,,ii #aafth ,,congress #ast ,session ,s4 #bcbf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #cj1 #bjai ,mr4 ,burr 7for himself1 ,mr4 ,bennet1 ,mr4 ,scott of ,south ,carolina1 and ,mr4 ,carper7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend titles ,,xi and ,,xviii of the ,social ,security ,act to provide for expedited coding and coverage of novel medical products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,new ,opportunities for ,value that ,extend ,lives ,act of #bjai or the ,,novel ,act of #bjai4 #b4 ,expedited coding of novel medical products ,section #aagd7;b77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#c7;b77#b77;,b77 is amended by adding at the end the following new clauses3 7iii7 ,expedited coding of novel medical products 7,i7 ,in general ,notwithstanding paragraph 7#a71 in the case of a novel medical product 7as defined in clause 7iv771 the ,secretary shall make modifications to the ,,hcpcs code set at least once every quarter4 7,,ii7 ,request ,upon the written confidential request of a manufacturer of a novel medical product1 the ,secretary shall make a determination whether to assign a ,,hcpcs code to such product4 ,such request may occur on or after the date on which the product receives a designation as a breakthrough therapy under section #ejf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771 a breakthrough device under section #eae;,b of such ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 or a regenerative advanced therapy under section #ejf7;g7 of such ,act 7#ba ,u4,s4,c4 #cef7;g774 7,,iii7 ,deadline for determination2 notification ,the ,secretary shall-- 7aa7 not later than #ahj calendar days after receiving the request of a manufacturer under subclause 7,,ii71 make a determination under such subclause with respect to the request2 and 7bb7 not later than #cj calendar days after making such determination1 notify the manufacturer of the determination4 7,,iv7 ,monitoring utilization and outcomes ,a ,,hcpcs code assigned under this clause shall allow for the reliable monitoring of utilization and outcomes of the novel medical product as described in clause 7vi74 7,v7 ,effective date of code assignment ,if the ,secretary makes a determination to assign a ,,hcpcs code to a product under subclause 7,,ii71 such code-- 7aa7 may be assigned within the first quarter after the manufacturer files1 with respect to such product1 a new drug application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b771 a biological product license application under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 a premarket application under section #eae7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c771 a report under section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfjk71 or a request for classification under section #eac7;f77#b7 of such ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b772 and 7bb7 may not take effect before the date the product is approved1 cleared1 or licensed by the ,food and ,drug ,administration4 7,,vi7 ,trade secrets and confidential information ,no information submitted under subclause 7,,ii7 shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7iv7 ,novel medical product defined ,for purposes of this subparagraph1 the term novel medical product means a drug1 biological product1 or medical device-- 7,i7 that has not been assigned a ,,hcpcs code2 and 7,,ii7 that has been designated as a breakthrough therapy under section #ejf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771 a breakthrough device under section #eae;,b of such ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 or a regenerative advanced therapy under section #ejf7;g7 of such ,act 7#ba ,u4,s4,c4 #cef7;g774 7v7 ,,hcpcs defined ,for purposes of this subparagraph1 the term ,,hcpcs means the ,healthcare ,common ,procedure ,coding ,system4 7vi7 ,inpatient products ,the ,secretary shall establish a code modifier within the hospital inpatient prospective payment system under section #ahhf7;d7 to track the utilization and outcomes of novel medical products that are assigned a ,,hcpcs code pursuant to the expedited coding process under clause 7iii7 and are furnished by hospitals in inpatient settings4 4 #c4 ,coverage determinations for novel medical products ,section #ahfb7l7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77 is amended by adding at the end the following new paragraph3 7#g7 ,coverage pathway for novel medical products 7,a7 ,in general ,the ,secretary shall facilitate an efficient coverage pathway to expedite a national coverage decision for coverage with evidence development process under this title for novel medical products described in subparagraph 7,d74 ,the ,secretary shall review such novel medical products for the coverage process on an expedited basis1 beginning as soon as the ,secretary assigns a ,,hcpcs code to the product under clause 7iii77,v77aa7 of section #aagd7;b77#b77;,b74 7,b7 ,determination of coverage with evidence development ,such coverage pathway shall include1 with respect to such novel medical products1 if the ,secretary determines coverage with evidence development is appropriate1 issuance of a national coverage determination of coverage with evidence development for a period up to1 but not to exceed1 #d years from the date of such determination4 7,c7 ,modernizing payment options for novel medical products ,not later than #d years after issuing such national coverage determination1 the ,secretary shall submit to ,congress and to the manufacturer of the novel medical product a report providing options for alternative payment models under this title for the novel medical product or class of such products1 which may include the utilization of existing models in the commercial health insurance market4 ,such report shall include any recommendations for legislation and administrative action as the ,secretary determines appropriate to facilitate such payment arrangements4 7,d7 ,novel medical products described ,for purposes of this paragraph1 a novel medical product described in this subparagraph is a novel medical product1 as defined in