```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7312 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 7312

 To provide for requirements for electronic-prescribing for controlled 
  substances under group health plans and group and individual health 
                          insurance coverage.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            February 9, 2024

Ms. Kuster (for herself, Mr. Balderson, and Ms. Letlow) introduced the 
   following bill; which was referred to the Committee on Energy and 
   Commerce, and in addition to the Committees on Education and the 
   Workforce, Ways and Means, and the Judiciary, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL

 
 To provide for requirements for electronic-prescribing for controlled 
  substances under group health plans and group and individual health 
                          insurance coverage.

    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 ``Electronic Prescribing for 
Controlled Substances Act'' or the ``EPCS 2.0 Act''.

SEC. 2. REQUIREMENTS FOR ELECTRONIC-PRESCRIBING FOR CONTROLLED 
              SUBSTANCES UNDER GROUP HEALTH PLANS AND GROUP AND 
              INDIVIDUAL HEALTH INSURANCE COVERAGE.

    (a) Public Health Service Act Amendment.--Section 2799A-7 of the 
Public Health Service Act (42 U.S.C. 300gg-117) is amended by adding at 
the end the following new subsection:
    ``(d) Requirements for Electronic-Prescribing for Controlled 
Substances.--
            ``(1) In general.--Except as provided pursuant to paragraph 
        (2), for plan years beginning on or after January 1, 2026, a 
        group health plan and a health insurance issuer offering group 
        or individual health insurance coverage, with respect to a 
        participating provider, as defined in section 2799-1(a)(3), 
        shall have in place policies, subject to paragraphs (4) and 
        (5), that require any prescription for a schedule II, III, IV, 
        or V controlled substance (as defined by section 202 of the 
        Controlled Substances Act) covered by the plan or coverage that 
        is transmitted by such a participating provider for such a 
        participant, beneficiary, or enrollee be electronically 
        transmitted consistent with standards established under 
        paragraph (3) of section 1860D-4(e) of the Social Security Act, 
        under an electronic prescription drug program that meets 
        requirements that are substantially similar (as jointly 
        determined by the Secretary, the Secretary of Labor, and the 
        Secretary of the Treasury) to the requirements of paragraph (2) 
        of such section 1860D-4(e).
            ``(2) Exception for certain circumstances.--The Secretary, 
        the Secretary of Labor, and the Secretary of the Treasury shall 
        jointly, through rulemaking, specify circumstances and 
        processes by which the requirement under paragraph (1) may be 
        waived, with respect to a schedule II, III, IV, or V controlled 
        substance that is a prescription drug covered by a group health 
        plan or group or individual health insurance coverage offered 
        by a health insurance issuer, including in the case of--
                    ``(A) a prescription issued when the participating 
                provider and dispensing pharmacy are the same entity;
                    ``(B) a prescription issued that cannot be 
                transmitted electronically under the most recently 
                implemented version of the National Council for 
                Prescription Drug Programs SCRIPT Standard;
                    ``(C) a prescription issued by a participating 
                provider who received a waiver (which may include a 
                waiver obtained pursuant to section 1860D-
                4(e)(7)(B)(iii) of the Social Security Act) or a 
                renewal thereof for a period of time as determined by 
                the Secretary, the Secretary of Labor, and the 
                Secretary of the Treasury, not to exceed one year, from 
                the requirement to use electronic prescribing due to 
                demonstrated economic hardship, technological 
                limitations that are not reasonably within the control 
                of the participating provider, or other exceptional 
                circumstance demonstrated by the participating 
                provider;
                    ``(D) a prescription issued by a participating 
                provider under circumstances in which, notwithstanding 
                the participating provider's ability to submit a 
                prescription electronically as required by this 
                subsection, such participating provider reasonably 
                determines that it would be impractical for the 
                individual involved to obtain substances prescribed by 
                electronic prescription in a timely manner, and such 
                delay would adversely impact the individual's medical 
                condition involved;
                    ``(E) a prescription issued by a participating 
                provider prescribing a drug under a research protocol;
                    ``(F) a prescription issued by a participating 
                provider for a drug for which the Food and Drug 
                Administration requires a prescription to contain 
                elements that are not able to be included in electronic 
                prescribing, such as a drug with risk evaluation and 
                mitigation strategies that include elements to assure 
                safe use;
                    ``(G) a prescription issued for an individual who 
                receives hospice care or for a resident of a nursing 
                facility (as defined in section 1919(a) of the Social 
                Security Act);
                    ``(H) a prescription issued under circumstances in 
                which electronic prescribing is not available due to 
                temporary technological or electrical failure, as 
                specified jointly by the Secretary, the Secretary of 
                Labor, and the Secretary of the Treasury through 
                rulemaking; and
                    ``(I) a prescription issued by a participating 
                provider allowing for the dispensing of a non-patient 
                specific prescription pursuant to a standing order, 
                approved protocol for drug therapy, collaborative drug 
                management, or comprehensive medication management, in 
                response to a public health emergency or other 
                circumstances under which the participating provider 
                may issue a non-patient specific prescription.
