,,ii #aafth ,,congress #ast ,session ,s4 #afha ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #bc 7legislative day1 ,may #bb71 #bjai,mr4 ,enzi 7for himself and ,ms4 ,hassan7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to educate health care providers and the public on biosimilar biological products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,advancing ,education on ,biosimilars ,act of #bjai4 #b4 ,education on biological products 7a7 ,in general ,subpart #a of part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended by adding at the end the following3 #ceb;,a4 ,education on biological products 7a7 ,internet website 7#a7 ,in general ,the ,secretary shall establish1 maintain1 and operate an internet website consisting of educational materials regarding the meaning and use of biosimilar biological products and interchangeable biological products4 7#b7 ,format ,the educational materials provided under paragraph 7#a7-- 7,a7 may be in the form of webinars1 continuing medical education modules1 videos1 fact sheets1 infographics1 stakeholder toolkits1 or other formats1 as the ,secretary determines appropriate2 7,b7 shall be presented in a manner1 using simple terminology1 that is easily comprehended by appropriate target audiences1 including accounting1 to the extent practicable1 for varying levels of health literacy among patients and caregivers2 7,c7 shall be tailored for the unique needs of appropriate target audiences1 including-- 7i7 health care providers with prescribing authority or dispensing authority under applicable ,state law1 including physicians1 nurses1 nurse practitioners1 physician assistants1 pharmacists1 and pharmacy technicians2 and 7ii7 patients and caregivers2 and 7,d7 may1 as appropriate1 be additionally tailored to health care providers practicing in specialties in which biological products commonly are prescribed or to patient populations to whom biological products commonly are prescribed or administered4 7#c7 ,content ,educational materials provided under paragraph 7#a7 shall include explanations of-- 7,a7 key statutory and regulatory definitions1 including the definitions of the terms biosimilar and interchangeable1 and clarification that an interchangeable product is not superior in quality to a biosimilar biological product2 7,b7 how the ,secretary determines the safety1 purity1 and potency of biological products that are the subjects of applications under subsections 7a7 and 7k7 of section #cea2 7,c7 the application of the same quality and manufacturing standards for biological products under #cea7;a71 biosimilar biological products under #cea7k71 and interchangeable biological products under #cea7k77#d72 7,d7 the development program and totality of the evidence required for biosimilar biological product development and how prescribers can evaluate such information2 7,e7 the process for reporting adverse events for all biological products1 including biosimilar and interchangeable biological products2 7,f7 the relationship between-- 7i7 variation among biological products licensed under section #cea7k7 and their reference products licensed under section #cea7;a72 and 7ii7 lot-to-lot variability for a biological product licensed under section #cea7;a7 or section #cea7k7 7including interchangeable biological products72 7,g7 how the ,food and ,drug ,administration assesses data regarding the risk of immunogenicity for originator biological products licensed under section #cea7;a7 and biosimilar biological products licensed under section #cea7k72 7,h7 whether the role of analytical characterization is novel to biosimilar biological product development2 and 7,i7 how the ,food and ,drug ,administration considers biosimilar biological products to be as safe and effective as their reference products4 7#d7 ,other information ,in addition to the information described in paragraph 7#c71 the internet website established under paragraph 7#a7 shall include the following information 7with redactions as required by law for trade secret and confidential commercial information71 as a single1 searchable database3 7,a7 ,the action package of each biological product licensed under subsection 7a7 or 7k71 within #cj days of approval of the application1 or1 in the case of a biological product licensed before the date of enactment of the ,advancing ,education on ,biosimilars ,act of #bjai1 not later than #a year after such date of enactment4 7,b7 ,the summary review of each biological product licensed under subsection 7a7 or 7k71 within #dh hours of approval of the application1 or1 in the case of a biological product licensed before the date of enactment of the ,advancing ,education on ,biosimilars ,act of #bjai1 not later than #a year after such date of enactment4 7,c7 ,the history and timing of manufacturing changes with respect to biological products licensed under section #cea7;a74 7b7 ,continuing medical education ,the ,secretary shall advance education and awareness among health care providers regarding biosimilar biological products1 including by developing or improving continuing medical education programs that advance the education of such providers on the prescribing of1 and relevant clinical considerations with respect to1 biosimilar biological products4 4 7b7 ,application under the ,medicare ,merit-,based ,incentive ,payment ,system ,section #ahdh7q77#e77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#e77;,c77 is amended by adding at the end the following new clause3 7iv7 ,clinical medical education program on biosimilar biological products ,completion of a clinical medical education program developed or improved under section #ceb;,a7b7 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 7#b77;,a77iii7 for such performance period4 ,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 lifetime4 4