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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Advancing Education 

5 on Biosimilars Act of 2019’’. 


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1 SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS. 

2 (a) WEBSITE; CONTINUING EDUCATION.—Subpart 1 

3 of part F of title III of the Public Health Service Act (42 

4 U.S.C. 262 et seq.) is amended by adding at the end the 

5 following: 

6 ‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 

7 ‘‘(a) INTERNET WEBSITE.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall main9 tain and operate an internet website to provide edu10 cational materials for health care providers, patients, 

11 and caregivers, regarding the meaning of the terms, 

12 and the standards for review and licensing of, bio13 logical products, including biosimilar biological prod14 ucts and interchangeable biosimilar biological prod15 ucts. 

16 ‘‘(2) CONTENT.—Educational materials pro17 vided under paragraph (1) may include— 

18 ‘‘(A) explanations of key statutory and 

19 regulatory terms, including ‘biosimilar’ and 

20 ‘interchangeable’, and clarification regarding 

21 the use of interchangeable biosimilar biological 

22 products; 

23 ‘‘(B) information related to development 

24 programs for biological products, including bio25 similar biological products and interchangeable 

26 biosimilar biological products and relevant clinVerDate Sep 11 2014 21:45 Sep 20, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4400.IH H4400

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1 ical considerations for prescribers, which may 

2 include, as appropriate and applicable, informa3 tion related to the comparability of such biologi4 cal products; 

5 ‘‘(C) an explanation of the process for re6 porting adverse events for biological products, 

7 including biosimilar biological products and 

8 interchangeable biosimilar biological products; 

9 and 

10 ‘‘(D) an explanation of the relationship be11 tween biosimilar biological products and inter12 changeable biosimilar biological products li13 censed under section 351(k) and reference 

14 products (as defined in section 351(i)), includ15 ing the standards for review and licensing of 

16 each such type of biological product. 

17 ‘‘(3) FORMAT.—The educational materials pro18 vided under paragraph (1) may be— 

19 ‘‘(A) in formats such as webinars, con20 tinuing medical education modules, videos, fact 

21 sheets, infographics, stakeholder toolkits, or 

22 other formats as appropriate and applicable; 

23 and 

24 ‘‘(B) tailored for the unique needs of 

25 health care providers, patients, caregivers, and 


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1 other audiences, as the Secretary determines 

2 appropriate. 

3 ‘‘(4) OTHER INFORMATION.—In addition to the 

4 information described in paragraph (2), the Sec5 retary shall continue to publish the following infor6 mation: 

7 ‘‘(A) The action package of each biological 

8 product licensed under subsection (a) or (k). 

9 ‘‘(B) The summary review of each biologi10 cal product licensed under subsection (a) or (k). 

11 ‘‘(5) CONFIDENTIAL AND TRADE SECRET IN12 FORMATION.—This subsection does not authorize 

13 the disclosure of any trade secret, confidential com14 mercial or financial information, or other matter de15 scribed in section 552(b) of title 5. 

16 ‘‘(b) CONTINUING EDUCATION.—The Secretary shall 

17 advance education and awareness among health care pro18 viders regarding biological products, including biosimilar 

19 biological products and interchangeable biosimilar biologi20 cal products, as appropriate, including by developing or 

21 improving continuing education programs that advance 

22 the education of such providers on the prescribing of, and 

23 relevant clinical considerations with respect to, biological 

24 products, including biosimilar biological products and 

25 interchangeable biosimilar biological products.’’. 


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1 (b) APPLICATION UNDER THE MEDICARE MERIT2 BASED INCENTIVE PAYMENT SYSTEM.—Section 

3 1848(q)(5)(C) of the Social Security Act (42 U.S.C. 

4 1395w–4(q)(5)(C)) is amended by adding at the end the 

5 following new clause: 

6 ‘‘(iv) CLINICAL MEDICAL EDUCATION

7 PROGRAM ON BIOSIMILAR BIOLOGICAL

8 PRODUCTS.—Completion of a clinical med9 ical education program developed or im10 proved under section 352A(b) of the Public 

11 Health Service Act by a MIPS eligible pro12 fessional during a performance period shall 

13 earn such eligible professional one-half of 

14 the highest potential score for the perform15 ance category described in paragraph 

16 (2)(A)(iii) for such performance period. A 

17 MIPS eligible professional may only count 

18 the completion of such a program for pur19 poses of such category one time during the 

20 eligible professional’s lifetime.’’. 

Æ 


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