Section 2 establishes an administrative penalty to be imposed against a manufacturer that fails to submit the required report.

Section 2 also provides that if a patient dies while being treated with an individualized investigational treatment or investigational drug, biological product or device, the debtheir relatedor toheirs suchof treatment.atientthe deceased patient are not personally liable for any outstanding Existingdebt lawrelated makes it a misdemeanor for any officer, employee or agent of this State to preventsuch ortreatment. attempt to prevent a patient from accessing an investigational drug, biological product or device if certain requirements are met.

Existing law makes it a misdemeanor for any officer, employee or agent of this State to prevent or attempt to prevent a patient from accessing an investigational drug, biological product or device if certain requirements are met.

(1) provides that counseling, advice or a recommendation -from *AB188_R1* – 3 – (2) makes it a misdemeanorphysician forconsistent suchwith anmedical officer,standards employeeof orcare agentis tonot prevent orand attempt to prevent a patientviolation; from accessing an individualized investigational treatment if the same requirements are met.

Sectionsand 4(2) andmakes 7it revisea themisdemeanor requirementsfor concerningsuch thean informed,officer, writtenemployee consentor thatagent ato physicianprevent isor requiredattempt to obtainprevent beforea prescribingpatient orfrom recommendingaccessing an individualized investigational treatment orif anthe investigationalsame drug,requirements biologicalare productmet. or device.

Sections 4 and 7 alsorevise requirethe arequirements physicianconcerning whothe prescribesinformed, orwritten recommendsconsent anthat individualizeda investigationalphysician treatmentis orrequired anto investigationalobtain drug,before informationprescribing concerning:or recommending an device.

(1)Sections the4 and 7 also require a physician who prescribes or recommends anroduct or individualized investigational treatment ornsor certainan investigational drug, biological product or device;device to provide the patient with a form that contains certain information concerning:

(1) the individualized investigational treatment or investigational drug, biological product or device;

Sections 4 and 7 require those boards toSenate submitAmendment toNo. the Legislature a biennial summary of the information reported to those boards and investigational drugs, biological products and devices.

Sections612 4 and 7eatments additionally authorize those boards to adoptAssembly regulationsBill toNo. ensure the safety and efficacy of individualized investigational treatments and investigational drugs, biological products and devices.

188 Page 5 to submit to the Legislature a biennial summary of the information reported to those boards pursuant to sections 2, 4 and 7 concerning individualized investigational treatments and investigational drugs, biological products and devices.

Sections 4 and 7 of individualized investigational treatments and investigational drugs, biologicalefficacy products and devices.

and (2) exempts from that criminal penalty a person who engages in certain acts to make an investigational drug or biological product available when certain requirements are met.

(NRS 454.351) Section 1 of this bill additionally exempts from the criminalrecriminal penalty a manufacturer who provides an individualized investigational treatment.

Existing law provides that a physician or person engaged in the practice of professional nursing who procures or administers a controlled substance or dangerous drug is not subject to professional discipline if the controlled substance or dangerous drug is an investigative drug or biological product prescribed by a physician.

Section 8 of this bill provides that the provisions of this bill expire on July 1, 2027.

Section 7.5 of this bill authorizes a patient who is being treated with anlyan 1, individualized investigational treatment or an investigational drug, biological product or device on June 30, 2027, to continue to receive such treatment on and after July 1, 2027, regardless of whether the patient remains eligible to receive such treatment.

W HEREASHEREAS, , As dedicated providers of health care committed to providing the highest standard of care, physicians are required to adhere to federal regulations governing the informed consent of patients;

and - *AB188_R1* – 4 – W HEREASHEREAS, , The provisions of 45 C.F.R.

and W HEREASHEREAS, , To ensure ethical research practices, 45 C.F.R.

and W HEREASHEREAS, , Such informed consent should be obtained under circumstances that allow the person providing informed consent sufficient opportunity to engage in discussions and consider participation while minimizing the potential for coercion and undue influence;

and W HEREASHEREAS, , Information provided to a person from whom such informed consent is sought must be conveyed in a language that is understandable to that person;

and W HEREASHEREAS, , Effective communication is crucial to ensure that the person from whom such informed consent is sought fully comprehends the nature of the research, the potential risks and benefits of participating in the research and the alternatives to such participation in order to make an informed decision concerning such participation;

and W HEREASHEREAS, , By adhering to the provisions of 45 C.F.R.

and W HEREASHEREAS, , Informed consent serves as a cornerstone of the ethical practice of medicine and osteopathic medicine by promoting transparency, trust and collaboration between physicians and their patients;

now, therefore, THESenate PEOPLEAmendment OFNo. THE STATE OF NEVADA, REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:

Section612 1.to Assembly Bill No.

