MD
Maryland House Bill HB96

Maryland 2024 Regular Session

Maryland House Bill HB96 Compare Versions

OldNewDifferences
1- WES MOORE, Governor Ch. 177
21
3-– 1 –
4-Chapter 177
5-(House Bill 96)
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+ *hb0096*
89
9-Health – Newborn Screening Program – Krabbe Leukodystrophy
10-Implementation of Testing
10+HOUSE BILL 96
11+J1 EMERGENCY BILL 4lr0937
12+ (PRE–FILED) CF SB 117
13+By: Delegate T. Morgan
14+Requested: October 12, 2023
15+Introduced and read first time: January 10, 2024
16+Assigned to: Health and Government Operations
17+Committee Report: Favorable with amendments
18+House action: Adopted
19+Read second time: March 21, 2024
1120
12-FOR the purpose of repealing the requirement that the Secretary of Health and the State
13-Advisory Council on Hereditary and Congenital Disorders determine whether to
14-approve the inclusion of a core condition in the system for newborn screening within
15-a certain time period after the addition of the condition to the Recommended Uniform
16-Screening Panel; requiring the Maryland Department of Health to implement
17-testing for a core condition listed in the Recommended Uniform Screening Panel
18-within a certain time period after the core condition is added to the Panel;
19-authorizing the Department to screen for any condition recommended by the
20-Advisory Council and approved by the Secretary; requiring that the Maryland
21-Department of Health’s newborn screening system include screening to implement
22-testing for Krabbe leukodystrophy within a certain period of time after the U.S.
23-Department of Health and Human Services issues a certain recommendation; and
24-generally relating to newborn screening.
21+CHAPTER ______
2522
26-BY repealing and reenacting, with amendments,
27- Article – Health – General
28-Section 13–111
29- Annotated Code of Maryland
30- (2023 Replacement Volume)
23+AN ACT concerning 1
3124
32- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
33-That the Laws of Maryland read as follows:
25+Health – Newborn Screening Program – Krabbe Leukodystrophy 2
26+Implementation of Testing 3
3427
35-Article – Health – General
28+FOR the purpose of repealing the requirement that the Secretary of Health and the State 4
29+Advisory Council on Hereditary and Congenital Disorders determine whether to 5
30+approve the inclusion of a core condition in the system for newborn screening within 6
31+a certain time period after the addition of the condition to the Recommended Uniform 7
32+Screening Panel; requiring the Maryland Department of Health to implement 8
33+testing for a core condition listed in the Recommended Uniform Screening Panel 9
34+within a certain time period after the core condition is added to the Panel; 10
35+authorizing the Department to screen for any condition recommended by the 11
36+Advisory Council and approved by the Secretary; requiring that the Maryland 12
37+Department of Health’s newborn screening system include screening to implement 13
38+testing for Krabbe leukodystrophy within a certain period of time after the U.S. 14
39+Department of Health and Human Services issues a certain recommendation; and 15
40+generally relating to newborn screening. 16
3641
37-13–111.
42+BY repealing and reenacting, with amendments, 17
43+ Article – Health – General 18
44+Section 13–111 19
45+ Annotated Code of Maryland 20
46+ (2023 Replacement Volume) 21
47+ 2 HOUSE BILL 96
3848
39- (a) The Department shall establish a coordinated statewide system for screening
40-all newborn infants in the State for certain hereditary and congenital disorders associated
41-with severe problems of health or development, except when the parent or guardian of the
42-newborn infant objects.
4349
44- (b) Except as provided in § 13–112 of this subtitle, the Department’s public health
45-laboratory is the sole laboratory authorized to perform tests on specimens from newborn
46-infants collected to screen for hereditary and congenital disorders as determined under
47-subsection (d)(2) of this section.