clause 7iv7 of section #aagd7;b77#b77;,b71 that is assigned a ,,hcpcs code pursuant to the expedited coding process under clause 7iii7 of such section4 7,e7 ,clarification ,nothing in this paragraph shall prevent the ,secretary from issuing a noncoverage or a national coverage determination for a novel medical product4 4 #d4 ,enhancing coordination with the ,food and ,drug ,administration 7a7 ,public ,meeting 7#a7 ,in general ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary shall convene a public meeting for the purposes of discussing and providing input on improvements to coordination between the ,food and ,drug ,administration and the ,centers for ,medicare ,medicaid ,services in preparing for the availability of novel medical products 7as defined in section #aagd7;b77#b77;,b77iv7 of the ,social ,security ,act1 as added by section #b7 on the market in the ,united ,states4 7#b7 ,attendees ,the public meeting shall include-- 7,a7 representatives of relevant ,federal agencies1 including representatives from each of the medical product centers within the ,food and ,drug ,administration and representatives from the coding1 coverage1 and payment offices within the ,centers for ,medicare ,medicaid ,services2 7,b7 stakeholders with expertise in the research and development of novel medical products1 including manufacturers of such products2 7,c7 representatives of commercial health insurance payers2 7,d7 stakeholders with expertise in the administration and use of novel medical products1 including physicians2 and 7,e7 stakeholders representing patients and with expertise in the utilization of patient experience data in medical product development4 7#c7 ,topics ,the public meeting shall include a discussion of-- 7,a7 the status of the drug and medical device development pipeline related to the availability of novel medical products2 7,b7 the anticipated expertise necessary to review the safety and effectiveness of such products at the ,food and ,drug ,administration and current gaps in such expertise1 if any2 7,c7 the expertise necessary to make coding1 coverage1 and payment decisions with respect to such products within the ,centers for ,medicare ,medicaid ,services1 and current gaps in such expertise1 if any2 7,d7 trends in the differences in the data necessary to determine the safety and effectiveness of a novel medical product and the data necessary to determine whether a novel medical product meets the reasonable and necessary requirements for coverage and payment under title ,,xviii of the ,social ,security ,act pursuant to section #ahfb7;a77#a77;,a7 of such ,act 7#db ,u4,s4,c4 #aciey7a77#a77;,a772 7,e7 the availability of information for sponsors of such novel medical products to meet each of those requirements2 and 7,f7 the coordination of information related to significant clinical improvement over existing therapies for patients between the ,food and ,drug ,administration and the ,centers for ,medicare ,medicaid ,services with respect to novel medical products4 7#d7 ,trade secrets and confidential information ,no information discussed as a part of the public meeting under this section shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7b7 ,improving transparency of criteria for ,medicare coverage 7#a7 ,updating guidance ,not later than #ah months after the public meeting under subsection 7a71 the ,secretary of ,health and ,human ,services shall update the final guidance entitled ,national ,coverage ,determinations with ,data ,collection as a ,condition of ,coverage3 ,coverage with ,evidence ,development to improve the availability and coordination of information as described in subparagraphs 7,d7 through 7,f7 subsection 7a77#c71 and clarify novel medical product clinical data requirements to meet reasonable and necessary requirements for coverage and payment under title ,,xviii of the ,social ,security ,act4 7#b7 ,finalizing updated guidance ,not later than #ab months after issuing draft guidance under paragraph 7#a71 the ,secretary shall finalize the updated guidance4 #e4 ,report on coding1 coverage1 and payment processes under ,medicare for new medical products 7a7 ,in general ,not later than #ab months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall publish a report on the internet website of the ,department of ,health and ,human ,services regarding processes under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 with respect to the coding1 coverage1 and payment of medical products described in subsection 7b74 ,such report shall include the following3 7#a7 ,a description of challenges in the coding1 coverage1 and payment processes under the ,medicare program for medical products described in such subsection4 7#b7 ,recommendations to-- 7,a7 incorporate patient experience data 7such as the impact of a disease or condition on the lives of patients and patient treatment preferences7 into the coverage and payment processes within the ,centers for ,medicare ,medicaid ,services2 7,b7 decrease the length of time to make national and local coverage determinations under the ,medicare program 7as those terms are defined in subparagraph 7,a7 and 7,b71 respectively1 of section #ahfb7l77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#f7772 7,c7 streamline the coverage process under the ,medicare program and incorporate input from relevant stakeholders into such coverage determinations2 and 7,d7 identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and ,state plans under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr et seq47 into the ,medicare program4 7b7 ,medical products described ,for purposes of subsection 7a71 a medical product described in this subsection is a medical product1 including a drug1 biological 7including gene and cell therapy and gene editing71 or medical device1 that has been designated as a breakthrough therapy under section #ejf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771 a breakthrough device under section #eae;,b of such ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 or a regenerative advanced therapy under section #ejf7;g7 of such ,act 7#ba ,u4,s4,c4 #cef7;g774