,i #aaith ,,congress #ast ,session ,h4 ,r4 #fheb ,,in ,,the ,,house ,,of ,,representatives ,december #ah1 #bjbe,mr4 ,evans of ,colorado introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 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 amend title ,,xviii of the ,social ,security ,act to adjust payment for skin substitute products under the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,advanced ,wound ,care and ,regenerative ,medicine ,access and ,reform ,act4 #b4 ,payment reform for skin substitute products 7a7 ,coverage of skin substitute products ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7#a7 in subparagraph 7,,ii71 by striking and at the end2 7#b7 in subparagraph 7,,jj71 by adding and at the end2 and 7#c7 by inserting after subparagraph 7,,jj7 the following new subparagraph3 7,,kk7 skin substitute products 7as defined in section #ahdg;,a7c77#f77;,j774 4 7b7 ,payment 7#a7 ,payment amount ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended-- 7,a7 in subsection 7a77#a7-- 7i7 by striking the period at the end and inserting 2 and2 7ii7 by striking shall apply to and inserting 8shall apply-- 7,a7 to 2 and 7iii7 by adding at the end the following new subparagraph3 7,b7 to payment for skin substitute products 7as defined in subsection 7c77#f77;,j77 that are furnished on or after ,january #a1 #bjbf4 2 and 7,b7 in subsection 7b7-- 7i7 in paragraph 7#a7-- 7,i7 in the text preceding subparagraph 7,a71 by inserting or a skin substitute product after drug or biological2 7,,ii7 in subparagraph 7,b71 by striking or at the end2 7,,iii7 in subparagraph 7,c71 by striking the period at the end and inserting 2 or2 and 7,,iv7 by adding at the end the following new subparagraph3 7,d7 in the case of a skin substitute product 7as defined in subsection 7c77#f77;,j771 the amount determined under paragraph 7#i74 2 and 7ii7 in paragraph 7#b7-- 7,i7 in subparagraph 7,a71 by inserting or a skin substitute product after drug or biological2 and 7,,ii7 in subparagraph 7,b71 by inserting 1 and1 with respect to a skin substitute product1 a square centimeter after pertaining to liquids2 and 7iii7 by adding at the end the following3 7#i7 ,skin substitute products 7,a7 ,payment amount 7i7 ,initial payment amount ,for #bjbf1 the amount determined under this paragraph for a skin substitute product is the volume-weighted average of the ,medicare payment allowance limits for skin substitute products1 as determined under subparagraph 7,b74 7ii7 ,annual update ,for #bjbg and each subsequent year1 the amount determined under this paragraph for a skin substitute product for such year is equal to the amount determined under this paragraph for the previous year1 adjusted by the percentage increase in the ,consumer ,price ,index for ,all ,urban ,consumers 7,united ,states city average7 for the #ab-month period ending with ,june of such previous year4 7,b7 ,volume-weighted average payment limit ,for purposes of subparagraph 7,a77i71 the volume-weighted average of the ,medicare payment allowance limits for skin substitute products is determined by-- 7i7 calculating1 with respect to each billing and payment code listed in the ,april #bjbc ,,asp ,pricing ,file for each skin substitute product1 an amount equal to the product of-- 7,i7 the payment limit included in such file with respect to such code2 and 7,,ii7 the number of units 7as specified under paragraph 7#b77-- 7aa7 billed with respect to such code for a date of service in #bjbc2 and 7bb7 listed in the ,,cms ,integrated ,data ,repository for ,part ,b 7,carrier ,,dme7 claims data2 7ii7 calculating the sum of all amounts determined under clause 7i72 and 7iii7 dividing the sum calculated under clause 7ii7 by the total number of units determined under clause 7i77,,ii74 4 7#b7 ,conforming amendments ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 in subparagraph 7,s77i71 by striking subject to subparagraph 7,,ee7'' and inserting #8#8subject to subparagraphs 7,,ee7 and 7,,ii7' 2 7,b7 by striking and 7,,hh7 and inserting 7,,hh72 and 7,c7 by inserting 1 and 7,,ii7 with respect to skin substitute products under section #ahfa7s77#b77,,kk71 the amount paid shall be #hj percent of the lesser of the actual charge or the payment amount established under section #ahdg;,a7b77#i7 before the semicolon at the end4 7c7 ,skin substitute product defined ,section #ahdg;,a7c77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77 is amended by adding at the end the following3 7,j7 ,skin substitute products ,the term skin substitute product-- 7i7 means a cellular1 tissue1 biological or synthetic material that-- 7,i7 is applied to a wound and intended to remain within the wound bed2 and 7,,ii7 is marketed pursuant to section #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 or section #cfa of the ,public ,health ,service ,act2 and 7ii7 does not include a product that is intended to temporarily protect or cover the wound bed and be removed without resorption such as a dressing2 and 7iii7 