50+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
51+That the Laws of Maryland read as follows: 2
4852
49- (c) The system for newborn screening shall include: Ch. 177 2024 LAWS OF MARYLAND
53+Article – Health – General 3
5054
51-– 2 –
55+13–111. 4
5256
53- (1) Laboratory testing and the reporting of test results; [and]
57+ (a) The Department shall establish a coordinated statewide system for screening 5
58+all newborn infants in the State for certain hereditary and congenital disorders associated 6
59+with severe problems of health or development, except when the parent or guardian of the 7
60+newborn infant objects. 8
5461
55- (2) Follow–up activities to facilitate the rapid identification and treatment
56-of an affected child; AND
62+ (b) Except as provided in § 13–112 of this subtitle, the Department’s public health 9
63+laboratory is the sole laboratory authorized to perform tests on specimens from newborn 10
64+infants collected to screen for hereditary and congenital disorders as determined under 11
65+subsection (d)(2) of this section. 12
5766
58- (3) SCREENING FOR KRABBE LEUKODYSTROPHY .
67+ (c) The system for newborn screening shall include: 13
5968
60- (d) In consultation with the State Advisory Council on Hereditary and Congenital
61-Disorders, the Department shall:
69+ (1) Laboratory testing and the reporting of test results; [and] 14
6270
63- (1) Establish protocols for a health care provider to obtain and deliver test
64-specimens to the Department’s public health laboratory;
71+ (2) Follow–up activities to facilitate the rapid identification and treatment 15
72+of an affected child; AND 16
6573
66- (2) Determine the screening tests that the Department’s public health
67-laboratory is required to perform;
74+ (3) SCREENING FOR KRABBE LEUKODYSTROPHY . 17
6875
69- (3) Maintain a coordinated statewide system for newborn screening that
70-carries out the purpose described in subsection (c) of this section that includes:
76+ (d) In consultation with the State Advisory Council on Hereditary and Congenital 18
77+Disorders, the Department shall: 19
7178
72- (i) Communicating the results of screening tests to the health care
73-provider of the newborn infant;
79+ (1) Establish protocols for a health care provider to obtain and deliver test 20
80+specimens to the Department’s public health laboratory; 21
7481
75- (ii) Locating newborn infants with abnormal test results;
82+ (2) Determine the screening tests that the Department’s public health 22
83+laboratory is required to perform; 23
7684
77- (iii) Sharing newborn screening information between hospitals,
78-health care providers, treatment centers, and laboratory personnel;
85+ (3) Maintain a coordinated statewide system for newborn screening that 24
86+carries out the purpose described in subsection (c) of this section that includes: 25
7987
80- (iv) Delivering needed clinical, diagnostic, and treatment
81-information to health care providers, parents, and caregivers; and
88+ (i) Communicating the results of screening tests to the health care 26
89+provider of the newborn infant; 27
8290
83- (v) Notifying parents and guardians of newborn infants that
84-laboratories other than the Department’s public health laboratory are authorized to
85-perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary
86-and congenital disorders; and
91+ (ii) Locating newborn infants with abnormal test results; 28
8792
88- (4) Adopt regulations that set forth the standards and requirements for
89-newborn screening for hereditary and congenital disorders that are required under this
90-subtitle, including:
93+ (iii) Sharing newborn screening information between hospitals, 29
94+health care providers, treatment centers, and laboratory personnel; 30
95+ HOUSE BILL 96 3
9196
92- (i) Performing newborn screening tests;
9397
94- (ii) Coordinating the reporting, follow–up, and treatment activities
95-with parents, caregivers, and health care providers; and
96- WES MOORE, Governor Ch. 177
98+ (iv) Delivering needed clinical, diagnostic, and treatment 1
99+information to health care providers, parents, and caregivers; and 2
97100
98-– 3 –
99- (iii) Establishing fees for newborn screening that do not exceed an
100-amount sufficient to cover the administrative, laboratory, and follow–up costs associated
101-with the performance of screening tests under this subtitle.
101+ (v) Notifying parents and guardians of newborn infants that 3
102+laboratories other than the Department’s public health laboratory are authorized to 4
103+perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 5
104+and congenital disorders; and 6
102105
103- (e) (1) (i) Subject to the approval of the Secretary and the Advisory Council
104-under subparagraph (ii) of this paragraph and notwithstanding any other provision of law,
105-the THE Department shall screen for each core condition listed in the U.S. Department of
106-Health and Human Services’ Recommended Uniform Screening Panel.
