LCD Reference Article Response To Comments Article

Response to Comments: Bladder/Urothelial Tumor

A55451

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
CGS Administrators, LLC	MAC - Part A	15101 - MAC A	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part B	15102 - MAC B	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part A	15201 - MAC A	J - 15	Ohio
CGS Administrators, LLC	MAC - Part B	15202 - MAC B	J - 15	Ohio

Article Information

General Information

Article ID
A55451

Article Title
Response to Comments: Bladder/Urothelial Tumor

Article Type
Response to Comments

Original Effective Date
03/06/2017

Retirement Date
N/A

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Article Text
The following address comments received by Noridian Healthcare Solutions on draft policies JE-DL36678 and JF-DL36680. as the policy was created to create an uniform LCD with other MACs CGS is attaching and will update their policy based on responses received.

Response To Comments

Number	Comment	Response
1	We agree with Noridian that the routine use of urinary markers for bladder cancer screening in place of cystoscopic evaluation is not recommended. For a patient’s first visit to the urologist for bladder cancer evaluation, we agree testing for bladder cancer tumor markers should be done only in conjunction with cystoscopy. The capacity of cystoscopy to detect bladder cancer is dependent on the anatomic site and the tumor morphology. In some situations, cystoscopy will fail to detect bladder cancer on the first visit, yet the patient’s symptoms persist (eg hematuria). The patient may have additional risk factors (eg >65 years of age, lifetime smoker). In subsequent visits, we recommend that the use of bladder tumor markers should be at the discretion of the urologist without the requirement for cystoscopy and cytology. For example, a flat high-grade lesion (CIS) is often missed by cystoscopy so additional cystoscopy may have little clinical utility for the diagnosis of bladder cancer. Cystoscopy cannot detect upper tract bladder cancer in the kidney or pelvis. In these situations, bringing a patient back for a second cystoscopy in order to collect urine for bladder tumor marker testing adds an additional invasive procedure as well as unnecessary expense to patient care. Consequently, we request that the limitation that bladder cancer tumor markers must be performed in conjunction with cystoscopy be removed from this LCD - after an initial urological evaluation and a prior atypical urine cytology result.	The policy has been changed to read: “Cystoscopy in conjunction with bladder tumor markers is standard practice to evaluate patients with symptoms suggesting bladder cancer and to monitor treated patients for recurrence or progression. Exceptions, such as high grade bladder cancers s/p radical cystectomy, do exist which preclude cystoscopy prior to testing.
2	Also, we are requesting clarification regarding UroVysion. UroVysion is molecular assay and not an immunoassay. Please confirm as to whether or not UroVysion is covered by the following statement: Bladder cancer tumor markers performed by immunoassay are ONLY considered medically necessary Response to Comments: Bladder/Urothelial Tumor Markers Page 4 of 10 https://localcoverage.cms.gov/local_coverage/view/article.aspx?contractInfo=378%3a1&a... 1/19/2017 as an adjunct in the diagnosis and monitoring of bladder cancer in conjunction with cystoscopy?	The policy has been changed to read: “Bladder cancer tumor markers performed by any technology, including FISH (Urovysion), are not covered for screening of patients with hematuria. Bladder tumor markers are not expected to be performed until other diagnostic studies fail to identify the etiology of the hematuria”.
3	We assert that the approach used to monitor bladder cancer progression should be left to the discretion of the urologist. The diagnostic work up used to detect the bladder cancer will demonstrate if cystoscopy, cytology and/or a urinary biomarker is best suited to monitor residual disease. Following a diagnosis of bladder cancer, we agree cystoscopy and cytology may be desirable. However, these methods may produce false negative results. For example, cystoscopy may miss flat high-grade lesions (CIS) and cytology may produce equivocal results. In those instances, a cell based urinary biomarker such as UroVysion FISH or Immunocyt may be the most appropriate methodology for monitoring residual disease. If cytology produces an equivocal result, then bringing a patient back for a second cystoscopy in order to collect urine for bladder tumor marker testing (UroVysion FISH, Immuncyt) adds unnecessary expense to patient care. The unintended consequence may be to encourage overuse of cystoscopy. Consequently, we request that the limitation that bladder cancer tumor markers must be performed in conjunction with cystoscopy be removed for patients with a history of bladder cancer.	The policy has been amended to reflect the fact that cystoscopy and cytology are desirable for patients with a history of bladder cancer, but recognize there are extenuating circumstances that may preclude cystoscopy. The policy reads: “Cystoscopy in conjunction with bladder tumor markers is standard practice to evaluate patients with symptoms suggesting bladder cancer and to monitor treated patients for recurrence or progression. Exceptions, such as high grade bladder cancers s/p radical cystectomy, do exist which preclude cystoscopy prior to testing.
4	In rare instances, more than one bladder cancer test per date of service (eg cytology with reflex FISH) is reasonable and necessary. For example, a patient with negative cystoscopy, equivocal cytology and positive UroVysion FISH may have upper tract bladder cancer (eg renal kidney pelvis is suspected). In these instances, left and right renal/ureter washes may be collected from left and right kidneys. Cytology is performed and when equivocal can be reflexed to urinary biomarkers tests (UroVysion FISH, Immuncyt) to determine which kidney is affected. This testing is critical to therapeutic decision making since surgical removal of the affected tumor will be considered for patient management. The goal is to limit nephrectomy to a single kidney while leaving the unaffected kidney intact.	This contractor recognizes that in rare instances more than one bladder cancer test may be reasonable and necessary. However, for these rare instances, a claim denial for multiple UroVysion tests on the same DOS may be overturned via the first level of appeal (redetermination) with supporting documentation. Cytology is not considered a bladder tumor marker.