the term skin substitute product shall include any products reimbursed pursuant to skin substitutes codes by the ,medicare program at any time prior to ,january #a1 #bjbf4 4 7d7 ,exclusion from reporting requirements ,section #ahdg;,a7f77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7f77#b77;,a77 is amended by inserting 7except that1 beginning ,january #a1 #bjbf1 a drug or biological so described does not include a skin substitute product 7as defined in subsection 7c77#f77;,j777 after products that are payable under this part as a drug or biological4 7e7 ,consolidated billing and payment code ,not later than ,january #a1 #bjbf1 the ,secretary of ,health and ,human ,services shall establish a new billing and payment code for all skin substitute products 7as defined in subparagraph 7,j7 of section #ahdg;,a7c77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f771 as added by subsection 7b774 #c4 ,equivalent reimbursement in outpatient sites of care ,the ,secretary shall ensure that reimbursement for skin substitutes products and outpatient applications of skin substitute products are equivalent to those payment amounts outlined in ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#i771 regardless of the site of care in which the skin substitute product is applied4 #d4 ,enhancing program integrity for skin substitute products ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7aa7 ,special payment rules for skin substitute products 7#a7 ,identification of outlier providers of skin substitute products 7,a7 ,in general ,not later than ,march #a1 #bjbf1 and every #b years thereafter through ,march #a1 #bjce1 the ,secretary shall determine the #c percent of the total number of providers of skin substitute products that are outlier providers of skin substitute products4 7,b7 ,outlier providers of skin substitute products ,the determination of an outlier provider of skin substitute products under this paragraph shall be based upon the providers 7as identified by national provider identification number7 that received the greatest total payment under this title for skin substitute products furnished in the year preceding the year in which the determination under subparagraph 7,a7 is made4 7,c7 ,referral to oig ,the ,secretary shall-- 7i7 make publicly available the list of outlier providers of skin substitute products identified under each determination under subparagraph 7,a72 and 7ii7 transmit such list to the ,inspector ,general of the ,department of ,health and ,human ,services for the assessment of potential fraud1 waste1 or abuse4 7#b7 ,initial prepayment claim review for certain outlier providers 7,a7 ,in general ,beginning ,march #a1 #bjbf1 the ,secretary shall conduct prepayment review of claims for skin substitute products submitted under this title by an outlier provider of skin substitute products unless #a or more of the conditions described in subparagraph 7,b7 is met with respect to such provider4 7,b7 ,limitation ,for purposes of subparagraph 7,a71 the conditions described in this subparagraph are1 with respect to an outlier provider of skin substitute products1 the following3 7i7 ,skin substitute products furnished by the provider are subject to prior authorization under paragraph 7#c74 7ii7 ,the rate of approval for claims for skin substitute products furnished by such provider that are subject to prepayment review under this paragraph exceeds #ij percent 7as determined over a period of time or number of claims specified by the ,secretary74 7iii7 ,the ,secretary determines that the billing practices of the provider are consistent with the applicable coverage criteria and requirements under this title4 7#c7 ,prior authorization for outlier providers of skin substitute products 7,a7 ,in general ,beginning not later than ,january #a1 #bjbg1 subject to subparagraph 7,b71 the ,secretary shall1 for a period determined appropriate by the ,secretary1 apply prior authorization for skin substitute products that are furnished by an outlier provider of skin substitute products identified under paragraph 7#a74 7,b7 ,removal from prior authorization ,in the event that the ,secretary determines1 with respect to an outlier provider of skin substitute products1 that the rate of approval for requests for prior authorization under this paragraph for skin substitute products furnished by such provider exceeds #ij percent 7as determined over a period of time or number of claims specified by the ,secretary71 the ,secretary may cease to apply prior authorization under this paragraph for skin substitute products furnished by such provider4 7,c7 ,funding ,for purposes of carrying out this paragraph1 the ,secretary shall provide for the transfer1 from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda1 to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 of #e1jjj1jjj for each of fiscal years #bjbg through #bjcj1 to remain available until expended4 7#d7 ,enrollment revocation or exclusion of noncompliant outlier