I 
118TH CONGRESS 
1ST SESSION H. R. 4011 
To amend title XXVII of the Public Health Service Act to improve patient 
access to oral medications, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 12, 2023 
Mr. BILIRAKIS (for himself and Ms. SEWELL) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend title XXVII of the Public Health Service Act 
to improve patient access to oral medications, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Timely Access to Clin-
ical Treatment Act of 2023’’ or the ‘‘TACT Act of 2023’’. 
SEC. 2. PATIENT ACCESS TO ORAL MEDICATIONS. 
(a) IN GENERAL.—Section 2719A of the Public 
Health Service Act (42 U.S.C. 300gg–19a) is amended by 
adding at the end the following new subsection: 
‘‘(f) ACCESS TO ORAL MEDICATIONS.— 
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‘‘(1) REQUIREMENTS
FOR
CONTRACTS
BE-
TWEEN GROUP HEALTH PLANS OR HEALTH INSUR-
ANCE ISSUERS AND PHARMACIES.—If a group health 
plan or a health insurance issuer offering group or 
individual health insurance coverage covers or pro-
vides any benefits for oral medications (as defined in 
paragraph (4)) and enters into a contract with a 
pharmacy, whether directly or through an agent of 
such plan or issuer (including a pharmacy benefits 
manager) to dispense such medications to partici-
pants, beneficiaries, or enrollees of the plan or cov-
erage, such plan or issuer shall require, as condi-
tions of such contract, such pharmacy to carry out 
the procedures described in paragraph (2). 
‘‘(2) PROCEDURES DESCRIBED.—For purposes 
of paragraph (1), the procedures described in this 
paragraph with respect to a participant, beneficiary, 
or enrollee of the plan or coverage and a health care 
provider who submits to such pharmacy a prescrip-
tion for an oral medication for such participant, ben-
eficiary, or enrollee are the following (as applicable): 
‘‘(A) PHARMACY CONFIRMATION OF ABIL-
ITY TO DISPENSE.—Not later than 24 hours 
after receiving such prescription— 
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‘‘(i) confirm to such health care pro-
vider that such pharmacy received such 
prescription; and 
‘‘(ii) inform such health care provider 
as well as such plan or issuer whether such 
pharmacy will dispense such oral medica-
tion to such participant, beneficiary, or en-
rollee by not later than 72 hours after re-
ceiving such prescription, including any 
time for benefits verification, prior author-
ization, or any other administrative proce-
dure required by the agent of such plan or 
issuer (including a pharmacy benefits man-
ager) prior to authorizing the pharmacy to 
dispense the medication. 
‘‘(B) PHARMACY ABLE TO FILL PRESCRIP-
TION.—In the case that such pharmacy informs 
such health care provider under subparagraph 
(A)(ii) that such pharmacy is able to dispense 
such oral medication to such participant, bene-
ficiary, or enrollee by the 72-hour deadline de-
scribed in such subparagraph, dispense such 
oral medication to such participant, beneficiary, 
or enrollee by such deadline. 
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‘‘(C) PHARMACY
UNABLE
TO
FILL
PRE-
SCRIPTION.—In the case that such pharmacy 
informs such health care provider under sub-
paragraph (A)(ii) that such pharmacy is not 
able to dispense such oral medication to such 
participant, beneficiary, or enrollee by the 72- 
hour deadline described in such subparagraph, 
immediately provide a written notice to— 
‘‘(i) the prescribing physician or other 
health care provider; 
‘‘(ii) the group health plan or a health 
insurance issuer offering group or indi-
vidual health insurance coverage; and 
‘‘(iii) such participant, beneficiary, or 
enrollee, 
with a clear and understandable explanation of 
such inability and of the option of such partici-
pant, beneficiary, or enrollee to be dispensed 
such oral medication from any provider or phar-
macy described in subparagraph (C) of para-
graph (3), in accordance with the requirements 
described in subparagraphs (A) and (B) of such 
paragraph. 
‘‘(D) PHARMACY
FAILURE
TO
COMMU-
NICATE.—If the pharmacy does not commu-
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nicate its ability to dispense as required by sub-
paragraph (A), or, after confirming that it will 
dispense an oral medication under such sub-
paragraph, does not actually dispense such 
medication by the 72-hour deadline described in 
such paragraph, such pharmacy shall be 
deemed to have confirmed that it is not able to 
dispense such medication under subparagraph 
(C). 
‘‘(3) REQUIREMENTS
FOR
GROUP
HEALTH 
PLANS AND HEALTH INSURANCE ISSUERS.— 
‘‘(A) PATIENT SELECTION OF ALTERNATE 
PROVIDER OR PHARMACY.—If a group health 
plan or a health insurance issuer offering group 
or individual health insurance coverage (or its 
agent, including a pharmacy benefits manager) 
described in paragraph (1) enters into a con-
tract described in such paragraph, with a phar-
macy and such pharmacy, with respect to a 
participant, beneficiary, or enrollee of the plan 
or coverage and a health care provider who sub-
mits to such pharmacy a prescription for an 
oral medication for such participant, bene-
ficiary, or enrollee, informs such health care 
provider under subparagraph (A)(ii) of such 
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‘‘(v) any cost-sharing payments made 
by the participant or beneficiary with re-
spect to such oral medication so furnished 
shall be counted toward any in-network de-
ductible or out-of-pocket maximums ap-
plied under the plan (and such in-network 
deductible and out-of-pocket maximums 
shall be applied) in the same manner as if 
such cost-sharing payments were made 
with respect to oral medication furnished 
by a participating provider or a partici-
pating pharmacy; and 
‘‘(vi) such medication will be provided 
without regard to any other term or condi-
tion of such coverage (other than exclusion 
or coordination of benefits, or an affiliation 
or waiting period, permitted under section 
2704 of this Act, including as incorporated 
pursuant to section 715 of the Employee 
Retirement Income Security Act of 1974 
and section 9815 of this Act, and other 
than applicable cost-sharing). 
