AB 188 — Revises provisions governing investigational treatments. (BDR 40-567)

Section 7.5 of this bill authorizes a patient who is being treated with anly 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 HEREAS , 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 HEREAS , The provisions of 45 C.F.R.

§ 46.116 establish requirements concerning the provision of written or oral informed consent by human subjects of research;

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

§ 46.116 requires an investigator to obtain legally effective informed consent from each human subject of research or the subject’s legally authorized representative;

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

§ 46.116, physicians and investigators demonstrate their commitment to the principles of patient autonomy, respect for patients and promoting the welfare of patients;

and W HEREAS , 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, THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:

(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.

- *AB188* – 4 – Sec.

and - *AB188_R1* – 6 – (2) Is subject to all Federalwide Assurance regulations, policies and guidelines, including, without limitation, renewals and updates;

A manufacturer that provides or makes available an individualized investigational treatment or investigational drug, biological product or device to a patient pursuant to subsection 1 or 2 shall:

(a) Establish a hotline that operates 24 hours a day, 7 days a week, including holidays, for patients who develop adverse effects or symptoms.

(b) On or before January 1, April 1, July 1 and October 1 of each year, or, if that date falls on a Saturday, Sunday or legal holiday, the next business day thereafter, submit to the Board of Medical Examiners and the State Board of Osteopathic Medicine a report summarizing information concerning the individualized investigational treatments or the investigational drugs, biological products or devices provided or made available to patients of physicians licensed by the board to which the report is submitted during the immediately preceding calendar quarter.

The report must include, without limitation:

(1) The number of patients who received the individualized investigational treatment or the investigational drug, biological product or device;

(2) Where applicable, the average number of doses received by patients;

(3) The name of the individualized investigational treatment or the investigational drug, biological product or device and, where applicable, the investigational new drug number assigned by the United States Food and Drug Administration;

(4) The disease or condition that the individualized investigational treatment or the investigational drug, biological product or device is intended to treat;

- *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;

and (6) Any known adverse effects or symptoms associated with the administration of the individualized investigational treatment or the investigational drug, biological product or device.

5.

[4.] 5.6.

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 - *AB188* – 5 – 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.

6.

Notwithstanding any provision of law to the contrary, if a patient dies while being treated with an individualized investigational treatment or investigational drug, biological product or device, the heir or heirs of the deceased patient must not be held personally liable for any outstanding debt related to such treatment.

ANotwithstanding violation of any provision of thislaw sectionto isthe contrary, if a misdemeanor.patient dies while being treated with an individualized investigational treatment or investigational drug, biological product or device, the heir or heirs of the deceased patient must not be held personally liable for any outstanding debt related to such treatment.

[5.] 8.

A violation of any provision of this section , except for subsection 4, is a misdemeanor.

[5.] 9.

If a manufacturer fails to comply with the provisions of subsection 4 and such failure is not caused by excusable neglect, technical problems or other extenuating circumstances, the manufacturer is liable for a civil penalty to be recovered by the Attorney General in an amount of $5,000 for each day of such failure.

The Attorney General shall deposit any civil penalties collected pursuant to this subsection with the State Treasurer for credit to the State General Fund.

10.

(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 coursemeaning ofascribed theto diseaseit orin condition21 isC.F.R. interrupted.

(e)§ “Severely312.81, debilitatingas diseaseinterpreted orby condition”any meansguidance aof diseasethe orUnited conditionStates thatFood causesand majorDrug irreversibleAdministration. morbidity.

-(e) *AB188*“Severely –debilitating 6disease –or Sec.condition” has the meaning ascribed to it in 21 C.F.R.

§ 312.81, as interpreted by any guidance of the United States Food and Drug Administration.

Sec.

- *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.

- *AB188* – 7 – (l) Failure by a licensee or applicant to report in writing, within 30 days, any criminal action taken or conviction obtained against the licensee or applicant, other than a minor traffic violation, in this State or any other state or by the Federal Government, a branch of the Armed Forces of the United States or any local or federal jurisdiction of a foreign country.

(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:

- *AB188* – 8 – 2.

[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,metabolites or an immunity panel, as applicable to the individualized investigational treatment;

An informed, written consent must be recorded on a form signed by the patient, or the representative or parent or legal guardian of the patient, as applicable,applicable that. contains:

(a)[, An explanation of all methods of treating the [terminal] life- threatening or severely debilitating disease or condition of the patient that arecontains:] currentlyThe approvedform bymust: the United States Food and Drug Administration;

(b)(a) A[An] statementTo that the patient,extent orpracticable, thebe representativein orthe parentpreferred orlanguage legal guardian of the patient, asor applicable, and the physicianrepresentative agree that no such method is likely to [significantly prolong the life] adequately treat the life-threatening or severelyparent debilitating disease or conditionlegal guardian of the patient;patient, as applicable.

(c)(b) ClearBe identificationin oflanguage thethat specificis individualizedat investigationalthe treatmentreading orlevel investigationalof drug,an biologicaleighth productgrader - *AB188* – 9 – or devicea proposedpupil toenrolled treatin thea [terminal]lower life-threateninggrade. or severely debilitating disease or condition of the patient;

(d)(c) AInclude description of the consequences of using the individualized investigational treatment or investigationalbe drug,accompanied biologicalby: product or device, which must include, without limitation:

(1) AAn overview of the provisions of this section and NRS 454.690, including, without limitation, a detailed description of the bestprovisions of subsection 1 and worstthe possibleterms outcomes;defined in subsection 8;

(2) A realisticcomprehensive descriptionexplanation of all methods of treating the most[terminal] likelylife-threatening outcome,or inseverely thedebilitating opiniondisease or condition of the physician;patient that are currently approved by the United States Food and Drug Administration [;] , including, without limitation, information concerning such methods published by the United States Food and Drug Administration, the National Institutes of Health or other federal agencies;

and[(b)] (3) A statement ofthat the possibilitypatient, thator using the individualizedrepresentative investigationalor treatmentparent or investigationallegal drug,guardian biologicalof productthe orpatient, deviceas mayapplicable, resultand inthe new,physician unanticipated,agree differentthat orno worsesuch symptomsmethod oris thelikely deathto of[significantly prolong the patientlife] occurringadequately soonertreat than if the individualizedlife-threatening investigational treatment or investigationalseverely drug,debilitating biologicaldisease product or devicecondition isof notthe used;patient;

(e)[(c)] A(4) statementClear thatidentification a health insurer of the patientspecific 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 or device unlessproposed suchto caretreat or treatment is specifically included in the policy[terminal] oflife-threatening insuranceor coveringseverely thedebilitating patientdisease andor thatcondition future benefits under the policy of insurance covering the patientpatient; may be affected by the patient’s use of the individualized investigational treatment or investigational drug, biological product or device;

and[(d)] (f)(5) A statementdetailed thatdescription the patient, or the representative or parent or legal guardian of the patient,consequences as applicable, understands that the patient is liable for all costs resulting from the use of theusing 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, andwhich thatmust suchinclude, liabilitywithout willlimitation: be passed on to the estate of the patient upon the death of the patient.

[(1)] (I) A detailed description of the best and worst possible outcomes;

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

(III) A detailed description of relevant information that is not known about the individualized investigational treatment or investigational drug, biological product or device;

and [(3)] (IV) A statement of the possibility that using the individualized investigational treatment or investigational drug, biological product or device may result in new, unanticipated, different or worse symptoms or the death of the patient occurring sooner than if the individualized investigational treatment or investigational drug, biological product or device is not used [;] and a detailed description of any known new, different or worse symptoms the patient may suffer;

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

(I) Make an informed decision concerning the use of the individualized investigational treatment or investigational drug, biological product or device;

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

(7) Information concerning resources that may be useful to the patient, including, without limitation, the contact information for agencies or organizations that may be able to provide support to the patient;

(8) A means by which the patient may contact the manufacturer of the individualized investigational treatment or investigational drug, biological product or device with any additional questions or concerns;

[(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 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 - *AB188_R1* – 13 – 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.

A physician iswho notprescribes subject to disciplinary action for prescribing or recommendingrecommends an individualized investigational treatment or investigational drug, biological product or device when authorized to doa sopatient pursuantshall provide to subsectionthe 1.patient a form that:

(a) To the extent practicable, is in the preferred language of the patient;

and (b) Contains:

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

(2) The instructions for use and, where applicable, the recommended dosage of the individualized investigational treatment or investigational drug, biological product or device;

(3) Where applicable, the investigational new drug number assigned by the United States Food and Drug Administration;

(4) The telephone number for the hotline established pursuant to subsection 4 of NRS 454.690;

(5) The contact information, telephone number, hours of operation and physical address of an emergency room or urgent care facility that is easily accessible to the patient if the patient experiences an adverse effect or symptom;

and (6) Any other information concerning the individualized investigational treatment or investigational drug, biological product or device that is relevant to the care of the patient.

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 physician who prescribed or recommended the individualized investigational treatment or investigational drug, biological product or device shall notify the Board.

5.

On or before January 31 of each odd-numbered year, the Board shall submit to the Director of the Legislative Counsel Bureau for transmittal to the next regular session of the Legislature a summary of the information reported to the Board pursuant to subsection 4 and subsection 4 of NRS 454.690 during the immediately preceding biennium.

6.

A physician is not subject to disciplinary action for prescribing or recommending an individualized investigational treatment or investigational drug, biological product or device when authorized to do so pursuant to subsection 1.

7.

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.

[4.] 8.

[(b) “Terminal condition”] - *AB188* – 10 – (c) “Life-threatening disease or condition” has the meaning ascribed to it in NRS 454.690.

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

- *AB188* – 11 – (7) Conviction for the use or unlawful possession of a controlled substance or dangerous drug as defined in chapter 454 of NRS.

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

- *AB188* – 12 – (q) Is an advanced practice registered nurse who has failed to obtain any training required by the Board pursuant to NRS 632.2375.

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

- *AB188* – 13 – (7) Sexual assault, statutory sexual seduction, incest, lewdness, indecent exposure or any other sexually related crime;

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

- *AB188* – 14 – (n) Terminating the medical care of a patient without adequate notice or without making other arrangements for the continued care of the patient.

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

- *AB188* – 15 – Sec.

[and] (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,metabolites or an immunity panel, as applicable to the individualized investigational treatment;

An informed, written consent must be recorded on a form signed by the patient, or the representative or parent or legal guardian of the patient, as applicable,applicable that. contains:

(a)[, An explanation of all methods of treating the [terminal] life- threatening or severely debilitating disease or condition of the patient that arecontains:] currentlyThe approvedform bymust: the United States Food and Drug Administration;

(b)(a) A[An] statementTo that the patient,extent orpracticable, thebe representativein orthe parentpreferred orlanguage legal guardian of the patient, asor applicable, and the osteopathicrepresentative physician agree that no such method is likely to [significantly prolong the life] adequately treat the life-threatening or severelyparent debilitating disease or conditionlegal guardian of the patient;patient, as applicable.

(c)(b) ClearBe identificationin oflanguage thethat specificis individualizedat investigationalthe treatmentreading orlevel investigationalof drug,an biologicaleighth productgrader or devicea proposedpupil toenrolled treatin thea [terminal]lower life-threateninggrade. or severely debilitating disease or condition of the patient;

(d) A description of the consequences of using the individualized investigational treatment or investigational drug, - *AB188**AB188_R1* – 1620 – biological(c) productInclude or device,be whichaccompanied mustby: include, without limitation:

(1) AAn overview of the provisions of this section and NRS 454.690, including, without limitation, a detailed description of the bestprovisions of subsection 1 and worstthe possibleterms outcomes;defined in subsection 8;

(2) A realisticcomprehensive descriptionexplanation of all methods of treating the most[terminal] likelylife-threatening outcome,or inseverely thedebilitating opiniondisease or condition of the osteopathicpatient physician;that are currently approved by the United States Food and Drug Administration [;] , including, without limitation, information concerning such methods published by the United States Food and Drug Administration, the National Institutes of Health or other federal agencies;

and[(b)] (3) A statement ofthat the possibilitypatient, thator using the individualizedrepresentative investigationalor treatmentparent or investigationallegal drug,guardian biologicalof productthe orpatient, deviceas mayapplicable, resultand inthe new,osteopathic unanticipated,physician differentagree orthat worseno symptomssuch ormethod theis deathlikely ofto the[significantly patientprolong occurringthe soonerlife] thanadequately iftreat the individualizedlife-threatening investigational treatment or investigationalseverely drug,debilitating biologicaldisease product or devicecondition isof notthe used;patient;

