HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/HB 1333 Donor Human Milk Bank Services
SPONSOR(S): Finance & Facilities Subcommittee, McFarland and others
TIED BILLS: IDEN./SIM. BILLS: SB 1770
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Finance & Facilities Subcommittee 18 Y, 0 N, As CS Lloyd Lloyd
2) Appropriations Committee 25 Y, 0 N Nobles Pridgeon
3) Health & Human Services Committee 16 Y, 0 N Lloyd Calamas
SUMMARY ANALYSIS
Breast milk is the best source of nutrition for most infants. Ideally, an infant should be fed his or her own
mother’s breast milk. Mothers of infants born prematurely are sometimes unable to produce milk because their
bodies aren’t ready, they too are sick, or they’re affected by the stress of having their premature infant in
intensive care. Breast milk donated by nursing mothers provides an option in such instances. Very few illnesses
are transmitted via breast milk, even in cases of donated milk.
Human donor breast milk can be effective for high-risk and very low birthweight infants if the child’s mother is
unable to provide enough milk. Authorities indicate that human donor breast milk can prevent some digestive
disorders but specify that any donor milk must come from safe facilities and is not recommended for sick infants
or those weighing less than 1,000 grams. Currently, the federal Food and Drug Administration considers human
donor breast milk a food source rather than a medical product and does not regulate human donor milk banks.
The Medicaid program is a joint federal-state program that finances health coverage for individuals, including
eligible low-income adults, children, pregnant women, elderly adults and persons with disabilities. Florida
Medicaid reimburses hospitals for inpatient use of infant nutritional supplementation through an all-inclusive
payment to the hospital, and outpatient prescription nutritional commercial formulas under the durable medical
equipment and supplies benefit. Human donor breast milk is not a covered benefit in the Medicaid program.
The bill authorizes Medicaid reimbursement for donor human milk for hospital inpatient use. The Medicaid
coverage would be for infants who are medically or physically unable to receive maternal breast milk or whose
mother medically or physically unable to produce maternal breast milk or breastfeed, and who also meet
specified clinical eligibility factors.
The bill has an insignificant recurring negative fiscal impact on AHCA, and no fiscal impact on local
governments.
The bill is effective July 1, 2022.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
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 FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Donor Human Breast Milk
According to the federal Centers for Disease Control and Prevention (CDC), breast milk is the best
source of nutrition for most infants.1 Ideally, an infant should be fed his or her own mother’s breast milk
because nutritional components within the mother’s breast milk change to meet the infant’s needs as
he or she ages.2 Mothers of infants born prematurely are sometimes unable to produce milk because
their bodies aren’t ready, they too are sick, or they’re affected by the stress of having their premature
infant in intensive care. Breast milk donated by nursing mothers provides an option for infants who are
unable to receive adequate nutrition from their mother’s own milk or from commercial infant formulas.
Very few illnesses are transmitted via breast milk, even in cases where someone else’s breast milk is
given to another child.3
The American Academy of Pediatrics (AAP) notes that human donor breast milk can be effective for
high-risk and very low birthweight infants if the child’s mother is unable to provide enough milk. 4
Additionally, the World Health Organization (WHO) indicates that human donor breast milk can prevent
some digestive disorders but specifies that any donor milk must come from safe facilities and is not
recommended for sick infants or those weighing less than 1,000 grams.5, 6 In the absence of mother’s
milk, the WHO notes that standard formula is also an acceptable alternative.7
Currently, the federal Food and Drug Administration (FDA) considers human donor breast milk a “food”
source rather than a medical product. The FDA has not established guidelines or standards for human
donor breast milk or milk banks, although it does recommend consulting with a health care provider
before feeding it to an infant.8 Additionally, the FDA recommends that the caregiver only feed an infant
milk from a source that has screened its donors and has taken precautions to ensure milk safety, such
as a milk bank.9
Human donor breast milk banks and processing entities are not licensed or regulated under Florida
law.
1 Centers for Disease Control and Prevention, Frequently Ask ed Questions (FAQ) (Aug. 10, 2021) available at
https://www.cdc.gov/breastfeeding/ faq/index.htm (last visited Jan. 22, 2022).
2 Id.
3 Id.
4 American Academy of Pediatrics Committee on Nutrition, Section on Breastfeeding and Committee on Fetus and
Newborn, Policy Statement, Donor Human Milk for the High-Risk Infant: Preparation, Safety, and Usage Options in the
United States (Jan. 2017) available at https://publications.aap.org/pediatrics/article/139/1/e20163440/52000/Donor -
Human-Milk-for-the-High-Risk-Infant (last visited Jan. 22, 2022).
5 Agency for Health Care Administration, Agency Analysis of House Bill 1333 (Jan. 12, 2022) (on file with House Finance
& Facilities Subcommittee).
