Measure Description
Pathology reports based on lung biopsy and/or cytology specimens with a diagnosis of primary non-small cell lung cancer classified into specific histologic type following the International Association for the Study of Lung Cancer (IASLC) guidance or classified as non-small cell lung cancer not otherwise specified (NSCLC-NOS) with an explanation included in the pathology report.
Instructions
This measure is to be submitted each time that is denominator eligible as defined in the denominator criteria.
Intent and Clinician Applicability:
The intent of this measure is to assess that lung biopsy and cytology specimen pathology reports for patients with nonsmall cell lung cancer are classified into specific histologic type following IASLC OR classified as NSCLC-NOS with an explanation included in the pathology report. This measure may be submitted by Merit-based Incentive Payment System (MIPS) eligible clinicians who perform the quality actions as defined by the numerator based on the 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 purposes of MIPS implementation, this procedure measure is submitted each time a procedure is performed during the performance period. Only one quality data code (QDC) per date of service for a patient is required.
Telehealth:
This measure is not appropriate for nor applicable to the telehealth setting. This measure is procedure based and therefore doesn’t allow for the denominator criteria to be conducted via telehealth. It would be appropriate to remove these patients 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
Lung biopsy and cytology specimen reports with a diagnosis of primary non-small cell lung cancer
Denominator Criteria (Eligible Cases):
Patients ≥ 18 years of age on date of service
AND
Diagnosis for lung cancer (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
AND
Patient encounter during performance period (CPT): 88104, 88108, 88112, 88173, 88305
AND NOT
DENOMINATOR EXCLUSION:
Specimen site other than anatomic location of lung or is not classified as primary non-small cell lung cancer: G9420
Numerator
Lung biopsy and cytology specimen reports with a diagnosis of primary non-small cell lung cancer classified into specific histologic type following IASLC guidance (see below) (including but not limited to squamous cell carcinoma or adenocarcinoma) OR classified as NSCLC-NOS with an explanation included in the pathology report
IASLC Guidance: The IASLC recommends the following regarding terminology for small biopsy and cytology specimens:
- Do not use the term “large cell carcinoma”
- Do not use the term “AIS (adenocarcinoma in situ)” or “MIA (minimally invasive adenocarcinoma)”— if a noninvasive pattern is present in a small biopsy, the term “lepidic growth” should be used instead
- Do not use the term “BAC (bronchioloalveolar carcinoma)”
All three recommendations must be followed in order for a case to be considered Met (i.e., if any one of these terms is present, the case is Not Met)
Numerator Options:
Performance Met: Primary non-small cell lung cancer lung biopsy and cytology specimen report documents classification into specific histologic type following IASLC guidance OR classified as NSCLC- NOS with an explanation (G9418)
OR
Denominator Exception: Documentation of medical reason(s) for not including the histological type OR NSCLC-NOS classification with an explanation (e.g. Specimen insufficient or non-diagnostic, specimen does not contain cancer, or other documented medical reasons) (G9419)
OR
Performance Not Met: Primary non-small cell lung cancer lung biopsy and cytology specimen report does not document classification into specific histologic type OR histologic type does not follow IASLC guidance OR is classified as NSCLC-NOS but without an explanation (G9421)
Rationale
Lung cancer is the most frequent cause of major cancer incidence and mortality worldwide. The classifications of lung cancer published by the World Health Organization (WHO) in 1967, 1981, and 1999 were written primarily by pathologists for pathologists. Only in the 2004 revision, relevant genetics and clinical information were introduced. Nevertheless, because of remarkable advances over the last 6 years in our understanding of lung adenocarcinoma, particularly in the area of medical oncology, molecular biology, and radiology, there is a pressing need for a revised classification, based not on pathology alone, but rather on an integrated multidisciplinary platform.
For the first time, this classification addresses an approach to small biopsies and cytology in lung cancer diagnosis. Recent data regarding epidermal growth factor receptor (EGFR) mutation predicting responsiveness to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), toxicities, and therapeutic efficacy have established the importance of distinguishing squamous cell carcinoma from adenocarcinoma and non-small cell lung carcinoma (NSCLC) not otherwise specified (NOS) in patients with advanced lung cancer. Approximately 70% of lung cancers are diagnosed and staged by small biopsies or cytology rather than surgical resection specimens, with increasing use of transbronchial needle aspiration (TBNA), endobronchial ultrasound-guided TBNA and esophageal ultrasound-guided needle aspiration. Within the NSCLC group, most pathologists can identify well- or moderately-differentiated squamous cell carcinomas or adenocarcinomas, but specific diagnoses are more difficult with poorly differentiated tumors. Nevertheless, in small biopsies and/or cytology specimens, upwards of 30% of specimens continue to be diagnosed as NSCLC-NOS. Consistent with most current recommendations, including the recent 2021 WHO paper, it is recommended pathologists “reduce use of the term NSCLC NOS as much as possible and classify tumors according to their specific histologic subtype.” (WHO, 2015).
Clinical Recommendation Statements
To address advances in oncology, molecular biology, pathology, radiology, and surgery of lung adenocarcinoma, an international multidisciplinary classification was sponsored by the International Association for the Study of Lung Cancer, American Thoracic Society, and European Respiratory Society. This new adenocarcinoma classification is needed to provide uniform terminology and diagnostic criteria, especially for bronchioloalveolar carcinoma (BAC), the overall approach to small non-resection cancer specimens, and for multidisciplinary strategic management of tissue for molecular and immunohistochemical studies.
For small biopsies and cytology, we recommend that NSCLC be further classified into a more specific histologic type, such as adenocarcinoma or squamous cell carcinoma, whenever possible (strong recommendation, moderate quality evidence).
The terms AIS or MIA should not be used in small biopsies or cytology specimens. If a noninvasive pattern is present in a small biopsy, it should be referred to as lepidic growth
The term large cell carcinoma should not be used for diagnosis in small biopsy or cytology specimens and should be restricted to resection specimens where the tumor is thoroughly sampled to exclude a differentiated component.
We recommend discontinuing the use of the term “BAC” We recommend that the term NSCLC-NOS be used as little as possible and we recommend it be applied only when a more specific diagnosis is not possible by morphology and/or special stains (strong recommendation, moderate quality evidence).
The above strategy for classification of adenocarcinoma versus other histologies and the terminology should be used in routine diagnosis and future research and clinical trials so that there is uniform classification of disease cohorts in relationship to tumor subtypes.
Travis WD, Brambilla E, Noguchi M, et al. International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society International Multidisciplinary Classification of Lung Adenocarcinoma. Journal of Thoracic Oncology 2011; 6:244-285.