            ``(3) Rules of construction.--
                    ``(A) Verification.--Nothing in this subsection 
                shall be construed as requiring a dispenser to verify 
                that a participating provider, with respect to a 
                prescription for a schedule II, III, IV, or V 
                controlled substance that is a prescription drug 
                covered by a group health plan or group or individual 
                health insurance coverage offered by a health insurance 
                issuer, has a waiver (or is otherwise exempt) under 
                paragraph (2) from the requirement under paragraph (1).
                    ``(B) Authority to dispense.--Nothing in this 
                subsection shall be construed as affecting the 
                authority of a group health plan or group or individual 
                health insurance coverage offered by a health insurance 
                issuer to cover, or the authority of a dispenser to 
                continue to dispense, a prescription drug if the 
                prescription for such drug is an otherwise valid 
                written, oral, or fax prescription that is consistent 
                with applicable law.
                    ``(C) Patient choice.--Nothing in this subsection 
                shall be construed as affecting the ability of an 
                individual who is a participant, beneficiary, or 
                enrollee of a group health plan or group or individual 
                health insurance coverage offered by a health insurance 
                issuer and who is prescribed a schedule II, III, IV, or 
                V controlled substance that is a prescription drug 
                covered by the plan or coverage to designate a 
                particular dispenser to dispense a prescribed 
                controlled substance to the extent consistent with the 
                requirements under this subsection.
            ``(4) Regulations on policy requirements.--The Secretary, 
        the Secretary of Labor, and the Secretary of the Treasury shall 
        promulgate regulations specifying requirements for the policies 
        established by group health plans and health insurance issuers 
        under paragraph (1). Such regulations shall include 
        requirements for--
                    ``(A) a uniform process by which plans and issuers 
                are required to set the e-prescribing requirements;
                    ``(B) a process by which plans and issuers are 
                required to grant waivers and exceptions to 
                participating providers pursuant to paragraph (2); and
                    ``(C) a mechanism for plans and issuers to 
                recognize waivers issued to participating providers 
                under part D of title XVIII of the Social Security Act, 
                pursuant to paragraph (2)(C).
            ``(5) Prohibitions.--The policies established pursuant to 
        paragraph (1) by a group health plan or health insurance issuer 
        offering group or individual health insurance coverage may 
        not--
                    ``(A) require dispensers of a schedule II, III, IV, 
                or V controlled substance to confirm that the 
                prescription for the controlled substance was 
                electronically issued by a participating provider in 
                accordance with such policies, as described in 
                paragraph (1);
                    ``(B) require dispensers of such controlled 
                substances to submit information or data beyond what is 
                otherwise required to process a prescription drug claim 
                in order to confirm a participating provider's 
                compliance with such policies;
                    ``(C) reject, deny, or recoup reimbursement for a 
                prescription drug claim based on the format in which 
                the prescription was issued; or
                    ``(D) require a participating provider to use a 
                specific vendor for electronic prescribing or a 
                specific electronic prescribing product or system.
