HR-HPV And P16 OPSCC - College Of American Pathologists

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CAP QCDR MeasureHR-HPV and p16 OPSCC –Surgical SpecimensCMS Measure ID/CMS QCDR ID: CAP 20Measure Title: High Risk HPV Testing and p16 Scoring in Surgical Specimens forPatients with Oropharyngeal Squamous Cell Carcinoma (OPSCC)Measure SpecificationsMeasureDescriptionPercentage of surgical pathology reports for invasive oropharyngealsquamous cell carcinoma (OPSCC) with HR-HPV testing by surrogate markerp16 performed AND that include quantitative p16 immunohistochemistry(IHC) results.INSTRUCTIONS: This measure has two performance rates that contribute tothe overall performance score:1. Percentage of surgical pathology reports for invasive OPSCC withHR-HPV testing by surrogate marker p16 IHC performed.2. Percentage of surgical pathology reports for invasive OPSCC withHR-HPV testing by surrogate marker p16 IHC performed AND thatinclude quantitative p16 IHC results based on the 70% nuclear andcytoplasmic staining.The overall performance score submitted is a simple average of:(Performance rate 1 Performance rate 2)/2.DenominatorStatementAll surgical pathology reports with a diagnosis of invasive OPSCC.CPT : 88305, 88309ANDICD10: C01: Malignant neoplasm of base of tongue C05.1: Malignant neoplasm of soft palate C09.0: Malignant neoplasm of tonsillar fossa C09.1: Malignant neoplasm of tonsillar pillar (anterior) (posterior) C09.8: Malignant neoplasm of overlapping sites of tonsil C09.9: Malignant neoplasm of tonsil, unspecified C10.0: Malignant neoplasm of vallecula C10.1: Malignant neoplasm of anterior surface of epiglottis C10.2: Malignant neoplasm of lateral wall of oropharynx C10.3: Malignant neoplasm of posterior wall of oropharynx C10.4: Malignant neoplasm of branchial cleft C10.8: Malignant neoplasm of overlapping sites of oropharynx C10.9: Malignant neoplasm of oropharynx, unspecified C14.0: Malignant neoplasm of pharynx, unspecified C14.2: Malignant neoplasm of Waldeyer's ring C14.8: Malignant neoplasm of overlapping sites of lip, oral cavity andpharynxDenominator definition: Includes invasive OPSCC reports for specimens fromprimary tumors (tonsils, soft palate, or base of tongue (posterior tocircumvallate papillae) and lateral and posterior pharyngeal walls) or othersite with metastatic OPSCC.Last updated: 1/21/2019Page 1 of 6CPT copyright: 2018 American Medical Association. All rights reserved. College of American Pathologists. All rights reserved. The College of American Pathologists (CAP) owns all rights, title, and interests in this qualitymeasure. This quality measure is provided solely for the benefit of CAP, its members and the Pathologists Quality Registry for the purposes specifiedherein and for other CAP purposes. It may not be used by other parties except with prior written approval of the CAP. Email mips@cap.org for moreinformation.

CAP QCDR MeasureHR-HPV and p16 OPSCC –Surgical tionsDocumentation of reason(s) p16 IHC testing was not performed (e.g., payorrelated limitations, patients who have declined testing, patients receivinghospice)NumeratorStatementNumerator 1: Pathology reports with HR-HPV testing by surrogate markerp16 IHC performedNumerator 2: Pathology reports with HR-HPV testing by surrogate markerp16 IHC performed AND the quantitative p16 IHC result was derived usingthe 70 nuclear and cytoplasmic staining*Numerator 2 guidanceQuantitative p16 IHC results may include: p16 IHC positive ( 70% nuclear and cytoplasmic moderate to strongstaining) p16 IHC negative ( 70% nuclear and cytoplasmic moderate to strongstaining) p16 previously performed p16 cannot be determined*p16 quantitation: Results must be based on 70% nuclear and cytoplasmicstaining with at least moderate to strong intensity.NumeratorExclusionsNoneMeasure InformationNQS DomainCommunication and Care CoordinationMeaningfulMeasuresArea(s)Transfer of Health Information and InteroperabilityMeaningfulMeasureRationaleHuman papillomavirus (HPV) is a major cause of oropharyngeal squamouscell carcinoma (OPSCC) and has contributed to its increased incidence (1).HPV-positive OPSCC differs from HPV-negative OPSCC related to other riskfactors including alcohol and tobacco use and has an improved response totreatment and better prognosis (2).Therefore, it is crucial to determine the HPV status of squamous cellcarcinomas of the oropharynx, as treating clinicians utilize this informationwhen developing a treatment plan for patients, which may include lessaggressive treatment modalities. In the clinical setting, p16 IHC is anapproach used to reliably diagnose HPV-induced OPSCC.The p16 test is considered to best stratify patient survival outcomes whilealso being practical and inexpensive (3). Furthermore, data suggest that theLast updated: 1/21/2019Page 2 of 6CPT copyright: 2018 American Medical Association. All rights reserved. College of American Pathologists. All rights reserved. The College of American Pathologists (CAP) owns all rights, title, and interests in this qualitymeasure. This quality measure is provided solely for the benefit of CAP, its members and the Pathologists Quality Registry for the purposes specifiedherein and for other CAP purposes. It may not be used by other parties except with prior written approval of the CAP. Email mips@cap.org for moreinformation.

