I 
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 subse-
quently 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 pur-
poses. 
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 ‘‘Advancing Education 
on Biosimilars Act of 2019’’. 
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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 main-
tain and operate an internet website to provide edu-
cational materials for health care providers, patients, 
and caregivers, regarding the meaning of the terms, 
and the standards for review and licensing of, bio-
logical products, including biosimilar biological prod-
ucts and interchangeable biosimilar biological prod-
ucts. 
‘‘(2) CONTENT.—Educational materials pro-
vided 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 bio-
similar biological products and interchangeable 
biosimilar biological products and relevant clin-
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ical considerations for prescribers, which may 
include, as appropriate and applicable, informa-
tion related to the comparability of such biologi-
cal products; 
‘‘(C) an explanation of the process for re-
porting adverse events for biological products, 
including biosimilar biological products and 
interchangeable biosimilar biological products; 
and 
‘‘(D) an explanation of the relationship be-
tween biosimilar biological products and inter-
changeable biosimilar biological products li-
censed under section 351(k) and reference 
products (as defined in section 351(i)), includ-
ing the standards for review and licensing of 
each such type of biological product. 
‘‘(3) FORMAT.—The educational materials pro-
vided under paragraph (1) may be— 
‘‘(A) in formats such as webinars, con-
tinuing 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 
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other audiences, as the Secretary determines 
appropriate. 
‘‘(4) OTHER INFORMATION.—In addition to the 
information described in paragraph (2), the Sec-
retary shall continue to publish the following infor-
mation: 
‘‘(A) The action package of each biological 
product licensed under subsection (a) or (k). 
‘‘(B) The summary review of each biologi-
cal product licensed under subsection (a) or (k). 
‘‘(5) CONFIDENTIAL AND TRADE SECRET IN-
FORMATION.—This subsection does not authorize 
the disclosure of any trade secret, confidential com-
mercial or financial information, or other matter de-
scribed in section 552(b) of title 5. 
‘‘(b) CONTINUING EDUCATION.—The Secretary shall 
advance education and awareness among health care pro-
viders regarding biological products, including biosimilar 
biological products and interchangeable biosimilar biologi-
cal 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.’’. 
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(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 med-
ical education program developed or im-
proved under section 352A(b) of the Public 
Health Service Act by a MIPS eligible pro-
fessional during a performance period shall 
earn such eligible professional one-half of 
the highest potential score for the perform-
ance 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 pur-
poses of such category one time during the 
eligible professional’s lifetime.’’. 
Æ 
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