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2025 MIPS Measure Positive PD-L1 Biomarker Expression Test Result Prior to First-Line Immune Checkpoint Inhibitor Therapy‌‌‌

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2025 COLLECTION TYPE:

MIPS CLINICAL QUALITY MEASURES (CQMS)

‌MEASURE TYPE: Process – High Priority

‌Description:

‌Percentage of patients aged 18 years and older with a diagnosis of metastatic non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (HNSCC) on first-line immune checkpoint inhibitor (ICI) therapy, who had a positive PD-L1 biomarker expression test result prior to giving ICI therapy.

‌Instructions:

This measure is to be submitted a minimum of once per performance period for patients with a diagnosis of NSCLC or HNSCC on first-line ICI therapy seen during the performance period. This measure is intended to reflect the quality of services provided for patients aged 18 years and older with a diagnosis of metastatic NSCLC or HNSCC on first-line ICI therapy, who had a positive PD-L1 biomarker expression test result prior to giving ICI therapy during the measurement period. This measure may be submitted by Merit-based Incentive Payment System (MIPS) eligible clinicians who perform the quality actions described in the measure based on services provided and the measure-specific denominator coding.

‌Measure Submission Type:

Measure data may be submitted by individual MIPS eligible clinicians, groups, or third-party intermediaries. The listed denominator criteria are used to identify the intended patient population. The numerator options included in this specification are used to submit the quality actions as allowed by the measure. The quality data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third-party intermediaries that utilize this modality for submissions; however, these codes may be submitted for those third-party intermediaries that utilize Medicare Part B claims data. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.

Denominator:

‌Patients aged 18 years and older with a diagnosis of metastatic non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (HNSCC) and on first-line immune checkpoint inhibitors without chemotherapy

‌Definitions:

‌Immune checkpoint inhibitors – Class of medications that prevent tumors from “hiding” or “evading” the body’s natural immune system. This is a form of cancer immunotherapy. Immune checkpoint inhibitor medications include PD-1 inhibitor drugs, PD-L1 inhibitor drugs, and CTLA-4 inhibitor drugs.

  • PD-1 inhibitors drugs include: Pembrolizumab, Nivolumab, Cemiplimab
  • ‌PD-L1 inhibitor drugs include: Atezolizumab
  • ‌CTLA-4 inhibitor drugs include: Ipilimumab‌First-line treatment – Initial or first treatment recommended for cancer
  • ‌Various treatment regimens were considered, including immune checkpoint inhibitors
  • PD-L1 testing required per FDA approval for the applicable histology

    Denominator Instructions:

    Additionally, immune checkpoint inhibitors FDA approved for specific histology must meet the following criteria to be considered denominator eligible:

  • Pembrolizumab (PD-1 inhibitor drug) AND
    • first-line treatment in patients with metastatic NSCLC
    • OR first-line treatment in patients with metastatic HNSCC
  • Cemiplimab (PD-1 inhibitor drug) AND
    • first-line treatment in patients with metastatic NSCLC
  • Atezolizumab (PD-L1 inhibitor drug) AND
    • first-line treatment in patients with metastatic NSCLC
  • Nivolumab (PD-1 inhibitor drug) and Ipilimumab (CTLA-4 inhibitor drug) combination AND
    • first-line treatment in patients with metastatic NSCLC

      DENOMINATOR NOTE: *Signifies that this CPT Category I code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for MIPS CQMs.

      Denominator Criteria (Eligible Cases):

      ‌Patients aged 18 years and older on the date of the encounter

      AND

      ‌Diagnosis for metastatic non-small cell lung cancer or squamous cell carcinoma of head and neck (ICD-10- CM): C34.00, C34.01, C34.02, C34.10, C34.11, C34.12, C34.2, C34.30, C34.31, C34.32, C34.80, C34.81, C34.82, C34.90, C34.91, C34.92, C00.0, C00.1, C00.2, C00.3, C00.4, C00.5, C00.6, C00.8, C00.9, C01, C02.0, C02.1,‌ C02.2, C02.3, C02.4, C02.8, C02.9, C03.0, C03.1, C03.9, C04.0, C04.1, C04.8, C04.9, C05.0, C05.1, C05.2, C05.8, C05.9, C06.0, C06.1, C06.2, C06.80, C06.89, C06.9, C09.0, C09.1, C09.8, C09.9, C10.0, C10.1, C10.2, C10.3, C10.4, C10.8, C10.9, C11.0, C11.1, C11.2, C11.3, C11.8, C11.9, C12, C13.0, C13.1, C13.2, C13.8, C13.9, C14.0, C14.2, C14.8, C30.0, C31.0, C31.1, C31.2, C31.3, C31.8, C31.9, C32.0, C32.1, C32.2, C32.3, C32.8, C32.9, C76.0

      AND

      Patient encounters during the performance period (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241*, 99242*, 99243*, 99244*, 99245*

      WITHOUT

      ‌Telehealth modifier (including but not limited to): GQ, GT, POS 02, POS 10

      AND

      Currently on first-line immune checkpoint inhibitors without chemotherapy: M1411

      AND NOT

      DENOMINATOR EXCLUSION:

      Patients with metastatic NSCLC with epidermal growth factor receptor (EGFR) mutations, ALK genomic tumor aberrations, or other targetable genomic abnormalities with approved first-line targeted therapy, such as NSCLC with ROS1 rearrangement, BRAF V600E mutation, NTRK 1/2/3 gene fusion, MET ex14 skipping mutation, and RET rearrangement: M1412

      Numerator:

      ‌Patients who had a positive PD-L1 biomarker expression test result prior to the initiation of first-line immune checkpoint inhibitor therapy

      Definitions:

      PD-L1 biomarker expression test – FDA-approved test that measures the expression of PD-L1 on cancer and/or immune cells.

      Positive PD-L1 biomarker expression test result – PD-L1 test is considered positive if the cancer and/or immune cells have an appropriate threshold of PD-L1 expression based on the approved companion diagnostic.

      ‌Numerator Instructions:

      ‌The denominator exception is applicable for the following situations:

  • ‌PD-L1 biomarker expression testing was unable to be performed prior to the initiation of first-line immune checkpoint inhibitor therapy due to an urgent or emergent situation where any treatment delay would jeopardize the patient’s health and/or cancer care.
  • ‌Lack of available tissue for PD-L1 biomarker expression testing due to a documented medical and/or surgical contraindication which would not allow for the patient to undergo a tissue biopsy safely.

Patients without a PD-L1 biomarker expression test prior to the initiation of first-line immune checkpoint inhibitor therapy who do not fall into the denominator exception should be considered performance not met.

‌NUMERATOR NOTE:

Test performance is necessary prior to initiation of first-line immune checkpoint inhibitor therapy for each new diagnosis of NSCLC or HNSCC. This ensures that there is not retesting of a recurrent disease where PD-L1 status

may have already been performed. Testing for PD-L1 performance has a look back period of 6 months prior to the current performance period.

Numerator Options:

Performance Met: Patients who had a positive PD-L1 biomarker expression test result prior to the initiation of first-line immune checkpoint inhibitor therapy (M1413)

OR

Denominator Exception: Documentation of medical reason(s) for not performing the PD-L1 biomarker expression test prior to initiation of first-line immune checkpoint inhibitor therapy (e.g., patient is in an urgent or emergent situation where delay of treatment would jeopardize the patient’s health status; other medical reasons/contraindication) (M1414)

OR

Performance Not Met: Patients who did not have a positive PD-L1 biomarker expression test result prior to the initiation of first-line immune checkpoint inhibitor therapy (M1415)

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