,i #aagth ,,congress #ast ,session ,h4 ,r4 #fjjj ,,in ,,the ,,house ,,of ,,representatives ,november #ag1 #bjba,ms4 ,de,gette 7for herself and ,mr4 ,upton7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 the ,budget1 ,science1 ,space1 and ,technology1 ,agriculture1 ,education and ,labor1 ,armed ,services1 ,natural ,resources1 ,veterans' ,affairs1 ,homeland ,security1 and the ,judiciary1 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 continue the acceleration of the discovery1 development1 and delivery of #bast century cures1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,cures #b4j ,act4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,title ,i--,public health,sec4 #aja4 ,further understanding the implications of long ,,covid4,sec4 #ajb4 ,national strategy to prevent and respond to pandemics4,sec4 #ajc4 ,pandemic preparedness rare disease support program4,sec4 #ajd4 ,vaccine and immunization programs4,sec4 #aje4 ,developing antimicrobial innovations4,title ,,ii--,patients and caregivers,sec4 #bja4 ,educational programs and training for caregivers4,sec4 #bjb4 ,increasing health literacy to promote better outcomes for patients4,sec4 #bjc4 ,increasing diversity in clinical trials4,sec4 #bjd4 ,patient experience data4,sec4 #bje4 ,ensuring coverage for clinical trials under existing standard of care4,title ,,iii--,food and ,drug ,administration,sec4 #cja4 ,report on collaboration and alignment in regulating digital health technologies4,sec4 #cjb4 ,grants for novel trial designs and other innovations in drug development4,sec4 #cjc4 ,,fda cell and gene therapy4,sec4 #cjd4 ,increasing use of real world evidence4,sec4 #cje4 ,improving ,,fda-,,cms communication regarding transformative new therapies4,sec4 #cjf4 ,establishment of additional ,intercenter ,institutes at the ,food and ,drug ,administration4,sec4 #cjg4 ,accelerating timeline for breakthrough and ,,rmat designations4,sec4 #cjh4 ,guidance regarding development and submission of chemistry1 manufacturing1 and controls information for expedited approval4,sec4 #cji4 ,post-approval study requirements for accelerated approval4,sec4 #caj4 ,recommendations to decentralize clinical trials4,title ,,iv--,centers for ,medicare ,medicaid ,services,sec4 #dja4 ,,gao study and report4,sec4 #djb4 ,strategies to increase access to telehealth under ,medicaid and ,children's ,health ,insurance ,program4,sec4 #djc4 ,extending ,medicare telehealth flexibilities4,sec4 #djd4 ,coverage and payment for breakthrough devices under the ,medicare program4,sec4 #dje4 ,secretary of ,health and ,human ,services report on coverage for innovative technologies4,sec4 #djf4 ,secretary of ,health and ,human ,services report on ,,cms computer systems4,sec4 #djg4 ,precision ,medicine ,answers for ,kids ,today4,sec4 #djh4 ,medicare coverage for consultations4,sec4 #dji4 ,prohibiting the use of geographic tracking features and biometrics within ,medicaid electronic visit verification systems4,sec4 #daj4 ,generally accepted standard for electronic prescribing4,sec4 #daa4 ,meaningful access to ,federal health plan claims data4,title ,v--,research,sec4 #eja4 ,advanced ,research ,projects ,agency for ,health4,sec4 #ejb4 ,research investment to spark the economy4,sec4 #ejc4 ,research ,policy ,board reauthorization4 ,i ,public health #aja4 ,further understanding the implications of long ,,covid 7a7 ,sources of coverage survey ,the ,secretary of ,health and ,human ,services shall-- 7#a7 conduct a large national survey of patients who self-identify as having long ,,covid to assess sources of health coverage1 long-term care coverage1 and disability coverage for long ,,covid and related symptoms2 and 7#b7 not later than #f months after the date of the enactment of this ,act1 complete such survey and submit a report on the results of such survey to the ,committees on ,energy and ,commerce1 ,ways and ,means1 and ,education and ,labor of the ,house of ,representatives and the ,committees on ,health1 ,education1 ,labor1 and ,pensions and ,finance of the ,senate4 7b7 ,learning collaborative 7#a7 ,national meetings ,the ,secretary of ,health and ,human ,services shall-- 7,a7 convene a series of not less than four national meetings1 that may be virtual1 to serve as the basis of an ongoing long ,,covid learning collaborative with individuals and organizations representing key sectors of the health care community2 and 7,b7 invite to participate in such meetings individuals who represent the views of health plan representatives1 health care providers 7including hospitals1 physicians1 and nurses71 medical and scientific researchers1 patient and consumer advocates1 data scientists1 health care service providers1 providers of workers compensation1 employers1 and developers of diagnostic and therapeutic products1 including clinical laboratories4 7#b7 ,termination of meetings ,the ,secretary shall continue to convene national meetings under paragraph 7#a7 for-- 7,a7 not less than #b years after the date of the enactment of this ,act2 and 7,b7 each fiscal year thereafter1 unless the ,secretary determines that the public health and medical knowledge with respect to long ,,covid has sufficiently advanced to ensure widespread understanding of the characteristics of long ,,covid1 including-- 7i7 the etiology1 progression1 similarity to other conditions1 and duration of long ,,covid2 and 7ii7 conditions that interact with long ,,covid4 7c7 ,long ,,covid scientific research for children 7#a7 ,in general ,beginning not later than #ahj days after the date of the enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall award grants to hospitals for children1 pediatric researchers1 academic medical centers1 and other appropriate organizations to research the long-term effects and treatment of ,,covid-#ai in children1 including long ,,covid4 7#b7 ,authorization of appropriations ,of the amounts made available for research and clinical trials related to long-term studies of ,,covid-#ai under the heading ,national ,institutes of ,health--,office of the ,director of title ,,iii of the ,consolidated ,appropriations ,act1 #bjba 7,public ,law #aaf-bfj71 there are authorized to be appropriated such sums as may be necessary to carry out this subsection4 7d7 ,study on disparities in long ,,covid 7#a7 ,in general ,not later than #ij days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall seek to enter into an arrangement with the ,national ,academy of ,medicine under which the ,academy conducts a study to evaluate disparities in racial and ethnic minority groups with respect to diagnosis of1 severity of symptoms1 access to care1 and treatment for long ,,covid4 7#b7 ,content ,the study under paragraph 7#a7 shall-- 7,a7 with respect to individuals who are ,black1 ,hispanic1 ,american ,indian1 ,alaska ,native1 or who belong to other racial and ethnic populations-- 7i7 evaluate the prevalence of long ,,covid2 7ii7 evaluate the rates of hospitalization and death from ,,covid-#ai2 and 7iii7 evaluate and identify factors that increase the risk of severity of long ,,covid2 and 7,b7 include recommendations to identify and address the disparities described in paragraph 7#a71 including the causes of such disparities4 7#c7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this subsection #e1jjj1jjj for fiscal year #bjbb1 to remain available until expended4 7e7 ,education and dissemination of information with respect to long-,term symptoms of ,,covid-#ai 7#a7 ,long ,,covid public education program ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall develop and disseminate to the public information regarding long ,,covid1 including information on-- 7,a7 the awareness1 incidence1 and common symptoms of long ,,covid2 and 7,b7 the availability1 as medically appropriate1 of treatment options for long ,,covid4 7#b7 ,long ,,covid provider education program ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall in consultation with communities of individuals diagnosed with long ,,covid1 develop and disseminate to health care providers information on long ,,covid for the purpose of ensuring that such providers remain informed about current information on long ,,covid4 7#c7 ,arrangement authority ,the ,secretary of ,health and ,human ,services may disseminate information under paragraphs 7#a7 and 7#b7 directly or through arrangements with intra-agency initiatives1 nonprofit organizations1 consumer groups1 institutions of higher learning 7as defined in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja771 or ,federal1 ,state1 or local public private partnerships4 7#d7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #cj1jjj1jjj for fiscal year #bjbb1 which shall remain available until expended4 #ajb4 ,national strategy to prevent and respond to pandemics 7a7 ,in general ,not later than #ij days after the date of the enactment of this ,act1 the ,president1 acting through the ,secretary of ,health and ,human ,services1 shall-- 7#a7 develop and implement a national strategy to prevent and respond to pandemics and other public health emergencies for which a declaration is made under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d72 and 7#b7 base such strategy on lessons learned1 and best practices developed1 as a result of the ,,covid-#ai pandemic4 7b7 ,contents ,the national strategy under subsection 7a7 shall at a minimum address each of the following3 7#a7 ,strategies for testing 7including point-of-care testing and testing at nonmedical sites7 to foster expedient results and personalized medical responses for patients and communities1 including for medically underserved populations4 7#b7 ,methods of data sharing to use testing to inform surveillance and other pandemic monitoring and response efforts4 7#c7 ,strategies to enable ,americans to continue to work1 or return to work1 or continue to remain in1 or return to1 in-person school and childcare settings safely4 7#d7 ,modernizing and expanding domestic drug manufacturing1 including through the use of continuous manufacturing4 7#e7 ,developing and administering vaccines1 therapeutics1 and other medical supplies1 including for children1 racial and ethnic minorities1 and people with disabilities4 #ajc4 ,pandemic preparedness rare disease support program ,subtitle ,b of title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj et seq47 is amended by inserting after section #bhae of such ,act the following3 #bhaf4 ,pandemic preparedness plan 7a7 ,in general ,the ,secretary1 acting through the ,administrator of the ,health ,resources and ,services ,administration and in collaboration with the ,director of the ,centers for ,disease ,control and ,prevention1 shall award grants to eligible organizations to develop a pandemic preparedness plan regarding-- 7#a7 the challenges faced by patients and the family caregivers of such patients served by the respective eligible organizations during the ,,covid-#ai pandemic2 7#b7 potential challenges for the respective eligible organizations during future pandemics and other public health emergencies2 7#c7 how the respective eligible organizations plan to overcome the challenges described in paragraphs 7#a7 and 7#b71 including how the respective organizations plan to support patients1 their families1 and health care providers to overcome such challenges2 and 7#d7 efforts to partner with local1 ,state1 and ,federal governments to promote a coordinated response to future pandemics and other public health emergencies4 7b7 ,priority ,in awarding grants under this section1 the ,secretary shall give priority to eligible organizations that are rare disease or condition organizations4 7c7 ,definitions ,in this section3 7#a7 ,the term eligible organization means an organization that-- 7,a7 is described in section #eja7;c7 of the ,internal ,revenue ,code of #aihf and exempt from tax under section #eja7;a7 of such ,code2 and 7,b7 provides support and other resources to patients and their families for accessing and paying for medical care4 7#b7 ,the term public health emergency means a public health emergency declared under section #cai4 7#c7 ,the term rare disease or condition has the meaning given to such term in section #ebf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7d7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #be1jjj1jjj for each of fiscal years #bjbb through #bjbd4 4 #ajd4 ,vaccine and immunization programs 7a7 ,additional funding for vaccine awareness ,there are authorized to be appropriated to the ,centers for ,disease ,control and ,prevention #be1jjj1jjj for each of fiscal years #bjbb through #bjbd for the purpose of carrying out an awareness campaign to educate the public with respect to the safety and importance of vaccines4 ,the amounts authorized by the preceding sentence are in addition to amounts otherwise available for such purpose4 7b7 ,strengthening the immunization information system ,there are authorized to be appropriated to the ,centers for ,disease ,control and ,prevention #be1jjj1jjj for each of fiscal years #bjbb through #bjbd for the purpose of strengthening immunization information systems4 ,the amounts authorized by the preceding sentence are in addition to amounts otherwise available for such purpose4 #aje4 ,developing antimicrobial innovations ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,developing antimicrobial innovations #cii,,oo4 ,establishment of ,committee2 subscription model2 advisory group 7a7 ,in general ,not later than #fj days after the date of the enactment of this part1 the ,secretary shall establish a ,committee on ,critical ,need ,antimicrobials and appoint members to the ,committee4 7b7 ,members 7#a7 ,in general ,the ,committee shall consist of at least one representative from each of the ,national ,institute of ,allergy and ,infectious ,diseases1 the ,centers for ,disease ,control and ,prevention1 the ,biomedical ,advanced ,research and ,development ,authority1 the ,food and ,drug ,administration1 the ,centers for ,medicare ,medicaid ,services1 the ,veterans ,health ,administration1 and the ,department of ,defense4 7#b7 ,chair ,the ,secretary shall appoint one of the members of the ,committee to serve as the ,chair of the ,committee4 7c7 ,duties ,not later than #a year after the appointment of all initial members of the ,committee1 the ,secretary1 in collaboration with the ,committee1 and in consultation with the ,critical ,need ,antimicrobials ,advisory ,group established under subsection 7g71 shall do the following3 7#a7 ,develop a list of infections for which new antimicrobial drug development is needed1 taking into account organisms1 sites of infection1 and type of infections for which there is an unmet medical need1 findings from the most recent report entitled ,antibiotic ,resistance ,threats in the ,united ,states issued by the ,centers for ,disease ,control and ,prevention1 or an anticipated unmet medical need1 including a potential global health security threat4 ,for the list developed under this paragraph1 the ,secretary1 in collaboration with the ,committee1 may use the infection list in such most recent report for up to #c years following the date of the enactment of this part and subsequently update the list under this paragraph in accordance with subsection 7e74 7#b7 ,develop regulations1 in accordance with subsection 7d71 outlining favored characteristics of critical need antimicrobial drugs1 that are evidence based1 clinically focused1 and designed to treat the infections described in paragraph 7#a71 and establishing criteria for how each such characteristic will adjust the monetary value of a subscription contract awarded under subsection 7f7 or section #cii,,qq4 ,the favored characteristics shall be weighed for purposes of such monetary value such that meeting certain characteristics1 or meeting more than one such characteristic1 increases the monetary value4 ,such favored characteristics of an antimicrobial drug shall include-- 7,a7 treating infections on the list under paragraph 7#a72 7,b7 improving clinical outcomes for patients with multi-drug-resistant infections2 7,c7 being a first-approved antimicrobial drug that has the potential to address unmet medical needs for the treatment of a serious or life-threatening infection1 and1 to a lesser extent1 second and third drugs that treat such infections2 7,d7 route of administration1 especially through oral administration2 7,e7 7i7 containing no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 that has been approved in any other application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or intending to be the subject of a new original biologics license application under section #cea7;a72 7ii7 being a member of a new class of drugs with a novel target and novel mode of action that are distinctly different from the target or mode of any antimicrobial drug approved under section #eje of such ,act or licensed under section #cea1 including reduced toxicity2 7iii7 not being affected by cross-resistance to any antimicrobial drug approved under such section #eje or licensed under such section #cea2 7,f7 addressing a multi-drug-resistant infection through a novel chemical scaffold or mechanism of action2 7,g7 having received a transitional subscription contract under subsection 7f72 and 7,h7 any other characteristic the ,secretary1 in collaboration with the ,committee1 determines necessary4 7d7 ,regulations 7#a7 ,in general ,not later than #a year after the appointment of the initial members of the ,committee1 the ,secretary shall issue proposed regulations which shall include-- 7,a7 a process by which the sponsors can apply for an antimicrobial drug to become a critical need antimicrobial drug under section #cii,,pp2 7,b7 how subscription contracts under such section shall be established and paid2 7,c7 the favored characteristics under subsection 7c77#b71 how such characteristics will be weighed1 and the minimum number and kind of favored characteristics needed for an antimicrobial drug to be designated a critical need antimicrobial drug2 and 7,d7 other elements of the subscription contract process1 in accordance with this part4 7#b7 ,development of final regulations ,before finalizing the regulations under paragraph 7#a71 the ,secretary shall solicit public comment and hold public meetings for the period beginning on the date on which the proposed regulations are issued and ending on the date that is #abj days after such date of issuance4 ,the ,secretary shall finalize and publish such regulations not later than #abj days after the close of such period of public comment and meetings4 7#c7 ,subscription contract office ,not later than #f months after the date of the enactment of this part1 the ,secretary shall propose an agency or office in the ,department of ,health and ,human ,services to manage the establishment and payment of subscription contracts awarded under section #cii,,qq1 including eligibility1 requirements1 and contract amounts4 ,the ,secretary shall solicit public comment and finalize the agency or office no later than #de days following the proposed agency or office4 ,such agency or office shall be referred to as the ,subscription ,contract ,office4 7e7 ,list of infections ,the ,secretary1 in collaboration with the ,committee1 shall update the list of infections under subsection 7c77#a7 at least every #b years4 7f7 ,transitional subscription contracts 7#a7 ,in general ,not earlier than #cj days after the date of the enactment of this part and ending on the date that the ,secretary finalizes the subscription contract regulations under subsection 7d71 the ,secretary may use up to #a1jjj1jjj1jjj of the amount appropriated under section #cii,,ss7a7 to engage in transitional subscription contracts of up to #c years in length with antimicrobial developers1 as determined by the ,secretary1 that have developed antimicrobial drugs treating infections listed in the most recent report entitled ,antibiotic ,resistance ,threats in the ,united ,states issued by the ,centers for ,disease ,control and ,prevention1 and may include antimicrobial drugs that are qualified infectious disease products 7as defined in section #eje;,e7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 innovative biological products1 or innovative drugs that achieve a clinical outcome through immunomodulation4 ,such a contract may authorize the contractor to use funds made available under the contract for completion of postmarketing clinical studies1 manufacturing1 and other preclinical and clinical efforts4 7#b7 ,requirements 7,a7 ,in general ,the ,secretary1 through the office described in paragraph 7#d71 may enter into a contract under paragraph 7#a7-- 7i7 if the ,secretary determines that the antimicrobial drug is intended to treat an infection for which there is an unmet clinical need1 an anticipated clinical need1 or drug resistance2 7ii7 subject to terms including-- 7,i7 that the ,secretary shall cease any payment installments under a transitional subscription contract if the sponsor does not-- 7aa7 ensure commercial and ,federal availability of the antimicrobial drug within #cj days of receiving first payment under the contract2 7bb7 identify1 track1 and publicly report drug resistance data and trends using available data related to the antimicrobial drug2 7cc7 develop and implement education and communications strategies1 including communications for individuals with limited ,english proficiency and individuals with disabilities1 for health care professionals and patients about appropriate use of the antimicrobial drug2 7dd7 submit a plan for registering the antimicrobial drug in additional countries where an unmet medical need exists1 which such plan may be consistent with the ,stewardship and ,access ,plan 7,,sap7 ,development ,guide 7#bjba72 7ee7 subject to subparagraph 7,b71 ensure a reliable drug supply chain1 thus leading to an interruption of the supply of