,,ii #aafth ,,congress #ast ,session ,s4 #bija ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #ai1 #bjai ,ms4 ,collins 7for herself and ,mrs4 ,shaheen7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to establish within the ,office of the ,secretary of ,health and ,human ,services a special task force on ensuring ,medicare beneficiary access to innovative diabetes technologies and services4 #a4 ,short title ,this ,act may be cited as the ,improving ,medicare ,beneficiary ,access to ,innovative ,diabetes ,technologies ,act of #bjai4 #b4 ,establishment of ,,hhs ,task ,force on coverage and payment for innovative diabetes technologies and services 7a7 ,definitions ,in this section3 7#a7 ,,cms ,the term ,,cms means the ,centers for ,medicare ,medicaid ,services4 7#b7 ,,fda ,the term ,,fda means the ,food and ,drug ,administration4 7#c7 ,innovative diabetes technologies and services ,the term innovative diabetes technologies and services means medical technologies and services for the treatment and management of diabetes for which coverage is not available under the ,medicare fee-for-service program4 7#d7 ,medicare ,the term ,medicare means the program of health insurance for the aged and disabled established under title ,,xviii of the ,social ,security ,act4 7#e7 ,medicare beneficiary ,the term ,medicare beneficiary means an individual who is entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act1 or enrolled under part ,b of such title1 or both4 7#f7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7b7 ,establishment2 mission 7#a7 ,establishment ,there is established within the ,office of the ,secretary the ,task ,force on ,innovative ,diabetes ,technologies and ,services 7in this section referred to as the ,task ,force74 7#b7 ,mission ,the mission of the ,task ,force is to-- 7,a7 advise the ,secretary with respect to accessibility to innovative diabetes technologies and services under ,medicare2 7,b7 make recommendations to support current and future access to innovative diabetes technologies and services under ,medicare2 and 7,c7 recommend changes to ,medicare to ensure appropriate access by ,medicare beneficiaries to such innovative diabetes technologies and services4 7c7 ,membership 7#a7 ,appointment ,the ,secretary shall appoint individuals with relevant expertise to the ,task ,force1 which shall include the following voting members3 7,a7 ,,cms officials 7i7 ,the ,director of the ,center for ,medicare4 7ii7 ,not more than #b additional officials or senior staff of ,,cms as the ,secretary may specify4 7,b7 ,beneficiary ombudsman ,the ,medicare ,beneficiary ,ombudsman4 7,c7 ,pharmaceutical and ,technology ,ombudsman ,the ,medicare ,pharmaceutical and ,technology ,ombudsman4 7,d7 ,,fda officials ,not more than #b officials or senior staff from the ,diabetes ,branch of the ,center for ,devices and ,radiological ,health of ,,fda as the ,commissioner of ,food and ,drugs may specify4 7,e7 ,patient groups ,representatives of-- 7i7 ,medicare beneficiaries2 7ii7 individuals enrolled under a ,state plan under title ,,xix of the ,social ,security ,act 7or a waiver of such a plan72 and 7iii7 individuals not described in clause 7i7 or 7ii7 who have a diagnosis of diabetes4 7,f7 ,health care providers ,representatives of providers of services1 physicians1 and practitioners who treat individuals with a diagnosis of diabetes4 7,g7 ,manufacturers ,representatives of manufacturers of diabetes technologies1 including innovative diabetes technologies and services4 7#b7 ,co-chairs 7,a7 ,in general ,of the members of the ,task ,force-- 7i7 one co-chair shall be the ,director of the ,center for ,medicare2 and 7ii7 one co-chair shall be designated by the ,secretary from among voting members appointed under subparagraph 7,e71 7,f71 or 7,g7 of paragraph 7#a74 7,b7 ,rotation of non-government co-chair ,the ,secretary shall rotate designations of co-chairs under subparagraph 7,a77ii7 from among voting members appointed under subparagraph 7,e71 7,f71 or 7,g7 of paragraph 7#a74 7,c7 ,term of service for non-government co-chair ,each co-chair designated under subparagraph 7,a77ii7 shall serve a term of #b years4 7#c7 ,compensation 7,a7 ,in general ,except as provided in subparagraph 7,b71 members of the ,task ,force shall serve without compensation4 7,b7 ,travel expenses ,a member of the ,task ,force may be allowed travel expenses1 including per diem in lieu of subsistence1 at rates authorized for an employee of an agency under subchapter ,i of chapter #eg of title #e1 ,united ,states ,code1 while away from the home or regular place of business of the member in the performance of the duties of the ,task ,force4 7d7 ,meetings ,the ,secretary shall convene the ,task ,force not less frequently than #d times each year4 ,the ,secretary shall convene the first meeting of the ,task ,force no later than ,july #a1 #bjbj4 7e7 ,duties ,the ,task ,force shall carry out the following duties3 7#a7 ,identification of innovative diabetes technologies and services ,the ,task ,force shall-- 7,a7 identify innovative diabetes technologies and services for the treatment of type ,i diabetes1 type ,,ii diabetes1 or both1 that are in development or that have been cleared or approved by ,,fda and that are wholly or partially inaccessible to ,medicare beneficiaries with diabetes under ,medicare2 7,b7 develop and consider possible alternative approaches to enable ,medicare beneficiaries to access innovative diabetes technologies and services2 and 7,c7 determine