Advancing Education on Biosimilars Act of 2019

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. Short title This Act may be cited as the Advancing Education on Biosimilars Act of 2019 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 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 interchangeable (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) (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. .

Summary: Advancing Education on Biosimilars Act of 2019This bill requires the Department of Health and Human Services (HHS) to maintain a website and undertake other activities to educate health care providers, patients, and caregivers about biological products, biosimilar biological products, and interchangeable biosimilar biological products. Among other activities, HHS must develop or improve continuing education programs that address clinical considerations for biological and related products. Health care providers eligible for the Merit-based Incentive Payment System in Medicare may count completion of such a program as a clinical practice improvement activity.