106+ (4) Adopt regulations that set forth the standards and requirements for 7
107+newborn screening for hereditary and congenital disorders that are required under this 8
108+subtitle, including: 9
107109
108- (ii) On or after January 1, 2023, the Secretary and the Advisory
109-Council shall determine whether to approve the inclusion of a condition in the system for
110-newborn screening within 1 year after the addition of the condition SUBJECT TO
111-SUBPARAGRAPH (III) OF THIS PARAGRAPH , THE DEPARTMENT SHALL IMPL EMENT
112-TESTING FOR A CORE C ONDITION WITHIN 1 YEAR AND 6 MONTHS AFTER THE COR E
113-CONDITION IS ADDED to the Recommended Uniform Screening Panel.
110+ (i) Performing newborn screening tests; 10
114111
115- (III) 1. IF THE DEPARTMENT IS UNABLE TO IMPLEMENT
116-TESTING WITHIN 1 YEAR AND 6 MONTHS AFTER A CORE CONDITION IS ADDED T O THE
117-RECOMMENDED UNIFORM SCREENING PANEL DUE TO A DELAY IN THE
118-PROCUREMENT OF EQUIP MENT OR SUPPLIES NEE DED TO IMPLEMENT THE TESTING,
119-THE DEPARTMENT SHALL REPO RT TO THE SENATE FINANCE COMMITTEE AND THE
120-HOUSE HEALTH AND GOVERNMENT OPERATIONS COMMITTEE, IN ACCORDANCE
121-WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, WITHIN 1 YEAR AND 3
122-MONTHS AFTER THE ADD ITION OF THE CORE CO NDITION TO THE RECOMMENDED
123-UNIFORM SCREENING PANEL AND EVERY 3 MONTHS THEREAFTER UN TIL THE
124-TESTING FOR THE CORE CONDITION IS IMPLEME NTED.
112+ (ii) Coordinating the reporting, follow–up, and treatment activities 11
113+with parents, caregivers, and health care providers; and 12
125114
126- 2. A REPORT REQUIRED UNDE R SUBSUBPARAGRAPH 1
127-OF THIS SUBPARA GRAPH SHALL INCLUDE THE REASON FOR THE D ELAY AND THE
128-ANTICIPATED TIMELINE FOR IMPLEMENTATION .
115+ (iii) Establishing fees for newborn screening that do not exceed an 13
116+amount sufficient to cover the administrative, laboratory, and follow–up costs associated 14
117+with the performance of screening tests under this subtitle. 15
129118
130- (iii) If the Secretary or Advisory Council does not approve the
131-inclusion of a core condition in the system for newborn screening under subparagraph (i) of
132-this paragraph:
119+ (e) (1) (i) Subject to the approval of the Secretary and the Advisory Council 16
120+under subparagraph (ii) of this paragraph and notwithstanding any other provision of law, 17
121+the THE Department shall screen for each core condition listed in the U.S. Department of 18
122+Health and Human Services’ Recommended Uniform Screening Panel. 19
133123
134- 1. Within 1 year after the addition of the condition to the
135-Recommended Uniform Screening Panel, the Department shall publicly post and submit to
136-the General Assembly, in accordance with § 2–1257 of the State Government Article, a
137-report that includes, as applicable, the Secretary’s justification for not approving the
138-inclusion and the final vote of the Advisory Council regarding the inclusion of the condition;
139-and
124+ (ii) On or after January 1, 2023, the Secretary and the Advisory 20
125+Council shall determine whether to approve the inclusion of a condition in the system for 21
126+newborn screening within 1 year after the addition of the condition SUBJECT TO 22
127+SUBPARAGRAPH (III) OF THIS PARAGRAPH , THE DEPARTMENT SHALL IMPL EMENT 23
128+TESTING FOR A CORE CONDITION WITHIN 1 YEAR AND 6 MONTHS AFTER THE COR E 24
129+CONDITION IS ADDED to the Recommended Uniform Screening Panel. 25
140130
141- 2. Each year after the initial disapproval, the Advisory
142-Council shall:
143- Ch. 177 2024 LAWS OF MARYLAND
131+ (III) 1. IF THE DEPARTMENT IS UNABLE TO IMPLEMENT 26
132+TESTING WITHIN 1 YEAR AND 6 MONTHS AFTER A CORE CONDITION IS ADDED T O THE 27
133+RECOMMENDED UNIFORM SCREENING PANEL DUE TO A DELAY IN THE 28
134+PROCUREMENT OF EQUIP MENT OR SUPPLIES NEE DED TO IMPLEMENT THE TESTING, 29
135+THE DEPARTMEN T SHALL REPORT TO TH E SENATE FINANCE COMMITTEE AND THE 30
136+HOUSE HEALTH AND GOVERNMENT OPERATIONS COMMITTEE, IN ACCORDANCE 31
137+WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, WITHIN 1 YEAR AND 3 32
