A04462
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
1202
Session of
2022
INTRODUCED BY BROOKS, SCHWANK, COSTA, J. WARD, STEFANO, COLLETT
AND PITTMAN, MAY 16, 2022
REFERRED TO HEALTH AND HUMAN SERVICES, MAY 16, 2022
AN ACT
Providing for access to pasteurized donor human milk, for duties
of Department of Health and for pasteurized donor human milk
coverage.
This act may be referred to as Owen's Law.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the Keystone
Access to Pasteurized Donor Human Milk Act.
Section 2. Declaration of purpose.
The General Assembly finds and declares as follows:
(1) In the United States, one in nine infants are born
prematurely, which is one of the highest rates among
developed countries.
(2) Up to 70% of mothers who have infants in neonatal
intensive care units are unable to provide enough breast milk
to meet all of their infants' needs, despite adequate
lactation support and effort.
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(3) Donor human milk provides a lifesaving health
benefit for high-risk infants as a supplement or bridge when
determined to be medically necessary.
(4) Donor human milk is evidence-based nutritional
medicine that is essential to the health of medically fragile
infants in both inpatient and outpatient settings due to its
anti-inflammatory and immunological components.
(5) A human milk diet for medically compromised infants
provides powerful, unparalleled protection against serious
health complications that can lead to longer hospital stays,
multiple medical and surgical procedures, readmissions,
lifelong disability or even death, while also increasing
rates of exclusive maternal breastfeeding.
(6) Pasteurized donor human milk dramatically reduces
the risk of necrotizing enterocolitis, which is the most
prevalent gastrointestinal emergency among preterm infants.
(7) Necrotizing enterocolitis has a 24% mortality rate
overall and surgical necrotizing enterocolitis has a 40%
mortality rate.
(8) Necrotizing enterocolitis is a devastating
complication that may result in the partial or complete
destruction of the intestinal lining and may lead to short-
term and lifelong health consequences, including premature
death.
(9) The use of pasteurized donor human milk has been
shown to decrease the overall incidence of necrotizing
enterocolitis by up to 80% and the rate of surgical
necrotizing enterocolitis by more than 90%.
(10) A National Academy of Medicine study identified
preterm birth as a leading cause of neonatal morbidity and
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disability, resulting in an annual total cost in the United
States of at least $26,000,000,000.
(11) Infants with a wide range of congenital or acquired
conditions can benefit from the use of medically prescribed
pasteurized donor human milk as a component of treatment when
their mothers' own milk is unavailable or cannot meet all of
their needs.
(12) Neonatal abstinence syndrome has tripled in the
last 10 years, including a seven-fold increase in neonatal
intensive care unit stays for drug exposed infants who suffer
from feeding intolerance and many other side effects.
(13) The incidence of neonatal abstinence syndrome among
infants insured by medical assistance has increased five-fold
in recent years and is equivalent to diagnosing one newborn
with neonatal abstinence syndrome every 25 minutes.
(14) The use of pasteurized donor human milk to meet the
nutritional needs of infants with neonatal abstinence
syndrome reduces their symptoms and decreases the need for
additional medical intervention and treatment.
(15) Cost is the main access barrier to pasteurized
donor human milk for outpatient infants, who would benefit
from insurance coverage with reimbursement for donor milk,
which includes its related costs for screening, testing and
processing.
(16) The availability of and access to pasteurized donor
human milk is impacted by significant, ongoing racial and
economic disparities.
(17) Insurance coverage with reimbursement for
prescribed and medically necessary pasteurized donor human
milk for inpatient and outpatient infants is necessary to
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improve health outcomes and reduce the costs for medical
treatment in this Commonwealth.
(18) This act has the following purposes:
(i) Promoting the health of medically fragile
infants through access to evidence-based pasteurized
donor human milk when medically prescribed and necessary.
(ii) Substantially reducing the incidence of
necrotizing enterocolitis in infants with risk factors
for the disease.
(iii) Improving medical outcomes for infants with
serious health conditions where access to donor milk will
aid in their recovery.
(iv) Reducing the symptomology of neonatal
abstinence syndrome for drug exposed infants to decrease
the need for extensive medical intervention and
treatment.
(v) Improving public awareness of the availability
of pasteurized donor human milk and educating families
about this life-saving medicine.
(vi) Requiring insurance coverage with reimbursement
for medically necessary pasteurized donor human milk.
(vii) Improving short-term and long-term health
outcomes for the smallest and most fragile residents of
this Commonwealth by providing access to donor milk not
only to reduce health care costs, but most importantly,
to save lives.
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
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"Department." The Department of Health of the Commonwealth.
"Health care provider." A person, corporation, facility,
institution or other entity licensed, certified or approved by
the Commonwealth to provide health care or professional medical
services.
"Inpatient infant." An infant who is younger than 12 months
of age based on the infant's corrected gestational age, who is
receiving care in an inpatient setting where pasteurized donor
human milk has been determined to be medically necessary and who
exhibits any of the following health conditions:
(1) An infant birth weight less than 1800 grams.
(2) An infant gestational age equal to or less than 34
weeks.
(3) Infant hypoglycemia.
(4) A high risk for development of necrotizing
enterocolitis, bronchopulmonary dysplasia or retinopathy of
prematurity.
(5) A congenital or acquired gastrointestinal condition
with long-term feeding or malabsorption complications.
(6) Congenital heart disease requiring surgery in the
first year of life.
(7) Has had or will have an organ or bone marrow
transplant.
(8) Sepsis.
(9) Congenital hypotonia associated with feeding or
malabsorption complications.
(10) Renal disease requiring dialysis in the first year
of life.
(11) Craniofacial anomalies.
(12) An immunologic deficiency.
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(13) Neonatal abstinence syndrome.
(14) Any other serious congenital or acquired condition.
"Licensed milk bank." A milk bank licensed in this
Commonwealth under the act of February 12, 2020 (P.L.13, No.7),
known as the Keystone Mother's Milk Bank Act.
"Necrotizing enterocolitis" or "NEC." A life-threatening
condition that most often occurs in a premature infant, but also
occurs in a term infant or near term infant, and that causes
intestinal inflammation characterized by variable injury or
damage to the intestinal tract resulting in the potential death
of intestinal tissue.
"Neonatal abstinence syndrome" or "NAS." A withdrawal
syndrome of an infant that occurs when an infant is born after
exposure to drugs, including opioids in utero, and that is
associated with multiple side effects, including tremors,
vomiting, poor feeding, poor weight gain and high-pitched
crying, which may lead to increased length of hospital stays and
additional health care costs depending on severity.
"Outpatient infant." An infant who is younger than 12 months
of age based on the infant's corrected gestational age, who is
receiving care in an outpatient setting where pasteurized donor
human milk has been determined to be medically necessary and who
exhibits any of the following health conditions:
(1) A congenital or acquired gastrointestinal condition
with long-term feeding or malabsorption complications.
(2) Congenital heart disease requiring surgery in the
first year of life.
(3) Has had or will have an organ or bone marrow
transplant.
(4) A history of sepsis.
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(5) Congenital hypotonia associated with feeding or
malabsorption complications.
(6) Renal disease requiring dialysis in the first year
of life.
(7) Craniofacial anomalies.
(8) An immunologic deficiency.
(9) Any other serious congenital or acquired condition.
"Pasteurized donor human milk" or "PDHM." Human milk derived
from a donor as defined in section 3 of the Keystone Mother's
Milk Bank Act, which is donated to a licensed milk bank for
processing and distribution.
Section 4. Access to pasteurized donor human milk.
A health care provider shall ensure that an inpatient infant
or outpatient infant under the health care provider's care
receives medically necessary PDHM when any of the following
apply:
(1) The infant's mother is medically or physically
unable to produce maternal breast milk.
(2) The infant's mother is medically or physically
unable to produce maternal breast milk in sufficient
quantities to meet the infant's needs.
(3) The infant's mother's maternal breast milk is
contraindicated.
Section 5. Duties of department.
(a) Public information campaign.--The department, in
collaboration with the Department of Human Services, shall
conduct a public information campaign to inform parents and
health care providers of the availability of PDHM in this
Commonwealth to treat inpatient infants and outpatient infants,
including the availability of health insurance coverage with
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reimbursement in accordance with section 6.
(b) Educational materials.--In conducting the public
information campaign under subsection (a), the department, in
collaboration with the Department of Human Services, shall
develop culturally and linguistically appropriate educational
materials regarding PDHM, including the availability of PDHM,
the importance of the use of PDHM in medically necessary
circumstances to prevent NEC and treat NAS and the requirements
of this act. The department shall make the educational materials
under this subsection publicly accessible at no cost and shall
develop the educational materials for specific audiences,
including parents, medical assistance recipients and health care
providers.
Section 6. Pasteurized donor human milk coverage.
(a) Coverage.--A health insurance policy or government
program covered under this section shall provide coverage with
reimbursement for PDHM prescribed for an inpatient infant or
outpatient infant when any of the following apply:
(1) The infant's mother is medically or physically
unable to produce maternal breast milk.
(2) The infant's mother is medically or physically
unable to produce maternal breast milk in sufficient
quantities to meet the infant's needs.
(3) The infant's mother's maternal breast milk is
contraindicated.
(b) Copayments, deductibles and coinsurance.--The coverage
with reimbursement provided under this section shall be subject
to copayment, deductible and coinsurance provisions and any
other general exclusions or limitations of a health insurance
policy or government program to the same extent as other medical
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services covered by the policy or program are subject to these
provisions.
(c) Reimbursement.-- Billing and reimbursement.--A health
care provider shall bill separately for PDHM and its
reimbursement. A health insurance policy or government program
covered under this section shall provide reimbursement for PDHM
separately from the health care provider payment for inpatient
services. Reimbursement for PDHM shall not be included in an
all-inclusive bundled payment.
(d) Construction.--Nothing in this section shall be
construed to limit benefits otherwise available to an individual
under a health insurance policy or government program.
(e) Applicability.--
(1) This section shall apply to any individual or group
health insurance policy, contract or plan that provides
medical or health care coverage on an expense-incurred
service or prepaid basis, that is offered, issued or renewed
in this Commonwealth on or after the effective date of this
section and that is offered by or governed under any of the
following:
(i) The act of May 17, 1921 (P.L.682, No.284), known
as The Insurance Company Law of 1921.
(ii) Subdivision (f) of Article IV of the act of
June 13, 1967 (P.L.31, No.21), known as the Human
Services Code.
(iii) The act of December 29, 1972 (P.L.1701,
No.364), known as the Health Maintenance Organization
Act.
(iv) The act of May 18, 1976 (P.L.123, No.54), known
as the Individual Accident and Sickness Insurance Minimum
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Standards Act.
(v) A nonprofit corporation subject to 40 Pa.C.S.
Ch. 61 (relating to hospital plan corporations) or 63
(relating to professional health services plan
corporations).
(2) This section shall not apply to any of the following
policies:
(i) An accident only policy.
(ii) A credit only policy.
(iii) A long-term care or disability income policy.
(iv) A specified disease policy.
(v) A Medicare supplement policy.
(vi) A Civilian Health and Medical Program of the
Uniformed Services (CHAMPUS) supplement policy.
(vii) A fixed indemnity policy.
(viii) A dental only policy.
(ix) A vision only policy.
(x) A workers' compensation policy.
(xi) An automobile medical payment policy.
(xii) A hospital indemnity policy.
(xiii) Another similar policy providing for limited
benefits.
Section 7. Applicability of policies.
For a health insurance policy for which a form or rate is
required to be filed with the Insurance Department or the
Federal Government, section 6 shall apply to a policy for which
a form or rate is first filed on or after the effective date of
this section. For a health insurance policy for which a form or
rate is not required to be filed with the Insurance Department
or the Federal Government, section 6 shall apply to a policy
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issued or renewed on or after 90 days after the effective date
of this section.
Section 8. Effective date.
This act shall take effect in 60 days.
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