the antimicrobial drug in the ,united ,states for more than #fj days2 or 7ff7 make meaningful progress toward completion of ,food and ,drug ,administration-required postmarketing studies1 including such studies that are evidence based2 and 7,,ii7 other terms as determined by the ,secretary2 and 7iii7 if-- 7,i7 a phase #c clinical study has been initiated for the antimicrobial drug2 or 7,,ii7 the antimicrobial drug has been approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea7;a74 7,b7 ,waiver ,the requirement under subparagraph 7,a77ii77,i77ee7 may be waived in the case that an emergency prohibits access to a reliable drug supply chain4 7#c7 ,transitional guidance ,not later than #abj days after the appointment of the initial members of the ,committee1 the ,secretary shall issue1 in consultation with the ,committee1 transitional guidance outlining the antimicrobial drugs that are eligible for transitional subscription contracts under paragraph 7#a71 the requirements to enter into a transitional subscription contract under paragraph 7#b71 and the process by which drug developers can enter into transitional subscription contracts with the ,secretary under this subsection4 7#d7 ,payment office and mechanism ,not later than #cj days after the date of the enactment of this part1 the ,secretary shall determine the agency or office in the ,department of ,health and ,human ,services that will manage the transitional subscription contracts1 including eligibility1 requirements1 and contract amounts1 during the period described in paragraph 7#a74 7g7 ,critical need antimicrobial advisory group 7#a7 ,in general ,not later than #cj days after the appointment of all initial members of the ,committee1 the ,secretary1 in collaboration with the ,committee1 shall establish a ,critical ,need ,antimicrobial ,advisory ,group 7referred to in this subsection as the ,advisory ,group7 and appoint members to the ,advisory ,group4 7#b7 ,members ,the members of the ,advisory ,group shall include-- 7,a7 not fewer than #f individuals who are-- 7i7 infectious disease specialists2 or 7ii7 other health experts with expertise in researching antimicrobial resistance1 health economics1 or commercializing antimicrobial drugs2 and 7,b7 not fewer than #e patient advocates4 7#c7 ,chair ,the ,secretary shall appoint one of the members of the ,advisory ,group to serve as the ,chair4 7#d7 ,conflicts of interest ,in appointing members under paragraph 7#b71 the ,secretary shall ensure that no member receives compensation in any manner from a commercial or for-profit entity that develops antimicrobials or that might benefit from antimicrobial development4 7#e7 ,applicability of ,,faca ,except as otherwise provided in this subsection1 the ,federal ,advisory ,committee ,act shall apply to the ,advisory ,group4 #cii,,pp4 ,critical need antimicrobial drug application and payment through subscription contracts 7a7 ,in general 7#a7 ,submission of request ,the sponsor of an application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 for an antimicrobial drug may request that the ,secretary designate the drug as a critical need antimicrobial4 ,a request for such designation may be submitted after the ,secretary grants for such drug an investigational new drug exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a77#c71 and shall be submitted not later than #e years after the date of approval under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea7;a74 7#b7 ,content of request ,a request under paragraph 7#a7 shall include information1 such as clinical1 preclinical and postmarketing data1 a list of the favorable characteristics described in section #cii,,oo7c77#b71 and any other material that the ,secretary in consultation with the ,committee requires4 7#c7 ,review by secretary ,the ,secretary shall promptly review all requests for designation submitted under this subsection1 assess all required application components1 and determine if the antimicrobial drug is likely to meet the favorable characteristics identified in the application upon the completion of clinical development4 ,after review1 the ,secretary shall approve or deny each request for designation not later than #ij days after receiving a request4 ,if the ,secretary approves a request1 it shall publish the value of the contract that the critical need antimicrobial developer would be eligible to receive if such developer successfully demonstrates that the drug meets the maximum value of the favored characteristics listed in the application4 7#d7 ,length of designation period ,a designation granted under this section shall be in effect for a period of #aj years after the date that the designation is approved1 and shall remain in effect for such period even if the infection treated by such drug is later removed from the list of infections under section #cii,,oo7c77#a74 7#e7 ,subsequent reviews ,no sooner than #b years after a designation approval or denial under subsection 7#c71 the sponsor may request a subsequent review to reevaluate the value of a contract to include any new information4 7b7 ,development of designated drugs ,if a critical need antimicrobial designation is granted during clinical development of an antimicrobial drug1 the ,secretary may work with the sponsor to maximize the opportunity for the sponsor to successfully demonstrate that the antimicrobial drug possesses the favored characteristics of high-monetary valued products identified under section #cii,,oo7c77#b74 7c7 ,appropriate use of critical need antimicrobial 7#a7 ,in general ,the sponsor of an antimicrobial drug that receives designation under subsection 7a7 shall within #ij days of such designation1 submit to the ,secretary a plan for appropriate use of diagnostics1 in order for the ,secretary and ,committee to consider such plan in developing clinical guidelines4 ,an appropriate use plan-- 7,a7 shall include-- 7i7 the appropriate use of the drug2 and 7ii7 the appropriate use of diagnostic tools1 where available1 such as diagnostic testing for biomarkers related to antimicrobial-resistant pathogens1 or other targeted diagnostic approaches1 to inform use of the drug2 and 7,b7 may be developed in partnership with the ,secretary1 infectious disease experts1 diagnostic experts or developers1 laboratory experts1 or another entity4 7#b7 ,consultation ,the ,secretary shall consult with relevant professional societies and the ,critical ,need ,antimicrobial ,advisory ,group established under section #cii,,oo7g7 to ensure that clinical guidelines issued by the ,secretary under paragraph 7#c71 with respect to an antimicrobial drug designated under subsection 7a71 includes the use of appropriate diagnostic approaches1 taking into consideration the diagnostic plan submitted by a sponsor under paragraph 7#a74 7#c7 ,publication of clinical guidelines ,not later than #a year after the ,secretary makes the first designation under subsection 7a71 and not less than every #c years thereafter1 the ,secretary shall publish clinical guidelines in consultation with relevant professional societies with respect to each antimicrobial drug that has been approved or licensed as described in subsection 7a77#a7 and that has been designated under subsection 7a71 which guidelines shall set forth the evidence-based recommendations for prescribing the drug1 in accordance with the submissions of the sponsor under paragraph 7#a7 and after consultation under paragraph 7#b71 as appropriate4 #cii,,qq4 ,subscription contracts 7a7 ,application for a subscription contract 7#a7 ,submission of applications ,after approval under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea7;a71 the sponsor of an antimicrobial drug designated as a critical need antimicrobial under section #cii,,pp may submit an application for a subscription contract with the ,secretary1 under a procedure established by the ,secretary4 7#b7 ,review of applications ,the ,secretary shall1 in consultation with the ,committee-- 7,a7 review all applications for subscription contracts under paragraph 7#a7 and assess all required application components2 7,b7 determine the extent to which the critical need antimicrobial meets the favored characteristics identified under section #cii,,oo7c77#b71 and deny any application for a drug that meets none of such characteristics2 and 7,c7 assign a monetary value to the contract based on the regulations developed under section #cii,,oo7d74 7b7 ,criteria ,to qualify for a subscription contract under this section1 the sponsor of an antimicrobial drug designated as a critical need antimicrobial shall agree to-- 7#a7 ensure commercial and ,federal availability of the antimicrobial drug within #cj days of receiving first payment under the contract1 and sufficient supply for susceptibility device manufacturers2 7#b7 identify1 track1 and publicly report drug resistance data and trends using available data related to the antimicrobial drug2 7#c7 develop and implement education and communications strategies1 including communications for individuals with limited ,english proficiency and individuals with disabilities1 for health care professionals and patients about appropriate use of the antimicrobial drug2 7#d7 submit an appropriate use assessment to the ,secretary1 ,committee1 ,food and ,drug ,administration1 and ,centers for ,disease ,control and ,prevention every #b years regarding use of the antimicrobial drug1 including how the drug is being marketed2 7#e7 submit a plan for registering the drug in additional countries where an unmet medical need exists2 7#f7 ensure a reliable drug supply chain1 where any interruption to the supply chain will not last for more than #fj days in the ,united ,states2 7#g7 complete any postmarketing studies required by the ,food and ,drug ,administration in a timely manner2 7#h7 produce the drug at a reasonable volume determined with the ,secretary to ensure patient access to the drug2 7#i7 price the drug at a price that is not lower than a comparable generic drug2 7#aj7 abide by the manufacturing and environmental best practices in the supply chain to ensure that there is no discharge into1 or contamination of1 the environment by antimicrobial agents or products as a result of the manufacturing process2 and 7#aa7 abide by other terms as the ,secretary may require4 7c7 ,amount and terms of contracts 7#a7 ,amounts ,a subscription contract under this section shall be for the sale to the ,secretary of any quantity of the antimicrobial drug needed over the term of the contract under paragraph 7#b71 at an agreed upon price1 for a total projected amount determined by the ,secretary that is not less than #gej1jjj1jjj and not more than #c1jjj1jjj1jjj1 adjusted for inflation1 accounting for the favored characteristics of the drug1 as determined by the ,secretary1 in consultation with the ,committee1 under subsection 7a77#b71 and shall be allocated from the amount made available under section #cii,,ss7a74 ,not later than #f months after the subscription contract is granted under subsection 7a71 the ,secretary shall provide payments for purchased drugs in installments established by the ,secretary in consultation with the sponsor of the antimicrobial drug and in accordance with subsection 7d77#c74 ,funds received by the sponsor shall be used to support criteria qualification under subsection 7b71 the completion of postmarketing clinical studies1 manufacturing1 other preclinical and clinical activities1 or other activities agreed to by the ,secretary and sponsor in the contract4 7#b7 ,terms 7,a7 ,initial term ,the initial term of a contract under this subsection shall be no less than #e years or greater than the greater of #aj years or the remaining period of time during which the sponsor has patent protections or a remaining exclusivity period with respect to the antimicrobial drug in the ,united ,states1 as listed in the publication of the ,food and ,drug ,administration entitled ,approved ,drug ,products with ,therapeutic ,equivalence ,evaluations4 ,payments may be in equal annual installments with the option to redeem #ej percent of the last year's reimbursement in year #a of the contract in order to offset costs of establishing manufacturing capacity1 or another subscription arrangement to which the ,secretary and sponsor agree4 ,subscription contracts shall remain in effect for such period even if the infection treated by such antimicrobial drug is later removed from the list of infections under section #cii,,oo7c77#a74 7,b7 ,extension of contracts ,the ,secretary may extend a subscription contract with a sponsor under this subsection beyond the initial contract period4 ,a single contract extension may be in effect not later than the date on which all periods of exclusivity granted by the ,food and ,drug ,administration expire and shall be in an amount not to exceed #be1jjj1jjj per year4 ,all other terms of an extended contract shall be the same as the terms of the initial contract4 ,the total amount of funding used on such contract extensions shall be no more than #a1jjj1jjj1jjj1 and shall be allocated from the amount made available under section #cii,,ss4 7,c7 ,modification of contracts ,the ,secretary or sponsor1 #a year after the start of the contract period under this subsection and every #b years thereafter1 may request a modification of the amount of the contract based on information that adjusts favored characteristics in section #cii,,oo7c77#b74 7#c7 ,adjustment ,in the case of an antimicrobial drug that received a transitional subscription contract under section #cii,,oo7f71 the amount of a subscription contract for such drug under this section shall be reduced by the amount of the transitional subscription contract under such section #cii,,oo7f7 for such drug4 7#d7 ,contracts for generic and biosimilar versions ,notwithstanding any other provision in this part1 the ,secretary may award a subscription contract under this section to a manufacturer of a generic or biosimilar version of an antimicrobial drug for which a subscription contract has been awarded under this section4 ,such contracts shall be awarded in accordance with a procedure1 including for determining the terms and amounts of such contracts1 established by the ,secretary4 7d7 ,annual antimicrobial drug sponsor revenue limitations 7#a7 ,reporting requirement 7,a7 ,in general ,not later than a date determined appropriate by the ,secretary following the end of each calendar year1 and not earlier than #f months after the end of each calendar year1 the head 7or a designee of such head7 of each ,federal agency carrying out a specified government program shall1 in accordance with this paragraph1 report to the ,subscription ,contract ,office established under section #cii,,oo7d77#c7 the total prescription drug sales for each applicable antimicrobial drug under contract with respect to such program for such calendar year4 7,b7 ,medicare ,part ,d program ,for purposes of subparagraph 7,a71 the ,secretary shall report1 for each applicable antimicrobial drug covered under part ,d of title ,,xviii of the ,social ,security ,act1 the product of-- 7i7 the per-unit ingredient cost1 as reported to the ,secretary by prescription drug plans and ,medicare ,advantage prescription drug plans1 minus any per-unit rebate1 discount1 or other price concession provided by the sponsor of such applicable antimicrobial drug1 as reported to the ,secretary by the prescription drug plans and the ,medicare ,advantage prescription drug plans2 and 7ii7 the number of units of such applicable antimicrobial drug paid for under such part ,d4 7,c7 ,medicare ,part ,b program 7i7 ,in general ,for purposes of subparagraph 7,a71 the ,secretary shall report1 for each applicable antimicrobial drug covered under part ,b of title ,,xviii of the ,social ,security ,act1 the product of-- 7,i7 the per-unit average sales price 7as defined in section #ahdg;,a7c7 of such ,act7 or the per-unit payment rate under such part ,b for a separately paid prescription drug without a reported average sales price2 and 7,,ii7 the number of units of such applicable antimicrobial drug paid for under such part ,b4 7ii7 ,units and allocated prices ,the ,secretary shall establish a process for determining the units and the allocated price for purposes of this subparagraph for those applicable antimicrobial drugs that are not separately payable or for which ,national ,drug ,codes are not reported4 7,d7 ,medicare ,part ,a program 7i7 ,in general ,for purposes of subparagraph 7,a71 the ,secretary shall report1 for each applicable antimicrobial drug covered under part ,a of title ,,xviii of the ,social ,security ,act1 the product of-- 7,i7 the per-unit price under such part ,a for the antimicrobial drug2 and 7,,ii7 the number of units of such antimicrobial drug paid for under such part ,a4 7ii7 ,special rule ,for purposes of clause 7i71 the ,secretary shall establish a process for determining the units and the allocated price for those prescription drugs that are not separately payable or for which ,national ,drug ,codes are not reported in the diagnosis-related groups4 7,e7 ,medicaid program ,under the authority of section #aijb7;a77#f7 of the ,social ,security ,act1 the ,secretary shall require each ,state that makes medical assistance available under the ,state plan under title ,,xix of such ,act 7or any waiver of such plan7 for an applicable antimicrobial drug 7including1 if applicable1 any such drug which is a covered outpatient drug under a rebate agreement entered into under section #aibg of such ,act7 to report1 in a form consistent with a standard reporting format established by the ,secretary1 not later than the date determined under subparagraph 7,a7-- 7i7 information on the total number of units of each dosage form and strength and package size of each applicable antimicrobial drug dispensed during the preceding calendar year under such ,state plan or waiver 7including any such drugs dispensed to an individual enrolled with a medicaid managed care organization or other specified entity 7as such terms are defined in section #aijc7m7 of such ,act772 and 7ii7 with respect to each dosage form and strength and package size of each such drug1 the amount equal to-- 7,i7 the product of-- 7aa7 the total number of units dispensed under the ,state plan or waiver during the preceding calendar year 7as determined under clause 7i772 and 7bb7 the per-unit ingredient cost paid by the ,state for each such unit2 minus 7,,ii7 any discounts or other price concessions provided and rebates paid to the ,state with respect to the dosage form and strength and package size of such drug and such calendar year 7including rebates paid under a rebate agreement under section #aibg of such ,act and any ,state supplemental rebates paid under a supplemental rebate agreement74 7,f7 ,department of ,veterans ,affairs ,for purposes of subparagraph 7,a71 the ,secretary of ,veterans ,affairs shall report the total amount paid for each applicable antimicrobial drug procured by the ,veterans ,health ,administration for individuals who receive health care from the ,administration4 7,g7 ,department of ,defense and ,,tricare program ,for purposes of subparagraph 7,a71 the ,secretary of ,defense shall report the sum of-- 7i7 the total amount paid for each applicable antimicrobial drug procured by the ,department of ,defense for individuals who receive health care from the ,department2 and 7ii7 for each applicable antimicrobial drug dispensed under the ,,tricare retail pharmacy program under section #ajgd;g7a77#b77;,e77ii7 of title #aj1 ,united ,states ,code1 the product of-- 7,i7 the per-unit ingredient cost1 minus any per-unit rebate paid by the sponsor of the applicable antimicrobial drug2 and 7,,ii7 the number of units of such applicable antimicrobial drug dispensed under such program4 7,h7 ,department of ,homeland ,security ,for purposes of subparagraph 7,a71 the ,secretary of ,homeland ,security shall report the total amount paid for each applicable antimicrobial drug procured by the ,department of ,homeland ,security for individuals who receive health care through a program carried out by the ,department4 7,i7 ,bureau of ,prisons ,for purposes of subparagraph 7,a71 the ,director of the ,bureau of ,prisons shall report the total amount paid for each applicable antimicrobial drug procured by the ,bureau of ,prisons for individuals who receive health care through the ,bureau4 7,j7 ,indian ,health ,service ,for purposes of subparagraph 7,a71 the ,secretary1 acting through the ,indian ,health ,service1 shall report the total amount paid for each applicable antimicrobial drug procured by the ,service for individuals who receive health care through the ,service4 7#b7 ,regulations ,not later than #a year after the date of the enactment of this part1 the ,secretary1 in consultation with the heads of ,federal agencies carrying out specified government programs1 shall issue regulations to assist such heads 7or their designees7 in carrying out the requirements under this section4 7#c7 ,subscription contract adjustment ,pursuant to the contract entered into under this section with respect to an applicable antimicrobial drug1 for each year of the term of such contract1 the ,secretary shall1 not earlier than #f months after the end of each calendar year1 subtract from the payment installments determined for such contract under subsection 7c77#a7 for such year the revenue of the sponsor of such drug from the previous year from sales of the applicable antimicrobial drug reported under paragraph 7#a7 for specified government programs4 7#d7 ,definitions ,in this subsection3 7,a7 ,applicable antimicrobial drug ,the term applicable antimicrobial drug means an antimicrobial drug for which the sponsor of such drug receives a subscription contract under subsection 7a74 7,b7 ,specified government program ,the term specified