6 World Health Organization, Recommendations for the Feeding of low-birth-weight infants in low- and middle-income
countries, available at https://www.who.int/elena/titles/full_recommendations/feeding_lbw/en/ (last visited Jan. 22, 2022).
7 Id.
8 U.S. Food and Drug Administration, Use of Donor Human Milk (Mar. 22, 2018) available at https://www.fda.gov/science-
research/pediatrics/use-donor-human-milk (last visited Jan. 22, 2022).
9 Id.
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 Human Milk Banking Accreditation and Guidelines
The Human Milk Banking Association of North America (HMBANA) is an accrediting organization for
nonprofit milk banks in the United States and Canada.10 The HMBANA is funded by membership fees
from its 31 member nonprofit milk banks, foundation funds, and individual donors. 11 There is one
HMBANA-accredited location in Florida – the Mother’s Milk Bank of Florida located in Orlando. 12 The
Mother’s Milk Bank of Florida supplies pasteurized donor human milk to 38 of the 68 neonatal intensive
care units (NICUs) in Florida, as well as to medically fragile babies at home. 13 A survey by the Agency
for Health Care Administration found that Mother’s Milk Bank of Florida supplied 81 percent of the
donated human milk used in Florida NICUs responding to the survey. 14
According to the HMBANA, its member milk banks follow guidelines developed in consultation with the
CDC and the FDA;15 however, the FDA says that it has not been involved in establishing any voluntary
guidelines.16
Under the HMBANA’s guidelines, before milk is collected, each donor is strictly screened for medical
and lifestyle risk factors and serum is screened for HIV, Human T-lymphotropic virus, syphilis, and
Hepatitis B and C.17 After the milk is collected, it is mixed and pooled so that each pool includes human
milk from three to five donors. This is done to ensure an even distribution of nutritional components.
Bottles are filled with the pooled milk and then the milk is pasteurized to eliminate potentially harmful
bacteria while retaining the majority of the milk’s beneficial nutrients.
Milk samples are taken during the pasteurization process and cultured to check for bacterial growth.
Any contaminated milk is discarded. No milk is dispensed after pasteurization until a culture is found to
be negative for bacteriological growth. After pasteurization, the milk is frozen and shipped to hospitals
and outpatient families.
AHCA Report on Donor Human Milk
In 2021, the Florida Legislature required AHCA, in consultation with the Department of Health (DOH),
to study and report on the use of donor human milk as a supplement to newborn care and health
specific to newborn infants born prematurely and hospitalized within the NICU. 18, 19 AHCA published the
report on November 1, 2021. It includes best practices recommendations for the oversight of milk
banks and their staff, operating procedures, standards for donor screening, and recommendations for
the collection, storage, handling, processing, and dispending of donor human milk. The report also
addresses the need for high-quality clinical studies to quantity the efficacy and cost-effectiveness of
donor human milk derivates.20
The report found that about 3,500 infants a year are born in Florida with a very low birth weight (VLBW)
- under 1,500 grams or about 3.3 pounds. These infants are at greater risk for a variety of infections
10 Human Milk Banking Association of North America, About Us, available at https://www.hmbana.org/about-us/ (last
visited Jan. 22, 2022).
11 Id.
12 Human Milk Banking Association of North America, Find a Milk Bank , available at https://www.hmbana.org/find-a-milk-
bank/ (last visited Jan. 22, 2022).
13 Mothers’ Milk Bank of Florida, Covid-19 Update, available at https://milkbankofflorida.org/covid-19-update/ (last visited
Jan. 22, 2022).
14 Agency for Health Care Administration, Donor Human Milk Legislative Report (Nov. 1, 2021), pp. 10-11, (on file with
House Finance & Facilities Subcommittee).
15 Human Milk Banking Association of North America, Milk Processing and Safety, available at
https://www.hmbana.org/our-work/milk-processing-safety.html (last visited Jan. 22, 2022).
16 Supra note 8.
17 Human Milk Banking Association of North America, Milk Bank ing and COVID-19 (Apr. 2, 2020) available at
https://www.hmbana.org/file_download/inline/a04ca2a1 -b32a-4c2e-9375-44b37270cfbd (last visited Jan. 22, 2022).
18 Agency for Health Care Administration, Donor Human Milk Legislative Report (Nov. 1, 2021) (on file with House
Finance & Facilities Subcommittee).
19 Chapter 2021-36, s. 3, Laws of Fla.
20 Supra note 14 at 35.
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 and adverse health conditions, including necrotizing enterocolitis (NEC), many of which lead to long-
term health problems. AHCA found that premature infants with health complications disproportionately
account for a large percentage of health care costs; costing four to seven times as much as premature
infants who do not suffer health complications. Much of this cost was driven by premature infants
suffering from NEC. U.S. rates of NEC in premature infants range from five percent to 10 percent with
increased mortality ranging from 16 percent to 42 percent. AHCA noted that feeding infants human
milk, whether it be their mother’s own milk or pasteurized donor human milk, is one of the few
evidence-based strategies for avoiding NEC.
