Constance C. McDaniel Medically Necessary Infant Formula and Donor Milk Act

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall establish a 3-year pilot program (to be known as the Medically Necessary Infant Formula Pilot Program and referred to in this Act as the Program) under which the Secretary will provide to eligible individuals financial assistance for purposes of purchasing covered infant formula or donor milk.

The Secretary may provide financial assistance through any means determined to be appropriate by the Secretary, including through—

(1) establishing a voucher program;

(2) providing for reimbursement to eligible individuals for expenses incurred in purchasing covered infant formula or donor milk; or

(3) providing a grant to governmental or nonprofit entities serving eligible individuals at the local level.

The Secretary shall, in consultation with health care providers, take such steps as may be necessary to ensure information about the Program is available to families.

The Secretary shall conduct an annual evaluation of performance of the Program with respect to delivery of assistance to parents and infants in need, including how many individuals benefitted from the Program and how much covered infant formula or donor milk was provided through the Program.

Not later than 1 year after the date on which the Program begins and annually thereafter, the Secretary shall submit a report to Congress on the findings of each evaluation conducted under paragraph (1).

In this section:

(1) The term covered infant formula means infant formula lawfully sold in the United States in compliance with section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a).

(2) The term donor milk means human milk that is collected, pasteurized, and dispensed by a donor human milk bank without additives.

(3) The term donor human milk bank means an organization that—

(A) meets standards established by the Food and Drug Administration for purposes of ensuring the safety of donor human milk and human milk banks; and

(B) collects, tests, processes, pasteurizes, and distributes donor human milk, in compliance with applicable Federal and State law.

(4) The term eligible individual means an individual who—

(A) is not eligible to participate in the special supplemental nutrition program for women, infants, and children under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);

(B) is the parent or legal guardian of a child who is less than one year of age (or such older age as may be necessary due to a medical issue diagnosed by a medical professional); and

(i) is a postpartum woman who has an inability to breastfeed, as diagnosed by a medical professional, due to—

(I) a physical factor as a result of a diagnosed medical condition;

(II) a chronic disease, such as cancer;

(III) a behavioral or mental health issue; or

(IV) such other medical issue, as may be determined by the Secretary;

(ii) has an inability to breastfeed due to—

(I) adoption;

(II) maternal mortality; or

(III) surrogacy following diagnosis of a medical condition; or

(iii) has a child who has—

(I) feeding tubes;

(II) digestive issues;

(III) latching issues (including anatomical issues, such as Ankyloglossia);

(IV) an allergy or intolerance; or

(V) such other medical issue, as may be determined by the Secretary.

(5) The term medical professional includes a pediatrician, an obstetrician-gynecologist, a general practitioner, or a nurse practitioner.

There are authorized to be appropriated to carry out this section $15,000,000 for each of fiscal years 2027 through 2031.

The authority of the Secretary to carry out this section shall terminate on the date that is 3 years after the date of the enactment of this Act.