government program means-- 7i7 the ,medicare part ,d program under part ,d of title ,,xviii of the ,social ,security ,act2 7ii7 the ,medicare ,part ,b program under part ,b of such title ,,xviii2 7iii7 the ,medicare ,part ,a program under part ,a of such title ,,xviii2 7iv7 the ,medicaid program established under title ,,xix of the ,social ,security ,act and includes1 with respect to a ,state1 any waiver in effect with respect to such program2 7v7 any program under which prescription drugs are procured by the ,department of ,veterans ,affairs2 7vi7 any program under which prescription drugs are procured by the ,department of ,defense2 7vii7 the ,,tricare retail pharmacy program under section #ajgd;g7a77#b77;,e77ii7 of title #aj1 ,united ,states ,code2 7viii7 any program under which prescription drugs are procured by the ,department of ,homeland ,security2 7ix7 any program under which prescription drugs are procured by the ,bureau of ,prisons2 or 7x7 any program under which prescription drugs are procured by the ,indian ,health ,service4 7e7 ,failure ,to adhere to terms ,the ,secretary shall cease any payment installments under a contract under this section if-- 7#a7 the sponsor-- 7,a7 permanently withdraws the antimicrobial drug from the market in the ,united ,states2 7,b7 fails to meet criteria under subsection 7b72 or 7,c7 does not complete a postmarket study required by the ,food and ,drug ,administration during the length of the term of the contract2 7#b7 the annual international and private insurance market revenues with respect to an antimicrobial drug 7not counting any subscription revenues from any source pursuant to a contract under this section or other international or private entities7 exceed #e times the average annual amount of the subscription contract paid by the ,secretary as certified by the sponsor annually2 or 7#c7 if the total revenue of the sponsor from specified government programs1 as defined in subsection 7d77#d71 for a year exceeds the amount of the subscription contract paid by the ,secretary for that year4 7f7 ,private payer and international payer participation ,the ,secretary shall make efforts to increase the participation of domestic private payors and international payors in subscription contracts or other types of value-based arrangements that are similar to the subscription contracts authorized under this section4 #cii,,rr4 ,encouraging appropriate use of antibiotics and combating resistance 7a7 ,establishment of hospital grant program 7#a7 ,in general ,not later than #a year after the date of the enactment of this part1 the ,secretary and the ,director of the ,centers for ,disease ,control and ,prevention shall coordinate with the ,administrator of the ,health ,resources and ,services ,administration1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,national ,coordinator for ,health ,information ,technology1 and other relevant agencies1 to establish a grant program under the ,centers for ,disease ,control and ,prevention to support hospital and other inpatient facility efforts-- 7,a7 to judiciously use antimicrobial drugs1 such as by establishing or implementing appropriate use programs1 including infectious disease telehealth programs1 using appropriate diagnostic tools1 partnering with academic hospitals1 increasing health care-associated infection reporting1 and monitoring antimicrobial resistance2 and 7,b7 to participate in the ,national ,healthcare ,safety ,network ,antimicrobial ,use and ,resistance ,module or the ,emerging ,infections ,program ,healthcare-,associated ,infections ,community ,interface activity of the ,centers for ,disease ,control and ,prevention or a similar reporting program1 as specified by the ,secretary1 relating to antimicrobial drugs4 7#b7 ,prioritization ,in awarding grants under paragraph 7#a71 the ,secretary shall prioritize hospitals without an existing program to judiciously use antimicrobial drugs1 subsection 7d7 hospitals 7as defined in subparagraph 7,b7 of section #ahhf7;d77#b7 of the ,social ,security ,act that are located in rural areas 7as defined in subparagraph 7,d7 of such section71 critical access hospitals 7as defined in section #ahfa7mm77#a7 of such ,act71 hospitals serving ,tribal-populations1 and safety-net hospitals4 7#c7 ,funding ,of the amounts appropriated under section #cii,,ss1 the ,secretary shall reserve #ejj1jjj1jjj to carry out this subsection4 7b7 ,surveillance and reporting of antibiotic use and resistance 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall use the ,national ,healthcare ,safety ,network and other appropriate surveillance systems to assess-- 7,a7 appropriate conditions1 outcomes1 and measures causally related to antibacterial resistance1 including types of infections1 the causes for infections1 and whether infections are acquired in a community or hospital setting1 increased lengths of hospital stay1 increased costs1 and rates of mortality2 and 7,b7 changes in bacterial resistance to antimicrobial drugs in relation to patient outcomes1 including changes in percent resistance1 prevalence of antibiotic-resistant infections1 and other such changes4 7#b7 ,antibiotic use data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall work with ,federal agencies 7including the ,department of ,veterans ,affairs1 the ,department of ,defense1 the ,department of ,homeland ,security1 the ,bureau of ,prisons1 the ,indian ,health ,service1 and the ,centers for ,medicare ,medicaid ,services71 private vendors1 health care organizations1 pharmacy benefit managers1 and other entities as appropriate to obtain reliable and comparable human antibiotic drug consumption data 7including1 as available and appropriate1 volume antibiotic distribution data and antibiotic use data1 including prescription data7 by ,state or metropolitan areas4 7#c7 ,antibiotic resistance trend data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall intensify and expand efforts to collect antibiotic resistance data and encourage adoption of the ,antibiotic ,use and ,resistance ,module within the ,national ,healthcare ,safety ,network among all health care facilities across the continuum of care1 including1 as appropriate1 acute care hospitals1 dialysis facilities1 nursing homes1 ambulatory surgical centers1 and other ambulatory health care settings in which antimicrobial drugs are routinely prescribed4 ,the ,secretary shall seek to collect such data from electronic medication administration reports and laboratory systems to produce the reports described in paragraph 7#d74 7#d7 ,public availability of data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall1 for the purposes of improving the monitoring of important trends in patient outcomes in relation to antibacterial resistance-- 7,a7 make the data derived from surveillance under this subsection publicly available through reports issued on a regular basis that is not less than annually2 and 7,b7 examine opportunities to make such data available in near real time4 #cii,,ss4 ,appropriations 7a7 ,in general ,to carry out this part1 there are hereby appropriated to the ,secretary1 out of amounts in the ,treasury not otherwise appropriated1 #aa1jjj1jjj1jjj1 for fiscal year #bjbb1 to remain available until expended4 7b7 ,emergency designation 7#a7 ,in general ,the amounts provided by this section are designated as an emergency requirement pursuant to section #d7;g7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj4 7#b7 ,designation in senate ,in the ,senate1 this section is designated as an emergency requirement pursuant to section #daab7;a7 of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress71 the concurrent resolution on the budget for fiscal year #bjah4 #cii,,tt4 ,studies and reports 7a7 ,in general ,not later than #f years after the date of the enactment of this part1 the ,comptroller ,general of the ,united ,states shall complete a study on the effectiveness of this part in developing priority antimicrobial drugs4 ,such study shall examine the indications for1 usage of1 development of resistance with respect to1 and private and societal value of critical need antimicrobial drugs1 and the impact of the programs under this part on patients and markets of critical need antimicrobial drugs4 ,the ,comptroller ,general shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on the findings of such study4 7b7 ,antibiotic use in the ,united ,states2 annual reports ,the ,director of the ,centers for ,disease ,control and ,prevention shall1 each year1 update the report entitled ,antibiotic ,use in the ,united ,states to include updated information on progress and opportunities with respect to data1 programs1 and resources for prescribers to promote appropriate use of antimicrobial drugs4 7c7 ,report on antimicrobial prophylactics ,not later than #c years after the date of the enactment of this part1 the ,director of the ,centers for ,disease ,control and ,prevention shall publish a report on antimicrobial prophylactics4 #cii,,uu4 ,definitions ,in this part-- 7#a7 the term antimicrobial drug-- 7,a7 means1 subject to subparagraph 7,b71 a product that is-- 7i7 a drug that directly inhibits replication of or kills bacteria or fungi relevant to the proposed indication at concentrations likely to be attainable in humans to achieve the intended therapeutic effect2 or 7ii7 a biological product that acts directly on bacteria or fungi or on the substances produced by such bacteria or fungi2 and 7,b7 does not include-- 7i7 a drug that achieves the effect described by subparagraph 7,a77i7 only at a concentration that cannot reasonably be studied in humans because of its anticipated toxicity2 or 7ii7 a vaccine2 and 7#b7 the term ,committee means the ,committee on ,critical ,need ,antimicrobials established under section #cii,,oo4 4 ,,ii ,patients and caregivers #bja4 ,educational programs and training for caregivers ,part ,d of title ,,vii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bid et seq47 is amended by adding at the end the following3 #gfj;,a4 ,educational programs and training for caregivers 7a7 ,in general ,the ,secretary may award grants for educational programs and training for caregivers to learn skills to empower them-- 7#a7 to be a member of a care team2 and 7#b7 to complement a clinical visit4 7b7 ,types of programs and training ,educational programs and training funded under subsection 7a7 may include-- 7#a7 specialized training in medication adherence and injections2 7#b7 complementary strategies to ensure adherence to physical1 occupational1 speech1 and habilitative therapy regimens2 7#c7 nutritional compliance2 7#d7 caregiver psychosocial support 7including cognitive-behavioral1 supportive1 and bereavement counseling72 7#e7 caregiver health self-management2 and 7#f7 other services provided in the home4 7c7 ,non-,duplication ,the ,secretary may not use the same requirements under this section for a grant1 contract1 or cooperative agreement under the ,geriatric ,workforce ,enhancement ,program under section #gec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bid;c74 7d7 ,caregiver defined ,in this section1 the term caregiver means an adult family member or other individual who has a significant relationship with1 and who provides a broad range of assistance to1 an individual with a chronic or other health condition1 disability1 or functional limitation4 7e7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #be1jjj1jjj for each of fiscal years #bjbb through #bjbd4 4 #bjb4 ,increasing health literacy to promote better outcomes for patients 7a7 ,in general ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall issue a request for information to solicit recommendations on ways the ,centers for ,medicare ,medicaid ,services can work with stakeholders of the ,federal health care programs 7as defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 to promote increased patient and family caregiver health literacy1 including recommendations for-- 7#a7 identifying culturally competent1 evidence-based interventions that have been proven to improve health literacy in populations served by such programs2 7#b7 identifying evidence-based health literacy approaches that can be used by the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 a ,state plan 7or waiver of such plan7 under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq471 a ,state child health plan 7or waiver of such plan7 under title ,,xxi of such ,act 7#db ,u4,s4,c4 #acig;aa et seq471 or health care providers participating in such program under such title ,,xviii1 under a ,state plan 7or waiver of such plan7 under such title ,,xix1 or under a ,state child health plan 7or waiver of such plan7 under such title ,,xxi1 and that-- 7,a7 have been proven to1 or show promise to1 reduce costs to individuals enrolled under a ,state plan 7or waiver of such plan7 under such title ,,xix1 or under a ,state child health plan 7or waiver of such plan7 under such title ,,xxi1 respectively1 and reduce expenditures under such respective titles2 or 7,b7 have been proven to increase patient and family caregiver satisfaction or improve the quality of care for at-risk populations1 including holistic and non-medication-based forms of care2 7#c7 how the ,centers for ,medicare ,medicaid ,services can encourage the use of evidence-based health literacy interventions through payment policies under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 a ,state plan under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq471 a ,state child health plan under title ,,xxi of such ,act 7#db ,u4,s4,c4 #acig et seq472 and 7#d7 improving patient and family caregiver health literacy with respect to health insurance1 including an understanding of in-network providers1 deductibles1 co-insurance1 co-payments1 and differences between payors4 #bjc4 ,increasing diversity in clinical trials 7a7 ,updated reporting on inclusion of demographic subgroups ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall-- 7#a7 not later than #ij days after the date of the enactment of this ,act1 submit to the ,food and ,drug ,administration1 and provide to the ,congress1 an updated version of the report under section #ijg7;a7 of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aae-eb72 and 7#b7 not later than #a year after the publication of the updated report pursuant to paragraph 7#a71 publish on the website of the ,food and ,drug ,administration1 and provide to the ,congress1 an updated version of the action plan under section #ijg7;b7 of such ,act4 7b7 ,,gao study on barriers to participation ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 complete a study-- 7,a7 to review how the ,department of ,health and ,human ,services addresses barriers to participation by individuals from underrepresented populations in conducting or supporting clinical trials2 and 7,b7 to formulate recommendations for addressing such barriers2 and 7#b7 submit a report to the ,congress on the results of such study4 7c7 ,public awareness campaign ,the ,secretary of ,health and ,human ,services shall-- 7#a7 carry out a public awareness campaign to increase awareness and understanding1 particularly in minority communities1 of-- 7,a7 upcoming and ongoing clinical trials2 7,b7 how to enroll as subjects in such clinical trials2 and 7,c7 the availability of databases and other resources relevant to clinical trial enrollment1 such as ,clinical,trials4gov2 and 7#b7 in carrying out such campaign1 utilize a variety of communication channels1 including through use of the explanation of ,medicare benefits under section #ahjf of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#g74 7d7 ,task force for making ,clinical,trials4gov more user-,friendly 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall convene a permanent task force to propose1 on a biennial basis1 recommendations for improving ,clinical,trials4gov by making it more user-friendly1 including for patients4 7#b7 ,membership ,the membership of the task force shall include representatives of-- 7,a7 the ,national ,institutes of ,health2 7,b7 the ,food and ,drug ,administration2 7,c7 academic researchers2 and 7,d7 patient organizations4 7e7 ,definition ,in this section1 the term ,clinical,trials4gov refers to the data bank described in section #djb7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;i774 #bjd4 ,patient experience data 7a7 ,policy ,section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is amended-- 7#a7 by redesignating subsections 7b7 and 7c7 as subsections 7c7 and 7d71 respectively2 and 7#b7 by inserting after subsection 7a7 the following new subsection3 7b7 ,collection1 submission1 and use of data 7#a7 ,in general ,the ,secretary shall-- 7,a7 for any drug for which an exemption is granted for investigational use under section #eje7;i7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 require the sponsor of the drug to collect standardized patient experience data as part of the clinical trials conducted pursuant to such exemption2 7,b7 require any application for the approval or licensing of such drug under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act to include-- 7i7 the standardized patient experience data so collected2 and 7ii7 such related information as the ,secretary may require2 and 7,c7 consider patient experience data and related information that is submitted pursuant to subparagraph 7,b7 in deciding whether to approve or license1 as applicable1 the drug involved4 7#b7 ,applicability ,paragraph 7#a7 applies only with respect to drugs for which a request for an exemption described in paragraph 7#a77;,a7 is submitted on or after the date of the enactment of the ,cures #b4j ,act1 or an application under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act is filed1 as applicable1 on or after the day that is #b years after the date of the enactment of the ,cures #b4j ,act4 4 7b7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall promulgate final regulations to implement section #efi;,c7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this section4 #bje4 ,ensuring coverage for clinical trials under existing standard of care 7a7 ,revision to definition of approved clinical trial in individual and group market 7#a7 ,in general ,subsection 7d77#a7 of the first section #bgji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#h7 7relating to coverage for individuals participating in approved clinical trials7 is amended by adding at the end the following new subparagraph3 7,d7 ,the study or investigation is approved or funded 7which may include funding through in-kind contributions7 by the ,patient ,centered ,outcomes ,research ,institute established under section #aaha of the ,social ,security ,act4 4 7#b7 ,effective date ,the amendment made by this paragraph shall apply with respect to plan years beginning on or after ,january #a1 #bjbb4 7b7 ,medicare coverage of routine costs associated with certain clinical trials 7#a7 ,in general ,section #ahfb7m77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4#aciey7m77#b77 is amended1 in the matter preceding subparagraph 7,a71 by inserting 7including a trial funded by the ,patient ,centered ,outcomes ,research ,institute established under section #aaha7 after means a trial4 7#b7 ,effective date ,the amendment made by this paragraph shall apply with respect to items and services furnished on or after the date of the enactment of this ,act4 ,,iii ,food and ,drug ,administration #cja4 ,report on collaboration and alignment in regulating digital health technologies 7a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall submit a report to the ,congress on the efforts to ensure collaboration and alignment across the centers and offices of the ,food and ,drug ,administration with respect to the regulation of digital health technologies4 7b7 ,contents ,the report under subsection 7a7 shall include a description of the following3 7#a7 ,how the ,commissioner of ,food and ,drugs and the heads of the centers and offices of the ,food and ,drug ,administration collaborate in regulating digital health technologies1 including recommendations with respect to-- 7,a7 the use of digital endpoints for regulatory review1 including the validation and qualification of digital endpoints and digital biomarkers2 7,b7 the acceptance of decentralized trials2 7,c7 the use of digital health technologies in patient-focused development of products2 and 7,d7 the use and validation of digital health technology tools2 7#b7 ,how the ,food and ,drug ,administration coordinates with foreign regulators to ensure harmonization on the regulation and use of digital health technologies4 7c7 ,definition ,in this section1 the term digital health technologies includes those technologies in health care or society that help deliver or provide access to health care products and services such as hardware 7for example1 wearable sensors1 virtual reality headsets1 and digitally-enabled drug delivery devices71 advanced analytics 7for example1 artificial intelligence1 machine learning1 and sophisticated computation71 cloud services 7for example1 storage1 computing1 and data processing71 and software 7for example1 mobile medical applications1 and software as a medical device74 #cjb4 ,grants for novel trial designs and other innovations in drug development 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall award grants for-- 7#a7 incorporating complex adaptive and other novel trial designs into clinical protocols and applications for drugs pursuant to an exemption for investigational use under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 and 7#b7 the collection of patient experience data with respect to drugs and the use of such data and related information in drug development4 7b7 ,prioritization ,in awarding grants under this section1 the ,secretary shall prioritize the incorporation of digital health