(e)[(c)] A(4) statementClear thatidentification a health insurer of the patientspecific 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 or device unlessproposed suchto caretreat or treatment is specifically included in the policy[terminal] oflife-threatening insuranceor coveringseverely thedebilitating patientdisease andor thatcondition future benefits under the policy of insurance covering the patientpatient; may be affected by the patient’s use of the individualized investigational treatment or investigational drug, biological product or device;

and[(d)] (f)(5) A statementdetailed thatdescription the patient, or the representative or parent or legal guardian of the patient,consequences as applicable, understands that the patient is liable for all costs resulting from the use of theusing 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, andwhich thatmust suchinclude, liabilitywithout willlimitation: be passed on to the estate of the patient upon the death of the patient.

[(1)] (I) A detailed description of the best and worst possible outcomes;

[(2)] (II) A realistic and detailed description of the most likely outcome, in the opinion of the osteopathic physician;

(III) A detailed description of relevant information that is not known about the individualized investigational treatment or investigational drug, biological product or device;

and [(3)] (IV) A statement of the possibility that using the individualized investigational treatment or investigational drug, biological product or device may result in new, unanticipated, different or worse symptoms or the death of the patient occurring sooner than if the individualized investigational treatment or investigational drug, biological product or device is not used [;] and a detailed description of any known new, different or worse symptoms the patient may suffer;

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

(I) Make an informed decision concerning the use of the individualized investigational treatment or investigational drug, biological product or device;

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;

(7) Information concerning resources that may be useful to the patient, including, without limitation, the contact information for agencies or organizations that may be able to provide support to the patient;

(8) A means by which the patient may contact the manufacturer of the individualized investigational treatment or investigational drug, biological product or device with any additional questions or concerns;

[(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 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.

An osteopathic physician iswho notprescribes subject to disciplinary action for prescribing or recommendingrecommends an individualized investigational treatment or investigational drug, biological product or device when authorized to doa sopatient pursuantshall provide to subsectionthe 1.patient a form that:

(a) To the extent practicable, is in the preferred language of the patient;

and (b) Contains:

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

(2) The instructions for use and, where applicable, the recommended dosage of the individualized investigational treatment or investigational drug, biological product or device;

(3) Where applicable, the investigational new drug number assigned by the United States Food and Drug Administration;

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

(5) The contact information, telephone number, hours of operation and physical address of an emergency room or urgent care facility that is easily accessible to the patient if the patient experiences an adverse effect or symptom;

and (6) Any other information concerning the individualized investigational treatment or investigational drug, biological product or device that is relevant to the care of the patient.

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

5.

On or before January 31 of each odd-numbered year, the Board shall submit to the Director of the Legislative Counsel Bureau for transmittal to the next regular session of the Legislature a summary of the information reported to the Board pursuant to subsection 4 and subsection 4 of NRS 454.690 during the immediately preceding biennium.

6.

An osteopathic physician is not subject to disciplinary action for prescribing or recommending an individualized investigational treatment or investigational drug, biological product or device when authorized to do so pursuant to subsection 1.

7.

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

[4.] 8.

- *AB188* – 17 – Sec.

7.3.

The provisions of subsection 1 of NRS 218D.380 do not apply to any provision of this act which adds or revises a requirement to submit a report to the Legislature.

Sec.

7.5.

1.

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.

2.

As used in this section:

(a) “Individualized investigational treatment” has the meaning ascribed to it in NRS 454.690, as amended by section 2 of this act.

(b) “Investigational drug, biological product or device” has the meaning ascribed to it in NRS 454.690, as amended by section 2 of this act.

Sec.

1.

H2. - *AB188*

Sections 1 to 7, inclusive, of this act expire by limitation on July 1, 2027.

H - *AB188_R1*