II
118THCONGRESS
1
STSESSION 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
JULY27, 2023
Ms. H
ASSAN(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 Re-
tirement 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 in-
surance coverage.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Electronic Prescribing 4
for Controlled Substances Act’’ or the ‘‘EPCS 2.0 Act’’. 5
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SEC. 2. REQUIREMENTS FOR ELECTRONIC-PRESCRIBING 1
FOR CONTROLLED SUBSTANCES UNDER 2
GROUP HEALTH PLANS AND GROUP AND IN-3
DIVIDUAL HEALTH INSURANCE COVERAGE. 4
(a) P
UBLICHEALTHSERVICEACTAMENDMENT.— 5
Section 2799A–7 of the Public Health Service Act (42 6
U.S.C. 300gg–117) is amended by adding at the end the 7
following new subsection: 8
‘‘(d) R
EQUIREMENTS FOR ELECTRONIC-PRE-9
SCRIBING FORCONTROLLEDSUBSTANCES.— 10
‘‘(1) I
N GENERAL.—Except as provided pursu-11
ant to paragraph (2), for plan years beginning on or 12
after January 1, 2025, a group health plan and a 13
health insurance issuer offering group or individual 14
health insurance coverage, with respect to a partici-15
pating provider, as defined in section 2799–1(a)(3), 16
shall have in place policies, subject to paragraph (4), 17
that require any prescription for a schedule II, III, 18
IV, or V controlled substance (as defined by section 19
202 of the Controlled Substances Act) covered under 20
the plan or coverage that is transmitted by such a 21
health care practitioner for such a participant, bene-22
ficiary, or enrollee be electronically transmitted in 23
accordance with such standards, consistent with 24
standards established under paragraph (3) of section 25
1860D–4(e) of the Social Security Act, under an 26
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•S 2666 IS
electronic prescription drug program that meets re-1
quirements that are substantially similar (as jointly 2
determined by the Secretary, Secretary of the Treas-3
ury, and Secretary of Labor) to the requirements of 4
paragraph (2) of such section 1860D–4(e). 5
‘‘(2) E
XCEPTION FOR CERTAIN CIR -6
CUMSTANCES.—The Secretary, Secretary of the 7
Treasury, and Secretary of Labor shall jointly, 8
through rulemaking, specify circumstances and proc-9
esses by which the requirement under paragraph (1) 10
may be waived, with respect to a schedule II, III, 11
IV, or V controlled substance that is a prescription 12
drug covered by a group health plan or group or in-13
dividual health insurance coverage offered by a 14
health insurance issuer, including in the case of— 15
‘‘(A) a prescription described in any of 16
clauses (i) through (vi) of section 1860D– 17
4(e)(7)(B) of the Social Security Act; 18
‘‘(B) a prescription issued for an individual 19
who receives hospice care or for a resident of a 20
nursing facility (as defined in section 1919(a) 21
of the Social Security Act); 22
‘‘(C) a prescription issued under cir-23
cumstances in which electronic prescribing is 24
not available due to temporary technological or 25
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•S 2666 IS
electrical failure, as specified jointly by the Sec-1
retary, Secretary of the Treasury, and Sec-2
retary of Labor through rulemaking; and 3
‘‘(D) a prescription issued by a practi-4
tioner allowing for the dispensing of a non-pa-5
tient specific prescription pursuant to a stand-6
ing order, approved protocol for drug therapy, 7
collaborative drug management, or comprehen-8
sive medication management, in response to a 9
public health emergency or other circumstances 10
under which the practitioner may issue a non- 11
patient specific prescription. 12
‘‘(3) R
ULES OF CONSTRUCTION .— 13
‘‘(A) V
ERIFICATION.—Nothing in this sub-14
section shall be construed as requiring a dis-15
penser to verify that a health care practitioner, 16
with respect to a prescription for a schedule II, 17
III, IV, or V controlled substance that is a pre-18
scription drug covered under a group health 19
plan or group or individual health insurance 20
coverage offered by a health insurance issuer, 21
has a waiver (or is otherwise exempt) under 22
paragraph (2) from the requirement under 23
paragraph (1). 24
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‘‘(B) AUTHORITY TO DISPENSE .—Nothing 1
in this subsection shall be construed as affect-2
ing the authority of a group health plan or 3
group or individual health insurance coverage 4
offered by a health insurance issuer to cover, or 5
