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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

-- [ Page 44 ] --

Gotto AM Jr, Whitney E, Stein EA, et al. Relation between baseline and on-treatment lipid parameters and first acute major coronary events in the Air Force/Texas Coronary Atherosclerosis Prevention Study AFCAPS/TexCAPS).

Circulation. 2000;101:477-484.

Greenland P, Abrams J, Aurigemma GP, et al. Prevention Conference V: Beyond secondary prevention: identifying the high-risk patient for primary prevention: noninvasive tests of atherosclerotic burden: Writing Group III. Circulation. 2000 Jan 4;101(1):E16-22.

Hayes, Inc. Health Technology Brief. CVProfilor® (Hypertension Diagnostics Inc.) for Early Detection of Cardiovascular Disease. Lansdale, PA: Hayes, Inc.; August 2005. Updated December 2007. Archived 2009.

Hayes Inc. Search and Summary. Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Test for Prediction of Coronary Heart Disease. September 2008.

Hayes Inc. Health Technology Brief. Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Test (PLAC Test; diaDexus) for Prediction of Ischemic Stroke. July 2009.

Hypertension Diagnostics, Inc. (HDI) [Internet]. Available at: http://www.hdi-pulsewave.com. Accessed July 28, 2009.

Koenig W, Twardella D, Brenner H, et al. Lipoprotein-associated phospholipase A2 predicts future cardiovascular events in patients with coronary heart disease independently of traditional risk factors, markers of inflammation, renal function, and hemodynamic stress. Arterioslerosis, Thrombosis & Vascular Biology. 2006;26(7):1586-93.

Lorenz, MW, Markus, HS, Bots, ML, et al. Prediction of clinical cardiovascular events with carotid intima-media thickness: a systematic review and meta-analysis. Circulation. 2007;115(4):459-467.

Luc G, Bard J-M, Arveiler D. et al. Lipoprotein(a) as a predictor of coronary heart disease: the PRIME Study.

Atherosclerosis. 2002; 163(2): 377-84.

May HT, Horne KBD, Anderson JL, et al. Lipoprotein-associated phospholipase A2 independently predicts the angiographic diagnosis of coronary artery disease and coronary death. American Heart Journal. 2006;152(5):997-1003.

Meisinger C, Loewel H, Mraz W et al. Prognostic value of apolipoprotein B and A-I in the prediction of myocardial infarction in middle-aged men and women: results from the MONICA/KORA Augsburg cohort study. European Heart Journal. 2004;26(3).

National Heart, Lung and Blood Institute (NHLBI). Third Report of the National Cholesterol Education Program (NCEP) Cardiovascular Disease Risk Tests - Commercial Medical Management Guideline

Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III):

Final Report. NIH Publication No. 02-5215. September 2002.

Oei HH, van der Meer IM, Hofman A, Koudstaal PJ, Stijnen T, Breteler MM, Witteman JC. Lipoprotein-associated phospholipase A2 activity is associated with risk of coronary heart disease and ischemic stroke: the Rotterdam Study.

Circulation. 2005 Feb 8;111(5):570-5.

Prisant LM, Resnick LM, Hollenberg SM. Arterial elasticity among normotensive subjects and treated and untreated hypertensive subjects. Blood Press Monit. 2001a Oct;6(5):233-7.

Prisant LM, Resnick LM, Hollenberg SM. Assessment of sequential same arm agreement of blood pressure measurements by a CVProfilor DO-2020 versus a Baumanometer mercury sphygmomanometer. Blood Press Monit.

2001b Jun;6(3):149-52.

Prisant LM, Resnick LM, Hollenberg SM, Jupin D. Arterial elasticity among normotensive subjects and treated and untreated hypertensive subjects: influence of race. Ethn Dis. 2002 Winter;12(1):63-8.

Sharrett AR, Ballantyne CM, Coady SA, et al. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001; 104(10): 1108-13.

Walldius G, Jungner I, Holme I, et al. High apolipoprotein B, low apolipoprotein A-I, and improvement in the prediction of fatal myocardial infarction (AMORIS study): a prospective study. Lancet. 2001;358(9298): 2026-33.

Wilson AM, O'Neal D, Nelson CL, et al. Comparison of arterial assessments in low and high vascular disease risk groups. Am J Hypertens. 2004 Apr;17(4):285-91.

Woodman RJ, Kingwell BA, Beilin LJ, et al. Assessment of central and peripheral arterial stiffness: studies indicating the need to use a combination of techniques. Am J Hypertens. 2005 Feb;18(2 Pt 1):249-60.

History/Updates Policy revision with changes to coverage rationale. CMS information updated. CPT codes 82172, 9/4/2009 83695, 83698 and 93799 added. CPT code 99199 removed. Policy 2009T0389D archived.

Policy update. CMS information updated. Policy 2008T0389C archived.

2/13/2009 Policy revised and renamed Cardiovascular Disease Risk Tests. Policy 2005T0389B, Arterial Elasticity 9/9/2008 as a Screening Tool for Cardiovascular Disease, archived. Policy held for posting due to implementation analysis review.

CPT Code 0126T added per direction from the Reimbursement Medical Policy Operations Manager 2/27/2007 Policy update with coverage rationale reworded to conform to proven/unproven language. Policy 11/17/2005 (2002T0389A) archived.

