,i #aadth ,,congress #ast ,session ,h4 ,r4 #ghf ,,in ,,the ,,house ,,of ,,representatives ,february #e1 #bjae ,mrs4 ,ellmers 7for herself and ,mr4 ,butterfield7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to improve access1 certainty1 and innovation with respect to vaccines4 #a4 ,short title ,this ,act may be cited as the ,vaccine ,access1 ,certainty1 and ,innovation ,act of #bjae4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,title ,i--,development1 ,licensure1 and ,recommendations ,sec4 #aja4 ,review of transparency and consistency of ,,acip recommendation process4 ,sec4 #ajb4 ,guidance on vaccine development4 ,sec4 #ajc4 ,meetings between ,,cdc and vaccine developers4 ,sec4 #ajd4 ,modifications to priority review voucher program for tropical diseases4 ,sec4 #aje4 ,guidance on changes to an approved application for biological products4 ,sec4 #ajf4 ,expediting the process for export certifications for vaccines4 ,sec4 #ajg4 ,,nih vaccine research4 ,title ,,ii--,medicare1 ,medicaid1 and other provisions ,sec4 #bja4 ,requiring prompt updates to ,medicare program upon issuance of ,,acip recommendations4 ,sec4 #bjb4 ,,gao study and report on ,medicare and ,medicaid beneficiary access for vaccines4 ,sec4 #bjc4 ,encouraging health plans to establish programs to increase adult immunization4 ,i ,development1 ,licensure1 and ,recommendations #aja4 ,review of transparency and consistency of ,,acip recommendation process 7a7 ,review ,the ,director of the ,centers for ,disease ,control and ,prevention shall conduct a review of the transparency and consistency of the process used by the ,advisory ,committee on ,immunization ,practices in formulating and issuing recommendations pertaining to vaccines4 7b7 ,considerations ,the review under subsection 7a7 shall include assessment of-- 7#a7 the criteria used to evaluate new and existing vaccines2 7#b7 the ,grading of ,recommendations1 ,assessment1 ,development1 and ,evaluation 7,,grade7 approach to the review and analysis of scientific and economic data1 including the scientific basis for such approach2 and 7#c7 the extent to which the processes used by the working groups of the ,advisory ,committee on ,immunization ,practices are transparent and consistent4 7c7 ,stakeholders ,in carrying out the review under subsection 7a71 the ,director of the ,centers for ,disease ,control and ,prevention shall solicit input from vaccine stakeholders4 7d7 ,report ,not later than #a year after the date of enactment of this ,act1 the ,director of the ,centers for ,disease ,control and ,prevention shall submit to the appropriate committees of the ,congress and make publicly available a report on the results of the review under subsection 7a71 including recommendations on improving the transparency and consistency of the process described in such subsection4 7e7 ,definition ,in this section1 the term ,advisory ,committee on ,immunization ,practices means the advisory committee on immunization practices established by the ,secretary of ,health and ,human ,services pursuant to section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a71 acting through the ,director of the ,centers for ,disease ,control and ,prevention4 #ajb4 ,guidance on vaccine development 7a7 ,issuance ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final guidance to facilitate the use of accelerated and expedited pathways for the development and licensure of vaccines to prevent-- 7#a7 emerging1 re-emerging1 or rare infectious diseases with respect to which the low prevalence or nature of the disease may render the existence or collection of clinical outcome data unlikely or impractical2 and 7#b7 infectious diseases with respect to which currently available vaccines are not addressing the full scope of public health needs4 7b7 ,considerations ,in developing the guidance required by this section1 the ,secretary of ,health and ,human ,services shall consider issues relating to clinical development strategies for diseases described in subsection 7a71 including the development and acceptability of novel clinical and surrogate endpoints1 the use of novel or accelerated study designs1 the use of observational real-world data1 the use of novel adjuvants1 the use of new technologies or approaches to collecting and monitoring patient-level data1 and the demonstration of efficacy through studies in healthy volunteers for the purpose of licensure4 #ajc4 ,meetings between ,,cdc and vaccine developers ,section #caj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbo7 is amended by adding at the end the following3 7c7 7#a7 ,in this subsection1 the term vaccine developer means a nongovernmental entity engaged in-- 7,a7 the