eCQM Title | # Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer
eCQM Identifier (Measure Authoring Tool) | 646 | eCQM Version Number | 4.0.000
NQF Number | Not Applicable | GUID | 224b1722-aef9-4e7f-97f8-284267fc1b00
Measurement Period | January 1, 20XX through December 31, 20XX
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 bladder cancer staging
Copyright |
    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 use or accuracy of third party codes contained in the specifications.

    CPT(R) contained in the Measure specifications is copyright 2004-2022. American Medical Association. LOINC(R) copyright 2004-2022 Regenstrief Institute, Inc. This material contains SNOMED Clinical Terms(R) (SNOMED CT[R]) copyright 2004-2022 International Health Terminology Standards Development Organisation. ICD-10 copyright 2022 World Health Organization. All Rights Reserved.
Disclaimer |
    The performance measure is not a clinical guideline and 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 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).
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).
Improvement Notation |
    A higher score is the preferred result and 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., & Urologic Diseases in America Project (2011). Compliance with Guidelines for Patients with Bladder Cancer: Variation in the Delivery of Care. Cancer.2011 Dec 1: 117(23): 5392--5401.
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3206145/'
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.M., & Mckiernan, J. M., (2016, April) American Urological Association. Non-Muscle Invasive Bladder Cancer.
    https://www.auanet.org/guidelines-and-quality/guidelines/bladder-cancer-non-muscle-invasive-guideline'
Reference |
    Reference Type: CITATION
    Reference Text: 'Hall, M.C., Chang, S.S., Dalbagni, G., Pruthi, R.S., Schellhammer, P.F., Seigne, J.D., Skinner, E.C., & Wolf .S., (2016). American Urological Association. Guideline for the Management of Non-muscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): Update 2016.
    https://www.auajournals.org/doi/10.1016/j.juro.2007.09.003'
Reference |
    Reference Type: CITATION
    Reference Text: 'Kassouf, W., Black, P., (2016) Treatment of primary non-muscle invasive urothelial bladder cancer. Literature review current through Dec. 2016.
    https://www.uptodate.com/contents/treatment-of-primary-non-muscle-invasive-urothelial-bladder-cancer?source=search_result&search=Treatment%20of%20primary%20non-muscle%20invasive%20urothelial%20bladder%20cancer&selectedTitle=1~150 T of primary'
Reference |
    Reference Type: CITATION
    Reference Text: 'NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). (2021). Bladder Cancer. Version 6.2021-December 6. 2021.
    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. SEER Cancer Stat Facts: Bladder Cancer. National Cancer Institute. Bethesda,MD, 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
    http://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 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 5.6.  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 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
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
Numerator |
    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
Denominator Exceptions |
    Unavailability of BCG within 6 months after Bladder Cancer Staging
Supplemental Data Elements |
    For every patient evaluated by this measure also identify payer, race, ethnicity and sex

## Table of Contents

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

### Population Criteria

- - Initial Population

    - -     "First Qualifying Bladder Cancer Staging Procedure" is not null
              and "Has Most Recent Bladder Cancer Tumor Staging is Ta HG, Tis, T1"
              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 Staging"
              or "Has Excluding Chemotherapy or Radiotherapy Procedure Before Staging"

- - Numerator

    - -     "First BCG Administered" is not null

- - Numerator Exclusions

    - -     None

- - Denominator Exceptions

    - -     exists "BCG Not Available Within 6 Months After Bladder Cancer Staging"

- - Stratification

    - -     None

### Definitions

- - Acute Tuberculosis Diagnosis

    - -     ["Diagnosis": "Active Tuberculosis for Urology Care"] ActiveTuberculosis
              with "First Bladder Cancer Staging Procedure" FirstBladderCancerStaging
                such that ActiveTuberculosis.prevalencePeriod overlaps after Global."NormalizeInterval" ( FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod )

  - BCG Not Available Within 6 Months After Bladder Cancer Staging

    - -     ( ["Medication, Not Administered": "BCG Bacillus Calmette Guerin for Urology Care"] BCGnotGiven
                with "First Bladder Cancer Staging Procedure" FirstBladderCancerStaging
                  such that BCGnotGiven.authorDatetime 6 months or less after start of Global."NormalizeInterval" ( FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod )
                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
              end of "Measurement Period"

  - Cystectomy Done

    - -     ["Procedure, Performed": "Cystectomy for Urology Care"] Cystectomy
              with "First Bladder Cancer Staging Procedure" FirstBladderCancerStaging
                such that Global.EarliestOf ( Cystectomy.relevantDatetime, Cystectomy.relevantPeriod ) 6 months or less before start of Global."NormalizeInterval" ( FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod )

  - Denominator

    - -     "Initial Population"

  - Denominator Exception

    - -     exists "BCG Not Available Within 6 Months After Bladder Cancer Staging"

  - Denominator Exclusion

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

  - First BCG Administered

    - -     First(["Medication, Administered": "BCG Bacillus Calmette Guerin for Urology Care"] BCG
                with "First Bladder Cancer Staging Procedure" FirstBladderCancerStaging
                  such that Global."NormalizeInterval"(BCG.relevantDatetime, BCG.relevantPeriod)starts 6 months or less after start of Global."NormalizeInterval"(FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod)
                sort by start of Global."NormalizeInterval"(relevantDatetime, relevantPeriod)
            )

  - First Bladder Cancer Staging Procedure

    - -     First(["Procedure, Performed": "Tumor staging (tumor staging)"] BladderCancerStaging
                with "Bladder Cancer Diagnosis" BladderCancer
                  such that Global."NormalizeInterval"(BladderCancerStaging.relevantDatetime, BladderCancerStaging.relevantPeriod)starts on or before day of start BladderCancer.prevalencePeriod
                sort by start of Global."NormalizeInterval"(relevantDatetime, relevantPeriod)
            )

  - First Qualifying Bladder Cancer Staging Procedure

    - -     "First Bladder Cancer Staging Procedure" FirstBladderCancerStaging
              where Global."NormalizeInterval" ( FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod ) during day of Interval["July 1 of Year Prior to the Measurement Period", "June 30 of the Measurement Period"]

  - Has Excluding HIV, Immunocompromised Conditions or Mixed Histology Before Staging

    - -     exists ( ( ["Diagnosis": "HIV"]
                union ["Diagnosis": "Immunocompromised Conditions"]
                union ["Diagnosis": "Mixed histology urothelial cell carcinoma for Urology Care"] ) ExclusionDiagnosis
                with "First Bladder Cancer Staging Procedure" FirstBladderCancerStaging
                  such that ExclusionDiagnosis.prevalencePeriod starts on or before start of Global."NormalizeInterval" ( FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod )
            )

  - Has Excluding Chemotherapy or Radiotherapy Procedure Before Staging

    - -     exists ( ( ["Medication, Active": "Chemotherapy Agents for Advanced Cancer"]
                union ["Procedure, Performed": "Combined radiotherapy (procedure)"] ) ExclusionMedsProcedures
                with "First Bladder Cancer Staging Procedure" FirstBladderCancerStaging
                  such that ExclusionMedsProcedures.relevantPeriod starts 6 months or less before Global."NormalizeInterval" ( FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod )
            )

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

    - -     ( "First Qualifying Bladder Cancer Staging Procedure" FirstBladderCancerStagingMP
                where FirstBladderCancerStagingMP.result ~ "T1: Urinary tract tumor invades subepithelial connective tissue (finding)"
                  or FirstBladderCancerStagingMP.result ~ "Ta: Noninvasive papillary carcinoma (urinary tract) (finding)"
                  or FirstBladderCancerStagingMP.result ~ "Tis: Carcinoma in situ (flat tumor of urinary bladder) (finding)"
                  or FirstBladderCancerStagingMP.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 Staging Procedure" FirstBladderCancerStaging
                such that Global."NormalizeInterval" ( ImmunosuppressiveDrugs.relevantDatetime, ImmunosuppressiveDrugs.relevantPeriod ) starts on or before start of Global."NormalizeInterval" ( FirstBladderCancerStaging.relevantDatetime, FirstBladderCancerStaging.relevantPeriod )

  - Initial Population

    - -     "First Qualifying Bladder Cancer Staging Procedure" is not null
              and "Has Most Recent Bladder Cancer Tumor Staging is Ta HG, Tis, T1"
              and "Has Qualifying Encounter"

  - July 1 of Year Prior to the Measurement Period

    - -     DateTime((year from start of "Measurement Period" - 1), 7, 1, 0, 0, 0, 0, 0)

  - June 30 of the Measurement Period

    - -     DateTime((year from start of "Measurement Period"), 6, 30, 23, 59, 59, 0, 0)

  - Numerator

    - -     "First BCG Administered" is not null

  - SDE Ethnicity

    - -     ["Patient Characteristic Ethnicity": "Ethnicity"]

  - SDE Payer

    - -     ["Patient Characteristic Payer": "Payer"]

  - SDE Race

    - -     ["Patient Characteristic Race": "Race"]

