The 2015 Physician Quality Reporting System reflects pathologists' role in lung cancer biomarker testing.

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It is widely recognized that the pathologist has the primary role in determining which patients with lung cancer receive predictive biomarker testing based on cell type diagnosis and in selecting the tissue to be tested. In addition to selection for predictive biomarker testing for targeted molecular therapy, the diagnosis of cell type by the pathologist is important for selection of therapy with bevacizumab and pemetrexed disodium. For several years, the pathology literature has encouraged the diagnosis of specific cell type for therapy selection in lung cancer specimens, including the 2011 International Association for the Study of Lung Cancer/American Thoracic Society/ European Respiratory Society International Multidisciplinary Classification of Lung Adenocarcinoma. The use of immunohistochemical profiles to differentiate adenocarcinoma from squamous cell carcinoma, particularly the nuclear stains TTF-1 for adenocarcinoma and p40 for squamous cell carcinoma, has been recommended for cases in which routine histology is ambiguous. These modifications in cell type diagnosis have led to major revisions in the 2015 World Health Organization Classification of Tumours of the Lung, Pleura, Thymus and Heart. The Centers for Medicare & Medicaid Services has added 2 new pathology measures related to the diagnosis of lung cancer cell type in the 2015 Physician Quality Reporting System (PQRS). The first measure is ‘‘Lung cancer reporting (biopsy/cytology specimens)’’: ‘‘Pathology reports based on biopsy and/or cytology specimens with a diagnosis of non small cell lung cancer classified into specific histologic type or classified as NSCLC-NOS with an explanation included in the pathology report.’’ Second is ‘‘Lung cancer reporting (resection specimens)’’: ‘‘Pathology reports based on resection specimens with a diagnosis of primary lung carcinoma that include the pT category, pN category, and non small cell lung cancer, histologic type.’’ The federal government is increasingly demanding more patient quality measurement and provider accountability. The Tax Relief and Health Care Act of 2006 established the Physician Quality Reporting Initiative, now the PQRS. The Medicare Improvements for Patients and Providers Act of 2008 established the permanency of the PQRS. The PQRS is one of several Centers for Medicare & Medicaid Services quality initiatives for providing information on the quality of patient care regarding hospital and other nonhospital health care settings. These lung cancer measures increase anatomic pathology’s presence in the PQRS. Cytopathology in particular will be involved in lung cancer measures. These evidence-based lung cancer measures illustrate pathologists’ commitment to improving the quality of health care. The focus on histologic type and tumor status demonstrates their immediate and direct influence on patient treatment. These measures also carry weight: ‘‘Participation in the 2015 PQRS will affect both the 2017 PQRS payment adjustment and the 2017 value-based modifier (VBM).’’ The College of American Pathologists has been instrumental in guiding policy makers at the Centers for Medicare & Medicaid Services in the development of these pathology measures and has an online tool to assist pathologists in determining their eligibility for this and other programs (www.cap.org).