5	The proposed policy states that the ICD-10 codes, R31.2, Z78.9, Z85.51, should be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis. We contend that the ICD- 10 codes Z85.51 (Personal history of malignant neoplasm of bladder) should be sufficient without a primary neoplastic diagnosis for bladder cancer monitoring in patients with a history of bladder cancer. In this instance, the Z85.51 codes specifies the medical necessity of testing for therapeutic decision making and the absence of the primary ICD-10 code should not be reason to disallow testing.	This contractor agrees that ICD Z85.51 (Personal history of malignant neoplasm of bladder) specifies the medical necessity of testing, and does not require a primary neoplastic disease diagnosis.
6	The references noted in the body of the draft LCD text do not match up with the reference list. For example, the LCD refers to reference 6, but no reference 6 is listed. We are requesting clarification of the appropriate references.	Reference 6 was a typographical error and has been removed
7	In reading this draft LCD, I noticed it included the UroVysion FISH test. My question is specifically regarding the Cxbladder ™ test by Pacific Edge Diagnostics (lab location in Hershey, Pennsylvania), which analyzes five (5) genes (MDK, HOXA13, CDC2/CDK1, IGFBP5, and CXCR2). http://www.cxbladder.com/for-healthcareprofessionals/ about-cxbladder/how-cxbladder-works/. This test is being coded with CPT 81479. If at all similar to the UroVysion, or perhaps used in place of the UroVysion test, would this test be considered for inclusion in this draft LCD when published? Or is the statement “All other bladder cancer marker assays, including but not limited to the following, regardless of the methodology are considered investigational and not covered by Medicare” found in the draft LCD anticipated to encompass this test, even though the CPT code used isn’t found in the LCD?	As a laboratory-developed test (LDT), the analytical validation, clinical validation and the clinical utility for CxbladderTM has not been assessed by MolDX. CxbladderTM is considered investigational and not covered by Medicare.
8	“Initial diagnosis” should be changed to “most recent occurrence” as the proposed bladder cancer evaluation, we agree testing for bladder cancer tumor markers should be done only in conjunction with cystoscopy. Wording precludes long term follow-up of recurrent bladder cancer and limits appropriate long-term followup because it is based on the initial occurrence in a disease that recurs 70% of the time, 10% greater than 10 years apart. Follow-up after initial diagnosis and treatment Response to Comments: Bladder/Urothelial Tumor Markers Page 7 of 10 https://localcoverage.cms.gov/local_coverage/view/article.aspx?contractInfo=378%3a1&a... 1/19/2017 Maximum of four (4) bladder tumor marker studies per year for years 1-2 Maximum of three (3) bladder tumor marker studies per year for year 3 Maximum of two (2) bladder tumor marker studies for year 4 and Maximum of one (1) bladder tumor marker studies follow-up annually for up to 15 years.	“Most recent occurrence” has been added to the policy.
9	Regarding the proposed "Bladder tumor marker" LCD DL36678, it would be helpful if the abbreviation "UC" was defined as either "urinary cancer" or "urine cytology". From its use in the LCD, it is not clear which is meant. The term "bladder tumor" used in the title really refers to "urothelial carcinoma" since malignancies of the hollow portion of the urinary system (most commonly transitional cell cancers which this LCD refers to mostly but also squamous cell cancers and adenocarcinomasfortunately less frequent) may occur in the renal pelvis, ureter, urethra as well as the bladder. The comments in this LCD really apply to each of these. Therefore, titling the policy "urothelial tumor markers" might be more useful. And of course, bear in mind that follow up of upper tract tumors (ureter or renal pelvis) may include a "bladder tumor marker" but not necessarily cystoscopy. Moreover, follow up of patients who have had a radical cystectomy with diversion may require cytology, FISH or other markers as follow up surveillance but not cystoscopy (they do not have a bladder and we do not routinely scope ileal loops or neo-bladders). Therefore, the requirement that cystoscopy be performed at the time of a bladder tumor marker or it will not be covered does not always apply (the code will still be "bladder cancer"). To avoid confusion and denial of coverage especially for those patients who need it most (high grade bladder cancers who have already had a radical cystectomy), the requirement that cystoscopy always must be done in conjunction with a tumor marker should be modified or dropped. I understand from your presentation that a urine cytology is not considered as a "bladder tumor marker" under this LCD. Therefore, comments covered indications or limitations and frequency do not pertain to urine cytology tests. Finally, do you include the "FISH" test under the category "immunoassay" as the term is used under the "limitations" portion of the LCD?	In the 4th paragraph under “Indications”, UC is defined as urinary cancer. The policy title has been changed to reflect “urothelial cancer”. The policy will be changed to read: Cystoscopy in conjunction with bladder tumor markers is standard practice to evaluate patients with symptoms suggesting bladder cancer and to monitor treated patients for recurrence or progression. Exceptions, such as high grade bladder cancers s/p radical cystectomy, do exist which preclude cystoscopy prior to testing. Testing indications, limitations and frequency do not apply to urine cytology. The policy will be changed to read: Bladder cancer tumor markers performed by immunoassay, molecular or FISH testing are not covered for screening of all patients with hematuria. Bladder tumor markers are not expected until other diagnostic studies fail to identify the etiology of the hematuria. Urine cytology is not considered a bladder tumor marker.

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Response to Comments: Bladder/Urothelial Tumor

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