I 
117TH CONGRESS 
1ST SESSION H. R. 4098 
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 HOUSE OF REPRESENTATIVES 
JUNE 23, 2021 
Mr. MCKINLEY (for himself, Ms. BLUNT ROCHESTER, Mr. CURTIS, and Mr. 
O’HALLERAN) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Non-Opioid Directive 
Act’’. 
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SEC. 2. NON-OPIOID PAIN MANAGEMENT FORM. 
(a) IN GENERAL.—Title V of the Public Health Serv-
ice Act (42 U.S.C. 290aa et seq.) is amended by inserting 
after section 552 of such Act the following: 
‘‘SEC. 553. NON-OPIOID PAIN MANAGEMENT DIRECTIVE. 
‘‘(a) DEVELOPMENT OF FORM.— 
‘‘(1) IN GENERAL.—The Secretary shall develop 
a non-opioid pain management form indicating to 
health care professionals, providers of services, and 
emergency medical services personnel that, except as 
provided in subsection (c) or in rules promulgated by 
the Secretary under subsection (e), an individual 
who has executed the form or who has had a form 
executed on the individual’s behalf must not be ad-
ministered (with the exception of intraoperative 
opioid use) an opioid or offered a prescription for an 
opioid for pain management, including post-surgical 
pain. 
‘‘(2) CONTENTS OF FORM.—The Secretary shall 
include on the non-opioid pain management form in-
structions on how the form may be revoked and any 
other information that the Secretary determines rel-
evant. 
‘‘(3) PUBLIC
AVAILABILITY
OF
FORM.—The 
Secretary shall— 
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‘‘(A) make the form available to the public 
on the website of the Department of Health and 
Human Services; 
‘‘(B) require each group health plan or 
health insurance issuer to make the form avail-
able to each enrollee; and 
‘‘(C) require each group health plan or 
health insurance issuer to include a notice of 
the individual’s choice for non-opioid pain man-
agement to health care providers, professionals, 
and such other entities as the Secretary may re-
quire for use during any preauthorization proc-
ess, including any prior authorization relating 
to an occupational injury or a workers’ com-
pensation claim. 
‘‘(b) EXECUTION, USE, 
AND
REVOCATION
OF 
FORM.— 
‘‘(1) EXECUTION.—A non-opioid pain manage-
ment form may be executed by— 
‘‘(A) an individual, on his or her own be-
half; or 
‘‘(B) a guardian or patient advocate of an 
individual on behalf of the individual, in the 
case of an individual who is a minor or who is 
incapacitated (as determined by the Secretary). 
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‘‘(2) INCLUSION IN MEDICAL RECORD.— 
‘‘(A) 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 professional, the health care professional 
shall make a copy of the form and include the 
copy in the individual’s medical record. 
‘‘(B) ELECTRONIC MEDICAL RECORDS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall establish procedures to ensure that 
any executed form is included in any elec-
tronic medical record relating to the indi-
vidual. 
‘‘(ii) 
REQUIREMENTS.—The 
proce-
dures established under clause (i) shall— 
‘‘(I) require health care providers 
and such other entities as the Sec-
retary may specify to include each in-
dividual’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 al-
lergies to treatments; 
‘‘(II) if an individual chooses to 
use the non-opioid directive, permit 
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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 
manager; and 
‘‘(III) require group health plans 
and health insurance issuers to pro-
vide a copy of the non-opioid pain 
management form during annual en-
rollment, specifically asking the indi-
vidual to opt-in or opt-out. 
‘‘(3) REVOCATION.— 
‘‘(A) 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 form. 
‘‘(B) BY
AN
AUTHORIZED
REPRESENTA-
TIVE.—A patient advocate or guardian may re-
voke a non-opioid pain management form on 
behalf of an individual at any time by issuing 
the revocation in writing and providing notice 
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