for their employees, and in the course of obtaining such insurance,
inform their insurance company that they do not want their health plan
to include contraceptive coverage of the type to which they object on
religious grounds. [The employers] would have no legal obligation to
provide such contraceptive coverage, would not pay for such coverage,
and would not be required to submit any separate notice to their
insurer, to the Federal government, or to their employees. At the same
time, [the employers'] insurance compan[ies]--aware that [the
employers] are not providing certain contraceptive coverage on
religious grounds--would separately notify [the employers'] employees
that the insurance company will provide cost-free contraceptive
coverage, and that such coverage is not paid for by [the employers] and
is not provided through [the employers'] health plan[s].'' \11\
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\10\ Zubik, 2016 WL 1203818, at *2.
\11\ Id.
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In response, the government explained:

For employers with insured plans, the Court described an
arrangement very similar to the existing accommodation. The
accommodation already relieves [employers with religious objections]
of any obligation to provide contraceptive coverage and instead
requires insurers to provide coverage separately. The only
difference is the way the accommodation is invoked. Currently, an
employer that chooses to opt out by notifying its insurer (rather
than HHS) must use a written form self-certifying its religious
objection and eligibility for the accommodation. The Court's order
posited an alternative procedure in which the employer could opt out
by asking an insurer for a policy that excluded contraceptives to
which it objects. That request would not need to take any particular
form, but the employer and the insurer would be in the same position
as after a self-certification: The employer's obligation to provide
contraceptive coverage would be extinguished, and the insurer would
instead be required to provide the coverage separately.'' Gov't
Supp. Brief 2 (citation omitted); see id. 3-7.\12\
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\12\ The government's supplemental brief is available at https://www.justice.gov/osg/brief/zubik-v-burwell-0. The government's
supplemental reply brief is available at https://www.justice.gov/osg/brief/zubik-v-burwell-1.

The government explained that because ``[i]nsurers have an
independent statutory obligation to provide contraceptive coverage,''
``the accommodation for employers with insured plans could be modified
to operate in the manner posited in the Court's order while still
ensuring that the affected women receive contraceptive coverage
seamlessly, together with the rest of their health coverage.'' Id. at
14-15. The government also noted, however, that the current requirement
of a written self-certification plays an important role in effectuating
the accommodation, and therefore cautioned that such a modification
could ``impose real costs on the parties whose rights and duties are
affected--including objecting employers.'' Id. at 14; see id. at 8-11
(describing the function of the self-certification requirement).
The Departments seek comments from all interested stakeholders,
including all objecting employers, on the procedure for invoking the
accommodation described above, including with respect to the following:
1. The Departments ask objecting organizations with insured plans
to indicate whether the alternative procedure described above would
resolve their RFRA objections to the accommodation. If it would not
resolve a particular organization's RFRA objection, the Departments ask
the organization to indicate whether its RFRA objection could be
resolved by any procedure(s) or system(s) in which the organization's
issuer provides contraceptive coverage to the women enrolled in the
organization's health plan, and, if so, describe the procedure(s) or
system(s) with specificity.
2. The Supreme Court's supplemental briefing order appears to
contemplate that, in requesting insurance coverage that excludes
contraceptive coverage, an employer would inform its issuer that it
objects to providing contraceptive coverage ``on religious grounds.''
\13\ The Departments ask objecting organizations to indicate whether
they would have any RFRA objection to informing their issuers that they
object to providing contraceptive coverage ``on religious grounds,'' or
to a further requirement that the request by an eligible organization
\14\ to its issuer be made in writing, or to a further requirement that
the request be made via a particular form.
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\13\ Zubik, 2016 WL 1203818, at *2.
\14\ An eligible organization, which may seek the accommodation
based on its sincerely held religious objection to providing
contraceptive coverage, is defined at 26 CFR 54.9815-2713A(a), 29
CFR 2590.715-2713A(a), and 45 CFR 147.131(b).
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3. The government's supplemental brief explained that eliminating
the written notification requirement in the existing accommodation
could impose additional burdens on objecting employers, issuers, and
regulators. Gov't Supp. Br. 8-10, 14-15. The Departments seek comment
on the extent of those burdens and what steps could be taken

[[Page 47744]]

to mitigate them. The Departments ask health insurance issuers, as well
as other commenters, to indicate whether it is feasible for issuers to
implement the accommodation without the written notification
requirement.
4. What impact would the alternative procedure described above have
on the ability of women enrolled in group health plans established by
objecting employers to receive seamless coverage for contraceptive
services?