providers 7,a7 ,in general ,beginning ,january #a1 #bjbh1 if the rate of denial for requests for prior authorization under paragraph 7#c7 for skin substitute products furnished by an outlier provider of skin substitute products exceeds #ge percent over a period of #f or more consecutive months1 the ,secretary shall determine that an abuse of billing privileges exists with respect to such provider for purposes of section #dbd4ece7;a77#h77;ii7 of title #db1 ,code of ,federal ,regulations4 7,b7 ,referral for exclusion ,if the ,secretary determines under subparagraph 7,a7 that an abuse of billing privileges exists with respect to an outlier provider of skin substitute products1 the ,secretary shall direct the ,inspector ,general of the ,department of ,health and ,human ,services to determine whether such provider should be excluded from participation in any ,federal health care program under section #aabh7;b77#f74 7#e7 ,skin substitute product wastage 7,a7 ,with respect to skin substitute products furnished for the treatment of chronic or acute wounds1 payment shall be only made for the reasonable and necessary portion of the skin substitute product used in the treatment of the wound1 excluding wastage4 7,b7 ,for the purpose of subparagraph 7,a71 the reasonable and necessary portion of the skin substitute product is defined as the greater of 7i7 #c square centimeters1 or 7ii7 #abj percent of the size of the treated wound4 7#f7 ,skin substitute product defined ,in this subsection1 the term skin substitute product has the meaning given such term in section #ahdg;,a7c77#f77;,j74 4 #e4 ,streamlining approval processes for human cells1 tissues and cellular and tissue-based products 7a7 ,in general ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall-- 7#a7 conduct a comprehensive review of the approval process applied to human cellular and tissue allografts and autografts that are not subject to regulation only under section #cfa of the ,public ,health ,service ,act1 including those processed into liquid1 gel1 or powder forms2 7#b7 identify opportunities to streamline application requirements1 review timelines1 and evidentiary standards for such products while maintaining appropriate safety and efficacy oversight2 7#c7 consider the development of a tiered review framework based on risk assessment factors including degree of manipulation1 processing methods1 mode or administration1 and clinical safety profile2 7#d7 evaluate the need for pre-market clinical evaluation and the appropriateness of leveraging existing clinical data1 real-world evidence1 and registry data to reduce duplicative clinical trial requirements where scientifically justified2 and 7#e7 assess mechanisms to harmonize requirements between products currently regulated only under section #cfa of the ,public ,health ,service ,act that may transition to section #cea regulation4 7b7 ,stakeholder consultation ,in conducting the review under paragraph 7#a71 the ,secretary shall consult with-- 7#a7 manufacturers of human tissue allografts2 7#b7 tissue banks and procurement organizations2 7#c7 clinicians specializing in wound care1 surgical reconstruction1 and regenerative medicine2 7#d7 patient advocacy organizations2 7#e7 health insurance payors2 and 7#f7 relevant scientific and medical professional societies4 7c7 ,considerations ,the review shall specifically consider-- 7#a7 appropriate modifications to ,chemistry1 ,manufacturing1 and ,controls 7,,cmc7 requirements reflecting the biological nature and donor-dependent variability of human tissue2 7#b7 potential use of expedited review pathways1 including priority review designations2 7#c7 opportunities for modular or staged application submissions2 7#d7 appropriate clinical endpoint criteria and study designs for different types of allografts and autografts2 7#e7 post-market surveillance requirements as an alternative to pre-market evidence requirements2 and 7#f7 international regulatory approaches to similar products4 7d7 ,guidance ,not later than #bd months after the date of enactment of this ,act1 the ,secretary shall issue draft guidance implementing any streamlining measures identified under subsection 7b71 and shall finalize such guidance not later than #ab months after the close of the public comment period4 7e7 ,report to congress ,not later than #cj months after the date of enactment of this ,act1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the review conducted under subsection 7b71 including-- 7#a7 findings and recommendations for regulatory streamlining2 7#b7 any administrative actions taken or proposed2 7#c7 recommendations for additional legislative action1 if any2 and 7#d7 estimated impacts on patient access and public health4 7f7 ,preservation of safety standards ,nothing in this section shall be construed to reduce or eliminate safety or efficacy standards applicable to human tissue allografts or autografts subject to licensure under section #cea of the ,public ,health ,service ,act4