CMS-10535_supporting statement 30d 3-06-2015_final

Supporting Statement – Part A
Employer Notification to HHS of its Objection to Providing Coverage for Contraceptive
Services
(CMS-10535)
A. Background
The Patient Protection and Affordable Care Act, Public Law 111-148, (the Affordable
Care Act) was signed into law 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 plans and non-grandfathered group and individual 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),
which guidelines HRSA adopted and released on August 1, 2011 (the HRSA Guidelines).
Under section 2713 of the PHS Act, its implementing regulations, and the HRSA
Guidelines, recommended preventive services required to be covered without cost
sharing by applicable plans and coverage include certain contraceptive services.
On August 3, 2011, the Departments amended the 2010 interim final rules (2011 interim
final rule amendments) 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 interim final rule amendments
specified a definition of religious employer. HRSA exercised its authority in the HRSA
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 15, 2012, the Departments published final rules that adopted the definition
of religious employer in the 2011 interim final rule amendments 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
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goals of providing coverage of recommended preventive services, including
contraceptive services, without cost sharing, while simultaneously protecting certain
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.
After consideration of the comments, the Departments published final regulations on July
2, 2013 (2013 final regulations). A contemporaneously-issued Department of Health and
Human Services (HHS) guidance document extended the temporary safe harbor from
enforcement of the contraceptive coverage requirement by the Departments against
qualifying employers, group health plans, and associated group health insurance coverage
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 the 2013 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 2013 final regulations also
provide that the third party administrator or 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.

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B. Justification.
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, or interim
order). The interim 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 conditions 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 published interim final regulations on August 27, 2014 (79 FR 51092)
(2014 interim final regulations), which provided that an eligible organization that has a
religious objection to providing contraceptive coverage may submit a notification to HHS
as an alternative to submitting the EBSA Form 700 to the eligible organization’s health
insurance issuer or third party administrator. The 2014 interim final regulations 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 Wheaton order.

2.

Information Users
The self-certification or notice to HHS is required to exempt eligible organizations from
otherwise applicable requirements regarding 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.

3.

Use of Information Technology
The 2014 interim final regulations do not limit the ability of affected eligible
organizations to furnish the self-certification or notice to HHS via electronic media.

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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 must 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 must maintain the notice in its own
records after it is provided to HHS. The eligible organization may provide the selfcertification 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 thus no way to ensure that issuers
or third party administrators will provide separate payments 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
A Federal Register notice was published on December 8, 2014 (79 FR 72685), providing
the public with a 60-day period to submit written comments on the information collection
request (ICR). HHS received comments from four commenters and is considering
making revisions to the model notification at a later date. A summary of comments is
provided in Appendix A.

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9.

Payments/Gifts to Respondents
No payments or gifts are associated with the ICR.

10.

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

11.

Sensitive Questions
The ICR involves no sensitive questions.

12.

Burden Estimates (Hours and Wages)
Each organization seeking to be treated as an eligible organization under the 2014 interim
final regulations 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 2014 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 2013 final regulations. In addition, the 2014 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 self-certification or notice to HHS in its records.
HHS does not know the total number of organizations that will seek an accommodation.
HHS knows, based on litigation, that at least 122 eligible organizations will now have the
option to provide the alternative notice to HHS rather than their third party administrators
or issuers.
Therefore, HHS assumes that at least 122 eligible organizations will seek accommodation
under the 2014 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 to the issuer or third party administrator as
appropriate, or send the notice to HHS. 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 will execute it. HHS estimates that an eligible organization will spend
approximately 50 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

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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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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 102 hours with an equivalent cost of
$6,425. As HHS and the Department of Labor share jurisdiction they are splitting the
hour burden so each will account for 51 burden hours with an equivalent cost of $3,213,
with a total of 61 respondents.
Table 1. Estimated Annualized Burden for the Notification

Notice
Notification
13.

Number of
respondents
61

Number of
responses
1

Estimated
Burden
Hours per
Respondent
0.83

Total
Estimated
Annual
Burden
Hours
51

Estimated
Burden Cost
Per
Respondent
$53

Total
Estimated
Annual
Cost
$3213

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.
Self-certifications or notices to HHS may be sent electronically or by mail. 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.

15.

Changes to Burden
HHS inadvertently estimated burden for the entire collection rather than splitting the
burden with the Department of Labor. The burden has been reduced to cover 61
respondents rather than the entire 122 respondents. Therefore, the burden has decreased
from 110 hours to 51 hours to correct that error and a calculation error.

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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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