B. Other Approaches With Respect to Insured Plans Described in the
Supplemental Briefing

In their supplemental brief, the plaintiffs in Zubik and the
consolidated cases proposed additional modifications to the existing
accommodation for insured plans, beyond those described in the Supreme
Court's supplemental briefing order and discussed above. As in the
alternative described above, the Zubik plaintiffs proposed that when an
eligible employer with an insured plan requests insurance coverage that
excludes contraceptive coverage to which the employer objects on
religious grounds, the employer's issuer should be required to provide
the required coverage separately. However, the Zubik plaintiffs further
proposed that the separate coverage provided by the issuer should
differ from the separate coverage required under the existing
accommodation in two respects. First, the Zubik plaintiffs proposed
that the issuer be required to offer women the opportunity to enroll in
contraceptive-only insurance policies, rather than the issuer providing
separate direct payments for contraceptive services. Second, the Zubik
plaintiffs proposed that the affected women should be required to take
affirmative steps to enroll in those contraceptive-only policies,
rather than being automatically eligible for payments by the issuer for
contraceptive services. Pet. Supp. Br. 3-12.\15\
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\15\ Petitioners' supplemental brief is available at http://www.scotusblog.com/wp-content/uploads/2016/04/Non-profits-response-to-Zubik-order-4-12-16.pdf. Petitioners' supplemental reply brief is
available at http://www.scotusblog.com/wp-content/uploads/2016/04/Zubik-order-non-profits-reply-brief-4-20-161.pdf.
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The Departments seek comments on this approach, including with
respect to the following:
1. The Departments ask objecting organizations with insured plans
to indicate whether this alternative procedure would resolve their RFRA
objections to the accommodation.
2. What impact would this approach have on the ability of women
enrolled in group health plans established by objecting employers to
receive seamless coverage for contraceptive services?
3. Is this approach feasible for health insurance issuers?
4. Relying on the record developed in the prior rulemaking
proceedings, the government's supplemental reply brief in Zubik
explained that contraceptive-only insurance policies would be
inconsistent with state laws regulating insurance and that an
affirmative enrollment requirement would impose a barrier to access to
preventive services. Gov't Supp. Reply Br. 3-6. The Departments seek
further comment on those issues in this RFI.
5. Are there alternative procedure(s) or systems (without relying
on contraceptive-only policies or imposing an affirmative enrollment
requirement) that would resolve objecting organizations' RFRA objection
to the accommodation? If so, please describe the procedure(s) or
system(s) with specificity.

C. Self-Insured Plans

The Supreme Court's supplemental briefing order in Zubik addressed
only employers with ``insured plans.'' \16\ In its supplemental brief,
the government described the operation of the accommodation for self-
insured plans and explained that an alternative process like the one
the Court posited for insured plans could not work for the many
employers with self-insured plans:
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\16\ Zubik, 2016 WL 1203818, at *2.

If an employer has a self-insured plan, the statutory obligation
to provide contraceptive coverage falls only on the plan--there is
no insurer with a preexisting duty to provide coverage. Accordingly,
to relieve self-insured employers of any obligation to provide
contraceptive coverage while still ensuring that the affected women
receive coverage without the employer's involvement, the
accommodation establishes a mechanism for the government to
designate the employer's TPA as a `plan administrator' responsible
for separately providing the required coverage under [ERISA]. That
designation is made by the government, not the employer, and the
employer does not fund, control, or have any other involvement with
the separate portion of the ERISA plan administered by the TPA.
The government's designation of the TPA must be reflected in a
written plan instrument. To satisfy that requirement, the
accommodation relies on either (1) a written designation sent by the
government to the TPA, which requires the government to know the
TPA's identity, or (2) the self-certification form, which the
regulations treat as a plan instrument in which the government
designates the TPA as a plan administrator. There is no mechanism
for requiring TPAs to provide separate contraceptive coverage
without a plan instrument; self-insured employers could not opt out
of the contraceptive-coverage requirement by simply informing their
TPAs that they do not want to provide coverage for contraceptives.
Gov't Supp. Br. 16-17 (citations omitted).

