10003 BANKED DONOR MILK

10003.1 Medicaid-reimbursable banked donor milk shall be provided on an outpatient basis for Medicaid-eligible mothers with infants, and shall be provided in accordance with the following requirements:

1. (a) The infant is between the age of zero (0) and twelve (12) months, unless DHCF or its agent grants prior authorization when an infant is older than twelve (12) months;
2. (b) The infant requires banked donor milk due to the following reasons:
3. (1) Banked donor milk is necessary for the infant to thrive because the infant is fragile, preterm, or is medically compromised, such as having a diagnosis of formula intolerance, metabolic conditions, or genetic conditions requiring human milk; and
4. (2) The mother cannot breastfeed due to illness, death, surgery, chronic condition, or drug or medication use that is contraindicated for breastfeeding;
5. (c) The requesting physician is the infant's treating physician and has documented medical necessity in accordance with Subsection 10003.2 of this chapter;
6. (d) The requesting physician has discussed with the parent or guardian the benefits and risks of using banked donor milk, including infectious disease, freshness, effects of pasteurization, nutrients, and growth factors;
7. (e) The requesting physician has addressed with the donated human milk bank donor screening, pasteurization, milk storage, and transport of the donated milk;
8. (f) The requesting physician has provided an informed consent form that the parent or guardian has signed and dated, and indicates that the risks and benefits of using banked donor milk have been discussed with them; and
9. (g) The banked donor milk is pasteurized, donated by a screened donor, and supplied by a donated human milk bank that meets the following requirements:
10. (1) Is screened and enrolled in Medicaid pursuant to the requirements set forth in Chapter 94 (Medicaid Provider and Supplier Screening,

Enrollment, and Termination) of Title 29 DCMR;

(2) Is approved by the Human Milk Bank Association of North America (HMBANA) and meets other standards as may be adopted by DHCF;

(3) Adheres to guidelines set forth by HMBANA and meets other standards as may be adopted by DHCF; and

(4) Transports banked donor milk in a manner that protects the milk from contamination, thawing, and refreezing.

10003.2 The following documentation shall be submitted to DHCF for review and approval in order to determine the medical necessity of banked donor milk:

(a) A Donated Human Milk Request Form that is:

(1) Completed and signed by the treating physician on an initial or continuing request for authorization, and specifies the quantity and time frame; and

(2) Completed by the donated human milk bank, and specifies the quantity and time frame;

(b) The following written documentation from the treating physician to support a finding that banked donor milk is medically necessary for the beneficiary:

(1) A detailed explanation of why the particular infant cannot survive and grow as expected on any other formula (e.g., elemental, special, or routine formulas or food) or any enteral nutritional product other than donor human milk;

(2) A detailed explanation of why donated human milk must be used to correct or ameliorate a documented condition or defect; and

(3) Documentation that the infant participated in a clinical feeding trial of an appropriate nutritional product every one hundred eighty (180) days. If the infant is too fragile for a feeding trial, documentation must support the illness that makes the infant too fragile to test; and

(c) The informed consent that identifies the risks and benefits for the parent or guardian of using banked donor milk.

10003.3 A request for authorization for banked donor milk shall be completed, signed, and submitted to DHCF by the treating physician every ninety (90) days, and shall expire upon the infant’s first birthday.

SOURCE: Final Rulemaking published at 64 DCR 791 (January 27, 2017).