Coding Section reviewed by the Reimbursement Medical Policy Operations Manager and no specific 1/13/2004 CPT/HCPCS codes suggested for this policy.





Medicare entry. No CMS issuance; no LMRP found.

2/12/2003 Cardiovascular Disease Risk Tests - Commercial Medical Management Guideline Contact Information For questions regarding this policy, send an email to the Medical Technology Interpretation Service at medical_drug_interpretation@uhc.com with the word "Medical" in the subject line.

Coding The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only.

Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document.

CPT Code Section 0126T Common carotid intima-media thickness (IMT) study for evaluation of atherosclerotic burden or coronary heart disease risk factor assessment 82172 Apolipoprotein, each 83695 Lipoprotein (a) 83698 Lipoprotein-associated phospholipase A2, (Lp-PLA2) 93799 Unlisted cardiovascular service or procedure This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Cardiovascular Disease Risk Tests - Commercial Medical Management Guideline

–  –  –

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supersede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and Cervical Cancer Screening - Commercial Medical Management Guideline the plan benefit coverage prior to use of this policy.

Papanicolaou (Pap) smear, thin-layer or liquid-based cytology screening methods are proven for cervical cancer screening.

Computer-assisted screening methods are proven for cervical cancer detection, with results comparable to those of standard Pap screening.

Hybrid capture human papillomavirus testing (HPV) is proven, when used in combination with conventional Pap smear, as a primary screening method for women 30 years of age and older or when used in the clinical planning and management of

women with equivocal Papanicolaou (Pap) smear results and used in accordance to FDA indications, including:

• atypical squamous cells of undetermined origin (ASCUS), OR

• low-grade squamous intraepithelial lesions (LSIL), OR

• monitoring women who are HPV positive with negative cytology Hybrid capture human papillomavirus testing (HPV) is unproven as a primary screening tool for cervical cancer in women younger than 30 years of age. Hybrid capture HPV testing has lowered specificity in this age group. It is also unproven in women with high-grade squamous intraepithelial lesion (HSIL) or where atypical squamous cells cannot exclude HSIL (ASC-H) cytology results. Although the rate of HPV infection in women younger than 30 years old is high, most infections are transient (short-lived) and not associated with cervical cancer. For women with ASC-H (atypical squamous cells cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesion) cytology results, the HPV test does not add significant information, and these women, who are at high risk, should be managed with colposcopy.

Cervicography is unproven for cervical cancer screening or for the evaluation of cervical abnormalities. Cervicography remains investigational because its accuracy and technical requirements are considered suboptimal. The sensitivity of cervicography is too low to be used as an alternative to Pap testing. Cervicography has not been proven to be effective as an adjunct to Pap testing because of low specificity which may result in increased colposcopy referrals.

Magnified chemiluminescent visual examination (speculoscopy) is unproven for the purpose of cervical cancer screening.

While it has been shown that addition of speculoscopy to Pap testing results in higher sensitivity for the detection of cervical precancers and cancers, the combined test has lower specificity than the Pap test alone, which results in significant numbers of patients being subjected to unnecessary biopsies and treatment. No studies have systematically evaluated diagnostic performance and/or the impact of the addition of speculoscopy to the Pap test on clinical decision-making, patient management or health outcomes. Therefore, it remains unknown whether adding speculoscopy to Pap test screening reduces cervical cancer morbidity and mortality.

The LUMA Cervical Imaging System is unproven for the purpose of cervical cancer screening. The evidence is insufficient to recommend LUMA Cervical Imaging System as an adjunct to colposcopy for cervical cancer screening. No peer-reviewed studies have systematically evaluated diagnostic performance and/or the impact of the addition of LUMA Cervical Imaging System to colposcopy on clinical decision-making, patient management or health outcomes. The studies summarized in the premarket approval application submitted to the FDA are contradictory and fail to provide conclusive evidence that this device increases the detection of cervical neoplasia. Therefore, it remains unknown whether adding LUMA Cervical Imaging System reduces cervical cancer morbidity and mortality.

Regulatory Requirements U.S. Food and Drug Administration (FDA): In November 1995, the PapNet® Testing System (Neuromedical Systems Inc, Suffern, NY) received FDA approval as a semiautomated, computer-assisted device for the rescreening of cervical Pap smears previously reported as negative. In October 1996, the FDA permitted an additional effectiveness claim that PapNet is significantly more sensitive in detecting false negatives than routine manual rescreening of the same slides. PapNet is no longer being marketed since the manufacturer declared bankruptcy in 1999. TriPath Imaging Inc, which manufactures a Cervical Cancer Screening - Commercial Medical Management Guideline competing device (see following paragraph), subsequently acquired Neuromedical Systems' intellectual property rights.

The AutoPap® 300 QC Automatic Pap Screener/QC System (TriPath Imaging Inc, Burlington, NC) was originally approved in September 1995 as an automated cervical cytology screening device intended for use in initial screening of Pap smear slides. As approved in 1998, the device was to be used only on conventionally-prepared Pap smear slides and was intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it was not intended to be used on slides designated by the laboratory as "high risk." In October 2001, the FDA granted approval for use of the device, to be marketed under the trade name AutoPap® Primary Screening System, now known as FocalPoint™ slide profiler, with AutoCyte PREP cervical cytology slides in addition to conventionally-prepared slides.



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