| Title |
Intravesical Bacillus–Calmette–Guerin for Non-Muscle Invasive Bladder Cancer |
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|---|---|---|---|
| CMS eCQM ID | CMS646v6 | CBE ID | Not Applicable |
| MIPS Quality ID | 481 | ||
| Measure Steward | Oregon Urology | ||
| Description | Percentage of patients initially diagnosed with non-muscle invasive bladder cancer and who received intravesical Bacillus-Calmette-Guerin (BCG) within 6 months of bladder cancer staging | ||
| Measure Scoring | Proportion | ||
| Measure Type | Process | ||
| Stratification | None | ||
| Risk Adjustment | None | ||
| Rationale | Bladder cancer is ranked 10th for new cancer cases in 2020 and is the ninth leading cause of cancer death in the United States. There are 81,400 estimated new cases in 2020 and 17,980 estimated deaths in 2020. In 2016, an estimated 699,450 people were living with bladder cancer in the United States. Early detection (discovery of cancer in situ or localized to the primary site) is found in 85% of the patients, and with these there is a five-year survival rate of 95.8% for In Situ and 69.2% for Localized. Bladder cancer is rarely found in patients under age 20, with the median age of diagnosis being 73 (NIH, 2020).
National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer (version 6.2021) defines intravesical BCG as Category 1 Treatment for T1, Tis and Ta – high grade, non-muscle invasive bladder cancer. Most public data reflects prophylactic or adjuvant use of intravesical therapy to prevent recurrence or delay progression to a higher grade or stage. BCG has been shown to be effective as prophylaxis to prevent bladder cancer recurrences following TURBT. The NCCN Bladder Cancer Panel Members recommend BCG as the preferred option over Mitomycin C for adjuvant treatment of high-grade lesions (Ta). BCG is also standard therapy for Primary Tis. Most T1 lesions are high-risk and are similarly treated with adjuvant intravesical therapy, with BCG being a Category 1 recommendation. (NCCN, 2021). |
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| Clinical Recommendation Statement | Intravesical BCG should be administered within 6 months of the initial diagnosis of non-muscle invasive bladder cancer. It may be administered 3-4 weeks after resection, but there needs to be pathological tumor confirmation and must be withheld if there is traumatic catheterization, bacteriuria, persistent gross hematuria, persistent severe local symptoms or systemic symptoms. The normal induction course is 6 weekly instillations of intravesical BCG (AUA Non-Muscle Invasive Bladder Cancer and American Urological Association (AUA) Guideline for the Management of Non-muscle Invasive Bladder Cancer: Stages T1, TIS, and Ta High Risk. | ||
| Improvement Notation | Higher score indicates better quality | ||
| Definition | Intravesical – Within the urinary bladder
Bacillus Calmette-Guerin (BCG) – A live attenuated strain of Mycobacterium bovis, first indicated as a tuberculosis vaccine, has had widespread use in intravesical immunotherapy since the 1970’s. Tumor location: urinary bladder Histology: urothelial carcinoma Primary Tumor (T) stage: T1- tumor invades subepithelial connective tissue (high grade or low grade) Tis – Carcinoma in situ: “flat tumor” Ta – Noninvasive and high grade |
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| Guidance | Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines.
The BCG dose can be full or partial and can be from any lot or manufacturer. This eCQM is a patient-based measure. Telehealth encounters are not eligible for this measure because the measure requires a clinical action that cannot be conducted via telehealth. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM. |
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| Initial Population | All patients initially diagnosed with T1, Tis or high grade Ta non-muscle invasive bladder cancer with bladder cancer staging within 6 months before to 6 months after the start of the measurement period and a qualified encounter in the measurement period | ||
| Denominator | Equals Initial Population | ||
| Denominator Exclusions | Immunosuppressed patients, includes HIV and immunocompromised state, with a diagnosis prior to Bladder Cancer Staging.
Immunosuppressive drug therapy starting on or before Bladder Cancer Staging. Active Tuberculosis diagnosis during the Bladder Cancer Staging. Mixed histology urothelial cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease prior to Bladder Cancer Staging. Patients who undergo cystectomy, chemotherapy or radiation within 6 months prior to Bladder Cancer Staging. |
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| Numerator | Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series: BCG is initiated within 6 months of the bladder cancer staging | ||
| Numerator Exclusions | None | ||
| Denominator Exceptions | Unavailability of BCG within 6 months after bladder cancer staging | ||
| Telehealth Eligible | No | ||
| Next Version | No Version Available | ||
| Previous Version | CMS646v5 | ||
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