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 Health Policy
BILL: SB 1770
INTRODUCER: Senator Book
SUBJECT: Donor Human Milk Bank Services
DATE: January 25, 2022
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Smith Brown HP Pre-meeting
2. AHS
3. AP
I. Summary:
SB 1770 authorizes Florida Medicaid to pay for donor human milk bank services as an optional
covered service in the fee-for service delivery system and requires health plans participating in
the Statewide Medicaid Managed Care program to cover donor human milk bank services. The
bill specifies health conditions for which human donor milk services would be medically
necessary and provides requirements that milk banks must meet in order to qualify as Medicaid
providers. The bill establishes that Medicaid’s reimbursement rates for donor human milk cannot
be less than the milk bank’s cost to procure it plus reasonable processing and handling fees.
Because human donor milk is not currently a covered service, the bill will have an indeterminate
negative fiscal impact on Florida Medicaid. See Section V of this analysis.
The bill provides an effective date of July 1, 2022.
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 aren’t ready, they too are sick, or they’re affected by the stress
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.
REVISED: BILL: SB 1770 Page 2
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 (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.
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
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
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
Supra note 1.
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.
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
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). BILL: SB 1770 Page 3
Florida supplies pasteurized donor human milk to 38 of the 68
14
neonatal intensive care units
(NICUs) in Florida, as well as to medically fragile babies at home.
15
HMBANA Safety Guidelines
16
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.
AHCA Report on Donor Human Milk
20
In 2021, the Florida Legislature passed the General Appropriations Act, SB 2500, which required
the 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. It 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. The report also
addresses the need for high-quality clinical studies to quantity the efficacy and cost-effectiveness
of donor human milk derivatives.
22
14
Supra note 3.
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
Supra note 9.
18
Supra note 6.
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).
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.
22
Supra note 20 at 45. BILL: SB 1770 Page 4
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.
23
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.
24
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.
25
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.
26
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
covering both acute and long-term care.
27
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.
28
23
Medicaid.gov, Medicaid, available at https://www.medicaid.gov/medicaid/index.html (last visited Jan. 22, 2022).
24
Section 20.42, F.S.
25
Medicaid.gov, Medicaid State Plan Amendments, available at https://www.medicaid.gov/medicaid/medicaid-state-plan-
amendments/index.html (last visited Jan. 22, 2022).
26
Id.
27
Id.
28
Id. BILL: SB 1770 Page 5
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
Pursuant to Rule 59G-1.010 of the Florida Administrative Code 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.
Under federal law, Medicaid states must have a process in place to pay for services that are
medically necessary but are not covered for recipients under the age of 21.
30
This is often
referred to as the federal Early and Periodic Screening, Diagnostic, and Treatment (EPSDT)
guidelines. Health plans participating in the SMMC program must also adhere to EPSDT
guidelines.
31
Coverage of Nutritional Supplements for Infants in Florida
32
Florida Medicaid covers prescription enteral and parenteral commercial formulas under the
Durable Medical Equipment and Supplies benefit, when medically necessary. Commercial
formula would be considered medically necessary for infants diagnosed with conditions such as
metabolic disorders or who are unable to accept nutrition orally. In addition, if an infant needs
commercial formula during an inpatient hospital stay, it would be covered as part of the all-
inclusive payment to the hospital, just as needed food or medicine would be covered for a patient
of any age.
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,
33
WIC can make exceptions and provide non-contract formulas with
29
Supra note 6.
30
42 C.F.R. s. 441 Subpart B.
31
Id.
32
Supra note 6.
33
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 Carlson, Robert Greenstein, and
Zoe Neuberger, Center on Budget and Policy Priorities, WIC’s Competitive Bidding Process for Infant Formula Is Highly BILL: SB 1770 Page 6
appropriate medical documentation. Contract formulas currently available through WIC include:
Enfamil, Enfagrow, Gerber Good Start Soy 1, and Gerber Good Start Soy 3. WIC does not
provide human donor breast milk to program participants.
Florida Medicaid does not reimburse separately for human donor breast milk or contract
formulas covered through WIC. If an infant needed human donor breast milk outside of the
hospital setting, a request would need to be made through the EPSDT coverage process. AHCA
reports that it is not aware of any such requests being made for infants in fee-for-service or
Medicaid managed care.
34
Most private insurers do not cover donor human breast milk, which costs approximately $4 an
ounce and can add up to over $1,000 per month per infant.
35
Through donations and fundraisers,
the Mother’s Milk Bank of Florida provides grants to low-income families to make donor human
breast milk more affordable.
36
Medicaid Coverage of Human Donor Breast Milk in Other States
At least seven states (California, Connecticut,
37
New York
38
, Missouri, Kansas, Texas, and Utah)
and the District of Columbia provide coverage for human donor breast milk under their state
Medicaid programs.
39
In July 2017, New York Medicaid began covering pasteurized human
donor breast milk, in both its fee-for-service and managed care delivery systems, but only during
the infant’s inpatient hospital stay.
40
California Medicaid has been covering human donor breast
milk since 1998, but only covers it when the mother is unable to utilize her own milk supply and
the infant cannot tolerate or has medical contraindications to the use of any formula, including
enteral formula.