the authority of a dispenser to continue to dis-6
pense, a prescription drug if the prescription 7
for such drug is an otherwise valid written, 8
oral, or fax prescription that is consistent with 9
applicable law. 10
‘‘(C) P
ATIENT CHOICE.—Nothing in this 11
subsection shall be construed as affecting the 12
ability of an individual who is a participant, 13
beneficiary, or enrollee of a group health plan 14
or group or individual health insurance cov-15
erage offered by a health insurance issuer and 16
who is prescribed a schedule II, III, IV, or V 17
controlled substance that is a prescription drug 18
covered under the plan or coverage to designate 19
a particular pharmacy to dispense a prescribed 20
controlled substance to the extent consistent 21
with the requirements under this subsection. 22
‘‘(4) P
ROHIBITIONS.—The policies established 23
pursuant to paragraph (1) by a group health plan or 24
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health insurance issuer offering group or individual 1
health insurance coverage may not— 2
‘‘(A) require dispensers of a schedule II, 3
III, IV, or V controlled substance to confirm 4
that the prescription for the controlled sub-5
stance was electronically issued by a health care 6
practitioner in accordance with such policies, as 7
described in paragraph (1); 8
‘‘(B) require dispensers of such controlled 9
substances to submit information or data be-10
yond what is otherwise required to process a 11
prescription drug claim in order to confirm a 12
practitioner’s compliance with such policies; or 13
‘‘(C) reject, deny, or recoup reimbursement 14
for a prescription drug claim based on the for-15
mat in which the prescription was issued. 16
‘‘(5) C
ONSULTATION REQUIREMENT FOR RULE -17
MAKING.—In promulgating regulations to carry out 18
this subsection, the Secretary, Secretary of the 19
Treasury, and Secretary of Labor shall jointly con-20
sult with dispensers of controlled substances, State 21
insurance regulators, and health care practitioners.’’. 22
(b) E
MPLOYEERETIREMENTINCOMESECURITYACT 23
OF1974 AMENDMENT.—Section 722 of the Employee Re-24
tirement Income Security Act of 1974 (29 U.S.C. 1185k) 25
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is amended by adding at the end the following new sub-1
section: 2
‘‘(d) R
EQUIREMENTS FOR ELECTRONIC-PRE-3
SCRIBING FORCONTROLLEDSUBSTANCES.— 4
‘‘(1) I
N GENERAL.—Except as provided pursu-5
ant to paragraph (2), for plan years beginning on or 6
after January 1, 2025, a group health plan and a 7
health insurance issuer offering group health insur-8
ance coverage, with respect to a participating pro-9
vider, as defined in section 716(a)(3), shall have in 10
place policies, subject to paragraph (4), that require 11
any prescription for a schedule II, III, IV, or V con-12
trolled substance (as defined by section 202 of the 13
Controlled Substances Act) covered under the plan 14
or coverage that is transmitted by such a health care 15
practitioner for such a participant or beneficiary be 16
electronically transmitted in accordance with such 17
standards, consistent with standards established 18
under paragraph (3) of section 1860D–4(e) of the 19
Social Security Act, under an electronic prescription 20
drug program that meets requirements that are sub-21
stantially similar (as jointly determined by the Sec-22
retary, Secretary of the Treasury, and Secretary of 23
Labor) to the requirements of paragraph (2) of such 24
section 1860D–4(e). 25
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‘‘(2) EXCEPTION FOR CERTAIN CIR -1
CUMSTANCES.—The Secretary, Secretary of the 2
Treasury, and Secretary of Health and Human 3
Services shall jointly, through rulemaking, specify 4
circumstances and processes by which the require-5
ment under paragraph (1) may be waived, with re-6
spect to a schedule II, III, IV, or V controlled sub-7
stance that is a prescription drug covered by a group 8
health plan or group health insurance coverage of-9
fered by a health insurance issuer, including in the 10
case of— 11
‘‘(A) a prescription described in any of 12
clauses (i) through (vi) of section 1860D– 13
4(e)(7)(B) of the Social Security Act; 14
‘‘(B) a prescription issued for an individual 15
who receives hospice care or for a resident of a 16
nursing facility (as defined in section 1919(a) 17
of the Social Security Act); 18
‘‘(C) a prescription issued under cir-19
cumstances in which electronic prescribing is 20
