Intravesical Bacillus-Calmette-Guerin for Non-Muscle Invasive Bladder Cancer
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| Measure Information | 2024 Performance Period | 2025 Performance Period | 2026 Performance Period | 2027 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 | CMS646v4 | CMS646v5 | CMS646v6 | CMS646v7 |
| 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 initial diagnosis of bladder cancer |
| Measure Scoring | Proportion | Proportion | Proportion | Proportion |
| Measure Type | Process | Process | Process | Process |
| Stratification |
None |
None |
None |
None |
| Risk Adjustment |
None |
None |
None |
None |
| 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). 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). |
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). |
Bladder cancer is ranked 6th for new cancer cases in 2025 and is the tenth leading cause of cancer death in the United States. There are 84,870 estimated new cases in 2025 and 17,420 estimated deaths in 2025. In 2022, an estimated 744,039 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 84% of the patients, and with these there is a five-year survival rate of 97.9% for In Situ and 72.6% for Localized. Bladder cancer is rarely found in patients under age 20, with the median age of diagnosis being 73 (NIH, 2025). 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). |
| 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 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). |
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. |
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 (Holzbeierlein, 2024). |
| Improvement Notation |
A higher score is the preferred result and indicates better quality |
A higher score is the preferred result and indicates better quality |
Higher score indicates better quality |
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: 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) |
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 |
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 1970s Tumor Location: Urinary bladder Histology: Urothelial carcinoma Primary Tumor (T) Stage:
|
| 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. |
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. |
To be included in the initial population, Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines. Regarding the numerator, 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 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 |
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 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, 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. |
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. |
Patients with one or more of the following are excluded from the measure:
|
| Numerator |
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 |
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 diagnosis |
| Numerator Exclusions |
Not Applicable |
Not Applicable |
None |
None |
| Denominator Exceptions |
Unavailability of BCG within 6 months after Bladder Cancer Staging |
Unavailability of BCG within 6 months after Bladder Cancer Staging |
Unavailability of BCG within 6 months after Bladder Cancer Staging |
Unavailability of BCG within 6 months after Bladder Cancer Diagnosis |
| Telehealth Eligible | No | No | No | No |
| Next Version | No Version Available | |||
| Previous Version | No Version Available |
Additional Resources for CMS646v7
Header
| TRN | Measure Section | Source of Change |
|---|---|---|
Updated the eCQM version number. | eCQM Version Number | Annual Update |
Updated the measurement period from 'January 1, 2026 through December 31, 2026' to 'January 1, 2027 through December 31, 2027.' | Measurement Period | Annual Update |
Updated copyright. | Copyright | Annual Update |
Updated grammar, wording, and/or formatting to improve readability and consistency. | Multiple Sections | Annual Update |
Updated all in-text citations from APA6 style to APA7 style. | Multiple Sections | Standards/Technical Update |
Updated references and measure header to reflect current evidence and new or updated literature. | Multiple Sections | Measure Lead |
Updated all References from APA6 style to APA7 style. | Reference | Standards/Technical Update |
Updated Guidance for clarity around BCG dose and Ta staging of bladder cancer. | Guidance | Annual Update |
Logic
| TRN | Measure Section | Source of Change |
|---|---|---|
Updated Measure Primary CQL Library Name from 'CMS646IntravesicalBCGforBladderCancerQDM' to 'CMS646BCGforBladderCancer' for alignment with the CQL Style Guide. | Definitions | Standards/Technical Update |
Updated CQL definitions, functions, and/or aliases for clarification and to align with the CQL Style Guide. | Definitions | Standards/Technical Update |
Updated all logic definitions to be written in initial case for alignment with the CQL Style Guide. | Definitions | Standards/Technical Update |
Updated measure logic to be centered around the timing of the first bladder cancer diagnosis instead of the first staging procedure to align with the measure intent. | Definitions | Measure Lead |
Revised measure logic to include anatomical site specificity for tumor staging. | Definitions | |
Updated Denominator Exclusion logic to account for interventions ordered or performed on the same day as the diagnosis. | Definitions | Annual Update |
Updated the 'Has Excluding Chemotherapy or Radiotherapy Procedure Before Staging' definition to include 'NormalizeInterval' to account for both relevantDatetime and relevantPeriod. | Definitions | |
Revised 'DateTime' operators to 'Date' in month interval definitions to account for time zone normalization and inclusivity. | Definitions | Annual Update |
Updated Measure Primary CQL Library Name from 'CMS646IntravesicalBCGforBladderCancerQDM' to 'CMS646BCGforBladderCancer' for alignment with the CQL Style Guide. | Functions | Standards/Technical Update |
Replaced Direct Reference Codes for cT1, cTa, cTis cancer stages (SNOMEDCT 1228883000, SNOMEDCT 1228884006, SNOMEDCT 1228889001) with pT1, pTa, and pTis Direct Reference Codes (SNOMEDCT 1228952000, SNOMEDCT 1228953005, SNOMEDCT 1228957006) to reflect pathological results, rather than clinical assessment staging. | Terminology | Measure Lead |
Replaced Direct Reference Code for Combined radiotherapy (SNOMEDCT 169331000) with Radiotherapy Direct Reference Code (SNOMEDCT 1287742003) based on code system/terminology updates. | Terminology | Annual 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.