technologies and real world evidence in drug development4 7c7 ,definitions ,in this section3 7#a7 ,the term digital health technologies has the meaning given to such term in section #cja4 7#b7 ,the term patient experience data has the meaning given to such term by section #efi;,c7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as redesignated by section #bjd of this ,act4 7#c7 ,the term real world evidence has the meaning given to that term in section #eje;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g74 7d7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #be1jjj1jjj for each of fiscal years #bjbb through #bjbd4 #cjc4 ,,fda cell and gene therapy ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall submit a report to the ,congress on the following3 7#a7 ,the foreseeable challenges to the ,food and ,drug ,administration with respect to cell and gene therapies during the next ten years4 7#b7 ,how the ,food and ,drug ,administration will address these challenges4 7#c7 ,the additional resources and authorities the ,food and ,drug ,administration needs to address these challenges4 7#d7 ,the current state of cell and gene therapies regulation by the ,food and ,drug ,administration1 including-- 7,a7 the amount and nature of the submissions filed with the ,food and ,drug ,administration2 7,b7 the status of such applications in the review process2 and 7,c7 the therapeutic areas intended to be addressed by the products that are subject to such applications4 #cjd4 ,increasing use of real world evidence 7a7 ,guidance 7#a7 ,issuance ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall issue guidance on the use of real world evidence in evaluating the safety and effectiveness of breakthrough devices 7developed pursuant to section #eae;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c77 and breakthrough drugs subsequent to the approval or licensing of such drugs pursuant to subsection 7a71 7b71 or 7c7 of section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 as a breakthrough therapy1 a fast track product1 or a product considered for accelerated approval4 7#b7 ,considerations ,the guidance under paragraph 7#a7 shall take into consideration each of the following3 7,a7 ,special and underrepresented populations4 7,b7 ,acceptable endpoints and outcomes measures4 7,c7 ,data quality standards4 7,d7 ,data transparency requirements4 7,e7 ,study design considerations4 7b7 ,identification and implementation of approaches 7#a7 ,identification ,consistent with the framework established under #eje;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g71 the ,secretary of ,health and ,human ,services shall1 by not later than #a year after the date of the enactment of this ,act-- 7,a7 identify consistent1 clear approaches for the ,department of ,health and ,human ,services to use real world evidence 7as defined in such section #eje;,f7-- 7i7 in conducting and supporting research2 and 7ii7 in regulating1 purchasing1 and supporting the purchase of health care products and services2 7,b7 include in such approaches recommendations for any additional statutory authorities needed2 7,c7 publish such approaches in the ,federal ,register2 and 7,d7 submit a report to the ,congress on such approaches4 7#b7 ,implementation ,upon publication under paragraph 7#a7 of the approaches identified pursuant to such paragraph1 consistent with the authorities vested in the ,department of ,health and ,human ,services by other provisions of law1 the ,secretary take such actions as may be appropriate to implement the approaches identified pursuant to paragraph 7#a74 7c7 ,real ,world ,evidence ,task ,force 7#a7 ,establishment ,the ,secretary shall establish a permanent task force1 to be known as the ,real ,world ,evidence ,task ,force 7in this subsection referred to as the ,task ,force7 to coordinate the programs and activities of the ,department of ,health and ,human ,services with regard to the collection and use of real world evidence4 7#b7 ,membership ,the members of the ,task ,force shall include the following3 7,a7 ,the ,secretary 7or the ,secretary's designee71 who shall serve as the ,chair of the ,task ,force4 7,b7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services 7or the ,administrator's designee74 7,c7 ,the ,commissioner of ,food and ,drugs 7or the ,commissioner's designee74 7,d7 ,the ,director of the ,national ,institutes of ,health 7or the ,director's designee74 7,e7 ,such additional ,federal officials 7or their designees7 as the ,secretary determines appropriate4 7,f7 ,private sector representatives1 including patient group representatives1 to be appointed by the ,secretary4 7#c7 ,recommendations ,in carrying paragraph 7#a71 the ,task ,force shall-- 7,a7 develop and periodically update recommendations on ways to encourage patients to-- 7i7 engage in the generation of real world evidence2 and 7ii7 participate in postapproval clinical trials for the collection of real world evidence2 and 7,b7 not later than #b years after the date of the enactment of this ,act1 and every #b years thereafter1 submit a report to the ,congress on such recommendations4 #cje4 ,improving ,,fda-,,cms communication regarding transformative new therapies 7a7 ,in general ,upon the designation of a product as a breakthrough therapy1 a fast track product1 or a product eligible for accelerated approval under subsection 7a71 7b71 or 7c71 respectively1 of section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef71 the ,commissioner of ,food and ,drugs and the ,administrator of the ,centers for ,medicare ,medicaid ,services shall-- 7#a7 maintain communication with each other regarding approval and coverage decisions with respect to such product2 and 7#b7 share such information with each other as may be appropriate to inform and coordinate such decisions4 7b7 ,separate and distinct ,in approving or designating a product described in subsection 7a71 the ,commissioner of ,food and ,drugs and the ,administrator of the ,centers for ,medicare ,medicaid ,services shall ensure that the process for approval or designation remains separate and distinct4 #cjf4 ,establishment of additional ,intercenter ,institutes at the ,food and ,drug ,administration 7a7 ,establishment ,subsection 7c7 of section #ajad of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;g7c77 is amended to read as follows3 7c7 ,timing ,not later than the date that is one year after the date of the enactment of the ,cures #b4j ,act or the end of the coronavirus disease #bjai 7,,covid-#ai7 pandemic public health emergency under section #cai of the ,public ,health ,service ,act1 whichever is later1 the ,secretary shall establish1 in accordance with this section1 at least two additional ,institutes under subsection 7a74 4 7b7 ,criteria ,in establishing the focus of the two ,institutes referenced in the amendment made by subsection 7a71 the ,secretary of ,health and ,human ,services shall ensure the following3 7#a7 ,one of the ,institutes focuses on a group of diseases meeting the following criteria3 7,a7 ,negatively affects at least one major body system4 7,b7 ,represents a major disease burden in the ,united ,states4 7,c7 ,represents a leading cause of mortality or disability in the ,united ,states4 7,d7 ,according to the ,national ,institutes of ,health1 affects at least an estimated #ej1jjj1jjj ,americans each year4 7,e7 ,contributes to increasing health care 7personal1 familial1 private sector1 and governmental7 expenditures and impacts the ,united ,states economy as a whole4 7,f7 ,for which the ,,sars-,co,v-#b virus exacerbates symptoms or causes serious complications4 7,g7 ,for which medical products are approved by the ,food and ,drug ,administration at a much lower rate than products for other disease areas1 including in abbreviated pathways4 7#b7 ,one of the ,institutes focuses on a group of diseases meeting the following criteria3 7,a7 ,affects1 individually1 fewer than #bjj1jjj people in the ,united ,states4 7,b7 ,over #ij percent of such diseases have no therapy approved by the ,food and ,drug ,administration4 7,c7 ,affects1 in total1 over #cj1jjj1jjj ,americans4 7,d7 ,over #ej percent of patients are children4 7c7 ,report on ,intercenter ,institutes ,not later than #b years after the date of the enactment of this ,act1 and annually thereafter1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate on the activities of the ,institutes established pursuant to this section4 #cjg4 ,accelerating timeline for breakthrough and ,,rmat designations 7a7 ,breakthrough therapies ,section #ejf7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a77#b77 is amended by striking ,a request for the designation may be made concurrently with1 or at any time after1 the submission of an application for the investigation of the drug under section #eje7;i7 or section #cea7;a77#c7 of the ,public ,health ,service ,act and inserting ,a request for the designation may be made at any point before or after submission of an application for approval of the drug under section #eje7;b7 of this ,act or licensure of the drug under section #cea7;a77#b7 of the ,public ,health ,service ,act and shall include clinical evidence1 including preliminary clinical evidence from clinical trials conducted outside of the ,united ,states4 7b7 ,regenerative advanced therapies ,section #ejf7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;g77#c77 is amended by striking concurrently with1 or at any time after1 submission of an application for the investigation of the drug under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act and inserting at any point before or after submission of an application for approval of the drug under section #eje7;b7 of this ,act or licensure of the drug under section #cea7;a77#b7 of the ,public ,health ,service ,act and shall include clinical evidence1 including preliminary clinical evidence from clinical trials conducted outside of the ,united ,states4 #cjh4 ,guidance regarding development and submission of chemistry1 manufacturing1 and controls information for expedited approval 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall-- 7#a7 not later than #f months after the date of the enactment of this ,act1 issue draft revised guidance to provide clarity regarding the development and submission of chemistry1 manufacturing1 and controls information for purposes of subsections 7a71 7b71 7c71 and 7g7 of section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef2 relating to breakthrough therapies1 fast track products1 accelerated approval1 and regenerative advanced therapies72 and 7#b7 not later than #ij days after the close of a period of public comment on such draft guidance1 finalize the guidance4 7b7 ,contents ,the guidance under subsection 7a7 shall address-- 7#a7 how the ,food and ,drug ,administration will determine how1 and by when1 chemistry1 manufacturing1 and controls information is required to be submitted throughout development and during the pre- and post-approval phases1 taking into consideration-- 7,a7 how such determinations will reflect the risks and benefits of such information given the seriousness or life-threatening nature of the disease the product is intended to diagnose1 cure1 mitigate1 treat1 or prevent2 7,b7 the phase and expedited nature of development2 and 7,c7 the availability of relevant data and information from nonclinical and clinical studies1 product applications1 and post-approval oversight2 and 7#b7 how the ,food and ,drug ,administration will provide ongoing advice and opportunities for sponsors to interact with the ,food and ,drug ,administration on1 and how the ,food and ,drug ,administration will facilitate1 the submission of chemistry1 manufacturing1 and controls information throughout the life cycle of the product4 #cji4 ,post-approval study requirements for accelerated approval ,section #ejf7;c77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77#b77;,a77 is amended after studies by inserting 1 or otherwise submit evidence based on analyses of data in clinical care data repositories1 patient registries1 or other sources of real world evidence14 #caj4 ,recommendations to decentralize clinical trials 7a7 ,in general ,not later than the end of fiscal year #bjbb1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall convene a meeting of covered representatives to recommend to the ,secretary innovative approaches and incentives to adopt decentralized clinical trials4 7b7 ,definitions ,in this section3 7#a7 ,covered representative ,the term covered representative means a representative of the following3 7,a7 ,sponsors of an application for approval of a drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7,b7 ,a manufacturer of a device 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba774 7,c7 ,clinical research organizations4 7,d7 ,the technology community4 7,e7 ,the patient community4 7#b7 ,decentralized clinical trial ,the term decentralized clinical trial means a clinical trial method that includes the use of telemedicine or digital technologies to allow for the remote collection of clinical trial data from subjects1 including in the home or office setting4 ,,iv ,centers for ,medicare ,medicaid ,services #dja4 ,,gao study and report ,not later than one year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on recommendations for administrative actions that may be taken by the ,secretary of ,health and ,human ,services 7as well as recommendations for legislative changes needed7 to-- 7#a7 enhance coverage and reimbursement approaches under the ,medicare program under title ,,xviii of the ,social ,security ,act for innovative technologies that increase access to health care1 improve health care quality1 decrease expenditures under such program1 or otherwise improve the ,medicare program or health care for beneficiaries under such program2 and 7#b7 better harmonize and integrate the operating structure of the ,medicare program 7and the ,centers for ,medicare ,medicaid ,services7 to improve interagency collaboration and communication4 #djb4 ,strategies to increase access to telehealth under ,medicaid and ,children's ,health ,insurance ,program 7a7 ,guidance ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue and disseminate guidance to ,states to clarify strategies to overcome existing barriers and increase access to telehealth under the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 and the ,children's ,health ,insurance ,program under title ,,xxi of such ,act 7#db ,u4,s4,c4 #acig;aa et seq474 ,such guidance shall include technical assistance and best practices regarding-- 7#a7 existing strategies ,states can use to integrate telehealth and other virtual health care services into value-based health care models2 and 7#b7 examples of ,states that have used waivers under the ,medicaid program to test expanded access to telehealth1 including during the emergency period described in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 7b7 ,studies 7#a7 ,telehealth impact on health care access ,not later than one year after the date of the enactment of this ,act1 the ,medicaid and ,,chip ,payment and ,access ,commission shall conduct a study1 with respect to a minimum of #aj ,states across geographic regions of the ,united ,states1 and submit to ,congress a report1 on the impact of telehealth on health care access1 utilization1 cost1 and outcomes1 broken down by race1 ethnicity1 sex1 age1 disability status1 and zip code4 ,such report shall-- 7,a7 evaluate cost1 access1 utilization1 outcomes1 and patient experience data from across the health care field1 including ,states1 ,medicaid managed care organizations1 provider organizations1 and other organizations that provide or pay for telehealth under the ,medicaid program and ,children's ,health ,insurance ,program2 7,b7 identify barriers and potential solutions to provider entry and participation in telehealth that ,states are experiencing1 as well as barriers to providing telehealth across ,state lines1 including during times of public health crisis or public health emergency2 7,c7 determine the frequency at which out-of-,state telehealth is provided to patients enrolled in the ,medicaid program and the potential impact on access to telehealth if ,state ,medicaid policies were more aligned2 and 7,d7 identify and evaluate opportunities for more alignment among such policies to promote access to telehealth across all ,states1 ,state ,medicaid plans under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 ,state child health plans under title ,,xxi of such ,act 7#db ,u4,s4,c4 #acig;aa et seq471 and ,medicaid managed care organizations1 including the potential for regional compacts or reciprocity agreements4 7#b7 ,federal agency telehealth collaboration ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study and submit to ,congress a report evaluating collaboration between ,federal agencies with respect to telehealth services furnished under the ,medicaid or ,,chip program to individuals under the age of #ah1 including such services furnished to such individuals in early care and education settings4 ,such report shall include recommendations on-- 7,a7 opportunities for ,federal agencies to improve collaboration with respect to such telehealth services2 and 7,b7 opportunities for collaboration between ,federal agencies to expand telehealth access to such individuals enrolled under the ,medicaid or ,,chip program1 including in early care and education settings4 #djc4 ,extending ,medicare telehealth flexibilities 7a7 ,expanding access to telehealth services 7#a7 ,in general ,section #ahcd7m77#d77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c77 is amended by adding at the end the following new clause3 7iii7 ,expanding access to telehealth services ,with respect to telehealth services furnished beginning on the first day after the end of the emergency period described in section #aace7;g77#a77;,b7 of this clause1 the term originating site means any site at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications system1 including the home of an individual4 4 7#b7 ,conforming amendments ,such section is amended-- 7,a7 in paragraph 7#b77;,b7-- 7i7 in clause 7i71 in the matter preceding subclause 7,i71 by striking clause 7ii7 and inserting clauses 7ii7 and 7iii72 and 7ii7 by adding at the end the following new clause3 7iii7 ,no facility fee for new sites ,with respect to telehealth services furnished on or after the date of the enactment of this clause1 a facility fee shall only be paid under this subparagraph to an originating site that is described in paragraph 7#d77;,c77ii7 7other than subclause 7,x7 of such paragraph74 2 7,b7 in paragraph 7#d77;,c7-- 7i7 in clause 7i71 in the matter preceding subclause 7,i71 by inserting and clause 7iii7 after and 7#g72 and 7ii7 in clause 7ii77,x71 by inserting prior to the first day after the end of the emergency period described in section #aace7;g77#a77;,b7 before the period2 7,c7 in paragraph 7#e71 by inserting and prior to the first day after the end of the emergency period described in section #aace7;g77#a77;,b7 after ,january #a1 #bjai12 7,d7 in paragraph 7#f77;,a71 by inserting and prior to the first day after the end of the emergency period described in section #aace7;g77#a77;,b71 after ,january #a1 #bjai12 and 7,e7 in paragraph 7#g71 by adding at the end the following new subparagraph3 7,c7 ,sunset ,the provisions of this paragraph shall not apply with respect to services furnished on or after the first day after the end of the emergency period described in section #aace7;g77#a77;,b74 4 7b7 ,expanding practitioners eligible ,to furnish telehealth services ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in paragraph 7#a71 by striking 7described in section #ahdb7;b77#ah77;,c77 and inserting 7defined in paragraph 7#d77;,e772 and 7#b7 in paragraph 7#d77;,e7-- 7,a7 by striking ,practitioner4--,the term and inserting 8,practitioner4-- 7,a7 ,in general ,subject to subparagraph 7,b71 the term 2 and 7,b7 by adding at the end the following new subparagraph3 7,b7 ,expansion ,the ,secretary1 after consulting with stakeholders regarding services that are clinically appropriate1 may expand the types of practitioners who may furnish telehealth services to include any health care professional that is eligible to bill the program under this title for their professional services4 4 7c7 ,retention of additional services and subregulatory process for modifications following emergency period ,section #ahcd7m77#d77;,f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,f77 is amended-- 7#a7 in clause 7i71 by inserting and clause 7iii7 after paragraph 7#h72 7#b7 in clause 7ii71 by striking ,the ,secretary and inserting ,subject to clause 7iii71 the ,secretary2 and 7#c7 by adding at the end the following new clause3 7iii7 ,retention of additional services and subregulatory process for modifications following emergency period ,with respect to telehealth services furnished after the last day of the emergency period described in section #aace7;g77#a77;,b71 the ,secretary may-- 7,i7 retain as appropriate the expanded list of telehealth services specified in clause 7i7 pursuant to the waiver authority under section #aace7;b77#h7 during such emergency period2 and 7,,ii7 retain the subregulatory process used to modify the services included on the list of such telehealth services pursuant to clause 7ii7 during such emergency period4 4 7d7 ,enhancing telehealth services for federally qualified health centers and rural health clinics ,section #ahcd7m77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#h77 is amended-- 7#a7 in the paragraph heading by inserting and after after during2 7#b7 in subparagraph 7,a71 in the matter preceding clause 7i71 by inserting and after after ,during2 and 7#c7 in the first sentence of subparagraph 7,b77i71 by inserting and after after during4 