188 Page 6 THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:

4 Section 1.

(a) To physicians licensed to practice in this State who have been authorized by the United States Food and Drug Administration to possess experimental drugs for the purpose of conducting research to evaluate the effectiveness of such drugs and who maintain complete and accurate records of the use of such drugs and - *AB188_R1* – 5 – submit clinical reports as required by the United States Food and Drug Administration.

and -Senate *AB188_R1*Amendment –No. 6 – (2) Is subject to all Federalwide Assurance regulations, policies and guidelines, including, without limitation, renewals and updates;

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188 Page 7 (2) Is subject to all Federalwide Assurance regulations, policies and guidelines, including, without limitation, renewals and updates;

- *AB188_R1* – 7 – (5) The uses for which the individualized investigational treatment or the investigational drug, biological product or device was provided or made available;

[4.][4. 6.

This5.] section6. does not create a private cause of action against the manufacturer of an individualized investigational treatment or investigational drug, biological product or device, or against any other person or entity involved in the care of a patient who uses an individualized investigational treatment or investigational drug, biological product or device for any harm done to the patient resulting from the individualized investigational treatment or investigational drug, biological product or device, if the manufacturer or other person or entity is complying in good faith with the provisions of this section and has exercised reasonable care.

7.This section does not create a private cause of action against the manufacturer of an individualized investigational treatment or investigational drug, biological product or device, or against any other person or entity involved in the care of a patient who uses an individualized investigational treatment or investigational drug, biological product or device for any harm done to the Senate Amendment No.

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188 Page 8 patient resulting from the individualized investigational treatment or investigational drug, biological product or device, if the manufacturer or other person or entity is complying in good faith with the provisions of this section and has exercised reasonable care.

[6.] 7.

[7.] 8.

[5.][5. 9.

8.] 9.

(b) “Individualized investigational treatment” means a drug, biological product or device that is unique to and produced - *AB188_R1* – 8 – exclusively for use by an individual patient based on the genetic profile of the patient, including, without limitation, by an analysis of the genomic sequence of the patient, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as enzymes and other types of proteins or metabolites.

[(c) “Terminal condition” means an incurable and irreversible condition that, without the administration of life-sustaining treatment, will, in the opinion of the attending physician, result in death within 1 year.] (d) “Life-threatening disease or condition” [means a disease or condition that has a high likelihood of death unless the course of the disease or condition is interrupted.] has the meaning ascribed to it in 21 C.F.R.

(e) “Severely debilitating disease or condition” [means a disease or condition that causes major irreversible morbidity.] has the meaning ascribed to it in 21 C.F.R.

(2)Senate WhichAmendment theNo. Board has determined is a violation of the standards of practice established by regulation of the Board;

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188 Page 9 (2) Which the Board has determined is a violation of the standards of practice established by regulation of the Board;

- *AB188_R1* – 9 – (e) Practicing or offering to practice beyond the scope permitted by law or performing services which the licensee knows or has reason to know that he or she is not competent to perform or which are beyond the scope of his or her training.

(q) Knowingly or willfully procuring or administering a controlled substance or a dangerous drug as defined in chapter 454 of NRS that is not approved by the United States Food and Drug - *AB188_R1* – 10 – Administration, unless the unapproved controlled substance or dangerous drug:

(2)Senate WasAmendment procuredNo. through a Canadian pharmacy which is licensed pursuant to chapter 639 of NRS and which has been recommended by the State Board of Pharmacy pursuant to subsection 4 of NRS 639.2328;

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188 Page 10 (2) Was procured through a Canadian pharmacy which is licensed pursuant to chapter 639 of NRS and which has been recommended by the State Board of Pharmacy pursuant to subsection 4 of NRS 639.2328;

[and] (c) For an individualized investigational treatment, conducted an analysis of the patient’s genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, - *AB188_R1* – 11 – gene products or metabolites [,] or an immunity panel, as applicable to the individualized investigational treatment;

(b)Senate BeAmendment inNo. language that is at the reading level of an eighth grader or a pupil enrolled in a lower grade.

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188 Page 11 (b) Be in language that is at the reading level of an eighth grader or a pupil enrolled in a lower grade.

- *AB188_R1* – 12 – [(2)] (II) A realistic and detailed description of the most likely outcome, in the opinion of the physician;

[(e)] (9) A statement that a health insurer of the patient may not be required to pay for care or treatment of any condition resulting from the use of the individualized investigational treatment or investigational drug, biological product orSenate deviceAmendment unlessNo. such care or treatment is specifically included in the policy of insurance covering the patient and that future benefits under the policy of insurance covering the patient may be affected by the patient’s use of the individualized investigational treatment or investigational drug, biological product or device;

and612 [(f)] (10) A statement that the patient, or the representative or parent or legal guardian of the patient, as applicable, understands that the patient is liable for all costs resulting from the use of the individualized investigational treatment or investigational drug, biological product or device, including, without limitation, costs resulting from care or treatment of any condition resulting from the use of the individualized investigational treatment or - *AB188_R1* – 13 – investigational drug, biological product or device, and that such liability will be passed on to theAssembly estateBill ofNo. the patient upon the death of the patient.