not available due to temporary technological or 21
electrical failure, as specified jointly by the Sec-22
retary, Secretary of the Treasury, and Sec-23
retary of Health and Human Services through 24
rulemaking; and 25
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‘‘(D) a prescription issued by a practi-1
tioner allowing for the dispensing of a non-pa-2
tient specific prescription pursuant to a stand-3
ing order, approved protocol for drug therapy, 4
collaborative drug management, or comprehen-5
sive medication management, in response to a 6
public health emergency or other circumstances 7
under which the practitioner may issue a non- 8
patient specific prescription. 9
‘‘(3) R
ULES OF CONSTRUCTION .— 10
‘‘(A) V
ERIFICATION.—Nothing in this sub-11
section shall be construed as requiring a dis-12
penser to verify that a health care practitioner, 13
with respect to a prescription for a schedule II, 14
III, IV, or V controlled substance that is a pre-15
scription drug covered under a group health 16
plan or group or individual health insurance 17
coverage offered by a health insurance issuer, 18
has a waiver (or is otherwise exempt) under 19
paragraph (2) from the requirement under 20
paragraph (1). 21
‘‘(B) A
UTHORITY TO DISPENSE .—Nothing 22
in this subsection shall be construed as affect-23
ing the authority of a group health plan or 24
group health insurance coverage offered by a 25
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health insurance issuer to cover, or the author-1
ity of a dispenser to continue to dispense, a pre-2
scription drug if the prescription for such drug 3
is an otherwise valid written, oral, or fax pre-4
scription that is consistent with applicable law. 5
‘‘(C) P
ATIENT CHOICE.—Nothing in this 6
subsection shall be construed as affecting the 7
ability of an individual who is a participant or 8
beneficiary of a group health plan or group or 9
individual health insurance coverage offered by 10
a health insurance issuer and who is prescribed 11
a schedule II, III, IV, or V controlled substance 12
that is a prescription drug covered under the 13
plan or coverage to designate a particular phar-14
macy to dispense a prescribed controlled sub-15
stance to the extent consistent with the require-16
ments under this subsection. 17
‘‘(4) P
ROHIBITIONS.—The policies established 18
pursuant to paragraph (1) by a group health plan or 19
health insurance issuer offering group health insur-20
ance coverage may not— 21
‘‘(A) require dispensers of a schedule II, 22
III, IV, or V controlled substance to confirm 23
that the prescription for the controlled sub-24
stance was electronically issued by a health care 25
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practitioner in accordance with such policies, as 1
described in paragraph (1); 2
‘‘(B) require dispensers of such controlled 3
substances to submit information or data be-4
yond what is otherwise required to process a 5
prescription drug claim in order to confirm a 6
practitioner’s compliance with such policies; or 7
‘‘(C) reject, deny, or recoup reimbursement 8
for a prescription drug claim based on the for-9
mat in which the prescription was issued. 10
‘‘(5) C
ONSULTATION REQUIREMENT FOR RULE -11
MAKING.—In promulgating regulations to carry out 12
this subsection, the Secretary, Secretary of the 13
Treasury, and Secretary of Health and Human 14
Services shall jointly consult with dispensers of con-15
trolled substances, State insurance regulators, and 16
health care practitioners.’’. 17
(c) I
NTERNALREVENUECODE OF1986 AMEND-18
MENT.—Section 9822 of the Internal Revenue Code of 19
1986 is amended by adding at the end the following new 20
subsection: 21
‘‘(d) R
EQUIREMENTS FOR ELECTRONIC-PRE-22
SCRIBING FORCONTROLLEDSUBSTANCES.— 23
‘‘(1) I
N GENERAL.—Except as provided pursu-24
ant to paragraph (2), for plan years beginning on or 25
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after January 1, 2025, a group health plan, with re-1
spect to a participating provider, as defined in sec-2
tion 9816(a)(3), shall have in place policies, subject 3
to paragraph (4), that require any prescription for 4
a schedule II, III, IV, or V controlled substance (as 5
defined by section 202 of the Controlled Substances 6
Act) covered under the plan that is transmitted by 7
such a health care practitioner for such a participant 8
or beneficiary be electronically transmitted in ac-9
cordance with such standards, consistent with stand-10
