Existing law requires each custodian of health care records to make health care records available for inspection by a patient, certain representatives of a patient and certain government officials. (NRS 629.061) Upon request of such a person, section 1 of this bill requires a custodian of health care records to electronically transmit the health care records to the person or, if the patient has provided written authorization for records to be furnished to another person or entity, to that person or entity. Existing law authorizes a custodian of health care records to charge certain fees for furnishing a copy of health care records. (NRS 629.061) Section 1: (1) generally prohibits a custodian of health care records from charging a fee that exceeds $40 or other amounts prescribed by existing law for furnishing a copy of health care records electronically if the custodian of health care records maintains such health care records electronically; and (2) authorizes a custodian of health care records, other than the health care records of a state or local governmental entity, to charge certain additional fees in certain circumstances. Section 2 of this bill makes a conforming change to indicate the proper placement of section 1 in the Nevada Revised Statutes. Existing law prohibits a person from disclosing or compelling a person to disclose the identity of a person who was the subject of a genetic test or any genetic information of another person, with certain exceptions, without first obtaining the informed consent of that person or his or her legal guardian. (NRS 629.171) Section 1.5 of this bill adds an exception to this prohibition to authorize a person to disclose such information as permitted by the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191. Existing federal law prohibits the introduction of a drug or biological product into interstate commerce if the drug or biological product has not received approval from the United States Food and Drug Administration. (21 U.S.C. § 355; 42 U.S.C. § 262) Existing federal regulations allow expanded access to investigational drugs and biological products for patients who have a life-threatening or severely debilitating disease or condition, or a serious or immediately life-threatening illness, under certain circumstances. (21 C.F.R. Part 312, Subparts E and I) Existing Nevada law authorizes the manufacturer of an investigational drug, biological product or device, upon the prescription or recommendation of a physician, to provide or make available the investigational drug, biological product or device to a patient who has been diagnosed with a terminal condition that will, without the administration of life-sustaining treatment, result in death within 1 year. (NRS 454.690) Existing law authorizes a physician to issue a prescription or recommendation for an investigational drug, biological product or device if the physician has: (1) diagnosed the patient with a terminal condition; (2) consulted with the patient and the patient and physician have determined that no treatment currently approved by the United States Food and Drug Administration is adequate to treat the terminal condition; and (3) obtained informed, written consent to the use of the investigational drug, biological product or device from the patient or his or her representative, parent or guardian. (NRS 630.3735, 633.6945) Sections 1.6, 1.9 and 2.7 of this bill: (1) remove the requirement that a patient be diagnosed with a terminal condition before a physician is authorized to prescribe or recommend, and a manufacturer is authorized to provide, an investigational drug, biological product or device; and (2) instead require the patient to be diagnosed with a life-threatening or severely debilitating disease or condition before such actions are authorized. Section 2.7 additionally: (1) authorizes the manufacturer of an individualized investigational treatment to make the treatment available to such a patient under similar conditions to an investigational drug, biological product or device if the manufacturer operates in a facility that meets certain federal requirements for the protection of human subjects; and (2) defines “individualized investigational treatment” to mean a drug, biological product or device that is unique to and produced exclusively for use by an individual patient based on the genetic profile of the patient. Sections 1.6 and 1.9 authorize a physician to prescribe or recommend an individualized investigational treatment under similar conditions to those under which a physician is authorized to recommend an investigational drug, biological product or device, except that sections 1.6 and 1.9 require the physician to additionally conduct certain biochemical analyses. Section 2.7 requires a manufacturer that provides or makes available an individualized investigational treatment or investigational drug, biological product or device to establish a hotline for patients who develop adverse effects or symptoms. Section 2.7 also requires such a manufacturer to submit quarterly reports to the Board of Medical Examiners and the State Board of Osteopathic Medicine summarizing the individualized investigational treatments or investigational drugs, biological products or devices provided to patients of physicians who are licensed by those boards. Section 2.7 establishes an administrative penalty to be imposed against a manufacturer that fails to submit the required report. Section 2.7 also provides that 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 are not personally liable for any outstanding debt related to such treatment. 