Transmittal 47 Date: FEBRUARY 24, 2006

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1 anual ystem Pub edicae National oveage Deteminations Depatment of Health & Human evices (DHH) ente fo edicae & edicaid evices () Tansmittal 47 Date: EBUAY 24, 2006 hange equest 4257 UBJET: hanges to the oveed ndications fo Tumo Antigen by mmunoassay A 125 to Add Pimay Peitoneal acinoma. UAY O HANGE: This tansmittal modifies the national coveage detemination (ND) fo Tumo Antigen by mmunoassay A 125 to add pimay peitoneal cacinoma as a coveed indication fo the test in accodance with the decision memoandum issued in AG on the coveage Web site at cms.hhs.gov/coveage. ystem changes to implement this policy change wee included in the Januay update to the laboatoy ND edit module softwae in accodance with 4161, tansmittal 758 dated Novembe 18, This tansmittal seves only to manualize the change. ystem changes fo this manual povision wee aleady included in 4161 which was eleased with a Januay 1, 2006 effective date. ystem changes fo this manual povision wee aleady included in 4161 which was eleased with a Januay 3, 2006 taget implementation date. NEW/EVED ATEAL: EETVE DATE: Januay 1, 2006 PLEENTATON DATE: Januay 3, 2006 Disclaime fo manual changes only: The evision date and tansmittal numbe apply only to ed italicized mateial. Any othe mateial was peviously published and emains unchanged. Howeve, if this evision contains a table of contents, you will eceive the new/evised infomation only, and not the entie table of contents.. HANGE N ANUAL NTUTON: = EVED, N = NEW, D = DELETED /N/D HAPTE / ETON / UBETON / TTLE 1/190.28/ Tumo Antigen by mmunoassay - A 125

2 . UNDNG: No additional funding will be povided by ; contacto activities ae to be caied out within thei Y 2006 opeating budgets. V. ATTAHENT: Business equiements anual nstuction *Unless othewise specified, the effective date is the date of sevice.

3 Attachment - Business equiements Pub Tansmittal: 47 Date: ebuay 24, 2006 hange equest 4257 UBJET: hanges to the oveed ndications fo Tumo Antigen by mmunoassay A 125 to Add Pimay Peitoneal acinoma. GENEAL NOATON A. Backgound: The national coveage deteminations (NDs) fo clinical diagnostic laboatoy sevices wee developed by the laboatoy negotiated ulemaking committee and published as a final ule on Novembe 23, The Laboatoy NDs ae detailed in Pub , the ND anual. uthe, to ensue nationally unifom implementation of the policies, lists of coveed codes ae maintained though softwae that is updated quately unde contact with ompute ciences opoation. B. Policy: n accodance with the ND pocess that is included unde section 731 of the edicae odenization Act of 2003, we have econsideed the coveed indications fo the ND fo Tumo Antigen by mmunoassay A 125 and have detemined that the test is easonable and necessay fo suveillance of pimay peitoneal cacinoma in edicae beneficiaies following teatment. A decision memoandum explaining this change can be found on the ntenet at by clicking national coveage analysis. This change becomes effective fo sevices funished on o afte Januay 1, The systems changes implementing this wee included in 4161, tansmittal 758 dated Novembe 18, 2005, announcing the Januay updates to the laboatoy edit module.. BUNE EQUEENT hall" denotes a mandatoy equiement "hould" denotes an optional equiement equiement Numbe equiements ontactos shall implement changes as outlined in 4161, issued 11/18/2005. This manualizes those changes. esponsibility ( X indicates the columns that apply) haed ystem aintaines Othe H a H i e X X D E V W. POVDE EDUATON equiement Numbe equiements esponsibility ( X indicates the columns that apply)

4 None. H H a i e D E haed ystem aintaines V W Othe V. UPPOTNG NOATON AND POBLE DEGN ONDEATON A. Othe nstuctions: N/A X-ef equiement # nstuctions B. Design onsideations: N/A X-ef equiement # ecommendation fo edicae ystem equiements. ntefaces: N/A D. ontacto inancial epoting /Wokload mpact: N/A E. Dependencies: N/A. Testing onsideations: N/A V. HEDULE, ONTAT, AND UNDNG Effective Date*: Januay 1, 2006 mplementation Date: Januay 3, 2006 Pe-mplementation ontact(s): Jackie heidan- ooe , [email protected] No additional funding will be povided by ; contacto activities ae to be caied out within thei Y 2006 opeating budgets. Post-mplementation ontact(s): Os *Unless othewise specified, the effective date is the date of sevice.

5 Tumo Antigen by mmunoassay A 125 (ev.47, ssued: , Effective: , mplementation: ) mmunoassay deteminations of the seum levels of cetain poteins o cabohydates seve as tumo makes. When elevated, seum concentation of these makes may eflect tumo size and gade. This policy specifically addesses tumo antigen A 125. ndications The A 125 is a high molecula weight seum tumo make elevated in 80 pecent of patients who pesent with epithelial ovaian cacinoma. t is also elevated in cacinomas of the fallopian tube, endometium, and endocevix. An elevated level may also be associated with the pesence of a malignant mesothelioma o pimay peitoneal cacinoma A A 125 level may be obtained as pat of the initial pe-opeative wok-up fo women pesenting with a suspicious pelvic mass to be used as a baseline fo puposes of postopeative monitoing. nitial declines in A 125 afte initial sugey and/o chemotheapy fo ovaian cacinoma ae also measued by obtaining thee seum levels duing the fist month post teatment to detemine the patient s A 125 half-life, which has significant pognostic implications. The A 125 levels ae again obtained at the completion of chemotheapy as an index of esidual disease. uveillance A 125 measuements ae geneally obtained evey 3 months fo 2 yeas, evey 6 months fo the next 3 yeas, and yealy theeafte. A 125 levels ae also an impotant indicato of a patient s esponse to theapy in the pesence of advanced o ecuent disease. n this setting, A 125 levels may be obtained pio to each teatment cycle. Limitations These sevices ae not coveed fo the evaluation of patients with signs o symptoms suggestive of malignancy. The sevice may be odeed at times necessay to assess eithe the pesence of ecuent disease o the patient s esponse to teatment with subsequent teatment cycles. The A 125 is specifically not coveed fo aiding in the diffeential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. n geneal, a single tumo make will suffice in following a patient with one of these malignancies. (This ND last eviewed Novembe 2005)