‘‘(C) 
PROVIDER
OR
PHARMACY
DE-
SCRIBED.—A provider or pharmacy described in 
this subparagraph, with respect to a partici-
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pant, beneficiary, or enrollee of a group health 
plan or group or individual health insurance 
coverage described in paragraph (1) and a pre-
scription for an oral medication for such partic-
ipant, beneficiary or enrollee, is a provider or 
pharmacy that— 
‘‘(i) is licensed by the State in which 
such provider or pharmacy is located to 
dispense such oral medication, if such a li-
cense is required by the State; 
‘‘(ii) is either located within a reason-
able distance (as determined by the Sec-
retary) of the residence of such partici-
pant, beneficiary, or enrollee, or is able to 
deliver such oral medication to such partic-
ipant, beneficiary, or enrollee at such resi-
dence; and 
‘‘(iii) is able to dispense (and if appli-
cable, deliver), such oral medication to 
such participant, beneficiary, or enrollee 
within 48 hours of the date on which it re-
ceives the prescription. 
For purposes of this section, a provider or 
pharmacy described in this subparagraph in-
cludes a physician or other health care practi-
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tioner authorized to dispense oral medication to 
such participant, beneficiary, or enrollee pursu-
ant to the law of the State in which the physi-
cian or other health care practitioner is located. 
‘‘(D) PRIOR
AUTHORIZATION
REQUIRE-
MENTS.—In the case of a group health plan or 
a health insurance issuer offering group or indi-
vidual health insurance coverage that requires 
prior authorization for an oral medication to be 
dispensed to a participant, beneficiary, or en-
rollee of the plan or coverage, such plan or 
issuer (or its agent, including a pharmacy bene-
fits manager) shall make a decision with respect 
to a request for such a prior authorization by 
not later than 72 hours after receiving such re-
quest. In the case that such plan or issuer (or 
its agent, including a pharmacy benefits man-
ager) does not make a decision with respect to 
a request for prior authorization for an oral 
medication to be dispensed to a participant, 
beneficiary, or enrollee of the plan or coverage 
by the 72-hour deadline described in the pre-
vious sentence, such participant, beneficiary or 
enrollee may select any pharmacy described in 
subparagraph (C) to dispense such oral medica-
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tion to such participant, beneficiary, or enrollee, 
in accordance with the cost-sharing require-
ments described in subparagraph (B). 
‘‘(E) USE OF RELEVANT QUALITY MEAS-
URES
UNDER
INCENTIVE
PAYMENT
AND
AD-
JUSTMENT SYSTEMS.—If a group health plan or 
a health insurance issuer offering group or indi-
vidual health insurance coverage uses an incen-
tive payment and adjustment system (as de-
fined by the Secretary) in determining phar-
macy reimbursement payments for oral medica-
tions, such system shall only use quality meas-
ures that are relevant to the performance of 
such pharmacy with respect to areas that the 
pharmacy can impact based on the oral medica-
tions dispensed and managed by the pharmacy. 
‘‘(4) ORAL
MEDICATION
DEFINED.—In this 
subsection, the term ‘oral medication’ means a drug 
or biological (as defined in section 1861(t) of the So-
cial Security Act) that is used for a medically ac-
cepted indication that is dispensed as an outpatient 
and taken by mouth.’’. 
(b) CONFORMING AMENDMENT.—Section 2719A(e) 
of the Public Health Service Act (42 U.S.C. 300gg– 
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19a(e)) is amended by inserting ‘‘(other than subsection 
(f))’’ after ‘‘The provisions of this section’’. 
(c) GAO REPORT AND RECOMMENDATIONS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, the Comptroller 
General of the United States shall submit to the 
Chair and Ranking Member of the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate and the Chair and Ranking Member of the Com-
mittee on Energy and Commerce of the House of 
Representatives a report on the effects of the imple-
mentation of subsection (f) of section 2719A of the 
Public Health Service Act (as added by subsection 
(a)) on the timely access of patients to oral medica-
tions (as defined in subsection (f)(4) of such sec-
tion), together with such recommendations as the 
Comptroller General determines are appropriate. 
(2) ITEMS INCLUDED.—The report submitted 
under paragraph (1) shall include— 
(A) a comparison of the amount of time 
between the date on which a prescription is 
written and the date on which a patient receives 
an oral medication before and after the imple-
mentation of subsection (f) of section 2719A of 
the Public Health Service Act; 
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