[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.''.
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