The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Appropriations
BILL: CS/SB 1770
INTRODUCER: Appropriations Committee (Recommended by Appropriations Subcommittee on Health
and Human Services) and Senators Book and Stewart
SUBJECT: Donor Human Milk Bank Services
DATE: February 25, 2022 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Smith Brown HP Favorable
2. McKnight Money AHS Recommend: Fav/CS
3. McKnight Sadberry AP Fav/CS
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 1770 authorizes the Florida Medicaid program to reimburse 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 is medically or physically
unable to produce maternal breast milk or breastfeed, and who also meet specified eligibility
factors. The bill also requires the Agency for Health Care Administration (AHCA) to establish
provider eligibility, by rule, and authorizes the AHCA to seek any necessary federal approvals to
implement the new coverage benefit.
The bill has a significant negative fiscal impact to the Florida Medicaid program. See Section V
of this analysis.
The bill takes effect on July 1, 2022.
BILL: CS/SB 1770 Page 2
II. Present Situation:
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 are not ready, they too are sick, or they are affected by the
stress of having their premature infant in intensive care.3 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.4
The American Academy of Pediatrics 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.5 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 1000 grams.6, 7 In
the absence of a mother’s milk, the WHO notes that standard formula is also an acceptable
alternative.8
Currently, the federal Food and Drug Administration (FDA) considers human donor breast milk
a “food” source rather than a medical product. The FDA does not have 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.9 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.10
1
Centers for Disease Control and Prevention, Frequently Asked Questions (FAQ) (Aug. 10, 2021) available at
https://www.cdc.gov/breastfeeding/faq/index.htm (last visited Jan. 22, 2022).
2
Id.
3
Naseem S. Miller, Bill aims to get Medicaid coverage for donor breast milk: 'Something like this makes smart policy',
Orlando Sentinel (Mar. 15, 2019) available at https://www.orlandosentinel.com/health/os-ne-mothers-milk-bank-bill-
20190315-story.html (last visited Jan. 22, 2022).
4
Centers for Disease Control and Prevention, Frequently Asked Questions (FAQ) (Aug. 10, 2021) available at
https://www.cdc.gov/breastfeeding/faq/index.htm (last visited Jan. 22, 2022).
5
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).
6
Agency for Health Care Administration, Senate Bill 240 Fiscal Analysis (Dec. 28, 2020) (on file with Senate Committee on
Health Policy).
7
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).
8
Id.
9
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).
10
Id.
BILL: CS/SB 1770 Page 3
The Human Milk Banking Association of North America (HMBANA)
Founded in 1985, the Human Milk Banking Association of North America (HMBANA) serves
as the professional organization that accredits nonprofit milk banks in the United States and
Canada.11 The HMBANA is funded by membership fees from its 31 member nonprofit milk
banks, foundation funds, and individual donors.12 There is one HMBANA-accredited location in
Florida – the Mother’s Milk Bank of Florida located in Orlando.13 The Mother’s Milk Bank of
Florida supplies pasteurized donor human milk to 38 of the 6814 neonatal intensive care units
(NICUs) in Florida, as well as to medically fragile babies at home.15
HMBANA Safety Guidelines16
The HMBANA reports that its member milk banks follow guidelines that were developed by the
HMBANA in consultation with the CDC and the FDA. The FDA reports that it has not been
involved in establishing these voluntary guidelines.17 According to the AHCA, no federal or state
regulations are in place to oversee the Mother’s Milk Bank of Florida.18
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, HTLV, syphilis, and Hepatitis
B and C.19 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.
11
Human Milk Banking Association of North America, About Us, available at https://www.hmbana.org/about-us/ (last
visited Jan. 22, 2022).
12
Id.
13
Id.
14
Naseem S. Miller, Bill aims to get Medicaid coverage for donor breast milk: 'Something like this makes smart policy',
Orlando Sentinel (Mar. 15, 2019) available at https://www.orlandosentinel.com/health/os-ne-mothers-milk-bank-bill-
20190315-story.html (last visited Jan. 22, 2022).
15
Mothers’ Milk Bank of Florida, Covid-19 Update, available at https://milkbankofflorida.org/covid-19-update/ (last visited
Jan. 22, 2022).
16
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).
17
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).
18
Agency for Health Care Administration, Senate Bill 240 Fiscal Analysis (Dec. 28, 2020) (on file with Senate Committee on
Health Policy).
19
Human Milk Banking Association of North America, Milk Banking 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).