138+MONTHS AFTER THE ADD ITION OF THE CORE CO NDITION TO THE RECOMMENDED 33
139+UNIFORM SCREENING PANEL AND EVERY 3 MONTHS THEREAFTER UN TIL THE 34
140+TESTING FOR THE CORE CONDITION IS IMPLEME NTED. 35
141+ 4 HOUSE BILL 96
144142
145-– 4 –
146- A. Review the medical literature published on the condition
147-since the initial evaluation and determine whether substantive updates have occurred that
148-would merit formal reevaluation of the inclusion of the condition; and
149143
150- B. If the Advisory Council upholds its disapproval of the
151-condition, publicly publish and submit to the General Assembly, in accordance with §
152-2–1257 of the State Government Article, a report on the reason for the disapproval.
144+ 2. A REPORT REQUIRED UNDE R SUBSUBPARAGRAPH 1 1
145+OF THIS SUBPARAGRAPH SHALL INCLUDE THE RE ASON FOR THE DELAY A ND THE 2
146+ANTICIPATED TIMELINE FOR IMPLEMENTATION. 3
153147
154- (2) Notwithstanding any other provision of law, if the Secretary of Health
155-and Human Services issues federal recommendations on critical congenital heart disease
156-screening of newborns, the Department shall adopt the federal screening recommendations.
148+ (iii) If the Secretary or Advisory Council does not approve the 4
149+inclusion of a core condition in the system for newborn screening under subparagraph (i) of 5
150+this paragraph: 6
157151
158- (3) THE DEPARTMENT MAY SCREEN FOR ANY CONDITION
159-RECOMMENDED BY THE ADVISORY COUNCIL AND APPROVED BY THE SECRETARY.
152+ 1. Within 1 year after the addition of the condition to the 7
153+Recommended Uniform Screening Panel, the Department shall publicly post and submit to 8
154+the General Assembly, in accordance with § 2–1257 of the State Government Article, a 9
155+report that includes, as applicable, the Secretary’s justification for not approving the 10
156+inclusion and the final vote of the Advisory Council regarding the inclusion of the condition; 11
157+and 12
160158
161- (f) If the Secretary and the Advisory Council approve the inclusion of a condition
162-in the system for the newborn screening under subsection (e) of this section, the
163-Department shall implement testing for the condition within 1 year after the date of the
164-approval.
159+ 2. Each year after the initial disapproval, the Advisory 13
160+Council shall: 14
165161
166- (g) (F) (1) The Secretary shall pay all fees collected under the provisions of
167-this subtitle to the Comptroller.
162+ A. Review the medical literature published on the condition 15
163+since the initial evaluation and determine whether substantive updates have occurred that 16
164+would merit formal reevaluation of the inclusion of the condition; and 17
168165
169- (2) The Comptroller shall distribute the fees to the Newborn Screening
170-Program Fund established under § 13–113 of this subtitle.
166+ B. If the Advisory Council upholds its disapproval of the 18
167+condition, publicly publish and submit to the General Assembly, in accordance with § 19
168+2–1257 of the State Government Article, a report on the reason for the disapproval. 20
171169
172- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
173-October 1, 2024.
170+ (2) Notwithstanding any other provision of law, if the Secretary of Health 21
171+and Human Services issues federal recommendations on critical congenital heart disease 22
172+screening of newborns, the Department shall adopt the federal screening recommendations. 23
174173
175- SECTION 2. AND BE IT FURTHER ENACTED, That:
174+ (3) THE DEPARTMENT MAY SCREEN FOR ANY CONDITION 24
175+RECOMMENDED BY THE ADVISORY COUNCIL AND APPROVED BY THE SECRETARY. 25
176176
177- (a) Subject to subsection (b) of this section and notwithstanding § 13–311(e)(1)(ii)
178-of the Health – General Article, as enacted by Section 1 of this Act, the Maryland
179-Department of Health shall implement testing for infantile Krabbe disease within 1 year
180-after the U.S. Department of Health and Human Services issues a final recommendation
181-to add screening of the condition to the federal Recommended Uniform Screening Panel.