The Zubik plaintiffs also stated that an arrangement like the one
posited in the Supreme Court's briefing order for insured plans could
not work for self-insured plans. See Pet. Supp. Br. 16-17.
Although the Departments have not identified any viable alternative
to the existing accommodation for self-insured plans, they seek comment
on any possible modifications to the accommodation for self-insured
plans, including self-insured church plans that would resolve objecting
organizations' RFRA objections while still providing seamless access to
coverage, including with respect to the following:
1. Are any reasonable alternative means available under existing
law by which the Departments could ensure that women enrolled in self-
insured plans maintained by objecting employers receive separate
contraceptive coverage that is not contracted, arranged, paid, or
referred for by the objecting organization but that is provided through
the same third party administrators that administer the rest of their
health benefits?
2. The Departments ask objecting organizations with self-insured
plans to indicate whether their RFRA objections to the existing
accommodation could be resolved by any alternative procedure or system
in which the objecting organization's third party administrator
provides contraceptive coverage to the women enrolled in the
organization's health plan, and, if so, to describe the procedure(s) or
system(s) with specificity.

III. Collection of Information Requirements

This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, it need not be reviewed by the Office of
Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).

[[Page 47745]]

Signed at Washington, DC, this 18th day of July, 2016.
Victoria A. Judson,
Associate Chief Counsel (Tax Exempt and Government Entities), Internal
Revenue Service, Department of the Treasury.
Signed this 18th day of July, 2016.
Robert J. Neis,
Benefits Tax Counsel, Department of the Treasury.
Signed this 18th day of July, 2016.
Phyllis C. Borzi,
Assistant Secretary, Employee Benefits Security Administration
Department of Labor.
Dated: July 14, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: July 15, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-17242 Filed 7-21-16; 8:45 am]
BILLING CODE 4120-01-P

