CMS-10535_IFR supporting_statement_8_19_14

Supporting Statement – Part A
Coverage of Certain Preventive Services Under the Affordable Care Act
(CMS-10535)
A. Background
The Patient Protection and Affordable Care Act, Public Law 111-148, (the Affordable
Care Act) was enacted by President Obama on March 23, 2010 and amended by the
Health Care and Education Reconciliation Act of 2010, Public Law 111-152 on March
30, 2010. The Affordable Care Act added section 2713 to the Public Health Service
(PHS) Act and incorporated this provision into the Employee Retirement Income
Security Act (ERISA) and the Internal Revenue Code (Code). The Departments of
Health and Human Services, Labor, and Treasury (the Departments) published interim
final rules (2010 interim final rules) on July 19, 2010 to require non-grandfathered group
health insurance coverage to provide benefits for certain preventive services without cost
sharing, including benefits for certain women’s preventive health services as provided for
in comprehensive guidelines supported by the Health Resources and Services
Administration (HRSA).
On August 1, 2011, HRSA adopted and released guidelines for women’s preventive
health services, including contraceptive services. On August 3, 2011, the Departments
amended the 2010 interim final rules (2011 amended interim final rules) to provide
HRSA with the authority to exempt group health plans established or maintained by
religious employers (and group health insurance coverage provided in connection with
such plans) from the requirement to cover contraceptive services consistent with the
HRSA guidelines. The 2011 amended interim final rules specified a definition of
religious employer. HRSA exercised its authority in its guidelines to exempt plans
established or maintained by religious employers (and group health insurance coverage
provided in connection with such plans) from the requirement to cover contraceptive
services.
On February 10, 2012, the Departments issued final rules that adopted the definition of
religious employer in the 2011 amended interim final rules without modification (2012
final regulations) and issued guidance establishing a one year enforcement safe harbor for
group health plans established or maintained by certain nonprofit organizations with
religious objections to contraceptive coverage (and group health insurance provided in
connection with such plans). The guidance provided that the temporary enforcement safe
harbor would remain in effect until the first plan year beginning on or after August 1,
2013. On March 21, 2012, the Departments published an advance notice of proposed
rulemaking that described and solicited comments on possible approaches to achieve the
goals of providing coverage of recommended preventive services, including
contraceptive services, without cost sharing, while simultaneously protecting certain

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additional nonprofit organizations with religious objections to contraceptive coverage
from having to contract, arrange, pay, or refer for such coverage.
On February 6, 2013, the Departments published proposed rules that proposed to simplify
and clarify the definition of religious employer and also proposed accommodations for
health coverage established or maintained or arranged by certain nonprofit religious
organizations with religious objections to contraceptive services (eligible organizations).
The rules proposed that, for insured plans, the health insurance issuer providing group
health insurance coverage in connection with the plan would be required to assume sole
responsibility, independent of the eligible organization and its plan, for providing
contraceptive coverage to plan participants and beneficiaries without cost sharing,
premium, fee, or other charge to plan participants or beneficiaries or to the eligible
organization or its plan. In the case of self-insured plans, the proposed regulations
presented potential approaches under which the third party administrator of the plan
would provide or arrange for a third party to provide separate contraceptive coverage to
plan participants and beneficiaries without cost sharing, premium, fee, or other charge to
plan participants or beneficiaries or to the eligible organization or its plan. The
Departments received over 400,000 comments (many of them standardized form letters)
in response to the proposed regulations.
After consideration of the comments, the Departments published final regulations on July
2, 2013. A contemporaneously-issued HHS guidance document extended the temporary
safe harbor from enforcement of the contraceptive coverage requirement by the
Departments to encompass plan years beginning on or after August 1, 2013, and before
January 1, 2014. This guidance included a form to be used by an organization during this
temporary period to self-certify that its plan qualifies for the temporary enforcement safe
harbor. In addition, HHS and the Department of Labor also issued a self-certification
form, EBSA Form 700, to be executed by an organization seeking to be treated as an
eligible organization for purposes of an accommodation under these final regulations.
This self-certification form was provided for use with the accommodations under the July
2013 final regulations, after the expiration of the temporary enforcement safe harbor (that
is, for plan years beginning on or after January 1, 2014). The rules also provide that the
third party administrator and issuer that is required to provide or arrange payments for
contraceptive services must provide plan participants and beneficiaries with written
notice of the availability of separate payments for contraceptive services
contemporaneous with, but separate from, any application materials distributed in
connection with enrollment for group health coverage for each plan year to which the
accommodation is to apply. The EBSA Form 700 and the notice to HHS are information
collection requests (ICRs) subject to the Paperwork Reduction Act.

