WES MOORE, Governor Ch. 960
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Chapter 960
(House Bill 676)
AN ACT concerning
Right to Try Act – Individualized Investigational Treatments
FOR the purpose of altering certain provisions of law authorizing certain activity by
manufacturers of investigational drugs, biological products, or devices under the
Right to Try Act to apply to manufacturers of certain individualized investigational
treatments; altering the definition of “eligible patient” under the Right to Try Act to
include individuals who have life–threatening or severely debilitating illnesses,
rather than only individuals who have terminal illnesses; repealing the restriction
on the receipt of payments from eligible patients by manufacturers of investigational
drugs, biological products, or devices; repealing the prohibition on manufacturers of
investigational drugs, biological products, or devices profiting from the provision of
the drugs, biological products, or devices; authorizing health insurance carriers,
third–party administrators, and government agencies to provide coverage for the
cost of investigational treatments and services related to the use of individualized
investigational treatments; and generally relating to the Right to Try Act and
individualized investigational treatments.
BY repealing and reenacting, with amendments,
Article – Health – General
Section 21–2B–01 through 21–2B–06
Annotated Code of Maryland
(2023 Replacement Volume)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Health – General
21–2B–01.
(a) In this subtitle the following words have the meanings indicated.
(b) “Carrier” has the meaning stated in § 15–10A–01(c) of the Insurance Article.
(C) “ELIGIBLE FACILITY ” MEANS AN INSTITUTION OPERATING UNDER A
FEDERALWIDE ASSURANC E FOR THE PROTECTION OF HUMAN SUBJECTS IN
ACCORDANCE WITH 42 U.S.C. § 289(A) AND 28 C.F.R. PART 46.
[(c)] (D) “Eligible patient” means an individual who:
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(1) Has a [terminal] LIFE–THREATENING OR SEVER ELY DEBILITATING
illness, attested to by the individual’s treating physician;
(2) Has considered all other treatment options currently approved by the
United States Food and Drug Administration;
(3) Has received a recommendation from the individual’s [treating]
physician for [the use of an investigational drug, biological product, or device] AN
INDIVIDUALIZED INVES TIGATIONAL TREATMENT BASED ON ANALYSIS OF THE
INDIVIDUAL’S GENOMIC SEQUENCE , HUMAN CHROMOSOMES , DEOXYRIBONUCLEIC
ACID, RIBONUCLEIC ACID , GENES, GENE PRODUCTS , INCLUDING ENZYMES AN D
OTHER TYPES OF PROTE INS, OR METABOLITES ;
(4) (i) Has given informed consent for the use of the [investigational
drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT ; or
(ii) If the individual is a minor or lacks the mental capacity to
provide informed consent, has a parent or legal guardian who has given informed consent
on the individual’s behalf for the use of the [investigational drug, biological product, or
device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT ; AND
(5) [Is ineligible for or unable to participate in a clinical trial; and
(6)] Has documentation from the individual’s [treating] physician that the
individual meets the requirements of items (1) through [(5)] (4) of this subsection.
[(d)] (E) “Health occupations board” means a board established under the
Health Occupations Article that issues licenses to practice a health occupation in the State.
(F) (1) “INDIVIDUALIZED INVEST IGATIONAL TREATMENT ” MEANS A
DRUG, BIOLOGICAL PRODUCT , OR DEVICE THAT IS UN IQUE TO AND PRODUCED
EXCLUSIVELY FOR USE BY AN INDIVIDUAL BAS ED ON THE GENETIC PR OFILE OF THE
INDIVIDUAL.
(2) “INDIVIDUALIZED INVEST IGATIONAL TREATMENT ” INCLUDES
INDIVIDUALIZED GENE THERAPY, ANTISENSE OLIGONUCLE OTIDES, AND
INDIVIDUALIZED NEOAN TIGEN VACCINES .
