No official summary available for this bill.
[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>
Introduced in House
Introduced in House
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.
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.
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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