MD
Maryland Senate Bill SB242

Maryland 2022 Regular Session

Maryland Senate Bill SB242 Compare Versions

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1- LAWRENCE J. HOGAN, JR., Governor Ch. 266
21
3-– 1 –
4-Chapter 266
5-(Senate Bill 242)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
4+ [Brackets] indicate matter deleted from existing law.
5+ Underlining indicates amendments to bill.
6+ Strike out indicates matter stricken from the bill by amendment or deleted from the law by
7+amendment.
8+ Italics indicate opposite chamber/conference committee amendments.
9+ *sb0242*
810
9-Maryland Department of Health – System for Newborn Screening –
10-Requirements
11+SENATE BILL 242
12+J1 (2lr0690)
13+ENROLLED BILL
14+— Finance/Health and Government Operations —
15+Introduced by Senator Hershey Senators Hershey, Beidle, Benson, and Klausmeier
1116
12-FOR the purpose of requiring the system for newborn screening in the Maryland
13-Department of Health to include screening for each core condition listed in the U.S.
14-Department of Health and Human Services’ Recommended Uniform Screening
15-Panel, subject to the approval of the State Advisory Council on Hereditary and
16-Congenital Disorders and the Secretary of Health; establishing certain requirements
17-related to the approval or disapproval of the inclusion of a condition and the
18-implementation of testing for a condition approved for inclusion in the system for
19-newborn screening; and generally relating to the system for newborn screening.
17+Read and Examined by Proofreaders:
2018
21-BY repealing and reenacting, with amendments,
22- Article – Health – General
23-Section 13–101 and 13–111
24- Annotated Code of Maryland
25- (2019 Replacement Volume and 2021 Supplement)
19+_______________________________________________
20+Proofreader.
21+_______________________________________________
22+Proofreader.
2623
27- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
28-That the Laws of Maryland read as follows:
24+Sealed with the Great Seal and presented to the Governor, for his approval this
2925
30-Article – Health – General
26+_______ day of _______________ at ________________________ o’clock, ________M.
3127
32-13–101.
28+______________________________________________
29+President.
3330
34- (a) In this subtitle the following words have the meanings indicated.
31+CHAPTER ______
3532
36- (B) “ADVISORY COUNCIL” MEANS THE STATE ADVISORY COUNCIL ON
37-HEREDITARY AND CONGENITAL DISORDERS.
33+AN ACT concerning 1
3834
39- [(b)] (C) “Commission” means the State Commission on Hereditary and
40-Congenital Disorders.
35+Maryland Department of Health – System for Newborn Screening – 2
36+Requirements 3
4137
42- [(c)] (D) (1) “Congenital disorder” means a significant structural or
43-functional abnormality of the body that is present at birth.
38+FOR the purpose of requiring the system for newborn screening in the Maryland 4
39+Department of Health to include screening for each core condition listed in the U.S. 5
40+Department of Health and Human Services’ Recommended Uniform Screening 6
41+Panel, subject to the approval of the State Advisory Council on Hereditary and 7
42+Congenital Disorders and the Secretary of Health; establishing certain requirements 8
43+related to the approval or disapproval of the inclusion of a condition and the 9
44+implementation of testing for a condition approved for inclusion in the system for 10
45+newborn screening; and generally relating to the system for newborn screening. 11
4446
45- (2) “Congenital disorder” does not include a condition that results from:
47+BY repealing and reenacting, with amendments, 12
48+ Article – Health – General 13
49+Section 13–101 and 13–111 14 2 SENATE BILL 242
4650
47- (i) An intrauterine infection; or
48- Ch. 266 2022 LAWS OF MARYLAND
4951
50-– 2 –
51- (ii) A birth injury.
52+ Annotated Code of Maryland 1
53+ (2019 Replacement Volume and 2021 Supplement) 2
5254
53- [(d)] (E) “Hereditary disorder” means any disorder that:
55+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 3
56+That the Laws of Maryland read as follows: 4
5457
55- (1) Is transmitted through the genetic material deoxyribonucleic acid
56-(DNA); or
58+Article – Health – General 5
5759
58- (2) Arises through the improper processing of the information in the genetic
59-material.