188 Page 12 or device unless such care or treatment is specifically included in the policy of insurance covering the patient and that future benefits under the policy of insurance covering the patient may be affected by the patient’s use of the individualized investigational treatment or investigational drug, biological product or device;

and [(f)] (10) A statement that the patient, or the representative or parent or legal guardian of the patient, as applicable, understands that the patient is liable for all costs resulting from the use of the individualized investigational treatment or investigational drug, biological product or device, including, without limitation, costs resulting from care or treatment of any condition resulting from the use of the individualized investigational treatment or investigational drug, biological product or device, and that such liability will be passed on to the estate of the patient upon the death of the patient.

The Board may adopt regulations to ensure the safety and efficacy of individualized investigational treatments and - *AB188_R1* – 14 – investigational drugs, biological products and devices prescribed or recommended pursuant to this section.

(b)Senate “InvestigationalAmendment drug,No. biological product or device” has the meaning ascribed to it in NRS 454.690.

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188 Page 13 (b) “Investigational drug, biological product or device” has the meaning ascribed to it in NRS 454.690.

- *AB188_R1* – 15 – (3) Impersonating another licensed practitioner or holder of a certificate.

(k)Senate HasAmendment falsifiedNo. information which was given to a physician, pharmacist, podiatric physician or dentist to obtain a controlled substance.

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188 Page 14 (k) Has falsified information which was given to a physician, pharmacist, podiatric physician or dentist to obtain a controlled substance.

- *AB188_R1* – 16 – (o) Has willfully failed to comply with a regulation, subpoena or order of the Board.

(b)Senate “InvestigationalAmendment drugNo. or biological product” has the meaning ascribed to it in NRS 454.351.

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188 Page 15 (b) “Investigational drug or biological product” has the meaning ascribed to it in NRS 454.351.

- *AB188_R1* – 17 – (2) A felony relating to the practice of osteopathic medicine or practice as a physician assistant;

- *AB188_R1* – 18 – (3) Is cannabis being used for medical purposes in accordance with chapter 678C of NRS;

(m)Senate Attempting,Amendment directlyNo. or indirectly, by intimidation, coercion or deception, to obtain or retain a patient or to discourage the use of a second opinion.

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188 Page 16 (m) Attempting, directly or indirectly, by intimidation, coercion or deception, to obtain or retain a patient or to discourage the use of a second opinion.

- *AB188_R1* – 19 – (z) Failure to comply with the provisions of NRS 441A.315 or any regulations adopted pursuant thereto.

[and] (c)Senate ForAmendment anNo. individualized investigational treatment, conducted an analysis of the patient’s genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products or metabolites or an immunity panel, as applicable to the individualized investigational treatment;

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188 Page 17 (c) For an individualized investigational treatment, conducted an analysis of the patient’s genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products or metabolites [,] or an immunity panel, as applicable to the individualized investigational treatment;

- *AB188_R1* – 20 – (c) Include or be accompanied by:

[(b)] (3) A statement that the patient, or the representative or parent or legal guardian of the patient, as applicable, and the osteopathic physician agree that no such method is likely to [significantly prolong the life] adequately treat the life-threateninglife- threatening or severely debilitating disease or condition of the patient;

(6)Senate AAmendment statementNo. of the rights of the patient, including, without limitation, the rights to:

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188 Page 18 (6) A statement of the rights of the patient, including, without limitation, the rights to:

and - *AB188_R1* – 21 – (II) Withdraw from or refuse treatment using the individualized investigational treatment or investigational drug, biological product or device at any time;

- *AB188_R1* – 22 – (4) The telephone number for the hotline established pursuant to subsection 4 of NRS 454.690;

Not later than 72 hours after the death or hospitalization of a patient which results from the use of an individualized investigational treatment or investigational drug, biological product or device, the osteopathic physician who prescribedSenate orAmendment recommendedNo. the individualized investigational treatment or investigational drug, biological product or device shall notify the Board.

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188 Page 19 prescribed or recommended the individualized investigational treatment or investigational drug, biological product or device shall notify the Board.

A patient who is being treated with an individualized investigational treatment or an investigational drug, - *AB188_R1* – 23 – biological product or device on June 30, 2027, may continue to receive such treatment on and after July 1, 2027, regardless of whether the patient remains eligible to receive such treatment.

H - *AB188_R1*