[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2666 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  1st Session
                                S. 2666

To amend the Public Health Service Act, the Employee Retirement Income 
Security Act of 1974, and the Internal Revenue Code of 1986 to provide 
 for requirements for electronic-prescribing for controlled substances 
  under group health plans and group and individual health insurance 
                               coverage.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 27, 2023

Ms. Hassan (for herself and Mr. Mullin) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act, the Employee Retirement Income 
Security Act of 1974, and the Internal Revenue Code of 1986 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, 2025, 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 paragraph (4), 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 under the plan or coverage 
        that is transmitted by such a health care practitioner for such 
        a participant, beneficiary, or enrollee be electronically 
        transmitted in accordance with such standards, 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, Secretary of 
        the Treasury, and Secretary of Labor) to the requirements of 
        paragraph (2) of such section 1860D-4(e).
            ``(2) Exception for certain circumstances.--The Secretary, 
        Secretary of the Treasury, and 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 
        plan or group or individual health insurance coverage offered 
        by a health insurance issuer, including in the case of--
                    ``(A) a prescription described in any of clauses 
                (i) through (vi) of section 1860D-4(e)(7)(B) of the 
                Social Security Act;
                    ``(B) 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);
                    ``(C) 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, Secretary of the 
                Treasury, and Secretary of Labor through rulemaking; 
                and
                    ``(D) a prescription issued by a practitioner 
                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 practitioner 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 health care practitioner, with respect to a 
                prescription for a schedule II, III, IV, or V 
                controlled substance that is a prescription drug 
                covered under 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 under the plan or coverage to designate a 
                particular pharmacy to dispense a prescribed controlled 
                substance to the extent consistent with the 
                requirements under this subsection.
            ``(4) 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 health care practitioner 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 practitioner's compliance with 
                such policies; or
                    ``(C) reject, deny, or recoup reimbursement for a 
                prescription drug claim based on the format in which 
                the prescription was issued.
            ``(5) Consultation requirement for rulemaking.--In 
        promulgating regulations to carry out this subsection, the 
        Secretary, Secretary of the Treasury, and Secretary of Labor 
        shall jointly consult with dispensers of controlled substances, 
        State insurance regulators, 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, 2025, 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 paragraph (4), 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 under the plan or coverage that is 
        transmitted by such a health care practitioner for such a 
        participant or beneficiary be electronically transmitted in 
        accordance with such standards, 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, Secretary of the 
        Treasury, and Secretary of Labor) to the requirements of 
        paragraph (2) of such section 1860D-4(e).
            ``(2) Exception for certain circumstances.--The Secretary, 
        Secretary of the Treasury, and Secretary of Health and Human 
        Services 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 described in any of clauses 
                (i) through (vi) of section 1860D-4(e)(7)(B) of the 
                Social Security Act;
                    ``(B) 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);
                    ``(C) 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, Secretary of the 
                Treasury, and Secretary of Health and Human Services 
                through rulemaking; and
                    ``(D) a prescription issued by a practitioner 
                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 practitioner 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 health care practitioner, with respect to a 
                prescription for a schedule II, III, IV, or V 
                controlled substance that is a prescription drug 
                covered under 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 under the plan or coverage to designate a 
                particular pharmacy to dispense a prescribed controlled 
                substance to the extent consistent with the 
                requirements under this subsection.
            ``(4) 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 health care practitioner 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 practitioner's compliance with 
                such policies; or
                    ``(C) reject, deny, or recoup reimbursement for a 
                prescription drug claim based on the format in which 
                the prescription was issued.
            ``(5) Consultation requirement for rulemaking.--In 
        promulgating regulations to carry out this subsection, the 
        Secretary, Secretary of the Treasury, and Secretary of Health 
        and Human Services shall jointly consult with dispensers of 
        controlled substances, State insurance regulators, 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, 2025, a 
        group health plan, with respect to a participating provider, as 
        defined in section 9816(a)(3), shall have in place policies, 
        subject to paragraph (4), 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 under the 
        plan that is transmitted by such a health care practitioner for 
        such a participant or beneficiary be electronically transmitted 
        in accordance with such standards, 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, Secretary of the 
        Treasury, and Secretary of Labor) to the requirements of 
        paragraph (2) of such section 1860D-4(e).
            ``(2) Exception for certain circumstances.--The Secretary, 
        Secretary of Health and Human Services, and 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 described in any of clauses 
                (i) through (vi) of section 1860D-4(e)(7)(B) of the 
                Social Security Act;
                    ``(B) 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);
                    ``(C) 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, Secretary of Health 
                and Human Services, and Secretary of Labor through 
                rulemaking; and
                    ``(D) a prescription issued by a practitioner 
                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 practitioner 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 health care practitioner, with respect to a 
                prescription for a schedule II, III, IV, or V 
                controlled substance that is a prescription drug 
                covered under 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 under the plan to designate a 
                particular pharmacy to dispense a prescribed controlled 
                substance to the extent consistent with the 
                requirements under this subsection.
            ``(4) 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 health care practitioner 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 practitioner's compliance with 
                such policies; or
                    ``(C) reject, deny, or recoup reimbursement for a 
                prescription drug claim based on the format in which 
                the prescription was issued.
            ``(5) Consultation requirement for rulemaking.--In 
        promulgating regulations to carry out this subsection, the 
        Secretary, Secretary of Health and Human Services, and 
        Secretary of Labor shall jointly consult with dispensers of 
        controlled substances, State insurance regulators, and health 
        care practitioners.''.
                                 <all>