View Information Collection Request (ICR) Package
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View ICR - Agency Submission
OMB Control No:
ICR Reference No:
202605-0938-009
Status:
Received in OIRA
Previous ICR Reference No:
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CCIIO
Title:
Notice Requirements for Fertility Excepted Benefits (CMS-10947)
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
05/13/2026
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
7,630,891
0
Time Burden (Hours)
541
0
Cost Burden (Dollars)
0
0
Abstract:
Section 2791(c)(2) of the Public Health Service Act (PHS Act), section 733(c)(2) of the Employee Retirement Income Security Act (ERISA), and section 9832(c)(2) of the Internal Revenue Code (Code) establishing four statutory categories of "excepted benefits" that are generally exempt from the health reform requirements added to those laws by the Health Insurance Portability and Accountability Act (HIPAA), the Patient Protection and Affordable Care Act (ACA), the No Surprises Act, and certain other federal laws specifically related to group health plans and group and individual health insurance coverage. On February 18, 2025, President Trump issued Executive Order 14216, "Expanding Access to In Vitro Fertilization," which instructs the Departments to provide support, awareness, and access to affordable fertility treatments, including reliable access to in vitro fertilization (IVF) treatment, by easing unnecessary statutory or regulatory burdens to make IVF treatment drastically more affordable. In the proposed rule "Excepted Fertility Benefits" (the proposed rule), the Departments propose to add new paragraph (c)(3)(ix) of 26 CFR 54.9831-1 and 29 CFR 2590.732, and new paragraph (b)(3)(ix) of 45 CFR 146.145 to establish fertility benefits as a new category of limited excepted benefits. The proposed rule would require that plans or issuers offering excepted fertility benefits provide written notice to plan participants and beneficiaries that includes a description of the coverage, including a summary of benefits and limitations of the coverage, including the lifetime dollar limit established by the plan or issuer that complies with the maximum lifetime dollar limit described in proposed paragraph (c)(3)(ix)(B) (or paragraph (b)(3)(ix)(B), as applicable),information on how to identify and utilize a network provider, if applicable, and how to submit a claim for reimbursement, including whether the benefit utilizes the same claims procedure as for the sponsor’s other group health plans. This notice requirement ensures that participants and beneficiaries are fully informed about the availability and requirements of their excepted fertility benefits coverage.
Authorizing Statute(s):
EO: EO 14216 Name/Subject of EO: Expanding Access to In Vitro Fertilization
PL:
Pub.L. 111 - 148 2791(c)(2)(C)
Name of Law: Patient Protection and Affordable Care Act – Excepted Benefits
Citations for New Statutory Requirements:
EO: EO 14216 Name/Subject of EO: Expanding Access to In Vitro Fertilization
PL: Pub.L. 111 - 148 2791(c)(2)(C) Name of Law: Patient Protection and Affordable Care Act – Excepted Benefits
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0938-AV94
Proposed rulemaking
91 FR 27140
05/13/2026
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Notice Requirements for Plans or Issuers Offering Excepted Fertility Benefits
ICR Summary of Burden
Total Request
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
7,630,891
0
7,630,891
0
0
0
Annual Time Burden (Hours)
541
0
541
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.
Annual Cost to Federal Government:
$0
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?
No
Agency Contact:
Jamaa Hill 301 492-4190
Common Form ICR:
No
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:
05/13/2026
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