[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4400 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 4400
To amend the Public Health Service Act to provide for an internet
website to provide educational materials for health care providers,
patients, and caregivers, regarding the meaning of the terms, and the
standards for review and licensing of, biological products, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 19, 2019
Mr. Bucshon (for himself and Mr. Engel) 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 provide for an internet
website to provide educational materials for health care providers,
patients, and caregivers, regarding the meaning of the terms, and the
standards for review and licensing of, biological products, 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 ``Advancing Education on Biosimilars
Act of 2019''.
SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS.
(a) Website; Continuing Education.--Subpart 1 of part F of title
III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended
by adding at the end the following:
``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.
``(a) Internet Website.--
``(1) In general.--The Secretary shall maintain and operate
an internet website to provide educational materials for health
care providers, patients, and caregivers, regarding the meaning
of the terms, and the standards for review and licensing of,
biological products, including biosimilar biological products
and interchangeable biosimilar biological products.
``(2) Content.--Educational materials provided under
paragraph (1) may include--
``(A) explanations of key statutory and regulatory
terms, including `biosimilar' and `interchangeable',
and clarification regarding the use of interchangeable
biosimilar biological products;
``(B) information related to development programs
for biological products, including biosimilar
biological products and interchangeable biosimilar
biological products and relevant clinical
considerations for prescribers, which may include, as
appropriate and applicable, information related to the
comparability of such biological products;
``(C) an explanation of the process for reporting
adverse events for biological products, including
biosimilar biological products and interchangeable
biosimilar biological products; and
``(D) an explanation of the relationship between
biosimilar biological products and interchangeable
biosimilar biological products licensed under section
351(k) and reference products (as defined in section
351(i)), including the standards for review and
licensing of each such type of biological product.
``(3) Format.--The educational materials provided under
paragraph (1) may be--
``(A) in formats such as webinars, continuing
medical education modules, videos, fact sheets,
infographics, stakeholder toolkits, or other formats as
appropriate and applicable; and
``(B) tailored for the unique needs of health care
providers, patients, caregivers, and other audiences,
as the Secretary determines appropriate.
``(4) Other information.--In addition to the information
described in paragraph (2), the Secretary shall continue to
publish the following information:
``(A) The action package of each biological product
licensed under subsection (a) or (k).
``(B) The summary review of each biological product
licensed under subsection (a) or (k).
``(5) Confidential and trade secret information.--This
subsection does not authorize the disclosure of any trade
secret, confidential commercial or financial information, or
other matter described in section 552(b) of title 5.
``(b) Continuing Education.--The Secretary shall advance education
and awareness among health care providers regarding biological
products, including biosimilar biological products and interchangeable
biosimilar biological products, as appropriate, including by developing
or improving continuing education programs that advance the education
of such providers on the prescribing of, and relevant clinical
considerations with respect to, biological products, including
biosimilar biological products and interchangeable biosimilar
biological products.''.
(b) Application Under the Medicare Merit-Based Incentive Payment
System.--Section 1848(q)(5)(C) of the Social Security Act (42 U.S.C.
1395w-4(q)(5)(C)) is amended by adding at the end the following new
clause:
``(iv) Clinical medical education program
on biosimilar biological products.--Completion
of a clinical medical education program
developed or improved under section 352A(b) of
the Public Health Service Act by a MIPS
eligible professional during a performance
period shall earn such eligible professional
one-half of the highest potential score for the
performance category described in paragraph
(2)(A)(iii) for such performance period. A MIPS
eligible professional may only count the
completion of such a program for purposes of
such category one time during the eligible
professional's lifetime.''.
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