#449: HER2 Negative or Undocumented Breast Cancer Patients Spared Treatment with HER2-Targeted Therapies

Quality ID

449

NQF

1857

High Priority Measure

Yes

Specifications

Registry

Measure Type

Process

Specialty

General Oncology

Measure Description

Proportion of female patients (aged 18 years and older) with breast cancer who are human epidermal growth factor receptor 2 (HER2)/neu negative who are not administered HER2-targeted therapies

 

Instructions

This measure is to be submitted a minimum of once per performance period for patients with breast cancer seen during the performance period. This measure may be submitted by eligible clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding.

Measure Submission:

The listed denominator criteria is used to identify the intended patient population. The numerator options included in this specification are used to submit the quality actions allowed by the measure. The quality-data codes listed do not need to be submitted for registry submissions; however, these codes may be submitted for those registries that utilize claims data.

 

Denominator

Adult women with breast cancer that are HER2 negative or HER2 undocumented

Definitions:

Use the following definitions to determine HER-2/neu status

Positive:
IHC 3+ based on circumferential membrane staining that is complete, intense ISH positive based on:

  • Single-probe average HER2 copy number =6. 0 signals/cell
  • Dual-probe HER2/CEP17 ratio = 2. 0 with an average HER2 copy number =4. 0 signals/cell
  • Dual-probe HER2/CEP17 ratio = 2. 0 with an average HER2 copy number <4. 0 signals/cell
  • Dual-probe HER2/CEP17 ratio < 2. 0 with an average HER2 copy number =6. 0 signals/cell

Equivocal:
IHC 2+ based on circumferential membrane staining that is incomplete and/or weak/moderate and within > 10% of the invasive tumor cells or complete and circumferential membrane staining that is intense and within = 10% of the invasive tumor cells ISH equivocal based on:

  • Single-probe ISH average HER2 copy number = 4. 0 and < 6. 0 signals/cell
  • Dual-probe HER2/CEP17 ratio < 2. 0 with an average HER2 copy number = 4. 0 and < 6. 0 signals/cell

Negative:
IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within > 10% of the invasive tumor cells or IHC 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within = 10% of the invasive tumor cells ISH negative based on:

  • Single-probe average HER2 copy number < 4. 0 signals/cell
  • Dual-probe HER2/CEP17 ratio < 2. 0 with an average HER2 copy number < 4. 0 signals/cell

Indeterminate:
Indeterminate if technical issues prevent one or both tests (IHC and ISH) from being reported as positive, negative, or equivocal. Conditions may include:

  • Inadequate specimen handling,
  • Artifacts (crush or edge artifacts) that make interpretation difficult
  • Analytic testing failure

Transferred to Practice:
Patients who have transferred to the reporting practice after the initiation of HER2 targeted therapy at another practice. This prevents practices from being held accountable for another practices’ prior treatment decisions. The eligible clinician submitting the measure should have initiated the treatment for the denominator eligible patient.

 

Denominator Criteria (Eligible Cases):

Female Patients aged ≥ 18 years on date of encounter

AND

Diagnosis of Breast Cancer (ICD-10-CM): C50. 011, C50. 012, C50. 019, C50. 111, C50. 112, C50. 119, C50. 211, C50. 212, C50. 219, C50. 311, C50. 312, C50. 319, C50. 411, C50. 412, C50. 419, C50. 511, C50. 512, C50. 519, C50. 611, C50. 612, C50. 619, C50. 811, C50. 812, C50. 819, C50. 911, C50. 912, C50. 919

AND

Patient encounter during performance period (CPT): 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215

AND

Two or more encounters at the reporting site

AND

HER-2/neu Negative or Undocumented/Unknown: G9825

AND NOT

DENOMINATOR EXCLUSION:

Patient transferred to practice after initiation of chemotherapy: G9826

 

Numerator

HER2-targeted therapies not administered during the initial course of treatment

NUMERATOR NOTE: HER-2 targeted therapies are defined as Trastuzumab, Pertuzumab and TDM1

Numerator Options:

Performance Met: HER2-targeted therapies not administered during the initial course of treatment (G9827)

OR

Performance Not Met: HER2-targeted therapies administered during the initial course of treatment (G9828)

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