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Chapter 177
(House Bill 96)
AN ACT concerning
Health – Newborn Screening Program – Krabbe Leukodystrophy
Implementation of Testing
FOR the purpose of repealing the requirement that the Secretary of Health and the State
Advisory Council on Hereditary and Congenital Disorders determine whether to
approve the inclusion of a core condition in the system for newborn screening within
a certain time period after the addition of the condition to the Recommended Uniform
Screening Panel; requiring the Maryland Department of Health to implement
testing for a core condition listed in the Recommended Uniform Screening Panel
within a certain time period after the core condition is added to the Panel;
authorizing the Department to screen for any condition recommended by the
Advisory Council and approved by the Secretary; requiring that the Maryland
Department of Health’s newborn screening system include screening to implement
testing for Krabbe leukodystrophy within a certain period of time after the U.S.
Department of Health and Human Services issues a certain recommendation; and
generally relating to newborn screening.
BY repealing and reenacting, with amendments,
Article – Health – General
Section 13–111
Annotated Code of Maryland
(2023 Replacement Volume)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Health – General
13–111.
(a) The Department shall establish a coordinated statewide system for screening
all newborn infants in the State for certain hereditary and congenital disorders associated
with severe problems of health or development, except when the parent or guardian of the
newborn infant objects.
(b) Except as provided in § 13–112 of this subtitle, the Department’s public health
laboratory is the sole laboratory authorized to perform tests on specimens from newborn
infants collected to screen for hereditary and congenital disorders as determined under
subsection (d)(2) of this section.
(c) The system for newborn screening shall include: Ch. 177 2024 LAWS OF MARYLAND
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(1) Laboratory testing and the reporting of test results; [and]
(2) Follow–up activities to facilitate the rapid identification and treatment
of an affected child; AND
(3) SCREENING FOR KRABBE LEUKODYSTROPHY .
(d) In consultation with the State Advisory Council on Hereditary and Congenital
Disorders, the Department shall:
(1) Establish protocols for a health care provider to obtain and deliver test
specimens to the Department’s public health laboratory;
(2) Determine the screening tests that the Department’s public health
laboratory is required to perform;
(3) Maintain a coordinated statewide system for newborn screening that
carries out the purpose described in subsection (c) of this section that includes:
(i) Communicating the results of screening tests to the health care
provider of the newborn infant;
(ii) Locating newborn infants with abnormal test results;
(iii) Sharing newborn screening information between hospitals,
health care providers, treatment centers, and laboratory personnel;
(iv) Delivering needed clinical, diagnostic, and treatment
information to health care providers, parents, and caregivers; and
(v) Notifying parents and guardians of newborn infants that
laboratories other than the Department’s public health laboratory are authorized to
perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary
and congenital disorders; and
(4) Adopt regulations that set forth the standards and requirements for
newborn screening for hereditary and congenital disorders that are required under this
subtitle, including:
(i) Performing newborn screening tests;
(ii) Coordinating the reporting, follow–up, and treatment activities
with parents, caregivers, and health care providers; and
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(iii) Establishing fees for newborn screening that do not exceed an
amount sufficient to cover the administrative, laboratory, and follow–up costs associated
with the performance of screening tests under this subtitle.
(e) (1) (i) Subject to the approval of the Secretary and the Advisory Council
under subparagraph (ii) of this paragraph and notwithstanding any other provision of law,
the THE Department shall screen for each core condition listed in the U.S. Department of
Health and Human Services’ Recommended Uniform Screening Panel.
(ii) On or after January 1, 2023, the Secretary and the Advisory
Council shall determine whether to approve the inclusion of a condition in the system for
newborn screening within 1 year after the addition of the condition SUBJECT TO
SUBPARAGRAPH (III) OF THIS PARAGRAPH , THE DEPARTMENT SHALL IMPL EMENT
TESTING FOR A CORE C ONDITION WITHIN 1 YEAR AND 6 MONTHS AFTER THE COR E
CONDITION IS ADDED to the Recommended Uniform Screening Panel.
