Health - Newborn Screening Program - Gaucher Disease

EXPLANATION: CAPITALS INDICATE MATTER ADDED TO EXISTING LAW.
[Brackets] indicate matter deleted from existing law.
*sb0495*

SENATE BILL 495
J1 6lr2491
CF 6lr2492
By: Senator Hettleman
Introduced and read first time: February 2, 2026
Assigned to: Finance

A BILL ENTITLED

AN ACT concerning 1

Health – Newborn Screening Program – Gaucher Disease 2

FOR the purpose of requiring the Maryland Department of Health, as part of the newborn 3
screening system, to screen for Gaucher disease; and generally relating to newborn 4
screening. 5

BY repealing and reenacting, with amendments, 6
Article – Health – General 7
Section 13–111 8
Annotated Code of Maryland 9
(2023 Replacement Volume and 2025 Supplement) 10

SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 11
That the Laws of Maryland read as follows: 12

Article – Health – General 13

13–111. 14

(a) The Department shall establish a coordinated statewide system for screening 15
all newborn infants in the State for certain hereditary and congenital disorders associated 16
with severe problems of health or development, except when the parent or guardian of the 17
newborn infant objects. 18

(b) Except as provided in § 13–112 of this subtitle, the Department’s public health 19
laboratory is the sole laboratory authorized to perform tests on specimens from newbo rn 20
infants collected to screen for hereditary and congenital disorders as determined under 21
subsection (d)(2) of this section. 22

(c) The system for newborn screening shall include: 23

2 SENATE BILL 495

(1) Laboratory testing and the reporting of test results; and 1

(2) Follow–up activities to facilitate the rapid identification and treatment 2
of an affected child. 3

(d) In consultation with the State Advisory Council on Hereditary and Congenital 4
Disorders, the Department shall: 5

(1) Establish protocols for a health care provider to obtain and deliver test 6
specimens to the Department’s public health laboratory; 7

(2) Determine the screening tests that the Department’s public health 8
laboratory is required to perform; 9

(3) Maintain a coordinated statewide system for newborn screening that 10
carries out the purpose described in subsection (c) of this section that includes: 11

(i) Communicating the results of screening tests to the health care 12
provider of the newborn infant; 13

(ii) Locating newborn infants with abnormal test results; 14

(iii) Sharing newborn screening information between hospitals, 15
health care providers, treatment centers, and laboratory personnel; 16

(iv) Delivering needed clinical, diagnostic, and treatment 17
information to health care providers, parents, and caregivers; and 18

(v) Notifying parents and guardians of newborn infants that 19
laboratories other than the Department’s public health laboratory are authorized to 20
perform postscreening confirmatory or diagnostic tests on newborn infants for hered itary 21
and congenital disorders; and 22

(4) Adopt regulations that set forth the standards and requirements for 23
newborn screening for hereditary and congenital disorders that are required under this 24
subtitle, including: 25

(i) Performing newborn screening tests; 26

(ii) Coordinating the reporting, follow –up, and treatment activities 27
with parents, caregivers, and health care providers; and 28

(iii) Establishing fees for newborn screening that do not exceed an 29
amount sufficient to cover the administrative, laboratory, and follow –up costs associated 30
with the performance of screening tests under this subtitle. 31

SENATE BILL 495 3

(e) (1) (i) The Department shall screen for each core condition listed in the 1
U.S. Department of Health and Human Services’ Recommended Uniform Screening Panel. 2

(ii) Subject to subparagraph (iii) of this paragraph, the Department 3
shall implement testing for a core condition within 1 year and 6 months after the core 4
condition is added to the Recommended Uniform Screening Panel. 5

(iii) 1. If the Department is unable to implement testing within 1 6
year and 6 months after a core condition is added to the Recommended Uniform Screening 7
Panel due to a delay in the procurement of equipment or supplies needed to implement the 8
testing, the Department shall r eport to the Senate Finance Committee and the House 9
Health and Government Operations Committee, in accordance with § 2 –1257 of the State 10
Government Article, within 1 year and 3 months after the addition of the core condition to 11
the Recommended Uniform Scre ening Panel and every 3 months thereafter until the 12
testing for the core condition is implemented. 13

2. A report required under subsubparagraph 1 of this 14
subparagraph shall include the reason for the delay and the anticipated timeline for 15
implementation. 16

(2) Notwithstanding any other provision of law, if the Secretary of Health 17
and Human Services issues federal recommendations on critical congenital heart disease 18
screening of newborns, the Department shall adopt the federal screening recommendations. 19

(3) The Department may screen for any condition recommended by the 20
Advisory Council and approved by the Secretary. 21

(4) THE DEPARTMENT SHALL SCREEN FOR GAUCHER DISEASE. 22

(f) (1) The Secretary shall pay all fees collected under the prov isions of this 23
subtitle to the Comptroller. 24

(2) The Comptroller shall distribute the fees to the Newborn Screening 25
Program Fund established under § 13–113 of this subtitle. 26

SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 27
October 1, 2026. 28