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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4011 Introduced in House (IH)]
<DOC>
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Timely Access to Clinical 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.--
``(1) Requirements for contracts between group health plans
or health insurance issuers and pharmacies.--If a group health
plan or a health insurance issuer offering group or individual
health insurance coverage covers or provides 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 participants,
beneficiaries, or enrollees of the plan or coverage, such plan
or issuer shall require, as conditions 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
prescription for an oral medication for such participant,
beneficiary, or enrollee are the following (as applicable):
``(A) Pharmacy confirmation of ability to
dispense.--Not later than 24 hours after receiving such
prescription--
``(i) confirm to such health care provider
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 medication to
such participant, beneficiary, or enrollee by
not later than 72 hours after receiving such
prescription, including any time for benefits
verification, prior authorization, or any other
administrative procedure required by the agent
of such plan or issuer (including a pharmacy
benefits manager) prior to authorizing the
pharmacy to dispense the medication.
``(B) Pharmacy able to fill prescription.--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, beneficiary, or enrollee by the 72-hour
deadline described in such subparagraph, dispense such
oral medication to such participant, beneficiary, or
enrollee by such deadline.
``(C) Pharmacy unable to fill prescription.--In the
case that such pharmacy informs such health care
provider under subparagraph (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 individual
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 participant,
beneficiary, or enrollee to be dispensed such oral
medication from any provider or pharmacy described in
subparagraph (C) of paragraph (3), in accordance with
the requirements described in subparagraphs (A) and (B)
of such paragraph.
``(D) Pharmacy failure to communicate.--If the
pharmacy does not communicate its ability to dispense
as required by subparagraph (A), or, after confirming
that it will dispense an oral medication under such
subparagraph, 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
contract described in such paragraph, with a pharmacy
and such pharmacy, with respect to a participant,
beneficiary, or enrollee of the plan or coverage and a
health care provider who submits to such pharmacy a
prescription for an oral medication for such
participant, beneficiary, or enrollee, informs such
health care provider under subparagraph (A)(ii) of such
paragraph that such pharmacy will not dispense such
oral medication to such participant, beneficiary, or
enrollee by the 72-hour deadline described in such
subparagraph (or in the case that the participant,
beneficiary, or enrollee has not received the oral
medication by the 72-hour deadline), the plan or
issuer--
``(i) shall authorize such participant,
beneficiary, or enrollee to select any provider
or pharmacy described in subparagraph (C) to
dispense such oral medication to such
participant, beneficiary, or enrollee based on
the written notice described in paragraph
(2)(C) or a certification by a the prescribing
physician or other health professional that the
participant, beneficiary, or enrollee has not
received the oral medication by the 72-hour
deadline; and
``(ii) in the case that the provider or
pharmacy selected under clause (i) does not
have a contract with such plan or issuer to
dispense such oral medication to such
participant, group health plan or a health
insurance issuer offering group or individual
health insurance coverage described in
paragraph (1) shall cover the medication and
pay the provider or pharmacy in accordance with
the provisions of subparagraph (B).
``(B) Coverage requirements for prescriptions
dispensed by alternate provider or pharmacy.--For
prescriptions dispensed by an alternate provider or
pharmacy in accordance with subparagraph (A) that does
not have a contract with 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)
to dispense such oral medication to such participant,
such group health plan or a health insurance issuer (or
its agent, including a pharmacy benefits manager) shall
cover the medication and pay the provider or pharmacy
subject to the following requirements--
``(i) such medication will be provided
without imposing any requirement under the plan
for prior authorization of the medication or
any limitation on coverage that is more
restrictive than the requirements or
limitations that apply to oral medications
received from participating providers and
pharmacies with respect to such plan;
``(ii) the cost-sharing requirement
(expressed as a copayment amount or coinsurance
rate) is not greater than the requirement that
would apply if such services were provided by a
participating provider or a participating
pharmacy;
``(iii) such cost-sharing requirement is
calculated as if the total amount that would
have been charged for such services by such
participating provider or participating
pharmacy were equal to the recognized amount
(as determined by the Secretary) for such oral
medications, plan, and year;
``(iv) the group health plan pays to such
provider or pharmacy, respectively, the amount
by which the recognized amount for such
services and year involved exceeds the cost-
sharing amount for such services (as determined
in accordance with clauses (ii) and (iii)) and
year;
``(v) any cost-sharing payments made by the
participant or beneficiary with respect to such
oral medication so furnished shall be counted
toward any in-network deductible or out-of-
pocket maximums applied 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 participating
pharmacy; and
``(vi) such medication will be provided
without regard to any other term or condition
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 described.--A provider
or pharmacy described in this subparagraph, with
respect to a participant, beneficiary, or enrollee of a
group health plan or group or individual health
insurance coverage described in paragraph (1) and a
prescription for an oral medication for such
participant, 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
license is required by the State;
``(ii) is either located within a
reasonable distance (as determined by the
Secretary) of the residence of such
participant, beneficiary, or enrollee, or is
able to deliver such oral medication to such
participant, beneficiary, or enrollee at such
residence; and
``(iii) is able to dispense (and if
applicable, deliver), such oral medication to
such participant, beneficiary, or enrollee
within 48 hours of the date on which it
receives the prescription.
For purposes of this section, a provider or pharmacy
described in this subparagraph includes a physician or
other health care practitioner authorized to dispense
oral medication to such participant, beneficiary, or
enrollee pursuant to the law of the State in which the
physician or other health care practitioner is located.
``(D) Prior authorization requirements.--In the
case of a group health plan or a health insurance
issuer offering group or individual health insurance
coverage that requires prior authorization for an oral
medication to be dispensed to a participant,
beneficiary, or enrollee of the plan or coverage, such
plan or issuer (or its agent, including a pharmacy
benefits manager) shall make a decision with respect to
a request for such a prior authorization by not later
than 72 hours after receiving such request. In the case
that such plan or issuer (or its agent, including a
pharmacy benefits manager) 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 previous sentence,
such participant, beneficiary or enrollee may select
any pharmacy described in subparagraph (C) to dispense
such oral medication to such participant, beneficiary,
or enrollee, in accordance with the cost-sharing
requirements described in subparagraph (B).
``(E) Use of relevant quality measures under
incentive payment and adjustment systems.--If a group
health plan or a health insurance issuer offering group
or individual health insurance coverage uses an
incentive payment and adjustment system (as defined by
the Secretary) in determining pharmacy reimbursement
payments for oral medications, such system shall only
use quality measures that are relevant to the
performance of such pharmacy with respect to areas that
the pharmacy can impact based on the oral medications
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 Social Security Act) that is used for
a medically accepted 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-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
Senate and the Chair and Ranking Member of the Committee on
Energy and Commerce of the House of Representatives a report on
the effects of the implementation 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 medications (as
defined in subsection (f)(4) of such section), 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 implementation of subsection (f) of section
2719A of the Public Health Service Act;
(B) an assessment of the effects on patient health
outcomes, including morbidity and mortality;
(C) an evaluation of costs to patients, health
insurance issuers, physicians, and other healthcare
providers; and
(D) a risk assessment with mitigation
recommendations on any actual or potential fraud, waste
and abuse relating to the implementation of such
subsection.
(d) Effective Date.--The amendments made by this section shall
apply with respect to plan years beginning on or after January 1, 2024.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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