            ``(6) Attestation of compliance.--Beginning on January 1, 
        2026, each group health plan and health insurance issuer 
        offering group or individual health insurance coverage shall 
        annually submit to the Secretary, the Secretary of Labor, and 
        the Secretary of the Treasury an attestation of compliance with 
        the requirements of this subsection.
            ``(7) Consultation requirement for rulemaking.--In 
        promulgating regulations to carry out this subsection, the 
        Secretary, the Secretary of the Labor, and the Secretary of the 
        Treasury shall jointly consult with dispensers of controlled 
        substances, State insurance regulators, health insurance 
        issuers offering group or individual health insurance coverage, 
        and health care practitioners.''.
    (b) Employee Retirement Income Security Act of 1974 Amendment.--
Section 722 of the Employee Retirement Income Security Act of 1974 (29 
U.S.C. 1185k) is amended by adding at the end the following new 
subsection:
    ``(d) Requirements for Electronic-Prescribing for Controlled 
Substances.--
            ``(1) In general.--Except as provided pursuant to paragraph 
        (2), for plan years beginning on or after January 1, 2026, a 
        group health plan and a health insurance issuer offering group 
        health insurance coverage, with respect to a participating 
        provider, as defined in section 716(a)(3), shall have in place 
        policies, subject to paragraphs (4) and (5), that require any 
        prescription for a schedule II, III, IV, or V controlled 
        substance (as defined by section 202 of the Controlled 
        Substances Act) covered by the plan or coverage that is 
        transmitted by such a participating provider for such a 
        participant or beneficiary be electronically transmitted 
        consistent with standards established under paragraph (3) of 
        section 1860D-4(e) of the Social Security Act, under an 
        electronic prescription drug program that meets requirements 
        that are substantially similar (as jointly determined by the 
        Secretary, the Secretary of Health and Human Services, and the 
        Secretary of the Treasury) to the requirements of paragraph (2) 
        of such section 1860D-4(e).
            ``(2) Exception for certain circumstances.--The Secretary, 
        the Secretary of Health and Human Services, and the Secretary 
        of the Treasury shall jointly, through rulemaking, specify 
        circumstances and processes by which the requirement under 
        paragraph (1) may be waived, with respect to a schedule II, 
        III, IV, or V controlled substance that is a prescription drug 
        covered by a group health plan or group health insurance 
        coverage offered by a health insurance issuer, including in the 
        case of--
                    ``(A) a prescription issued when the participating 
                provider and dispensing pharmacy are the same entity;
                    ``(B) a prescription issued that cannot be 
                transmitted electronically under the most recently 
                implemented version of the National Council for 
                Prescription Drug Programs SCRIPT Standard;
                    ``(C) a prescription issued by a participating 
                provider who received a waiver (which may include a 
                waiver obtained pursuant to section 1860D-
                4(e)(7)(B)(iii) of the Social Security Act) or a 
                renewal thereof for a period of time as determined by 
                the Secretary, the Secretary of Health and Human 
                Services, and the Secretary of the Treasury, not to 
                exceed one year, from the requirement to use electronic 
                prescribing due to demonstrated economic hardship, 
                technological limitations that are not reasonably 
                within the control of the participating provider, or 
                other exceptional circumstance demonstrated by the 
                participating provider;
                    ``(D) a prescription issued by a participating 
                provider under circumstances in which, notwithstanding 
                the participating provider's ability to submit a 
                prescription electronically as required by this 
                subsection, such participating provider reasonably 
                determines that it would be impractical for the 
                individual involved to obtain substances prescribed by 
                electronic prescription in a timely manner, and such 
                delay would adversely impact the individual's medical 
                condition involved;
                    ``(E) a prescription issued by a participating 
                provider prescribing a drug under a research protocol;
                    ``(F) a prescription issued by a participating 
                provider for a drug for which the Food and Drug 
                Administration requires a prescription to contain 
                elements that are not able to be included in electronic 
                prescribing, such as a drug with risk evaluation and 
                mitigation strategies that include elements to assure 
                safe use;
                    ``(G) a prescription issued for an individual who 
                receives hospice care or for a resident of a nursing 
                facility (as defined in section 1919(a) of the Social 
                Security Act);
                    ``(H) a prescription issued under circumstances in 
                which electronic prescribing is not available due to 
                temporary technological or electrical failure, as 
                specified jointly by the Secretary, the Secretary of 
                Health and Human Services, and the Secretary of the 
                Treasury through rulemaking; and
                    ``(I) a prescription issued by a participating 
                provider allowing for the dispensing of a non-patient 
                specific prescription pursuant to a standing order, 
                approved protocol for drug therapy, collaborative drug 
                management, or comprehensive medication management, in 
                response to a public health emergency or other 
                circumstances under which the participating provider 
                may issue a non-patient specific prescription.
