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Maryland House Bill HB676

Maryland 2024 Regular Session

Maryland House Bill HB676 Compare Versions

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1- WES MOORE, Governor Ch. 960
21
3-– 1 –
4-Chapter 960
5-(House Bill 676)
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+ *hb0676*
89
9-Right to Try Act – Individualized Investigational Treatments
10+HOUSE BILL 676
11+J1 4lr1694
1012
11-FOR the purpose of altering certain provisions of law authorizing certain activity by
12-manufacturers of investigational drugs, biological products, or devices under the
13-Right to Try Act to apply to manufacturers of certain individualized investigational
14-treatments; altering the definition of “eligible patient” under the Right to Try Act to
15-include individuals who have life–threatening or severely debilitating illnesses,
16-rather than only individuals who have terminal illnesses; repealing the restriction
17-on the receipt of payments from eligible patients by manufacturers of investigational
18-drugs, biological products, or devices; repealing the prohibition on manufacturers of
19-investigational drugs, biological products, or devices profiting from the provision of
20-the drugs, biological products, or devices; authorizing health insurance carriers,
21-third–party administrators, and government agencies to provide coverage for the
22-cost of investigational treatments and services related to the use of individualized
23-investigational treatments; and generally relating to the Right to Try Act and
24-individualized investigational treatments.
13+By: Delegates M. Morgan, Alston, Arikan, Bagnall, Chisholm, Fisher, Howard,
14+Hutchinson, S. Johnson, Kerr, Kipke, Pena –Melnyk, Reilly, and Szeliga
15+Szeliga, Bhandari, Cullison, Guzzone, Hill, Kaiser, R. Lewis, Lopez,
16+Martinez, Rosenberg, Taveras, White Holland, and Woods
17+Introduced and read first time: January 25, 2024
18+Assigned to: Health and Government Operations
19+Committee Report: Favorable with amendments
20+House action: Adopted
21+Read second time: March 1, 2024
2522
26-BY repealing and reenacting, with amendments,
27- Article – Health – General
28-Section 21–2B–01 through 21–2B–06
29- Annotated Code of Maryland
30- (2023 Replacement Volume)
23+CHAPTER ______
3124
32- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
33-That the Laws of Maryland read as follows:
25+AN ACT concerning 1
3426
35-Article – Health – General
27+Right to Try Act – Individualized Investigational Treatments 2
3628
37-21–2B–01.
29+FOR the purpose of altering certain provisions of law authorizing certain activity by 3
30+manufacturers of investigational drugs, biological products, or devices under the 4
31+Right to Try Act to apply to manufacturers of certain individualized investigational 5
32+treatments; altering the definition of “eligible patient” under the Right to Try Act to 6
33+include individuals who have life–threatening or severely debilitating illnesses, 7
34+rather than only individuals who have terminal illnesses; repealing the restriction 8
35+on the receipt of payments from eligible patients by manufacturers of investigational 9
36+drugs, biological products, or devices; repealing the prohibition on manufacturers of 10
37+investigational drugs, biological products, or devices profiting from the provision of 11
38+the drugs, biological products, or devices; authorizing health insurance carriers, 12
39+third–party administrators, and government agencies to provide coverage for the 13
40+cost of investigational treatments and services related to the use of individualized 14
41+investigational treatments; and generally relating to the Right to Try Act and 15
42+individualized investigational treatments. 16
3843
39- (a) In this subtitle the following words have the meanings indicated.
44+BY repealing and reenacting, with amendments, 17
45+ Article – Health – General 18
46+Section 21–2B–01 through 21–2B–06 19
47+ Annotated Code of Maryland 20
48+ (2023 Replacement Volume) 21 2 HOUSE BILL 676
4049
41- (b) “Carrier” has the meaning stated in § 15–10A–01(c) of the Insurance Article.
4250
43- (C) “ELIGIBLE FACILITY ” MEANS AN INSTITUTION OPERATING UNDER A
44-FEDERALWIDE ASSURANC E FOR THE PROTECTION OF HUMAN SUBJECTS IN
45-ACCORDANCE WITH 42 U.S.C. § 289(A) AND 28 C.F.R. PART 46.
