EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb0676*
HOUSE BILL 676
J1 4lr1694
By: Delegates M. Morgan, Alston, Arikan, Bagnall, Chisholm, Fisher, Howard,
Hutchinson, S. Johnson, Kerr, Kipke, Pena–Melnyk, Reilly, and Szeliga
Introduced and read first time: January 25, 2024
Assigned to: Health and Government Operations
A BILL ENTITLED
AN ACT concerning 1
Right to Try Act – Individualized Investigational Treatments 2
FOR the purpose of altering certain provisions of law authorizing certain activity by 3
manufacturers of investigational drugs, biological products, or devices under the 4
Right to Try Act to apply to manufacturers of certain individualized investigational 5
treatments; altering the definition of “eligible patient” under the Right to Try Act to 6
include individuals who have life–threatening or severely debilitating illnesses, 7
rather than only individuals who have terminal illnesses; repealing the restriction 8
on the receipt of payments from eligible patients by manufacturers of investigational 9
drugs, biological products, or devices; repealing the prohibition on manufacturers of 10
investigational drugs, biological products, or devices profiting from the provision of 11
the drugs, biological products, or devices; authorizing health insurance carriers, 12
third–party administrators, and government agencies to provide coverage for the 13
cost of investigational treatments and services related to the use of individualized 14
investigational treatments; and generally relating to the Right to Try Act and 15
individualized investigational treatments. 16
BY repealing and reenacting, with amendments, 17
Article – Health – General 18
Section 21–2B–01 through 21–2B–06 19
Annotated Code of Maryland 20
(2023 Replacement Volume) 21
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 22
That the Laws of Maryland read as follows: 23
Article – Health – General 24
21–2B–01. 25
2 HOUSE BILL 676
(a) In this subtitle the following words have the meanings indicated. 1
(b) “Carrier” has the meaning stated in § 15–10A–01(c) of the Insurance Article. 2
(C) “ELIGIBLE FACILITY ” MEANS AN INSTITUTION OPERATING UNDER A 3
FEDERALWIDE ASSURANC E FOR THE PROTECTION OF HUMAN SUBJECTS IN 4
ACCORDANCE WITH 42 U.S.C. § 289(A) AND 28 C.F.R. PART 46. 5
[(c)] (D) “Eligible patient” means an individual who: 6
(1) Has a [terminal] LIFE–THREATENING OR SEVERELY DEBILITATING 7
illness, attested to by the individual’s treating physician; 8
(2) Has considered all other treatment options currently approved by the 9
United States Food and Drug Administration; 10
(3) Has received a recommendation from the individual’s [treating] 11
physician for [the use of an investigational drug, biological product, or device] AN 12
INDIVIDUALIZED INVES TIGATIONAL TREATMENT BASED ON ANALYSIS OF THE 13
INDIVIDUAL’S GENOMIC SEQUENCE , HUMAN CHROMOSOMES , DEOXYRIBONUCLEIC 14
ACID, RIBONUCLEIC ACID , GENES, GENE PRODUCTS , INCLUDING ENZYMES AN D 15
OTHER TYPES OF PROTE INS, OR METABOLITES; 16
(4) (i) Has given informed consent for the use of the [investigational 17
drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT ; or 18
(ii) If the individual is a minor or lacks the mental capacity to 19
provide informed consent, has a parent or legal guardian who has given informed consent 20
on the individual’s behalf for the use of the [investigational drug, biological product, or 21
device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT ; AND 22
(5) [Is ineligible for or unable to participate in a clinical trial; and 23
(6)] Has documentation from the individual’s [treating] physician that the 24
individual meets the requirements of items (1) through [(5)] (4) of this subsection. 25
[(d)] (E) “Health occupations board” means a board established under the 26
Health Occupations Article that issues licenses to practice a health occupation in the State. 27
(F) (1) “INDIVIDUALIZED INVEST IGATIONAL TREATMENT ” MEANS A 28
DRUG, BIOLOGICAL PRODUCT , OR DEVICE THAT IS UN IQUE TO AND PRODUCED 29
EXCLUSIVELY FOR USE BY AN INDIVIDUAL BASED ON THE GENETIC PROFI LE OF THE 30
INDIVIDUAL. 31
HOUSE BILL 676 3
(2) “INDIVIDUALIZED INVESTIGATIONAL TREA TMENT” INCLUDES 1
INDIVIDUALIZED GENE THERAPY, ANTISENSE OLIGONUCLE OTIDES, AND 2
INDIVIDUALIZED NEOAN TIGEN VACCINES . 3
[(e)] (G) “Informed consent” means a written document prepared using the 4