development or production of a vaccine2 and 7,b7 vaccine research4 7#b7 7,a7 ,upon the submission of a written request by a vaccine developer1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall convene a meeting of representatives of the vaccine developer and experts in immunization programs1 epidemiology1 and other relevant areas1 including such experts from the ,food and ,drug ,administration and the ,national ,vaccine ,program1 at which the ,director 7or the ,director's designee71 for the purpose of informing the vaccine developer's understanding of public health needs and priorities1 shall provide the perspectives of the ,centers for ,disease ,control and ,prevention and other relevant ,federal agencies regarding-- 7i7 public health needs1 epidemiology1 and implementation considerations with regard to a vaccine developer's potential vaccine profile2 and 7ii7 potential implications of such perspectives for the vaccine developer's vaccine research and development planning4 7,b7 ,the ,director of the ,centers for ,disease ,control and ,prevention 7or the ,director's designee7 shall convene a meeting requested under subparagraph 7,a7 not later than #ij business days after receipt of the request for the meeting4 7#c7 7,a7 ,upon the submission of a written request by a vaccine developer1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall provide to the vaccine developer any age-based disease epidemiological analyses or data that-- 7i7 are specified in the request2 7ii7 have been published2 7iii7 have been performed by or are in the possession of the ,centers2 and 7iv7 are not a trade secret or otherwise confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7,b7 ,the ,secretary shall provide analyses requested by a vaccine manufacturer under subparagraph 7,a7 not later than #ij business days after receipt of the request for the analyses4 7#d7 ,the ,secretary shall promptly notify a vaccine developer if-- 7,a7 the ,secretary becomes aware of any change to information that was-- 7i7 shared by the ,secretary with the vaccine developer during a meeting under paragraph 7#b72 or 7ii7 provided by the ,secretary to the vaccine developer in one or more analyses under paragraph 7#c72 and 7,b7 the change may have implications for the vaccine developer's vaccine research and development4 4 #ajd4 ,modifications to priority review voucher program for tropical diseases ,section #ebd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#c7-- 7i7 in the matter before subparagraph 7,a71 by striking ,this term and inserting ,in this section1 this term2 and 7ii7 in subparagraph 7,r71 by striking designated by order of the ,secretary and inserting designated by the ,secretary pursuant to paragraph 7#d72 7,b7 by redesignating paragraph 7#d7 as paragraph 7#e72 and 7,c7 by inserting after paragraph 7#c7 the following3 7#d7 ,designation of other infectious diseases as tropical diseases 7,a7 ,in general ,the ,secretary shall establish a process under which the ,secretary-- 7i7 using a methodology that is made available to the public on the ,internet site of the ,food and ,drug ,administration1 designates infectious diseases other than the diseases specified in subparagraphs 7,a7 through 7,q7 of paragraph 7#c7 to be tropical diseases for purposes of this section2 and 7ii7 publishes on such ,internet site a complete1 updated list of the diseases that are tropical diseases for purposes of this section4 7,b7 ,considerations ,in designating an infectious disease as a tropical disease under subparagraph 7,a71 the ,secretary shall-- 7i7 consider the potential impact of the disease on the public health due to-- 7,i7 the potential rate of spread of the disease2 and 7,,ii7 the potential severity of the disease in terms of human morbidity and mortality2 and 7ii7 consult with experts in tropical infectious diseases1 including the ,centers for ,disease ,control and ,prevention1 the ,food and ,drug ,administration1 medical professionals1 the clinical research community1 and the ,world ,health ,organization4 7,c7 ,review ,every #e years1 or more frequently as determined necessary by the ,secretary1 the ,secretary shall review1 provide modifications to1 and re-publish the list published under subparagraph 7,a7 and any revisions made to the methodology for designation of diseases under such subparagraph4 2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b71 by striking ,the sponsor of a tropical disease and inserting3 7,a7 ,in general ,the sponsor of a tropical disease 2 7,b7 by inserting after such paragraph 7#b77;,a7 the following3 7,b7 ,notification of transfer ,each person to whom a priority review voucher is transferred shall notify the ,secretary of