  - SDE Sex

    - -     ["Patient Characteristic Sex": "ONC 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 "Carcinoma in situ of bladder" ("ICD10CM Code (D09.0)")
- code "Combined radiotherapy (procedure)" ("SNOMEDCT Code (169331000)")
- code "T1: Urinary tract tumor invades subepithelial connective tissue (finding)" ("SNOMEDCT Code (369935001)")
- code "Ta: Noninvasive papillary carcinoma (urinary tract) (finding)" ("SNOMEDCT Code (369949005)")
- code "Tis: Carcinoma in situ (flat tumor of urinary bladder) (finding)" ("SNOMEDCT Code (369934002)")
- code "Tumor staging (tumor staging)" ("SNOMEDCT Code (254292007)")
- code "virtual" ("ActCode Code (VR)")
- valueset "Active Tuberculosis for Urology Care" (2.16.840.1.113762.1.4.1151.56)
- valueset "BCG Bacillus Calmette Guerin for Urology Care" (2.16.840.1.113762.1.4.1151.52)
- valueset "Bladder Cancer for Urology Care" (2.16.840.1.113762.1.4.1151.45)
- valueset "Chemotherapy Agents for Advanced Cancer" (2.16.840.1.113762.1.4.1151.60)
- valueset "Cystectomy for Urology Care" (2.16.840.1.113762.1.4.1151.55)
- valueset "Ethnicity" (2.16.840.1.114222.4.11.837)
- valueset "HIV" (2.16.840.1.113883.3.464.1003.120.12.1003)
- valueset "Immunocompromised Conditions" (2.16.840.1.113883.3.666.5.1940)
- valueset "Immunosuppressive Drugs for Urology Care" (2.16.840.1.113762.1.4.1151.32)
- valueset "Mixed histology urothelial cell carcinoma for Urology Care" (2.16.840.1.113762.1.4.1151.39)
- valueset "Office Visit" (2.16.840.1.113883.3.464.1003.101.12.1001)
- valueset "ONC Administrative Sex" (2.16.840.1.113762.1.4.1)
- valueset "Payer" (2.16.840.1.114222.4.11.3591)
- valueset "Race" (2.16.840.1.114222.4.11.836)
- valueset "Unavailability of Bacillus Calmette Guerin for urology care" (2.16.840.1.113762.1.4.1151.44)

### Data Criteria (QDM Data Elements)

- "Diagnosis: Active Tuberculosis for Urology Care" using "Active Tuberculosis for Urology Care (2.16.840.1.113762.1.4.1151.56)"
- "Diagnosis: Bladder Cancer for Urology Care" using "Bladder Cancer for Urology Care (2.16.840.1.113762.1.4.1151.45)"
- "Diagnosis: HIV" using "HIV (2.16.840.1.113883.3.464.1003.120.12.1003)"
- "Diagnosis: Immunocompromised Conditions" using "Immunocompromised Conditions (2.16.840.1.113883.3.666.5.1940)"
- "Diagnosis: Mixed histology urothelial cell carcinoma for Urology Care" using "Mixed histology urothelial cell carcinoma for Urology Care (2.16.840.1.113762.1.4.1151.39)"
- "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 (2.16.840.1.113762.1.4.1151.60)"
- "Medication, Active: Immunosuppressive Drugs for Urology Care" using "Immunosuppressive Drugs for Urology Care (2.16.840.1.113762.1.4.1151.32)"
- "Medication, Administered: BCG Bacillus Calmette Guerin for Urology Care" using "BCG Bacillus Calmette Guerin for Urology Care (2.16.840.1.113762.1.4.1151.52)"
- "Medication, Not Administered: BCG Bacillus Calmette Guerin for Urology Care" using "BCG Bacillus Calmette Guerin for Urology Care (2.16.840.1.113762.1.4.1151.52)"
- "Patient Characteristic Ethnicity: Ethnicity" using "Ethnicity (2.16.840.1.114222.4.11.837)"
- "Patient Characteristic Payer: Payer" using "Payer (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: ONC Administrative Sex" using "ONC Administrative Sex (2.16.840.1.113762.1.4.1)"
- "Procedure, Performed: Combined radiotherapy (procedure)" using "Combined radiotherapy (procedure) (SNOMEDCT Code 169331000)"
- "Procedure, Performed: Cystectomy for Urology Care" using "Cystectomy for Urology Care (2.16.840.1.113762.1.4.1151.55)"
- "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"]

- SDE Race

  - -     ["Patient Characteristic Race": "Race"]

- SDE Sex

  - -     ["Patient Characteristic Sex": "ONC Administrative Sex"]

### Risk Adjustment Variables

- None

Measure Set |
    None