[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8574 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 8574
To amend the Public Health Service Act to reform the 340B drug pricing
program, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 28, 2024
Mr. Bucshon (for himself, Mr. Carter of Georgia, and Mrs. Harshbarger)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on Ways and
Means, 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 amend the Public Health Service Act to reform the 340B drug pricing
program, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``340B Affording
Care for Communities and Ensuring a Strong Safety-net Act'' or the
``340B ACCESS Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Prevention of Medicaid duplicate discounts; oversight of
covered entities.
Sec. 4. Hospital child site requirements.
Sec. 5. Contract pharmacies.
Sec. 6. Ensuring patient affordability of drugs purchased under section
340B.
Sec. 7. Requirements for nonhospital covered entities and subgrantees.
Sec. 8. Claims modifiers; covered entity data submission.
Sec. 9. Covered entity reporting on scope of grant, contract, and
project.
Sec. 10. Ensuring covered entity transparency.
Sec. 11. Revisions to existing 340B hospital eligibility requirements.
Sec. 12. Additional requirements for 340B hospitals.
Sec. 13. 340B program.
Sec. 14. Audits of private nonhospital contracts with State and local
governments.
Sec. 15. Ensuring covered entity compliance with transparency
requirements.
Sec. 16. 340B claims data clearinghouse.
Sec. 17. Limitation on administrator service fees and contract pharmacy
fees.
Sec. 18. Clarification.
Sec. 19. Ensuring the equitable treatment of 340B covered entities and
pharmacies participating in the 340B drug
discount program.
Sec. 20. Effective date.
SEC. 2. DEFINITIONS.
(a) Definition of Patient.--Section 340B(b) of the Public Health
Service Act (42 U.S.C. 256b(b)) is amended by adding at the end the
following:
``(3) Patient.--
``(A) In general.--In this section, the term
`patient' means, with respect to a covered entity
described in subsection (a)(4), an individual who, on a
prescription-by-prescription or order-by-order basis--
``(i) is dispensed or administered a
covered outpatient drug that is--
``(I) directly related to the
service described in clause (iii);
``(II) ordered or prescribed by a
covered entity provider described in
clause (ii) as a result of the service
described in clause (iii); and
``(III) dispensed or administered
on site at a covered entity location, a
child site (as defined in subsection
(a)(5)(E)), or an entity pharmacy (as
defined in subsection (a)(5)(F)) listed
in the identification system described
in subsection (d)(2)(B)(iv), or on site
at a contract pharmacy in accordance
with subsection (a)(5)(F) or dispensed
through a mail order pharmacy in
accordance with subsection (a)(5)(F);
``(ii) receives the health care service
described in clause (iii) from a `covered
entity provider', meaning a health care
professional who either--
``(I) is an employee or independent
contractor of the covered entity, such
that the covered entity bills for
services furnished by the health care
professional and is responsible for the
care furnished by such professional; or
``(II) furnishes health care
services under an ongoing contractual
obligation to the covered entity such
that responsibility for the care
provided remains with the covered
entity and meets the other requirements
in this paragraph, in the event State
law prohibits or otherwise
substantially limits the ability of the
covered entity to bill for services of
the health care professional;
``(iii) receives a covered outpatient drug
in connection with a health care service
furnished at the covered entity (including a
child site) and such drug and service are paid
by the insurer or third-party payor as
outpatient items and services (or where third-
party reimbursement is not made, such items and
services are deemed outpatient if less than 24
hours have elapsed between such individual's
hospital registration and discharge);
``(iv) is described in a category of
individuals within the scope of, and receives a
health care service at the covered entity
(including a child site) that is within the
scope of--
``(I) the Federal grant, project,
or Federal grant-authorizing statute,
as applicable, that qualifies such
entity for participation in the program
under this section, if the covered
entity is described in one of
subparagraphs (A) through (K) of
subsection (a)(4); or
``(II) the contract as required in
paragraphs (4)(L)(i) and (11) of
subsection (a), if the covered entity
is a private nonprofit hospital which
has, as the basis for participating in
the program under this section, a
contract with a State or local
government to provide health care
services to specified individuals,
provided that clause (iv) shall not
apply with respect to a covered entity
described in subsection (a)(4)(N) or a
sole community hospital described in
subsection (a)(4)(O); and
``(v) has an ongoing relationship with the
covered entity such that the covered entity
creates and maintains auditable health care
records which demonstrate compliance with this
paragraph and that the covered entity--
``(I) has a provider-to-patient
relationship with the individual;
``(II) is responsible for the
individual's health care service that
resulted in the prescription or order
for the drug; and
``(III)(aa) has provided a health
care service to the individual through
an in-person visit within the past 12
months, if the covered entity is a
hospital described in subparagraph (L)
or subparagraph (M) of subsection
(a)(4) or is a rural referral center
described in subparagraph (O) of such
subsection; or
``(bb) has provided a health care
service to the individual through an
in-person visit within the past 24
months, if the covered entity is
described in one of subparagraphs (A)
through (K) of subsection (a)(4),
subparagraph (N) of such subsection, or
is a sole community hospital described
in subparagraph (O) of such subsection.