47742 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Proposed Rules

Internal Revenue Code (Code) to logistical, or administrative obstacles.4 judgments of the courts below and
incorporate the provisions of part A of Minimizing such obstacles is essential remanded Zubik and several other cases
title XXVII of the PHS Act into ERISA to achieving the purpose of the raising parallel RFRA challenges to the
and the Code, and to make those Affordable Care Act’s preventive accommodation. 136 S. Ct. at 1560–
provisions applicable to group health services provision, which seeks to 1561. The Court emphasized that it
plans and health insurance issuers remove barriers to the use of preventive ‘‘expresse[d] no view on the merits of
providing health insurance coverage in services and to ensure that women the cases’’ and, in particular, that it did
connection with group health plans. receive full and equal health coverage not ‘‘decide whether [the employers’]
The sections of the PHS Act appropriate to their medical needs. religious exercise has been substantially
incorporated into ERISA and the Code Under the Departments’ regulations, burdened, whether the Government has
are sections 2701 through 2728. an eligible organization may invoke the a compelling interest, or whether the
Section 2713 of the PHS Act, as added accommodation by self-certifying its current regulations are the least
by the Affordable Care Act and eligibility using a form provided by the restrictive means of serving that
incorporated into ERISA and the Code, Department of Labor, EBSA Form 700, interest.’’ Id. at 1560. The Court,
requires that non-grandfathered group and providing the form to its health however, stated that in light of what it
health plans and health insurance insurance issuer (to the extent it has an viewed as ‘‘the substantial clarification
issuers offering non-grandfathered insured plan) or third party and refinement in the positions of the
group or individual health insurance administrator (to the extent it has a self- parties’’ in their supplemental briefs,
coverage provide coverage of certain insured plan).5 Alternatively, instead of the parties ‘‘should be afforded an
specified preventive services without sending the self-certification form to its opportunity to arrive at an approach
cost sharing. These preventive services issuer or third party administrator, the going forward that accommodates [the
include preventive care and screenings regulations allow an eligible objecting employers’] religious exercise
for women provided for in organization to invoke the while at the same time ensuring that
comprehensive guidelines supported by accommodation by providing certain women covered by [the employers’]
the Health Resources and Services information to HHS, without using any health plans ‘receive full and equal
Administration (HRSA). On August 1, particular form.6 health coverage, including contraceptive
2011, the Departments amended In Zubik v. Burwell, 136 S. Ct. 1557 coverage.’’’ Id. (citation omitted).
regulations to cover women’s preventive (2016), the Supreme Court considered As the government explained in its
services provided for in HRSA claims by a number of employers that, briefs in Zubik, the Departments
guidelines,1 and HRSA adopted and even with the accommodation provided continue to believe that the existing
released such guidelines, which were in the regulations, the contraceptive- accommodation regulations are
based on recommendations of the coverage requirement violates the consistent with RFRA for two
independent organization, the National Religious Freedom Restoration Act of independent reasons. First, as eight of
Academy of Medicine (formerly 1993 (RFRA). Following oral argument, the nine courts of appeals to consider
Institute of Medicine). The preventive the Court requested supplemental the issue have held, the accommodation
services identified in the HRSA briefing from the parties. The Court’s does not substantially burden objecting
