EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
Italics indicate opposite chamber/conference committee amendments.
*sb0242*
SENATE BILL 242
J1 (2lr0690)
ENROLLED BILL
— Finance/Health and Government Operations —
Introduced by Senator Hershey Senators Hershey, Beidle, Benson, and Klausmeier
Read and Examined by Proofreaders:
_______________________________________________
Proofreader.
_______________________________________________
Proofreader.
Sealed with the Great Seal and presented to the Governor, for his approval this
_______ day of _______________ at ________________________ o’clock, ________M.
______________________________________________
President.
CHAPTER ______
AN ACT concerning 1
Maryland Department of Health – System for Newborn Screening – 2
Requirements 3
FOR the purpose of requiring the system for newborn screening in the Maryland 4
Department of Health to include screening for each core condition listed in the U.S. 5
Department of Health and Human Services’ Recommended Uniform Screening 6
Panel, subject to the approval of the State Advisory Council on Hereditary and 7
Congenital Disorders and the Secretary of Health; establishing certain requirements 8
related to the approval or disapproval of the inclusion of a condition and the 9
implementation of testing for a condition approved for inclusion in the system for 10
newborn screening; and generally relating to the system for newborn screening. 11
BY repealing and reenacting, with amendments, 12
Article – Health – General 13
Section 13–101 and 13–111 14 2 SENATE BILL 242
Annotated Code of Maryland 1
(2019 Replacement Volume and 2021 Supplement) 2
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 3
That the Laws of Maryland read as follows: 4
Article – Health – General 5
13–101. 6
(a) In this subtitle the following words have the meanings indicated. 7
(B) “ADVISORY COUNCIL” MEANS THE STATE ADVISORY COUNCIL ON 8
HEREDITARY AND CONGENITAL DISORDERS. 9
[(b)] (C) “Commission” means the State Commission on Hereditary and 10
Congenital Disorders. 11
[(c)] (D) (1) “Congenital disorder” means a significant structural or 12
functional abnormality of the body that is present at birth. 13
(2) “Congenital disorder” does not include a condition that results from: 14
(i) An intrauterine infection; or 15
(ii) A birth injury. 16
[(d)] (E) “Hereditary disorder” means any disorder that: 17
(1) Is transmitted through the genetic material deoxyribonucleic acid 18
(DNA); or 19
(2) Arises through the improper processing of the information in the genetic 20
material. 21
13–111. 22
(a) The Department shall establish a coordinated statewide system for screening 23
all newborn infants in the State for certain hereditary and congenital disorders associated 24
with severe problems of health or development, except when the parent or guardian of the 25
newborn infant objects. 26
(b) Except as provided in § 13–112 of this subtitle, the Department’s public health 27
laboratory is the sole laboratory authorized to perform tests on specimens from newborn 28
infants collected to screen for hereditary and congenital disorders as determined under 29
subsection (d)(2) of this section. 30 SENATE BILL 242 3
(c) The system for newborn screening shall include: 1
(1) Laboratory testing and the reporting of test results; and 2
(2) Follow–up activities to facilitate the rapid identification and treatment 3
of an affected child. 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
4 SENATE BILL 242
(iii) Establishing fees for newborn screening that do not exceed an 1
amount sufficient to cover the administrative, laboratory, and follow–up costs associated 2
with the performance of screening tests under this subtitle. 3
(e) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF THE 4
SECRETARY AND THE ADVISORY COUNCIL UNDER SUBPARAGRAPH (II) OF THIS 5
PARAGRAPH AND NOTWITHSTANDING ANY OTHER PROVISION OF LAW, THE 6
DEPARTMENT SHALL SCRE EN FOR EACH CORE CONDITION LISTED IN THE U.S. 7
DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM 8
SCREENING PANEL. 9
(II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL 10
INCLUDE IN THE SYSTE M FOR NEWBORN SCREEN ING ANY CORE OR SECO NDARY 11
CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL 12
SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO 13
APPROVE THE INCLUSIO N OF A CONDITION IN THE SYSTEM FOR NEWBO RN 14
SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO 15
THE PANEL RECOMMENDED UNIFORM SCREENING PANEL. 16
(III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT 17
APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBORN 18
SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH: 19
1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE 20
CONDITION TO THE RECOMMENDED UNIFORM SCREENING PANEL, THE 21
DEPARTMENT SHALL PUBL ICLY POST AND SUBMIT TO THE GENERAL ASSEMBLY, IN 22
ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, A REPORT 23
THAT INCLUDES , AS APPLICABLE , THE SECRETARY’S JUSTIFICATION FOR NOT 24
APPROVING THE INCLUS ION AND THE FINAL VO TE OF THE ADVISORY COUNCIL 25
REGARDING THE INCLUS ION OF THE CONDITION ; AND 26
2. EACH YEAR AFTER THE I NITIAL DISAPPROVAL , THE 27
ADVISORY COUNCIL SHALL: 28
A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N 29
THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER 30
SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL 31
REEVALUATION OF THE INCLUSION OF THE CON DITION; AND 32
B. IF THE ADVISORY COUNCIL UPHOLDS ITS 33
DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE 34
GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT 35
ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROV AL. 36
SENATE BILL 242 5
(2) Notwithstanding any other provision of law, if the Secretary of Health 1
and Human Services issues federal recommendations on critical congenital heart disease 2
screening of newborns, the Department shall adopt the federal screening recommendations. 3
(F) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE 4
INCLUSION OF A CONDI TION IN THE SYSTEM F OR THE NEWBORN SCREE NING UNDER 5
SUBSECTION (E) OF THIS SECTION, THE DEPARTMENT SHALL IMPL EMENT TESTING 6
FOR THE CONDITION WI THIN 1 YEAR AFTER THE DATE OF THE APPROVAL . 7
(f) (G) (1) The Secretary shall pay all fees collected under the provisions of 8
this subtitle to the Comptroller. 9
(2) The Comptroller shall distribute the fees to the Newborn Screening 10
Program Fund established under § 13–113 of this subtitle. 11
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 12
October 1, 2022. 13
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
President of the Senate.
________________________________________________________________________________
Speaker of the House of Delegates.