B. Justification.

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1.

Need and Legal Basis
On July 3, 2014, the Supreme Court of the United States issued an interim order in
connection with an application for an injunction in the pending case of Wheaton College
v. Burwell, ruling that, “[i]f [Wheaton College] informs the Secretary of Health and
Human Services in writing that it is a non-profit organization that holds itself out as
religious and has religious objections to providing coverage for contraceptive services,
the [Departments of Labor, Health and Human Services, and the Treasury] are enjoined
from enforcing against [Wheaton College]” certain provisions of the Affordable Care Act
and related regulations requiring coverage without cost-sharing of certain contraceptive
services “pending final disposition of appellate review” (Wheaton order). The order
stated that Wheaton College need not use EBSA Form 700 or send a copy of the executed
form to its health insurance issuers or third party administrators to meet the condition for
this injunctive relief. The order also stated that it neither affected “the ability of [Wheaton
College’s] employees and students to obtain, without cost, the full range of FDA
approved contraceptives,” nor precluded the Government from relying on the notice it
receives from Wheaton College “to facilitate the provision of full contraceptive coverage
under the Act.”
The Departments are issuing the interim final regulations in light of the Supreme Court’s
interim order concerning notification to the Federal government that an eligible
organization has a religious objection to providing contraceptive coverage, as an
alternative to the EBSA Form 700, and to preserve participants’ and beneficiaries’ access
to coverage for the full range of FDA-approved contraceptives, as prescribed by a health
care provider, without cost sharing, which is also consistent with the Supreme Court’s
order.
The interim final regulations amend the EBSA Form 700 ICR. HHS is revising this ICR
pursuant to the emergency PRA clearance procedures set forth under 5 CFR 1320.13 in
order to implement the Supreme Court's order and make an alternative process for
eligible organizations available as soon as possible. The use of normal Paperwork
Reduction Act clearance procedures would delay implementation of the Court's order and
the ability of eligible organizations to avail themselves of this alternative process.

2.

Information Users
The requirement to provide a self-certification or notice to HHS is a third-party reporting
disclosure. These disclosures are required to exempt eligible organizations from
contracting, arranging, paying, or referring for contraceptive coverage. Eligible
organizations seeking the accommodation must maintain the self-certification or notice to
HHS in a manner consistent with the record retention requirements under section 107 of
the Employee Retirement Income Security Act of 1974, which generally requires records
to be maintained for six years.
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3.

Use of Information Technology
The interim final regulations do not limit the ability of affected eligible organizations to
furnish the self-certification or notice to HHS via electronic media.

4.

Duplication of Efforts
The information collection does not require duplicative information.

5.

Small Businesses
The eligible organization only has to complete the self-certification or notice to HHS one
time, unless there is a change in its qualifications as an eligible organization, religious
objection, health insurance issuer, or third party administrator.
If completing the EBSA Form 700, the eligible organization may maintain the selfcertification in its own records after it is provided to issuers or third party administrators
(as outlined in the regulations), and is not required to submit it to the government. If
providing notice to HHS, the eligible organization may maintain the notice in its own
records after it is provided to the government. The eligible organization may provide the
self-certification electronically to further reduce burden.
For eligible organizations that provide notice to HHS, the Departments are providing
model language that can be used to satisfy the notice requirement to minimize burden.

6.

Less Frequent Collection
If the self-certification or notice to HHS does not occur, there is no way to verify that an
eligible organization is seeking an accommodation and there is no way to ensure that
issuers or third party administrators will provide benefits for contraceptive services to
participants and beneficiaries.

7.

Special Circumstances
The regulations require the self-certification or notice to HHS to be maintained in a manner
consistent with the record retention requirements under section 107 of the Employee
Retirement Income Security Act of 1974, which generally requires records to be kept for six
years.

8.