(III) 1. IF THE DEPARTMENT IS UNABLE TO IMPLEMENT
TESTING WITHIN 1 YEAR AND 6 MONTHS AFTER A CORE CONDITION IS ADDED T O THE
RECOMMENDED UNIFORM SCREENING PANEL DUE TO A DELAY IN THE
PROCUREMENT OF EQUIP MENT OR SUPPLIES NEE DED TO IMPLEMENT THE TESTING,
THE DEPARTMENT SHALL REPO RT TO THE SENATE FINANCE COMMITTEE AND THE
HOUSE HEALTH AND GOVERNMENT OPERATIONS COMMITTEE, IN ACCORDANCE
WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, WITHIN 1 YEAR AND 3
MONTHS AFTER THE ADD ITION OF THE CORE CO NDITION TO THE RECOMMENDED
UNIFORM SCREENING PANEL AND EVERY 3 MONTHS THEREAFTER UN TIL THE
TESTING FOR THE CORE CONDITION IS IMPLEME NTED.
2. A REPORT REQUIRED UNDE R SUBSUBPARAGRAPH 1
OF THIS SUBPARA GRAPH SHALL INCLUDE THE REASON FOR THE D ELAY AND THE
ANTICIPATED TIMELINE FOR IMPLEMENTATION .
(iii) If the Secretary or Advisory Council does not approve the
inclusion of a core condition in the system for newborn screening under subparagraph (i) of
this paragraph:
1. Within 1 year after the addition of the condition to the
Recommended Uniform Screening Panel, the Department shall publicly post and submit to
the General Assembly, in accordance with § 2–1257 of the State Government Article, a
report that includes, as applicable, the Secretary’s justification for not approving the
inclusion and the final vote of the Advisory Council regarding the inclusion of the condition;
and
2. Each year after the initial disapproval, the Advisory
Council shall:
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A. Review the medical literature published on the condition
since the initial evaluation and determine whether substantive updates have occurred that
would merit formal reevaluation of the inclusion of the condition; and
B. If the Advisory Council upholds its disapproval of the
condition, publicly publish and submit to the General Assembly, in accordance with §
2–1257 of the State Government Article, a report on the reason for the disapproval.
(2) Notwithstanding any other provision of law, if the Secretary of Health
and Human Services issues federal recommendations on critical congenital heart disease
screening of newborns, the Department shall adopt the federal screening recommendations.
(3) THE DEPARTMENT MAY SCREEN FOR ANY CONDITION
RECOMMENDED BY THE ADVISORY COUNCIL AND APPROVED BY THE SECRETARY.
(f) If the Secretary and the Advisory Council approve the inclusion of a condition
in the system for the newborn screening under subsection (e) of this section, the
Department shall implement testing for the condition within 1 year after the date of the
approval.
(g) (F) (1) The Secretary shall pay all fees collected under the provisions of
this subtitle to the Comptroller.
(2) The Comptroller shall distribute the fees to the Newborn Screening
Program Fund established under § 13–113 of this subtitle.
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
October 1, 2024.
SECTION 2. AND BE IT FURTHER ENACTED, That:
(a) Subject to subsection (b) of this section and notwithstanding § 13–311(e)(1)(ii)
of the Health – General Article, as enacted by Section 1 of this Act, the Maryland
Department of Health shall implement testing for infantile Krabbe disease within 1 year
after the U.S. Department of Health and Human Services issues a final recommendation
to add screening of the condition to the federal Recommended Uniform Screening Panel.
(b) (1) If the Department is unable to implement testing for infantile Krabbe
disease within the time period required under subsection (a) of this section due to a delay
in the procurement of equipment or supplies needed to implement the testing, the
Department shall report to the Senate Finance Committee and the House Health and
Government Operations Committee, in accordance with § 2–1257 of the State Government
Article, within 9 months after the addition of the final recommendation to add screening of
infantile Krabbe disease to the federal Recommended Uniform Screening Panel and every
3 months thereafter until testing for infantile Krabbe disease is implemented.
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(2) The report required under paragraph (1) of this subsection shall include
information on the equipment or supplies needed, the reason for the delay, and the
anticipated timeline for implementation.
SECTION 3. AND BE IT FURTHER ENACTED, That this Act is an emergency
measure, is necessary for the immediate preservation of the public health or safety, has
been passed by a yea and nay vote supported by three–fifths of all the members elected to
each of the two Houses of the General Assembly, and shall take effect from the date it is
enacted.
Approved by the Governor, April 25, 2024.