guidelines include all Food and Drug order noted that under the existing employers’ exercise of religion. Second,
Administration (FDA)-approved regulations, an objecting employer with as some of those courts have also held,
contraceptives, sterilization procedures, an insured plan that seeks to invoke the the accommodation is the least
and patient education and counseling accommodation by contacting its issuer restrictive means of furthering the
for women with reproductive capacity, must use a form of notice provided by government’s compelling interest in
as prescribed by a health care provider the government.7 The Court directed the ensuring that women receive full and
(collectively, contraceptive services).2 parties to file supplemental briefs equal health coverage, including
The Departments issued regulations addressing ‘‘whether contraceptive contraceptive coverage. Nevertheless,
that provide an accommodation for coverage could be provided to [the the Departments also are committed to
eligible organizations that object on objecting employers’] employees, respecting the beliefs of religious
religious grounds to providing coverage through [the employers’] insurance employers that object to providing
for contraceptive services.3 Under the contraceptive coverage, and the
companies, without any such notice.’’ 8
accommodation, an eligible organization Departments have consistently sought to
After consideration of the supplemental
does not have to contract, arrange, pay, accommodate religious objections to the
briefing, the Supreme Court vacated the
or provide a referral for contraceptive contraceptive-coverage requirement
coverage. At the same time, the 4 An accommodation is also available with even where not required to do so by
accommodation generally ensures that respect to student health insurance coverage RFRA. Consistent with that approach,
women enrolled in the health plan arranged by eligible organizations that are the Departments are issuing this Request
established by the eligible organization, institutions of higher education. 45 CFR 147.131(f). for Information (RFI) to determine, as
like women enrolled in health plans For ease of use, this RFI refers only to ‘‘employers’’
with religious objections to the contraceptive-
contemplated by the Supreme Court’s
maintained by other employers, receive coverage requirement, but references to employers opinion in Zubik, whether
contraceptive coverage seamlessly—that with respect to insured group health plans should modifications to the existing
is, through the same issuers or third also be considered to include institutions of higher accommodation procedure could
party administrators that provide or education that are eligible organizations with resolve the objections asserted by the
respect to student health insurance coverage.
administer the rest of their health 5 The EBSA form 700 is available at: https:// plaintiffs in the pending RFRA cases
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coverage, and without financial, www.dol.gov/ebsa/pdf/preventiveserviceseligible while still ensuring that the affected
organizationcertificationform.pdf women seamlessly receive full and
1 26 CFR 54.9815–2713, 29 CFR 2590.715–2713, 6 A model notice to HHS that eligible
equal health coverage, including
45 CFR 147.130. organizations may, but are not required to, use is contraceptive coverage.
2 The HRSA guidelines exclude services relating available at: http://www.cms.gov/cciio/resources/
Regulations-and-Guidance/index.html#Prevention.
The Departments are using the RFI
to a man’s reproductive capacity, such as
vasectomies and condoms. 7 Zubik v. Burwell, Nos. 14–1418 et al., 2016 WL procedure because the issues addressed
3 26 CFR 54.9815–2713A, 29 CFR 2590.715– 1203818, at *2 (Mar. 29, 2016). in the supplemental briefing in Zubik
2713A, 45 CFR 147.131. 8 Id. affect a wide variety of stakeholders,

