PRINTER'S NO. 1448
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
983
Session of
2020
INTRODUCED BY DiSANTO, BROWNE, MENSCH, COLLETT, MARTIN, FONTANA,
MASTRIANO, TARTAGLIONE AND PITTMAN, JANUARY 15, 2020
REFERRED TO AGING AND YOUTH, JANUARY 15, 2020
AN ACT
Amending the act of September 9, 1965 (P.L.497, No.251),
entitled "An act requiring physicians, hospitals and other
institutions to administer or cause to be administered tests
for genetic diseases upon infants in certain cases," further
providing for definitions and for Newborn Child Screening and
Follow-up Program; and providing for Newborn Child Screening
Program Account, for newborn child screening fee and for
mandated screening and follow-up.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definitions of "board" and "disease" in
section 2 of the act of September 9, 1965 (P.L.497, No.251),
known as the Newborn Child Testing Act, are amended and the
section is amended by adding definitions to read:
Section 2. 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:
"Birthing facilities." An inpatient or ambulatory health
care facility licensed by the department that provides birthing
and newborn care services.
"Board." The [State Advisory Health] Newborn Screening and
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Follow-up Technical Advisory Board in the Department of Health.
"Certified-nurse midwife." An individual licensed by the
State Board of Medicine to practice midwifery under section 35
of the act of December 20, 1985 (P.L.457, No.112), known as the
Medical Practice Act of 1985.
* * *
"Direct-entry midwife." An independent practitioner educated
in the discipline of midwifery through self-study,
apprenticeship, a midwifery school or a college or university-
based program distinct from the discipline of nursing. The term
includes certified professional midwives, traditional midwives,
Amish, Mennonite or Plain midwives and other specific cultural
or spiritual community-based midwives not licensed by the State
Board of Medicine as a certified-nurse midwife.
"Disease." Diseases listed by the Department of Health by
regulation which lead to [mental retardation or physical
defects] intellectual disability, physical disability or death,
including, without limitation, Phenylketonuria (PKU), maple
syrup urine disease (MSUD) and sickle-cell disease
(hemoglobinopathies).
"Health care practitioner." As the term is defined in
section 103 of the act of July 19, 1979 (P.L.130, No.48), known
as the Health Care Facilities Act.
* * *
Section 2. Section 3(a), (b.1), (d) and (e) of the act are
amended to read:
Section 3. Newborn Child Screening and Follow-up Program.--
(a) In order to assist health care providers to determine
whether treatment or other services are necessary to avert
[mental retardation, permanent disabilities] intellectual
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disability, physical disability or death, the department, [with
the approval of the Newborn Screening and Follow-up Technical
Advisory Committee] in consultation with the board, shall
establish a program providing for:
(1) The screening tests of newborn children and follow-up
services for the following diseases:
(i) Phenylketonuria (PKU).
(ii) Maple syrup urine disease (MSUD).
(iii) Sickle-cell disease (hemoglobinopathies).
(iv) Galactosemia.
(v) Congenital adrenal hyperplasia (CAH).
(vi) Primary congenital hypothyroidism.
[(vii) Certain Lysosomal storage disorders (LSDs),
including:
(A) Globoid Cell Leukodystrophy (Krabbe).
(B) Fabry.
(C) Pompe.
(D) Niemann-Pick.
(E) Gaucher.
(F) Hurler Syndrome (MPS I).
(2) Follow-up services relating to case management,
referrals, confirmatory testing, assessment and diagnosis of
newborn children with abnormal, inconclusive or unacceptable
screening test results for the following diseases:
(i) Phenylketonuria (PKU).
(ii) Maple syrup urine disease (MSUD).
(iii) Sickle-cell disease (hemoglobinopathies).
(iv) Isovaleric acidemia/Isovalery-CoA dehydrogenase
deficiency (IVA).
(v) Glutaric acidemia Type I/Glutaryl-CoA dehydrogenase
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deficiency Type I (GA I).
(vi) 3-Hydroxy 3-methylglutaryl-CoA lyase deficiency (HMG).
(vii) Multiple carboxylase deficiency (MCD).
(viii) Methylmalonic acidemia (mutase deficiency) (MUT).
(ix) Methylmalonic acidemia (Cbl A,B).
(x) 3-Methylcrontonyl-CoA carboxylase deficiency (3MCC).
(xi) Propionic acidemia/Propionyl-CoA carboxylase deficiency
(PROP).
(xii) Beta-ketothiolase deficiency (BKT).
(xiii) Medium chain acyl-CoA dehydrogenase deficiency
(MCAD).
(xiv) Very long-chain acyl-CoA dehydrogenase deficiency
(VLCAD).
(xv) Long-chain L-3-OH acyl-CoA dehydrogenase deficiency
(LCHAD).
(xvi) Trifunctional protein deficiency (TFP).
(xvii) Carnitine uptake defect (CUD).
(xviii) Homocystinuria (HCY).
(xix) Tyrosinemia type I (TYR I).
(xx) Argininosuccinic acidemia (ASA).
(xxi) Citrullinemia (CIT).
(xxii) Hb S/Beta-thalassemia (Hb S/Th).
(xxiii) Hb S/C disease (Hb S/C).
(xxiv) Congenital hypothyroidism (HYPOTH).
(xxv) Biotinidase deficiency (BIOT).
(xxvi) Congenital adrenal hyperplasia (CAH).
