MD
Maryland House Bill HB109

Maryland 2022 Regular Session

Maryland House Bill HB109 Compare Versions

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1- LAWRENCE J. HOGAN, JR., Governor Ch. 265
21
3-– 1 –
4-Chapter 265
5-(House Bill 109)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTING LA W.
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+ *hb0109*
810
9-Maryland Department of Health – System for Newborn Screening –
10-Requirements
11+HOUSE BILL 109
12+J1 (2lr0689)
13+ENROLLED BILL
14+— Health and Government Operations/Finance —
15+Introduced by Delegate Shetty
1116
12-FOR the purpose of requiring the system for newborn screening in the Maryland
13-Department of Health to include screening for each 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+Speaker.
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 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 HOUSE BILL 109
4650
47- (i) An intrauterine infection; or
48- Ch. 265 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
59-genetic 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) (1) IN THIS SECTION , “SPECIALIZED TESTING EQUIPMENT” MEANS
64-EQUIPMENT NECESSARY TO RUN A TEST APPROV ED BY THE U.S. FOOD AND DRUG
65-ADMINISTRATION OR A L ABORATORY –DEVELOPED TEST .
64+ (B) “ADVISORY COUNCIL” MEANS THE STATE ADVISORY COUNCIL ON 8
65+HEREDITARY AND CONGENITAL DISORDERS. 9
6666
67- (2) “SPECIALIZED TESTING E QUIPMENT” DOES NOT INCLUDE :
67+ [(b)] (C) “Commission” means the State Commission on Hereditary and 10
68+Congenital Disorders. 11
6869
69- (I) TESTING REAGENTS ; OR
70+ [(c)] (D) (1) “Congenital disorder” means a significant structural or 12
71+functional abnormality of the body that is present at birth. 13
7072
71- (II) DISPOSABLE LABORATORY EQUIPMENT.
73+ (2) “Congenital disorder” does not include a condition that results from: 14
7274
73- (a) (B) (a) The Department shall establish a coordinated statewide system for
74-screening all newborn infants in the State for certain hereditary and congenital disorders
75-associated with severe problems of health or development, except when the parent or
76-guardian of the newborn infant objects.
75+ (i) An intrauterine infection; or 15
7776
78- (b) (C) (b) Except as provided in § 13–112 of this subtitle, the Department’s public
79-health laboratory is the sole laboratory authorized to perform tests on specimens from
80-newborn infants collected to screen for hereditary and congenital disorders as determined
81-under subsection (d)(2) (E)(2) (d)(2) of this section.
77+ (ii) A birth injury. 16
8278
83- (c) (D) (c) The system for newborn screening shall include:
79+ [(d)] (E) “Hereditary disorder” means any disorder that: 17
8480
85- (1) Laboratory testing and the reporting of test results; and
81+ (1) Is transmitted through the genetic material deoxyribonucleic acid 18
82+(DNA); or 19
8683
87- (2) Follow–up activities to facilitate the rapid identification and treatment
88-of an affected child.
84+ (2) Arises through the improper processing of the information in the 20
85+genetic material. 21
8986
90- (d) (E) (d) In consultation with the State Advisory Council on Hereditary and
91-Congenital Disorders, the Department shall:
87+13–111. 22
9288
93- (1) Establish protocols for a health care provider to obtain and deliver test
94-specimens to the Department’s public health laboratory;
95- LAWRENCE J. HOGAN, JR., Governor Ch. 265
89+ (A) (1) IN THIS SECTION , “SPECIALIZED TESTING EQUIPMENT” MEANS 23
90+EQUIPMENT NECESSARY TO RUN A TEST APPROV ED BY THE U.S. FOOD AND DRUG 24
91+ADMINISTRATION OR A L ABORATORY –DEVELOPED TEST . 25
9692
97-– 3 –
98- (2) Determine the screening tests that the Department’s public health
99-laboratory is required to perform;
93+ (2) “SPECIALIZED TESTING E QUIPMENT” DOES NOT INCLUDE : 26
10094
101- (3) Maintain a coordinated statewide system for newborn screening that
102-carries out the purpose described in subsection (c) (D) (c) of this section that includes:
95+ (I) TESTING REAGENTS ; OR 27
10396
104- (i) Communicating the results of screening tests to the health care
105-provider of the newborn infant;
97+ (II) DISPOSABLE LABORATORY EQUIPMENT. 28 HOUSE BILL 109 3
10698
107- (ii) Locating newborn infants with abnormal test results;
10899
109- (iii) Sharing newborn screening information between hospitals,
110-health care providers, treatment centers, and laboratory personnel;
111100
112- (iv) Delivering needed clinical, diagnostic, and treatment
113-information to health care providers, parents, and caregivers; and
101+ (a) (B) (a) The Department shall establish a coordinated statewide system for 1
102+screening all newborn infants in the State for certain hereditary and congenital disorders 2
