Pasteurized Donor Human Breast Milk
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Policy governing medical necessity, ordering, limits, and acceptable sources for pasteurized donor human milk (PDHM) for Scripps Health Plan members; applies to commercial lines and Scripps Health Plan UM processes.
No material clinical or coverage changes in this revision.
Coverage Criteria
Medical necessity criteria
Covered when ALL of the following are met:
Main criteria
A. Qualifying newborn clinical situations (any one)
- Mother is unable to breastfeed due to medical conditions.
- Infant cannot tolerate or has medical contraindications to formulas, including elemental formulas.
- Infant born at very low birthweight (<1500 g) and very premature (<32 weeks gestation).
- Gastrointestinal anomaly, metabolic or digestive disorder, or recovery from intestinal surgery when digestive needs require additional support.
- Diagnosed failure to thrive (not appropriately gaining weight/growing).
- Formula intolerance with documented feeding difficulty or weight loss.
- Infant hypoglycemia (low blood sugar).
- Congenital heart disease.
- Pre‑ or post‑organ transplant.
- Other serious health conditions where banked donor milk is medically necessary and supports treatment and recovery.
- Mother's own milk is contraindicated, unavailable (medical or psychological reasons), or available but insufficient in quantity or quality to meet the infant's needs.
B. Authorized ordering provider
- Physicians.
- Advanced practice nurses (nurse practitioners, clinical nurse specialists, certified nurse midwives).
- Physician assistants.
- C. Order limits and authorization unit: Prescription/order must not exceed 35 ounces per day, per infant; units are 3‑ounce units and the 35 ounces/day limit is only good for 30 days per authorization.<= 35 ounces/day
3 ounces per unit; 35 ounces/day limit applies and order validity is 30 days
- D. Coverage duration: Coverage may be authorized for up to 12 months of age when medically necessary and appropriate.<= 12 months of age
- E. Acceptable source accreditation: Human milk banks must be accredited by the Human Milk Banking Association of North America (HMBANA).HMBANA accredited
Banked donor milk from non‑HMBANA banks or peer‑to‑peer sources is not covered.
Banked donor human milk is covered only when it meets the medical necessity criteria in this policy and is sourced from an accredited human milk bank. Claims will be denied when any of the following apply: milk is obtained from a non-HMBANA-accredited milk bank; obtained via peer-to-peer donation, sale, or other non-bank sources; provided for convenience (for example, to facilitate a mother’s return to work); billed with separate shipping charges; intended for a healthy, normal birthweight infant; or when the ordered amount exceeds 35 ounces/day per infant.
Use of banked human milk for healthy, normal birthweight infants is considered not covered / not medically necessary. Similarly, providing PDHM purely for convenience (for example to facilitate a mother’s return to work) is not covered. Coverage is limited to PDHM obtained from HMBANA-accredited milk banks and must adhere to the policy’s ordering and daily volume limits, including the 35 ounces/day per infant cap.
Coding
| T2101 | Human breast milk processing storage |
Provider Actions & Authorization
Prior authorization and order limits
PDHM must be ordered by an authorized provider (physician, advance practice nurse, or physician assistant). The prescription/order must not exceed 35 ounces per day per infant and is issued in 3-ounce units; the 35 oz/day limit applies to a 30‑day authorization unit. Coverage may be authorized up to 12 months of age when medically necessary.
- Authorized prescribers: physicians; advance practice nurses (NPs, CNS, CNMs); physician assistants
- Order limit: not to exceed 35 ounces/day per infant (3 ounces per unit; 35 ounces per day only good for 30 days)
- Coverage duration: up to 12 months of age if medically necessary
Step therapy
No step therapy requirements are specified in this policy.
Required documentation
A completed order/prescription from an authorized provider is required and must specify the medical indication and the amount not to exceed 35 ounces per day; if applicable, documentation must show the mother's own milk is contraindicated, unavailable, or insufficient.
- Order/prescription from physician, advance practice nurse, or physician assistant
- Specify amount (≤35 oz/day) and medical indication
- Document mother's milk contraindication, unavailability, or insufficiency when relevant
Coverage exclusions and denial triggers
Claims will be denied if PDHM is sourced from non-HMBANA accredited milk banks, obtained via peer-to-peer donation or sale, provided for convenience (e.g., to facilitate return to work), billed with separate shipping charges, supplied for healthy normal birthweight infants, or if orders exceed 35 ounces/day per infant.
- Non-HMBANA accredited milk banks are not covered
- Peer-to-peer donation or sale is not covered
- Banked donor milk provided for convenience is not covered
- Separate shipping charges are not covered
- More than 35 ounces/day per infant will be denied
- Use for healthy, normal birthweight infants is not covered
Background
Pasteurized donor human milk (PDHM) is recommended to support growth and development of preterm and low-birthweight infants and to provide safe human milk when a mother’s own milk is unavailable or contraindicated. This policy requires PDHM be obtained from licensed sources accredited by the Human Milk Banking Association of North America (HMBANA) to ensure safety and quality. When medically necessary, coverage may be authorized for up to 12 months of age, subject to the clinical criteria and provider ordering requirements in this policy.
Definitions
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