(xxvii) Galactosemia (GALT).
(xxviii) Cystic fibrosis (CF).]
(vii) Globoid Cell Leukodystrophy (Krabbe).
(viii) Pompe.
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(ix) Hurler Syndrome (MPS I).
(x) Adrenoleukodystrophy (ALD).
(xi) Isovaleric acidemia/Isovalery-CoA dehydrogenase
deficiency (IVA).
(xii) Glutaric acidemia Type I/Glutaryl-CoA dehydrogenase
deficiency Type I (GA I).
(xiii) 3-Hydroxy 3-methylglutaryl-CoA lyase deficiency
(HMG).
(xiv) Multiple carboxylase deficiency (MCD).
(xv) Methylmalonic acidemia (mutase deficiency) (MUT).
(xvi) Methylmalonic acidemia (Cbl A, B).
(xvii) 3-Methylcrontonyl-CoA carboxylase deficiency (3MCC).
(xiii) Propionic acidemia/Propionyl-CoA carboxylase
deficiency (PROP).
(xix) Beta-ketothiolase deficiency (BKT).
(xx) Medium chain acyl-CoA dehydrogenase deficiency (MCAD).
(xxi) Very long-chain acyl-CoA dehydrogenase deficiency
(VLCAD).
(xxii) Long-chain L-3-OH acyl-CoA dehydrogenase deficiency
(LCHAD).
(xxiii) Trifunctional protein deficiency (TFP).
(xxiv) Carnitine uptake defect (CUD).
(xxv) Homocystinuria (HCY).
(xxvi) Tyrosinemia type I (TYR I).
(xxvii) Argininosuccinic acidemia (ASA).
(xxviii) Citrullinemia (CIT).
(xxix) Hb S/Beta-thalassemia (Hb S/Th).
(xxx) Hb S/C disease (Hb S/C).
(xxxi) Congenital hypothyroidism (HYPOTH).
(xxxii) Biotinidase deficiency (BIOT).
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(xxxiii) Cystic fibrosis (CF).
(xxxiv) Severe combined immunodeficiency disease (SCID).
(xxxv) Spinal Muscular Atrophy (SMA).
(2) (Reserved).
(b.1) All laboratories performing the screening tests for
newborn children shall report the results to the department for
follow-up activities. Follow-up services provided by the program
shall include case management, referrals, confirmatory testing,
assessment and diagnosis of newborn children with abnormal,
inconclusive or unacceptable screening test results up to a
newborn child's first year of life.
* * *
(d) The department, [with the approval of the Newborn
Screening and Follow-up Technical Advisory Committee] in
consultation with the board, shall establish, by transmitting
notice to the Legislative Reference Bureau for periodic
publication in the Pennsylvania Bulletin, [changes] additions to
the [lists] list under subsection (a)(1) [and (2)] of those
diseases for which newborn children shall be screened and
laboratory screening results reported.
(e) Notwithstanding any provisions of this act or the act of
April 23, 1956 (1955 P.L.1510, No.500), known as the "Disease
Prevention and Control Law of 1955," to the contrary, test
results and diagnoses based upon screening tests for the
diseases listed in this section for newborn children shall be
reported to the department. The department shall establish, by
transmitting notice to the Legislative Reference Bureau for
periodic publication in the Pennsylvania Bulletin, the method
for reporting test results to the department.
* * *
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Section 3. The act is amended by adding sections to read:
Section 3.1. Newborn Child Screening Program Account.--(a)
There is established a special restricted account within the
State Treasury to be known as the Newborn Child Screening
Program Account, which shall receive money from the fee
established under section 3.2 and any other money from any
source designated for deposit in the account.
(b) The fees deposited in the account are hereby
appropriated, upon approval of the Governor, to the department
for the use of screening newborn children, tracking screening
outcomes, follow-up services and referrals for treatment for up
to the first year of life as described in section 3(b.1).
(c) All earnings received from the investment or deposit of
the money in the account shall be paid into the account for
purposes authorized under this act.
(d) Unexpended money and interest earned on the money in the
account shall not lapse to the General Fund, but shall remain in
the account to be used by the department for purposes specified
in this act.
(e) As used in this section the term "account" shall mean
the Newborn Child Screening Program Account established under
subsection (a).
Section 3.2. Newborn Child Screening Fee.--(a) In order to
safeguard newborn health and appropriately fund the screening of
newborns, tracking of screening outcomes, follow-up services and
referrals for treatment, the department shall impose a fee on
birthing facilities, certified-nurse midwives, direct-entry
midwives and health care practitioners for each newborn child
screened.
(b) The fee shall be deposited in the Newborn Child
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Screening Program Account established under section 3.1.
(c) The amount of the fee shall be determined by the
department and shall not exceed an amount sufficient to cover
the administrative, laboratory and follow-up costs associated
with the performance of screening tests.
(d) At least annually the department shall transmit notice
of the amount of the fee to the Legislative Reference Bureau for
publication in the Pennsylvania Bulletin.
Section 3.3. Mandated Screening and Follow-up.--Diseases and
conditions mandated for screenings and follow-up services shall,
at a minimum, include:
(1) diseases listed under section 3(a)(1);
(2) diseases added by the board under section 3(d) to the
list of diseases under section 3(a)(1); and
(3) conditions listed in the Recommended Uniform Screening
Panel by the United States Department of Health and Human
Services.
Section 4. This act shall take effect in 180 days.
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