,i #aagth ,,congress #ast ,session ,h4 ,r4 #egde ,,in ,,the ,,house ,,of ,,representatives ,october #bg1 #bjba,mr4 ,dunn 7for himself and ,mr4 ,jackson7 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 clarify ,medicare coverage for ,,covid-#ai testing and to provide support for cellular immune response research for ,,covid-#ai1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,covid-#ai ,access to ,testing and ,support for ,immune ,response ,research ,act of #bjba4 #b4 ,findings ,congress finds the following3 7#a7 ,a public health emergency regarding the ,,covid-#ai pandemic was first declared on ,january #ca1 #bjbj1 and has been subsequently renewed repeatedly1 most recently on ,july #ai1 #bjba1 by the ,secretary of ,health and ,human ,services under both ,republican and ,democratic administrations4 7#b7 ,in the spring of #bjbj1 the only tests available to determine whether a person had a recent or prior infection of ,,sars-,co,v-#b were serology tests which could identify whether a person had antibodies specific to the ,,sars-,co,v-#b virus4 7#c7 ,on ,may #h1 #bjbj1 the ,centers for ,medicare ,medicaid ,services 7,,cms71 citing the ongoing ,,covid-#ai public health emergency1 issued an interim final rule which recognized on an interim basis that certain ,food and ,drug ,administration-authorized serology tests fall under the ,medicare benefit category for diagnostic laboratory tests4 7#d7 ,on ,march #e1 #bjba1 the ,food and ,drug ,administration issued the first authorization for the emergency use of a cellular 7,t-cell7 immune response ,,covid-#ai test intended for use as an aid in identifying individuals with an adaptive ,t-cell immune response to ,,sars-,co,v-#b1 indicating recent or prior infection with ,,sars-,co,v-#b4 7#e7 ,,cms has yet to update its ,may #h1 #bjbj1 interim final rule or provide separate guidance to clarify that ,medicare coverage extends to other ,food and ,drug ,administration-authorized tests1 including ,t-cell tests1 that are intended for diagnosing recent or prior infection with ,,sars-,co,v-#b4 7#f7 ,in research and development related to infectious diseases and vaccines1 including ,,sars-,co,v-#b1 historically the antibody response1 which is only half of the adaptive immune system1 has been the primary tool for assessment4 7#g7 ,the other half of the adaptive immune response1 the ,t-cell response1 has historically been more difficult to assess1 but scientific and technological advances now allow for standardized and sensitive methods to measure ,t-cells4 7#h7 ,the ,national ,institutes of ,health have integrated ,t-cell testing into certain studies regarding the impact of ,t-cells in detecting and defending against ,,sars-,co,v-#b variants1 and there exist additional research opportunities regarding the cellular immune response to ,,sars-,co,v-#b1 including-- 7,a7 identifying the type and duration of ,t-cell response that confers immunity 7including to variants7 following natural infection1 vaccination1 or both2 7,b7 understanding the ,t-cell response in different populations1 including children1 the elderly1 and immunocompromised individuals2 and 7,c7 understanding the ,t-cell response in patients facing long-term ,,covid-#ai symptoms4 7#i7 ,evidence shows ,t-cells play an important role in the immune response to ,,covid-#ai and points to the need for a concerted research effort1 which could have profound consequences on public health1 such as policies on boosters or the development of therapeutics for patients suffering from post-acute sequelae of ,,covid-#ai infection4 #c4 ,clarifying ,medicare coverage of ,,covid-#ai diagnostic laboratory tests 7a7 ,in general ,the ,administrator of the ,centers for ,medicare ,medicaid ,services shall by interim rule1 subregulatory guidance1 or otherwise1 provide for coverage of ,t-cell diagnostic laboratory tests furnished during the period beginning on ,january #a1 #bjbb1 and ending on the last date of the public health emergency period 7described in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b777 for beneficiaries with current or known prior ,,covid-#ai infection or suspected current or suspected past ,,covid-#ai infection4 7b7 ,t-,cell diagnostic laboratory test defined ,for purposes of subsection 7a71 the term ,t-cell diagnostic laboratory test means a clinical laboratory test that is-- 7#a7 intended to identify an adaptive ,t-cell immune response to ,,sars-,co,v-#b indicative of recent or prior infection with ,,sars-,co,v-#b2 and 7#b7 cleared1 approved1 or otherwise authorized pursuant to the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #d4 ,national strategy for ,,covid-#ai cellular immune response research 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7-- 7#a7 shall-- 7,a7 expand1 intensify1 and coordinate the programs and activities of the ,national ,institutes of ,health and the ,centers for ,disease ,control and ,prevention with respect to scientific and clinical research on the cellular immune response related to ,,covid-#ai2 7,b7 develop and implement a national strategy to research the cellular immune response to ,,sars-,co,v-#b1 which shall include research on-- 7i7 the type and duration of ,t-cell responses to ,,covid-#ai vaccines and how such responses confer immunity and contribute to protection from infection with ,,sars-,co,v-#b variants of concern2 7ii7 the type and duration of ,t-cell responses in patients who have recovered from ,,covid-#ai and how such responses may confer immunity2 7iii7 the type and duration of ,t-cell immune responses in patients facing long-term ,,covid-#ai symptoms2 and 7iv7 the type and duration of ,t-cell responses to vaccination and natural infection in certain populations1 such as children1 the elderly1 and immunocompromised individuals2 and 7,c7 update the strategy under subparagraph 7,b7 as appropriate2 and 7#b7 subject to the availability of appropriations1 may make grants to ,states1 political subdivisions1 public-private partnerships1 academic institutions1 and other public entities to carry out scientific and clinical research on the cellular immune response related to ,,covid-#ai and to implement the strategy under paragraph 7#b74 7b7 ,consultation ,in carrying out subsection 7a71 the ,secretary shall consult with relevant individuals1 as appropriate1 such as-- 7#a7 clinicians1 public health professionals1 and others with expertise in cellular immune response2 7#b7 representatives of patient advocacy and research organizations with interest in cellular immune research2 7#c7 researchers with expertise in cellular immunology2 and 7#d7 epidemiologists with experience in cellular immune response4 7c7 ,public meeting ,not later than #c months after the date of the enactment of this ,act1 the ,secretary1 acting through the ,director of the ,national ,institutes of ,health1 shall convene a public meeting composed of subject matter experts and stakeholders to identify research needs and opportunities4 7d7 ,publication of strategy ,the ,secretary shall make public the strategy under subsection 7a77#a77;,b71 including initial funding opportunity announcements1 within #f months of the date of enactment of this ,act4