            ``(3) Rules of construction.--
                    ``(A) Verification.--Nothing in this subsection 
                shall be construed as requiring a dispenser to verify 
                that a participating provider, with respect to a 
                prescription for a schedule II, III, IV, or V 
                controlled substance that is a prescription drug 
                covered by a group health plan or group or individual 
                health insurance coverage offered by a health insurance 
                issuer, has a waiver (or is otherwise exempt) under 
                paragraph (2) from the requirement under paragraph (1).
                    ``(B) Authority to dispense.--Nothing in this 
                subsection shall be construed as affecting the 
                authority of a group health plan or group health 
                insurance coverage offered by a health insurance issuer 
                to cover, or the authority of a dispenser to continue 
                to dispense, a prescription drug if the prescription 
                for such drug is an otherwise valid written, oral, or 
                fax prescription that is consistent with applicable 
                law.
                    ``(C) Patient choice.--Nothing in this subsection 
                shall be construed as affecting the ability of an 
                individual who is a participant or beneficiary of a 
                group health plan or group or individual health 
                insurance coverage offered by a health insurance issuer 
                and who is prescribed a schedule II, III, IV, or V 
                controlled substance that is a prescription drug 
                covered by the plan or coverage to designate a 
                particular dispenser to dispense a prescribed 
                controlled substance to the extent consistent with the 
                requirements under this subsection.
            ``(4) Regulations on policy requirements.--The Secretary, 
        the Secretary of Health and Human Services, and the Secretary 
        of the Treasury shall promulgate regulations specifying 
        requirements for the policies established by group health plans 
        and health insurance issuers under paragraph (1). Such 
        regulations shall include requirements for--
                    ``(A) a uniform process by which plans and issuers 
                are required to set the e-prescribing requirements;
                    ``(B) a process by which plans and issuers are 
                required to grant waivers and exceptions to 
                participating providers pursuant to paragraph (2); and
                    ``(C) a mechanism for plans and issuers to 
                recognize waivers issued to participating providers 
                under part D of title XVIII of the Social Security Act, 
                pursuant to paragraph (2)(C).
            ``(5) Prohibitions.--The policies established pursuant to 
        paragraph (1) by a group health plan or health insurance issuer 
        offering group health insurance coverage may not--
                    ``(A) require dispensers of a schedule II, III, IV, 
                or V controlled substance to confirm that the 
                prescription for the controlled substance was 
                electronically issued by a participating provider in 
                accordance with such policies, as described in 
                paragraph (1);
                    ``(B) require dispensers of such controlled 
                substances to submit information or data beyond what is 
                otherwise required to process a prescription drug claim 
                in order to confirm a participating provider's 
                compliance with such policies;
                    ``(C) reject, deny, or recoup reimbursement for a 
                prescription drug claim based on the format in which 
                the prescription was issued; or
                    ``(D) require a participating provider to use a 
                specific vendor for electronic prescribing or a 
                specific electronic prescribing product or system.
            ``(6) Attestation of compliance.--Beginning on January 1, 
        2026, each group health plan and health insurance issuer 
        offering group health insurance coverage shall annually submit 
        to the Secretary, the Secretary of Health and Human Services, 
        and the Secretary of the Treasury an attestation of compliance 
        with the requirements of this subsection.
            ``(7) Consultation requirement for rulemaking.--In 
        promulgating regulations to carry out this subsection, the 
        Secretary, the Secretary of Health and Human Services, and the 
        Secretary of the Treasury shall jointly consult with dispensers 
        of controlled substances, State insurance regulators, health 
        insurance issuers offering group or individual health insurance 
        coverage, and health care practitioners.''.
    (c) Internal Revenue Code of 1986 Amendment.--Section 9822 of the 
Internal Revenue Code of 1986 is amended by adding at the end the 
following new subsection:
    ``(d) Requirements for Electronic-Prescribing for Controlled 
Substances.--
            ``(1) In general.--Except as provided pursuant to paragraph 
        (2), for plan years beginning on or after January 1, 2026, a 
        group health plan, with respect to a participating provider, as 
        defined in section 9816(a)(3), shall have in place policies, 
        subject to paragraphs (4) and (5), that require any 
        prescription for a schedule II, III, IV, or V controlled 
        substance (as defined by section 202 of the Controlled 
        Substances Act) covered by the plan that is transmitted by such 
        a participating provider for such a participant or beneficiary 
        be electronically transmitted consistent with standards 
        established under paragraph (3) of section 1860D-4(e) of the 
        Social Security Act, under an electronic prescription drug 
        program that meets requirements that are substantially similar 
        (as jointly determined by the Secretary, the Secretary of 
        Health and Human Services, and the Secretary of Labor) to the 
        requirements of paragraph (2) of such section 1860D-4(e).
            ``(2) Exception for certain circumstances.--The Secretary, 
        the Secretary of Health and Human Services, and the Secretary 
        of Labor shall jointly, through rulemaking, specify 
        circumstances and processes by which the requirement under 
        paragraph (1) may be waived, with respect to a schedule II, 
        III, IV, or V controlled substance that is a prescription drug 
        covered by a group health, including in the case of--
                    ``(A) a prescription issued when the participating 
                provider and dispensing pharmacy are the same entity;
                    ``(B) a prescription issued that cannot be 
                transmitted electronically under the most recently 
                implemented version of the National Council for 
                Prescription Drug Programs SCRIPT Standard;
                    ``(C) a prescription issued by a participating 
                provider who received a waiver (which may include a 
                waiver obtained pursuant to section 1860D-
                4(e)(7)(B)(iii) of the Social Security Act) or a 
                renewal thereof for a period of time as determined by 
                the Secretary, the Secretary of Health and Human 
                Services, and the Secretary of Labor, not to exceed one 
                year, from the requirement to use electronic 
                prescribing due to demonstrated economic hardship, 
                technological limitations that are not reasonably 
                within the control of the participating provider, or 
                other exceptional circumstance demonstrated by the 
                participating provider;
                    ``(D) a prescription issued by a participating 
                provider under circumstances in which, notwithstanding 
                the participating provider's ability to submit a 
                prescription electronically as required by this 
                subsection, such participating provider reasonably 
                determines that it would be impractical for the 
                individual involved to obtain substances prescribed by 
                electronic prescription in a timely manner, and such 
                delay would adversely impact the individual's medical 
                condition involved;
                    ``(E) a prescription issued by a participating 
                provider prescribing a drug under a research protocol;
                    ``(F) a prescription issued by a participating 
                provider for a drug for which the Food and Drug 
                Administration requires a prescription to contain 
                elements that are not able to be included in electronic 
                prescribing, such as a drug with risk evaluation and 
                mitigation strategies that include elements to assure 
                safe use;
                    ``(G) a prescription issued for an individual who 
                receives hospice care or for a resident of a nursing 
                facility (as defined in section 1919(a) of the Social 
                Security Act);
                    ``(H) a prescription issued under circumstances in 
                which electronic prescribing is not available due to 
                temporary technological or electrical failure, as 
                specified jointly by the Secretary, the Secretary of 
                Health and Human Services, and the Secretary of Labor 
                through rulemaking; and
                    ``(I) a prescription issued by a participating 
                provider allowing for the dispensing of a non-patient 
                specific prescription pursuant to a standing order, 
                approved protocol for drug therapy, collaborative drug 
                management, or comprehensive medication management, in 
                response to a public health emergency or other 
                circumstances under which the participating provider 
                may issue a non-patient specific prescription.
