eCQM Title

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

CMS ID

646

eCQM Version Number

7.0.000

CBE Number

Not Applicable

GUID

224b1722-aef9-4e7f-97f8-284267fc1b00

Measurement Period

January 1, 2027 through December 31, 2027

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 initial diagnosis of bladder cancer

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 the use or accuracy of third-party codes contained in the specifications.

CPT (R) only Copyright 2025 American Medical Association. All rights Reserved. No fee schedules, basic unit, relative values or related listings are included in CPT (R). AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for data contained herein.

This material contains content from LOINC (http://loinc.org). LOINC is copyright (C) Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC (R) is a registered United States trademark of Regenstrief Institute, Inc.

This material includes SNOMED Clinical Terms (R) (SNOMED CT [R]) which is used by permission of the International Health Terminology Standards Development Organisation (IHTSDO). All rights reserved. SNOMED CT (R), was originally created by The College of American Pathologists. "SNOMED" and "SNOMED CT" are registered trademarks of the IHTSDO.

Disclaimer

The performance measure is not a clinical guideline, 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].

Measure Scoring

Proportion

Measure Type

Process

Stratification

None

Risk Adjustment

None

Rate Aggregation

None

Rationale

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 (Holzbeierlein, 2024).

Improvement Notation

Higher score indicates better quality

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. (2011). Compliance with guidelines for patients with bladder cancer: Variation in the delivery of care. Cancer, 117(23), 5392–5401. https://doi.org/10.1002/cncr.26198

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. D., & McKiernan, J. M. (2016). Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. Journal of Urology, 196(4), 1021–1029. https://doi.org/10.1016/j.juro.2016.06.049

Reference

Reference Type: Citation

Reference Text:

Holzbeierlein, J. M., Bixler, B. R., Buckley, D. I., Chang, S. S., Holmes, R., James, A. C., Kirkby, E., McKiernan, J. M., Schuckman, A. K. (2024). Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. Journal of Urology, 211(4), 533–538. https://doi.org/10.1097/JU.0000000000003846

Reference

Reference Type: Citation

Reference Text:

Kassouf, W., & Black, P. (2016). Treatment of primary non-muscle invasive urothelial carcinoma of the bladder (S. Lerner & S. M. Shah, Eds.). UpToDate. https://www.uptodate.com/contents/treatment-of-primary-non-muscle-invasive-urothelial-carcinoma-of-the-bladder

Reference

Reference Type: Citation

Reference Text:

National Comprehensive Cancer Network. (2021). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). National Comprehensive Cancer Network. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf

Reference

Reference Type: Citation

Reference Text:

NIH National Cancer Institute Surveillance, Epidemiology, and End Results Program. (2025). Cancer of the urinary bladder - Cancer stat facts. SEER Cancer Stat Facts: Bladder Cancer; National Cancer Institute. https://seer.cancer.gov/statfacts/html/urinb.html

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. Patient-Centered Outcomes Research Institute. https://www.pcori.org/sites/default/files/PCORI-Assessment-Options-Advisory-Panel-Fall-2016-Topic-Brief-Non-Muscle-Invasive-Bladder-Cancer.pdf

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 1970s

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

Guidance

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 eCQI resource center (https://ecqi.healthit.gov/qdm) for more information on the QDM.

Transmission Format

TBD

Initial Population

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

Denominator Exclusions

Patients with one or more of the following are excluded from the measure:

Active Tuberculosis Diagnosis overlaps Bladder Cancer Diagnosis
Immunosuppressive Drug Therapy starting on or before Bladder Cancer Diagnosis
Cystectomy done within 6 months prior to Bladder Cancer Diagnosis
HIV or Immunocompromised Conditions (diagnosis prior to Bladder Cancer Diagnosis)
Mixed Histology Urothelial Cell Carcinoma (including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma, and squamous disease) prior to Bladder Cancer Diagnosis
Chemotherapy or Radiation Therapy procedures within 6 months prior to Bladder Cancer Diagnosis

Numerator

Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series: BCG is initiated within 6 months of the bladder cancer diagnosis

Numerator Exclusions

None

Denominator Exceptions

Unavailability of BCG within 6 months after Bladder Cancer Diagnosis

Supplemental Data Elements

For every patient evaluated by this measure also identify payer, race, ethnicity and sex

Population Criteria
Definitions
Functions
Terminology
Data Criteria (QDM Data Elements)
Supplemental Data Elements
Risk Adjustment Variables