60+13–101. 6
6061
61-13–111.
62+ (a) In this subtitle the following words have the meanings indicated. 7
6263
63- (a) The Department shall establish a coordinated statewide system for screening
64-all newborn infants in the State for certain hereditary and congenital disorders associated
65-with severe problems of health or development, except when the parent or guardian of the
66-newborn infant objects.
64+ (B) “ADVISORY COUNCIL” MEANS THE STATE ADVISORY COUNCIL ON 8
65+HEREDITARY AND CONGENITAL DISORDERS. 9
6766
68- (b) Except as provided in § 13–112 of this subtitle, the Department’s public health
69-laboratory is the sole laboratory authorized to perform tests on specimens from newborn
70-infants collected to screen for hereditary and congenital disorders as determined under
71-subsection (d)(2) of this section.
67+ [(b)] (C) “Commission” means the State Commission on Hereditary and 10
68+Congenital Disorders. 11
7269
73- (c) The system for newborn screening shall include:
70+ [(c)] (D) (1) “Congenital disorder” means a significant structural or 12
71+functional abnormality of the body that is present at birth. 13
7472
75- (1) Laboratory testing and the reporting of test results; and
73+ (2) “Congenital disorder” does not include a condition that results from: 14
7674
77- (2) Follow–up activities to facilitate the rapid identification and treatment
78-of an affected child.
75+ (i) An intrauterine infection; or 15
7976
80- (d) In consultation with the State Advisory Council on Hereditary and Congenital
81-Disorders, the Department shall:
77+ (ii) A birth injury. 16
8278
83- (1) Establish protocols for a health care provider to obtain and deliver test
84-specimens to the Department’s public health laboratory;
79+ [(d)] (E) “Hereditary disorder” means any disorder that: 17
8580
86- (2) Determine the screening tests that the Department’s public health
87-laboratory is required to perform;
81+ (1) Is transmitted through the genetic material deoxyribonucleic acid 18
82+(DNA); or 19
8883
89- (3) Maintain a coordinated statewide system for newborn screening that
90-carries out the purpose described in subsection (c) of this section that includes:
84+ (2) Arises through the improper processing of the information in the genetic 20
85+material. 21
9186
92- (i) Communicating the results of screening tests to the health care
93-provider of the newborn infant;
87+13–111. 22
9488
95- (ii) Locating newborn infants with abnormal test results;
96- LAWRENCE J. HOGAN, JR., Governor Ch. 266
89+ (a) The Department shall establish a coordinated statewide system for screening 23
90+all newborn infants in the State for certain hereditary and congenital disorders associated 24
91+with severe problems of health or development, except when the parent or guardian of the 25
92+newborn infant objects. 26
9793
98-– 3 –
99- (iii) Sharing newborn screening information between hospitals,
100-health care providers, treatment centers, and laboratory personnel;
94+ (b) Except as provided in § 13–112 of this subtitle, the Department’s public health 27
95+laboratory is the sole laboratory authorized to perform tests on specimens from newborn 28
96+infants collected to screen for hereditary and congenital disorders as determined under 29
97+subsection (d)(2) of this section. 30 SENATE BILL 242 3
10198
102- (iv) Delivering needed clinical, diagnostic, and treatment
103-information to health care providers, parents, and caregivers; and
10499
105- (v) Notifying parents and guardians of newborn infants that
106-laboratories other than the Department’s public health laboratory are authorized to
107-perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary
108-and congenital disorders; and
109100
110- (4) Adopt regulations that set forth the standards and requirements for
111-newborn screening for hereditary and congenital disorders that are required under this
112-subtitle, including:
101+ (c) The system for newborn screening shall include: 1
113102
114- (i) Performing newborn screening tests;
103+ (1) Laboratory testing and the reporting of test results; and 2
115104
116- (ii) Coordinating the reporting, follow–up, and treatment activities
117-with parents, caregivers, and health care providers; and
105+ (2) Follow–up activities to facilitate the rapid identification and treatment 3
106+of an affected child. 4
118107
119- (iii) Establishing fees for newborn screening that do not exceed an
120-amount sufficient to cover the administrative, laboratory, and follow–up costs associated
121-with the performance of screening tests under this subtitle.
