,,ii #aagth ,,congress #ast ,session ,s4 #bdaf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ba1 #bjba,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 title ,,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 #bjba or the ,,novel ,act of #bjba4 #b4 ,expedited coding of novel medical products ,section #ahgd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciekk7 is amended by adding at the end the following new subsection3 7h7 ,expedited coding of novel medical products 7#a7 ,in general ,on and after the date that is #ahj calendar days after the date of enactment of this subsection1 in the case of a novel medical product1 the ,secretary shall make modifications to the ,,hcpcs code set at least once every quarter4 7#b7 ,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#c7 ,deadline for determination and notification 7,a7 ,complete request ,if the ,secretary finds that a manufacturer has submitted a complete request under paragraph 7#b71 the ,secretary shall-- 7i7 make a determination under such paragraph with respect to the request by not later than #ahj calendar days after receiving the request2 and 7ii7 notify the manufacturer of the determination by not later than #cj calendar days after making such determination4 7,b7 ,incomplete request ,if the ,secretary finds that a manufacturer has submitted an incomplete request under paragraph 7#b71 the ,secretary shall notify the manufacturer of such finding by not later than #aj calendar days after receiving the request4 ,such notification shall contain detailed instructions on how the manufacturer can rectify any issue with the request4 7#d7 ,monitoring utilization ,a ,,hcpcs code assigned under this subsection shall allow for the reliable monitoring of utilization of the novel medical product as described in paragraph 7#g74 7#e7 ,effective date of code assignment ,if the ,secretary makes a determination to assign a ,,hcpcs code to a product under paragraph 7#b71 such code-- 7,a7 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 7,b7 may not take effect before the date the product is approved1 cleared1 or licensed by the ,food and ,drug ,administration4 7#f7 ,trade secrets and confidential information ,no information submitted under paragraph 7#b7 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 7#g7 ,inpatient products ,the ,secretary shall establish a code modifier within the hospital inpatient prospective payment system under section #ahhf7;d7 to track the utilization and1 to the extent practicable1 outcomes of novel medical products that are assigned a ,,hcpcs code pursuant to the expedited coding process under this subsection and are furnished by hospitals in inpatient settings4 7#h7 ,authority 7,a7 ,incorporation into an existing process ,the ,secretary may1 as determined appropriate1 incorporate the request process under this subsection into another ,,hcpcs code request process that the ,secretary has in place4 7,b7 ,waiver of elements of existing processes ,in implementing this subsection1 the ,secretary may waive such elements of other ,,hcpcs code request processes relating to advance planning as the ,secretary determines appropriate4 7#i7 ,definitions ,in this subsection3 7,a7 ,novel medical product defined ,the term novel medical product means a drug1 biological product1 or medical device-- 7i7 that has not been assigned a ,,hcpcs code2 and 7ii7 that has been designated as-- 7,i7 a breakthrough therapy under section #ejf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a772 7,,ii7 a breakthrough device under section #eae;,b of such ,act 7#ba ,u4,s4,c4 #cfj;e-#c72 or 7,,iii7 a regenerative advanced therapy under section #ejf7;g7 of such ,act 7#ba ,u4,s4,c4 #cef7;g774 7,b7 ,,hcpcs defined ,the term ,,hcpcs means the ,healthcare ,common ,procedure ,coding ,system4 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 pursuant to the expedited coding process under section #ahgd7;h74 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 a national coverage determination pursuant to this paragraph1 the ,secretary shall submit to ,congress and to the manufacturer of the novel medical product a report providing options for implementing alternative payment models under this title for the class of products to which the novel medical product belongs1 which may include the utilization of existing models in the commercial health insurance market or any other payment model deemed appropriate by the ,secretary4 ,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 paragraph 7#i77;,a7 of section #ahgd7;h71 that is assigned a ,,hcpcs code pursuant to the expedited coding process under 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 product described in subparagraph 7,d74 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 enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 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 #ahgd7;h77#i77;,a7 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 common differences in the data sets necessary to determine the safety and effectiveness of a novel medical product and the data sets 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 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 of subsection 7a77#c71 and clarify novel medical product clinical data requirements to meet the 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