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

2026 COLLECTION TYPE:‌

MERIT-BASED INCENTIVE PAYMENT SYSTEM (MIPS) CLINICAL QUALITY MEASURE (CQM)

‌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:‌

Reporting Frequency:

This measure is to be submitted a minimum of once per performance period for denominator eligible cases as defined in the denominator criteria.

‌Intent and Clinician Applicability:

This measure is intended to reflect the quality of services provided for patients on first-line immune checkpoint inhibitor (ICI) 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 Strata and Performance Rates:

This measure contains one strata defined by a single submission criteria. This measure produces a single performance rate.

‌Implementation Considerations:

For the purposes of MIPS implementation, this patient-process measure is submitted a minimum of once per patient during the performance period. The most advantageous quality data code will be used if the measure is submitted more than once.

‌Telehealth:

NOT TELEHEALTH ELIGIBLE: This measure is not appropriate for nor applicable to the telehealth setting. Patient encounters for this measure conducted via telehealth should be removed from the denominator eligible patient population. Therefore, if the patient meets all denominator criteria but the encounter is conducted via telehealth, it would be appropriate to remove them from the denominator eligible patient population. Telehealth eligibility is at the measure level for inclusion within the denominator eligible patient population and based on the measure specification definitions which are independent of changes to coding and/or billing practices.

‌Measure Submission:

The quality data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third party intermediaries that utilize this collection type for submissions; however, these codes may be submitted for those third party intermediaries that utilize Medicare Part B claims data. The coding provided to identify the measure criteria: Denominator or Numerator, may be an example of coding that could be used to identify patients that meet the intent of this clinical topic. When implementing this measure, please refer to the ‘Reference Coding’ section to determine if other codes or code languages that meet the intent of the criteria may also be used within the medical record to identify and/or assess patients. 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 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

‌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.