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The 2015 Physician Quality Reporting System Reflects Pathologists' Role in Lung Cancer Biomarker Testing.

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. (1,2) 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. (3)

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. (4) 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. (3, 5) 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. (6) 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). (7,8) 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. (7)

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)." (8) 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).

References

(1.) Lindeman NI, Cagle PT, Beasley MB, et al. Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Arch Pathol Lab Med. 2013; 137(6):828-860.

(2.) Cagle PT, Sholl LM, Lindeman NI, et al. Template for reporting results of biomarker testing of specimens from patients with non-small cell carcinoma of the lung. Arch Pathol Lab Med. 2014; 138(2):171-174.

(3.) Travis WD, Brambilla E, Noguchi M, et al. Diagnosis of lung cancer in small biopsies and cytology: implications of the 2011 International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society classification. Arch Pathol Lab Med. 2013; 137(5):668-684.

(4.) 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. J Thorac Oncol. 2011; 6(2):244-285.

(5.) Bishop JA, Teruya-Feldstein J, Westra WH, Pelosi G, Travis WD, Rekhtman N. p40 (ANp63) is superior to p63 for the diagnosis of pulmonary squamous cell carcinoma. Mod Pathol. 2012; 25(3):405-415.

(6.) Travis WD, Brambilla E, Burke A, Marx A, Nicholson A, eds. WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. 4th ed. Lyon, France: International Agency for Research on Cancer, World Health Organization; 2015. In press. Bosman F, Jaffe ES, Lakhani SR, Ohgaki H, series eds. WHO Classification of Tumours.

(7.) Physician Quality Reporting System-Centers for Medicare & Medicaid Services Web site. Potential Pathology Preferred Specialty Measure Set. http:// www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ PQRS/Downloads/Potential_Pathology_Preferred_Specialty_Measure_Set.pdf. Updated 2014. Accessed December 4, 2014.

(8.) College of American Pathologists Statline Special Alert Web site. CMS adopts CAP IHC recommendations, PQRS measures for 2015. http://www.cap. org/apps//cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets% 2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt% 7BactionForm.contentReference%7D=statline%2Fspecial-report-cms-adoptsihc-recommendations.html&_state=maximized&_pageLabel=cntvwr. Published October 31, 2014. Updated 2014. Accessed December 4, 2014.

Philip T. Cagle, MD; Timothy Craig Allen, MD, JD

Accepted for publication December 9, 2014.

Published as an Early Online Release February 2, 2015.

From the Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas (Dr Cagle); and the Department of Pathology, University of Texas Medical Branch, Galveston (Dr Allen).

The authors have no relevant financial interest in the products or companies described in this article.

doi: 10.5858/arpa.2014-0619-ED

Reprints: Philip T. Cagle, MD, Department of Pathology and Genomic Medicine, Houston Methodist Hospital, 6565 Fannin St, Main Building, Room 227, Houston, TX 77030 (e-mail: pcagle@HoustonMethodist.org).
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Author:Cagle, Philip T.; Allen, Timothy Craig
Publication:Archives of Pathology & Laboratory Medicine
Date:Apr 1, 2015
Words:944
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