7e7 ,use of telehealth1 as clinically appropriate1 ,to conduct face-to-,face encounter for hospice care ,section #ahad7;a77#g77;,d77i77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii77 is amended by inserting and after such emergency period as clinically appropriate after #aace7;g77#a77;,b74 7f7 ,use of telehealth1 as clinically appropriate1 ,to conduct face-to-,face clinical assessments for home dialysis ,clause 7iii7 of section #ahha7;b77#c77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#c77;,b77 is amended-- 7#a7 by moving such clause #d ems to the left2 and 7#b7 by inserting and after such emergency period as clinically appropriate before the period4 7g7 ,implementation ,notwithstanding any provision of law1 the ,secretary may implement the provisions of1 and amendments made by1 this section by interim final rule1 program instruction1 or otherwise4 #djd4 ,coverage and payment for breakthrough devices under the ,medicare program 7a7 ,in general ,part ,e of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex et seq47 is amended by adding at the end the following new section3 #ahii;,c4 ,coverage of breakthrough devices 7a7 ,breakthrough devices ,for purposes of this section1 the term breakthrough device means a medical device that is a device 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 and that is-- 7#a7 provided with review priority by the ,secretary under subsection 7d77#e7 of section #eae of such ,act2 and 7#b7 approved or cleared pursuant to section #eaj7k71 #eac7;f71 or #eae of such ,act for use in treating an indication on or after ,march #ae1 #bjba4 ,such term also includes a breakthrough device that is a specified breakthrough device 7as defined in subsection 7e77#a77;,b77 approved or cleared pursuant to section #eaj7k71 #eac7;f71 or #eae of such ,act for use in treating an indication on or after ,march #ae1 #bjba4 7b7 ,coverage 7#a7 ,transitional coverage 7,a7 ,in general ,during the transitional coverage period 7as defined in subparagraph 7,b77 a breakthrough device shall be-- 7i7 deemed to be reasonable and necessary for purposes of section #ahfb7;a77#a77;,a72 7ii7 deemed to be approved for an additional payment under section #ahhf7;d77#e77,k7 7other than with respect to the cost criterion under clause 7ii77,i7 of such section72 7iii7 deemed to be approved for pass-through payment under section #ahcc7t77#f7 and section #ahcc7;i7 7other than with respect to the cost criterion under section #ahcc7t77#f77;,a77iv772 and 7iv7 insofar as such breakthrough device may be furnished in a setting for which payment is made under an applicable payment system described in subparagraphs 7,d7 through 7,i7 of subsection 7c77#d71 deemed eligible for an additional payment or payment adjustment1 as the case may be1 pursuant to subsection 7d77#c7 when furnished in a setting for which payment is made under such an applicable payment system during such transitional coverage period4 7,b7 ,transitional coverage period defined ,as used in this section1 the term transitional coverage period means1 with respect to a breakthrough device1 the period that-- 7i7 begins on the date of the approval under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or of the clearance under section #eaj7k7 of such ,act1 as applicable1 of such device by the ,secretary for the indication described in subsection 7a77#a72 and 7ii7 ends on the last day of the #d-year period that begins on the date that the ,secretary1 pursuant to subsection 7c77#b71 updates the relevant applicable payment system 7as defined in subsection 7c77#d77 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such breakthrough device1 except as provided in subsections 7d77#a77;,b7 and 7d77#b77;,b74 7,c7 ,data used to meet the ntap and pass-through cost criteria ,in determining whether a breakthrough device qualifies for an additional payment under section #ahhf7;d77#e77,k7 or for pass-through payment under section #ahcc7t77#f7 or section #ahcc7;i71 the ,secretary shall use the most recently available data and information on the costs of such breakthrough device1 which may include list prices and invoice prices charged for such breakthrough device4 7#b7 ,process for regular coverage ,for purposes of the application of section #ahfb7;a77#a77;,a7 to a breakthrough device furnished after the transitional coverage period 7as defined in paragraph 7#a77;,b77 for such device1 the ,secretary shall establish a process for the coverage of such breakthrough devices under this title after such period as follows3 7,a7 ,identification of additional evidence 7i7 ,in general ,with respect to a breakthrough device1 not later than #a year after the date of the approval of such device under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or of the clearance of such device under section #eaj7k7 of such ,act1 as applicable1 the ,secretary shall identify whether any additional data or evidence is required with respect to any indications for such device for purposes of the application of such section #ahfb7;a77#a77;,a7 to such device for such indications4 7ii7 ,non-duplication of data requests ,in carrying out clause 7i7 with respect to a breakthrough device1 the ,secretary shall ensure that data or evidence identified-- 7,i7 does not duplicate data required to be collected by the ,food and ,drug ,administration with respect to such breakthrough device2 7,,ii7 minimizes the administrative burdens of data collection and reporting on providers of services1 suppliers1 and manufacturers of breakthrough devices2 and 7,,iii7 is not otherwise unnecessary or redundant4 7,b7 ,proposal for coverage after the transitional coverage period ,not later than #b years after the date of the approval or clearance of a breakthrough device by the ,food and ,drug ,administration1 the ,secretary shall develop a proposal for coverage under this title of such breakthrough device for such indications as the ,secretary determines to be appropriate1 based on the data and evidence collected under subparagraph 7,a71 for such devices furnished after the transitional coverage period under paragraph 7#a7 for such device4 ,if the ,secretary does not1 on a date that is before the end of such two-year period1 take action to modify the indications for which coverage of a breakthrough device may be provided under this title after such period1 for purposes of section #ahfb7;a77#a77;,a7 coverage under this title of such breakthrough device shall be made for all indications for which such device is approved under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or cleared under section #eaj7k7 of such ,act4 7#c7 ,rules of construction ,nothing in this section shall be construed to-- 7,a7 affect the ability of the manufacturer of a breakthrough device to seek approval for pass-through payment status under section #ahcc7t77#f7 or to seek approval for an additional payment under section #ahhf7;d77#e77,k7 insofar as such breakthrough device does not qualify for transitional coverage under paragraph 7#a72 7,b7 affect the application and approval process for pass-through payment status under section #ahcc7t77#f7 or for an additional payment under section #ahhf7;d77#e77,k7 in the case of a medical device that is not approved by the ,food and ,drug ,administration as a breakthrough device2 or 7,c7 prohibit the ,secretary from using existing authority under this title to suspend or terminate coverage of a breakthrough device if the ,secretary1 based on clinical evidence1 determines that-- 7i7 such breakthrough device offers no clinical benefit to ,medicare beneficiaries2 or 7ii7 furnishing such breakthrough device to ,medicare beneficiaries causes1 or may cause1 serious harm to ,medicare beneficiaries4 7c7 ,coding 7#a7 ,prompt assignment ,not later than three months after the date of approval or clearance of a breakthrough device by the ,food and ,drug ,administration1 the ,secretary shall assign a unique temporary or permanent code or codes for purposes of coverage and payment for such breakthrough device under the applicable payment systems 7described in paragraph 7#d774 7#b7 ,updates 7,a7 ,,ipps ,the ,secretary shall provide for semiannual updates under the applicable payment system described in paragraph 7#d77;,a7 7relating to the inpatient hospital prospective payment system7 to recognize the code or codes assigned under paragraph 7#a74 7,b7 ,,opps ,the ,secretary shall provide for quarterly updates under the applicable payment system described in paragraph 7#d77;,b7 7relating to the outpatient hospital prospective payment system7 to recognize the code or codes assigned under paragraph 7#a74 7,c7 ,other payment systems ,the ,secretary shall provide for semiannual or quarterly updates1 as the case may be1 under the applicable payment systems described in subparagraphs 7,c7 through 7,l7 of paragraph 7#d7 to recognize the code or codes assigned under paragraph 7#a74 7#c7 ,transparency ,the process for the assignment of a code or codes under this subsection shall provide for public notice and a meaningful opportunity for public comment from affected parties4 7#d7 ,applicable payment systems described ,for purposes of this subsection1 the term applicable payment systems means-- 7,a7 with respect to inpatient hospital services1 the prospective payment system for inpatient hospital services established under section #ahhf7;d72 7,b7 with respect to outpatient hospital services1 the prospective payment system for covered ,,opd services established under section #ahcc7t72 7,c7 with respect to ambulatory surgical center services1 the fee schedule for such services established under #ahcc7;i72 7,d7 with respect to physicians' services1 the physician fee schedules established under section #ahdh2 7,e7 with respect to covered items of durable medical equipment1 the applicable fee schedules established under section #ahcd2 7,f7 with respect to diagnostic laboratory tests1 the payment amounts under section #ahcd;,a and the fee schedules establish under section #ahdh1 as the case may be2 7,g7 with respect to inpatient hospital services furnished by rehabilitation facilities1 the prospective payment system established under section #ahhf7;j72 7,h7 with respect to inpatient hospital services furnished by long-term care hospitals1 the prospective payment system under section #ahhf7m72 7,i7 with respect to inpatient hospital services furnished by psychiatric hospitals and psychiatric units1 the prospective payment system under section #ahhf7s72 7,j7 with respect to home health services1 the prospective payment system under section #ahie2 and 7,k7 with respect to items and services1 or a provider of services or supplier1 not described in subparagraphs 7,a7 through 7,i71 the payment system established under this title for such items and services when furnished by such provider of services or supplier4 7d7 ,payment 7#a7 ,inpatient hospital prospective payment system3 deemed eligibility for breakthrough payment ,the ,secretary shall deem each breakthrough device as approved for an additional payment under section #ahhf7;d77#e77,k7 for the #d-year period that begins-- 7,a7 except as provided in subparagraph 7,b71 on the date that the ,secretary1 pursuant to subsection 7c77#b77;,a71 updates the payment system under section #ahhf7;d7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such breakthrough device2 or 7,b7 in the case of a device that has not received approval or clearance as a breakthrough device by the ,food and ,drug ,administration before such payment system is updated under subsection 7c77#b77;,a7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such device1 on the date of such approval or clearance4 ,nothing in this paragraph shall be construed to affect the authority of the ,secretary to use claims data to establish new diagnosis or procedure codes for breakthrough devices or to identify appropriate diagnosis-related groups for the assignment of breakthrough devices under annual rulemaking to carry out section #ahhf7;d77#e77,k74 7#b7 ,outpatient prospective payment system3 deemed eligibility for pass-through payment ,the ,secretary shall deem each breakthrough device as approved for pass-through payment under section #ahcc7t77#f7 7including for purposes of section #ahcc7;i77#b77;,d77 during the #d-year period that begins-- 7,a7 except as provided in subparagraph 7,b71 on the date that the ,secretary1 pursuant to subsection 7c77#b77;,b71 updates the payment system under section #ahcc7t7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such breakthrough device2 or 7,b7 in the case of a device that has not received approval or clearance as a breakthrough device by the ,food and ,drug ,administration before such payment system is updated under subsection 7c77#b77;,b7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such device1 on the date of such approval or clearance4 ,nothing in this paragraph shall be construed to affect the authority of the ,secretary to use claims data to establish new ambulatory payment classification groups for breakthrough devices or to revise such groups to take into account breakthrough devices under annual rulemaking to carry out section #ahcc7t74 7#c7 ,other payment systems 7,a7 ,in general ,in the case of a breakthrough device that is furnished and for which payment may be made under the payment system established under section #ahcd1 #ahcd;,a1 #ahdh1 #ahhf7;j71 #ahhf7m71 #ahhf7s71 or #ahie or any other provision of this title 7other than sections #ahcc7;i71 #ahcc7t71 and #ahhf7;d771 the ,secretary shall provide for an additional payment for such breakthrough device under such applicable payment system or an adjustment to such applicable payment system1 as the case may be4 ,the payment basis for such additional payment or adjustment1 as the case may be1 shall equal an amount that the ,secretary determines covers the costs of such breakthrough device4 7,b7 ,cost information ,in determining the costs of a breakthrough device for purposes of determining an additional payment or payment adjustment under subparagraph 7,a71 the ,secretary shall use the most recently available data and information on the costs of such breakthrough device1 which may include list prices and invoice prices charged for such breakthrough device4 7,c7 ,rule of construction ,nothing in this paragraph shall be construed to affect the authority of the ,secretary to use claims data to establish new or modify existing ambulatory payment classification groups1 diagnosis-related groups1 level ,,ii ,,hcpcs codes or such other groups or codes as the ,secretary may establish under the annual rulemaking authority under the provisions referred to in subparagraph 7,a74 7,d7 ,clinical diagnostic laboratory tests ,an additional payment or payment adjustment under subparagraph 7,a7 for a breakthrough device under the applicable payment system established in section #ahcd;,a may be in the form of an increase to the amount determined for the breakthrough device using cross-walking under section #ahcd;,a7c77#a77;,a71 an extension of the initial period of payment applicable to advance diagnostic laboratory tests under section #ahcd;,a7d77#a77;,a71 and in such other form or manner as the ,secretary determines reflects the costs for such breakthrough device under the relevant provisions of section #ahcd;,a4 7#d7 ,payment for breakthrough devices after the transitional coverage period ,payment for a breakthrough device that is furnished after the conclusion of the transitional coverage period under subsection 7b77#a7 for such device shall be made pursuant to the applicable payment system involved1 taking into account the additional evidence and data collected under subsection 7b77#b74 7e7 ,special rules for certain breakthrough devices 7#a7 ,coverage of specified breakthrough devices 7,a7 ,in general ,subject to the succeeding provisions of this subsection and notwithstanding any other provision of law1 the ,secretary shall provide for coverage and payment pursuant to this section of a specified breakthrough device 7as defined in subparagraph 7,b774 7,b7 ,specified breakthrough device defined ,in this section1 the term specified breakthrough device means a breakthrough device with respect to which no ,medicare benefit category exists4 7#b7 ,period of transitional coverage 7,a7 ,in general ,subject to subparagraph 7,c71 the provisions of subsection 7b77#a7 7relating to the transitional coverage period and payment for breakthrough devices1 including the use of the most recently available data and information on costs7 shall apply to a specified breakthrough device in the same manner as such provisions apply to a breakthrough device4 ,the ,secretary may use methodologies under existing payment systems established under this title1 may provide for appropriate adjustments to such methodologies1 or may establish a new payment methodology under this title1 to provide for payment for a specified breakthrough device to ensure the payment basis for such payment covers costs of the specified breakthrough device are covered by such payment4 7,b7 ,report 7i7 ,in general ,with respect to each specified breakthrough device1 the ,secretary shall submit to ,congress a report on the coverage of and payment for such specified breakthrough device under this section that includes the following information3 7,i7 ,the manner in which coverage is provided and payment is made for the specified breakthrough device1 including how such device was classified 7such as an item of durable medical equipment or otherwise7 and the payment methodology the ,secretary applied with respect to such device4 7,,ii7 ,the impact of the availability of the specified breakthrough device to ,medicare beneficiaries1 including impacts on the quality of patient care1 patient outcomes1 and patient experience4 7,,iii7 ,the impact of the availability of the specified breakthrough device to ,medicare beneficiaries on program expenditures under this title4 7,,iv7 ,such other information as the ,secretary determines to be appropriate4 7ii7 ,deadline 7,i7 ,in general ,except as provided in subclause 7,,ii71 the ,secretary shall submit a report required under this subparagraph no later than the end of the transitional period of coverage and payment applicable to such specified breakthrough device4 7,,ii7 ,extension to generate additional data ,if the ,secretary determines that additional data or evidence is required to complete a report required under this subparagraph with respect to a specified breakthrough device1 the deadline under this clause may be extended for an additional two years4 7,c7 ,additional period of transitional coverage to develop additional data ,insofar as the ,secretary determines that additional data or evidence is required to complete a report required under subparagraph 7,b7 with respect to a specified breakthrough device1 the transitional coverage period of coverage and payment for such device shall be extended by the lesser of-- 7i7 two years2 or 7ii7 the amount of additional time required for the submission of the report with respect to such device4 7#c7 ,coverage and payment after the transitional period ,the ,secretary may continue to provide for coverage of and payment for a specified breakthrough device after the end of the transitional period of coverage and payment for breakthrough devices through the national coverage determination process if the ,secretary determines that the specified breakthrough device-- 7,a7 improves the quality of care and patient outcomes2 7,b7 improves the delivery of care2 or 7,c7 reduces spending under this title without reducing the quality of care4 4 7b7 ,conforming amendments 7#a7 ,inpatient prospective payment system ,section #ahhf7;d77#e77,k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77 is amended by adding at the end the following new clause3 7x7 ,effective for discharges occurring on or after ,october #a1 #bjai1 in the case of a new medical service or technology that is a breakthrough device 7as defined in section #ahii;,c7a771 the additional payment established for such breakthrough device under this subparagraph shall be made for the #d-year period applicable to such breakthrough device under section #ahii;,c7d77#a74 ,in determining the amount of the additional payment for a breakthrough device under this subparagraph during such #d-year period1 the ,secretary shall apply section #dab4hh7;b7 of title #db1 ,code of ,federal ,regulations1 as in effect on the date of the enactment of this clause1 except as if the reference in such section to #fe percent were a reference to #fe percent 7or such greater percent specified by the ,secretary74 4 7#b7 ,outpatient prospective payment system ,section #ahcc7t77#f77;,c7 of such ,act 7#db ,u4,s4,c4 #aciel7t77#f77;,c77 is amended by adding at the end the following new clause3 7iii7 ,special rule for breakthrough devices ,notwithstanding clause 7i7 or 7ii71 or any other provision of this paragraph to the contrary1 in the case of a breakthrough device 7as defined in section #ahii;,c7a77 that is furnished on or after ,january #a1 #bjbj1 payment under this paragraph for such breakthrough device shall be made for the #d-year period applicable to such breakthrough device under section #ahii;,c7d77#b74 ,the provisions of this clause shall also apply for purposes of transitional pass-through payment under section #ahcc7;i77#b77;,d74 4 7c7 ,effective date ,this section1 and the amendments made by this section1 shall take effect on the date of the enactment of this ,act and1 unless otherwise specified in this section 7or in an amendment made by this section71 shall apply to breakthrough devices 7as defined in section #ahii;,c7a7 of the ,social ,security ,act1 as added by subsection 7a771 approved or cleared on or after ,july #a1 #bjai1 or1 in the case of a specified breakthrough device 7as defined in such section as so added71 