103+associated with severe problems of health or development, except when the parent or 3
104+guardian of the newborn infant objects. 4
114105
115- (v) Notifying parents and guardians of newborn infants that
116-laboratories other than the Department’s public health laboratory are authorized to
117-perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary
118-and congenital disorders; and
106+ (b) (C) (b) Except as provided in § 13–112 of this subtitle, the Department’s public 5
107+health laboratory is the sole laboratory authorized to perform tests on specimens from 6
108+newborn infants collected to screen for hereditary and congenital disorders as determined 7
109+under subsection (d)(2) (E)(2) (d)(2) of this section. 8
119110
120- (4) Adopt regulations that set forth the standards and requirements for
121-newborn screening for hereditary and congenital disorders that are required under this
122-subtitle, including:
111+ (c) (D) (c) The system for newborn screening shall include: 9
123112
124- (i) Performing newborn screening tests;
113+ (1) Laboratory testing and the reporting of test results; and 10
125114
126- (ii) Coordinating the reporting, follow–up, and treatment activities
127-with parents, caregivers, and health care providers; and
115+ (2) Follow–up activities to facilitate the rapid identification and treatment 11
116+of an affected child. 12
128117
129- (iii) Establishing fees for newborn screening that do not exceed an
130-amount sufficient to cover the administrative, laboratory, and follow–up costs associated
131-with the performance of screening tests under this subtitle.
118+ (d) (E) (d) In consultation with the State Advisory Council on Hereditary and 13
119+Congenital Disorders, the Department shall: 14
132120
133- (e) (F) (e) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF
134-THE SECRETARY AND THE ADVISORY COUNCIL UNDER PARAGRA PH (2) OF THIS
135-SUBSECTION AND NOTWI THSTANDING ANY OTHER PROVISION OF LAW, THE
136-DEPARTMENT SHALL SCRE EN FOR EACH CORE CONDITION LISTED IN THE U.S.
137-DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM
138-SCREENING PANEL.
121+ (1) Establish protocols for a health care provider to obtain and deliver test 15
122+specimens to the Department’s public health laboratory; 16
139123
140- (II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL
141-INCLUDE IN THE SYSTEM FOR NEWBORN S CREENING ANY CORE OR SECONDARY
142-CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL
143-SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO Ch. 265 2022 LAWS OF MARYLAND
124+ (2) Determine the screening tests that the Department’s public health 17
125+laboratory is required to perform; 18
144126
145-– 4 –
146-APPROVE THE INCLUSIO N OF A CONDITION IN THE SYSTEM FOR NEWBO RN
147-SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO
148-THE PANEL RECOMMENDED UNIFORM SCREENING PANEL.
127+ (3) Maintain a coordinated statewide system for newborn screening that 19
128+carries out the purpose described in subsection (c) (D) (c) of this section that includes: 20
149129
150- (III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT
151-APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBORN
152-SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH :
130+ (i) Communicating the results of screening tests to the health care 21
131+provider of the newborn infant; 22
153132
154- 1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE
155-CONDITION TO THE RECOMMENDED UNIFORM SCREENING PANEL, THE
156-DEPARTMENT SHALL PUBL ICLY POST AND SUBMIT TO THE GENERAL ASSEMBLY, IN
157-ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, A REPORT
158-THAT INCLUDES , AS APPLICABLE , THE SECRETARY’S JUSTIFICATION FOR NOT
159-APPROVING THE INCLUS ION AND THE FINAL VO TE OF THE ADVISORY COUNCIL
160-REGARDING THE INCLUS ION OF THE CONDITION ; AND
133+ (ii) Locating newborn infants with abnormal test results; 23
161134
162- 2. EACH YEAR AFTER THE I NITIAL DISAPPROVAL , THE
163-ADVISORY COUNCIL SHALL:
135+ (iii) Sharing newborn screening information between hospitals, 24
136+health care providers, treatment centers, and laboratory personnel; 25
164137
165- A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N
166-THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER
167-SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL
168-REEVALUATION OF THE INCLUSION OF THE CON DITION; AND
138+ (iv) Delivering needed clinical, diagnostic, and treatment 26
139+information to health care providers, parents, and caregivers; and 27
169140
170- B. IF THE ADVISORY COUNCIL UPHOLDS ITS
171-DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE
172-GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT
173-ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROV AL.