4651
47- [(c)] (D) “Eligible patient” means an individual who:
48- Ch. 960 2024 LAWS OF MARYLAND
52+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
53+That the Laws of Maryland read as follows: 2
4954
50-– 2 –
51- (1) Has a [terminal] LIFE–THREATENING OR SEVER ELY DEBILITATING
52-illness, attested to by the individual’s treating physician;
55+Article – Health – General 3
5356
54- (2) Has considered all other treatment options currently approved by the
55-United States Food and Drug Administration;
57+21–2B–01. 4
5658
57- (3) Has received a recommendation from the individual’s [treating]
58-physician for [the use of an investigational drug, biological product, or device] AN
59-INDIVIDUALIZED INVES TIGATIONAL TREATMENT BASED ON ANALYSIS OF THE
60-INDIVIDUAL’S GENOMIC SEQUENCE , HUMAN CHROMOSOMES , DEOXYRIBONUCLEIC
61-ACID, RIBONUCLEIC ACID , GENES, GENE PRODUCTS , INCLUDING ENZYMES AN D
62-OTHER TYPES OF PROTE INS, OR METABOLITES ;
59+ (a) In this subtitle the following words have the meanings indicated. 5
6360
64- (4) (i) Has given informed consent for the use of the [investigational
65-drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT ; or
61+ (b) “Carrier” has the meaning stated in § 15–10A–01(c) of the Insurance Article. 6
6662
67- (ii) If the individual is a minor or lacks the mental capacity to
68-provide informed consent, has a parent or legal guardian who has given informed consent
69-on the individual’s behalf for the use of the [investigational drug, biological product, or
70-device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT ; AND
63+ (C) “ELIGIBLE FACILITY ” MEANS AN INSTITUTION OPERATING UNDER A 7
64+FEDERALWIDE ASSURANC E FOR THE PROTECTION OF HUMAN SUBJECTS IN 8
65+ACCORDANCE WITH 42 U.S.C. § 289(A) AND 28 C.F.R. PART 46. 9
7166
72- (5) [Is ineligible for or unable to participate in a clinical trial; and
67+ [(c)] (D) “Eligible patient” means an individual who: 10
7368
74- (6)] Has documentation from the individual’s [treating] physician that the
75-individual meets the requirements of items (1) through [(5)] (4) of this subsection.
69+ (1) Has a [terminal] LIFE–THREATENING OR SEVER ELY DEBILITATING 11
70+illness, attested to by the individual’s treating physician; 12
7671
77- [(d)] (E) “Health occupations board” means a board established under the
78-Health Occupations Article that issues licenses to practice a health occupation in the State.
72+ (2) Has considered all other treatment options currently approved by the 13
73+United States Food and Drug Administration; 14
7974
80- (F) (1) “INDIVIDUALIZED INVEST IGATIONAL TREATMENT ” MEANS A
81-DRUG, BIOLOGICAL PRODUCT , OR DEVICE THAT IS UN IQUE TO AND PRODUCED
82-EXCLUSIVELY FOR USE BY AN INDIVIDUAL BAS ED ON THE GENETIC PR OFILE OF THE
83-INDIVIDUAL.
75+ (3) Has received a recommendation from the individual’s [treating] 15
76+physician for [the use of an investigational drug, biological product, or device] AN 16
77+INDIVIDUALIZED INVES TIGATIONAL TREATMENT BASED ON ANALYSIS OF THE 17
78+INDIVIDUAL’S GENOMIC SEQUENCE , HUMAN CHROMOSOMES , DEOXYRIBONUCLEIC 18
79+ACID, RIBONUCLEIC ACID , GENES, GENE PRODUCTS , INCLUDING ENZYMES AN D 19
80+OTHER TYPES OF PROTE INS, OR METABOLITES ; 20
8481
85- (2) “INDIVIDUALIZED INVEST IGATIONAL TREATMENT ” INCLUDES
86-INDIVIDUALIZED GENE THERAPY, ANTISENSE OLIGONUCLE OTIDES, AND
87-INDIVIDUALIZED NEOAN TIGEN VACCINES .