whether the existing administrative systems1 benefit categories1 and coverage1 coding and payment policies under ,medicare would provide or impede access to1 and appropriate payment for1 innovative diabetes technologies and services4 7#b7 ,analysis of access disparities 7,a7 ,private payor policies ,the ,task ,force shall review coverage policies developed by private payors for innovative diabetes technologies and services and determine whether disparities exist between patients with diabetes insured by private payors as compared to ,medicare beneficiaries with diabetes4 7,b7 ,case studies ,the ,task ,force shall recommend to the ,secretary the development of real-world patient case studies and health care provider case studies that identify barriers to access1 and access disparities1 under ,medicare with respect to innovative diabetes technologies and services4 7#c7 ,identification of changes in relevant ,,fda approval and ,,cms coverage policies 7,a7 ,,cms regulatory barriers to coverage ,the ,task ,force shall-- 7i7 identify all the categories of items and services for which coverage is available under ,medicare whether established by title ,,xviii of the ,social ,security ,act or otherwise 7in this section referred to as benefit categories7 that may be used to provide for coverage of diabetes technologies and services1 including innovative diabetes technologies and services2 7ii7 review regulations and subregulatory guidance for the benefit categories identified under clause 7i7 to identify policies that limit coverage of1 and payment for1 diabetes technologies and services under ,medicare1 especially innovative diabetes technologies and services2 and 7iii7 recommend specific changes to such regulations and subregulatory guidance to provide for coverage of1 and payment for1 innovative diabetes technologies and services under ,medicare4 7,b7 ,interagency collaboration ,the ,task ,force shall identify strategies to improve collaboration between ,,fda and ,,cms that facilitate expeditious clearance or approval of innovative diabetes technologies and services by ,,fda and expeditious coverage of innovative diabetes technologies and services under ,medicare4 7#d7 ,identification of strategies to support coverage of innovative diabetes technologies and services ,the ,task ,force shall identify strategies not otherwise described in this subsection to facilitate access to innovative diabetes technologies and services by ,medicare beneficiaries as well as by other patients and their health care providers4 7f7 ,recommendations ,not less frequently than annually1 the ,task ,force shall make recommendations to the ,secretary with respect to-- 7#a7 existing benefit categories under which innovative diabetes technologies and services should be covered2 7#b7 legislative changes to title ,,xviii of the ,social ,security ,act and administrative changes to regulations promulgated and subregulatory guidance issued with respect to existing benefit categories that are necessary to provide for coverage of1 and payment for1 innovative diabetes technologies and services2 7#c7 elimination of other unnecessary burdens that impede coverage of1 and payment for1 innovative diabetes technologies and services under ,medicare2 7#d7 proposals for a new ,medicare benefit category to provide for coverage of innovative diabetes technologies and services that cannot otherwise be covered through administrative changes to regulations and subregulatory guidance for existing benefit categories1 and specifications for any new benefit category2 and 7#e7 proposals to streamline interagency administrative processes through greater collaboration between ,,fda and ,,cms to facilitate prompt approval or clearance and coverage under ,medicare of innovative diabetes technologies and services for ,medicare beneficiaries with diabetes4 7g7 ,response 7#a7 ,in general ,with respect to each recommendation made by the ,task ,force under subsection 7f71 not later than #ij days after the date of receipt of each such recommendation1 the ,secretary shall make a determination whether to implement or reject the recommendation4 7#b7 ,implementation ,in the case of a determination by the ,secretary to implement a recommendation under paragraph 7#a71 the ,secretary shall provide the ,task ,force with a plan for such implementation1 including specific details about and a timetable for the implementation4 7#c7 ,rejection ,in the case of a determination by the ,secretary to reject a recommendation under paragraph 7#a71 the ,secretary shall provide the ,task ,force with-- 7,a7 a detailed explanation of the rationale for the determination2 and 7,b7 recommendations for alternative policies for consideration by the ,task ,force4 7h7 ,report ,the ,secretary shall submit an annual report to ,congress that describes the activities of the ,task ,force for the year involved4 ,each such report shall include such recommendations for improving access to innovative diabetes technologies and services as the ,task ,force determines appropriate4 7i7 ,application of ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app471 other than section #ad of such ,act1 shall apply to the ,task ,force4 7j7 ,rule of construction ,the deliberations of the ,task ,force shall not be construed as interfering with or impeding any decision1 determination1 rulemaking1 or issuance of subregulatory guidance by the ,secretary that provides for coverage of1 and payment for1 innovative diabetes technologies and services4