141+ (v) Notifying parents and guardians of newborn infants that 28
142+laboratories other than the Department’s public health laboratory are authorized to 29
143+perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 30
144+and congenital disorders; and 31
145+ 4 HOUSE BILL 109
174146
175- (2) Notwithstanding any other provision of law, if the Secretary of Health
176-and Human Services issues federal recommendations on critical congenital heart disease
177-screening of newborns, the Department shall adopt the federal screening recommendations.
178147
179- (F) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE
180-INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER
181-SUBSECTION (E) OF THIS SECTION, THE DEPARTMENT SHALL IMPL EMENT TESTING
182-FOR THE CONDITION WI THIN 1 YEAR AFTER THE DATE OF THE APPROVAL .
148+ (4) Adopt regulations that set forth the standards and requirements for 1
149+newborn screening for hereditary and congenital disorders that are required under this 2
150+subtitle, including: 3
183151
184- (G) (1) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE
185-INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER
186-SUBSECTION (F) OF THIS SECTION , WITHIN 1 YEAR AFTER THE DATE OF THE
187-APPROVAL, THE DEPARTMENT SHALL :
188- LAWRENCE J. HOGAN, JR., Governor Ch. 265
152+ (i) Performing newborn screening tests; 4
189153
190-– 5 –
191- (I) IF TESTING FOR THE CO NDITION CAN BE IMPLE MENTED
192-WITHOUT THE PROCUREMENT OF SPECIALIZED TESTI NG EQUIPMENT , IMPLEMENT
193-TESTING FOR THE COND ITION; OR
154+ (ii) Coordinating the reporting, follow–up, and treatment activities 5
155+with parents, caregivers, and health care providers; and 6
194156
195- (II) IF THE IMPLEMENTATION OF TESTING REQUIRES THE
196-PROCUREMENT OF SPECI ALIZED TESTING EQUIP MENT, SIGN A FINAL
197-PROCUREMENT CONTRACT WITH A VENDOR FOR AL L EQUIPMENT NECESSARY TO
198-IMPLEMENT TESTING .
157+ (iii) Establishing fees for newborn screening that do not exceed an 7
158+amount sufficient to cover the administrative, laboratory, and follow–up costs associated 8
159+with the performance of screening tests under this subtitle. 9
199160
200- (2) FOR PROCUREMENTS REQU IRED UNDER PARAGRAPH (1)(II) OF
201-THIS SUBSECTION :
161+ (e) (F) (e) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF 10
162+THE SECRETARY AND THE ADVISORY COUNCIL UNDER PARAGRA PH (2) OF THIS 11
163+SUBSECTION AND NOTWI THSTANDING ANY OTHER PROVISION OF LAW, THE 12
164+DEPARTMENT SHALL SCRE EN FOR EACH CORE CONDITION LISTED IN THE U.S. 13
165+DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM 14
166+SCREENING PANEL. 15
202167
203- (I) NOTWITHSTANDING ANY O THER PROVISION OF LA W, THE
204-DEPARTMENT MAY USE EX PEDITED PROCUREMENT UNDER § 13–108 OF THE STATE
205-FINANCE AND PROCUREMENT ARTICLE; AND
168+ (II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL 16
169+INCLUDE IN THE SYSTE M FOR NEWBORN SCREEN ING ANY CORE OR SECO NDARY 17
170+CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL 18
171+SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO 19
172+APPROVE THE INCLUSIO N OF A CONDITION IN THE SYSTEM FOR NEWBO RN 20
173+SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO 21
174+THE PANEL RECOMMENDED UNIFORM SCREENING PANEL. 22
206175
207- (II) THE PROCUREMENT CONTR ACT SHALL INCLUDE A CLAUSE
208-AUTHORIZING THE STATE TO TERMINATE TH E CONTRACT IF THE VE NDOR HAS NOT
209-FULFILLED THE CONTRA CT WITHIN 6 MONTHS.
176+ (III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT 23
177+APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBORN 24
178+SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH : 25
210179
211- (f) (H) (f) (G) (1) The Secretary shall pay all fees collected under the
212-provisions of this subtitle to the Comptroller.