82+ (4) (i) Has given informed consent for the use of the [investigational 21
83+drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT ; or 22
8884
89- [(e)] (G) “Informed consent” means a written document prepared using the
90-informed consent form developed by the Office of the Attorney General in accordance with
91-[§ 21–2B–02(d)(1)] § 21–2B–02(B)(1) of this subtitle that:
85+ (ii) If the individual is a minor or lacks the mental capacity to 23
86+provide informed consent, has a parent or legal guardian who has given informed consent 24
87+on the individual’s behalf for the use of the [investigational drug, biological product, or 25
88+device] INDIVIDUALIZED INVESTIGATIO NAL TREATMENT ; AND 26
9289
93- (1) Is signed by the patient or a parent or legal guardian of the patient;
94- WES MOORE, Governor Ch. 960
90+ (5) [Is ineligible for or unable to participate in a clinical trial; and 27
9591
96-– 3 –
97- (2) Is attested to by the patient’s treating physician and a witness; and
92+ (6)] Has documentation from the individual’s [treating] physician that the 28
93+individual meets the requirements of items (1) through [(5)] (4) of this subsection. 29
94+ HOUSE BILL 676 3
9895
99- (3) At a minimum:
10096
101- (i) Explains the currently approved products and treatments for the
102-[disease or condition] LIFE–THREATENING OR SEVER ELY DEBILITATING ILL NESS from
103-which the patient suffers, INCLUDING ALTERNATIV E PROCEDURES OR COUR SES OF
104-TREATMENT , IF KNOWN TO THE TREA TING PHYSIC IAN, THAT MIGHT BE
105-ADVANTAGEOUS TO THE PATIENT;
97+ [(d)] (E) “Health occupations board” means a board established under the 1
98+Health Occupations Article that issues licenses to practice a health occupation in the State. 2
10699
107- (ii) Attests to the fact that the patient concurs with the patient’s
108-treating physician in believing that all currently approved and conventionally recognized
109-treatments are unlikely to prolong the patient’s life;
100+ (F) (1) “INDIVIDUALIZED INVEST IGATIONAL TREATMENT ” MEANS A 3
101+DRUG, BIOLOGICAL PRODUCT , OR DEVICE THAT IS UN IQUE TO AND PRODUCED 4
102+EXCLUSIVELY FOR USE BY AN INDIVIDUAL BAS ED ON THE GENETIC PR OFILE OF THE 5
103+INDIVIDUAL. 6
110104
111- (iii) Identifies clearly the specific proposed [investigational drug,
112-biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT that the
113-patient is seeking to use;
105+ (2) “INDIVIDUALIZED INVEST IGATIONAL TREATMENT ” INCLUDES 7
106+INDIVIDUALIZED GENE THERAPY, ANTISENSE OLIGONUCLEOTIDES , AND 8
107+INDIVIDUALIZED NEOAN TIGEN VACCINES . 9
114108
115- (iv) Informs the provider and eligible patient of any known or,
116-anticipated, OR REASONABLY FORESE EABLE side effects, risks, or reported patient
117-discomfort that is likely related to the treatment;
109+ [(e)] (G) “Informed consent” means a written document prepared using the 10
110+informed consent form developed by the Office of the Attorney General in accordance with 11
111+[§ 21–2B–02(d)(1)] § 21–2B–02(B)(1) of this subtitle that: 12
118112
119- (v) Describes the best and worst potential outcomes of using the
120-[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
121-TREATMENT with a realistic description of the most likely outcome, including the
122-possibility that new, unanticipated, different, or worse symptoms might result and that
123-death could be hastened by the proposed treatment, based on the treating physician’s
124-knowledge of the proposed treatment in conjunction with an awareness of the patient’s
125-condition;
113+ (1) Is signed by the patient or a parent or legal guardian of the patient; 13
126114
127- (vi) Makes clear that the patient’s carrier and health care provider
128-are not obligated to pay for any care or treatments that are necessary as a result of the use
129-of the [investigational drug, biological product, or device] INDIVIDUALIZED
130-INVESTIGATIONAL TREA TMENT except as required by federal or State law or contract;
115+ (2) Is attested to by the patient’s treating physician and a witness; and 14