108+ (d) In consultation with the State Advisory Council on Hereditary and Congenital 5
109+Disorders, the Department shall: 6
122110
123- (e) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF THE
124-SECRETARY AND THE ADVISORY COUNCIL UNDER SUBPARAGRAPH (II) OF THIS
125-PARAGRAPH AND NOTWITHSTANDING ANY OTHER PROVISION OF LAW, THE
126-DEPARTMENT SHALL SCRE EN FOR EACH CORE CONDITION LISTED IN THE U.S.
127-DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM
128-SCREENING PANEL.
111+ (1) Establish protocols for a health care provider to obtain and deliver test 7
112+specimens to the Department’s public health laboratory; 8
129113
130- (II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL
131-INCLUDE IN THE SYSTE M FOR NEWBORN SCREEN ING ANY CORE OR SECO NDARY
132-CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL
133-SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO
134-APPROVE THE INCLUSIO N OF A CONDITION IN THE SYSTEM FOR NEWBO RN
135-SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO
136-THE PANEL RECOMMENDED UNIFORM SCREENING PANEL.
114+ (2) Determine the screening tests that the Department’s public health 9
115+laboratory is required to perform; 10
137116
138- (III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT
139-APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBORN
140-SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH :
117+ (3) Maintain a coordinated statewide system for newborn screening that 11
118+carries out the purpose described in subsection (c) of this section that includes: 12
141119
142- 1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE
143-CONDITION TO T HE RECOMMENDED UNIFORM SCREENING PANEL, THE Ch. 266 2022 LAWS OF MARYLAND
120+ (i) Communicating the results of screening tests to the health care 13
121+provider of the newborn infant; 14
144122
145-– 4 –
146-DEPARTMENT SHALL PUBL ICLY POST AND SUBMIT TO THE GENERAL ASSEMBLY, IN
147-ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, A REPORT
148-THAT INCLUDES , AS APPLICABLE , THE SECRETARY’S JUSTIFICATION FOR NOT
149-APPROVING THE INCLUSION AND THE FINAL VOTE OF TH E ADVISORY COUNCIL
150-REGARDING THE INCLUS ION OF THE CONDITION ; AND
123+ (ii) Locating newborn infants with abnormal test results; 15
151124
152- 2. EACH YEAR AFTER THE I NITIAL DISAPPROVAL , THE
153-ADVISORY COUNCIL SHALL:
125+ (iii) Sharing newborn screening information between hospitals, 16
126+health care providers, treatment centers, and laboratory personnel; 17
154127
155- A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N
156-THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER
157-SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL
158-REEVALUATION OF THE INCLUSION OF THE CON DITION; AND
128+ (iv) Delivering needed clinical, diagnostic, and treatment 18
129+information to health care providers, parents, and caregivers; and 19
159130
160- B. IF THE ADVISORY COUNCIL UPHOLDS ITS
161-DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE
162-GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT
163-ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROV AL.
131+ (v) Notifying parents and guardians of newborn infants that 20
132+laboratories other than the Department’s public health laboratory are authorized to 21
133+perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 22
134+and congenital disorders; and 23
164135
165- (2) Notwithstanding any other provision of law, if the Secretary of Health
166-and Human Services issues federal recommendations on critical congenital heart disease
167-screening of newborns, the Department shall adopt the federal screening recommendations.
136+ (4) Adopt regulations that set forth the standards and requirements for 24
137+newborn screening for hereditary and congenital disorders that are required under this 25
138+subtitle, including: 26
168139
169- (F) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE
170-INCLUSION OF A CONDI TION IN THE SYSTEM F OR THE NEWBORN SCREENING UNDER
171-SUBSECTION (E) OF THIS SECTION, THE DEPARTMENT SHALL IMPL EMENT TESTING
172-FOR THE CONDITION WI THIN 1 YEAR AFTER THE DATE OF THE APPROVAL .