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Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Proposed Rules 47743

including many who are not parties to employers] would contract to provide together with the rest of their health
the cases that were before the Supreme health insurance for their employees, coverage.’’ Id. at 14–15. The government
Court. Other employers also have and in the course of obtaining such also noted, however, that the current
brought RFRA challenges to the insurance, inform their insurance requirement of a written self-
accommodation, and their views may company that they do not want their certification plays an important role in
differ from the views held by the health plan to include contraceptive effectuating the accommodation, and
employers in Zubik and the coverage of the type to which they therefore cautioned that such a
consolidated cases. In addition, any object on religious grounds. [The modification could ‘‘impose real costs
change to the accommodation could employers] would have no legal on the parties whose rights and duties
have implications for the rights and obligation to provide such contraceptive are affected—including objecting
obligations of issuers, third party coverage, would not pay for such employers.’’ Id. at 14; see id. at 8–11
administrators, and women enrolled in coverage, and would not be required to (describing the function of the self-
health plans established by objecting submit any separate notice to their certification requirement).
employers. RFIs are commonly used to insurer, to the Federal government, or to The Departments seek comments from
solicit public comments on potential their employees. At the same time, [the all interested stakeholders, including all
rulemaking in a transparent and open employers’] insurance compan[ies]— objecting employers, on the procedure
way. Information gathered through this aware that [the employers] are not for invoking the accommodation
RFI will be used to determine whether providing certain contraceptive described above, including with respect
changes to the current regulations coverage on religious grounds—would to the following:
should be made and, if so, to inform the separately notify [the employers’] 1. The Departments ask objecting
nature of those changes. The employees that the insurance company organizations with insured plans to
Departments welcome comments from will provide cost-free contraceptive indicate whether the alternative
all stakeholders. A principal purpose of coverage, and that such coverage is not procedure described above would
this RFI is to determine whether there paid for by [the employers] and is not resolve their RFRA objections to the
are modifications to the accommodation provided through [the employers’] accommodation. If it would not resolve
that would be available under current health plan[s].’’ 11 a particular organization’s RFRA
law and that could resolve the RFRA In response, the government objection, the Departments ask the
claims raised by organizations that explained: organization to indicate whether its
object to the existing accommodation on For employers with insured plans, the RFRA objection could be resolved by
religious grounds. The Departments Court described an arrangement very similar any procedure(s) or system(s) in which
invite all such organizations to submit to the existing accommodation. The the organization’s issuer provides
comments, and request that their accommodation already relieves [employers contraceptive coverage to the women
submissions include specific responses with religious objections] of any obligation to enrolled in the organization’s health
to the questions posed below.9 provide contraceptive coverage and instead plan, and, if so, describe the
requires insurers to provide coverage procedure(s) or system(s) with
II. Solicitation of Comments separately. The only difference is the way the specificity.
accommodation is invoked. Currently, an
A. Notification to Issuers Without Self- employer that chooses to opt out by notifying
2. The Supreme Court’s supplemental
Certification its insurer (rather than HHS) must use a briefing order appears to contemplate
written form self-certifying its religious that, in requesting insurance coverage
In its request for supplemental that excludes contraceptive coverage, an
objection and eligibility for the
briefing in Zubik, the Supreme Court accommodation. The Court’s order posited an employer would inform its issuer that it
asked the parties to address whether alternative procedure in which the employer objects to providing contraceptive
and how ‘‘contraceptive coverage may could opt out by asking an insurer for a coverage ‘‘on religious grounds.’’ 13 The
be obtained by [objecting employers’] policy that excluded contraceptives to which Departments ask objecting organizations
employees through [the employers’] it objects. That request would not need to
to indicate whether they would have
insurance companies, but in a way that take any particular form, but the employer
and the insurer would be in the same any RFRA objection to informing their
does not require any involvement of [the issuers that they object to providing
employers] beyond their own decision position as after a self-certification: The
employer’s obligation to provide contraceptive coverage ‘‘on religious
to provide health insurance without contraceptive coverage would be grounds,’’ or to a further requirement
contraceptive coverage to their extinguished, and the insurer would instead that the request by an eligible
employees.’’ 10 In particular, the Court be required to provide the coverage organization 14 to its issuer be made in
posited ‘‘a situation in which [objecting separately.’’ Gov’t Supp. Brief 2 (citation writing, or to a further requirement that
omitted); see id. 3–7.12
9 Consistent with the Supreme Court’s decision in
the request be made via a particular
The government explained that form.
Zubik, the Departments seek to determine whether
changes to the existing accommodation could because ‘‘[i]nsurers have an 3. The government’s supplemental
resolve the pending RFRA claims brought by independent statutory obligation to brief explained that eliminating the
objecting employers. The Supreme Court separately provide contraceptive coverage,’’ ‘‘the written notification requirement in the
specified that, while the RFRA litigation remains accommodation for employers with existing accommodation could impose
pending, ‘‘the Government may not impose taxes or
penalties on [the plaintiffs] for failure to provide the insured plans could be modified to additional burdens on objecting
. . . notice’’ required under the existing operate in the manner posited in the employers, issuers, and regulators. Gov’t
accommodation regulations. Zubik, 136 S. Ct. at Court’s order while still ensuring that Supp. Br. 8–10, 14–15. The Departments
1561. At the same time, the Court also emphasized the affected women receive seek comment on the extent of those
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that ‘‘[n]othing in [its] opinion, or in the opinions
or orders of the courts below, is to affect the ability contraceptive coverage seamlessly, burdens and what steps could be taken
of the Government to ensure that women covered
by [plaintiffs’] health plans ‘obtain, without cost, 11 Id. 13 Zubik, 2016 WL 1203818, at *2.
the full range of FDA approved contraceptives.’’’ Id. 12 Thegovernment’s supplemental brief is 14 An eligible organization, which may seek the
at 1560–1561 (quoting Wheaton College v. Burwell, available at https://www.justice.gov/osg/brief/zubik- accommodation based on its sincerely held
134 S. Ct. 2806, 2807 (2014)). As such, those v-burwell-0. The government’s supplemental reply religious objection to providing contraceptive
interim matters are not within the scope of this RFI. brief is available at https://www.justice.gov/osg/ coverage, is defined at 26 CFR 54.9815–2713A(a),
10 Zubik, 2016 WL 1203818, at *2. brief/zubik-v-burwell-1. 29 CFR 2590.715–2713A(a), and 45 CFR 147.131(b).