131116
132- (vii) Makes clear that the patient’s eligibility for hospice care may be
133-withdrawn if the patient begins curative treatment with the [investigational drug,
134-biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT and that
135-hospice care may be reinstated if this treatment ends and the patient meets hospice
136-eligibility requirements; and
117+ (3) At a minimum: 15
137118
138- (viii) States that the patient understands that the patient may be
139-liable for all expenses relating to the use of the [investigational drug, biological product, or
140-device] INDIVIDUALIZED INVES TIGATIONAL TRE ATMENT and that this liability extends
141-to the patient’s estate, but not the heirs or legatees of the patient; AND Ch. 960 2024 LAWS OF MARYLAND
119+ (i) Explains the currently approved products and treatments for the 16
120+[disease or condition] LIFE–THREATENING OR SEVER ELY DEBILITATING ILL NESS from 17
121+which the patient suffers, INCLUDING ALTERNATIV E PROCEDURES OR COUR SES OF 18
122+TREATMENT , IF KNOWN TO THE TREA TING PHYSICIAN , THAT MIGHT BE 19
123+ADVANTAGEOUS TO THE PATIENT; 20
142124
143-– 4 –
125+ (ii) Attests to the fact that the patient concurs with the patient’s 21
126+treating physician in believing that all currently approved and conventionally recognized 22
127+treatments are unlikely to prolong the patient’s life; 23
144128
145- (IX) INCLUDES A STATEMENT DESCRIBING THE EXTEN T TO
146-WHICH CONFIDENTIALIT Y OF RECORDS THAT ID ENTIFY THE PATIENT W ILL BE
147-MAINTAINED .
129+ (iii) Identifies clearly the specific proposed [investigational drug, 24
130+biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT that the 25
131+patient is seeking to use; 26
148132
149- [(f) “Investigational drug, biological product, or device” means a drug, biological
150-product, or device that:
133+ (iv) Informs the provider and eligible patient of any known or, 27
134+anticipated, OR REASONABLY FORESE EABLE side effects, risks, or reported patient 28
135+discomfort that is likely related to the treatment; 29
151136
152- (1) Has successfully completed Phase I of a clinical trial but has not yet
153-been approved for general use by the United States Food and Drug Administration; and
137+ (v) Describes the best and worst potential outcomes of using the 30
138+[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 31
139+TREATMENT with a realistic description of the most likely outcome, including the 32
140+possibility that new, unanticipated, different, or worse symptoms might result and that 33
141+death could be hastened by the proposed treatment, based on the treating physician’s 34 4 HOUSE BILL 676
154142
155- (2) Remains under investigation or in a clinical trial approved by the
156-United States Food and Drug Administration.
157143
158- (g) “Terminal illness” means a disease or condition that, without life–sustaining
159-procedures, will result in death or a state of permanent unconsciousness from which
160-recovery is unlikely within 12 months.]
144+knowledge of the proposed treatment in conjunction with an awareness of the patient’s 1
145+condition; 2
161146
162- (H) “LIFE–THREATENING ” HAS THE MEANING STAT ED IN 21 C.F.R. §
163-312.81.
147+ (vi) Makes clear that the patient’s carrier and health care provider 3
148+are not obligated to pay for any care or treatments that are necessary as a result of the use 4
149+of the [investigational drug, biological product, or device] INDIVIDUALIZED 5
150+INVESTIGATIONAL TREA TMENT except as required by federal or State law or contract; 6
164151
165- (I) “SEVERELY DEBILITATING ” HAS THE MEANING STAT ED IN 21 C.F.R. §
166-312.81.
152+ (vii) Makes clear that the patient’s eligibility for hospice care may be 7
153+withdrawn if the patient begins curative treatment with the [investigational drug, 8
154+biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT and that 9
155+hospice care may be reinstated if this treatment ends and the patient meets hospice 10
156+eligibility requirements; and 11
167157
168-21–2B–02.
