No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3731 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 3731
To amend title XI of the Social Security Act to establish a research
and development-intensive small biotech manufacturer exception from the
Medicare drug price negotiation program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 4, 2025
Mr. Pfluger (for himself and Mr. Kustoff) 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 title XI of the Social Security Act to establish a research
and development-intensive small biotech manufacturer exception from the
Medicare drug price negotiation program.
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 ``Small Biotech Innovation Act''.
SEC. 2. RESEARCH AND DEVELOPMENT-INTENSIVE SMALL BIOTECH MANUFACTURER
EXCEPTION FROM MEDICARE DRUG PRICE NEGOTIATION PROGRAM.
Section 1192(d)(2) of the Social Security Act (42 U.S.C. 1320f-
1(d)(2)) is amended by adding at the end the following new
subparagraph:
``(D) Research and development-intensive small
biotech manufacturer exception for 2029 and subsequent
years.--
``(i) In general.--With respect to initial
price applicability years (beginning with
initial price applicability year 2029), subject
to the succeeding provisions of this
subparagraph, the term `negotiation eligible
drug' shall not include a qualifying single
source drug (as defined in subsection (e)) of a
research and development-intensive small
biotech manufacturer (as defined in clause
(ii)).
``(ii) Definitions.--In this subparagraph:
``(I) Applicable percent.--The term
`applicable percent' means--
``(aa) in the case of a
small biotech manufacturer that
has 1 qualifying single source
drug, 30 percent;
``(bb) in the case of a
small biotech manufacturer that
has 2 qualifying single source
drugs, 40 percent;
``(cc) in the case of a
small biotech manufacturer that
has 3 qualifying single source
drugs, 50 percent;
``(dd) in the case of a
small biotech manufacturer that
has 4 qualifying single source
drugs, 60 percent; and
``(ee) in the case of a
small biotech manufacturer that
has 5 qualifying single source
drugs, 70 percent.
``(II) Small biotech manufacturer
defined.--The term `small biotech
manufacturer' means a manufacturer
that--
``(aa) has 5 or less
qualifying single source drugs;
and
``(bb) is not owned by,
controlled by, or subject to
the jurisdiction or direction
of a government of a foreign
country, or organized under the
laws of a foreign country that
is a covered nation (as defined
in section 4872(f) of title 10,
United States Code).
``(III) Research and development-
intensive small biotech manufacturer
defined.--The term `research and
development-intensive small biotech
manufacturer' means a small biotech
manufacturer that invests at least the
applicable percent of their net revenue
from the average of the previous three
years in research and development
(determined based on generally accepted
accounting principles).
``(iii) Treatment in case of acquisition.--
A drug shall not be considered to be a
qualifying single source drug of a research and
development-intensive small biotech
manufacturer if the manufacturer of such drug
is acquired after 2029 by another manufacturer
that does not meet the definition of a research
and development-intensive small biotech
manufacturer, effective at the beginning of the
plan year immediately following such
acquisition.
``(iv) Annual application.--In order for a
qualifying single source drug of a research and
development-intensive small biotech
manufacturer to be eligible for the exception
under this subparagraph with respect to an
initial price applicability year (beginning
with initial price applicability year 2029),
the manufacturer shall submit an application to
the Secretary (at a time specified by the
Secretary) containing--
``(I) information on the net
product revenue and research and
development expenditures of the
manufacturer during the relevant time
period;
``(II) a certification that the
information submitted by the
manufacturer under subclause (I) is
accurate and complete to the best of
the manufacturer's knowledge; and
``(III) such other information as
the Secretary may specify.
``(v) Dispute resolution.--The Secretary
shall develop a process under which a
manufacturer may appeal a determination by the
Secretary that the manufacturer is not a
research and development-intensive small
biotech manufacturer. Such process shall
conclude, with respect to a manufacturer, not
later than the selected drug publication date
with respect to the initial price applicability
year for which the manufacturer submitted an
application under clause (iv).''.
<all>
Introduced in House
Introduced in House
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.
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.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line