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47744 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Proposed Rules

to mitigate them. The Departments ask objecting employers to receive seamless contraceptive-coverage requirement by
health insurance issuers, as well as coverage for contraceptive services? simply informing their TPAs that they do not
other commenters, to indicate whether 3. Is this approach feasible for health want to provide coverage for contraceptives.
it is feasible for issuers to implement the insurance issuers? Gov’t Supp. Br. 16–17 (citations omitted).
accommodation without the written 4. Relying on the record developed in
notification requirement. the prior rulemaking proceedings, the The Zubik plaintiffs also stated that an
4. What impact would the alternative government’s supplemental reply brief arrangement like the one posited in the
procedure described above have on the in Zubik explained that contraceptive- Supreme Court’s briefing order for
ability of women enrolled in group only insurance policies would be insured plans could not work for self-
health plans established by objecting inconsistent with state laws regulating insured plans. See Pet. Supp. Br. 16–17.
employers to receive seamless coverage insurance and that an affirmative Although the Departments have not
for contraceptive services? enrollment requirement would impose a identified any viable alternative to the
barrier to access to preventive services. existing accommodation for self-insured
B. Other Approaches With Respect to
Gov’t Supp. Reply Br. 3–6. The plans, they seek comment on any
Insured Plans Described in the
Departments seek further comment on possible modifications to the
Supplemental Briefing
those issues in this RFI. accommodation for self-insured plans,
In their supplemental brief, the 5. Are there alternative procedure(s)
plaintiffs in Zubik and the consolidated including self-insured church plans that
or systems (without relying on
cases proposed additional modifications contraceptive-only policies or imposing would resolve objecting organizations’
to the existing accommodation for an affirmative enrollment requirement) RFRA objections while still providing
insured plans, beyond those described that would resolve objecting seamless access to coverage, including
in the Supreme Court’s supplemental organizations’ RFRA objection to the with respect to the following:
briefing order and discussed above. As accommodation? If so, please describe 1. Are any reasonable alternative
in the alternative described above, the the procedure(s) or system(s) with means available under existing law by
Zubik plaintiffs proposed that when an specificity. which the Departments could ensure
eligible employer with an insured plan that women enrolled in self-insured
C. Self-Insured Plans
requests insurance coverage that plans maintained by objecting
excludes contraceptive coverage to The Supreme Court’s supplemental employers receive separate
which the employer objects on religious briefing order in Zubik addressed only contraceptive coverage that is not
grounds, the employer’s issuer should employers with ‘‘insured plans.’’ 16 In
contracted, arranged, paid, or referred
be required to provide the required its supplemental brief, the government
for by the objecting organization but that
coverage separately. However, the Zubik described the operation of the
accommodation for self-insured plans is provided through the same third party
plaintiffs further proposed that the
and explained that an alternative administrators that administer the rest
separate coverage provided by the issuer
process like the one the Court posited of their health benefits?
should differ from the separate coverage
required under the existing for insured plans could not work for the 2. The Departments ask objecting
accommodation in two respects. First, many employers with self-insured organizations with self-insured plans to
the Zubik plaintiffs proposed that the plans: indicate whether their RFRA objections
issuer be required to offer women the If an employer has a self-insured plan, the to the existing accommodation could be
opportunity to enroll in contraceptive- statutory obligation to provide contraceptive resolved by any alternative procedure or
only insurance policies, rather than the coverage falls only on the plan—there is no system in which the objecting
issuer providing separate direct insurer with a preexisting duty to provide organization’s third party administrator
payments for contraceptive services. coverage. Accordingly, to relieve self-insured
employers of any obligation to provide
provides contraceptive coverage to the
Second, the Zubik plaintiffs proposed contraceptive coverage while still ensuring women enrolled in the organization’s
that the affected women should be that the affected women receive coverage health plan, and, if so, to describe the
required to take affirmative steps to without the employer’s involvement, the procedure(s) or system(s) with
enroll in those contraceptive-only accommodation establishes a mechanism for specificity.
policies, rather than being automatically the government to designate the employer’s
eligible for payments by the issuer for TPA as a ‘plan administrator’ responsible for III. Collection of Information
contraceptive services. Pet. Supp. Br. separately providing the required coverage Requirements
under [ERISA]. That designation is made by
3–12.15
the government, not the employer, and the This document does not impose
The Departments seek comments on employer does not fund, control, or have any
this approach, including with respect to information collection requirements,
other involvement with the separate portion
the following: of the ERISA plan administered by the TPA.
that is, reporting, recordkeeping or
1. The Departments ask objecting The government’s designation of the TPA third-party disclosure requirements.
organizations with insured plans to must be reflected in a written plan Consequently, it need not be reviewed
indicate whether this alternative instrument. To satisfy that requirement, the by the Office of Management and
procedure would resolve their RFRA accommodation relies on either (1) a written Budget under the authority of the
objections to the accommodation. designation sent by the government to the Paperwork Reduction Act of 1995 (44
2. What impact would this approach TPA, which requires the government to know
the TPA’s identity, or (2) the self-certification U.S.C. 3501 et seq.).
have on the ability of women enrolled
form, which the regulations treat as a plan
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in group health plans established by instrument in which the government
designates the TPA as a plan administrator.
15 Petitioners’ supplemental brief is available at
There is no mechanism for requiring TPAs to
http://www.scotusblog.com/wp-content/uploads/ provide separate contraceptive coverage
2016/04/Non-profits-response-to-Zubik-order-4-12-
without a plan instrument; self-insured
16.pdf. Petitioners’ supplemental reply brief is
available at http://www.scotusblog.com/wp-content/ employers could not opt out of the
uploads/2016/04/Zubik-order-non-profits-reply-
brief-4-20-161.pdf. 16 Zubik, 2016 WL 1203818, at *2.