158+ (viii) States that the patient understands that the patient may be 12
159+liable for all expenses relating to the use of the [investigational drug, biological product, or 13
160+device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT and that this liability extends 14
161+to the patient’s estate, but not the heirs or legatees of the patient; AND 15
169162
170- (a) A manufacturer of an [investigational drug, biological product, or device]
171-INDIVIDUALIZED INVES TIGATIONAL TREATMENT OPERATING WITHIN AN ELIGIBLE
172-FACILITY AND IN COMP LIANCE WITH ALL LAWS APPLICABLE TO AN ELI GIBLE
173-FACILITY may:
163+ (IX) INCLUDES A STATEMENT DESCRIBING THE EXTEN T TO 16
164+WHICH CONFIDENTIALIT Y OF RECORDS THAT ID ENTIFY THE PATIENT W ILL BE 17
165+MAINTAINED . 18
174166
175- (1) Provide the manufacturer’s [investigational drug, biological product, or
176-device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT to an eligible patient without
177-compensation; or
167+ [(f) “Investigational drug, biological product, or device” means a drug, biological 19
168+product, or device that: 20
178169
179- (2) [Subject to subsection (b) of this section, require] REQUIRE an eligible
180-patient to pay the costs of or associated with the manufacture of the [investigational drug,
181-biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT provided
182-to the eligible patient.
170+ (1) Has successfully completed Phase I of a clinical trial but has not yet 21
171+been approved for general use by the United States Food and Drug Administration; and 22
183172
184- [(b) (1) Any payment required by a manufacturer under subsection (a)(2) of this
185-section shall be limited to the recovery of the costs of or associated with the manufacture of
186-the specific investigational drug or biological product dosages or devices provided to the
187-eligible patient. WES MOORE, Governor Ch. 960
173+ (2) Remains under investigation or in a clinical trial approved by the 23
174+United States Food and Drug Administration. 24
188175
189-– 5 –
176+ (g) “Terminal illness” means a disease or condition that, without life–sustaining 25
177+procedures, will result in death or a state of permanent unconsciousness from which 26
178+recovery is unlikely within 12 months.] 27
190179
191- (2) A manufacturer of an investigational drug, biological product, or device
192-may not profit from providing an investigational drug, biological product, or device provided
193-to an eligible patient.
180+ (H) “LIFE–THREATENING ” HAS THE MEANING STAT ED IN 21 C.F.R. § 28
181+312.81. 29
194182
195- (c) After the date that an eligible patient begins taking or using the
196-investigational drug, biological product, or device and during the time the eligible patient
197-is taking or using the investigational drug, biological product, or device, the manufacturer
198-shall notify the eligible patient and the eligible patient’s health care provider of any side
199-effects or risks associated with the investigational drug, biological product, or device that
200-are required to be disclosed to the United States Food and Drug Administration during the
201-drug approval process.]
183+ (I) “SEVERELY DEBILITATING ” HAS THE MEANING STAT ED IN 21 C.F.R. § 30
184+312.81. 31
202185
203- [(d)] (B) (1) The Office of the Attorney General shall develop an informed
204-consent form that:
186+21–2B–02. 32
187+ HOUSE BILL 676 5
205188
206- (i) Complies with the requirements of [§ 21–2B–01(e)(3)] §
207-21–2B–01(G)(3) of this subtitle;
208189
209- (ii) Includes instructions for the physician or patient on how to
210-complete the form; and
190+ (a) A manufacturer of an [investigational drug, biological product, or device] 1
191+INDIVIDUALIZED INVES TIGATIONAL TREATMENT OPERATING WITHIN AN ELIGIBLE 2
192+FACILITY AND IN COMP LIANCE WITH ALL LAWS APPLICABLE TO AN ELI GIBLE 3
193+FACILITY may: 4
211194
212- (iii) Provides spaces for a physician to include the information
213-relating to a particular patient and the physician’s recommendation for the patient.
195+ (1) Provide the manufacturer’s [investigational drug, biological product, or 5
196+device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT to an eligible patient without 6
197+compensation; or 7
214198
215- (2) This subsection may not be construed to prohibit a treating physician
216-or a manufacturer of an [investigational drug, biological product, or device]
217-INDIVIDUALIZED INVES TIGATIONAL TREATMENT from including additional information
218-or advisements with the informed consent form developed under paragraph (1) of this
219-subsection.