Federal Register/Outside Consultation
As discussed in Item 1 above, HHS is revising this ICR pursuant to the emergency PRA
clearance procedures set forth under 5 CFR 1320.13. The OMB emergency approval
expires on February 28, 2015. Therefore, contemporaneously with the publication of
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these interim final regulations, the Department has published a notice elsewhere in
today’s issue of the Federal Register informing the public of its intention to extend the
OMB approval for three years. The notice solicits comments on the revisions to the ICR
and provides the public with 60 days to comment as required by 5 CFR 1320.8(d).
9.

Payments/Gifts to Respondents
No payments or gifts are associated with these ICRs.

10.

Confidentiality
Privacy of the information provided will be protected to the extent provided by law.

11.

Sensitive Questions
These ICRs involve no sensitive questions.

12.

Burden Estimates (Hours and Wages)
Each organization seeking to be treated as an eligible organization under the interim final
rules must provide a self-certification to each third party administrator or issuer, or notice
to HHS, of its religious objection to coverage of all or a subset of contraceptive services.
The interim final regulations continue to allow such eligible organizations to notify an
issuer or third party administrator using EBSA Form 700, as set forth in the July 2013
final regulations. In addition, the interim final regulations permit an alternative process,
consistent with the Supreme Court’s interim order in Wheaton College, under which an
eligible organization may notify HHS of its religious objection to coverage of all or a
subset of contraceptive services. The eligible organization must maintain the selfcertification or notice to HHS in its records.
HHS does not know the total number of organizations that would seek an
accommodation. HHS sought comment on the likely number of organizations seeking an
accommodation and the number of participants and beneficiaries in the plans of such
organizations when the proposed regulations were issued in 2013, but received no
comments. HHS knows, based on litigation, that approximately 122 eligible
organizations would now have the option to provide the alternative notice to HHS rather
than their third party administrators or issuers.
Therefore, HHS assumes that 122 eligible organizations will seek accommodation under
the interim final regulations. In order to complete this task, HHS assumes that clerical
staff for each eligible organization will gather and enter the necessary information and
send the self-certification electronically to the issuer or third party administrator as

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appropriate, or send the notice to HHS electronically.1 HHS assumes that a compensation
and benefits manager and inside legal counsel will review the self-certification or notice
to HHS and a senior executive would execute it. HHS estimates that an eligible
organization would spend approximately 45 minutes (30 minutes of clerical labor at a
cost of $30 per hour, 10 minutes for a compensation and benefits manager at a cost of
$102 per hour, 5 minutes for legal counsel at a cost of $127, and 5 minutes by a senior
executive at a cost of $121) preparing and sending the self-certification or notice to HHS
and filing it to meet the recordkeeping requirement. Therefore, the total annual burden
for preparing and providing the information in the self-certification or notice to HHS will
require approximately 50 minutes for each eligible organization with an equivalent cost
burden of approximately $53 for a total hour burden of 110 hours with an equivalent cost
of $6,425.
Table 1. Estimated Annualized Burden for the Notification

Notice
SelfCertification

13.

Number of
respondents
122

Number of
responses

Estimated
Burden
Hours per
Respondent

1

0.83

Total
Estimated
Annual
Burden Hours
110

Estimated
Total
Burden
Estimated
Cost Per
Annual
Respondent
Cost
$53

Capital Costs
HHS estimates that each self-certification or notice to HHS will require $0.49 in postage
and $0.05 in materials cost (paper and ink) and the total postage and materials cost for
each self-certification or notice sent via mail will be $0.54.
For purposes of this analysis, HHS assumes that all self-certifications or notices to HHS
will be mailed. The total cost burden for the self-certifications or notices to HHS is
approximately $66.
As the Department of Labor and the Department of Health and Human Services share
jurisdiction they are splitting the cost burden so each will account for $33 of the cost
burden.

14.

Costs to the Federal Government
There is no cost to the federal government.

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For purposes of this analysis, HHS assumes that the same amount of time will be required to prepare the selfcertification and the notice to HHS.
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$6425

15.

Changes to Burden
The information collection has been revised by new interim final regulations.

16.

Publication/Tabulation Dates
There are no publication or tabulation dates associated with these ICRs.

17.

Expiration Date
There is no expiration date for this collection requirement.

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