Final Rule with Comment Period on Medicare OPPS - Ropes & Gray

Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / <strong>Rule</strong>s and Regulations74247jlentini on DSK4TPTVN1PROD <strong>with</strong> RULES2single-layer technique. In the CY 2011OPPS/ASC final rule <strong>with</strong> commentperiod (75 FR 72402), we assigned CPTcode 65780 to APC 0244 (Corneal andAmniotic Membrane Transplant) <strong>with</strong> aCY 2011 payment rate of approximately$2,681. We assigned CPT code 65778 toAPC 0239 (Level II Repair and PlasticEye Procedures) <strong>with</strong> a payment rate ofapproximately $559, and CPT code65779 to APC 0255 (Level II AnteriorSegment Eye Procedures) <strong>with</strong> apayment rate of approximately $519. Inaddition, we assigned both CPT codes65778 and 65779 to comment indicator‘‘NI’’ in Addendum B of the CY 2011OPPS/ASC final rule <strong>with</strong> commentperiod to indicate that both codes werenew codes for CY 2011 <strong>with</strong> an interimAPC assignment subject to publiccomment. We further stated that wewould address any public comments onissues regarding these new codes in thisCY 2012 OPPS/ASC final rule <strong>with</strong>comment period.At the APC Panel at the February 28–March 1, 2011 meeting, a presenterrequested the reassignment of both newCPT codes 65778 and 65779 to APC0244, which is the same APC to whichCPT code 65780 is assigned. Thepresenter indicated that, prior to CY2011, the procedures described by CPTcodes 65578 and 65779 were previouslyreported under the original version ofCPT code 65780, which did not specify‘‘multiple layers,’’ and, as such, thesenew codes should continue to beassigned to APC 0244. Further, thepresenter stated that the costs of thenew procedures described by CPT codes65778 and 65779 are very similar to theprocedure described by CPT code65780.The APC Panel recommended thatCMS reassign both CPT codes 65778and 65779 to APC 0233 (Level IIIAnterior Segment Eye Procedures),citing clinical similarity to proceduresalready in APC 0233. Based on clinicalas well as resource similarity to theother procedures currently assigned toAPC 0233, in the CY 2012 OPPS/ASCproposed rule (76 FR 42237), weproposed to accept the APC Panel’srecommendations to reassign CPT code65778 from APC 0239 to APC 0233 andto reassign CPT code 65779 from APC0255 to APC 0233. However, basedupon our further review and analysis ofthe clinical characteristics of theprocedure described by CPT code65778, we also proposed toconditionally package CPT code 65778.The service described by CPT code65778 would rarely be provided as aseparate, stand-alone service in theHOPD; it would almost exclusively beprovided in addition to and followinganother procedure or service. Ourmedical advisors indicated that theprocedure described by CPT code 65778is not significantly different thanplacing a bandage contact lens on thesurface of the eye to cover a cornealepithelial defect. CPT code 65778describes the simple placement of aspecial type of bandage (a self-retainingamniotic membrane device) on thesurface of the eye, which would mostcommonly be used in the HOPD tocover the surface of the eye after aprocedure that results in a cornealepithelial defect. In fact, the selfretainingamniotic membrane device isstructurally similar to a bandage contactlens, except that the central material isamniotic membrane instead of contactlens polymer. Given the characteristicsof this procedure, the device used in theprocedure, and its likely use in theHOPD, we proposed to conditionallypackage CPT code 65778 for CY 2012and reassign its status indicator from‘‘T’’ to ‘‘Q2’’ to indicate that theprocedure is packaged when it is billedon the same date <strong>with</strong> anotherprocedure or service that is alsoassigned to status indicator ‘‘T.’’Otherwise, separate payment would bemade for the procedure.In summary, for CY 2012, weproposed to reassign CPT code 65778from APC 0239 to APC 0233 <strong>with</strong> aconditionally packaged status of ‘‘Q2,’’to reassign CPT code 65779 from APC0255 to APC 0233, which had aproposed median cost of approximately$1,214, and to continue to assign CPTcode 65780 to APC 0244, which had aproposed median cost of approximately$2,767.At the August 2011 APC PanelMeeting, a presenter urged the Panel torecommend to CMS not to conditionallypackage CPT code 65778 for CY 2012,and instead, assign it to status indicator‘‘T.’’ Based on information presented atthe meeting, and after further discussionon the issue, the APC Panelrecommended that CMS reassign thestatus indicator for CPT code 65778from conditionally packaged ‘‘Q2’’ tostatus indicator ‘‘T.’’<strong>Comment</strong>: Several commenters urgedCMS not to finalize its proposal toconditionally package CPT code 65778by assigning it to status indicator ‘‘Q2,’’and instead adopt the APC Panel’srecommendation to assign it to statusindicator ‘‘T.’’ One commenterexpressed concern that conditionallypackaging CPT code 65778 isinappropriate because it will result inno payment for the procedure despitethe significant costs hospitals incur infurnishing the service, which includesthe cost of the Prokera device (the self-VerDate Mar2010 17:08 Nov 29, 2011 Jkt 226001 PO 00000 Frm 00127 Fmt 4701 Sfmt 4700 E:\FR\FM\30NOR2.SGM 30NOR2retaining amniotic membrane device)that is used <strong>with</strong> this procedure.Further, this same commenter disagreed<strong>with</strong> CMS’ assertion that the servicedescribed by CPT code 65778 is merelya minor procedure that involves placinga bandage contact lens on the surface ofthe eye, and stated that the service is asignificant, separate procedure thatshould continue to be separately paid.Response: We disagree that theprocedure described by CPT code 65778is a significant procedure. Theprocedure has been described by themanufacturer as ‘‘like inserting a contactlens.’’ The manufacturer’s Web sitestates the following about the Prokeraself-retaining amniotic membranedevice: ‘‘The ProKera® deviceconfiguration enables easy insertion inthe office, hospital bedside or followingsurgical procedures to preventadhesions while delivering the woundrepair and wound healing actions ofamniotic membrane.’’ Because this is atype of specialized bandage that istypically placed on the surface of theeye immediately after a surgery that hasresulted in a corneal epithelial defect,we believe that assigning CPT code65778 to a conditionally packaged statusencourages hospitals to use resourcesmore efficiently. We expect hospitals toprovide only necessary, high qualitycare and to provide that care asefficiently as possible. We expect that,for most surgically induced cornealepithelial defects, hospitals will use aconventional eye patch or a standardbandage contact lens to promote fasterwound healing and greater patientcomfort, and that they will reserve veryhigh cost products, such as the selfretainingamniotic membrane device, forrare and exceptional vision-threateningcases. We believe that the conditionalpackaging of CPT code 65778 isconsistent <strong>with</strong> this expectation andwill encourage efficient hospitaloutpatient care under thesecircumstances. Based on the nature ofthis procedure, we believe thatassigning CPT code 65778 to statusindicator ‘‘Q2’’ is appropriate under thehospital OPPS. Therefore, we are notaccepting the APC Panel’srecommendation to reassign thisprocedure to status indicator ‘‘T.’’After consideration of the publiccomments we received and the APCPanel’s August 2011 recommendation,we are finalizing our proposal, <strong>with</strong>outmodification, to assign status indicator‘‘Q2’’ to CPT code 65778. When theservice is furnished <strong>with</strong> a separatelypayable surgical procedure <strong>with</strong> statusindicator ‘‘T’’’ on the same day,payment for CPT code 65778 ispackaged. Otherwise, payment for CPT