approved or cleared on or after ,december #a1 #bjah4 #dje4 ,secretary of ,health and ,human ,services report on coverage for innovative technologies ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in collaboration with the ,administrator of the ,centers for ,medicare ,medicaid ,services1 and following a request for information1 shall submit to ,congress a report containing a proposal that-- 7#a7 specifies1 for purposes of payment and coverage under title ,,xviii of the ,social ,security ,act1 a definition for digital alternatives to treatment and therapies1 including wearables and digital applications and platforms2 7#b7 establishes a standardized process for determining which technologies satisfy the definition pursuant to paragraph 7#a72 7#c7 establishes a standardized process for determining coverage under such title of digital alternatives as defined pursuant to paragraph 7#a7 that are prescribed by a physician2 and 7#d7 identifies an innovative system for payment under such title for such alternatives4 #djf4 ,secretary of ,health and ,human ,services report on ,,cms computer systems ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report on the following3 7#a7 ,the current state of computer systems of the ,centers for ,medicare ,medicaid ,services1 including an analysis of the capabilities and deficiencies of such systems in helping to managing the operations of the programs administered by the ,centers for ,medicare ,medicaid ,services4 7#b7 ,the cost1 taking into account ways to lower or defray costs to the ,federal ,government1 of each of the following3 7,a7 ,replacing or updating such systems identified under paragraph 7#a74 7,b7 ,contractors and other third parties to solve for deficiencies in such system identified under paragraph 7#a74 #djg4 ,precision ,medicine ,answers for ,kids ,today 7a7 ,centers for ,medicare ,medicaid ,services ,guidance on the ,early and ,periodic ,screening1 ,diagnostic1 and ,treatment ,benefit ,not later than #f months after the date of the enactment of this ,act1 the ,centers for ,medicare ,medicaid ,services shall issue guidance to ,states on authority and requirements under the ,medicaid program under title ,,xix of the ,social ,security ,act to provide medically necessary health care that falls within the scope of services specified under section #aije7r7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7r77 to a child1 regardless of whether the service is available for adults under the ,state plan 7or waiver of such plan7 under such title4 ,the guidance shall-- 7#a7 include technical and educational assistance on how to increase the frequency of coverage under the ,state plan 7or waiver7 pursuant to paragraphs 7#d7 and 7#af7 of section #aije7;a7 of such ,act 7#db ,u4,s4,c4 #acif;d7a77 for genetic and genomic testing diagnostic services1 including whole exome sequencing1 whole genome sequencing1 and gene panels when recommended by a qualified treating provider as a first- or second-tier test for pediatric patients1 including those who-- 7,a7 have a positive result from a newborn screening program2 7,b7 have one or more neurodevelopmental or congenital anomalies2 7,c7 are experiencing developmental delay or intellectual disability2 7,d7 are having seizures2 7,e7 have been referred or admitted to a pediatric or neonatal intensive care unit for a chronic or undiagnosed disease2 7,f7 have been seen by at least one medical specialist for such chronic or undiagnosed disease2 or 7,g7 are suspected by at least one healthcare provider to have a neonatal- or pediatric-onset genetic disease2 7#b7 provide education and support to providers to minimize denials of claims for medical assistance under the ,state plan under title ,,xix of the ,social ,security ,act resulting from deficient or inadequate paperwork2 and 7#c7 ensure that providers and ,medicaid-eligible children and the families are aware of the ,early and ,periodic ,screening1 ,diagnostic and ,treatment ,benefit under title ,,xix of the ,social ,security ,act and have access to required screenings and necessary treatment services4 7b7 ,demonstration program ,to provide genetic and genomic testing for certain children 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall enter into agreements with up to #ae ,states submitting applications under paragraph 7#c7 for the purpose of conducting1 in accordance with this subsection1 demonstration projects under section #aaae of the ,social ,security ,act 7#db ,u4,s4,c4 #acae7 in such ,states during the #c-year period beginning on the first date of the first fiscal quarter than begins on or after the date of the enactment of this subsection to test and evaluate the provision of medical assistance under the ,state plans under title ,,xix of such ,act 7or waivers of such plans7 to eligible individuals for purposes of providing such individuals with genetic and genomic testing4 7#b7 ,demonstration project payment requirements ,under each demonstration project under this section conducted by a ,state1 the following shall apply3 7,a7 ,the ,state shall provide a health care provider 7as defined by the ,state7 with payments for the provision of genetic and genomic testing to any eligible individual4 ,payments made to a health care provider for such services shall be treated as medical assistance for purposes of section #aijc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7a771 except that the ,federal medical assistance percentage applicable to such payments shall be equal to #ajj percent4 7,b7 ,the ,state shall specify the methodology the ,state will use for determining payment for the provision of genetic and genomic testing4 ,such methodology for determining payment shall be established consistent with section #aijb7;a77#cj77;,a7 of such ,act 7#db ,u4,s4,c4 #acif;a7a77#cj77;,a774 7#c7 ,applications 7,a7 ,in general ,a ,state desiring to enter into an agreement under paragraph 7#a7 with the ,secretary for conducting a demonstration project shall submit to the ,secretary an application1 in accordance with such form and manner1 and application priorities1 as specified by the ,secretary and that at a minimum includes the following3 7i7 ,an explanation of how and the extent to which genetic and genomic testing under the demonstration project of the ,state will provide information and data on how such services improve the diagnosis of eligible individuals4 7ii7 ,an explanation of how and the extent to which coverage under the ,state plan 7or waiver7 pursuant to the demonstration project will increase the use of genetic and genomic testing that may increase the use of genetic and genomic testing that may improve clinical outcomes for eligible individuals4 7iii7 ,procedures for referring any eligible individual who seeks or needs treatment in a hospital emergency department to a health care provider who is qualified 7as determined by the ,state7 to provide genetic and genomic testing4 7iv7 ,an explanation of how genetic and genomic testing may improve health outcomes for all populations in the ,state1 including-- 7,i7 individuals with a rare genetic disease1 including a metabolic disease1 neurologic disorders1 or hereditary cancer testing in the presence of a suspected or confirmed cancer diagnosis2 and 7,,ii7 special populations1 including infants and children who are critically ill 7non-infectious and non-trauma7 patients1 transplant patients1 individuals with cardiac disease1 and individuals with1 or who have a family history of1 a birth defect or developmental disability4 7,b7 ,preferences in considering applications ,in considering applications submitted under subparagraph 7,a71 the ,secretary of ,health and ,human ,services shall give preference to ,states that can demonstrate underutilization of genetic and genomic sequencing clinical services 7with priority given to ,states that do not cover whole-genome sequencing or do not cover the majority of genetic and genomic clinical services7 in pediatric populations under the ,state plan under title ,,xix of the ,social ,security ,act 7or waiver of such plan74 7#d7 ,technical assistance ,the ,secretary of ,health and ,human ,services shall provide technical assistance to assist ,states in planning and designing the demonstration project for purposes of applying for conducting such project under this section4 7#e7 ,reports by ,states ,not later than one year after the date on which a ,state enters into an agreement under paragraph 7#a7 with the ,secretary for conducting a demonstration project1 the ,state shall submit a report to the ,administrator of the ,centers for ,medicare ,medicaid ,services and the ,administrator of the ,health ,resources and ,services ,administration on the extent to which genetic and genomic testing improved outcomes and reduced health disparities4 ,such report shall include information on the number of patients receiving genetic and genomic testing1 the types of services provided1 and such other information as the ,secretary shall prescribe4 7#f7 ,reports by health care providers ,as a condition for receiving payment for genetic and genomic testing provided to an eligible individual under a demonstration project conducted by a ,state under this subsection1 a health care provider shall report to the ,state1 in accordance with such requirements as the ,secretary shall specify1 on all applicable measures for determining the quality and efficacy of such services4 7#g7 ,definitions ,in this subsection3 7,a7 ,eligible individual ,the term eligible individual means1 with respect to a ,state1 an individual who-- 7i7 is eligible for medical assistance under the ,state plan under title ,,xix of the ,social ,security ,act 7or a waiver of such plan72 7ii7 is under the age of #ba 7or1 at the option of the ,state1 under the age of #bj1 #ai1 or #ah as the ,state may choose71 or in the case of an individual described in section #aijb7;a77#aj77;,a77i77,,ix7 of such ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77i77,,ix771 under the age of #bf2 7iii7 has been referred or admitted to an intensive care unit1 or has been seen by at least one medical specialist1 for a suspected genetic or undiagnosed disease2 or 7iv7 is suspected by at least one medical specialist to have a neonatal-onset or pediatric-onset genetic disease4 7,b7 ,genetic and genomic testing ,the term genetic and genomic testing1 with respect to an eligible individual-- 7i7 means the determination of a sequence of deoxyribonucleic acid bases in the genome of such individual1 and1 if for the sole benefit of the individual1 a biological parent of such individual for the purpose of determining whether one or more potentially disease-causing genetic variants are present in the genome of such individual or such biological parent2 and 7ii7 includes-- 7,i7 the sequencing of the whole genome1 the whole exome1 or a panel of genes2 and 7,,ii7 any analysis1 interpretation1 and data report derived from such sequencing4 7c7 ,national ,academy of ,medicine study 7#a7 ,in general ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall enter into an arrangement with the ,national ,academy of ,medicine under which the ,academy agrees to study-- 7,a7 how genetic and genomic testing may improve preventative care and precision medicine2 7,b7 disparities in access to precision diagnostics and associated therapeutics2 7,c7 how genetic and genomic testing may be used to reduce health disparities in marginalized communities2 7,d7 how the ,federal ,government may help to reduce barriers to genetic and genomic testing1 including-- 7i7 encouraging the expansion of health insurance coverage of genetic and genomic testing1 including diagnostic1 predictive1 and presymptomatic testing1 and genetic and genomic testing 7as defined in subsection 7b77#g77;,b772 7ii7 supporting the collection of evidence for the clinical utility and appropriate use of genetic and genomic tests2 and 7iii7 improving access to genetic counselors1 pathologists1 and other relevant professions1 including strengthening related workforce education and training efforts2 7,e7 7i7 the extent to which coverage provisions in the ,medicare and ,medicaid programs under titles ,,xviii and ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq41 #acif et seq47 may restrain the use of genetic and genomic testing that may improve clinical outcomes for beneficiaries2 7ii7 the extent to which coverage provided pursuant to subsection 7a7 increased the use of genetic and genomic testing and improved clinical outcomes for beneficiaries2 and 7iii7 how the ,centers for ,medicare ,medicaid ,services may make coverage determinations that better suit a precision medicine approach to treatment2 and 7,f7 how genetic and genomic testing may improve health outcomes for all pediatric populations in the ,united ,states1 including-- 7i7 children with a rare disease1 including a metabolic disease1 neurologic disorder1 or hereditary cancer testing in the presence of a suspected or confirmed cancer diagnosis2 and 7ii7 special populations1 including-- 7,i7 critically ill 7non-infectious and non-trauma7 patients2 7,,ii7 transplant patients2 7,,iii7 individuals with cardiac disease2 and 7,,iv7 individuals with1 or who have a family history of1 a birth defect or developmental disability4 7#b7 ,report 7,a7 ,in general ,the arrangement under paragraph 7#a7 shall provide for the ,national ,academy of ,medicine to submit1 not later than #b years after the date of the enactment of this ,act1 a report on the results of the study under paragraph 7#a7 to-- 7i7 the ,secretary of ,health and ,human ,services2 7ii7 the ,committee on ,ways and ,means and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7iii7 the ,committee on ,finance and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7,b7 ,consultation ,the arrangement under paragraph 7#a7 shall provide for the ,national ,academy of ,medicine1 in developing the report required by subparagraph 7,a71 to consult with physicians1 other health professionals1 health educators1 health professional organizations1 relevant companies1 patients1 patient organizations1 the ,health ,resources and ,services ,administration1 the ,national ,cancer ,institute1 the ,national ,institutes of ,health1 the ,agency for ,healthcare ,research and ,quality1 and the ,centers for ,medicare ,medicaid ,services4 7,c7 ,use of information ,the ,national ,academy of ,medicine shall1 to the extent possible1 in conducting the study under paragraph 7#a71 utilize information included in the reports submitted pursuant to subsections 7f7 and 7g7 of section #b4 7d7 ,centers for ,medicare ,medicaid ,services report on ,medicaid ,coverage for genetic and genomic testing ,not later than one year after the date of the enactment of this ,act1 and annually thereafter for the subsequent #c years1 the ,centers for ,medicare ,medicaid ,services shall submit to the ,secretary of ,health and ,human ,services1 the ,committees on ,ways and ,means and on ,energy and ,commerce of the ,house of ,representatives1 and the ,committees on ,finance and ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the extent to which each of the #ej ,states provide coverage under the ,state plan under title ,,xix of the ,social ,security ,act 7or waiver of such plan7 of genetic and genomic testing 7as defined in subsection 7b77#g77;,b77 7including whole exome1 whole genome1 gene panels1 single gene tests1 ,chromosomal microarray analysis1 ,fluorescence in situ hybridization1 and other genetic and genomic tests71 including information on-- 7#a7 how often genetic and genomic diagnostic testing services are covered and reimbursed2 7#b7 the frequency of denials for coverage and the rationale for denying coverage2 7#c7 an analysis of which genetic and genomic diagnostic tests are being approved or denied2 7#d7 how often test genetic counseling is covered pre- and post-genetic and genomic diagnostic testing2 7#e7 the turn-around time for prior authorization requests2 and 7#f7 any barriers to coverage of genetic and genomic testing services identified4 #djh4 ,medicare coverage for consultations 7a7 ,inclusion of consultations as a ,medicare benefit ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended-- 7#a7 in subsection 7s77#b7-- 7,a7 by striking and at the end of subparagraph 7,,gg72 7,b7 by striking the period at the end of subparagraph 7,,hh7 and inserting 2 and2 and 7,c7 by adding at the end the following new subparagraph3 7,,ii7 pharmacogenetic consultations provided by a qualified clinical pharmacist1 genetic counselor1 or pathologist 7as such terms are defined in subsection 7lll774 2 and 7#b7 by adding at the end the following new subsection3 7lll7 ,definitions ,in this section3 7#a7 ,pharmacogenetic consultation ,the term pharmacogenetic consultation means1 with respect to a genetic or genomic test furnished to an individual1 a consultation with respect to such test requested by the physician treating such individual to provide such physician with advice and recommendations regarding the dosage1 safety1 and efficacy of particular drugs1 biologicals1 and other treatments based on the individual's pharmacogenetic result4 7#b7 ,genetic counselor ,the term genetic counselor means an individual who-- 7,a7 is licensed as a genetic counselor by the ,state in which the individual furnishes genetic counseling services2 or 7,b7 in the case of an individual practicing in a ,state that does not license genetic counselors1 meets such other criteria as the ,secretary establishes4 7#c7 ,qualified clinical pharmacist ,the term qualified clinical pharmacist means an individual-- 7,a7 with a doctoral degree in pharmacy2 7,b7 who is licensed as a pharmacist in the ,state in which such individual furnishes consultations2 7,c7 has appropriate pharmacy specialty certifications or appropriate training1 as determined by the ,secretary2 and 7,d7 meets other qualifications as specified by the ,secretary4 4 7b7 ,payment for pharmacogenetic consultation ,section #ahcb7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciek7a77#b77 is amended-- 7#a7 by striking and at the end of subparagraph 7,i72 7#b7 by striking the period at the end of subparagraph 7,j7 and inserting 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,k7 pharmacogenetic consultations 7as defined in subsection 7lll774 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall apply to consultations furnished during a cost reporting period beginning on or after the date of the enactment of such subsections4 #dji4 ,prohibiting the use of geographic tracking features and biometrics within ,medicaid electronic visit verification systems 7a7 ,in general ,section #aijc7l77#e77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7l77#e77;,a77 is amended by inserting 7without the use of geographic tracking or biometrics7 after electronically verified4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to calendar quarters beginning on or after ,june #a1 #bjbb4 #daj4 ,generally accepted standard for electronic prescribing ,section #ahfj;,d-#d7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77 is amended by adding at the end the following new paragraph3 7#h7 ,generally accepted standards 7,a7 ,designation of standards maintenance organization to recognize generally accepted standards ,not later than #f months after the date of the enactment of this paragraph1 the ,secretary shall designate through rulemaking a standards maintenance organization with the authority to establish1 maintain1 and modify generally accepted standards for electronic prescribing and electronic prior authorization4 ,the standards maintenance organization named by the ,secretary shall be a standard setting body that-- 7i7 is a not-for-profit2 7ii7 has established a multi-stakeholder forum for development and approval of electronic prescribing and electronic prior authorization standards2 7iii7 is a standards development organization accredited by the ,american ,national ,standards ,institute2 and 7iv7 includes in its membership pharmacies1 prescribers1 prescription drug plans1 health information technology developers1 and representatives from the ,centers for ,medicare ,medicaid ,services and the ,food and ,drug ,administration4 ,in providing the standards maintenance organization with the authority to establish1 maintain1 and modify generally accepted standards1 the ,secretary shall permit the standards maintenance organization to recognize up to two versions of a standard as being generally accepted to facilitate the testing of newer standards and to allow a smooth transition from one standard to another4 7,b7 ,adoption of generally accepted standards ,not later than six months after making the designation under paragraph 7#h71 the ,secretary shall require prescriptions and other information described in paragraph 7#b77;,a7 for covered ,part ,d drugs prescribed for ,part ,d eligible individuals that are transmitted electronically to be transmitted only in accordance with generally accepted standards1 as designated by the standards maintenance organization named by the ,secretary under subparagraph 7,a71 under an electronic prescription drug program that meets the requirements of paragraph 7#b74 4 #daa4 ,meaningful access to ,federal health plan claims data 7a7 ,findings ,congress finds as follows3 7#a7 ,clinician-led clinical data registries serve an important role in promoting1 facilitating1 and conducting medical research and improving quality of healthcare by providing timely and actionable feedback to practitioners on their performance in relation to other practitioners and best clinical practices4 7#b7 ,clinician-led clinical data registries are hindered in their ability to promote medical research and quality improvement by their lack of meaningful access to claims data4 7#c7 ,while the ,centers for ,medicare ,medicaid ,services has established programs for providing