,,ii #aadth ,,congress #b;d ,session ,s4 #cdeg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #bh1 #bjaf,mr4 ,gardner 7for himself and ,mr4 ,coons7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to establish ,centers for ,medicare ,medicaid ,services ,,sbir or ,,sttr program grants which shall be known as ,medicare commercialization grants4 #a4 ,short title ,this ,act may be cited as the ,reducing ,medicare ,costs through ,innovation ,act4 #b4 ,medicare commercialization grants 7a7 ,definitions ,in this section3 7#a7 ,the term-- 7,a7 ,administrator means the ,administrator of the ,centers for ,medicare ,medicaid ,services2 and 7,b7 ,secretary means the ,secretary of ,health and ,human ,services4 7#b7 ,the terms commercialization1 ,phase ,i1 ,phase ,,ii1 ,phase ,,iii1 ,,sbir1 and ,,sttr have the meanings given those terms in section #i7;e7 of the ,small ,business ,act 7#ae ,u4,s4,c4 #fch7;e774 7#c7 ,the term eligible medical product means a product-- 7,a7 for which a grant recipient received a ,medicare commercialization grant2 7,b7 which will maintain or improve quality of care while reducing costs 7as determined by the ,secretary72 and 7,c7 7i7 that is a drug1 as defined under section #bja7;g77#a7 of ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a772 7ii7 that is a biological product1 as defined in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7iii7 that is a combination product1 as described in section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g772 or 7iv7 that is a device1 as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h771 for which approval under section #eae of such ,act is required4 7#d7 ,the term eligible small business concern means a small business concern that-- 7,a7 has a focus on the diseases or conditions that are the top #aj cost drivers in the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 as determined by the ,secretary in accordance with subsection 7b77#c72 7,b7 is otherwise eligible for a ,centers for ,medicare ,medicaid ,services ,,sbir or ,,sttr program grant2 7,c7 has completed ,phase ,i activities2 and 7,d7 has funding for ,phase ,,ii activities4 7#e7 ,the term small business concern has the meaning given the term in section #c of the ,small ,business ,act 7#ae ,u4,s4,c4 #fcb74 7b7 ,medicare commercialization grants 7#a7 ,establishment of program ,the ,secretary shall establish within the ,centers for ,medicare ,medicaid ,services ,,sbir or ,,sttr program a grant program referred to as the ,medicare commercialization grant program through which the ,secretary shall award grants to eligible small business concerns with approved applications to assist such small business concerns in ,phase ,,iii activities related to developing novel eligible medical products and receiving approval or clearance by the ,food and ,drug ,administration for such eligible medical products in accordance with paragraph 7#b74 7#b7 ,approval process for grant recipient's novel drugs1 devices1 or diagnostics ,a grantee may choose to submit an application for approval of novel drugs1 devices1 or diagnostics through a traditional approval process or through the pilot program for parallel review of medical products described in subsection 7c74 7#c7 ,applications 7,a7 ,solicitation of applications ,the ,secretary shall issue an annual solicitation of applications for the grant program under paragraph 7#a71 with a focus on the diseases or conditions that are the top #aj cost drivers in the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 as determined by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,cost drivers in ,medicare ,the ,secretary shall assess1 in consultation with stakeholders1 and take into consideration for purposes of determining such cost drivers and the eligibility of a small business concern1 as described in subsection 7a77#d77;,a7-- 7i7 high volume medical procedures that are paid for under the ,medicare program2 7ii7 diseases or conditions that a high number of ,medicare beneficiaries are affected by2 7iii7 high cost medical procedures that are paid for under the ,medicare program2 7iv7 diseases or conditions that ,medicare beneficiaries are affected by that result in a high cost to the ,medicare program2 and 7v7 areas described in clauses 7i7 through 7iv7 for which there is a high potential for innovation or cost reduction4 7,c7 ,application requirement ,each eligible small business concern that applies for a ,medicare commercialization grant shall include in the application for such grant a description of each source of funding for the eligible business concern and the amount of funding from each such source4 