| TRN | Measure Section | Source of Change |
|---|---|---|
Added new Value Set 'Bladder Cancer Site' (2.16.840.1.113762.1.4.1248.409) based on SME/Expert recommendations and public comment or implementer feedback. | Terminology | Annual Update |
Value Set 'Cystectomy for Urology Care' (2.16.840.1.113762.1.4.1248.358): Added 2 SNOMEDCT codes (1344644000, 288013007) based on code system/terminology updates. Added 25 SNOMEDCT codes (176275001, 81232004, 1287782005, 439497008, 287708003, 388230004, 63016009, 2813008, 446586007, 78585009, 425779004, 108034003, 84575008, 447308003, 236211007, 176234008, 84042007, 287707008, 287720006, 176246007, 73966002, 447307008, 66943005, 236200004, 236253008) based on SME/Expert recommendations. | Terminology | Annual Update |
Value Set 'Immunocompromised Conditions' (2.16.840.1.113762.1.4.1248.363): Deleted 4 SNOMEDCT codes (404147001, 404148006, 404149003, 404150003) based on code system/terminology updates. Deleted 8 ICD10CM codes (C86.6, C86.4, C86.3, C86.2, C86.1, C86.0, C88.4, C83.39) based on code system/terminology updates. Added 9 ICD10CM codes (C86.60, C86.40, C86.30, C86.20, C86.10, C86.00, C88.40, C83.398, C83.390) based on code system/terminology updates. | Terminology | Annual Update |
Value Set 'Immunosuppressive Drugs for Urology Care' (2.16.840.1.113762.1.4.1248.364): Deleted 3 RxNorm codes (342977, 582670, 793099) based on SME/Expert recommendations. Added 2 RxNorm codes (2392140, 2462521) based on SME/Expert recommendations. | Terminology | Annual Update |
Value Set 'Office Visit' (2.16.840.1.113883.3.464.1003.101.12.1001): Added 8 CPT codes (98000, 98001, 98002, 98003, 98004, 98005, 98006, 98007) based on SME/Expert recommendations. Added 2 SNOMEDCT codes (30346009, 37894004) based on SME/Expert recommendations. | Terminology | Annual Update |
Value Set 'Payer Type' (2.16.840.1.114222.4.11.3591): Deleted 42 SOPT codes (111, 1112, 3111, 3112, 3114, 3115, 3116, 3119, 3121, 3122, 3211, 3212, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 3222, 3223, 3229, 3711, 3712, 3713, 3811, 3812, 3813, 3819, 6, 61, 611, 612, 613, 614, 619, 62, 621, 622, 623, 629) based on new or changed coding guidance. | Terminology | Annual Update |
Value Set 'Tuberculosis for Urology Care' (2.16.840.1.113762.1.4.1248.351): Added 3 SNOMEDCT codes (1362007008, 1362008003, 1363113005) based on code system/terminology updates. Deleted 1 SNOMEDCT code (473114006) based on SME/Expert recommendation. | Terminology | Annual Update |