New collection (Request for a new OMB Control Number)
Yes
Regular
05/13/2026
table that charts list comparision
Requested
Previously Approved
36 Months From Approved
17,868,973
0
270
0
446,704
0
On February 18, 2025, Executive Order 14216 was issued to ensure reliable access to in vitro fertilization (IVF) and provide more affordable treatment options, recognizing both the medical necessity of infertility treatment for affected individuals and the broader importance of supporting American families in achieving their reproductive goals. This proposed rule would implement that approach by recognizing limited fertility benefits as âother similar, limited benefitsâ specified in regulations.
Under the proposal, limited fertility benefits would include benefits substantially all of which are for the diagnosis, mitigation, or treatment of infertility or infertility-related reproductive health conditions by medical professionals authorized to practice under applicable law, including evidence-based items or services targeted to address such conditions. In the group market, such benefits would be excepted only if they are provided under a separate policy, certificate, or contract of insurance or are otherwise not an integral part of the plan, satisfy a lifetime dollar limit of $120,000 as adjusted for medical inflation, and are accompanied by a written notice to participants and beneficiaries. The notice would describe the coverage, including benefits and limitations, explain how to identify and use network providers if applicable, and explain how to submit claims for reimbursement. The Department of Health and Human Services also proposes to amend the individual market excepted benefits regulations to recognize limited fertility benefits as limited excepted benefits in the individual market if they are offered under a separate policy, certificate, or contract of insurance and satisfy the scope, lifetime dollar limit, and notice requirements. The proposed rule is intended to provide employers and issuers with additional flexibility to offer standalone fertility-related coverage, including coverage for services such as diagnostic testing, infertility treatment, and IVF, while reducing regulatory burden and promoting access to fertility benefits.
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:
(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;
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.