Population Criteria

Initial Population

  "Has First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start"
    and "Has Most Recent Bladder Cancer Tumor Staging Is T1, Tis, Ta HG"
    and "Has Qualifying Encounter"

- Denominator
  - "Initial Population"

Denominator Exclusions

  exists "Acute Tuberculosis Diagnosis"
    or exists "Immunosuppressive Drugs"
    or exists "Cystectomy Done"
    or "Has Excluding HIV, Immunocompromised Conditions Or Mixed Histology Before Diagnosis"
    or "Has Excluding Chemotherapy Or Radiotherapy Procedure Before Diagnosis"

- Numerator
  - "First BCG Administered" is not null

- Numerator Exclusions
  - None

Denominator Exceptions

  exists "BCG Not Available Within 6 Months After First Bladder Cancer Diagnosis"

- Stratification
  - None

Definitions

Acute Tuberculosis Diagnosis

  ["Diagnosis": "Tuberculosis for Urology Care"] ActiveTuberculosis
    with "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" FirstBladderCancerDx
      such that ActiveTuberculosis.prevalencePeriod overlaps FirstBladderCancerDx.prevalencePeriod

BCG Not Available Within 6 Months After First Bladder Cancer Diagnosis

  ( ["Medication, Not Administered": "Bacillus Calmette Guerin for Urology Care"] BCGnotGiven
    with "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" FirstBladderCancerDx
      such that BCGnotGiven.authorDatetime 6 months or less after day of start of FirstBladderCancerDx.prevalencePeriod
        where BCGnotGiven.negationRationale in "Unavailability of Bacillus Calmette Guerin for Urology Care"
  )

Bladder Cancer Diagnosis

  ["Diagnosis": "Bladder Cancer for Urology Care"] BladderCancer
    where BladderCancer.prevalencePeriod starts before day of end of "Measurement Period"

Cystectomy Done

  ["Procedure, Performed": "Cystectomy for Urology Care"] Cystectomy
    with "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" FirstBladderCancerDx
      such that Global.EarliestOf (Cystectomy.relevantDatetime, Cystectomy.relevantPeriod) 6 months or less on or before day of start of FirstBladderCancerDx.prevalencePeriod

Denominator
- - "Initial Population"

Denominator Exception

  exists "BCG Not Available Within 6 Months After First Bladder Cancer Diagnosis"

Denominator Exclusion

  exists "Acute Tuberculosis Diagnosis"
    or exists "Immunosuppressive Drugs"
    or exists "Cystectomy Done"
    or "Has Excluding HIV, Immunocompromised Conditions Or Mixed Histology Before Diagnosis"
    or "Has Excluding Chemotherapy Or Radiotherapy Procedure Before Diagnosis"

First BCG Administered

  First( ["Medication, Administered": "Bacillus Calmette Guerin for Urology Care"] BCG
    with "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" FirstBladderCancerDx
      such that Global."NormalizeInterval"(BCG.relevantDatetime, BCG.relevantPeriod) starts 6 months or less after day of start of FirstBladderCancerDx.prevalencePeriod
    sort by start of Global."NormalizeInterval"(relevantDatetime, relevantPeriod)
  )

First Bladder Cancer Diagnosis

  First( "Bladder Cancer Diagnosis" BladderCancerDx
    with ["Procedure, Performed": "Tumor staging (tumor staging)"] BladderCancerStaging
      such that BladderCancerStaging.anatomicalLocationSite in "Bladder Cancer Site"
        and BladderCancerDx.prevalencePeriod starts on or before day of start of Global."NormalizeInterval"(BladderCancerStaging.relevantDatetime, BladderCancerStaging.relevantPeriod)
  )

First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start

  "First Bladder Cancer Diagnosis" FirstBladderCancerDx
    where start of FirstBladderCancerDx.prevalencePeriod during day of Interval["July 1 Of Year Prior To The Measurement Period", "June 30 Of The Measurement Period"]

Has Excluding Chemotherapy Or Radiotherapy Procedure Before Diagnosis

  exists ( 
    ( ["Medication, Active": "Chemotherapy Agents for Advanced Cancer"]
      union ["Procedure, Performed": "Radiotherapy (procedure)"] 
    ) ExclusionMedsProcedures
      with "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" FirstBladderCancerDx
        such that Global."NormalizeInterval"(ExclusionMedsProcedures.relevantDatetime, ExclusionMedsProcedures.relevantPeriod) starts 6 months or less on or before day of start of FirstBladderCancerDx.prevalencePeriod
  )

