,,ii #aaith ,,congress #ast ,session ,s4 #aicj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #c1 #bjbe ,mr4 ,cassidy introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xi of the ,social ,security ,act to establish a research and development-intensive small biotech manufacturer exception from the ,medicare drug price negotiation program4 #a4 ,short title ,this ,act may be cited as the ,small ,biotech ,innovation ,act4 #b4 ,research and development-intensive small biotech manufacturer exception from ,medicare drug price negotiation program ,section #aaib7;d77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7;d77#b77 is amended by adding at the end the following new subparagraph3 7,d7 ,research and development-intensive small biotech manufacturer exception for #bjbi and subsequent years 7i7 ,in general ,with respect to initial price applicability years 7beginning with initial price applicability year #bjbi71 subject to the succeeding provisions of this subparagraph1 the term negotiation eligible drug shall not include a qualifying single source drug 7as defined in subsection 7e77 of a research and development-intensive small biotech manufacturer 7as defined in clause 7ii774 7ii7 ,definitions ,in this subparagraph3 7,i7 ,applicable percent ,the term applicable percent means-- 7aa7 in the case of a small biotech manufacturer that has #a qualifying single source drug1 #cj percent2 7bb7 in the case of a small biotech manufacturer that has #b qualifying single source drugs1 #dj percent2 7cc7 in the case of a small biotech manufacturer that has #c qualifying single source drugs1 #ej percent2 7dd7 in the case of a small biotech manufacturer that has #d qualifying single source drugs1 #fj percent2 and 7ee7 in the case of a small biotech manufacturer that has #e qualifying single source drugs1 #gj percent4 7,,ii7 ,small biotech manufacturer defined ,the term small biotech manufacturer means a manufacturer that-- 7aa7 has #e or less qualifying single source drugs2 and 7bb7 is not owned by1 controlled by1 or subject to the jurisdiction or direction of a government of a foreign country1 or organized under the laws of a foreign country that is a covered nation 7as defined in section #dhgb7;f7 of title #aj1 ,united ,states ,code74 7,,iii7 ,research and development-intensive small biotech manufacturer defined ,the term research and development-intensive small biotech manufacturer means a small biotech manufacturer that invests at least the applicable percent of their net revenue from the average of the previous three years in research and development 7determined based on generally accepted accounting principles74 7iii7 ,treatment in case of acquisition ,a drug shall not be considered to be a qualifying single source drug of a research and development-intensive small biotech manufacturer if the manufacturer of such drug is acquired after #bjbi by another manufacturer that does not meet the definition of a research and development-intensive small biotech manufacturer1 effective at the beginning of the plan year immediately following such acquisition4 7iv7 ,annual application ,in order for a qualifying single source drug of a research and development-intensive small biotech manufacturer to be eligible for the exception under this subparagraph with respect to an initial price applicability year 7beginning with initial price applicability year #bjbi71 the manufacturer shall submit an application to the ,secretary 7at a time specified by the ,secretary7 containing-- 7,i7 information on the net product revenue and research and development expenditures of the manufacturer during the relevant time period2 7,,ii7 a certification that the information submitted by the manufacturer under subclause 7,i7 is accurate and complete to the best of the manufacturer's knowledge2 and 7,,iii7 such other information as the ,secretary may specify4 7v7 ,dispute ,resolution ,the ,secretary shall develop a process under which a manufacturer may appeal a determination by the ,secretary that the manufacturer is not a research and development-intensive small biotech manufacturer4 ,such process shall conclude1 with respect to a manufacturer1 not later than the selected drug publication date with respect to the initial price applicability year for which the manufacturer submitted an application under clause 7iv74 4