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Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Proposed Rules 47745

Signed at Washington, DC, this 18th day of the revisions to these regulations are submissions, and general guidance on
July, 2016. mainly administrative in nature, but making effective comments, please visit
Victoria A. Judson, also include technical corrections and a http://www2.epa.gov/dockets/
Associate Chief Counsel (Tax Exempt and few substantive changes to several of the commenting-epa-dockets.
Government Entities), Internal Revenue rules. In addition, EPA is proposing a FOR FURTHER INFORMATION CONTACT:
Service, Department of the Treasury. correction to the Rhode Island SIP to Susan Lancey, Air Permits, Toxics and
Signed this 18th day of July, 2016. remove Rhode Island’s odor regulation Indoor Programs Unit, Office of
Robert J. Neis, because it was previously erroneously Ecosystem Protection, 5 Post Office
Benefits Tax Counsel, Department of the approved into the SIP. The intended Square—Suite 100, (Mail code OEP05–
Treasury. effect of this action is to propose to 2), Boston, MA 02109–3912, telephone
Signed this 18th day of July, 2016. approve Rhode Island’s fifteen revised 617–918–1656, fax 617–918–0656, email
Phyllis C. Borzi, regulations into the Rhode Island SIP lancey.susan@epa.gov.
Assistant Secretary, Employee Benefits and correct the Rhode Island SIP by
SUPPLEMENTARY INFORMATION: In the
Security Administration Department of Labor. removing Rhode Island’s odor
regulation. This action is being taken in Rules and Regulations section of this
Dated: July 14, 2016. Federal Register, EPA is approving the
Andrew M. Slavitt,
accordance with the Clean Air Act.
State’s SIP submittal as a direct final
DATES: Written comments must be
Acting Administrator, Centers for Medicare rule without prior proposal because the
& Medicaid Services. received on or before August 22, 2016. Agency views this as a noncontroversial
Approved: July 15, 2016. ADDRESSES: Submit your comments, submittal and anticipates no adverse
Sylvia M. Burwell, identified by Docket ID No. EPA–R01– comments. A detailed rationale for the
Secretary, Department of Health and Human OAR–2015–0306 at http:// approval is set forth in the direct final
Services. www.regulations.gov, or via email to rule. If no adverse comments are
[FR Doc. 2016–17242 Filed 7–21–16; 8:45 am]
mcdonnell.ida@epa.gov. For comments received in response to this action rule,
submitted at Regulations.gov, follow the no further activity is contemplated. If
BILLING CODE 4120–01–P
online instructions for submitting EPA receives adverse comments, the
comments. Once submitted, comments direct final rule will be withdrawn and
cannot be edited or removed from all public comments received will be
ENVIRONMENTAL PROTECTION Regulations.gov. For either manner of
AGENCY addressed in a subsequent final rule
submission, the EPA may publish any based on this proposed rule. EPA will
40 CFR Part 52 comment received to its public docket. not institute a second comment period.
Do not submit electronically any Any parties interested in commenting
[EPA–R01–OAR–2015–0306; A–1–FRL– information you consider to be on this action should do so at this time.
9949–31–Region 1] Confidential Business Information (CBI) Please note that if EPA receives adverse
or other information whose disclosure is comment on an amendment, paragraph,
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Correction, Administrative and
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Miscellaneous Revisions
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AGENCY: Environmental Protection The written comment is considered the as final those provisions of the rule that
Agency. official comment and should include are not the subject of an adverse
ACTION: Proposed rule. discussion of all points you wish to comment.
make. The EPA will generally not For additional information, see the
SUMMARY: The Environmental Protection consider comments or comment direct final rule which is located in the
Agency (EPA) is proposing to approve a contents located outside of the primary Rules and Regulations section of this
State Implementation Plan (SIP) submission (i.e. on the web, cloud, or Federal Register.
revision submitted by the State of Rhode other file sharing system). For
Island. This SIP revision includes additional submission methods, please Dated: July 5, 2016.
fifteen revised Rhode Island Air contact the person identified in the ‘‘For H. Curtis Spalding,
Pollution Control Regulations. These Further Information Contact’’ section. Regional Administrator, EPA New England.
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ehiers on DSK5VPTVN1PROD with PROPOSALS

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Document Created: 2016-07-22 02:38:32
Document Modified: 2016-07-22 02:38:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Request for information.
Dates		Comments must be submitted on or before September 20, 2016.
Contact		David Mlawsky, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, at (410) 786-1565.
FR Citation		81 FR 47741
CFR Citation		26 CFR 54 29 CFR 2590 45 CFR 147

81 FR 47741 - Coverage for Contraceptive Services

DEPARTMENT OF THE TREASURYInternal Revenue ServiceDEPARTMENT OF LABOREmployee Benefits Security AdministrationDEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 141 (July 22, 2016)

DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF LABOR
Employee Benefits Security Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES