Sec. 2. Liability protections for opioid overdose reversal drugs
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In this section: The term first responder means— a first responder as defined in section 3025 of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10705 ); or a special agent or task force officer of the Drug Enforcement Administration. The term health care provider has the meaning given such term in section 101 of the Family and Medical Leave Act of 1993 ( 29 U.S.C. 2611 ). The term lay administrator — means— an individual at risk of undergoing an opioid-related overdose; an individual in a position to assist an individual at risk of undergoing an opioid-related overdose, including a family member or friend of such an individual at risk; or an employee or volunteer of a community-based organization; and excludes a first responder as defined in paragraph (1).
The term opioid overdose reversal drug means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) that is designed to rapidly reverse the effects of an opioid-related overdose. A health care provider, engaged in or affecting interstate or foreign commerce, may, subject to subparagraphs
(B)and (C), prescribe, dispense, or distribute an opioid overdose reversal drug to— an individual at risk of undergoing an opioid-related overdose; or an individual who is in a position to assist an individual at such risk, including a family member or friend of such an individual at risk. Upon prescribing, dispensing, or distributing an opioid overdose reversal drug to any individual as described in subparagraph (A), a health care provider (or designated staff of such provider) shall provide to that individual (or, with respect an individual described in subparagraph (A)(i), a family member or caregiver of such individual as the health care provider determines appropriate) education and training that includes information on— the importance of seeking medical care for the individual undergoing the opioid-related overdose immediately after the drug is administered; how to access substance use disorder treatment services; how the opioid overdose reversal drug operates to stop an opioid-related overdose; when the administration of the opioid overdose reversal drug is medically indicated; how to properly administer the opioid overdose reversal drug and circumstances under which administration of the opioid overdose reversal drug is contraindicated; precautions, warnings, and potential reactions with respect to the opioid overdose reversal drug; techniques on how to recognize symptoms of an opioid-related overdose; standards and procedures for the storage of the drug; proper disposal of expired opioid overdose reversal drugs; and emergency follow-up procedures. A health care provider shall maintain a record of each individual to whom the health care provider (or designated staff) has provided the education and training under subparagraph (B). Each such record shall be maintained for a period of 2 years beginning on the date on which the health care provider (or designated staff) provides the education and training. A health care provider, engaged in or affecting interstate or foreign commerce, shall be immune from civil liability, criminal prosecution, or disciplinary or other adverse action under any professional licensing statute for any outcomes resulting from— an action taken by the provider that is authorized under paragraph (1); or the administration by a person other than the health care provider of the opioid overdose reversal drug to an individual regardless of whether that individual is the person to whom the provider prescribed the drug. Subparagraph
(A)shall not apply in the case that personal injury results from the gross negligence or willful or wanton misconduct of the health care provider. A first responder, engaged in or affecting interstate or foreign commerce, may, subject to subparagraphs
(B)and (C), receive a prescription or supply allocation for an opioid overdose reversal drug (including through a standing order), maintain the drug in the possession of the first responder, administer the drug to any individual who is undergoing or whom the responder believes is undergoing an opioid-related overdose, or distribute the drug to an individual described in clause
(i)or
(ii)of subsection (b)(1)(A). Prior to receiving a prescription or supply allocation for an opioid overdose reversal drug as described in subparagraph (A), a first responder shall— complete the education and training provided by a health care provider (or designated staff) under subsection (b)(1)(B); or review the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration (or a successor publication), or a substantially similar publication from the applicable State public health agency. The requirement under clause
(i)to complete the education and training or review the toolkit described in such clause shall be completed not less than once every 2 years. A first responder shall maintain— a record of each instance in which the first responder administers or distributes an opioid overdose reversal drug in accordance with subparagraph
(A)for a period of 2 years beginning on the date on which the first responder administers or distributes the drug; and verification that the first responder has complied with the requirements under subparagraph
(B)for a period of 2 years following each completion or review described in such subparagraph. A first responder who takes any action authorized under paragraph
(1)shall be immune from civil liability, criminal prosecution, or disciplinary or other adverse action under any professional licensing statute for any outcomes resulting from such action. Subparagraph
(A)shall not apply in the case that personal injury results from the gross negligence or willful or wanton misconduct of the first responder. A lay administrator, engaged in or affecting interstate or foreign commerce, may, subject to subparagraphs
(B)and (C), receive a prescription for an opioid overdose reversal drug (including through a standing order), maintain the drug in the possession of the lay administrator, and administer the drug to— in the case of a lay administrator described in subsection (a)(3)(A)(i), the lay administrator; in the case of a lay administrator described in subsection (a)(3)(A)(ii), the individual at risk described in such subsection; or in the case of a lay administrator described in subsection (a)(3)(A)(iii), any individual who is undergoing, or who is believed to be undergoing an opioid-related overdose, and is being served through the organization described in such subsection. Prior to receiving a prescription for an opioid overdose reversal drug as described in subparagraph (A), a lay administrator shall— complete the education and training provided by a health care provider (or designated staff) under subsection (b)(1)(B); or review the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration (or a successor publication), or a substantially similar publication from the applicable State public health agency. The requirement under clause
(i)to complete the education and training or review the toolkit described in such clause shall be completed not less than once every 2 years. A lay administrator shall maintain verification that the lay administrator has complied with the requirements under subparagraph
(B)for a period of 2 years following each completion or review described in such subparagraph. A lay administrator who takes any action authorized under paragraph
(1)shall be immune from civil liability, criminal prosecution, or disciplinary or other adverse action under any professional licensing statute (including any penalties for the unauthorized practice of medicine) for any outcomes resulting from such action. Subparagraph
(A)shall not apply in the case that personal injury results from the gross negligence or willful or wanton misconduct of the lay administrator. It is the sense of Congress that a lay administrator should— call 9–1–1 immediately following administering an opioid overdose reversal drug to an individual as described in paragraph (1)(A); and report to a first responder— the name, address, and phone number of any individual for whom the opioid overdose reversal drug was administered as described in such paragraph; and the status as an injection or spray of the opioid overdose reversal drug used in such administration. This section shall preempt any State law that conflicts with the authorities and protections provided under this section, except in the case of a State law that provides greater protection from liability than the protection provided under this section. This section shall cease to have any force or effect on the date that is 90 days after the last day of the public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ) with respect to the opioid crisis, including any renewal of such emergency.
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Sec. 2
Liability protections for opioid overdose reversal drugs
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