2026 MIPS Measure #506: Positive PD-L1 Biomarker Expression Test Result Prior to First-Line Immune Checkpoint Inhibitor Therapy

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.

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.

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.

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 on the date of the encounter (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

Encounters conducted via telehealth: M1426

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

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

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.

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)

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.