ards established under paragraph (3) of section 11
1860D–4(e) of the Social Security Act, under an 12
electronic prescription drug program that meets re-13
quirements that are substantially similar (as jointly 14
determined by the Secretary, Secretary of the Treas-15
ury, and Secretary of Labor) to the requirements of 16
paragraph (2) of such section 1860D–4(e). 17
‘‘(2) E
XCEPTION FOR CERTAIN CIR -18
CUMSTANCES.—The Secretary, Secretary of Health 19
and Human Services, and Secretary of Labor shall 20
jointly, through rulemaking, specify circumstances 21
and processes by which the requirement under para-22
graph (1) may be waived, with respect to a schedule 23
II, III, IV, or V controlled substance that is a pre-24
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scription drug covered by a group health, including 1
in the case of— 2
‘‘(A) a prescription described in any of 3
clauses (i) through (vi) of section 1860D– 4
4(e)(7)(B) of the Social Security Act; 5
‘‘(B) a prescription issued for an individual 6
who receives hospice care or for a resident of a 7
nursing facility (as defined in section 1919(a) 8
of the Social Security Act); 9
‘‘(C) a prescription issued under cir-10
cumstances in which electronic prescribing is 11
not available due to temporary technological or 12
electrical failure, as specified jointly by the Sec-13
retary, Secretary of Health and Human Serv-14
ices, and Secretary of Labor through rule-15
making; and 16
‘‘(D) a prescription issued by a practi-17
tioner allowing for the dispensing of a non-pa-18
tient specific prescription pursuant to a stand-19
ing order, approved protocol for drug therapy, 20
collaborative drug management, or comprehen-21
sive medication management, in response to a 22
public health emergency or other circumstances 23
under which the practitioner may issue a non- 24
patient specific prescription. 25
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‘‘(3) RULES OF CONSTRUCTION .— 1
‘‘(A) V
ERIFICATION.—Nothing in this sub-2
section shall be construed as requiring a dis-3
penser to verify that a health care practitioner, 4
with respect to a prescription for a schedule II, 5
III, IV, or V controlled substance that is a pre-6
scription drug covered under a group health 7
plan, has a waiver (or is otherwise exempt) 8
under paragraph (2) from the requirement 9
under paragraph (1). 10
‘‘(B) A
UTHORITY TO DISPENSE .—Nothing 11
in this subsection shall be construed as affect-12
ing the ability of a group health plan to cover, 13
or the ability of a dispenser to continue to dis-14
pense, a prescription drug if the prescription 15
for such drug is an otherwise valid written, 16
oral, or fax prescription that is consistence with 17
applicable laws and regulations. 18
‘‘(C) P
ATIENT CHOICE.—Nothing in this 19
subsection shall be construed as affecting the 20
ability of an individual who is a participant or 21
beneficiary of a group health plan and who is 22
prescribed a schedule II, III, IV, or V con-23
trolled substance that is a prescription drug 24
covered under the plan to designate a particular 25
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pharmacy to dispense a prescribed controlled 1
substance to the extent consistent with the re-2
quirements under this subsection. 3
‘‘(4) P
ROHIBITIONS.—The policies established 4
pursuant to paragraph (1) by a group health plan 5
may not— 6
‘‘(A) require dispensers of a schedule II, 7
III, IV, or V controlled substance to confirm 8
that the prescription for the controlled sub-9
stance was electronically issued by a health care 10
practitioner in accordance with such policies, as 11
described in paragraph (1); 12
‘‘(B) require dispensers of such controlled 13
substances to submit information or data be-14
yond what is otherwise required to process a 15
prescription drug claim in order to confirm a 16
practitioner’s compliance with such policies; or 17
‘‘(C) reject, deny, or recoup reimbursement 18
for a prescription drug claim based on the for-19
mat in which the prescription was issued. 20
‘‘(5) C
ONSULTATION REQUIREMENT FOR RULE -21
MAKING.—In promulgating regulations to carry out 22
this subsection, the Secretary, Secretary of Health 23
and Human Services, and Secretary of Labor shall 24
jointly consult with dispensers of controlled sub-25
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stances, State insurance regulators, and health care 1
practitioners.’’. 2
Æ
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