,,ii #aagth ,,congress #ast ,session ,s4 #abib ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #ba1 #bjba ,mr4 ,manchin 7for himself and ,mr4 ,scott of ,south ,carolina7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to develop a non-opioid pain management directive indicating to health care professionals and emergency medical services personnel that an individual with respect to whom a form has been executed must not be administered an opioid or offered a prescription for an opioid1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,non-,opioid ,directive ,act4 #b4 ,non-opioid pain management form 7a7 ,in general ,title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is amended by inserting after section #eeb of such ,act the following3 #eec4 ,non-opioid pain management directive 7a7 ,development of form 7#a7 ,in general ,the ,secretary shall develop a non-opioid pain management form indicating to health care professionals1 providers of services1 and emergency medical services personnel that1 except as provided in subsection 7c7 or in rules promulgated by the ,secretary under subsection 7e71 an individual who has executed the form or who has had a form executed on the individual's behalf must not be administered 7with the exception of intraoperative opioid use7 an opioid or offered a prescription for an opioid for pain management1 including post-surgical pain4 7#b7 ,contents of form ,the ,secretary shall include on the non-opioid pain management form instructions on how the form may be revoked and any other information that the ,secretary determines relevant4 7#c7 ,public availability of form ,the ,secretary shall-- 7,a7 make the form available to the public on the website of the ,department of ,health and ,human ,services2 7,b7 require each group health plan or health insurance issuer to make the form available to each enrollee2 and 7,c7 require each group health plan or health insurance issuer to include a notice of the individual's choice for non-opioid pain management to health care providers1 professionals1 and such other entities as the ,secretary may require for use during any preauthorization process1 including any prior authorization relating to an occupational injury or a workers' compensation claim4 7b7 ,execution1 use1 and revocation of form 7#a7 ,execution ,a non-opioid pain management form may be executed by-- 7,a7 an individual1 on his or her own behalf2 or 7,b7 a guardian or patient advocate of an individual on behalf of the individual1 in the case of an individual who is a minor or who is incapacitated 7as determined by the ,secretary74 7#b7 ,inclusion in medical record 7,a7 ,in general ,if a non-opioid pain management form is executed by or on behalf of an individual and is presented to a health care professional1 the health care professional shall make a copy of the form and include the copy in the individual's medical record4 7,b7 ,electronic medical records 7i7 ,in general ,the ,secretary shall establish procedures to ensure that any executed form is included in any electronic medical record relating to the individual4 7ii7 ,requirements ,the procedures established under clause 7i7 shall-- 7,i7 require health care providers and such other entities as the ,secretary may specify to include each individual's choice to exercise a non-opioid pain management directive in a clear part in the medical records in a similar manner as it would display allergies to treatments2 7,,ii7 if an individual chooses to use the non-opioid directive1 permit the individual to report the existence of a non-opioid pain management form to their employer or group health plan or health insurance issuer to serve as notice to the health plan or issuer and any pharmacy benefit manager2 and 7,,iii7 require group health plans and health insurance issuers to provide a copy of the non-opioid pain management form during annual enrollment1 specifically asking the individual to opt in or opt out4 7#c7 ,revocation 7,a7 ,by the individual ,an individual may revoke a non-opioid pain management form executed by themselves at any time and in any manner by which they are able to communicate their intent to revoke the form4 7,b7 ,by an authorized representative ,a patient advocate or guardian may revoke a non-opioid pain management form on behalf of an individual at any time by issuing the revocation in writing and providing notice of the revocation to the individual's health care professional4 7#d7 ,notification requirement ,in the case of a non-opioid pain management form executed by a patient advocate or guardian on behalf of an individual pursuant to paragraph 7#a77;,b71 any health care professional who copied and included the form in the individual's medical record shall notify the patient of such form upon the patient turning #ah1 or regaining capacity1 as applicable4 7c7 ,exception for emergencies 7#a7 ,in general ,a health care professional who is authorized to dispense a particular opioid under the ,controlled ,substances ,act and is authorized to dispense controlled substances by the ,state in which the health care professional practices may administer that opioid to an individual who has executed a non-opioid pain management form or who has had a non-opioid pain management form executed on their behalf if-- 7,a7 the individual is-- 7i7 receiving emergency treatment in a hospital or outside of a hospital2 or 7ii7 receiving the opioid through intraoperative use during surgery2 and 7,b7 in the treating health care professional's opinion1 after due consideration of other options and inquiring about a history of opioid use1 the administration of the opioid is medically necessary to treat the individual4 7#b7 ,provision of information on adverse events1 opioid use disorder1 and treatment services ,if an opioid is administered under this subsection1 the health care professional shall ensure that the individual is provided with information on adverse events1 opioid use disorder1 and treatment services of opioid use disorder4 7d7 ,limitation on liability 7#a7 ,in general ,except as otherwise provided by law1 the individuals and entities described in paragraph 7#b7 shall not be subject to civil or criminal liability or professional disciplinary action for failing to administer1 prescribe1 or dispense an opioid1 or for the inadvertent administration of an opioid1 to an individual who has executed a non-opioid pain management form or who has had a non-opioid pain management form executed on his or her behalf1 if the failure to act or act was done reasonably and in good faith4 7#b7 ,individuals and entities described ,the individuals and entities described in this paragraph are the following3 7,a7 ,a health care professional whose scope of practice includes the prescribing1 administering1 or dispensing of a controlled substance4 7,b7 ,a provider of services4 7,c7 ,an employee of a health care professional4 7,d7 ,an employee of a provider of services4 7,e7 ,emergency and intraoperative medical services personnel4 7e7 ,regulations ,the ,secretary shall promulgate such rules and regulations as may be required to implement this section1 including the following3 7#a7 ,procedures to record a non-opioid pain management form in a medical record1 including an electronic medical record4 7#b7 ,procedures to revoke a non-opioid pain management form4 7#c7 ,procedures to ensure that the recording1 disclosure1 or distribution of data relating to a non-opioid pain management form or the transmission of a non-opioid pain management form complies with ,state and ,federal confidentiality and consent laws1 rules1 and regulations4 7#d7 ,exceptions for administering or prescribing an opioid to an individual who has executed a non-opioid pain management form or who has had a non-opioid pain management form executed on his or her behalf if the opioid is administered or prescribed to treat the individual for a substance use disorder4 7#e7 ,exceptions for administering or prescribing an opioid to an individual who has executed a non-opioid pain management form or who has had a non-opioid pain management form executed on his or her behalf if the individual is a hospice patient4 7#f7 ,the rules promulgated under this section must allow a health care professional or provider of services to incorporate a non-opioid pain management form into an existing patient form or into other documentation used by the health care professional or provider of services4 7f7 ,definitions ,in this section3 7#a7 ,group health plan2 health insurance issuer ,the terms group health plan and health insurance issuer have the meanings given such terms in section #bgia4 7#b7 ,guardian ,the term guardian means a person with the powers and duties to make medical treatment decisions on behalf of a patient to the extent granted by court order4 7#c7 ,non-opioid pain management form ,the term non-opioid pain management form means the non-opioid pain management form developed by the ,secretary under subsection 7a74 7#d7 ,patient advocate ,the term patient advocate means an individual designated to make medical treatment decisions for a patient4 7#e7 ,provider of services ,the term provider of services has the meaning given such term in section #ahfa7u7 of the ,social ,security ,act4 4 7b7 ,effective date ,section #eec of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect on ,january #a1 #bjbb4