[(e)] (G) “Informed consent” means a written document prepared using the
informed consent form developed by the Office of the Attorney General in accordance with
[§ 21–2B–02(d)(1)] § 21–2B–02(B)(1) of this subtitle that:
(1) Is signed by the patient or a parent or legal guardian of the patient;
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(2) Is attested to by the patient’s treating physician and a witness; and
(3) At a minimum:
(i) Explains the currently approved products and treatments for the
[disease or condition] LIFE–THREATENING OR SEVER ELY DEBILITATING ILL NESS from
which the patient suffers, INCLUDING ALTERNATIV E PROCEDURES OR COUR SES OF
TREATMENT , IF KNOWN TO THE TREA TING PHYSIC IAN, THAT MIGHT BE
ADVANTAGEOUS TO THE PATIENT;
(ii) Attests to the fact that the patient concurs with the patient’s
treating physician in believing that all currently approved and conventionally recognized
treatments are unlikely to prolong the patient’s life;
(iii) Identifies clearly the specific proposed [investigational drug,
biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT that the
patient is seeking to use;
(iv) Informs the provider and eligible patient of any known or,
anticipated, OR REASONABLY FORESE EABLE side effects, risks, or reported patient
discomfort that is likely related to the treatment;
(v) Describes the best and worst potential outcomes of using the
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
TREATMENT with a realistic description of the most likely outcome, including the
possibility that new, unanticipated, different, or worse symptoms might result and that
death could be hastened by the proposed treatment, based on the treating physician’s
knowledge of the proposed treatment in conjunction with an awareness of the patient’s
condition;
(vi) Makes clear that the patient’s carrier and health care provider
are not obligated to pay for any care or treatments that are necessary as a result of the use
of the [investigational drug, biological product, or device] INDIVIDUALIZED
INVESTIGATIONAL TREA TMENT except as required by federal or State law or contract;
(vii) Makes clear that the patient’s eligibility for hospice care may be
withdrawn if the patient begins curative treatment with the [investigational drug,
biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT and that
hospice care may be reinstated if this treatment ends and the patient meets hospice
eligibility requirements; and
(viii) States that the patient understands that the patient may be
liable for all expenses relating to the use of the [investigational drug, biological product, or
device] INDIVIDUALIZED INVES TIGATIONAL TRE ATMENT and that this liability extends
to the patient’s estate, but not the heirs or legatees of the patient; AND Ch. 960 2024 LAWS OF MARYLAND
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(IX) INCLUDES A STATEMENT DESCRIBING THE EXTEN T TO
WHICH CONFIDENTIALIT Y OF RECORDS THAT ID ENTIFY THE PATIENT W ILL BE
MAINTAINED .
[(f) “Investigational drug, biological product, or device” means a drug, biological
product, or device that:
(1) Has successfully completed Phase I of a clinical trial but has not yet
been approved for general use by the United States Food and Drug Administration; and
(2) Remains under investigation or in a clinical trial approved by the
United States Food and Drug Administration.
(g) “Terminal illness” means a disease or condition that, without life–sustaining
procedures, will result in death or a state of permanent unconsciousness from which
recovery is unlikely within 12 months.]
(H) “LIFE–THREATENING ” HAS THE MEANING STAT ED IN 21 C.F.R. §
312.81.
(I) “SEVERELY DEBILITATING ” HAS THE MEANING STAT ED IN 21 C.F.R. §
312.81.
21–2B–02.
(a) A manufacturer of an [investigational drug, biological product, or device]
INDIVIDUALIZED INVES TIGATIONAL TREATMENT OPERATING WITHIN AN ELIGIBLE
FACILITY AND IN COMP LIANCE WITH ALL LAWS APPLICABLE TO AN ELI GIBLE
FACILITY may:
(1) Provide the manufacturer’s [investigational drug, biological product, or
device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT to an eligible patient without
compensation; or
(2) [Subject to subsection (b) of this section, require] REQUIRE an eligible
patient to pay the costs of or associated with the manufacture of the [investigational drug,
biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT provided
to the eligible patient.
[(b) (1) Any payment required by a manufacturer under subsection (a)(2) of this
section shall be limited to the recovery of the costs of or associated with the manufacture of
the specific investigational drug or biological product dosages or devices provided to the
eligible patient. WES MOORE, Governor Ch. 960
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(2) A manufacturer of an investigational drug, biological product, or device
may not profit from providing an investigational drug, biological product, or device provided
to an eligible patient.