140+ (i) Performing newborn screening tests; 27
173141
174- (f) (G) (1) The Secretary shall pay all fees collected under the provisions of
175-this subtitle to the Comptroller.
142+ (ii) Coordinating the reporting, follow–up, and treatment activities 28
143+with parents, caregivers, and health care providers; and 29
144+ 4 SENATE BILL 242
176145
177- (2) The Comptroller shall distribute the fees to the Newborn Screening
178-Program Fund established under § 13–113 of this subtitle.
179146
180- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
181-October 1, 2022.
147+ (iii) Establishing fees for newborn screening that do not exceed an 1
148+amount sufficient to cover the administrative, laboratory, and follow–up costs associated 2
149+with the performance of screening tests under this subtitle. 3
182150
183-Approved by the Governor, May 12, 2022.
151+ (e) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF THE 4
152+SECRETARY AND THE ADVISORY COUNCIL UNDER SUBPARAGRAPH (II) OF THIS 5
153+PARAGRAPH AND NOTWITHSTANDING ANY OTHER PROVISION OF LAW, THE 6
154+DEPARTMENT SHALL SCRE EN FOR EACH CORE CONDITION LISTED IN THE U.S. 7
155+DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM 8
156+SCREENING PANEL. 9
157+
158+ (II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL 10
159+INCLUDE IN THE SYSTE M FOR NEWBORN SCREEN ING ANY CORE OR SECO NDARY 11
160+CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL 12
161+SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO 13
162+APPROVE THE INCLUSIO N OF A CONDITION IN THE SYSTEM FOR NEWBO RN 14
163+SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO 15
164+THE PANEL RECOMMENDED UNIFORM SCREENING PANEL. 16
165+
166+ (III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT 17
167+APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBORN 18
168+SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH: 19
169+
170+ 1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE 20
171+CONDITION TO THE RECOMMENDED UNIFORM SCREENING PANEL, THE 21
172+DEPARTMENT SHALL PUBL ICLY POST AND SUBMIT TO THE GENERAL ASSEMBLY, IN 22
173+ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, A REPORT 23
174+THAT INCLUDES , AS APPLICABLE , THE SECRETARY’S JUSTIFICATION FOR NOT 24
175+APPROVING THE INCLUS ION AND THE FINAL VO TE OF THE ADVISORY COUNCIL 25
176+REGARDING THE INCLUS ION OF THE CONDITION ; AND 26
177+
178+ 2. EACH YEAR AFTER THE I NITIAL DISAPPROVAL , THE 27
179+ADVISORY COUNCIL SHALL: 28
180+
181+ A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N 29
182+THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER 30
183+SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL 31
184+REEVALUATION OF THE INCLUSION OF THE CON DITION; AND 32
185+
186+ B. IF THE ADVISORY COUNCIL UPHOLDS ITS 33
187+DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE 34
188+GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT 35
189+ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROV AL. 36
190+ SENATE BILL 242 5
191+
192+
193+ (2) Notwithstanding any other provision of law, if the Secretary of Health 1
194+and Human Services issues federal recommendations on critical congenital heart disease 2
195+screening of newborns, the Department shall adopt the federal screening recommendations. 3
196+
197+ (F) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE 4
198+INCLUSION OF A CONDI TION IN THE SYSTEM F OR THE NEWBORN SCREE NING UNDER 5
199+SUBSECTION (E) OF THIS SECTION, THE DEPARTMENT SHALL IMPL EMENT TESTING 6
200+FOR THE CONDITION WI THIN 1 YEAR AFTER THE DATE OF THE APPROVAL . 7
201+
202+ (f) (G) (1) The Secretary shall pay all fees collected under the provisions of 8
203+this subtitle to the Comptroller. 9
204+
205+ (2) The Comptroller shall distribute the fees to the Newborn Screening 10
206+Program Fund established under § 13–113 of this subtitle. 11
207+
208+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 12
209+October 1, 2022. 13
210+
211+
212+
213+
214+Approved:
215+________________________________________________________________________________
216+ Governor.
217+________________________________________________________________________________
218+ President of the Senate.
219+________________________________________________________________________________
220+ Speaker of the House of Delegates.