Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer
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| Measure Information | 2022 Performance Period | 2023 Performance Period | 2024 Performance Period | 2025 Performance Period |
|---|---|---|---|---|
| Title | Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer | Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer | Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer | Intravesical Bacillus-Calmette-Guerin for Non-Muscle Invasive Bladder Cancer |
| CMS eCQM ID | CMS646v2 | CMS646v3 | CMS646v4 | CMS646v5 |
| CBE ID* | Not Applicable | Not Applicable | Not Applicable | Not Applicable |
| MIPS Quality ID | 481 | 481 | 481 | 481 |
| Measure Steward | Oregon Urology | Oregon Urology | Oregon Urology | 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. |
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 |
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 |
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 | Proportion measure | Proportion measure | Proportion measure |
| Measure Type | Process | Process | Process | Process |
| Stratification | *See CMS646v2.html | *See CMS646v3.html |
None |
None |
| Risk Adjustment | *See CMS646v2.html | *See CMS646v3.html |
None |
None |
| Rationale | *See CMS646v2.html | *See CMS646v3.html |
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). National Comprehensive Cancer Network (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). |
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). National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer (version 6.2021) 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, 2021). |
| Clinical Recommendation Statement | *See CMS646v2.html | *See CMS646v3.html |
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 Ta High Risk, T1 and TIS). |
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 Ta High Risk, T1 and TIS). |
| Improvement Notation |
A higher score is the preferred result and indicates better quality |
A higher score is the preferred result and indicates better quality |
A higher score is the preferred result and indicates better quality |
A higher score is the preferred result and indicates better quality |
| Definition | *See CMS646v2.html | *See CMS646v3.html |
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) |
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) |
| 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 5.5. Please refer to the eCQI resource center for more information on the QDM. |
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. |
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. |
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. |
| 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. |
All patients initially diagnosed with T1, Tis or high grade Ta non-muscle invasive bladder cancer and a qualified encounter in the measurement period |
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 |
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 |
Equals Initial Population |
Equals Initial Population |
Equals Initial Population |
| 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. |
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. |
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 of Bladder Cancer Staging |
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. |
| 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. |
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 |
Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series: BCG is initiated within 6 months of the bladder cancer staging |
Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series: BCG is initiated within 6 months of the bladder cancer staging |
| Numerator Exclusions |
Not Applicable |
Not Applicable |
Not Applicable |
Not Applicable |
| Denominator Exceptions |
Unavailability of BCG |
Unavailability of BCG |
Unavailability of BCG within 6 months after Bladder Cancer Staging |
Unavailability of BCG within 6 months after Bladder Cancer Staging |
| Telehealth Eligible | No | No | No | No |
| Next Version | No Version Available | No Version Available | ||
| Previous Version | No Version Available |
Additional Resources for CMS646v3
Header
Updated copyright.
Measure Section: Copyright
Source of Change: Annual Update
Updated citations to align with APAv6 Style Guide standards.
Measure Section: Rationale
Source of Change: Measure Lead
Updated references.
Measure Section: Reference
Source of Change: Measure Lead
Updated version number of the Quality Data Model (QDM) used in the measure specification to v5.6.
Measure Section: Guidance
Source of Change: Standards/Technical Update
Updated grammar, punctuation, and formatting to improve readability.
Measure Section: Multiple Sections
Source of Change: Measure Lead
Logic
Restructured denominator exclusion definitions into a group to streamline by combining definitions with the same timing.
Measure Section: Definitions
Source of Change: Measure Lead
Removed one set of open brackets from each exclusion definition to comply with the CQL Style Guide.
Measure Section: Definitions
Source of Change: Measure Lead
Revised timing from 'end Measurement Period' to 'end of Measurement Period' in the 'Bladder Cancer Diagnoses' definition to improve readability.
Measure Section: Definitions
Source of Change: Measure Lead
Replaced 'Bladder Cancer Diagnoses' definition in the initial population with 'First Bladder Cancer Staging Procedure during Measurement Period' to align with measure intent to capture patients whose first bladder cancer staging occurred during the measurement period.
Measure Section: Definitions
Source of Change: Measure Lead
Updated the names of CQL definitions, functions, and/or aliases for clarification and to align with the CQL Style Guide.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update
Updated the version number of the Measure Authoring Tool (MAT) Global Common Functions Library to v7.0.000.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update
Replaced direct reference code SNOMED CT code (258232002) with direct reference code SNOMED CT code (254292007).
Measure Section: Multiple Sections
Source of Change: Measure Lead
Updated logic using the new QDM 5.6 'Encounter, Performed' class attribute to exclude telehealth (or virtual) encounters using the logical representation (class !~ virtual), for measures containing telehealth-eligible codes, where telehealth is not appropriate. For more information, please refer to the 2023 Telehealth Guidance document.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update
Updated the version of the Quality Data Model (QDM) to 5.6 and Clinical Quality Language (CQL) to 1.5.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update
Value set
The VSAC is the source of truth for the value set content, please visit the VSAC for downloads of current value sets.
Value set Immunocompromised Conditions (2.16.840.1.113883.3.666.5.1940): Deleted 1 SNOMED CT code (404145009) based on new or changed coding guidelines. Deleted 1 ICD-10-CM code (D84.8) based on new or changed coding guidelines.
Measure Section: Terminology
Source of Change: Annual Update
Replaced direct reference code SNOMED CT code (258232002) with direct reference code SNOMED CT code (254292007) based on terminology updates and review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead
Value set HIV (2.16.840.1.113883.3.464.1003.120.12.1003): Added 13 SNOMED CT codes based on review by technical experts, SMEs, and/or public feedback. Added 6 ICD-10-CM codes (O98.711, O98.712, O98.713, O98.719, O98.72, O98.73) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead
Added direct reference code ActCode code (VR) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead