Sec. 351. Education on biological products
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/bill/116/hr/19/ih/section-351A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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: 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. Educational materials provided under paragraph
(1)may include— explanations of key statutory and regulatory terms, including biosimilar and interchangeable , and clarification regarding the use of interchangeable biosimilar biological products; 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; an explanation of the process for reporting adverse events for biological products, including biosimilar biological products and interchangeable biosimilar biological products; and 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. The educational materials provided under paragraph
(1)may be— in formats such as webinars, continuing medical education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary determines appropriate. In addition to the information described in paragraph (2), the Secretary shall continue to publish the following information: The action package of each biological product licensed under subsection
(a)or (k). The summary review of each biological product licensed under subsection
(a)or (k). 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. 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. . 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: 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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- 42 USC 1395w–4(q)(5)(C)
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