177+ (f) If the Secretary and the Advisory Council approve the inclusion of a condition 26
178+in the system for the newborn screening under subsection (e) of this section, the 27
179+Department shall implement testing for the condition within 1 year after the date of the 28
180+approval. 29
182181
183- (b) (1) If the Department is unable to implement testing for infantile Krabbe
184-disease within the time period required under subsection (a) of this section due to a delay
185-in the procurement of equipment or supplies needed to implement the testing, the
186-Department shall report to the Senate Finance Committee and the House Health and
187-Government Operations Committee, in accordance with § 2–1257 of the State Government
188-Article, within 9 months after the addition of the final recommendation to add screening of
189-infantile Krabbe disease to the federal Recommended Uniform Screening Panel and every
190-3 months thereafter until testing for infantile Krabbe disease is implemented.
191- WES MOORE, Governor Ch. 177
182+ (g) (F) (1) The Secretary shall pay all fees collected under the provisions of 30
183+this subtitle to the Comptroller. 31
192184
193-– 5 –
194- (2) The report required under paragraph (1) of this subsection shall include
195-information on the equipment or supplies needed, the reason for the delay, and the
196-anticipated timeline for implementation.
185+ (2) The Comptroller shall distribute the fees to the Newborn Screening 32
186+Program Fund established under § 13–113 of this subtitle. 33
197187
198- SECTION 3. AND BE IT FURTHER ENACTED, That this Act is an emergency
199-measure, is necessary for the immediate preservation of the public health or safety, has
200-been passed by a yea and nay vote supported by three–fifths of all the members elected to
201-each of the two Houses of the General Assembly, and shall take effect from the date it is
202-enacted.
188+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 34
189+October 1, 2024. 35 HOUSE BILL 96 5
203190
204-Approved by the Governor, April 25, 2024.
191+
192+ SECTION 2. AND BE IT FURTHER ENACTED, That: 1
193+
194+ (a) Subject to subsection (b) of this section and notwithstanding § 13–311(e)(1)(ii) 2
195+of the Health – General Article, as enacted by Section 1 of this Act, the Maryland 3
196+Department of Health shall implement testing for infantile Krabbe disease within 1 year 4
197+after the U.S. Department of Health and Human Services issues a final recommendation 5
198+to add screening of the condition to the federal Recommended Uniform Screening Panel. 6
199+
200+ (b) (1) If the Department is unable to implement testing for infantile Krabbe 7
201+disease within the time period required under subsection (a) of this section due to a delay 8
202+in the procurement of equipment or supplies needed to implement the testing, the 9
203+Department shall report to the Senate Finance Committee and the House Health and 10
204+Government Operations Committee, in accordance with § 2–1257 of the State Government 11
205+Article, within 9 months after the addition of the final recommendation to add screening of 12
206+infantile Krabbe disease to the federal Recommended Uniform Screening Panel and every 13
207+3 months thereafter until testing for infantile Krabbe disease is implemented. 14
208+
209+ (2) The report required under paragraph (1) of this subsection shall include 15
210+information on the equipment or supplies needed, the reason for the delay, and the 16
211+anticipated timeline for implementation. 17
212+
213+ SECTION 3. AND BE IT FURTHER ENACTED, That this Act is an emergency 18
214+measure, is necessary for the immediate preservation of the public health or safety, has 19
215+been passed by a yea and nay vote supported by three–fifths of all the members elected to 20
216+each of the two Houses of the General Assembly, and shall take effect from the date it is 21
217+enacted. 22
218+
219+
220+
221+
222+Approved:
223+________________________________________________________________________________
224+ Governor.
225+________________________________________________________________________________
226+ Speaker of the House of Delegates.
227+________________________________________________________________________________
228+ President of the Senate.