Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-10653)

Forms and Documents

Document Name	Status
Form CMS-10653 Model Notice to HHS Form and Instruction	New
Form CMS-10653 Notice of Availability of Separate Payments for Contraceptive Services Form and Instruction	New
Form CMS-10653 Self-Certification & Notice to HHS Form and Instruction	New
CMS-10653 - Emergency Clearance of the Paperwork Reduction Act Package.pdf Supplementary Document	2017-10-10
CMS-10653 Supporting Statement 10-2-17 clean.docx Supporting Statement A	2017-10-06

IC Document Collections

IC ID	Document Title	Status
228593	Model Notice to HHS Form and Instruction	New
228592	Notice of Availability of Separate Payments for Contraceptive Services Form and Instruction	New
228591	Self-Certification & Notice to HHS Form and Instruction	New

ICR Details

OMB Control No: 0938-1344	ICR Reference No: 201710-0938-006
Status: Historical Active	Previous ICR Reference No: 201710-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-10653)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/13/2017
	Date Received in OIRA: 10/13/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	6 Months From Approved
Responses	274,675	0	0
Time Burden (Hours)	181	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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 interim final rules also leave the accommodation process in place as an optional process for objecting 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 (for insured group health plans or student health insurance coverage). The issuer that receives the self-certification must provide 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.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 1563 Name of Law: Conforming amendments
   US Code: 42 USC 300gg-13 Name of Law: Coverage of preventive health services
   EO: EO 13765 Name/Subject of EO: Executive Order Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pen
   EO: EO 13798 Name/Subject of EO: Executive Order Promoting Free Speech and Religious Liberty
   PL: Pub.L. 111 - 148 1001 Name of Law: Amendments to the Public Health Service Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 1001 Name of Law: Amendments to the Public Health Service Act
PL: Pub.L. 111 - 148 1563 Name of Law: Conforming amendments
US Code: 42 USC 300gg-13 Name of Law: Coverage of preventive health services

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT20	Final or interim final rulemaking	82 FR 47792	10/13/2017

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Self-Certification & Notice to HHS	CMS-10653	Certification Form
Notice of Availability of Separate Payments for Contraceptive Services	CMS-10653	Notice to Enrollees
Model Notice to HHS	CMS-10653	Notice of Availability of Separate Payments for Contraceptive Services

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	274,675	0	274,675	0	0	0
Annual Time Burden (Hours)	181	0	181	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government:

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/06/2017

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