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. *sb0242* SENATE BILL 242 J1 2lr0690 CF HB 109 By: Senator Hershey Senators Hershey, Beidle, Benson, and Klausmeier Introduced and read first time: January 14, 2022 Assigned to: Finance Committee Report: Favorable with amendments Senate action: Adopted Read second time: February 12, 2022 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; and generally relating to the system for newborn screening. 7 BY repealing and reenacting, with amendments, 8 Article – Health – General 9 Section 13–111 10 Annotated Code of Maryland 11 (2019 Replacement Volume and 2021 Supplement) 12 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 13 That the Laws of Maryland read as follows: 14 Article – Health – General 15 13–111. 16 (a) The Department shall establish a coordinated statewide system for screening 17 all newborn infants in the State for certain hereditary and congenital disorders associated 18 with severe problems of health or development, except when the parent or guardian of the 19 newborn infant objects. 20 2 SENATE BILL 242 (b) Except as provided in § 13–112 of this subtitle, the Department’s public health 1 laboratory is the sole laboratory authorized to perform tests on specimens from newborn 2 infants collected to screen for hereditary and congenital disorders as determined under 3 subsection (d)(2) of this section. 4 (c) The system for newborn screening shall include: 5 (1) Laboratory testing and the reporting of test results; and 6 (2) Follow–up activities to facilitate the rapid identification and treatment 7 of an affected child. 8 (d) In consultation with the State Advisory Council on Hereditary and Congenital 9 Disorders, the Department shall: 10 (1) Establish protocols for a health care provider to obtain and deliver test 11 specimens to the Department’s public health laboratory; 12 (2) Determine the screening tests that the Department’s public health 13 laboratory is required to perform; 14 (3) Maintain a coordinated statewide system for newborn screening that 15 carries out the purpose described in subsection (c) of this section that includes: 16 (i) Communicating the results of screening tests to the health care 17 provider of the newborn infant; 18 (ii) Locating newborn infants with abnormal test results; 19 (iii) Sharing newborn screening information between hospitals, 20 health care providers, treatment centers, and laboratory personnel; 21 (iv) Delivering needed clinical, diagnostic, and treatment 22 information to health care providers, parents, and caregivers; and 23 (v) Notifying parents and guardians of newborn infants that 24 laboratories other than the Department’s public health laboratory are authorized to 25 perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 26 and congenital disorders; and 27 (4) Adopt regulations that set forth the standards and requirements for 28 newborn screening for hereditary and congenital disorders that are required under this 29 subtitle, including: 30 (i) Performing newborn screening tests; 31 SENATE BILL 242 3 (ii) Coordinating the reporting, follow–up, and treatment activities 1 with parents, caregivers, and health care providers; and 2 (iii) Establishing fees for newborn screening that do not exceed an 3 amount sufficient to cover the administrative, laboratory, and follow–up costs associated 4 with the performance of screening tests under this subtitle. 5 (e) (1) (I) NOTWITHSTANDING ANY O THER PROVISION OF LA W, 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 SECONDARY 11 CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL WITHIN 2 12 YEARS AFTER THE ADDI TION OF THE CONDITIO N TO THE PANEL. 13 (2) Notwithstanding any other provision of law, if the Secretary of Health 14 and Human Services issues federal recommendations on critical congenital heart disease 15 screening of newborns, the Department shall adopt the federal screening recommendations. 16 (f) (1) The Secretary shall pay all fees collected under the provisions of this 17 subtitle to the Comptroller. 18 (2) The Comptroller shall distribute the fees to the Newborn Screening 19 Program Fund established under § 13–113 of this subtitle. 20 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 21 October 1, 2022. 22 Approved: ________________________________________________________________________________ Governor. ________________________________________________________________________________ President of the Senate. ________________________________________________________________________________ Speaker of the House of Delegates.