Has Excluding HIV, Immunocompromised Conditions Or Mixed Histology Before Diagnosis

  exists ( 
    ( ["Diagnosis": "HIV"]
      union ["Diagnosis": "Immunocompromised Conditions"]
      union ["Diagnosis": "Mixed Histology Urothelial Cell Carcinoma for Urology Care"] 
    ) ExclusionDiagnosis
      with "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" FirstBladderCancerDx
        such that ExclusionDiagnosis.prevalencePeriod starts on or before day of start of FirstBladderCancerDx.prevalencePeriod
  )

Has First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start

  "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" is not null

Has Most Recent Bladder Cancer Tumor Staging Is T1, Tis, Ta HG

  Last( ["Procedure, Performed": "Tumor staging (tumor staging)"] BladderCancerStaging
    where BladderCancerStaging.anatomicalLocationSite in "Bladder Cancer Site"
      and Global."NormalizeInterval"(BladderCancerStaging.relevantDatetime, BladderCancerStaging.relevantPeriod) during day of Interval["July 1 Of Year Prior To The Measurement Period", "June 30 Of The Measurement Period"]
        and (
          BladderCancerStaging.result ~ "American Joint Committee on Cancer pT1 (qualifier value)"
          or BladderCancerStaging.result ~ "American Joint Committee on Cancer pTis (qualifier value)"
          or BladderCancerStaging.result ~ "American Joint Committee on Cancer pTa (qualifier value)"
          or BladderCancerStaging.result ~ "Carcinoma in situ of bladder"
        )
  ) is not null

Has Qualifying Encounter

  exists ["Encounter, Performed": "Office Visit"] ValidEncounter
    where ValidEncounter.relevantPeriod during day of "Measurement Period"
      and ValidEncounter.class !~ "virtual"

Immunosuppressive Drugs

  ["Medication, Active": "Immunosuppressive Drugs for Urology Care"] ImmunosuppressiveDrugs
    with "First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start" FirstBladderCancerDx
      such that Global."NormalizeInterval"(ImmunosuppressiveDrugs.relevantDatetime, ImmunosuppressiveDrugs.relevantPeriod) starts on or before day of start of FirstBladderCancerDx.prevalencePeriod

Initial Population

  "Has First Bladder Cancer Diagnosis During 6 Months Prior To or After Measurement Period Start"
    and "Has Most Recent Bladder Cancer Tumor Staging Is T1, Tis, Ta HG"
    and "Has Qualifying Encounter"

July 1 Of Year Prior To The Measurement Period

  Date((year from start of "Measurement Period" - 1), 7, 1)

June 30 Of The Measurement Period

  Date((year from start of "Measurement Period"), 6, 30)

Numerator
- - "First BCG Administered" is not null

SDE Ethnicity

  ["Patient Characteristic Ethnicity": "Ethnicity"]

SDE Payer

  ["Patient Characteristic Payer": "Payer Type"]

SDE Race

  ["Patient Characteristic Race": "Race"]

SDE Sex

  ["Patient Characteristic Sex": "Federal Administrative Sex"]

Functions

Global.Earliest(period Interval<DateTime>)

  if ( HasStart(period)) then start of period 
    else 
  end of period

Global.EarliestOf(pointInTime DateTime, period Interval<DateTime>)
- - Earliest(NormalizeInterval(pointInTime, period))

Global.HasStart(period Interval<DateTime>)

  not ( start of period is null
      or start of period = minimum DateTime
  )

Global.NormalizeInterval(pointInTime DateTime, period Interval<DateTime>)

  if pointInTime is not null then Interval[pointInTime, pointInTime]
    else if period is not null then period 
    else null as Interval<DateTime>

