Emergency Justification - Signed

DEPARTM ENT OF HEA LTH & HUMAN SERVI CES
Centers fo r Medi care & Medicaid Services
7500 Security Bou levard
Ba ltimore. Mary land 2 1244- 1850
CENTERS FOR MED ICARE & MEDICA ID SERVICE!

DA TE:

October 6, 2017

TO:

Neomi Rao
Administrator, OIRA

FROM:

Seema Verma C~ ·
Administrator 7J

SUBJECT:

Request for Emergency Clearance of the Paperwork Reduction Act Package for
Coverage of Certain Preventive Services Under the Affordable Care Act (CMS] 0653 ; OMB# 0938-New)

Emergency Justification
The Centers for Medicare & Medicaid Services (CMS) is requesting that an information
collection request associated with the coverage of certain preventive services under the
Affordable Care Act be processed in accordance with the implementing regulations of the
Paperwork Reduction Act of 1995 at 5 CFR 1320.13(a)(2)(i). We believe public harm is
reasonably likely to occur if the normal , non-emergency clearance procedures are followed.
Specifically, we are requesting emergency review and approval in order to implement provisions
regarding self-certification or notices to HHS from eligible organizations (§ 14 7.131 (c )(3)),
notice of availability of separate payments for contraceptive services(§ 147. 131 (e)), and notice of
revocation of accommodation (§147.13l(c)(4)). Normal clearance procedures wi ll likely
prevent or disrupt the collection of information associated with § 14 7.13 1(c )(3), § 14 7.131 (e), and
§147.131(c)(4). In accordance with 5 CFR 1320.13(a)(2)(i), we believe that public harm is
reasonably likely to ensue if the normal clearance procedures is followed . The use of normal
clearance procedures is reasonably likely to prevent or disrupt the collection of information.
Similarly, in acco rdance with 5 CFR 1320.13(a)(2)(iii), we believe the use of normal clearance
procedures is reasonably likely to cause a statutory or court ordered deadline to be missed. Many
cases related to the provision of contraceptive services have been on remand for over a year from
the Supreme Court asking the Departments of Health and Human Services, Labor, and Treasury
(the Departments) and the parties to resolve this matter. The Departments are in the process of
issuing interim final rules that expand exemptions to entities, which involves no collection of
information and which the Departments have statutory authority to do by the use of interim final
rules. If the information collection involved in the amended accommodation process is not
approved on an emergency basis, newly exempt entities that wish to opt into the amended
accommodation process might not be able to do so until normal clearance procedures are
completed.

1

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 Act and incorporated this
provision into the Employee Retirement Income Security Act (ERISA) and the Internal Revenue
Code (Code). The Departments published interim final rules (2010 interim final rules) on July
19, 2010 (75 FR 41726) 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, 20 11 , the Departments amended the 2010 interim final rules (76 FR 46621) (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
reli gious employer, which was adopted in the final regulations published on February 15, 2012
(77 FR 8725). Since then, the Departments have published several regulations to simplify and
clarify the definition of religious employer and also provide accommodations for health coverage
established or maintained or arranged by certain nonprofit religious organizations and closelyheld for-profit organizations with religious objections to contraceptive services.
The 2017 interim final regulations titled "Religious Exemptions and Accommodations for
Coverage of Certain Preventive Services Under the Affordable Care Act" and "Moral
Exemptions and Accommodations for Coverage of Certain Preventive Services Under the
Affordable Care Act" expand exemptions for religious beliefs and moral convictions for certain
entities or individuals whose health plans may otherwise be subject to a mandate of contraceptive
coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act.
The interim final rules extend the exemption to health insurance issuers that hold religious or
moral objections in certain circumstances. The interim final rules also allow plan participants
and enrollees with sincerely held religious or moral objections to request coverage that does not
include contraceptive services.
The 2017 rules also leave the accommodation process in place as an optional process for certain
exempt entities who wish to use it voluntarily. To avoid contracting, arranging, paying, or
referring for contraceptive coverage, an organization seeking to be treated as an eligible
organization may self-certify (by using EBSA Form 700), prior to the beginning of the first plan
year to which an accommodation is to apply, that it meets the definition of an eligible
organization. The eligible organization must provide a copy of its self-certification to each health
insurance issuer that would otherwise provide such coverage in connection with the health plan
2

(for insured group health plans or student health insurance coverage). The issuer that receives
the self-certification must provide for separate payments for contraceptive services for plan
participants and beneficiaries (or students and dependents). For a self-insured group health plan,
the self-certification must be provided to its third party administrator. An eligible organization
may alternatively 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. A health
insurance issuer or third party administrator providing or arranging payments for contraceptive
services for participants and beneficiaries in plans (or student enrollees and covered dependents
in student health insurance coverage) of eligible organizations must provide a written notice to
such plan participants and beneficiaries (or such student enrollees and covered dependents)
informing them of the availability of such payments.
Eligible organizations can revoke at any time the accommodation process if participants and
beneficiaries receive written notice of such revocation from the issuer or third party
administrator in accordance with guidance issued by the Secretary, and if the accommodation
process is currently being utilized, such revocation will be effective on the first day of the first
plan year that begins on or after thirty days after the date of revocation.

3