access to claims data1 those programs fail to provide clinician-led clinical data registries with meaningful access to such data4 7#d7 ,ensuring clinician-led clinical data registries meaningful access to claims data will enable such entities to better track patient outcomes over time1 expand their ability to assess the safety and effectiveness of medical treatments1 and provide them with the information necessary to assess the cost-effectiveness of therapies4 7b7 ,ensuring meaningful access to claims data 7#a7 ,establishment of a new program ,the ,secretary shall establish a new program 7separate from any existing data access programs1 including1 without limitation1 the ,centers for ,medicare ,medicaid ,services ,qualified ,entity 7in this section1 referred to as ,,qe7 ,program 7#db ,u4,s4,c4 #aciekk7e71 #aciekk-#b7 7in this section1 referred to as the ,medicare ,data ,sharing for ,performance ,measurement ,program7 and the ,research ,data ,assistance ,center 7in this section1 referred to as the ,res,d,a,c7 process7 under which the ,secretary shall1 at the request of a clinician-led clinical data registry1 provide timely1 broad1 and continuous access to a database of claims data to such clinician-led clinical data registry for purposes of research1 quality of care measurement and reporting to health care providers1 linking such data with clinical data and performing risk-adjusted1 scientifically valid analyses and research to support quality improvement or patient safety1 and other purposes and uses described herein or approved by the ,secretary4 ,access to a database of claims data pursuant to this subsection shall not be more restrictive than access to data provided under the ,,qe ,program or the ,res,d,a,c process4 7#b7 ,streamlined application process 7,a7 ,initial and recertification application ,prior to gaining access to a database of claims data under the program established in subsection 7a71 a clinician-led clinical data registry shall submit to the ,secretary an application demonstrating that it is qualified 7as determined by the ,secretary7 to use claims data4 ,upon the ,secretary's approval of a clinician-led clinical data registry's application described in this subparagraph1 the ,secretary shall provide access to a database of claims data to such clinician-led clinical data registry for a period of at least #e years4 ,after the expiration of the time period described in this subparagraph1 the clinician-led clinical data registry shall reapply to access the database of claims data under the program established in subsection 7a74 7,b7 ,process ,the ,secretary shall establish a streamlined initial application and recertification application process under which the ,secretary shall approve or deny the clinician-led clinical data registry's application described in subparagraph 7#b77;,a7 within #fj calendar days after receiving the application unless the ,secretary demonstrates a compelling reason for needing additional time to complete the process4 ,if the clinician-led clinical data registry's application described in subparagraph 7#b77;,a7 is denied1 the ,secretary shall provide the reason7s7 for denial4 7#c7 ,appeal rights 7,a7 ,opportunity to appeal ,the ,secretary shall develop and maintain a process by which a clinician-led clinical data registry may appeal-- 7i7 the ,secretary's decision to deny an application described in paragraph 7#b72 and 7ii7 the ,secretary's failure to approve or deny the clinician-led clinical data registry's application described in paragraph 7#b7 within a reasonable time frame established by the ,secretary4 7,b7 ,deadline for decision ,the ,secretary shall render a decision with respect to an appeal filed by a clinician-led clinical data registry pursuant to subparagraph 7,a7 in a timely manner1 not to exceed #fj calendar days after the ,secretary receives the clinician-led clinical data registry's request for an appeal4 ,notice of such decision shall be provided to the clinician-led clinical data registry filing the appeal before the conclusion of such #fj-;day period4 7#d7 ,broad and timely access to data ,the ,secretary shall structure its database of claims data to allow for various data set queries1 including1 but not limited to1 provider-specific claims data1 clinical specialty-specific claims data1 state-specific claims data1 and nationwide claims data4 ,the ,secretary shall promptly make available to a clinician-led clinical data registry access to claims data requested by such clinician-led clinical data registry within a reasonable timeframe1 not to exceed #cj calendar days1 after the ,secretary approves the request from the clinician-led clinical data registry4 7c7 ,permissible uses of claims data ,clinician-led clinical data registries may-- 7#a7 make available to the public reports evaluating the performance of providers of services and suppliers using the claims data provided to such clinician-led clinical data registry under subsection 7a7 in combination with registry data2 7#b7 use claims data received under subsection 7a7 combined with registry data to conduct additional nonpublic analyses and provide or charge an access fee for such analyses to authorized users for nonpublic use2 7#c7 provide or charge an access fee for data sets that link claims data received under subsection 7a7 with registry data to authorized users for nonpublic use2 and 7#d7 provide or charge an access fee for claims data received under subsection 7a7 to authorized users for nonpublic use4 7d7 ,fees 7#a7 ,claims data provided to clinician-led clinical data registries ,claims data shall be provided to a clinician-led clinical data registry under subsection 7a7 at a reasonable fee based on the cost of providing such data to the clinician-led clinical data registry4 ,such fee shall be based at least in part on the number of patients included in the claims data provided to such clinician-led clinical data registry4 ,any fee collected pursuant to the preceding sentences shall be deposited in the ,centers for ,medicare ,medicaid ,services ,program ,management ,account4 7#b7 ,analyses and data provided to authorized users ,a clinician-led clinical data registry may charge a reasonable1 cost-based fee for providing to authorized users claims data1 data sets linking claims data with registry data1 or analyses described in subsection 7b74 7e7 ,protection of information 7#a7 ,privacy1 security1 and disclosure laws ,the ,secretary shall provide access to a database of claims data pursuant to subsection 7a7 in accordance with applicable information1 privacy1 security1 and disclosure laws1 including1 without limitation1 the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia7 as amended by the privacy and security provisions set forth in section #acdjj of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7,public ,law #aaa-e71 the regulations promulgated thereunder codified at parts #afj and #afd of title #de1 ,code of ,federal ,regulations1 and subparagraphs 7,a7 through 7,b7 of section #aje7;a77#c7 of the ,medicare ,access and ,,chip ,reauthorization ,act of #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#c774 7#b7 ,prohibition on using analyses or data for marketing purposes ,an authorized user shall not use analyses or data provided or sold under paragraphs 7#b7 through 7#d7 of subsection 7b7 for marketing purposes4 7#c7 ,no redisclosure of analyses or data ,an authorized user in receipt of an analysis or datum provided or sold under paragraphs 7#b7 through 7#d7 of subsection 7b7 shall comply with section #aje7;a77#e7 of ,medicare ,access and ,,chip ,reauthorization ,act of #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#e774 7#d7 ,opportunity for providers of services and suppliers to review ,prior to a clinician-led clinical data registry using1 providing1 or charging an access fee for claims data1 data sets linking claims data with registry data1 or analyses described in subsection 7b71 to the extent that such data1 data sets1 or analyses would individually identify a provider of services or supplier who is not being provided or sold such data1 data sets1 or analyses1 such clinician-led clinical data registry shall confidentially make available such data1 data sets1 or analyses to such provider of services or supplier and provide such provider of services or supplier with the opportunity to appeal and correct errors4 7f7 ,data use agreement ,a clinician-led clinical data registry and an authorized user shall enter into a data use agreement regarding the use or disclosure of any claims data or data sets that link claims data with registry data that the clinician-led clinical data registry is providing or charging an access fee to the authorized user under paragraphs 7#c7 through 7#d7 of subsection 7b74 ,such agreement shall include the requirements and prohibitions described in section #aje7;a77#d7 of the ,medicare ,access and ,,chip ,reauthorization ,act of #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#d774 7g7 ,assessment for a breach 7#a7 ,in general ,in the case of a breach of a data use agreement described in subsection 7e71 the ,secretary shall impose an assessment on the clinician-led clinical data registry and the authorized user4 7#b7 ,assessment ,the assessment under paragraph 7#a7 shall be in an amount up to #ajj for each individual entitled to1 or enrolled for1 benefits under part ,a of title ,,xviii of the ,social ,security ,act or enrolled for benefits under part ,b of such title for whom the clinician-led clinical data registry provided data on to the authorized user4 7#c7 ,deposit of amounts collected ,any amounts collected pursuant to this subsection shall be deposited in the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda of the ,social ,security ,act 7#db ,u4,s4,c4 #aciet74 7h7 ,discovery or admission as evidence ,claims data released to a clinician-led clinical data registry under subsection 7a7 shall not be subject to discovery or admission as evidence in judicial or administrative proceedings without consent of the applicable provider of services or supplier4 7i7 ,report to ,congress ,not later than #b years after the date of the enactment of this ,act1 and annually thereafter1 the ,secretary shall submit to ,congress a report on the extent to which clinician-led clinical data registries are afforded meaningful access to claims data4 7j7 ,definitions ,in this subtitle3 7#a7 ,authorized user ,the term authorized user has the meaning given such term in section #aje7;a77#i77;,a7 of the ,medicare ,access and ,,chip ,reauthorization ,act of #bjae 7#db ,u4,s4,c4 #aciekk-#b7;a77#i77;,a771 as well as a government agency or other governmental entity1 researchers1 entities that seek data for purposes of complying with regulations or other requirements of the ,federal ,food and ,drug ,administration1 and other entities approved by the ,secretary4 7#b7 ,claims data ,the term claims data has the meaning given to the term data in section #aje7;b77#a77;,b7 of the ,medicare ,access and ,,chip ,reauthorization ,act of #bjae 7#db ,u4,s4,c4 #aciekk-#b7;b77#a77;,b774 7#c7 ,clinician-led clinical data registry ,the term clinician-led clinical data registry has the meaning given such term in section #djje7;b7 of the #bast ,century ,cures ,act4 7#d7 ,nonpublic use ,the term nonpublic use means a use for the purpose of-- 7,a7 promoting1 facilitating1 and conducting medical research1 assisting providers of services and suppliers to improve patient safety1 and to develop and participate in quality and patient care improvement activities1 including developing new models of care2 7,b7 assisting clinician-led clinical data registries in developing and reporting quality measures to health care providers quality measures2 7,c7 educating a government agency or other governmental entity2 and 7,d7 supporting clinical trials and other activities necessary to comply with pre- or post-market approval or adverse event reporting requirements or conditions imposed by the ,food and ,drug ,administration1 and other purpose approved by the ,secretary4 7#e7 ,provider of services ,the term provider of services has the meaning given such term in section #ahfa7u7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7u774 7#f7 ,supplier ,the term supplier has the meaning given such term in section #ahfa7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7d774 7k7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate final regulations to implement the provisions of the preceding sections of this subtitle4 ,v ,research #eja4 ,advanced ,research ,projects ,agency for ,health 7a7 ,establishment ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 shall establish the ,advanced ,research ,projects ,agency for ,health 7to be referred to in this ,act as ,,arpa-,h7 to transform and improve important areas of medicine and health for the well-being of all individuals in the ,united ,states4 7b7 ,goals 7#a7 ,in general ,the goals of ,,arpa-,h shall be to deliver breakthrough capabilities through technologies1 systems1 and platforms that-- 7,a7 accelerate the discovery and application of transformational innovations in health and medical product development2 and 7,b7 reduce the human and economic cost of disease4 7#b7 ,means ,,arpa-,h may achieve the established goals under paragraph 7#a71 including by any of the following means3 7,a7 ,promoting high-risk1 high-reward innovation4 7,b7 ,identifying and promoting revolutionary advances in biomedical and health research that enable new paradigms in health4 7,c7 ,accelerating transformational health advances in areas that the relevant industries by themselves are not likely to undertake because of technical1 financial1 or other uncertainty4 7,d7 ,prioritizing project investments based on scientific opportunity and uniqueness of fit to ,,arpa-,h strategies and operating practice1 together with the prospective impact on disease burden 7regardless of disease prevalence71 both human and fiscal1 including the health care fiscal liability of the ,federal government4 7,e7 ,partnering with1 and providing funding to1 a broad range of institutions1 including universities1 national laboratories1 public sector organizations1 private companies1 nonprofit organizations1 and foreign institutions4 7c7 ,director 7#a7 ,in general ,,arpa-,h shall be headed by a ,director1 who shall be appointed by and serve at the pleasure of the ,president 7referred to in this section as the ,director of ,,arpa-,h74 7#b7 ,selection ,the ,director of ,,arpa-,h shall-- 7,a7 be an individual who1 by reason of professional background and experience1 is qualified to advise the ,secretary on1 and manage research programs addressing1 matters pertaining to long-term and high-risk barriers to the development of health innovation2 7,b7 have authority to execute contracts developed by in-house program managers who select external performers1 and maintain1 enhance or terminate projects based on performance against explicit milestones2 and 7,c7 have a time-limited appointment of #e years with the opportunity1 at the discretion of the ,president1 of one extension4 7#c7 ,duties ,the duties of the ,director of ,,arpa-,h shall be to-- 7,a7 set national research priorities to advance the mission of the agency as informed by a multi-sectoral board of advisors2 7,b7 approve all new programs within ,,arpa-,h2 7,c7 have final funding authority to initiate and terminate program funding2 7,d7 establish criteria for funding and assessing the success of programs through the establishment of technical milestones2 7,e7 appoint the personnel necessary1 consistent with subsection 7d71 to successfully execute the goals of ,,arpa-,h2 and 7,f7 designate employees to serve as program managers to carry out the duties described in subsection 7e7 for each of the programs established pursuant to the responsibilities established for ,,arpa-,h4 7#d7 ,authority ,the ,director of ,,arpa-,h is authorized to-- 7,a7 acquire 7by purchase1 lease1 condemnation1 or otherwise71 construct1 improve1 repair1 operate1 and maintain such real and personal property as are necessary to carry out this section2 and 7,b7 lease an interest in property for not more than #bj years1 notwithstanding section #acda7;a77#a7 of title #ca1 ,united ,states ,code4 7d7 ,personnel management authority 7#a7 ,special ,personnel ,management ,authority ,the ,director of ,,arpa-,h may-- 7,a7 make appointments to positions of administration or management of ,,arpa-,h without regard to any provision in title #e1 ,united ,states ,code1 governing appointments under the civil service laws and fix the compensation of such positions at a rate not to exceed the amount of annual compensation 7excluding expenses7 specified in section #ajb of title #c1 ,united ,states ,code1 notwithstanding section #bjb of ,department of ,health and ,human ,services ,appropriations ,act1 #aiic 7,public ,law #ajb-cid72 7,b7 hire personnel under section #bjg7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bji7;f77 and establish governing criteria to recruit1 appoint1 and compensate personnel under this section notwithstanding section #bjb of ,department of ,health and ,human ,services ,appropriations ,act1 #aiic 7,public ,law #ajb-cid7 or any provision of title #e1 ,united ,states ,code1 governing the rates of pay or classification of employees in the ,executive branch2 7,c7 make additional appointments of scientific1 medical1 and professional personnel under this section without regard to any provision in title #e1 ,united ,states ,code1 governing appointments under the civil service laws and fix the compensation of such personnel at a rate to be determined by the ,director1 up to the amount of annual compensation 7excluding expenses7 specified in section #ajb of title #c1 ,united ,states ,code1 notwithstanding section #bjb of ,department of ,health and ,human ,services ,appropriations ,act1 #aiic 7,public ,law #ajb-cid7 or any provision of title #e1 ,united ,states ,code1 governing the rates of pay or classification of employees in the ,executive branch2 and 7,d7 recruit and retain a diverse workforce1 including individuals underrepresented in science and medicine and racial and ethnic minorities4 7#b7 ,additional staff ,the ,director of ,,arpa-,h may use all authorities in existence on the date of enactment of this ,act that are provided to the ,secretary to hire administrative1 financial1 information technology staff1 and any other staff the ,director of ,,arpa-,h determines are necessary to carry out this section4 7#c7 ,limitation on term 7,a7 ,in general ,except as provided in subparagraph 7,b71 the service of an employee under an appointment under paragraph 7#a77;,a7 in the position of a program manager may not exceed #c years4 7,b7 ,extension ,the ,director of ,,arpa-,h may1 in the case of a particular employee1 extend the period to which service is limited under subparagraph 7,a7 by up to #c years if the ,director determines that such action is necessary to promote the efficiency of ,,arpa-,h4 7#d7 ,limitation on additional payments ,the total amount of the additional payments paid to an employee under paragraph 7#a77;,c7 for any #ab-month period may not exceed the least of the following amounts3 7,a7 #be1jjj4 7,b7 ,the amount equal to #be percent of the employee's annual rate of basic pay4 7,c7 ,the amount of the limitation that is applicable for a calendar year under section #ecjg7;a77#a7 of title #e1 ,united ,states ,code4 7e7 ,program managers ,an employee designated as a program manager pursuant to subsection 7c77#c77;,f7 shall-- 7#a7 define the research and development goals and milestones of the program involved1 in line with guidance from the ,director2 7#b7 track progress and course-correct projects when needed2 7#c7 recommend1 as necessary1 the restructuring or termination of projects supported by ,,arpa-,h2 and 7#d7 select1 on the basis of merit and need1 each of the projects to be supported under the program involved after considering-- 7,a7 the novelty and scientific and technical merit of the proposed projects2 7,b7 the demonstrated capabilities of the applicants to successfully carry out the proposed project2 7,c7 the consideration by the applicant of future commercial applications of the project2 or 7,d7 the unmet need within patient populations4 7f7 ,reports 7#a7 ,strategic vision ,not later than #ahj days after the date of the enactment of this ,act1 the ,director of ,,arpa-,h shall provide to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate a report describing the strategic vision that ,,arpa-,h will use to guide the choices of ,,arpa-,h for future health investments over the following #c fiscal years beginning on or after the date of the enactment of this ,act4 7#b7 ,annual budget request ,as part of the annual budget request submitted for each fiscal year1 the ,director of ,,arpa-,h shall provide to the congressional committees specified in paragraph 7#a7 a report describing-- 7,a7 projects supported by ,,arpa-,h during the previous fiscal year1 including-- 7i7 the transition of projects' outcomes to clinical practice2 7ii7 the impact on clinical outcome2 and 7iii7 the creation of biomedical capabilities2 and 7,b7 successes and barriers to scientific interchanges2 7,c7 rapid knowledge transfer2 7,d7 resource optimization2 and 7,e7 heightened investment impact among collaborators4 7#c7 ,report on cooperative agreements and other transaction ,not later than #ij days after the end of each fiscal year1 the ,director of ,,arpa-,h shall submit to the congressional committees specified in paragraph 7#a7 a report on all cooperative agreements and other transactions 7other than contracts and grants7 entered into under this subsection during such fiscal year4 ,the report shall contain1 with respect to such cooperative agreement and transaction1 the following3 7,a7 ,a general description of