Non-Opioid Directive Act

II 117TH CONGRESS 1ST SESSION S. 1292 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 opioid, and for other purposes. IN THE SENATE OF THE UNITED STATES APRIL 21, 2021 Mr. MANCHIN (for himself and Mr. SCOTT of South Carolina) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To develop a non-opioid pain management directive indi- cating to health care professionals and emergency med- ical services personnel that an individual with respect to whom a form has been executed must not be adminis- tered an opioid or offered a prescription for an opioid, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Non-Opioid Directive 4 Act’’. 5 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 1292 IS SEC. 2. NON-OPIOID PAIN MANAGEMENT FORM. 1 (a) IN GENERAL.—Title V of the Public Health Serv- 2 ice Act (42 U.S.C. 290aa et seq.) is amended by inserting 3 after section 552 of such Act the following: 4 ‘‘SEC. 553. NON-OPIOID PAIN MANAGEMENT DIRECTIVE. 5 ‘‘(a) DEVELOPMENT OF FORM.— 6 ‘‘(1) IN GENERAL.—The Secretary shall develop 7 a non-opioid pain management form indicating to 8 health care professionals, providers of services, and 9 emergency medical services personnel that, except as 10 provided in subsection (c) or in rules promulgated by 11 the Secretary under subsection (e), an individual 12 who has executed the form or who has had a form 13 executed on the individual’s behalf must not be ad- 14 ministered (with the exception of intraoperative 15 opioid use) an opioid or offered a prescription for an 16 opioid for pain management, including post-surgical 17 pain. 18 ‘‘(2) CONTENTS OF FORM.—The Secretary shall 19 include on the non-opioid pain management form in- 20 structions on how the form may be revoked and any 21 other information that the Secretary determines rel- 22 evant. 23 ‘‘(3) PUBLIC AVAILABILITY OF FORM.—The 24 Secretary shall— 25 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 1292 IS ‘‘(A) make the form available to the public 1 on the website of the Department of Health and 2 Human Services; 3 ‘‘(B) require each group health plan or 4 health insurance issuer to make the form avail- 5 able to each enrollee; and 6 ‘‘(C) require each group health plan or 7 health insurance issuer to include a notice of 8 the individual’s choice for non-opioid pain man- 9 agement to health care providers, professionals, 10 and such other entities as the Secretary may re- 11 quire for use during any preauthorization proc- 12 ess, including any prior authorization relating 13 to an occupational injury or a workers’ com- 14 pensation claim. 15 ‘‘(b) EXECUTION, USE, AND REVOCATION OF 16 FORM.— 17 ‘‘(1) EXECUTION.—A non-opioid pain manage- 18 ment form may be executed by— 19 ‘‘(A) an individual, on his or her own be- 20 half; or 21 ‘‘(B) a guardian or patient advocate of an 22 individual on behalf of the individual, in the 23 case of an individual who is a minor or who is 24 incapacitated (as determined by the Secretary). 25 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 1292 IS ‘‘(2) INCLUSION IN MEDICAL RECORD.— 1 ‘‘(A) IN GENERAL.—If a non-opioid pain 2 management form is executed by or on behalf 3 of an individual and is presented to a health 4 care professional, the health care professional 5 shall make a copy of the form and include the 6 copy in the individual’s medical record. 7 ‘‘(B) ELECTRONIC MEDICAL RECORDS.— 8 ‘‘(i) IN GENERAL.—The Secretary 9 shall establish procedures to ensure that 10 any executed form is included in any elec- 11 tronic medical record relating to the indi- 12 vidual. 13 ‘‘(ii) REQUIREMENTS.—The proce- 14 dures established under clause (i) shall— 15 ‘‘(I) require health care providers 16 and such other entities as the Sec- 17 retary may specify to include each in- 18 dividual’s choice to exercise a non- 19 opioid pain management directive in a 20 clear part in the medical records in a 21 similar manner as it would display al- 22 lergies to treatments; 23 ‘‘(II) if an individual chooses to 24 use the non-opioid directive, permit 25 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 1292 IS the individual to report the existence 1 of a non-opioid pain management 2 form to their employer or group 3 health plan or health insurance issuer 4 to serve as notice to the health plan 5 or issuer and any pharmacy benefit 6 manager; and 7 ‘‘(III) require group health plans 8 and health insurance issuers to pro- 9 vide a copy of the non-opioid pain 10 management form during annual en- 11 rollment, specifically asking the indi- 12 vidual to opt in or opt out. 13 ‘‘(3) REVOCATION.— 14 ‘‘(A) BY THE INDIVIDUAL.—An individual 15 may revoke a non-opioid pain management form 16 executed by themselves at any time and in any 17 manner by which they are able to communicate 18 their intent to revoke the form. 19 ‘‘(B) BY AN AUTHORIZED REPRESENTA- 20 TIVE.—A patient advocate or guardian may re- 21 voke a non-opioid pain management form on 22 behalf of an individual at any time by issuing 23 the revocation in writing and providing notice 24 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 1292 IS of the revocation to the individual’s health care 1 professional. 2 ‘‘(4) NOTIFICATION REQUIREMENT.—In the 3 case of a non-opioid pain management form executed 4 by a patient advocate or guardian on behalf of an 5 individual pursuant to paragraph (1)(B), any health 6 care professional who copied and included the form 7 in the individual’s medical record shall notify the pa- 8 tient of such form upon the patient turning 18, or 9 regaining capacity, as applicable. 