41
III. Effect of Proposed Changes:
Section 1 of the bill amends s. 409.906, F.S., to authorize the AHCA to reimburse through
Florida Medicaid for the cost of donor human milk for home and inpatient use for an infant who:
Is medially or physically unable to receive maternal breast milk or whose mother medically
or physically unable to produce maternal breast milk or breastfeed; and
Cost-Effective (Feb. 17, 2017) available at https://www.cbpp.org/sites/default/files/atoms/files/6-26-15fa.pdf (last viewed
Mar. 4, 2021).
34
Supra note 6.
35
Supra note 3.
36
Id.
37
Naomi Bar-Yam, Ph.D., Mother’s Milk Bank Northeast, Medicaid Coverage of Donor Milk Now Law in Connecticut (July
23, 2019) available at https://milkbankne.org/2019/07/medicaid-coverage-of-donor-milk-now-law-in-connecticut/ (last
visited Jan. 22, 2022).
38
Anna Berry, Nonprofit Quarterly, Liquid Gold: 6 States Allow Medicaid Access for Breast Milk (Apr. 2017) available at
https://nonprofitquarterly.org/liquid-gold-6-states-allow-medicaid-access-breast-milk/ (last visited Jan. 22, 2022).
39
Center for Evidence-based Policy, Oregon Health & Science University, Donor Human Milk for Low-Birthweight Infants:
Effectiveness and Policies (Apr. 2017) at 22 available at https://www.health.ny.gov/health_care/medicaid/ebbrac/docs/2017-
06-13_donor_human_milk.pdf (last visited Jan. 22, 2022).
40
New York State Department of Health, Medicaid Update, NYS Medicaid Coverage of Pasteurized Donor Human Milk
(July 2017) available at https://www.health.ny.gov/health_care/medicaid/program/update/2017/2017-07.htm (last visited Jan.
22, 2022).
41
Supra note 6. BILL: SB 1770 Page 7
Has a documented birth weight of 1,500 grams or less; has a congenital or acquired intestinal
condition and is at high risk for developing a feeding intolerance, necrotizing enterocolitis, or
an infection; or otherwise requires nourishment by breast milk.
Because a service covered under Florida Medicaid is only considered to be medically necessary
if no equally effective and more conservative or less costly treatment is available, a provider
seeking to be reimbursed under the Medicaid program would need to demonstrate that the infant
cannot tolerate or has medical contra-indications for commercial formula (available through
programs like WIC or prescription formulas already covered under Medicaid) to the extent that
these options are more cost effective.
The bill requires the donor human milk to be procured from a nonprofit milk bank certified by
the Human Milk Banking Association of North America (HMBANA). For a milk bank to
procure donor human milk, it would need to enroll as a Durable Medical Equipment provider
under Florida Medicaid and to comply with provider requirements such as providing a surety
bond of $50,000 pursuant to s. 409.912(8)(b), F.S.
The bill specifies that coverage for donor human milk may not be for less than the reasonable
cost of the milk procured from a HMBANA-certified milk bank, plus reasonable processing and
handling fees.
Section 2 of the bill amends s. 409.908, F.S., to authorize Florida Medicaid to pay for donor
human milk bank services as an optional covered service in the fee-for service delivery system.
Section 3 of the bill amends s. 409.973, F.S., to require health plans participating in the
Statewide Medicaid Managed Care (SMMC) program to cover donor human milk bank services.
Section 4 of the bill provides an effective date of July 1, 2022.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None. BILL: SB 1770 Page 8
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
In order to be reimbursed for donor human milk provided to infants enrolled in SMMC
plans, milk banks would need to contract with the plans.
C. Government Sector Impact
42
:
Because human donor milk is not currently a covered service, the bill will have
indeterminate negative fiscal impact on Florida Medicaid. It is unknown how many
infants would satisfy the health conditions specified in the bill and meet Medicaid’s
medical necessity criteria. Therefore, the AHCA’s projected fiscal impact focuses on a
percentage of infants with a very low birth weight of 1,500 grams or less in a NICU.
In 2021, the AHCA provided a fiscal estimate for SB 240 which was at the time, identical
to this bill with an effective date of July 1, 2021. In the 2019-2020 fiscal year, there were
2,494 infants with a very low birth weight of 1,500 grams or less in a NICU covered by
Medicaid. AHCA’s analysis assumes that 47.60 percent of these infants will receive
donor milk for the first six months of life. (These infants may be eligible to receive donor
milk for up to 12 months.) The 47.60 percent figure is based on the count for breastfed
babies in Florida who are not breastfeeding at six months according to information from
the CDC. Based on those assumptions, the AHCA’s estimated cost to the Medicaid
program in the 2022-2023 fiscal year was $29,867,890 with $11,657,438 being the state
share.
The changes in this bill would require the AHCA to update its rules, fee schedules, and
contracts with the SMMC health plans. These actions are part of the AHCA’s routine
business practices and ACHA reports that this can be accomplished using existing
resources.
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
42
Supra note 6. BILL: SB 1770 Page 9
VIII. Statutes Affected:
This bill substantially amends the following sections of the Florida Statutes: 409.906, 409.908,
and 409.973.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.