Immunohistochemistry Reporting For Human Papillomavirus In .
CAP QCDR MeasureHR-HPV in OPSCCCMS Measure ID/CMS QCDR ID: CAP 36Measure Title: p16 Immunohistochemistry Reporting for Human Papillomavirus inPatients with Oropharyngeal Squamous Cell Carcinoma (OPSCC)Measure SpecificationsMeasureDescriptionPercentage of surgical pathology reports for invasive oropharyngealsquamous cell carcinoma (OPSCC) with quantitative p16immunohistochemistry (IHC) using a 70% nuclear and cytoplasmic stainingcutoff performed as a surrogate for HR-HPV statusDenominatorStatementAll 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 andpharynx C77.0: Secondary and unspecified malignant neoplasm of lymphnodes of head, face and neckDenominatorExclusionsNon-squamous cell carcinoma of the oropharynxNon-oropharyngeal primary tumors of the head and neckDenominatorExceptionsDocumentation of reason(s) p16 IHC testing was not performed (e.g., payorrelated limitations, patients who have declined testing, patients receivinghospice)NumeratorStatementPathology reports containing documentation of p16 IHC performed (currentlyor previously) as a surrogate marker for presence of HR-HPV AND wherep16 status is described using the 70% nuclear and cytoplasmic stainingcutoff*Last updated: 12/21/2020Page 1 of 5CPT copyright: 2020 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 in OPSCC*p16 quantitation: p16 IHC is considered positive and a surrogate for thepresence of HR-HPV when the tumor shows 70% nuclear and cytoplasmicimmunoreactivity with moderate to strong or GuidanceIncludes invasive OPSCC reports for specimens from primary tumors (tonsils,soft palate, or base of tongue (posterior to circumvallate papillae) and lateraland posterior pharyngeal walls) OR metastatic squamous cell carcinoma ofunknown primary in a cervical upper or mid jugular chain lymph node.Secondary malignant neoplasms elsewhere in the body are not considered.Numerator 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 (includes recurrent tumors where testingwas performed on the primary tumor) p16 cannot be determinedThe pathology report must include an interpretation statement (as notedabove) by the reporting pathologist; a link to a report from a reference lab orstatement about ordering testing is not sufficientMeasure 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 thecorrelation between HPV positivity and p16 overexpression is highest whenthe 70% staining for p16 overexpression is applied (4).Last updated: 12/21/2020Page 2 of 5CPT copyright: 2020 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 in OPSCC1. 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 ofPerformanceGapEvidenceIn 2019, one practice reported this measure to CMS via the PathologistsQuality Registry. The performance rate of that practice was 85.71%. This wasusing a previous version of the measure, but the overall quality action wasthe same.In a meta-review of 39 studies, 17 studies (n 1684) used a minimum of 569% staining to indicated positive results, 7 studies (n 764) used 70% andfifteen studies (n 1478) referred to a verbal definition (1). Therefore only 7studies (17.9%) were in compliance with the guideline. A separate metaanalysis found that of 22 papers published between 2010 and 2017, all ofwhich reported IHC staining, only 11 (50%) used the 70% staining cutoff toindicate positive results (2).1. C Grønhøj Larsen, M Gyldenløve, D H Jensen, M H Therkildsen, KKiss, B Norrild, L Konge & C von Buchwald. (2014) Correlationbetween human papillomavirus and p16 overexpression inoropharyngeal tumours: a systematic review. British Journal of Cancer110:1587–15942. Prigge, E. , Arbyn, M. , von Knebel Doeberitz, M. and Reuschenbach,M. (2017), Diagnostic accuracy of p16INK4a immunohistochemistry inoropharyngeal squamous cell carcinomas: A systematic review andmeta‐analysis. Int. J. Cancer, 140: 1186-1198.MeasureOwnerCollege of American PathologistsNQF IDN/ANumber ofPerformanceRates1Last updated: 12/21/2020Page 3 of 5CPT copyright: 2020 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 in OPSCCOverallPerformanceRate1st Performance RateHigh-priorityYesImprovementNotationInverse Measure: NoProportional Measure: Yes (Higher score indicates better quality)Continuous Variable Measure: NoRatio Measure: NoRisk-adjusted: NoCare SettingandSpecialtyCare Setting: Other—Laboratories; Telehealth not applicableSpecialty: PathologyCurrentClinicalGuideline theMeasure isDerived FromPathologists should perform high-risk human papillomavirus (HR-HPV)testing on all patients with newly diagnosed oropharyngeal squamous cellcarcinoma (OPSCC),. This testing may be performed on the primary tumor oron a regional lymph node metastasis when the clinical findings are consistentwith 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: 12/21/2020Page 4 of 5CPT copyright: 2020 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 in OPSCCMeasure FlowNumeratorDenominatorStart: 100 casesReport contains p16IHC results where p16is described w/70%cutoffYesNumerator/Performance Met:60 cases (b)YesDenominatorException: 10 cases(c)YesPerformance NotMet: 10 cases (d)NoProcedure as listed indenominator (CPT 88305,88309): 100 casesNoDocumentation ofmedical, patient orsystem reason p16 notperformedYesNoNot in EligiblePopulation/DenominatorNoDiagnosis as listed indenominator (invasiveOPSCC): 100 casesYesYesNon-squamous cellcarcinomaORNon-oropharnygealprimary tumors: 10 cases(a)Report does notcontain statementabout p16 testing ordoes not use 70%cutoffNoPerformance Rate:Met (b) Data Completeness Numerator – Denominator Exceptions (c)NoEligible Population/Denominator: 90 cases(x)Data Completeness:Denominator Exceptions (c) Met (b) Not Met (d) 10 60 10Eligible Population (x)90Data Completeness NotMet: 10 cases (e)Last updated: 12/21/2020Page 5 of 5CPT copyright: 2020 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.6070
Dec 21, 2020 · Pathologists should perform high-risk human papillomavirus (HR-HPV) testing on all patients with newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC),. This testing may be performed on the primary tumor or on a regional lymph node metastasis when the clinical findings are consistent
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