BILL: CS/SB 1770 Page 4
AHCA Report on Donor Human Milk20
In 2021, the Legislature required the Agency for Health Care Administration (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.21 On November 1, 2021, the report was
published. The study reports that a survey of Florida NICUs in 2021 determined that 86 percent
of them use pasteurized donor human milk (PDHM). The most common reasons for
administering PDHM were prematurity (92 percent), birth weight threshold (76 percent), and
medical necessity (71 percent) determined by the attending physician based on diagnosis and
symptoms.
The report includes recommendations of best practices 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. In addition, the
report addresses the need for high-quality clinical studies to quantify the efficacy and cost-
effectiveness of donor human milk derivatives.
The AHCA report also conducted an economic analysis on the impact of inpatient feeding of
PDHM. While PDHM use is not currently reimbursable by the Florida Medicaid program or
commercial health insurance companies, some Florida hospitals have earned grant funding or
donations to support the provision of PDHM, and most large facilities using PDHM have chosen
to do so knowing that the cost will not be reimbursed. These facilities balance the direct costs of
PDHM use with better outcomes, in hopes that improved outcomes will ultimately decrease total
cost of care by reducing risk and severity of necrotizing enterocolitis (NEC), a severe and lethal
complication affecting premature and low birth weight infants, and other illnesses associated
with prematurity.
In Florida, approximately 3,500 infants are born with a very low birth weight (VLBW) (birth
weight less than 1,500 grams or 3.5 pounds) annually. The AHCA report found that if Florida
NICUs were to stop using PDHM, there would be a 5 percent increase in the number NEC cases
from the 2,755 VLBW infants born annually in Florida. As illustrated in the chart below, when
comparing costs of providing PDHM ($1.1 million) to estimated costs of not using PDHM ($5.2
million), there is an estimated $4.1 million cost avoidance statewide among all payers.
20
Agency for Health Care Administration, Donor Human Milk Legislative Report (Nov. 1, 2021) (on file with Senate
Committee on Health Policy).
21
Chapter 2021-36, s. 3, Laws of Fla.
BILL: CS/SB 1770 Page 5
The report finds that the avoided cost is largely predicated on the management of NEC. This
cost-avoidance is among all payers; however, it is particularly relevant to the Florida Medicaid
program given its coverage of over 50 percent of births in the State of Florida. Furthermore, the
report states that this cost-avoidance with PDHM is an underestimate, as it does not factor in
additional benefits after the birth hospitalization with respect to readmissions, home nursing, and
emergency room visits.
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.22 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 the AHCA and financed through state and
federal funds.23
A Medicaid state plan is an agreement between a state and the federal government describing
how the state administers its Medicaid programs. The state plan establishes groups of individuals
covered under the Medicaid program, services that are provided, payment methodologies, and
other administrative and organizational requirements.
In order to participate in Medicaid, federal law requires states to cover certain population groups
(mandatory eligibility groups) and gives states the flexibility to cover other population groups
(optional eligibility groups). States set individual eligibility criteria within federal minimum
standards. The AHCA may seek an amendment to the state plan as necessary to comply with
federal or state laws or to implement program changes. States send state plan amendments to the
federal CMS for review and approval.24
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, the
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.
In Florida, the majority of Medicaid recipients receive their services through a managed care
plan contracted with the AHCA under the Statewide Medicaid Managed Care (SMMC)
program.25 The SMMC program has two components, the Managed Medical Assistance (MMA)
program and the Long-Term Care program. Florida’s SMMC offers a health care package
22
Medicaid.gov, Medicaid, available at https://www.medicaid.gov/medicaid/index.html (last visited Jan. 22, 2022).
23
Section 20.42, F.S.
24
Medicaid.gov, Medicaid State Plan Amendments, available at https://www.medicaid.gov/medicaid/medicaid-state-plan-
amendments/index.html (last visited Jan. 22, 2022).
25
Id.
BILL: CS/SB 1770 Page 6
covering both acute and long-term care.26 The SMMC benefits are authorized by federal
authority and are specifically required in ss. 409.973 and 409.98, F.S.
The AHCA contracts with managed care plans on a regional basis to provide services to eligible
recipients. The MMA program, which covers most medical and acute care services for managed
care plan enrollees, was fully implemented in August 2014, and was re-procured for a period
beginning December 2018 and ending in 2023.27 In 2020, the Legislature extended the allowable
term of the SMMC contracts from five to six years.28 As a result, the AHCA’s current contracts
will end in December 2024.
Medical Necessity Requirements
Florida Medicaid covers services that are medically necessary, as defined in its Medicaid state
plan pursuant to Rule 59G-1.010 of the Florida Administrative Code. The 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.29
Care, goods, and services are deemed 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
re