7#d7 ,duration ,an eligible small business concern may receive a ,medicare commercialization grant for a period of not less than #a year and not more than #c years4 7#e7 ,no limit on number of recipients ,the ,secretary shall not limit the number of eligible small business concerns that may receive a ,medicare commercialization grant4 7#f7 ,periodic assessment ,at the completion of the third year for which grants are awarded under this subsection1 the ,secretary shall prepare an assessment containing information about the cost reductions and improvements in care that result from such grants1 including-- 7,a7 a general assessment of the cost drivers that the grants were intended to address2 7,b7 information about the novel eligible medical products that the grantees developed or received approval or clearance for with the aid of grant funding under this subsection2 and 7,c7 the potential for a reduction in costs that may result if such novel eligible medical products were used nationwide4 7#g7 ,report ,the ,secretary shall prepare and submit to ,congress1 at the completion of the third year for which grants are awarded under this subsection and following the assessment described in paragraph 7#f71 a summary report containing the information described in paragraph 7#f74 ,the ,secretary shall also post each such report on the website of the ,department of ,health and ,human ,services4 7#h7 ,funding ,to carry out the grant program under this subsection1 the ,secretary shall use amounts allocated for the ,,sbir and ,,sttr programs of the ,department of ,health and ,human ,services under subsections 7f7 and 7n71 respectively1 of section #i of the ,small ,business ,act 7#ae ,u4,s4,c4 #fch74 7#i7 ,collaboration ,the ,secretary shall collaborate with the heads of other divisions within the ,department of ,health and ,human ,services as the ,secretary determines necessary to carry out this subsection4 7c7 ,pilot program for parallel review of medical products 7#a7 ,in ,general ,not later than #fj days after the date of enactment of this section1 the ,secretary and the ,administrator shall jointly establish a pilot program for parallel review of eligible medical products that is similar to the ,pilot ,program for ,parallel ,review of ,medical ,products described in the notice of the ,centers for ,medicare ,medicaid ,services1 published in the ,federal ,register on ,october #aa1 #bjaa 7#gf ,fed4 ,reg4 #fbhjh7 7referred to in this subsection as the pilot program74 ,such pilot program shall not affect the applicable criteria or standards for approving1 clearing1 or classifying medical products under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja7 and shall not affect the criteria and standards relating to determinations about a reimbursement designation or a national coverage determination under the ,medicare program under title ,,xviii of the ,social ,security ,act4 7#b7 ,purpose ,the purposes of the pilot program are to-- 7,a7 reduce the timeline of the review processes for purposes of approval by the ,food and ,drug ,administration under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja7 and a reimbursement designation and a national coverage determination under the ,medicare program under title ,,xviii of the ,social ,security ,act for certain medical products developed by ,medicare commercialization grant recipients2 and 7,b7 increase the efficiency of1 and communication between1 the ,department of ,health and ,human ,services and the ,centers for ,medicare ,medicaid ,services4 7#c7 ,eligible participants ,the pilot program established under this subsection shall be available-- 7,a7 only to recipients of a ,medicare commercialization grant under this subsection 7b7 who choose to participate in such pilot program2 and 7,b7 only for the review of eligible medical products4 7#d7 ,parallel review process ,as part of the pilot program-- 7,a7 to the extent practicable1 the ,secretary and the ,administrator shall notify participating grant recipients of the data that may be necessary for the grant recipient to submit at the beginning of the review process2 and 7,b7 the ,administrator shall begin review for purposes of a reimbursement designation and a national coverage determination under the ,medicare program under title ,,xviii of the ,social ,security ,act for an eligible medical product while the ,secretary of ,health and ,human ,services is reviewing that eligible medical product for approval under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja74 7#e7 ,allocation of resources ,the ,administrator shall allocate the resources necessary to carry out the pilot program4