AHCA found that processing and distribution of donor human milk has increased over seven-fold since
2006 when less than one million ounces were distributed annually in the U.S. compared to 2020 and
2021 when more than seven million ounces were distributed each of those years. AHCA determined
that 86 percent of Florida NICUs feed pasteurized donor human milk to their patients. Most of the ones
that did not were not the highest level of NICU and did not receive/treat infants under 1,000 grams in
weight. The one high level NICU (and two other lower level NICUs) that did not feed infants pasteurized
donor human milk reported that cost was a factor in that decision.
AHCA also conducted an economic analysis on the impact of inpatient feeding of pasteurized donor
human milk. It found that on $1.1 million in spending for pasteurized donor human milk, $5.2 million in
avoided additional treatment costs attributable to assumed increases in NEC cases resulted. The
following illustrates AHCA’s economic analysis.
Florida Medicaid Program
The Medicaid program is a joint federal-state program that finances health coverage for individuals,
including eligible low-income adults, children, pregnant women, elderly adults and persons with
disabilities.21 The Centers for Medicare and Medicaid Services (CMS) within the U.S. Department of
Health and Human Services (HHS) is responsible for administering the federal Medicaid program.
Florida Medicaid is the health care safety net for low-income Floridians. Florida’s program is
administered by AHCA and financed through state and federal funds.22
In order to participate in Medicaid, federal law requires states to cover certain population groups and
benefits and gives states the flexibility to cover other groups and benefits. States can add “optional”
benefits, such as prescription drugs, adult dental services, and dialysis, with federal approval. AHCA
may seek CMS approval for program changes through an amendment to the state plan or waiver.23
21 Medicaid.gov, Medicaid, available at https://www.medicaid.gov/medicaid/index.html (last visited Jan. 22, 2022).
22 Section 20.42, F.S.
23 Medicaid.gov, Medicaid State Plan Amendments, available at https://www.medicaid.gov/medicaid/medicaid-state-plan-
amendments/index.html (last visited Jan. 22, 2022).
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 Medicaid enrollees generally receive benefits through one of two service-delivery systems: fee-for-
service (FFS) or managed care. Under FFS, health care providers are paid by the state Medicaid
program for each service provided to a Medicaid enrollee. Under managed care, AHCA contracts with
private managed care plans for the coordination and payment of services for Medicaid enrollees. The
state pays the managed care plans a capitation payment, or fixed monthly payment, per recipient
enrolled in the managed care plan. Approximately 78 percent of Florida Medicaid recipients receive
their benefits in the managed care model.
Medicaid Medical Necessity
Florida Medicaid covers services that are medically necessary, as defined in its Medicaid state plan.
AHCA routinely reviews new health services, products, and supplies to assess potential coverage
under Florida Medicaid which depends on whether that service, product, or supply is medically
necessary.24 Care, goods, and services are medically necessary if they are:
 Necessary to protect life, to prevent significant illness or significant disability, or to alleviate
severe pain;
 Individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or
injury under treatment, and not in excess of the patient’s needs;
 Consistent with generally accepted professional medical standards as determined by the
Medicaid program, and not experimental or investigational;
 Reflective of the level of service that can be safely furnished, and for which no equally effective
and more conservative or less costly treatment is available statewide; and
 Furnished in a manner not primarily intended for the convenience of the recipient, the recipient’s
caretaker, or the provider.25
Under federal law, Medicaid states must pay for non-covered services that are medically necessary for
recipients under the age of 21.26 This is often referred to as the federal Early and Periodic Screening,
Diagnostic, and Treatment (EPSDT) guidelines. Health plans participating in Medicaid managed care
must also adhere to EPSDT guidelines.27
Coverage of Nutritional Supplements for Infants in Florida28
Most private insurers do not cover donor human breast milk, which costs approximately $5 an ounce
and can add up to over $1,000 per month per infant. 29
WIC
The Women, Infants, and Children (WIC) program is a federally funded program that provides
nutritional support for women and children. Administered by the DOH, WIC provides food assistance
such as milk and infant and toddler formulas. If a child is not able to consume a contract formula,30 WIC
can make exceptions and provide non-contract formulas with appropriate medical documentation.
24 Supra note 5.
24 Supra note 6.
25 Rule 59G-1.010, Florida Administrative Code.
26 42 C.F.R. s. 441 Subpart B.
27 Id.
28 Supra note 5.
28 Supra note 6.
29 Agency for Health Care Administration, Donor Human Milk Legislative Report (Nov. 1, 2021) (on file with House
Finance & Facilities Subcommittee).
30 Commercial infant formula manufacturers provide substantial discounts, in the form of rebates, to state WIC programs
in return for the exclusive right to provide their products to the state’s WIC participants. Commercial formulas whose
manufacturers have those exclusive rights are considered “contract formulas.” See Steven Carl