[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8988 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 8988

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 HOUSE OF REPRESENTATIVES

                           September 26, 2022

Mr. O'Halleran introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
      Education and Labor, and Ways and Means, 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 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, 2024, a 
        group health plan and a health insurance issuer offering group 
        or individual health insurance coverage shall, with respect to 
        health care practitioners that have a contractual relationship 
        with such plan or issuer for furnishing items or services to 
        participants and beneficiaries under such plan or coverage, 
        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 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 
        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 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
                    ``(C) 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 ability 
                of a group health plan or group or individual health 
                insurance coverage offered by a health insurance issuer 
                to cover, or the ability of a pharmacist 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 or group or individual health 
                insurance coverage offered by a health insurance issuer 
                and who is being 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 such 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, 2024, a 
        group health plan and a health insurance issuer offering group 
        health insurance coverage shall, with respect to health care 
        practitioners that have a contractual relationship with such 
        plan or issuer for furnishing items or services to participants 
        and beneficiaries under such plan or coverage, 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 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 
        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 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
                    ``(C) 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 ability 
                of a group health plan or group health insurance 
                coverage offered by a health insurance issuer to cover, 
                or the ability of a pharmacist 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 or group or individual health 
                insurance coverage offered by a health insurance issuer 
                and who is being 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 such 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 Labor 
        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, 2024, a 
        group health plan shall, with respect to health care 
        practitioners that have a contractual relationship with such 
        plan for furnishing items or services to participants and 
        beneficiaries under such plan, 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 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, 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 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
                    ``(C) 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 
                pharmacist 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 being 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 such 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 the Treasury, and Secretary of Labor 
        shall jointly consult with dispensers of controlled substances, 
        State insurance regulators, and health care practitioners.''.
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