Measure 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: Ipilimumab
First-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)
Rationale
The evidence-based NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer and NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancer address the measure’s quality actions of a positive PD-L1 biomarker expression test prior to giving first-line immune checkpoint inhibitor therapy in the metastatic NSCLC or squamous cell carcinoma of head and neck populations (NCCN Guidelines: NSCLC, 2024; NCCN Guidelines HNSCC, 2024). The measure will enhance compliance with the clinical guidelines by ensuring the eligible provider addresses timely biomarker testing that makes a difference in treatment decisions and improves patient outcomes.
Clinical Recommendation Statements
Biomarker testing that is not timely may make a difference in treatment decisions and/or patient outcomes. Appropriate treatment delivery could be delayed, or ineffective therapies could be prescribed, resulting in poor clinical outcomes and unnecessary healthcare costs (Pai et al., 20120 Lim et al., 2015).
The NCCN NSCLC Panel emphasizes that clinicians should obtain molecular testing results for actionable biomarkers before administering first-line ICI therapy, if feasible (NCCN Guidelines: NSCLC, 2024).
Despite the ambiguities of PD-L1 testing and definitions, PD-L1 expression may be associated with better outcomes from immunotherapy for recurrent or metastatic HNSCC (i.e., greater likelihood of response to pembrolizumab and greater survival benefit in response to nivolumab) (NCCN Guidelines: HNSCC, 2024).