199+ (2) [Subject to subsection (b) of this section, require] REQUIRE an eligible 8
200+patient to pay the costs of or associated with the manufacture of the [investigational drug, 9
201+biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT provided 10
202+to the eligible patient. 11
220203
221-21–2B–03.
204+ [(b) (1) Any payment required by a manufacturer under subsection (a)(2) of this 12
205+section shall be limited to the recovery of the costs of or associated with the manufacture of 13
206+the specific investigational drug or biological product dosages or devices provided to the 14
207+eligible patient. 15
222208
223- (a) A health occupations board may not revoke, fail to renew, suspend, or take
224-any action against a health care provider’s license based solely on the health care provider’s
225-recommendation to an eligible patient regarding access to or treatment with an
226-[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
227-TREATMENT .
209+ (2) A manufacturer of an investigational drug, biological product, or device 16
210+may not profit from providing an investigational drug, biological product, or device provided 17
211+to an eligible patient. 18
228212
229- (b) The Department may not take action against a health care provider’s
230-Medicare certification based solely on the health care provider’s recommendation that an
231-eligible patient have access to an [investigational drug, biological product, or device]
232-INDIVIDUALIZED INVES TIGATIONAL TREATMENT or the health care provider’s
233-treatment of an eligible patient with an [investigational drug, biological product, or device]
234-INDIVIDUALIZED INVES TIGATIONAL TREATMENT . Ch. 960 2024 LAWS OF MARYLAND
213+ (c) After the date that an eligible patient begins taking or using the 19
214+investigational drug, biological product, or device and during the time the eligible patient 20
215+is taking or using the investigational drug, biological product, or device, the manufacturer 21
216+shall notify the eligible patient and the eligible patient’s health care provider of any side 22
217+effects or risks associated with the investigational drug, biological product, or device that 23
218+are required to be disclosed to the United States Food and Drug Administration during the 24
219+drug approval process.] 25
235220
236-– 6 –
221+ [(d)] (B) (1) The Office of the Attorney General shall develop an informed 26
222+consent form that: 27
237223
238-21–2B–04.
224+ (i) Complies with the requirements of [§ 21–2B–01(e)(3)] § 28
225+21–2B–01(G)(3) of this subtitle; 29
239226
240- (a) An official, employee, or agent of the State may not block or attempt to block
241-an eligible patient’s access to an [investigational drug, biological product, or device]
242-INDIVIDUALIZED INVES TIGATIONAL TREATMENT .
227+ (ii) Includes instructions for the physician or patient on how to 30
228+complete the form; and 31
243229
244- (b) This section does not prohibit a licensed health care provider from providing
245-counsel, advice, or a recommendation that is consistent with medical standards of care.
230+ (iii) Provides spaces for a physician to include the information 32
231+relating to a particular patient and the physician’s recommendation for the patient. 33
246232
247-21–2B–05.
233+ (2) This subsection may not be construed to prohibit a treating physician 34
234+or a manufacturer of an [investigational drug, biological product, or device] 35
235+INDIVIDUALIZED INVES TIGATIONAL TREATMENT from including additional information 36 6 HOUSE BILL 676
248236
249- This subtitle does not create a private cause of action against a manufacturer of an
250-[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
251-TREATMENT or against another person involved in the care of an eligible patient using the
252-[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
253-TREATMENT for any harm to the eligible patient resulting from the [investigational drug,
254-biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT if the
255-manufacturer or other person is complying in good faith with this subtitle and has exercised
256-reasonable care.
257237
258-21–2B–06.
238+or advisements with the informed consent form developed under paragraph (1) of this 1
239+subsection. 2
259240
260- (A) This subtitle does not affect the coverage requirements under Title 15,
261-Subtitle 8 of the Insurance Article.
241+21–2B–03. 3
262242
263- (B) A CARRIER, THIRD–PARTY ADMINISTRATOR , OR GOVERNMENT AGENCY
264-MAY PROVIDE COVERAGE FOR THE COST OF AN I NDIVIDUALIZ ED INVESTIGATIONAL
265-TREATMENT OR THE COS T OF SERVICES RELATE D TO THE USE OF AN
266-INDIVIDUALIZED INVES TIGATIONAL TREATMENT UNDER THIS SUBTITLE .