informed consent form developed by the Office of the Attorney General in accordance with 5
[§ 21–2B–02(d)(1)] § 21–2B–02(B)(1) of this subtitle that: 6
(1) Is signed by the patient or a parent or legal guardian of the patient; 7
(2) Is attested to by the patient’s treating physician and a witness; and 8
(3) At a minimum: 9
(i) Explains the currently approved products and treatments for the 10
[disease or condition] LIFE–THREATENING OR SEVER ELY DEBILITATING ILL NESS from 11
which the patient suffers; 12
(ii) Attests to the fact that the patient concurs with the patient’s 13
treating physician in believing that all currently approved and conventionally recognized 14
treatments are unlikely to prolong the patient’s life; 15
(iii) Identifies clearly the specific proposed [investigational drug, 16
biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT that the 17
patient is seeking to use; 18
(iv) Informs the provider and eligible patient of any known or 19
anticipated side effects, risks, or reported patient discomfort that is likely related to the 20
treatment; 21
(v) Describes the best and worst potential outcomes of using the 22
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 23
TREATMENT with a realistic description of the most likely outcome, including the 24
possibility that new, unanticipated, different, or worse symptoms might result and that 25
death could be hastened by the proposed treatment, based on the treating physician’s 26
knowledge of the proposed treatment in conjunction with an awareness of the patient’s 27
condition; 28
(vi) Makes clear that the patient’s carrier and health care provider 29
are not obligated to pay for any care or treatments that are necessary as a result of the use 30
of the [investigational drug, biological product, or device] INDIVIDUALIZED 31
INVESTIGATIONAL TRE ATMENT except as required by federal or State law or contract; 32
(vii) Makes clear that the patient’s eligibility for hospice care may be 33
withdrawn if the patient begins curative treatment with the [investigational drug, 34
biological product, or device] INDIVIDUALIZED INVESTI GATIONAL TREATMENT and that 35 4 HOUSE BILL 676
hospice care may be reinstated if this treatment ends and the patient meets hospice 1
eligibility requirements; and 2
(viii) States that the patient understands that the patient may be 3
liable for all expenses relating to the use of the [investigational drug, biological product, or 4
device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT and that this liability extends 5
to the patient’s estate, but not the heirs or legatees of the patient. 6
[(f) “Investigational drug, biological product, or device” means a drug, biological 7
product, or device that: 8
(1) Has successfully completed Phase I of a clinical trial but has not yet 9
been approved for general use by the United States Food and Drug Administration; and 10
(2) Remains under investigation or in a clinical trial approved by the 11
United States Food and Drug Administration. 12
(g) “Terminal illness” means a disease or condition that, without life–sustaining 13
procedures, will result in death or a state of permanent unconsciousness from which 14
recovery is unlikely within 12 months.] 15
(H) “LIFE–THREATENING ” HAS THE MEANING STAT ED IN 21 C.F.R. § 16
312.81. 17
(I) “SEVERELY DEBILITATING ” HAS THE MEANING STAT ED IN 21 C.F.R. § 18
312.81. 19
21–2B–02. 20
(a) A manufacturer of an [investigational drug, biological product, or device] 21
INDIVIDUALIZED INVES TIGATIONAL TREATMENT OPERATING WITHIN AN ELIGIBLE 22
FACILITY AND IN COMPLIANCE WITH ALL LAWS APPLICABLE TO A N ELIGIBLE 23
FACILITY may: 24
(1) Provide the manufacturer’s [investigational drug, biological product, or 25
device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT to an eligible patient without 26
compensation; or 27
(2) [Subject to subsection (b) of this section, require] REQUIRE an eligible 28
patient to pay the costs of or associated with the manufacture of the [investigational drug, 29
biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT provided 30
to the eligible patient. 31
[(b) (1) Any payment required by a manufacturer under subsection (a)(2) of this 32
section shall be limited to the recovery of the costs of or associated with the manufacture of 33 HOUSE BILL 676 5