CAP QCDR MeasureHR-HPV and p16 OPSCC –Surgical Specimenscorrelation between HPV positivity and p16 overexpression is highest whenthe 70% staining for p16 overexpression is applied (4).1. Chaturvedi AK, Engels EA, Pfeiffer RM, et al. Human papillomavirusand rising oropharyngeal cancer incidence in the United States. J ClinOncol. 2011;29(32):4294–4301.2. Wang MB, Liu IY, Gornbein JA, Nguyen CT. HPV-positiveoropharyngeal carcinoma: a systematic review of treatment andprognosis. Otolaryngol Head Neck Surg. 2015. Nov;153(5):758-69.3. Lewis JS Jr, Beadle B, Bishop JA, Chemock RD, Colasacco C,Lacchetti C, et al. Human papillomavirus testing in head and neckcarcinomas: guideline from the College of American Pathologists.Arch Pathol Lab Med. 2018;142:559–597.4. Grønhøj Larsen C, Gyldenløve M, Jensen DH, Therkildsen MH, KissK, Norrild B, Konge L, von Buchwald C. Correlation between humanpapillomavirus and p16 overexpression in oropharyngeal tumours: asystematic review. Br J Cancer. 2014. Mar 18;110(6):1587-94.MeasureTypeProcessData SourceLaboratory Information Systems; pathology reportsSummary ofPerformanceGapEvidenceHuman papillomavirus (HPV) is a major cause of oropharyngeal squamouscell carcinoma (OPSCC) and has contributed to its increased incidence (1).HPV-positive OPSCC differs from HPV-negative OPSCC related to other riskfactors including alcohol and tobacco use and has an improved response totreatment and better prognosis (2). Therefore, it is crucial to determine theHPV status of squamous cell carcinomas of the oropharynx, as treatingclinicians utilize this information when developing a treatment plan forpatients, which may include less aggressive treatment modalities. In theclinical setting, p16 IHC is an approach used to reliably diagnose HPVinduced OPSCC. The p16 test is considered to best stratify patient survivaloutcomes while also being practical and inexpensive (3). Furthermore, datasuggest that the correlation between HPV positivity and p16 overexpressionis highest when the 70% staining for p16 overexpression is applied (4).1. Chaturvedi AK, Engels EA, Pfeiffer RM, et al. Human papillomavirusand rising oropharyngeal cancer incidence in the United States. J ClinOncol. 2011;29(32):4294–4301.2. Wang MB, Liu IY, Gornbein JA, Nguyen CT. HPV-positiveoropharyngeal carcinoma: a systematic review of treatment andprognosis. Otolaryngol Head Neck Surg. 2015. Nov;153(5):758-69.3. Lewis JS Jr, Beadle B, Bishop JA, Chemock RD, Colasacco C,Lacchetti C, et al. Human papillomavirus testing in head and neckcarcinomas: guideline from the College of American Pathologists.Arch Pathol Lab Med. 2018;142:559–597.4. Grønhøj Larsen C, Gyldenløve M, Jensen DH, Therkildsen MH, KissK, Norrild B, Konge L, von Buchwald C. Correlation between humanpapillomavirus and p16 overexpression in oropharyngeal tumours: asystematic review. Br J Cancer. 2014. Mar 18;110(6):1587-94.Last updated: 1/21/2019Page 3 of 6CPT copyright: 2018 American Medical Association. All rights reserved. College of American Pathologists. All rights reserved. The College of American Pathologists (CAP) owns all rights, title, and interests in this qualitymeasure. This quality measure is provided solely for the benefit of CAP, its members and the Pathologists Quality Registry for the purposes specifiedherein and for other CAP purposes. It may not be used by other parties except with prior written approval of the CAP. Email mips@cap.org for moreinformation.