243+ (a) A health occupations board may not revoke, fail to renew, suspend, or take 4
244+any action against a health care provider’s license based solely on the health care provider’s 5
245+recommendation to an eligible patient regarding access to or treatment with an 6
246+[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 7
247+TREATME NT. 8
267248
268- (C) THIS SUBTITLE DOES NO T REQUIRE:
249+ (b) The Department may not take action against a health care provider’s 9
250+Medicare certification based solely on the health care provider’s recommendation that an 10
251+eligible patient have access to an [investigational drug, biological product, or device] 11
252+INDIVIDUALIZED INVES TIGATIONAL TREATMENT or the health care provider’s 12
253+treatment of an eligible patient with an [investigational drug, biological product, or device] 13
254+INDIVIDUALIZED INVES TIGATIONAL TREATMENT . 14
269255
270- (1) A GOVERNMENT AGENCY TO PAY COSTS ASSOCIATED WITH THE
271-USE, CARE, OR TREA TMENT OF AN INDIVIDU AL WITH AN INDIVIDUA LIZED
272-INVESTIGATIONAL TREA TMENT; OR
256+21–2B–04. 15
273257
274- (2) A HOSPITAL OR ANOTHER HEALTH CARE FACILITY TO PROVIDE
275-NEW OR ADDITIONAL SE RVICES UNLESS APPROV ED BY THE HOSPITAL O R HEALTH
276-CARE FACILITY.
258+ (a) An official, employee, or agent of the State may not block or attempt to block 16
259+an eligible patient’s access to an [investigational drug, biological product, or device] 17
260+INDIVIDUALIZED INVES TIGATIONAL TREATMENT . 18
277261
278- SECTION 2. AND BE IT FURTHER ENA CTED, That this Act shall take effect
279-October 1, 2024.
280- WES MOORE, Governor Ch. 960
262+ (b) This section does not prohibit a licensed health care provider from providing 19
263+counsel, advice, or a recommendation that is consistent with medical standards of care. 20
281264
282-– 7 –
283-Approved by the Governor, May 16, 2024.
265+21–2B–05. 21
266+
267+ This subtitle does not create a private cause of action against a manufacturer of an 22
268+[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 23
269+TREATMENT or against another person involved in the care of an eligible patient using the 24
270+[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 25
271+TREATMENT for any harm to the eligible patient resulting from the [investigational drug, 26
272+biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT if the 27
273+manufacturer or other person is complying in good faith with this subtitle and has exercised 28
274+reasonable care. 29
275+
276+21–2B–06. 30
277+
278+ (A) This subtitle does not affect the coverage requirements under Title 15, 31
279+Subtitle 8 of the Insurance Article. 32
280+
281+ (B) A CARRIER, THIRD–PARTY ADMINISTRATOR , OR GOVERNMENT AGENCY 33
282+MAY PROVIDE COVERAGE FOR THE COST OF AN I NDIVIDUALIZED INVEST IGATIONAL 34 HOUSE BILL 676 7
283+
284+
285+TREATMENT OR THE COST OF SERVICES REL ATED TO THE USE OF A N 1
286+INDIVIDUALIZED INVES TIGATIONAL TREATMENT UNDER THIS SUBTITLE . 2
287+
288+ (C) THIS SUBTITLE DOES NO T REQUIRE: 3
289+
290+ (1) A GOVERNMENT AGENCY TO PAY COSTS ASSOCIATED WITH THE 4
291+USE, CARE, OR TREATMENT OF AN I NDIVIDUAL WITH AN IN DIVIDUALIZED 5
292+INVESTIGATIONAL TREA TMENT; OR 6
293+
294+ (2) A HOSPITAL OR ANOTHER HEALTH CARE FACILITY TO PROVIDE 7
295+NEW OR ADDITIONAL SE RVICES UNLESS APPROV ED BY THE HOSPITAL O R HEALTH 8
296+CARE FACILITY. 9
297+
298+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effe ct 10
299+October 1, 2024. 11
300+
301+
302+
303+
304+Approved:
305+________________________________________________________________________________
306+ Governor.
307+________________________________________________________________________________
308+ Speaker of the House of Delegates.
309+________________________________________________________________________________
310+ President of the Senate.