Terminology

code "American Joint Committee on Cancer pT1 (qualifier value)" ("SNOMEDCT Code (1228957006)")
code "American Joint Committee on Cancer pTa (qualifier value)" ("SNOMEDCT Code (1228952000)")
code "American Joint Committee on Cancer pTis (qualifier value)" ("SNOMEDCT Code (1228953005)")
code "Carcinoma in situ of bladder" ("ICD10CM Code (D09.0)")
code "Radiotherapy (procedure)" ("SNOMEDCT Code (1287742003)")
code "Tumor staging (tumor staging)" ("SNOMEDCT Code (254292007)")
code "virtual" ("ActCode Code (VR)")
valueset "Bacillus Calmette Guerin for Urology Care" (2.16.840.1.113762.1.4.1248.353)
valueset "Bladder Cancer for Urology Care" (2.16.840.1.113762.1.4.1248.354)
valueset "Bladder Cancer Site" (2.16.840.1.113762.1.4.1248.409)
valueset "Chemotherapy Agents for Advanced Cancer" (2.16.840.1.113762.1.4.1248.355)
valueset "Cystectomy for Urology Care" (2.16.840.1.113762.1.4.1248.358)
valueset "Ethnicity" (2.16.840.1.114222.4.11.837)
valueset "Federal Administrative Sex" (2.16.840.1.113762.1.4.1021.121)
valueset "HIV" (2.16.840.1.113883.3.464.1003.120.12.1003)
valueset "Immunocompromised Conditions" (2.16.840.1.113762.1.4.1248.363)
valueset "Immunosuppressive Drugs for Urology Care" (2.16.840.1.113762.1.4.1248.364)
valueset "Mixed Histology Urothelial Cell Carcinoma for Urology Care" (2.16.840.1.113762.1.4.1248.365)
valueset "Office Visit" (2.16.840.1.113883.3.464.1003.101.12.1001)
valueset "Payer Type" (2.16.840.1.114222.4.11.3591)
valueset "Race" (2.16.840.1.114222.4.11.836)
valueset "Tuberculosis for Urology Care" (2.16.840.1.113762.1.4.1248.351)
valueset "Unavailability of Bacillus Calmette Guerin for Urology Care" (2.16.840.1.113762.1.4.1248.369)

Data Criteria (QDM Data Elements)

"Diagnosis: Bladder Cancer for Urology Care" using "Bladder Cancer for Urology Care (2.16.840.1.113762.1.4.1248.354)"
"Diagnosis: HIV" using "HIV (2.16.840.1.113883.3.464.1003.120.12.1003)"
"Diagnosis: Immunocompromised Conditions" using "Immunocompromised Conditions (2.16.840.1.113762.1.4.1248.363)"
"Diagnosis: Mixed Histology Urothelial Cell Carcinoma for Urology Care" using "Mixed Histology Urothelial Cell Carcinoma for Urology Care (2.16.840.1.113762.1.4.1248.365)"
"Diagnosis: Tuberculosis for Urology Care" using "Tuberculosis for Urology Care (2.16.840.1.113762.1.4.1248.351)"
"Encounter, Performed: Office Visit" using "Office Visit (2.16.840.1.113883.3.464.1003.101.12.1001)"
"Medication, Active: Chemotherapy Agents for Advanced Cancer" using "Chemotherapy Agents for Advanced Cancer (2.16.840.1.113762.1.4.1248.355)"
"Medication, Active: Immunosuppressive Drugs for Urology Care" using "Immunosuppressive Drugs for Urology Care (2.16.840.1.113762.1.4.1248.364)"
"Medication, Administered: Bacillus Calmette Guerin for Urology Care" using "Bacillus Calmette Guerin for Urology Care (2.16.840.1.113762.1.4.1248.353)"
"Medication, Not Administered: Bacillus Calmette Guerin for Urology Care" using "Bacillus Calmette Guerin for Urology Care (2.16.840.1.113762.1.4.1248.353)"
"Patient Characteristic Ethnicity: Ethnicity" using "Ethnicity (2.16.840.1.114222.4.11.837)"
"Patient Characteristic Payer: Payer Type" using "Payer Type (2.16.840.1.114222.4.11.3591)"
"Patient Characteristic Race: Race" using "Race (2.16.840.1.114222.4.11.836)"
"Patient Characteristic Sex: Federal Administrative Sex" using "Federal Administrative Sex (2.16.840.1.113762.1.4.1021.121)"
"Procedure, Performed: Cystectomy for Urology Care" using "Cystectomy for Urology Care (2.16.840.1.113762.1.4.1248.358)"
"Procedure, Performed: Radiotherapy (procedure)" using "Radiotherapy (procedure) (SNOMEDCT Code 1287742003)"
"Procedure, Performed: Tumor staging (tumor staging)" using "Tumor staging (tumor staging) (SNOMEDCT Code 254292007)"

Supplemental Data Elements

SDE Ethnicity

  ["Patient Characteristic Ethnicity": "Ethnicity"]

SDE Payer

  ["Patient Characteristic Payer": "Payer Type"]

SDE Race

  ["Patient Characteristic Race": "Race"]

SDE Sex

  ["Patient Characteristic Sex": "Federal Administrative Sex"]

Risk Adjustment Variables

None

Measure Set

None