such change in ownership of the voucher not later than #cj business days after such transfer4 2 7,c7 in paragraph 7#d71 by striking ,the sponsor of a human drug application and inserting3 7,a7 ,in general ,the sponsor of a human drug application 2 and 7,d7 by inserting after paragraph 7#d77;,a71 as designated by subparagraph 7,d71 the following3 7,b7 ,transfer after notice ,the sponsor of a human drug application that provides notification of intent under subparagraph 7,a7 may transfer the voucher after such notification is provided1 if such sponsor has not yet submitted the human drug application described in the notification4 ,upon such a transfer1 notwithstanding subparagraph 7,a71 such sponsor shall not remain legally committed to pay a user fee because of the sponsor's notification of intent under such subparagraph4 2 and 7#c7 in subsection 7c71 by amending paragraph 7#b7 to read as follows3 7#b7 ,fee amount ,the amount of the priority review user fee shall be determined each fiscal year by the ,secretary based on the difference between-- 7,a7 the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year2 and 7,b7 the average cost incurred by the ,food and ,drug ,administration in the review of a human drug application that is not subject to priority review in the previous fiscal year4 4 #aje4 ,guidance on changes to an approved application for biological products ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final guidance that-- 7#a7 addresses changes in a licensed biological product or the labeling1 production process1 quality controls1 equipment1 facilities1 or responsible personnel for such a product established in the application for the product that was approved under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7#b7 does not address such changes for specified biotechnology or specified synthetic biological products listed in section #fja4b7;c7 of title #ba of the ,code of ,federal ,regulation2 and 7#c7 updates and supersedes the guidance entitled ,changes to an ,approved ,application3 ,biological ,products1 that was issued by the ,food and ,drug ,administration in ,july1 #aiig4 #ajf4 ,expediting the process for export certifications for vaccines ,section #hja7;e77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77 is amended-- 7#a7 in the matter following clause 7ii7 in subparagraph 7,a71 by striking within #bj days of the receipt of a request for such certification and inserting within #bj business days of the receipt of a request for such certification1 except that in the case of a vaccine the ,secretary shall issue such certification within #aj business days of the receipt of a request for such certification2 and 7#b7 in subparagraph 7,b71 by striking within the #bj days prescribed by subparagraph 7,a7 and inserting within the period prescribed by subparagraph 7,a74 #ajg4 ,,nih vaccine research 7a7 ,in general ,subpart #f of part ,c of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhe;f et seq47 is amended by adding at the end the following3 #ddg;,d4 ,advancement of vaccine development ,in carrying out the general purpose described in section #ddf1 the ,director of the ,institute shall conduct or support translational science1 research1 and research training to advance the development of vaccines for the prevention of diseases1 including the advancement of vaccine development programs into clinical trials4 4 7b7 ,review of ,,nih vaccine research 7#a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall-- 7,a7 conduct a review on vaccine research being conducted or supported by the ,institutes2 and 7,b7 publish a report on the results of such review4 7#b7 ,contents ,at a minimum1 the report under paragraph 7#a77;,b7 shall-- 7,a7 describe intramural and extramural vaccine research and development programs that are being conducted or supported by the ,national ,institutes of ,health1 including those that are translational or clinical phase studies2 7,b7 provide a summary of funding allocations made to conduct or support the matters described in section #ddg;,d of the ,public ,health ,service ,act1 as added by subsection 7a71 and identify projected funding needs with regard to future research or support with regard to these matters2 and 7,c7 identify funding and collaborations with the private sector through-- 7i7 the ,small ,business ,innovation ,research and ,small ,business ,technology ,transfer programs2 and 7ii7 cooperative research and development agreements4 ,,ii ,medicare1 ,medicaid1 and other provisions #bja4 ,requiring prompt updates to ,medicare program upon issuance of ,,acip recommendations ,in the case that the advisory committee on immunization practices established by