EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb0096*
HOUSE BILL 96
J1 4lr0937
(PRE–FILED) CF SB 117
By: Delegate T. Morgan
Requested: October 12, 2023
Introduced and read first time: January 10, 2024
Assigned to: Health and Government Operations
A BILL ENTITLED
AN ACT concerning 1
Health – Newborn Screening Program – Krabbe Leukodystrophy 2
FOR the purpose of requiring that the Maryland Department of Health’s newborn 3
screening system include screening for Krabbe leukodystrophy; and generally 4
relating to newborn 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) 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 newborn 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 HOUSE BILL 96
(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; AND 3
(3) SCREENING FOR KRABBE LEUKODYSTROPHY . 4
(d) In consultation with the State Advisory Council on Hereditary and Congenital 5
Disorders, the Department shall: 6
(1) Establish protocols for a health care provider to obtain and deliver test 7
specimens to the Department’s public health laboratory; 8
(2) Determine the screening tests that the Department’s public health 9
laboratory is required to perform; 10
(3) Maintain a coordinated statewide system for newborn screening that 11
carries out the purpose described in subsection (c) of this section that includes: 12
(i) Communicating the results of screening tests to the health care 13
provider of the newborn infant; 14
(ii) Locating newborn infants with abnormal test results; 15
(iii) Sharing newborn screening information between hospitals, 16
health care providers, treatment centers, and laboratory personnel; 17
(iv) Delivering needed clinical, diagnostic, and treatment 18
information to health care providers, parents, and caregivers; and 19
(v) Notifying parents and guardians of newborn infants that 20
laboratories other than the Department’s public health laboratory are authorized to 21
perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 22
and congenital disorders; and 23
(4) Adopt regulations that set forth the standards and requirements for 24
newborn screening for hereditary and congenital disorders that are required under this 25
subtitle, including: 26
(i) Performing newborn screening tests; 27
(ii) Coordinating the reporting, follow–up, and treatment activities 28
with parents, caregivers, and health care providers; and 29
(iii) Establishing fees for newborn screening that do not exceed an 30
amount sufficient to cover the administrative, laboratory, and follow–up costs associated 31 HOUSE BILL 96 3
with the performance of screening tests under this subtitle. 1
(e) (1) (i) Subject to the approval of the Secretary and the Advisory Council 2
under subparagraph (ii) of this paragraph and notwithstanding any other provision of law, 3
the Department shall screen for each core condition listed in the U.S. Department of Health 4
and Human Services’ Recommended Uniform Screening Panel. 5
(ii) On or after January 1, 2023, the Secretary and the Advisory 6
Council shall determine whether to approve the inclusion of a condition in the system for 7
newborn screening within 1 year after the addition of the condition to the Recommended 8
Uniform Screening Panel. 9
(iii) If the Secretary or Advisory Council does not approve the 10
inclusion of a core condition in the system for newborn screening under subparagraph (i) of 11
this paragraph: 12
1. Within 1 year after the addition of the condition to the 13
Recommended Uniform Screening Panel, the Department shall publicly post and submit to 14
the General Assembly, in accordance with § 2–1257 of the State Government Article, a 15
report that includes, as applicable, the Secretary’s justification for not approving the 16
inclusion and the final vote of the Advisory Council regarding the inclusion of the condition; 17
and 18
2. Each year after the initial disapproval, the Advisory 19
Council shall: 20
A. Review the medical literature published on the condition 21
since the initial evaluation and determine whether substantive updates have occurred that 22
would merit formal reevaluation of the inclusion of the condition; and 23
B. If the Advisory Council upholds its disapproval of the 24
condition, publicly publish and submit to the General Assembly, in accordance with § 25
2–1257 of the State Government Article, a report on the reason for the disapproval. 26
(2) Notwithstanding any other provision of law, if the Secretary of Health 27
and Human Services issues federal recommendations on critical congenital heart disease 28
screening of newborns, the Department shall adopt the federal screening recommendations. 29
(f) If the Secretary and the Advisory Council approve the inclusion of a condition 30
in the system for the newborn screening under subsection (e) of this section, the 31
Department shall implement testing for the condition within 1 year after the date of the 32
approval. 33
(g) (1) The Secretary shall pay all fees collected under the provisions of this 34
subtitle to the Comptroller. 35
(2) The Comptroller shall distribute the fees to the Newborn Screening 36 4 HOUSE BILL 96
Program Fund established under § 13–113 of this subtitle. 1
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 2
October 1, 2024. 3