EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTING LA W.
[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.
*hb0109*
HOUSE BILL 109
J1 (2lr0689)
ENROLLED BILL
— Health and Government Operations/Finance —
Introduced by Delegate Shetty
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.
______________________________________________
Speaker.
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 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 HOUSE BILL 109
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 20
genetic material. 21
13–111. 22
(A) (1) IN THIS SECTION , “SPECIALIZED TESTING EQUIPMENT” MEANS 23
EQUIPMENT NECESSARY TO RUN A TEST APPROV ED BY THE U.S. FOOD AND DRUG 24
ADMINISTRATION OR A L ABORATORY –DEVELOPED TEST . 25
(2) “SPECIALIZED TESTING E QUIPMENT” DOES NOT INCLUDE : 26
(I) TESTING REAGENTS ; OR 27
(II) DISPOSABLE LABORATORY EQUIPMENT. 28 HOUSE BILL 109 3
(a) (B) (a) The Department shall establish a coordinated statewide system for 1
screening all newborn infants in the State for certain hereditary and congenital disorders 2
associated with severe problems of health or development, except when the parent or 3
guardian of the newborn infant objects. 4
(b) (C) (b) Except as provided in § 13–112 of this subtitle, the Department’s public 5
health laboratory is the sole laboratory authorized to perform tests on specimens from 6
newborn infants collected to screen for hereditary and congenital disorders as determined 7
under subsection (d)(2) (E)(2) (d)(2) of this section. 8
(c) (D) (c) The system for newborn screening shall include: 9
(1) Laboratory testing and the reporting of test results; and 10
(2) Follow–up activities to facilitate the rapid identification and treatment 11
of an affected child. 12
(d) (E) (d) In consultation with the State Advisory Council on Hereditary and 13
Congenital Disorders, the Department shall: 14
(1) Establish protocols for a health care provider to obtain and deliver test 15
specimens to the Department’s public health laboratory; 16
(2) Determine the screening tests that the Department’s public health 17
laboratory is required to perform; 18
(3) Maintain a coordinated statewide system for newborn screening that 19
carries out the purpose described in subsection (c) (D) (c) of this section that includes: 20
(i) Communicating the results of screening tests to the health care 21
provider of the newborn infant; 22
(ii) Locating newborn infants with abnormal test results; 23
(iii) Sharing newborn screening information between hospitals, 24
health care providers, treatment centers, and laboratory personnel; 25
(iv) Delivering needed clinical, diagnostic, and treatment 26
information to health care providers, parents, and caregivers; and 27
(v) Notifying parents and guardians of newborn infants that 28
laboratories other than the Department’s public health laboratory are authorized to 29
perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 30
and congenital disorders; and 31
4 HOUSE BILL 109
(4) Adopt regulations that set forth the standards and requirements for 1
newborn screening for hereditary and congenital disorders that are required under this 2
subtitle, including: 3
(i) Performing newborn screening tests; 4
(ii) Coordinating the reporting, follow–up, and treatment activities 5
with parents, caregivers, and health care providers; and 6
(iii) Establishing fees for newborn screening that do not exceed an 7
amount sufficient to cover the administrative, laboratory, and follow–up costs associated 8
with the performance of screening tests under this subtitle. 9
(e) (F) (e) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF 10
THE SECRETARY AND THE ADVISORY COUNCIL UNDER PARAGRA PH (2) OF THIS 11
SUBSECTION AND NOTWI THSTANDING ANY OTHER PROVISION OF LAW, THE 12
DEPARTMENT SHALL SCRE EN FOR EACH CORE CONDITION LISTED IN THE U.S. 13
DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM 14
SCREENING PANEL. 15
(II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL 16
INCLUDE IN THE SYSTE M FOR NEWBORN SCREEN ING ANY CORE OR SECO NDARY 17
CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL 18
SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO 19
APPROVE THE INCLUSIO N OF A CONDITION IN THE SYSTEM FOR NEWBO RN 20
SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO 21
THE PANEL RECOMMENDED UNIFORM SCREENING PANEL. 22
(III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT 23
APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBORN 24
SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH : 25
1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE 26
CONDITION TO THE RECOMMENDED UNIFORM SCREENING PANEL, THE 27
DEPARTMENT SHALL PUBL ICLY POST AND SUBMIT TO THE GENERAL ASSEMBLY, IN 28
ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, A REPORT 29
THAT INCLUDES , AS APPLICABLE , THE SECRETARY’S JUSTIFICATION FOR NOT 30
APPROVING THE INCLUS ION AND THE FINAL VO TE OF THE ADVISORY COUNCIL 31
REGARDING THE INCLUS ION OF THE CONDITION ; AND 32
2. EACH YEAR AFTER THE I NITIAL DISAPPROVAL , THE 33
ADVISORY COUNCIL SHALL: 34
HOUSE BILL 109 5
A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N 1
THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER 2
SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL 3
REEVALUATION OF THE INCLUSION OF THE CON DITION; AND 4
B. IF THE ADVISORY COUNCIL UPHOLDS ITS 5
DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE 6
GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT 7
ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROV AL. 8
(2) Notwithstanding any other provision of law, if the Secretary of Health 9
and Human Services issues federal recommendations on critical congenital heart disease 10
screening of newborns, the Department shall adopt the federal screening recommendations. 11
(F) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE 12
INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER 13
SUBSECTION (E) OF THIS SECTION, THE DEPARTMENT SHALL IMPL EMENT TESTING 14
FOR THE CONDITION WI THIN 1 YEAR AFTER THE DATE OF THE APPROVAL . 15
(G) (1) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE 16
INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER 17
SUBSECTION (F) OF THIS SECTION , WITHIN 1 YEAR AFTER THE DATE OF THE 18
APPROVAL, THE DEPARTMENT SHALL : 19
(I) IF TESTING FOR THE CO NDITION CAN BE IMPLE MENTED 20
WITHOUT THE PROCUREMENT OF SPECIALIZED TESTI NG EQUIPMENT , IMPLEMENT 21
TESTING FOR THE COND ITION; OR 22
(II) IF THE IMPLEMENTATION OF TESTING REQUIRES THE 23
PROCUREMENT OF SPECI ALIZED TESTING EQUIP MENT, SIGN A FINAL 24
PROCUREMENT CONTRACT WITH A VENDOR FOR AL L EQUIPMENT NECESSARY TO 25
IMPLEMENT TESTING . 26
(2) FOR PROCUREMENTS REQU IRED UNDER PARAGRAPH (1)(II) OF 27
THIS SUBSECTION : 28
(I) NOTWITHSTANDING ANY O THER PROVISION OF LA W, THE 29
DEPARTMENT MAY USE EX PEDITED PROCUREMENT UNDER § 13–108 OF THE STATE 30
FINANCE AND PROCUREMENT ARTICLE; AND 31
(II) THE PROCUREMENT CONTR ACT SHALL INCLUDE A CLAUSE 32
AUTHORIZING THE STATE TO TERMINATE TH E CONTRACT IF THE VE NDOR HAS NOT 33
FULFILLED THE CONTRA CT WITHIN 6 MONTHS. 34
6 HOUSE BILL 109
(f) (H) (f) (G) (1) The Secretary shall pay all fees collected under the 1
provisions of this subtitle to the Comptroller. 2
(2) The Comptroller shall distribute the fees to the Newborn Screening 3
Program Fund established under § 13–113 of this subtitle. 4
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take e ffect 5
October 1, 2022. 6
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.