the specific investigational drug or biological product dosages or devices provided to the 1
eligible patient. 2
(2) A manufacturer of an investigational drug, biological product, or device 3
may not profit from providing an investigational drug, biological product, or device provided 4
to an eligible patient. 5
(c) After the date that an eligible patient begins taking or using the 6
investigational drug, biological product, or device and during the time the eligible patient 7
is taking or using the investigational drug, biological product, or device, the manufacturer 8
shall notify the eligible patient and the eligible patient’s health care provider of any side 9
effects or risks associated with the investigational drug, biological product, or device that 10
are required to be disclosed to the United States Food and Drug Administration during the 11
drug approval process.] 12
[(d)] (B) (1) The Office of the Attorney General shall develop an informed 13
consent form that: 14
(i) Complies with the requirements of [§ 21–2B–01(e)(3)] § 15
21–2B–01(G)(3) of this subtitle; 16
(ii) Includes instructions for the physician or patient on how to 17
complete the form; and 18
(iii) Provides spaces for a physician to include the information 19
relating to a particular patient and the physician’s recommendation for the patient. 20
(2) This subsection may not be construed to prohibit a treating physician 21
or a manufacturer of an [investigational drug, biological product, or device] 22
INDIVIDUALIZED INVES TIGATIONAL TREATMENT from including additional information 23
or advisements with the informed consent form developed under paragraph (1) of this 24
subsection. 25
21–2B–03. 26
(a) A health occupations board may not revoke, fail to renew, suspend, or take 27
any action against a health care provider’s license based solely on the health care provider’s 28
recommendation to an eligible patient regarding access to or treatment with an 29
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 30
TREATMENT . 31
(b) The Department may not take action against a health care provider’s 32
Medicare certification based solely on the health care provider’s recommendation that an 33
eligible patient have access to an [investigational drug, biological product, or device] 34
INDIVIDUALIZED INVESTIGATIONAL TREATMENT or the health care provider’s 35 6 HOUSE BILL 676
treatment of an eligible patient with an [investigational drug, biological product, or device] 1
INDIVIDUALIZED INVES TIGATIONAL TREATMENT . 2
21–2B–04. 3
(a) An official, employee, or agent of the State may not block or attempt to block 4
an eligible patient’s access to an [investigational drug, biological product, or device] 5
INDIVIDUALIZED INVES TIGATIONAL TREATMENT . 6
(b) This section does not prohibit a licensed health care provider from providing 7
counsel, advice, or a recommendation that is consistent with medical standards of care. 8
21–2B–05. 9
This subtitle does not create a private cause of action against a manufacturer of an 10
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 11
TREATMENT or against another person involved in the care of an eligible patient using the 12
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL 13
TREATMENT for any harm to the eligible patient resulting from the [investigational drug, 14
biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT if the 15
manufacturer or other person is complying in good faith with this subtitle and has exercised 16
reasonable care. 17
21–2B–06. 18
(A) This subtitle does not affect the coverage requirements under Title 15, 19
Subtitle 8 of the Insurance Article. 20
(B) A CARRIER, THIRD–PARTY ADMINISTRATOR , OR GOVERNMENT AGENCY 21
MAY PROVIDE COVERAGE FOR THE COS T OF AN INDIVIDUALIZ ED INVESTIGATIONAL 22
TREATMENT OR THE COS T OF SERVICES RELATE D TO THE USE OF AN 23
INDIVIDUALIZED INVES TIGATIONAL TREATMENT UNDER THIS SUBTITLE . 24
(C) THIS SUBTITLE DOES NO T REQUIRE: 25
(1) A GOVERNMENT AGENCY TO PAY COSTS ASSOCIATED WITH THE 26
USE, CARE, OR TREATMENT OF AN INDIVIDUAL WITH AN I NDIVIDUALIZED 27
INVESTIGATIONAL TREA TMENT; OR 28
(2) A HOSPITAL OR ANOTHER HEALTH CARE FA CILITY TO PROVIDE 29
NEW OR ADDITIONAL SE RVICES UNLESS APPROV ED BY THE HOSPITAL O R HEALTH 30
CARE FACILITY. 31
SECTION 2. AND BE IT FURTHER ENACTED, That t his Act shall take effect 32
October 1, 2024. 33