CAP QCDR MeasureHR-HPV and p16 OPSCC –Surgical SpecimensMeasureOwnerCollege of American PathologistsNQF IDN/ANumber ofPerformanceRates1OverallPerformanceRate1st Performance RateHigh-priorityYesImprovementNotationInverse Measure: NoProportional Measure: Yes (Higher score indicates better quality)Continuous Variable Measure: NoRatio Measure: NoRisk-adjusted: NoSpecialtyPathologyCurrentClinicalGuideline theMeasure isDerived FromPathologists should perform high-risk human papillomavirus (HR-HPV)testing on all patients with newly diagnosed oropharyngeal squamous cellcarcinoma (OPSCC), including all histologic subtypes. This testing may beperformed on the primary tumor or on a regional lymph node metastasiswhen the clinical findings are consistent with an oropharyngeal primary(Strong Recommendation) (1).For oropharyngeal tissue specimens (i.e., noncytology), pathologists shouldperform HR HPV testing by surrogate marker p16 immunohistochemistry(IHC). Additional HPV-specific testing may be done at the discretion of thepathologist and/or treating clinician, or in the context of a clinical trial(Recommendation) (1).Pathologists should report p16 IHC positivity as a surrogate for HR-HPV intissue specimens (i.e., noncytology) when there is at least 70% nuclear andcytoplasmic expression with at least moderate to strong intensity (ExpertConsensus Opinion) (1).Tumor human papillomavirus (HPV) testing by p16 immunohistochemistry(IHC) required as part of the workup for cancer of the oropharynx (Category2A) (2).1. Lewis JS Jr, Beadle B, Bishop JA, Chemock RD, Colasacco C,Lacchetti C, et al. Human papillomavirus testing in head and neckcarcinomas: guideline from the College of American Pathologists.Arch Pathol Lab Med. 2018;142:559–597.2. Pfister DG, Spencer S, Adelstein D, Adkins D, Brizel DM, Burtness B,et al. NCCN clinical practice guidelines in oncology: head and neckcancers, version 2.2018. National Comprehensive Cancer Network.Available athttps://www.nccn.org/professionals/physician gls/recently updated.aspxLast updated: 1/21/2019Page 4 of 6CPT copyright: 2018 American Medical Association. All rights reserved. College of American Pathologists. All rights reserved. The College of American Pathologists (CAP) owns all rights, title, and interests in this qualitymeasure. This quality measure is provided solely for the benefit of CAP, its members and the Pathologists Quality Registry for the purposes specifiedherein and for other CAP purposes. It may not be used by other parties except with prior written approval of the CAP. Email mips@cap.org for moreinformation.

CAP QCDR MeasureHR-HPV and p16 OPSCC –Surgical SpecimensMeasure FlowLast updated: 1/21/2019Page 5 of 6CPT copyright: 2018 American Medical Association. All rights reserved. College of American Pathologists. All rights reserved. The College of American Pathologists (CAP) owns all rights, title, and interests in this qualitymeasure. This quality measure is provided solely for the benefit of CAP, its members and the Pathologists Quality Registry for the purposes specifiedherein and for other CAP purposes. It may not be used by other parties except with prior written approval of the CAP. Email mips@cap.org for moreinformation.

CAP QCDR MeasureHR-HPV and p16 OPSCC –Surgical SpecimensLast updated: 1/21/2019Page 6 of 6CPT copyright: 2018 American Medical Association. All rights reserved. College of American Pathologists. All rights reserved. The College of American Pathologists (CAP) owns all rights, title, and interests in this qualitymeasure. This quality measure is provided solely for the benefit of CAP, its members and the Pathologists Quality Registry for the purposes specifiedherein and for other CAP purposes. It may not be used by other parties except with prior written approval of the CAP. Email mips@cap.org for moreinformation.

Jan 21, 2019 · and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011;29(32):4294–4301. 2. Wang MB, Liu IY, Gornbein JA, Nguyen CT. HPV-positive oropharyngeal carcinoma: a systematic review of treatment and prognosis. Otolaryngol Head Neck Surg. 2015. Nov;153(5):758-69. 3. L

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