Senate Bill S10260

                                 
BILL NUMBER: S10260

SPONSOR: WEBB
 
TITLE OF BILL:

An act to amend the public health law, in relation to newborn screening
for CLN2, MPS IVA, MPS VI, MPS VII and Fabry diseases

 
PURPOSE:

Requires adding conditions with FDA approved therapies to the New York
State newborn screening panel.

 
SUMMARY OF PROVISIONS:

Section 1 amends subdivision 1 of section 2500-a of the Public Health
Law by adding five new paragraphs: (I) late infantile neuronal ceroid
lipofuscinosis type 2 (CLN2); (m) Mucopolysaccharidosis type IVA (MPS
IVA) ;(n) Mucopolysaccharidosis type IV (MPS VI); (o) Mucopolysacchari-
dosis type VII (MPS VII); and (p) Fabry.

Section 2 amends section 2500-a of the Public Health Law to require the
              

Commissioner of Health to ensure that all diseases and conditions
included in the new paragraphs (I), (m), (n), (o), and (p) have tests
available for every infant or child within twelve months of the law's
effective date.

Section 3 establishes the effective date.

 
JUSTIFICATION:

The Recommended Uniform Screening Panel (RUSP) is a list of conditions
that the United States Department of Health and Human Services (HHS)
recommends that all states include in their newborn screening programs.
It currently includes 38 core conditions and 26 secondary ones.

The Advisory Committee on Heritable Disorders In Newborns and Children
(ACHDNC) was the federal body that advised the Secretary of HHS on
updates to the RUSP and broader screening policies, but this committee
was officially disbanded in April 2025.

With the federal advisory Infrastructure no longer active, state-level
efforts are now critical to ensure timely updates to screening panels
and expanded access to testing.

There would be minimal additional cost to hospitals for adding CLN2, MPS
IVA, MPS VI, Fabry disease, and MPS VII to the newborn screening panel.
Screening can be performed using existing platforms, and statewide
expansion would require no additional laboratory equipment or infras-
tructure.

Although each of these conditions is rare, together they represent a
meaningful burden of serious, progressive pediatric disease with well-
documented diagnostic delays and irreversible harm when diagnosis occurs
late. Statewide newborn screening ensures that all newborns - regardless
of race, geography, family history, or access to specialists - have
equitable access to early diagnosis, treatment, and genetic counseling.
Adding these conditions to the newborn screening panel would build on

existing infrastructure to prevent avoidable disability, improve long-
term outcomes, and promote health equity statewide.

Further explanation of the diseases to be included is as follows:

CLN2 Disease (Late Infantile Neuronal Ceroid Lipofuscinosis Type 2) is a
devastating, inherited neurodegenerative disorder that causes progres-
sive loss of motor function, speech, vision, and cognition.

MPS IVA (Morquio A Syndrome) is a serious, inherited lysosomal storage
disorder that leads to progressive skeletal disease, cardiopulmonary
complications, vision and hearing impairment, and significant physical
disability.

MPS VI (Maroteaux-Lamy Syndrome) is a progressive, inherited lysosomal
storage disorder that causes multi-system disease, including severe
skeletal abnormalities, cardiopulmonary disease, vision and hearing
loss, joint stiffness, and reduced life expectancy.

MPS VII (Sly Syndrome): MPS VII is a serious, inherited lysosomal stor-
age disorder that causes progressive, multi-system disease due to the
absence of the enzyme betaglucuronidase.

Fabry Disease: Fabry disease is a serious, inherited lysosomal storage
disorder that interferes with the body's ability to break down glycos-
phingolipids, leading to progressive damage to vital organs.

 
LEGISLATIVE HISTORY:

New bill

 
FISCAL IMPLICATIONS:

Minimal to hospitals

 
EFFECTIVE DATE:
This act shall take effect immediately.