Advancing Education on Biosimilars Act of 2019

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Advancing Education 4 on Biosimilars Act of 2019’’. 5 VerDate Sep 11 2014 21:45 Sep 20, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4400.IH H4400 kjohnson on DSK79L0C42 with BILLS 2 •HR 4400 IH SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS. 1 (a) WEBSITE; CONTINUING EDUCATION.—Subpart 1 2 of part F of title III of the Public Health Service Act (42 3 U.S.C. 262 et seq.) is amended by adding at the end the 4 following: 5 ‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 6 ‘‘(a) INTERNET WEBSITE.— 7 ‘‘(1) IN GENERAL.—The Secretary shall main- 8 tain and operate an internet website to provide edu- 9 cational materials for health care providers, patients, 10 and caregivers, regarding the meaning of the terms, 11 and the standards for review and licensing of, bio- 12 logical products, including biosimilar biological prod- 13 ucts and interchangeable biosimilar biological prod- 14 ucts. 15 ‘‘(2) CONTENT.—Educational materials pro- 16 vided under paragraph (1) may include— 17 ‘‘(A) explanations of key statutory and 18 regulatory terms, including ‘biosimilar’ and 19 ‘interchangeable’, and clarification regarding 20 the use of interchangeable biosimilar biological 21 products; 22 ‘‘(B) information related to development 23 programs for biological products, including bio- 24 similar biological products and interchangeable 25 biosimilar biological products and relevant clin- 26 VerDate Sep 11 2014 21:45 Sep 20, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4400.IH H4400 kjohnson on DSK79L0C42 with BILLS 3 •HR 4400 IH ical considerations for prescribers, which may 1 include, as appropriate and applicable, informa- 2 tion related to the comparability of such biologi- 3 cal products; 4 ‘‘(C) an explanation of the process for re- 5 porting adverse events for biological products, 6 including biosimilar biological products and 7 interchangeable biosimilar biological products; 8 and 9 ‘‘(D) an explanation of the relationship be- 10 tween biosimilar biological products and inter- 11 changeable biosimilar biological products li- 12 censed under section 351(k) and reference 13 products (as defined in section 351(i)), includ- 14 ing the standards for review and licensing of 15 each such type of biological product. 16 ‘‘(3) FORMAT.—The educational materials pro- 17 vided under paragraph (1) may be— 18 ‘‘(A) in formats such as webinars, con- 19 tinuing medical education modules, videos, fact 20 sheets, infographics, stakeholder toolkits, or 21 other formats as appropriate and applicable; 22 and 23 ‘‘(B) tailored for the unique needs of 24 health care providers, patients, caregivers, and 25 VerDate Sep 11 2014 21:45 Sep 20, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4400.IH H4400 kjohnson on DSK79L0C42 with BILLS 4 •HR 4400 IH other audiences, as the Secretary determines 1 appropriate. 2 ‘‘(4) OTHER INFORMATION.—In addition to the 3 information described in paragraph (2), the Sec- 4 retary shall continue to publish the following infor- 5 mation: 6 ‘‘(A) The action package of each biological 7 product licensed under subsection (a) or (k). 8 ‘‘(B) The summary review of each biologi- 9 cal product licensed under subsection (a) or (k). 10 ‘‘(5) CONFIDENTIAL AND TRADE SECRET IN- 11 FORMATION.—This subsection does not authorize 12 the disclosure of any trade secret, confidential com- 13 mercial or financial information, or other matter de- 14 scribed in section 552(b) of title 5. 15 ‘‘(b) CONTINUING EDUCATION.—The Secretary shall 16 advance education and awareness among health care pro- 17 viders regarding biological products, including biosimilar 18 biological products and interchangeable biosimilar biologi- 19 cal products, as appropriate, including by developing or 20 improving continuing education programs that advance 21 the education of such providers on the prescribing of, and 22 relevant clinical considerations with respect to, biological 23 products, including biosimilar biological products and 24 interchangeable biosimilar biological products.’’. 25 VerDate Sep 11 2014 21:45 Sep 20, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4400.IH H4400 kjohnson on DSK79L0C42 with BILLS 5 •HR 4400 IH (b) APPLICATION UNDER THE MEDICARE MERIT- 1 BASED INCENTIVE PAYMENT SYSTEM.—Section 2 1848(q)(5)(C) of the Social Security Act (42 U.S.C. 3 1395w–4(q)(5)(C)) is amended by adding at the end the 4 following new clause: 5 ‘‘(iv) CLINICAL MEDICAL EDUCATION 6 PROGRAM ON BIOSIMILAR BIOLOGICAL 7 PRODUCTS.—Completion of a clinical med- 8 ical education program developed or im- 9 proved under section 352A(b) of the Public 10 Health Service Act by a MIPS eligible pro- 11 fessional during a performance period shall 12 earn such eligible professional one-half of 13 the highest potential score for the perform- 14 ance category described in paragraph 15 (2)(A)(iii) for such performance period. A 16 MIPS eligible professional may only count 17 the completion of such a program for pur- 18 poses of such category one time during the 19 eligible professional’s lifetime.’’. 20 Æ VerDate Sep 11 2014 21:45 Sep 20, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H4400.IH H4400 kjohnson on DSK79L0C42 with BILLS