The payment for skin substitute products that do not qualify for OOPS pass-through status are packaged into the OPPS payment for the associated skin substitute application procedure. This policy is also implemented in the ASC payment system. The skin substitute products are divided into two groups:
1) High cost skin substitute products, and
2) Low cost skin substitute products for packaging purposes.
Table 5 lists the skin substitute products and their assignment as either a high cost or a low cost skin substitute product, when applicable. ASCs should not separately bill for packaged skin substitutes (ASC PI=N1).
High cost skin substitute products should only be utilized in combination with the performance of one of the skin application procedures described by CPT codes 15271-15278. Low cost skin substitute products should only be utilized in combination with the performance of one of the skin application procedures described by HCPCS code C5271-C5278. All OPPS pass-through skin substitute products (ASC PI=K2) should be billed in combination with one of the skin application procedures described by CPT codes 15271-15278.
Table 5 - Skin Substitute Product Assignment to High Cost/Low Cost Status for CY 2015
CY 2015 HCPCS Code | CY 2015 Short Descriptor | ASC PI | Low/High Cost Skin Substitute |
C9349 | Fortaderm, fortaderm antimic | N1 | High |
C9358 | SurgiMend, fetal | N1 | Low |
C9360 | SurgiMend, neonatal | N1 | Low |
C9363 | Integra Meshed bil Wound Mat | N1 | High |
Q4100 | Skin substitute, NOS | N1 | Low |
Q4101 | Apligraf | N1 | High |
Q4102 | Oasis wound matrix | N1 | Low |
Q4103 | Oasis burn matrix | N1 | Low |
Q4104 | Integra BMWD | N1 | High |
Q4105 | Integra DRT | N1 | High |
Q4106 | Dermagraft | N1 | High |
Q4107 | Graftjacket | N1 | High |
Q4108 | Integra Matrix | N1 | High |
Q4110 | Primatrix | N1 | High |
Q4111 | Gammagraft | N1 | High |
Q4112 | Cymetra injectable | N1 | N/A |
Q4113 | GraftJacket Xpress | N1 | N/A |
Q4114 | Integra Flowable Wound Matrix | N1 | N/A |
Q4115 | Alloskin | N1 | Low |
Q4116 | Allodern | N1 | High |
Q4117 | Hyalomatrix | N1 | Low |
Q4118 | Matristem Micromatrix | N1 | N/A |
Q4119 | Matristem Wound Matrix | N1 | Low |
Q4120 | Matristem Burn Matrix | N1 | Low |
Q4121 | Theraskin | K2 | High |
Q4122 | Dermacell | K2 | High |
Q4123 | Alloskin | N1 | High |
Q4124 | Oasis Tri-layer Wound Matrix | N1 | Low |
Q4125 | Arthroflex | N1 | High |
Q4126 | Memoderm/derma/tranz/integup | N1 | High |
Q4127 | Talymed | K2 | High |
Q4128 | Flexhd/Allopatchhd/matrixhd | N1 | High |
Q4129 | Unite Biomatrix | N1 | High |
Q4131 | Epifix | N1 | High |
Q4132 | Grafix core | N1 | High |
Q4133 | Grafix prime | N1 | High |
Q4134 | Hmatrix | N1 | High |
Q4135 | Mediskin | N1 | Low |
Q4136 | Ezderm | N1 | Low |
Q4137 | Amnioexcel or Biodexcel, 1 cm | N1 | High |
Q4138 | BioDfence DryFlex, 1 cm | N1 | High |
Q4139 | Amniomatrix or Biodmatrix, 1cc | N1 | N/A |
Q4140 | Biodfence 1 cm | N1 | High |
Q4141 | Alloskin ac, 1 cm | N1 | Low |
Q4142 | Xcm biologic tiss matrix 1cm | N1 | Low |
Q4143 | Repriza, 1cm | N1 | Low |
Q4145 | Epifix, 1mg | N1 | N/A |
Q4146 | Tensix, 1cm | N1 | Low |
Q4147 | Architect ecm px fx 1 sq cm | N1 | High |
Q4148 | Neox 1k, 1cm | N1 | High |
Q4149 | Excellagen, 0.1 cc | N1 | N/A |
Q4150 | Allowrap DS or Dry 1 sw cm | N1 | Low |
Q4151 | AmnioBand, Guardian 1sq cm | N1 | Low |
Q4152* | Dermapure 1 sq cm | N1 | High |
Q4153 | Dermavest 1 sq cm | N1 | Low |
Q4154 | Biovance 1 square cm | N1 | High |
Q4155 | NeoxFlo or Clarix Flo 1 mg | N1 | N/A |
Q4156 | Neox 100 1 square cm | N1 | High |
Q4157 | Revitalon 1 square cm | N1 | Low |
Q4158 | MariGen 1 square cm | N1 | Low |
Q4159 | Affinity 1 square cm | N1 | High |
Q4160 | NuShield 1 square cm | N1 | High |
• Drugs and Biological Based on ASP Methodology with Restated Payment Rates
Some drugs and biologicals based on ASP methodology may have payment rates that are corrected retroactivetly. These retroactive corrections typically occur on a quarterly basis. Suppliers, who think they may have received an incorrect payment for drugs and biologicals impacted by these corrections, may request their MAC's adjustment of the previously processed claims.
• CY 2015 ASC Wage index
As discussed and finalized in the CY 2015 OPPS/ASC final rule with comment (79 FR 66937), in CY 2015, CMS is using the new Core Based Statistical Area (CBSA) delineations issued by the Office of Management and Budget (OMB) in OMB Bulletin 13-01, dated February 28, 2013 for the IPPS hospital wage index. Therefore, because the ASC wage indexes are the pre-floor and pre-reclassified IPPS hospital wage indexes, the CY 2015 ASC wage indexed reflect the new OMB deline actions.
In CY2015, where the CY 2015 ASC wage index value with the CY 2015 CBSAs is lower than the CY 2014 CBSA values, CMS calculates, or blends, the CY 2015 ASC wage index adjusted payment rates such that it will equal 50 percent of the ASC wage index based in the CY 2014 CBSA value and 50 percent of the ASC wage index based on the new CY 2015 CBSA value. The blending of these specific wage index values will mitigate any short-term instability to ASC payments. CY 2015 CBSAs with wage index value that are higher than the CY 2015 are not transitioned or blended and reflect the full higher wage index value.
• Coverage Determinations
The fact that a drug, device, procedure, or service is assigned a HCPCS code and a payment rate under the OPPS does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. MACs determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary's condition and whether it is excluded from payment.
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