10 ‘‘(c) EXCEPTION FOR EMERGENCIES.— 11 ‘‘(1) IN GENERAL.—A health care professional 12 who is authorized to dispense a particular opioid 13 under the Controlled Substances Act and is author- 14 ized to dispense controlled substances by the State 15 in which the health care professional practices may 16 administer that opioid to an individual who has exe- 17 cuted a non-opioid pain management form or who 18 has had a non-opioid pain management form exe- 19 cuted on their behalf if— 20 ‘‘(A) the individual is— 21 ‘‘(i) receiving emergency treatment in 22 a hospital or outside of a hospital; or 23 ‘‘(ii) receiving the opioid through 24 intraoperative use during surgery; and 25 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 1292 IS ‘‘(B) in the treating health care profes- 1 sional’s opinion, after due consideration of 2 other options and inquiring about a history of 3 opioid use, the administration of the opioid is 4 medically necessary to treat the individual. 5 ‘‘(2) PROVISION OF INFORMATION ON ADVERSE 6 EVENTS, OPIOID USE DISORDER, AND TREATMENT 7 SERVICES.—If an opioid is administered under this 8 subsection, the health care professional shall ensure 9 that the individual is provided with information on 10 adverse events, opioid use disorder, and treatment 11 services of opioid use disorder. 12 ‘‘(d) LIMITATION ON LIABILITY.— 13 ‘‘(1) IN GENERAL.—Except as otherwise pro- 14 vided by law, the individuals and entities described 15 in paragraph (2) shall not be subject to civil or 16 criminal liability or professional disciplinary action 17 for failing to administer, prescribe, or dispense an 18 opioid, or for the inadvertent administration of an 19 opioid, to an individual who has executed a non- 20 opioid pain management form or who has had a non- 21 opioid pain management form executed on his or her 22 behalf, if the failure to act or act was done reason- 23 ably and in good faith. 24 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 8 •S 1292 IS ‘‘(2) INDIVIDUALS AND ENTITIES DE- 1 SCRIBED.—The individuals and entities described in 2 this paragraph are the following: 3 ‘‘(A) A health care professional whose 4 scope of practice includes the prescribing, ad- 5 ministering, or dispensing of a controlled sub- 6 stance. 7 ‘‘(B) A provider of services. 8 ‘‘(C) An employee of a health care profes- 9 sional. 10 ‘‘(D) An employee of a provider of services. 11 ‘‘(E) Emergency and intraoperative med- 12 ical services personnel. 13 ‘‘(e) REGULATIONS.—The Secretary shall promulgate 14 such rules and regulations as may be required to imple- 15 ment this section, including the following: 16 ‘‘(1) Procedures to record a non-opioid pain 17 management form in a medical record, including an 18 electronic medical record. 19 ‘‘(2) Procedures to revoke a non-opioid pain 20 management form. 21 ‘‘(3) Procedures to ensure that the recording, 22 disclosure, or distribution of data relating to a non- 23 opioid pain management form or the transmission of 24 a non-opioid pain management form complies with 25 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 9 •S 1292 IS State and Federal confidentiality and consent laws, 1 rules, and regulations. 2 ‘‘(4) Exceptions for administering or pre- 3 scribing an opioid to an individual who has executed 4 a non-opioid pain management form or who has had 5 a non-opioid pain management form executed on his 6 or her behalf if the opioid is administered or pre- 7 scribed to treat the individual for a substance use 8 disorder. 9 ‘‘(5) Exceptions for administering or pre- 10 scribing an opioid to an individual who has executed 11 a non-opioid pain management form or who has had 12 a non-opioid pain management form executed on his 13 or her behalf if the individual is a hospice patient. 14 ‘‘(6) The rules promulgated under this section 15 must allow a health care professional or provider of 16 services to incorporate a non-opioid pain manage- 17 ment form into an existing patient form or into 18 other documentation used by the health care profes- 19 sional or provider of services. 20 ‘‘(f) DEFINITIONS.—In this section: 21 ‘‘(1) GROUP HEALTH PLAN; HEALTH INSUR- 22 ANCE ISSUER.—The terms ‘group health plan’ and 23 ‘health insurance issuer’ have the meanings given 24 such terms in section 2791. 25 VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS 10 •S 1292 IS ‘‘(2) GUARDIAN.—The term ‘guardian’ means a 1 person with the powers and duties to make medical 2 treatment decisions on behalf of a patient to the ex- 3 tent granted by court order. 4 ‘‘(3) NON-OPIOID PAIN MANAGEMENT FORM.— 5 The term ‘non-opioid pain management form’ means 6 the non-opioid pain management form developed by 7 the Secretary under subsection (a). 8 ‘‘(4) PATIENT ADVOCATE.—The term ‘patient 9 advocate’ means an individual designated to make 10 medical treatment decisions for a patient. 11 ‘‘(5) PROVIDER OF SERVICES.—The term ‘pro- 12 vider of services’ has the meaning given such term 13 in section 1861(u) of the Social Security Act.’’. 14 (b) EFFECTIVE DATE.—Section 553 of the Public 15 Health Service Act, as added by subsection (a), shall take 16 effect on January 1, 2022. 17 Æ VerDate Sep 11 2014 03:54 May 22, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S1292.IS S1292 pbinns on DSKJLVW7X2PROD with BILLS