Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer

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Measure Information	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
CMS eCQM ID	CMS646v3	CMS646v4	CMS646v5
CBE ID*	Not Applicable	Not Applicable	Not Applicable
MIPS Quality ID	481	481	481
Measure Steward	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
Measure Scoring	Proportion measure	Proportion measure	Proportion measure
Measure Type	Process	Process	Process
Stratification	*See CMS646v3.html	None	None
Risk Adjustment	*See CMS646v3.html	None	None
Rationale	*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). Show more > 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). Show less	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). Show more > 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). Show less
Clinical Recommendation Statement	*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). Show more > 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). Show less	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). Show more > 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). Show less
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
Definition	*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) Show more > 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) Show less	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) Show more > 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) Show less
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. Show more > 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. Show less	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. Show more > 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. Show less	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. Show more > 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. Show less
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 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
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. Show more > 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. Show less	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 Show more > 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 Show less	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. Show more > 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. Show less
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	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
Denominator Exceptions	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
Next Version	No Version Available	CMS646v5	No Version Available
Previous Version	No Version Available	CMS646v3	CMS646v4

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CMS646v4-TRN.xlsx

Header

Updated copyright.
Measure Section: Copyright
Source of Change: Annual Update
Updated references.
Measure Section: Reference
Source of Change: Measure Lead
Updated language in the initial population to better align with measure intent and reflect updated timing constraints.
Measure Section: Initial Population
Source of Change: Measure Lead
Updated language in the denominator exclusions to include applicable timing and align with the logic.
Measure Section: Denominator Exclusions
Source of Change: Measure Lead
Updated language in the numerator to align with the applicable timing to meet measure intent.
Measure Section: Numerator
Source of Change: Measure Lead
Updated language in the denominator exception to specify the applicable timing and align with the logic.
Measure Section: Denominator Exceptions
Source of Change: Measure Lead
Updated grammar, wording, and/or formatting to improve readability and consistency.
Measure Section: Multiple Sections
Source of Change: Annual Update

Logic

Updated the timing precision in definitions by adding 'day of' to align with the measure intent and for consistency across eCQMs.
Measure Section: Definitions
Source of Change: Measure Lead
Revised the timing of the bladder cancer staging to occur six months before or after the start of the measurement period so all data collection occurs by the end of 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: Definitions
Source of Change: Standards/Technical Update
Updated definition to remove the timing constraint for the staging procedure to overlap the diagnosis for consistency with measure intent.
Measure Section: Definitions
Source of Change: Measure Lead

Value Set

The VSAC is the source of truth for the value set content, please visit the VSAC for downloads of current value sets.

Replaced value set Chemotherapy for Advanced Cancer (2.16.840.1.113883.3.7643.3.1048) with value set Chemotherapy Agents for Advanced Cancer (2.16.840.1.113762.1.4.1151.60) based on 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 1 SNOMED CT code (1187001009) based on review by technical experts, SMEs, and/or public feedback. Deleted 3 SNOMED CT codes (72621000119104, 72631000119101, 442134007) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead
Value set Immunocompromised Conditions (2.16.840.1.113883.3.666.5.1940): Deleted 8 SNOMED CT codes (109965004, 188729005, 277473004, 277637000, 277651000, 277653002, 722953004, 190993005) based on terminology update.
Measure Section: Terminology
Source of Change: Annual Update
Value set Immunosuppressive Drugs for Urology Care (2.16.840.1.113762.1.4.1151.32): Deleted 1 RxNorm code (1551887) based on terminology update.
Measure Section: Terminology
Source of Change: Annual Update
Value set Mixed histology urothelial cell carcinoma for Urology Care (2.16.840.1.113762.1.4.1151.39): Added 1 SNOMED CT code (1187332001) based on terminology update. Deleted 1 SNOMED CT code (35917007) based on terminology update.
Measure Section: Terminology
Source of Change: Annual Update
Value set Payer (2.16.840.1.114222.4.11.3591): Added 5 SOP codes (1111, 1112, 142, 344, 141) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead