Non-Opioid Directive Act
Bill: H.R.4098 | Sponsor: Rep. McKinley, David B. (R-WV)
Policy area: Health

Summary:
Non-Opioid Directive Act
This bill requires the Department of Health and Human Services (HHS) to develop a non-opioid pain management directive. This is a form that an individual may use to inform health care providers of the individual's choice to avoid opioid medications for pain management. The bill also sets out requirements for the execution, use, and revocation of these forms.
HHS must make the form available on its website, and health insurers must make it available to their plan enrollees. Insurers must also share an enrollee's choice about opioid treatment with health care providers during pre-authorization processes.
The bill allows health care providers to override a patient's form in specified circumstances. It also extends liability protections for providers who reasonably and in good faith administer or prescribe an opioid to a patient with an executed form in place.

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Non-Opioid Directive Act''.

SEC. 2. NON-OPIOID PAIN MANAGEMENT FORM.

    (a) In General.--Title V of the Public Health Service 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 administered 
        (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 instructions on how the form 
        may be revoked and any other information that the Secretary 
        determines relevant.
            ``(3) Public availability of form.--The Secretary shall--
                    ``(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 available 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 management to 
                health care providers, professionals, and such other 
                entities as the Secretary may require for use during 
                any preauthorization process, including any prior 
                authorization relating to an occupational injury or a 
                workers' compensation claim.
    ``(b) Execution, Use, and Revocation of Form.--
            ``(1) Execution.--A non-opioid pain management form may be 
        executed by--
                    ``(A) an individual, on his or her own behalf; 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).
            ``(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 electronic 
                        medical record relating to the individual.
                            ``(ii) Requirements.--The procedures 
                        established under clause (i) shall--
                                    ``(I) 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 treatments;
                                    ``(II) if an individual chooses to 
                                use the non-opioid directive, 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 manager; and
                                    ``(III) require group health plans 
                                and health insurance issuers to provide 
                                a copy of the non-opioid pain 
                                management form during annual 
                                enrollment, specifically asking the 
                                individual 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 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 professional.
            ``(4) 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 
        (1)(B), 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 18, or regaining 
        capacity, as applicable.
    ``(c) Exception for Emergencies.--
            ``(1) 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--
                    ``(A) the individual is--
                            ``(i) receiving emergency treatment in a 
                        hospital or outside of a hospital; or
                            ``(ii) receiving the opioid through 
                        intraoperative use during surgery; and
                    ``(B) in the treating health care professional's 
                opinion, after due consideration of other options and 
                inquiring about a history of opioid use, the 
                administration of the opioid is medically necessary to 
                treat the individual.
            ``(2) Provision of information on adverse events, opioid 
        use disorder, and treatment services.--If an opioid is 
        administered under this subsection, the health care 
        professional shall ensure that the individual is provided with 
        information on adverse events, opioid use disorder, and 
        treatment services of opioid use disorder.
    ``(d) Limitation on Liability.--
            ``(1) In general.--Except as otherwise provided by law, the 
        individuals and entities described in paragraph (2) shall not 
        be subject to civil or criminal liability or professional 
        disciplinary action for failing to administer, prescribe, or 
        dispense an opioid, or for the inadvertent administration of 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 failure to act or 
        act was done reasonably and in good faith.
            ``(2) Individuals and entities described.--The individuals 
        and entities described in this paragraph are the following:
                    ``(A) A health care professional whose scope of 
                practice includes the prescribing, administering, or 
                dispensing of a controlled substance.
                    ``(B) A provider of services.
                    ``(C) An employee of a health care professional.
                    ``(D) An employee of a provider of services.
                    ``(E) Emergency and intraoperative medical services 
                personnel.
    ``(e) Regulations.--The Secretary shall promulgate such rules and 
regulations as may be required to implement this section, including the 
following:
            ``(1) Procedures to record a non-opioid pain management 
        form in a medical record, including an electronic medical 
        record.
            ``(2) Procedures to revoke a non-opioid pain management 
        form.
            ``(3) Procedures to ensure that the recording, disclosure, 
        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 laws, rules, and regulations.
            ``(4) 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 
        disorder.
            ``(5) 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 patient.
            ``(6) 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 services.
    ``(f) Definitions.--In this section:
            ``(1) Group health plan; health insurance issuer.--The 
        terms `group health plan' and `health insurance issuer' have 
        the meanings given such terms in section 2791.
            ``(2) 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 order.
            ``(3) 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 
        (a).
            ``(4) Patient advocate.--The term `patient advocate' means 
        an individual designated to make medical treatment decisions 
        for a patient.
            ``(5) Provider of services.--The term `provider of 
        services' has the meaning given such term in section 1861(u) of 
        the Social Security Act.''.
    (b) Effective Date.--Section 553 of the Public Health Service Act, 
as added by subsection (a), shall take effect on January 1, 2022.
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