(c) After the date that an eligible patient begins taking or using the
investigational drug, biological product, or device and during the time the eligible patient
is taking or using the investigational drug, biological product, or device, the manufacturer
shall notify the eligible patient and the eligible patient’s health care provider of any side
effects or risks associated with the investigational drug, biological product, or device that
are required to be disclosed to the United States Food and Drug Administration during the
drug approval process.]
[(d)] (B) (1) The Office of the Attorney General shall develop an informed
consent form that:
(i) Complies with the requirements of [§ 21–2B–01(e)(3)] §
21–2B–01(G)(3) of this subtitle;
(ii) Includes instructions for the physician or patient on how to
complete the form; and
(iii) Provides spaces for a physician to include the information
relating to a particular patient and the physician’s recommendation for the patient.
(2) This subsection may not be construed to prohibit a treating physician
or a manufacturer of an [investigational drug, biological product, or device]
INDIVIDUALIZED INVES TIGATIONAL TREATMENT from including additional information
or advisements with the informed consent form developed under paragraph (1) of this
subsection.
21–2B–03.
(a) A health occupations board may not revoke, fail to renew, suspend, or take
any action against a health care provider’s license based solely on the health care provider’s
recommendation to an eligible patient regarding access to or treatment with an
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
TREATMENT .
(b) The Department may not take action against a health care provider’s
Medicare certification based solely on the health care provider’s recommendation that an
eligible patient have access to an [investigational drug, biological product, or device]
INDIVIDUALIZED INVES TIGATIONAL TREATMENT or the health care provider’s
treatment of an eligible patient with an [investigational drug, biological product, or device]
INDIVIDUALIZED INVES TIGATIONAL TREATMENT . Ch. 960 2024 LAWS OF MARYLAND
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21–2B–04.
(a) An official, employee, or agent of the State may not block or attempt to block
an eligible patient’s access to an [investigational drug, biological product, or device]
INDIVIDUALIZED INVES TIGATIONAL TREATMENT .
(b) This section does not prohibit a licensed health care provider from providing
counsel, advice, or a recommendation that is consistent with medical standards of care.
21–2B–05.
This subtitle does not create a private cause of action against a manufacturer of an
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
TREATMENT or against another person involved in the care of an eligible patient using the
[investigational drug, biological product, or device] INDIVIDUALIZED INVES TIGATIONAL
TREATMENT for any harm to the eligible patient resulting from the [investigational drug,
biological product, or device] INDIVIDUALIZED INVES TIGATIONAL TREATMENT if the
manufacturer or other person is complying in good faith with this subtitle and has exercised
reasonable care.
21–2B–06.
(A) This subtitle does not affect the coverage requirements under Title 15,
Subtitle 8 of the Insurance Article.
(B) A CARRIER, THIRD–PARTY ADMINISTRATOR , OR GOVERNMENT AGENCY
MAY PROVIDE COVERAGE FOR THE COST OF AN I NDIVIDUALIZ ED INVESTIGATIONAL
TREATMENT OR THE COS T OF SERVICES RELATE D TO THE USE OF AN
INDIVIDUALIZED INVES TIGATIONAL TREATMENT UNDER THIS SUBTITLE .
(C) THIS SUBTITLE DOES NO T REQUIRE:
(1) A GOVERNMENT AGENCY TO PAY COSTS ASSOCIATED WITH THE
USE, CARE, OR TREA TMENT OF AN INDIVIDU AL WITH AN INDIVIDUA LIZED
INVESTIGATIONAL TREA TMENT; OR
(2) A HOSPITAL OR ANOTHER HEALTH CARE FACILITY TO PROVIDE
NEW OR ADDITIONAL SE RVICES UNLESS APPROV ED BY THE HOSPITAL O R HEALTH
CARE FACILITY.
SECTION 2. AND BE IT FURTHER ENA CTED, That this Act shall take effect
October 1, 2024.
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Approved by the Governor, May 16, 2024.