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Intravesical Bacillus-Calmette-Guerin for Non-Muscle Invasive Bladder Cancer

Compare Versions of: "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
Specifications
Attachment Size
CMS646v5.html 80.45 KB
CMS646v5.zip 80.5 KB
CMS646v5-TRN.xlsx 22.56 KB
eCQM Jira Issue Tracker
*Note there may be more tickets in the eCQM Tracker - ONC Project Tracking System (Jira) for this measure. Only tickets tagged with their associated CMS measure ID appear.

Header

  • Updated the eCQM version number.

    Measure Section:

    eCQM Version Number

    Source of Change:

    Annual Update

  • Changed all references from NQF to CBE to identify the consensus-based entity role.

    Measure Section:

    CBE Number

    Source of Change:

    Annual Update

  • Updated copyright.

    Measure Section:

    Copyright

    Source of Change:

    Annual Update

  • Updated wording from 'within 6 months of Bladder Cancer Staging' to 'within 6 months prior to the Bladder Cancer Staging' to align with measure logic.

    Measure Section:

    Denominator Exclusions

    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

  • Updated references and measure header to reflect current evidence and new or updated literature.

    Measure Section:

    Multiple Sections

    Source of Change:

    Measure Lead

Logic

  • Updated the Initial Population definition to remove duplication of the definition 'First Bladder Cancer Staging Procedure during 6 Months Prior to Measurement Period through the First 6 Months of Measurement Period,' which is checked later in the measure logic.

    Measure Section:

    Initial Population

    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 the version number of the Measure Authoring Tool (MAT) Global Common Functions Library to v8.0.000 and the library name from 'MATGlobalCommonFunctions' to 'MATGlobalCommonFunctionsQDM.'

    Measure Section:

    Definitions

    Source of Change:

    Annual Update

  • Renamed value set to 'Payer Type' to more accurately reflect the contents and intent of the value set.

    Measure Section:

    Definitions

    Source of Change:

    Standards/Technical Update

  • Updated the version number of the Measure Authoring Tool (MAT) Global Common Functions Library to v8.0.000 and the library name from 'MATGlobalCommonFunctions' to 'MATGlobalCommonFunctionsQDM.'

    Measure Section:

    Functions

    Source of Change:

    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.

  • Removed ICD-9 extensional value sets from select grouping value sets, leaving codes from active terminologies (ICD-10 and SNOMED), to reduce implementer burden.

    Measure Section:

    Terminology

    Source of Change:

    Standards/Technical Update

  • Value set Chemotherapy Agents for Advanced Cancer (2.16.840.1.113762.1.4.1151.60): Added 4 RxNorm codes (1441408, 1441414, 1441419, 1441425) based on review by technical experts, SMEs, and/or public feedback. Deleted 1 RxNorm code (1918045) based on terminology update.

    Measure Section:

    Terminology

    Source of Change:

    Measure Lead

  • Value set HIV (2.16.840.1.113883.3.464.1003.120.12.1003): Added 2 SNOMED CT codes (1187000005, 1260096003) based on review by technical experts, SMEs, and/or public feedback. Deleted 1 SNOMED CT code (420687005) based on review by technical experts, SMEs, and/or public feedback. Deleted 3 ICD-9-CM codes (042, 079.53, V08) based on applicability of value set and/or OID.

    Measure Section:

    Terminology

    Source of Change:

    Measure Lead

  • Value set Immunocompromised Conditions (2.16.840.1.113883.3.666.5.1940): Added 9 SNOMED CT codes (838355002, 1255796007, 1255805006, 1255806007, 1255807003, 1255895001, 1255906008, 1255907004, 1162928000) based on terminology update. Deleted 17 SNOMED CT codes 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 (763564) based on terminology update.

    Measure Section:

    Terminology

    Source of Change:

    Annual Update

  • Value set Office Visit (2.16.840.1.113883.3.464.1003.101.12.1001): Deleted 2 SNOMED CT codes (30346009, 37894004) based on updated evidence in published guidelines, published literature, or from published specialty medical society or group recommendations. Deleted 1 CPT code (99201) based on updated evidence in published guidelines, published literature, or from published specialty medical society or group recommendations.

    Measure Section:

    Terminology

    Source of Change:

    Measure Lead

  • Value set (2.16.840.1.114222.4.11.3591): Renamed to Payer Type based on recommended value set naming conventions.

    Measure Section:

    Terminology

    Source of Change:

    Annual Update

  • Replaced direct reference code SNOMED CT code (369935001) with direct reference code SNOMED CT code (1228889001) based on terminology update.

    Measure Section:

    Terminology

    Source of Change:

    Annual Update

  • Replaced direct reference code SNOMED CT code (369949005) with direct reference code SNOMED CT code (1228883000) based on terminology update.

    Measure Section:

    Terminology

    Source of Change:

    Annual Update

  • Replaced direct reference code SNOMED CT code (369934002) with direct reference code SNOMED CT code (1228884006) based on terminology update.

    Measure Section:

    Terminology

    Source of Change:

    Annual Update

Last Updated: Jun 17, 2024