2023 Pennsylvania Consolidated & Unconsolidated Statutes › Act 32 - HUMAN SERVICES CODE - MEDICAL ASSISTANCE COVERAGE FOR PASTEURIZED DONOR HUMAN MILK

Session of 2023
No. 2023-32
SB 500
AN ACT
Amending the act of June 13, 1967 (P.L.31, No.21), entitled "An act to consolidate,
            editorially revise, and codify the public welfare laws of the Commonwealth," in public
            assistance, providing for medical assistance coverage for pasteurized donor human
            milk.
This act may be referred to as Owen's Law.
The General Assembly finds and declares as follows:
(1)  In the United States, one in nine infants are born prematurely, one of the highest
            rates among developed countries.
(2)  Up to 70% of mothers with infants in neonatal intensive care units cannot provide
            enough breast milk to meet all of their infants' needs, despite adequate lactation
            support and effort.
(3)  Pasteurized donor human milk provides a lifesaving health benefit for high-risk infants
            as a supplement or bridge when determined to be medically necessary.
(4)  Pasteurized 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 unparalleled protection
            against serious health complications that can lead to longer hospital stays, multiple
            medical and surgical procedures, readmissions, lifelong disability or even death.
(6)  Along with avoiding serious medical complications, the use of pasteurized donor human
            milk in a hospital increases exclusive maternal breastfeeding rates. A mother's own
            milk provides the ultimate nutrition for the infant but is not always adequate to
            meet the infant's needs.
(7)  Pasteurized donor human milk dramatically reduces the risk of necrotizing enterocolitis,
            the most prevalent gastrointestinal emergency among preterm infants.
(8)  Necrotizing enterocolitis has a 24% mortality rate overall and surgical necrotizing
            enterocolitis has a 40% mortality rate and 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)  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.
(11)  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. 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.
(12)  Medical assistance coverage for prescribed and medically necessary pasteurized donor
            human milk for inpatient and outpatient infants is necessary to improve health outcomes
            and reduce medical treatment costs in this Commonwealth.
(13)  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 pasteurized donor human 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)  Requiring medical assistance coverage for medically necessary pasteurized donor human
            milk for inpatient and outpatient infants when needed.
(vi)  Providing public awareness of the availability of pasteurized donor human milk and
            educating families and health care providers about this life-saving medicine.
(vii)  Improving short-term and long-term health outcomes for the smallest and most fragile
            residents of this Commonwealth by providing needed access to pasteurized donor human
            milk not only to reduce health care costs but, most importantly, to save lives.
The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:
Section 1.  The act of June 13, 1967 (P.L.31, No.21), known as the Human Services Code, is amended
            by adding a section to read:
Section 443.14.  Medical Assistance Coverage for Pasteurized Donor Human Milk.--(a)  Pasteurized donor human milk is compensable under the medical assistance program in
            accordance with the Commonwealth's approved State plan if:
(1)  The pasteurized donor human milk is medically necessary for an inpatient infant or
            an outpatient infant.
(2)  The infant's mother is medically or physically unable to produce maternal breast milk
            or produce maternal breast milk in sufficient quantities to meet the infant's needs
            or if the maternal breast milk is contraindicated.
(b)  The department shall regularly review and update, as needed, written guidance regarding
            pasteurized donor human milk. Any updated pasteurized donor human milk guidance shall
            be posted on the department's publicly accessible Internet website.
(c)  The Department of Health, in collaboration with the department, shall develop and
            conduct a public information campaign to inform families and health care providers
            of the availability of pasteurized donor human milk in this Commonwealth to treat
            inpatient infants and outpatient infants, as provided in this section and as medically
            necessary, including the availability of coverage through medical assistance.
(d)  The following words and phrases when used in this section shall have the meanings
            given to them in this subsection unless the context clearly indicates otherwise:
"Inpatient infant."  An infant who is younger than twelve months of age based on the infant's corrected
            gestational age, who is receiving care in an inpatient setting, for whom pasteurized
            donor human milk is medically necessary. Pasteurized donor human milk is medically
            necessary for an infant with any of the following health conditions:
(1)  An infant birth weight equal to or less than one thousand eight hundred grams.
(2)  An infant gestational age equal to or less than thirty-four weeks.
(3)  A high risk for development of necrotizing enterocolitis, bronchopulmonary dysplasia,
            sepsis or retinopathy of prematurity.
(4)  A congenital or acquired gastrointestinal condition or other serious medical condition
            associated with long-term feeding or malabsorption complications.
(5)  Congenital heart disease requiring surgery in the first year of life.
(6)  Has had or will have an organ or bone marrow transplant, or has an immunologic deficiency.
(7)  Renal disease requiring dialysis in the first year of life.
(8)  Infant hypoglycemia or jaundice.
(9)  Neonatal abstinence syndrome.
(10)  Any other health condition for which the use of pasteurized donor human milk is medically
            necessary as determined by the department.
"Licensed milk bank."  A milk bank licensed in this Commonwealth or through a hospital licensure process
            in accordance with the act of February 12, 2020 (P.L.13, No.7), known as the "Keystone
            Mother's Milk Bank Act."
"Necrotizing enterocolitis."  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."  A withdrawal syndrome of an infant that occurs when an infant is born after exposure
            to substance abuse 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 twelve months of age based on the infant's corrected
            gestational age, who is receiving care in an outpatient setting, for whom pasteurized
            donor human milk is medically necessary. Pasteurized donor human milk is medically
            necessary for an infant with any of the following health conditions:
(1)  A congenital or acquired gastrointestinal condition or other serious medical condition
            associated 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 or has an immunologic deficiency.
(4)  A history of sepsis.
(5)  Renal disease requiring dialysis in the first year of life.
(6)  Any other health condition for which the use of pasteurized donor human milk is medically
            necessary as determined by the department.
"Pasteurized donor human milk."  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 2.  This act shall take effect in 60 days.
APPROVED--The 21st day of November, A.D. 2023.
JOSH SHAPIRO