            ``(3) Rules of construction.--
                    ``(A) Verification.--Nothing in this subsection 
                shall be construed as requiring a dispenser to verify 
                that a participating provider, with respect to a 
                prescription for a schedule II, III, IV, or V 
                controlled substance that is a prescription drug 
                covered by a group health plan, has a waiver (or is 
                otherwise exempt) under paragraph (2) from the 
                requirement under paragraph (1).
                    ``(B) Authority to dispense.--Nothing in this 
                subsection shall be construed as affecting the ability 
                of a group health plan to cover, or the ability of a 
                dispenser to continue to dispense, a prescription drug 
                if the prescription for such drug is an otherwise valid 
                written, oral, or fax prescription that is consistence 
                with applicable laws and regulations.
                    ``(C) Patient choice.--Nothing in this subsection 
                shall be construed as affecting the ability of an 
                individual who is a participant or beneficiary of a 
                group health plan and who is prescribed a schedule II, 
                III, IV, or V controlled substance that is a 
                prescription drug covered by the plan to designate a 
                particular dispenser to dispense a prescribed 
                controlled substance to the extent consistent with the 
                requirements under this subsection.
            ``(4) Regulations on policy requirements.--The Secretary, 
        the Secretary of Health and Human Services, and the Secretary 
        of Labor shall promulgate regulations specifying requirements 
        for the policies established by group health plans under 
        paragraph (1). Such regulations shall include requirements 
        for--
                    ``(A) a uniform process by which plans are required 
                to set the e-prescribing requirements;
                    ``(B) a process by which plans are required to 
                grant waivers and exceptions to participating providers 
                pursuant to paragraph (2); and
                    ``(C) a mechanism for plans to recognize waivers 
                issued to participating providers under part D of title 
                XVIII of the Public Health Service Act, pursuant to 
                paragraph (2)(C).
            ``(5) Prohibitions.--The policies established pursuant to 
        paragraph (1) by a group health plan may not--
                    ``(A) require dispensers of a schedule II, III, IV, 
                or V controlled substance to confirm that the 
                prescription for the controlled substance was 
                electronically issued by a participating provider in 
                accordance with such policies, as described in 
                paragraph (1);
                    ``(B) require dispensers of such controlled 
                substances to submit information or data beyond what is 
                otherwise required to process a prescription drug claim 
                in order to confirm a participating provider's 
                compliance with such policies;
                    ``(C) reject, deny, or recoup reimbursement for a 
                prescription drug claim based on the format in which 
                the prescription was issued; or
                    ``(D) require a participating provider to use a 
                specific vendor for electronic prescribing or a 
                specific electronic prescribing product or system.
            ``(6) Attestation of compliance.--Beginning on January 1, 
        2026, each group health plan shall annually submit to the 
        Secretary, the Secretary of Health and Human Services, and the 
        Secretary of Labor an attestation of compliance with the 
        requirements of this subsection.
            ``(7) Consultation requirement for rulemaking.--In 
        promulgating regulations to carry out this subsection, the 
        Secretary, the Secretary of Health and Human Services, and the 
        Secretary of Labor shall jointly consult with dispensers of 
        controlled substances, State insurance regulators, health 
        insurance issuers offering group or individual health insurance 
        coverage, and health care practitioners.''.
    (d) Update of Biometric Component of Multifactor Authentication.--
Not later than 1 year after the date of enactment of this Act, the 
Attorney General shall finalize a regulation updating the requirements 
for the biometric component of multifactor authentication with respect 
to electronic prescriptions of controlled substances, as required under 
section 2003(c) of the SUPPORT for Patients and Community Act (Public 
Law 115-271).
                                 <all>
```