``(B) Telehealth and telemedicine.--
``(i) In general.--A prescription for a
covered outpatient drug resulting from a health
care service furnished to an individual through
telehealth, telemedicine, or other remote
health care service arrangements shall not
qualify for pricing described in subsection
(a)(1) unless--
``(I) the covered entity (including
child site, as applicable) at which
such service is furnished is a covered
entity (or a child site of a covered
entity, as applicable) described in one
of subparagraphs (A) through (K) of
subsection (a)(4), subparagraph (N) of
such subsection, or is a sole community
hospital described in subparagraph (O)
of such subsection; and
``(II) subject to the exception in
clause (ii), a covered entity provider
has conducted an in-person examination
of the individual within the 6-month
time period immediately preceding the
health care service resulting in the
prescription or order for the drug.
``(ii) Exception.--The requirement in
clause (i)(II) shall not apply with respect to
an individual for whom the covered entity
maintains auditable records sufficient to
demonstrate that such entity verified such
individual is determined eligible for benefits
under either title II of the Social Security
Act or title XVI of such Act in accordance with
the provisions of such applicable title.
``(C) Prescriptions from non-covered entity
providers ineligible.--
``(i) In general.--Subject to the exception
for a qualifying referral described in clause
(ii), a covered outpatient drug prescribed or
ordered for an individual by a health care
professional who is not a covered entity
provider shall not qualify for pricing
described in subsection (a)(1).
``(ii) Exception for qualifying
referrals.--In the case of a `qualifying
referral', all requirements in subparagraph (A)
shall apply, except for clauses (i)(I),
(i)(II), (ii), (iii), and (v)(II) of such
subparagraph. For purposes of this paragraph, a
`qualifying referral' shall refer to the
sequence of occurrences described in this
clause for which a covered entity maintains
documentation sufficient to demonstrate that--
``(I) a covered entity provider
evaluates and recommends to the
individual, during an encounter at the
covered entity (including child site,
as applicable), that such individual
receive a specified type of specialty
health care not available at the
covered entity and such recommendation
is contemporaneously documented, at the
time of such encounter, in the medical
record the covered entity creates and
maintains for such individual;
``(II) within one year of the date
of the encounter and recommendation
described in subclause (I), the
individual receives a health care
service from a medical specialist of
the type described in such
recommendation;
``(III) within the time period
specified in subclause (II), the
covered entity provider making the
recommendation receives, directly from
the medical specialist that furnishes
the health care service described in
subclause (II), written documentation
specifying the service or services
furnished to such individual and the
diagnoses made in connection with such
service or services; and
``(IV) the covered entity retains
overall responsibility for the care of
the individual.
``(iii) Covered entity eligibility for
qualifying referrals.--Notwithstanding any
other provision in this section, a covered
entity shall not qualify for pricing described
in subsection (a)(1) with respect to a
prescription or order for a covered outpatient
drug resulting from a qualifying referral
unless such covered entity--
``(I) is described in subparagraph
(N) of subsection (a)(4);
``(II) is a sole community hospital
described in subparagraph (O) of such
subsection; or
``(III) is described in one of
subparagraphs (A) through (K) of such
subsection, is not a specified
nonhospital covered entity (as defined
in subsection (b)(4)), and has a
Federal grant that requires such entity
to contract or refer for the health
care service or services furnished to
the individual by the medical
specialist described in clause (ii).
``(D) Health care service required.--For purposes
of this section, an individual shall not be considered
a patient of the covered entity described in subsection
(a)(4) if the individual receives from the covered
entity only the administration or infusion of a drug or
drugs, or the dispensing of a drug or drugs for
subsequent self-administration or administration in the
home setting, without a covered entity provider-to-
patient encounter involving the provision of a health
care service.''.
(b) Definition of Specified Nonhospital Covered Entity.--Section
340B(b) of the Public Health Service Act (42 U.S.C. 256b(b)) is further
amended by adding at the end the following:
``(4) Specified nonhospital covered entity.--In this
section, the term `specified nonhospital covered entity' means
a covered entity that--
``(A) is described in one of subparagraphs (B)
through (K) of subsection (a)(4), other than a covered
entity described in subparagraph (G) of such
subsection, and--
``(i) has average annual operating revenues
exceeding $1,000,000,000 calculated over the
most recent three-year period for which data
are available, which revenue threshold shall be
adjusted for inflation annually to reflect rate
of change in the Consumer Price Index for All
Urban Consumers published by the Bureau of
Labor Statistics; or
``(ii) is an affiliate of a hospital; or
``(B) is described in subsection (a)(4)(A) and
becomes affiliated with a hospit