Statewide Review of Donor Human Milk Legislation and Regulation

Background: The use of donor human milk (DHM) is the appropriate nutrition for high-risk infants when the supply of maternal milk is insufficient. Financial burden, policy differences, and limited education all contribute to inequitable access to this therapy. The American Academy of Pediatrics (AAP) and the United States Surgeon General have called for investigation into barriers that prevent the use of DHM and for changes to public policy to improve availability and affordability of DHM. As a response to this call to action, we review the current legislative and regulatory landscape surrounding DHM use.

Methods: Using commercial legal databases as well as state-government provided websites and legal research strategies, we examined proposed and enacted legislation and regulations related to DHM provision and insurance reimbursement. We evaluated and compared states’ approaches by donor milk coverage details including private versus public payer reimbursement, inpatient versus outpatient coverage, patient age limits, and definitions of medical necessity. By considering the 50-state DHM law and regulation data in light of Center for Disease Control and Prevention natality data, we report on the number of very low birth weight infants less than 1500 grams born between 2007 and 2019 in states with donor milk laws and regulations.

Results: As of June 30, 2021, fifteen states and the District of Columbia have enacted DHM legislation or regulation. Over half of the policies have been created since the 2017 publication of the AAP Policy on DHM. However, specific details of implementation are not always publicly accessible. Insurance reimbursement is limited to Medicaid in most states, while four require all insurance providers to cover the cost. Six states provide inpatient coverage of DHM, while four states provide only outpatient coverage. Eligibility is limited to infants less than three months of age in two states, and only four provide coverage up to or beyond 12 months. Definitions of medical necessity varied widely by state. Of infants with a birth weight <1500g, 44% are born in a state with DHM regulations. (Figure 1) This does not guarantee insurance coverage or access given the identified policy differences.

Conclusion: The majority of high-risk infants who need access to DHM are not born in a state or district where that access is guaranteed, and no state requires comprehensive insurance coverage for DHM. State and federal level advocacy is needed to ensure that policies provide for DHM based on medical necessity and not geography or ability to pay. High-risk infants would benefit from legislative and regulatory changes that would increase patient access to and affordability of DHM, including mandated coverage and clarity and transparency of definitions of medical necessity.