,,ii #aaith ,,congress #ast ,session ,s4 #befa ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ca1 #bjbe,mr4 ,cassidy 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 reform the payment rules regarding skin substitute products4 #a4 ,short title ,this ,act may be cited as the ,skin ,substitute ,access and ,payment ,reform ,act of #bjbe4 #b4 ,findings ,congress finds the following3 7#a7 ,skin substitute products are advanced biological therapies used to treat chronic1 non-healing wounds1 such as diabetic foot ulcers and venous leg ulcers4 ,each year1 more than #aj1ejj1jjj ,medicare beneficiaries will require medical care for treatment of a wound4 ,by improving healing rates and reducing the rate of lower limb amputation1 skin substitute products improve the health and wellness of ,medicare beneficiaries4 7#b7 ,these treatments vary in makeup and source material1 including human tissue-derived products1 non-human1 animal-derived products1 and synthetic products4 ,studies show that different skin substitute products are similarly safe and effective in treating chronic wounds1 and ,medicare coverage does not currently differentiate between different types of lawfully marketed skin substitutes4 ,healthcare providers are well-informed about alternative skin substitute products and are in the best position to determine which specific product would best suit each specific patient based on the patient's specific needs and the provider's knowledge and experience4 7#c7 ,the ,centers for ,medicare ,medicaid ,services has faced challenges in determining consistent and accurate pricing and payment for services that involve skin substitute products1 resulting in uncertainty and significant price differences among these products4 7#d7 ,the ,medicare payment systems in place at the date of enactment of this ,act incentivize use of more expensive products and continued price increases while failing to recognize the similar clinical effects of skin substitute products4 ,medicare expenditures for skin substitute products rose significantly in #bjbd and #bjbe4 7#e7 ,it is therefore necessary to reform the ,medicare payment and coverage rules for skin substitute products to appropriately recognize the well-established and known clinical value of these treatments while containing costs4 #c4 ,payment reform for skin substitute products 7a7 ,in general ,section #ahdg;,a7b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 subparagraph 7,b71 by striking or at the end2 7,b7 in subparagraph 7,c71 by striking the period at the end and inserting 2 or2 and 7,c7 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 7#b7 by adding at the end the following new paragraph3 7#i7 ,skin substitute products 7,a7 ,in general ,beginning on ,january #a1 #bjbf1 for any skin substitute product 7as defined in subsection 7c77#f771 the amount specified in this paragraph is the volume-weighted average of the payment allowance limit calculated under subparagraph 7,b74 7,b7 ,volume-weighted average payment limit ,the volume-weighted average of the payment allowance limit of a skin substitute product under this paragraph is determined by-- 7i7 calculating the sum of the products of-- 7,i7 the published payment allowance limit for each billing and payment code listed in the ,,asp ,pricing ,file published by the ,secretary for the fourth calendar quarter of #bjbc for each skin substitute product2 and 7,,ii7 the total number of units1 as specified under paragraph 7#b71 for each billing and payment code described in subclause 7,i71 billed with dates of service from ,october #a1 #bjbc1 to ,december #ca1 #bjbc1 and listed in the ,integrated ,data ,repository for ,part ,b claims data2 and 7ii7 dividing the sum calculated under clause 7i7 by the total number of units under subclause 7,,ii74 7,c7 ,updates to payment amounts ,for #bjbg and each subsequent year1 the amount specified in this paragraph shall be adjusted for the percentage increase in the consumer price index for all urban consumers 7,u4,s4 city average7 for the #ab-month period ending with ,june of the previous year4 4 7b7 ,definition and other rules for skin substitute products ,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 following new subparagraph3 7,j7 ,skin substitute products 7i7 ,in general ,the term skin substitute product-- 7,i7 means a cellular1 biological or synthetic material or tissue applied to a wound and intended to remain within the wound bed1 including a product approved1 cleared1 or authorized to section #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #bfj;c7f77#b71 #cfj;e7 or section #cfa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfd71 and their implementing regulations2 and 7,,ii7 does not include-- 7aa7 any product that is intended to temporarily protect or cover the wound bed and be removed before complete resorption1 such as a dressing2 7bb7 any liquid1 gel1 powder1 or other similarly constituted item2 or 7cc7 any product that would otherwise meet the requirements of subclause 7,i71 but is approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or licensed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 7ii7 ,consolidated billing and payment code ,not later than ,january #a1 #bjbf1 the ,secretary shall establish a new billing and payment code for all skin substitute products4 7iii7 ,special rules ,beginning on ,january #a1 #bjbf1 the following rules shall apply3 7,i7 ,each skin substitute product shall be subject to the same criteria when determining whether such skin substitute product is reasonable and necessary for the diagnosis or treatment of illness or injury under section #ahfb7;a77#a77;,a71 unless determined by the ,secretary that such product is unsafe based on evidence of contamination1 serious infectious disease1 or serious adverse reactions caused by such product4 7,,ii7 ,the ,secretary may not determine that a skin substitute product is not considered reasonable and necessary for the diagnosis or treatment of illness or injury under section #ahfb7;a77#a77;,a7 based solely on analysis of any clinical evidence relating to such product4 7,,iii7 ,a manufacturer of a skin substitute product shall not be required to report the average sales price for such product under section #aibg7;b77#c77;,a77iii7 or subsection 7f77#b74 4