eCQM Title |
Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer |
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eCQM Identifier (Measure Authoring Tool) | 646 | eCQM Version Number | 3.0.000 |
NQF Number | Not Applicable | GUID | 224b1722-aef9-4e7f-97f8-284267fc1b00 |
Measurement Period | January 1, 20XX through December 31, 20XX | ||
Measure Steward | Oregon Urology | ||
Measure Developer | Oregon Urology | ||
Endorsed By | None | ||
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 |
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Copyright |
Limited proprietary coding is contained in the measure specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets. Oregon Urology Institute (OUI) and Large Urology Group Practice Association (LUGPA) disclaim all liability for use or accuracy of third party codes contained in the specifications. CPT(R) contained in the Measure specifications is copyright 2004-2021. American Medical Association. LOINC(R) copyright 2004-2021 Regenstrief Institute, Inc. This material contains SNOMED Clinical Terms(R) (SNOMED CT[R]) copyright 2004-2021 International Health Terminology Standards Development Organisation. ICD-10 copyright 2021 World Health Organization. All Rights Reserved. |
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Disclaimer |
The performance measure is not a clinical guideline and does not establish a standard of medical care, and has not been tested for all potential applications. THE MEASURES AND SPECIFICATIONS ARE PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND. Due to technical limitations, registered trademarks are indicated by (R) or [R] and unregistered trademarks are indicated by TM or [TM]. |
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Measure Scoring | Proportion | ||
Measure Type | Process | ||
Stratification |
None |
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Risk Adjustment |
None |
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Rate Aggregation |
None |
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Rationale |
Bladder cancer is ranked 10th for new cancer cases in 2020 and is the 9th 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, there were an estimated 699,450 people 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). NCCN Guidelines for Bladder Cancer (version 6.2020) defines intravesical BCG as Category 1 Treatment for Ta - high grade, T1 and Tis non-muscle invasive bladder cancer. Most public data reflects prophylactic or adjuvant use of intravesical therapy with the goal of preventing recurrence or delaying 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, 2020). |
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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 AUA Guideline for the Management of Non-muscle Invasive Bladder Cancer: Stages Ta High Risk, T1 and TIS). |
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Improvement Notation |
A higher score is the preferred result and indicates better quality |
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Reference |
Reference Type: CITATION Reference Text: 'Chamie, K., Saigal, C.S., Lai, J., Hanley, J.M., Setodji, C.M., Konety, B.R., Litwin, M.S., & Urologic Diseases in America Project (2011). Compliance with Guidelines for Patients with Bladder Cancer: Variation in the Delivery of Care. Cancer.2011 Dec 1: 117(23): 5392--5401. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3206145/' |
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Reference |
Reference Type: CITATION Reference Text: 'Chang, S.S., Boorjian, S.A., Chou, R., Clark, P.E., Daneshmand, S., Konety, B.R., Pruthi, R., Quale, D.Z., Ritch, C.R., Seigne, J.D., Skinner, E.C., Smith, N.M., & Mckiernan, J. M., (2016, April) American Urological Association. Non-Muscle Invasive Bladder Cancer. https://www.auanet.org/education/guidelines/non-muscle-invasive-bladder-cancer.cfm' |
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Reference |
Reference Type: CITATION Reference Text: 'Hall, M.C., Chang, S.S., Dalbagni, G., Pruthi, R.S., Schellhammer, P.F., Seigne, J.D., Skinner, E.C., & Wolf .S., (2016). American Urological Association. Guideline for the Management of Non-muscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): Update 2016. https://www.auajournals.org/doi/10.1016/j.juro.2007.09.003' |
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Reference |
Reference Type: CITATION Reference Text: 'Kassouf, W., Black, P., (2016) Treatment of primary non-muscle invasive urothelial bladder cancer. Literature review current through Dec. 2016. https://www.uptodate.com/contents/treatment-of-primary-non-muscle-invasive-urothelial-bladder-cancer?source=search_result&search=Treatment%20of%20primary%20non-muscle%20invasive%20urothelial%20bladder%20cancer&selectedTitle=1~150 T of primary' |
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Reference |
Reference Type: CITATION Reference Text: 'NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). (2021). Bladder Cancer. Version 6.2021-December 6. 2021. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf' |
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Reference |
Reference Type: CITATION Reference Text: 'NIH National Cancer Institute Surveillance, Epidemiology, and End Results Program. SEER Cancer Stat Facts: Bladder Cancer. National Cancer Institute. Bethesda,MD, https://seer.cancer.gov/statfacts/html/urinb.html' |
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Reference |
Reference Type: CITATION Reference Text: 'Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University. (2016). PCORI Topic Brief. Comparative Effectiveness of Treatments for Non-Muscle-Invasive Bladder Cancer http://www.pcori.org/sites/default/files/PCORI-Assessment-Options-Advisory-Panel-Fall-2016-Topic-Brief-Non-Muscle-Invasive-Bladder-Cancer.pdf' |
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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: Ta - Noninvasive and high grade Tis - Carcinoma in situ: "flat tumor" T1- tumor invades subepithelial connective tissue (high grade or low 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 eCQI resource center (https://ecqi.healthit.gov/qdm) for more information on the QDM. |
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Transmission Format |
None |
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Initial Population |
All patients initially diagnosed with T1, Tis or high grade Ta non-muscle invasive bladder cancer and a qualified encounter in the measurement period |
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Denominator |
Equals Initial Population |
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Denominator Exclusions |
Immunosuppressed patients, includes HIV and immunocompromised state. Immunosuppressive drug therapy. Active Tuberculosis. Mixed histology urothelial cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease. Patients who undergo cystectomy, chemotherapy or radiation within 6 months of 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 and during the measurement period |
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Numerator Exclusions |
Not Applicable |
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Denominator Exceptions |
Unavailability of BCG |
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Supplemental Data Elements |
For every patient evaluated by this measure also identify payer, race, ethnicity and sex |
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