180+ 1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE 26
181+CONDITION TO THE RECOMMENDED UNIFORM SCREENING PANEL, THE 27
182+DEPARTMENT SHALL PUBL ICLY POST AND SUBMIT TO THE GENERAL ASSEMBLY, IN 28
183+ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, A REPORT 29
184+THAT INCLUDES , AS APPLICABLE , THE SECRETARY’S JUSTIFICATION FOR NOT 30
185+APPROVING THE INCLUS ION AND THE FINAL VO TE OF THE ADVISORY COUNCIL 31
186+REGARDING THE INCLUS ION OF THE CONDITION ; AND 32
213187
214- (2) The Comptroller shall distribute the fees to the Newborn Screening
215-Program Fund established under § 13–113 of this subtitle.
188+ 2. EACH YEAR AFTER THE I NITIAL DISAPPROVAL , THE 33
189+ADVISORY COUNCIL SHALL: 34
190+ HOUSE BILL 109 5
216191
217- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take e ffect
218-October 1, 2022.
219192
220-Approved by the Governor, May 12, 2022.
193+ A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N 1
194+THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER 2
195+SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL 3
196+REEVALUATION OF THE INCLUSION OF THE CON DITION; AND 4
197+
198+ B. IF THE ADVISORY COUNCIL UPHOLDS ITS 5
199+DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE 6
200+GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT 7
201+ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROV AL. 8
202+
203+ (2) Notwithstanding any other provision of law, if the Secretary of Health 9
204+and Human Services issues federal recommendations on critical congenital heart disease 10
205+screening of newborns, the Department shall adopt the federal screening recommendations. 11
206+
207+ (F) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE 12
208+INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER 13
209+SUBSECTION (E) OF THIS SECTION, THE DEPARTMENT SHALL IMPL EMENT TESTING 14
210+FOR THE CONDITION WI THIN 1 YEAR AFTER THE DATE OF THE APPROVAL . 15
211+
212+ (G) (1) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE 16
213+INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER 17
214+SUBSECTION (F) OF THIS SECTION , WITHIN 1 YEAR AFTER THE DATE OF THE 18
215+APPROVAL, THE DEPARTMENT SHALL : 19
216+
217+ (I) IF TESTING FOR THE CO NDITION CAN BE IMPLE MENTED 20
218+WITHOUT THE PROCUREMENT OF SPECIALIZED TESTI NG EQUIPMENT , IMPLEMENT 21
219+TESTING FOR THE COND ITION; OR 22
220+
221+ (II) IF THE IMPLEMENTATION OF TESTING REQUIRES THE 23
222+PROCUREMENT OF SPECI ALIZED TESTING EQUIP MENT, SIGN A FINAL 24
223+PROCUREMENT CONTRACT WITH A VENDOR FOR AL L EQUIPMENT NECESSARY TO 25
224+IMPLEMENT TESTING . 26
225+
226+ (2) FOR PROCUREMENTS REQU IRED UNDER PARAGRAPH (1)(II) OF 27
227+THIS SUBSECTION : 28
228+
229+ (I) NOTWITHSTANDING ANY O THER PROVISION OF LA W, THE 29
230+DEPARTMENT MAY USE EX PEDITED PROCUREMENT UNDER § 13–108 OF THE STATE 30
231+FINANCE AND PROCUREMENT ARTICLE; AND 31
232+
233+ (II) THE PROCUREMENT CONTR ACT SHALL INCLUDE A CLAUSE 32
234+AUTHORIZING THE STATE TO TERMINATE TH E CONTRACT IF THE VE NDOR HAS NOT 33
235+FULFILLED THE CONTRA CT WITHIN 6 MONTHS. 34
236+ 6 HOUSE BILL 109
237+
238+
239+ (f) (H) (f) (G) (1) The Secretary shall pay all fees collected under the 1
240+provisions of this subtitle to the Comptroller. 2
241+
242+ (2) The Comptroller shall distribute the fees to the Newborn Screening 3
243+Program Fund established under § 13–113 of this subtitle. 4
244+
245+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take e ffect 5
246+October 1, 2022. 6
247+
248+
249+
250+
251+Approved:
252+________________________________________________________________________________
253+ Governor.
254+________________________________________________________________________________
255+ Speaker of the House of Delegates.
256+________________________________________________________________________________
257+ President of the Senate.