the cooperative agreement or other transaction 7as the case may be71 including the innovations for which advanced research is provided for under such agreement or transaction4 7,b7 ,the potential clinical and1 if any1 commercial utility of such innovations4 7,c7 ,the reasons for not using a contract or grant to provide support for such advanced research4 7,d7 ,the amount of the payments1 if any1 referred to in subsection 7i77#b7 that were received by the ,federal ,government in connection with such cooperative agreement or other transaction during the fiscal year covered by the report4 7,e7 ,the amount of the payments reported under subparagraph 7,d71 if any1 that were credited to the account established under subsection 7i77#g74 7g7 ,coordination and nonduplication 7#a7 ,in general ,the ,director of ,,arpa-,h shall ensure effective1 early1 and frequent coordination between ,,arpa-,h and the heads of the research1 public health1 and regulatory agencies of the ,department of ,health and ,human ,services1 including-- 7,a7 the ,director of the ,national ,institutes of ,health2 7,b7 the ,commissioner of ,food and ,drugs2 7,c7 the ,administrator of the ,centers for ,medicare ,medicaid ,services2 7,d7 the ,director of the ,centers for ,disease ,control and ,prevention2 and 7,e7 the ,assistant ,secretary for ,preparedness and ,response4 7,f7 ,the ,director of the ,national ,science ,foundation4 7,g7 ,the ,director of the ,office of ,science of the ,department of ,energy4 7#b7 ,coordination ,the ,director shall also coordinate among the full set of advanced research project agencies including-- 7,a7 the ,defense ,advanced ,research ,project ,agency2 7,b7 the ,advanced ,research ,project ,agency-,energy2 and 7,c7 others as they may be established4 7h7 ,advice 7#a7 ,in general ,the ,director of ,,arpa-,h may seek advice on any aspect of ,,arpa-,h from-- 7,a7 any advisory committee that1 as of the date of the enactment of this ,act1 is providing advice to the ,secretary of ,health and ,human ,services 7or any head of a research1 public health1 or regulatory agency of the ,department of ,health and ,human ,services72 and 7,b7 an advisory committee established on or after such date of the enactment to support the programs of ,,arpa-,h and to provide advice and assistance on-- 7i7 specific program tasks2 or 7ii7 overall direction of ,,arpa-,h4 7#b7 ,additional sources ,in addition to the advisory committees specified in paragraph 7#a71 the ,director of ,,arpa-,h may seek advice and review from-- 7,a7 the ,president's ,committee of ,advisors on ,science and ,technology2 7,b7 any professional or scientific organization with expertise in specific processes or technologies under development by ,,arpa-,h2 and 7,c7 representatives of patient communities4 7i7 ,cooperative agreements and other transactions 7#a7 ,in general ,the ,director of ,,arpa-,h1 in carrying out advanced research projects through ,,arpa-,h1 may enter into grants1 contracts1 cooperative agreements1 cash prizes1 and other transactions 7as defined in section #cai,l7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7a777 with any person1 any agency or instrumentality of the ,united ,states1 any unit of ,state or local government1 and any other entity institutions1 including universities1 national laboratories1 public sector organizations1 private companies1 nonprofit organizations1 and foreign institutions4 7#b7 ,terms 7,a7 ,required provisions ,the ,director of ,,arpa-,h shall ensure that1 in entering into cooperative agreements and other transactions under paragraph 7#a7-- 7i7 to the extent the ,director of ,,arpa-,h determines practicable1 the ,federal funds provided under the cooperative agreement or other transaction do not exceed the total amount provided by other parties to the cooperative agreement or other transaction2 and 7ii7 the authority under paragraph 7#a7 is used only when the use of standard contracts or grants is not feasible or appropriate4 7,b7 ,optional provision ,cooperative agreements and other transactions entered into by the ,director of ,,arpa-,h under paragraph 7#a7 may include a clause that requires a person or other entity to make payments to ,,arpa-,h 7or any other department or agency of the ,federal ,government7 as a condition for receiving support under the agreement or other transaction4 7#c7 ,duplicative research ,the ,director of ,,arpa-,h shall ensure that to the maximum extent practicable1 a cooperative agreement or other transaction under this section does not provide for research that duplicates research being conducted under existing programs carried out by the ,department of ,health and ,human ,services1 the ,department of ,defense1 or other ,federal ,government entities4 7#d7 ,amount of payments ,the amount of any payment received by the ,federal ,government pursuant to a requirement imposed under paragraph 7#a7 may be credited1 to the extent authorized by the ,director of ,,arpa-,h1 to the account established under paragraph 7#g74 ,amounts so credited shall be merged with other funds in the account and shall be available for the same purposes and the same period for which other funds in such account are available4 7#e7 ,multi-year contracts 7,a7 ,in general ,the ,director of ,,arpa-,h may enter into a multi-year contract if-- 7i7 funds are available and obligated for the contract for the full period of the contract1 or for the first fiscal year in which the contract is in effect1 and for the estimated costs associated with a necessary termination of the contract2 7ii7 the ,director determines that a multiyear contract will serve the best interests of the ,federal ,government in carrying out this section2 and 7iii7 the contract includes a provision that the contract shall be terminated if funds are not made available for the continuation of the contract in a fiscal year covered by the contract4 7,b7 ,termination costs ,a provision referred to in subparagraph 7,a77iii7 shall provide that funds available for paying termination costs shall remain available for that purpose until the costs associated with termination of the contract are paid4 7#f7 ,application of other provisions ,the authority provided under paragraph 7#a7 may be exercised without regard to section #ccbd of title #ca1 ,united ,states ,code4 7#g7 ,account ,there is hereby established on the books of the ,treasury an account for support of advanced research projects provided for in cooperative agreements and other transactions entered into under paragraph 7#a74 ,funds in such account shall be available for the payment of such support4 7#h7 ,prize competitions ,the ,director of ,,arpa-,h may carry out prize competitions in accordance with section #bd of the ,stevenson-,wydler ,technology ,innovation ,act of #aihj 7#ae ,u4,s4,c4 #cgai77 in support of the goals specified in subsection 7b74 7#i7 ,nonapplicability of certain provisions ,research funded pursuant to this section shall not be subject to-- 7,a7 advisory council approval under section #dje7;b77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd7;b77#b772 7,b7 advisory council review under section #djf7;a77#c77;,a77ii7 of such ,act 7#db ,u4,s4,c4 #bhd;a7a77#c77;,a77ii772 or 7,c7 the peer review requirements under section #dib of such ,act 7#db ,u4,s4,c4 #bhd7;b77#b71 #bhi;a74 7j7 ,confidentiality 7#a7 ,in general ,the information specified in paragraph 7#b7 shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code 7commonly referred to as the ,freedom of ,information ,act74 7#b7 ,information ,the information specified in this paragraph is information collected by ,,arpa-,h from recipients of financial assistance awards1 including the following3 7,a7 ,plans for commercialization of technologies developed under the award1 including business plans1 technology-to-market plans1 market studies1 and cost and performance models4 7,b7 ,investments provided to an awardee from third parties 7such as venture capital firms1 hedge funds1 and private equity firms71 including the amounts and the percentage of ownership of the awardee provided in return for the investments4 7k7 ,expediting breakthroughs through cooperation with ,food and ,drug ,administration 7#a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs and in consultation with the ,director of ,,arpa-,h1 may take actions to facilitate transformation of biomedical breakthroughs into tangible solutions for patients and to expedite development of medical products1 including through any of the following means3 7,a7 ,helping to ensure that medical product development programs1 in as efficient a manner as possible1 gather the nonclinical and clinical data necessary to advancing the development of such products and to obtaining their approval1 licensure1 or clearance1 as applicable1 by the ,food and ,drug ,administration under sections #eje1 #eaj7k71 and #eae of such ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7 and section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7,b7 ,expediting review of investigational new drug applications under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 review of investigational device exemptions under section #ebj7;g7 of such ,act 7#ba ,u4,s4,c4 #cfj;j7g771 and review of applications for approval1 licensure1 and clearance of medical products under sections #eje1 #eaj7k71 and #eae of such ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7 and section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7,c7 ,meeting at appropriate intervals with the ,director of ,,arpa-,h and any other appropriate medical product development partners1 such as the ,director of the ,biomedical ,advanced ,research and ,development ,authority to discuss the development status of medical products and projects that are the highest priorities to ,,arpa-,h1 unless the ,director of ,,arpa-,h and the ,commissioner of ,food and ,drugs determine that any such meetings are not necessary4 7#b7 ,relation to otherwise authorized activities of the ,,fda ,the authority specified in paragraph 7#a7 shall not be construed as limiting the authority of the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs with respect to the review and approval1 clearance1 authorization for emergency use1 or licensure of a medical product under the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba et seq47 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#c7 ,reimbursement ,utilizing interagency agreements or other appropriate resource allocation mechanisms available1 the ,director of ,,arpa-,h1 using funds made available to ,,arpa-,h1 shall reimburse the ,food and ,drug ,administration for expenditures made by the ,food and ,drug ,administration for activities carried out under this section that have been identified by the ,commissioner of ,food and ,drugs and the ,director of ,,arpa-,h as being carried out by the ,food and ,drug ,administration4 7#d7 ,medical product defined ,in this section1 the term medical product means a drug 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba771 a device 7as defined in such section #bja71 or a biological product 7as defined in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb774 7l7 ,authorization of ,appropriations and ,bypass ,budget ,authority 7#a7 ,authorization of ,appropriations ,there is authorized to be appropriated to carry out this section #f1ejj1jjj1jjj for fiscal year #bjbb1 to remain available until expended4 7#b7 ,bypass ,budget ,authority ,the budget of ,,arpa-,h shall be a separate line item in the annual budget request submitted by the ,president to the ,congress4 ,,arpa-,h shall have the authority to submit its annual budget request directly to ,congress concurrently with its submission to the ,office of ,management and ,budget4 #ejb4 ,research investment to spark the economy 7a7 ,authority 7#a7 ,in general ,each officer specified in paragraph 7#b7 may exercise the authorities described in paragraph 7#c74 7#b7 ,officers ,the officers specified in this paragraph are as follows3 7,a7 ,the ,secretary of ,commerce1 acting through the ,administrator of the ,national ,oceanic and ,atmospheric ,administration and the ,director of the ,national ,institute of ,standards and ,technology4 7,b7 ,the ,secretary of ,agriculture4 7,c7 ,the ,secretary of ,defense4 7,d7 ,the ,secretary of ,education4 7,e7 ,the ,secretary of ,energy1 acting for the ,department of ,energy 7with respect to ,energy ,efficiency and ,renewable ,energy1 ,nuclear ,energy1 and ,fossil ,research and ,development7 and through the ,office of ,science1 the ,advanced ,research ,projects ,agency-,energy 7,,arpa-,e71 and the ,office of ,electricity4 7,f7 ,the ,secretary of the ,interior1 acting through the ,director of the ,united ,states ,geological ,survey4 7,g7 ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health4 7,h7 ,the ,secretary of ,transportation4 7,i7 ,the ,administrator of the ,national ,aeronautics and ,space ,administration4 7,j7 ,the ,administrator of the ,environmental ,protection ,agency4 7,k7 ,the ,director of the ,national ,science ,foundation4 7#c7 ,authorities ,the officers specified in paragraph 7#b7 may-- 7,a7 provide supplemental funding to extend the duration of an award disrupted because of the ,,covid-#ai public health emergency to a research institution1 ,research ,laboratory1 or individual that was awarded before the date of the enactment of this ,act1 or to expand the purposes of such an award1 in order to-- 7i7 enable a postsecondary student or post-doctoral researcher to complete work2 7ii7 enable research scientists1 technical staff1 research associates1 and principal investigators to complete work2 7iii7 extend the training of a postsecondary student1 or the employment of a post-doctoral researcher1 on an ongoing research project for up to #b years because of the disruption of the job market2 7iv7 create research opportunities for up to #b years for graduate students and post-doctoral researchers2 7v7 replace1 refurbish1 or otherwise make usable laboratory animals1 reagents1 equipment1 or other items required for research2 7vi7 facilitate other research 7including field work71 training1 and ongoing construction activities1 including at institutions that are disproportionately affected by the ,,covid-#ai public health emergency 7such as minority-serving institutions and #b-year institutions of higher education72 7vii7 enable experimental field campaigns and maintenance of field infrastructure1 including through replacement of disrupted experimental data to enable completion of impacted research2 and 7viii7 support training in online course delivery and virtual research experiences that will improve quality and access needed to continue undergraduate1 graduate1 and post-doctoral training2 7,b7 issue awards to research institutions1 ,research ,laboratories1 or other individuals to conduct research on the effects of the ,,covid-#ai and future potential pandemics1 on the effects and effectiveness of responses to such diseases1 and on improving the prediction of the possible courses of such pandemics2 and 7,c7 provide flexibility on an award for funds made available to an agency1 by any prior or subsequent ,act1 by modifying the terms and conditions of the award with a research institution1 ,research ,laboratory1 or individual due to facility closures or other limitations during the ,,covid-#ai public health emergency4 7#d7 ,modifications ,the modifications authorized by paragraph 7#c77;,c7 include-- 7,a7 the provision of supplemental funding to extend the duration of the award concerned2 or 7,b7 flexibility on the allowable expenses under such award4 7b7 ,procedures ,the officers specified in subsection 7a77#b7 shall each establish procedures to carry out subsection 7a74 7c7 ,expedited awards ,awards under subsection 7a7 shall be issued as expeditiously as possible4 7d7 ,authorizations of appropriations 7#a7 ,department of ,commerce ,there is authorized to be appropriated for fiscal year #bjba for the ,department of ,commerce1 #dej1jjj1jjj to carry out subsection 7a71 of which-- 7,a7 #cjj1jjj1jjj shall be for use by the ,national ,oceanic and ,atmospheric ,administration2 and 7,b7 #aej1jjj1jjj shall be for use by the ,national ,institute of ,standards and ,technology4 7#b7 ,department of ,agriculture ,there is authorized to be appropriated for fiscal year #bjba for the ,department of ,agriculture1 #chj1jjj1jjj to carry out subsection 7a74 7#c7 ,department of ,defense ,there is authorized to be appropriated for fiscal year #bjba for the ,department of ,defense1 #c1jjj1jjj1jjj to carry out subsection 7a74 7#d7 ,department of ,education ,there is authorized to be appropriated for fiscal year #bjba for the ,department of ,education1 #bjj1jjj1jjj to carry out subsection 7a71 which shall be for use by the ,institute for ,education ,sciences4 7#e7 ,department of ,energy ,there is authorized to be appropriated for fiscal year #bjba for the ,department of ,energy1 #e1jjj1jjj1jjj to carry out subsection 7a71 of which-- 7,a7 not less than #c1jjj1jjj1jjj shall be for use by the ,office of ,science2 7,b7 not less than #ijj1jjj1jjj shall be for ,energy ,efficiency and ,renewable ,energy2 7,c7 not less than #dej1jjj1jjj shall be for ,nuclear ,energy2 7,d7 not less than #cjj1jjj1jjj shall be for ,fossil ,research and ,development2 7,e7 not less than #aej1jjj1jjj shall be for use by the ,advanced ,research ,projects ,agency-,energy2 and 7,f7 not less than #ajj1jjj1jjj shall be for use by the ,office of ,electricity4 7#f7 ,department of the ,interior ,there is authorized to be appropriated for fiscal year #bjba for the ,department of the ,interior1 #cjj1jjj1jjj to carry out subsection 7a71 which shall be for use by the ,united ,states ,geological ,survey4 7#g7 ,department of ,health and ,human ,services ,there is authorized to be appropriated for fiscal year #bjba for the ,department of ,health and ,human ,services1 #aj1jjj1jjj1jjj to carry out subsection 7a71 which shall be for use by the ,national ,institutes of ,health4 7#h7 ,department of ,transportation ,there is authorized to be appropriated for fiscal year #bjba for the ,department of ,transportation1 #cjj1jjj1jjj to carry out subsection 7a71 of which not less than #acj1jjj1jjj shall be for use by the ,federal ,aviation ,administration4 7#i7 ,national ,aeronautics and ,space ,administration ,there is authorized to be appropriated for fiscal year #bjba for the ,national ,aeronautics and ,space ,administration1 #b1jjj1jjj1jjj to carry out subsection 7a74 7#aj7 ,environmental ,protection ,agency ,there is authorized to be appropriated for fiscal year #bjba for the ,environmental ,protection ,agency1 #bjj1jjj1jjj to carry out subsection 7a74 7#aa7 ,national ,science ,foundation ,there is authorized to be appropriated for fiscal year #bjba for the ,national ,science ,foundation1 #c1jjj1jjj1jjj to carry out subsection 7a74 7#ab7 ,availability of funds for administration 7,a7 ,in general ,amounts authorized to be appropriated by this subsection may be used for the payment of indirect costs of ,federal awards under subsection 7a71 up to the limit otherwise allowable by law and subject to the requirements of part #bjj of title #b1 ,code of ,federal ,regulations4 7,b7 ,limitation ,not more than #e percent of each of the amounts appropriated pursuant to this subsection may be used for administration of awards under subsection 7a74 7#ac7 ,duration of availability ,amounts authorized to be appropriated by this subsection shall be available for the purposes described in this subsection through fiscal year #bjba4 7e7 ,definitions ,in this section3 7#a7 ,award ,the term award includes a grant1 cooperative agreement1 or other financial assistance4 7#b7 ,,covid-#ai public health emergency ,the term ,,covid-#ai public health emergency means the public health emergency declared by the ,secretary of ,health and ,human ,services under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 on ,january #ca1 #bjbj1 with respect to coronavirus disease #bjai 7,,covid-#ai74 7#c7 ,research institution ,the term research institution means the following3 7,a7 ,an institution of higher education 7as defined in section #aja7;a7 of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja7;a7774 7,b7 ,a ,tribal ,college or ,university 7as defined in section #caf of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajei;c774 7,c7 ,a nonprofit entity that conducts federally funded research4 7#d7 ,research laboratory ,the term ,research ,laboratory means the following3 7,a7 ,a ,national ,laboratory 7as defined in section #b of the ,energy ,policy ,act of #bjje 7#db ,u4,s4,c4 #aehja774 7,b7 ,a ,federally ,funded ,research and ,development ,center for purposes of section #c4e4jag of title #dh1 ,code of ,federal ,regulations4 #ejc4 ,research ,policy ,board reauthorization 7a7 ,extension of sunset ,section #bjcd7;f77#f7 of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #ceja note7 is amended by striking ,september #cj1 #bjba and inserting ,september #cj1 #bjbf4 7b7 ,participation by ,director of ,,nih 7#a7 ,inclusion as member ,section #bjcd7;f77#b77;,a7 of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #ceja note7 is amended-- 7,a7 by redesignating clause 7v7 as clause 7vi72 7,b7 by inserting after clause 7iv7 the following3 7iv7 ,the ,director of the ,national ,institutes of ,health4 4 7#b7 ,limitations relating to indirect costs ,section #bjcd7;f77#b7 of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #ceja note7 is amended by adding at the end the following3 7,c7 ,limitations relating to indirect costs ,notwithstanding any other provision of law1 the ,director of the ,national ,institutes of ,health may participate in the activities of the ,board1 including the formulation of recommendations1 without regard to limitations relating to indirect costs in part #ge of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 4