the ,secretary of ,health and ,human ,services pursuant to section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a7 issues a recommendation for a vaccine or an update to a recommendation for a vaccine that the ,secretary is using under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 with respect to coverage of vaccines or immunizations under such title1 the ,secretary shall determine whether or not to update policies under such title with respect to such coverage on a date that is not later than #fj business days after the date on which such advisory committee issues such recommendation or update4 #bjb4 ,,gao study and report on ,medicare and ,medicaid beneficiary access for vaccines 7a7 ,study ,the ,comptroller ,general of the ,united ,states 7in this section referred to as the ,comptroller ,general7 shall conduct a study on the impact of reimbursement rates under the ,medicare program under parts ,b1 ,c1 and ,d of title ,,xviii of the ,social ,security ,act and under the ,medicaid program under title ,,xix of such ,act on access by targeted individuals to vaccines recommended by the ,advisory ,committee on ,immunization ,practices of the ,centers for ,disease ,control and ,prevention4 ,such study shall include an analysis and determination of-- 7#a7 the reimbursement rates for vaccines under such parts of the ,medicare program and under the ,medicaid program1 including those rates paid by a ,,pdp sponsor under part ,d of title ,,xviii of such ,act1 ,medicare ,advantage organizations under part ,c of such title1 and ,medicaid managed care organizations 7as defined in section #aijc7m77#a77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#a77;,a772 7#b7 the number of targeted individuals during the #c-year period prior to the study who were eligible for a vaccination recommended by the ,advisory ,committee on ,immunization ,practices of the ,centers for ,disease ,control and ,prevention2 7#c7 the number of such targeted individuals who actually received a vaccination described in paragraph 7#b71 with a particular breakdown of adults1 the elderly1 and populations located in rural or underserved communities2 and 7#d7 the extent to which the reimbursement rates under such parts of the ,medicare program and under the ,medicaid program for vaccinations described in paragraph 7#b7 affect their use by physicians or access for such targeted individuals4 7b7 ,targeted individuals ,for purposes of subsection 7a71 the term targeted individual means and individual who is-- 7#a7 7,a7 entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act or enrolled in part ,b of such ,act2 or 7,b7 eligible for medical assistance under title ,,xix of such ,act2 and 7#b7 within a vulnerable population4 7c7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general shall submit to the appropriate committees of the ,congress a report containing the results of the study conducted under subsection 7a71 including-- 7#a7 a summary of the findings of the study2 and 7#b7 recommendations based on the results of the study1 including recommendations for such legislative and administrative action as the ,comptroller ,general determines appropriate4 #bjc4 ,encouraging health plans to establish programs to increase adult immunization 7a7 ,private health plans ,section #bgah of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ah7 is amended by adding at the end the following new subsection3 7f7 ,programs to increase adult immunization 7#a7 ,in general ,for purposes of this section1 for plan years beginning on or after the date of enactment of the ,vaccine ,access1 ,certainty1 and ,innovation ,act of #bjae1 activities that improve health care quality described in subsection 7a77#b7 shall include programs to increase adult immunization4 7#b7 ,administration ,not later than ,december #ca1 #bjaf1 the ,secretary shall establish standardized methodologies1 including definitions1 for which activities1 and in what regard such activities1 constitute programs to increase adult immunization in accordance with this subsection4 ,the ,secretary shall consult with relevant stakeholders in establishing such methodologies4 4 7b7 ,medicare ,advantage and part ,d plans ,section #aheg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is amended by adding at the end the following new paragraph3 7#e7 ,inclusion of expenditures on programs to increase adult immunization in minimum medical loss ratio calculation ,for purposes of calculating the minimum medical loss ratio under paragraph 7#d71 for plan years beginning at least #ab months after the date of enactment of this ,act1 the numerator shall include any expenditures on programs to increase adult immunization4 4