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. (NRS 454.690) Section 2.7 additionally: (1) provides that counseling, advice or a recommendation from a physician consistent with medical standards of care is not a violation; and (2) makes it a misdemeanor for such an officer, employee or agent to prevent or attempt to prevent a patient from accessing an individualized investigational treatment if the same requirements are met. Sections 1.6 and 1.9 revise the requirements concerning the informed, written consent that a physician is required to obtain before prescribing or recommending an individualized investigational treatment or an investigational drug, biological product or device. Sections 1.6 and 1.9 also require a physician who prescribes or recommends an individualized investigational treatment or an investigational drug, biological product or 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; and (2) the treatment of adverse effects or symptoms caused by the individualized investigational treatment or investigational drug, biological product or device. Sections 1.6 and 1.9 require such a physician to report to the Board of Medical Examiners or the State Board of Osteopathic Medicine, as appropriate, if a patient dies or is hospitalized as the result of using an individualized investigational treatment or investigational drug, biological product or device. Sections 1.6 and 1.9 require those boards to submit to the Legislature a biennial summary of the information reported to those boards pursuant to sections 1.6, 1.9 and 2.7 concerning individualized investigational treatments and investigational drugs, biological products and devices. Sections 1.6 and 1.9 additionally authorize those boards to adopt regulations to ensure the safety and efficacy of individualized investigational treatments and investigational drugs, biological products and devices. Existing law: (1) generally makes it a misdemeanor for any person to possess, procure, obtain, process, produce, derive, manufacture, sell, offer for sale, give away or otherwise furnish any drug which may not be lawfully introduced into interstate commerce under the Federal Food, Drug and Cosmetic Act; 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 2.5 of this bill additionally exempts from the criminal 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. (NRS 630.306, 632.347, 633.511) Sections 1.55, 1.7 and 1.8 of this bill additionally exempt such persons from professional discipline if the substance is an individualized investigational treatment. Existing law requires a collection agency, not less than 60 days before taking any action to collect a medical debt, to send by registered or certified mail to the medical debtor written notification setting forth certain information. (NRS 649.366) Section 2.3 of this bill removes the requirement that the written notification be sent by mail that is registered or certified. Existing law provides for the payment of compensation to employees who are injured or disabled as a result of an occupational injury or disease. (Chapters 616A-616D and 617 of NRS) Existing law entitles any injured employee or a person who has been authorized by the injured employee to information from the records of an insurer or employer to the extent necessary for the proper presentation of such a claim. (NRS 616B.012) Existing regulations: (1) prescribe a process for an injured employee or person who has been authorized by the injured employee to request such information from the records of an insurer or employer; and (2) prohibit an insurer or employer from charging a fee that is more than 30 cents per page when providing the requested information. (NAC 616B.008) Upon receiving such a request for health care records, section 3 of this bill requires an insurer, third-party administrator or employer to furnish any health care records to the injured employee or his or her legal representative. Section 3 authorizes an insurer, third-party administrator or employer to electronically transmit such health care records using a method of secure electronic transmission. Section 3 prescribes the maximum amounts of fees for furnishing health care records in response to such a request, which depend on whether the records are furnished by electronic mail, through a secure electronic method of file sharing or in a nonelectronic format. Section 4 of this bill makes a conforming change to clarify that section 3 provides an exception to the general requirement that information obtained from an insurer or employer remain confidential. Section 8 of this bill provides that the provisions of sections 1.55-1.9, 2.5 and 2.7 expire on July 1, 2027. Section 6 of this bill authorizes a patient who is being treated with an 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.

Statutes affected:
As Introduced: 641.2291, 616B.012
Reprint 1: 641.2291, 616B.012
Reprint 2: 629.171, 641.2291, 616B.012
Reprint 3: 629.171, 630.306, 630.3735, 632.347, 633.511, 633.6945, 641.2291, 649.366, 454.351, 454.690, 616B.012
As Enrolled: 629.171, 630.306, 630.3735, 632.347, 633.511, 633.6945, 641.2291, 649.366, 454.351, 454.690, 616B.012
BDR: 641.2291, 616B.012