Cardiac Disease Screening Lipid Profile Date of Origin: 04/2003 Last Review Date: 08/23/2017 Effective Date: 08/23/2017 Dates Reviewed: 01/2004, 04/2005, 12/2005, 06/2006, 06/2007, 07/2008, 6/2011, 05/2012, 03/2013, 07/2014, 09/2015, 09/2016, 08/2017 Developed By: Medical Necessity Criteria Committee I. Description The traditional risk factors for cardiovascular disease include smoking, hypertension, diabetes, obesity, age, family history, lipid abnormalities and sedentary lifestyle. Nearly half of the patients that present with a myocardial infarction do not have these classic risk factors. This finding has directed research to look for other risk factors that may be responsible for coronary artery disease and to develop screening tests to predict future coronary events in healthy individuals. Cholesterol screening consisting of a lipid profile which includes total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, and triglycerides are covered for members with coverage for preventative services. Several nontraditional markers of cardiovascular risk have been developed to improve identification of patients at high risk. These include the following laboratory tests: High Sensitivity C-reactive protein (hs-crp): (CPT 86141) It is thought that certain markers of inflammation may indicate the development of atherosclerosis. High sensitivity C-reactive protein is a systemic marker of inflammation that has been used as a screening test for assessing cardiovascular disease risk. Homocysteine: (CPT 83090) is an amino acid normally found in the body. Studies suggest that high blood levels of homocysteine may increase an individual s chance of developing heart disease, stroke and damage to arteries. Apolipoprotein A-I, LDL gradient gel electrophoresis, and Lipoprotein (a) immunoassay: (CPT 82172, 83695) these tests are performed to help determine coronary heart disease risk and to guide drug and diet therapy in patients with established coronary artery disease. Apolipoprotein B: is thought to be a useful risk assessment tool in patients with normal LDL who have a high family risk for premature coronary artery disease. However, apo B assays have not been fully standardized and there is no consensus on predictive or treatment value. Apolipoprotein E polymorphisms have functional effects on lipoprotein metabolism and have been studied in disorders associated with elevated cholesterol levels and lipid derangements. Research investigators have found Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 1/9
that the apo E genotype yields poor predictive values when screening for clinically defined atherosclerosis. LDL subspecies: Larger and smaller low-density lipoprotein (LDL) particle size may be associated with coronary heart disease. In addition, nearly half of patients with coronary atherosclerotic disease have dense LDL particles. When present, dense LDL greatly increases the risk of coronary disease. HDL subspecies: High-density lipoprotein (HDL) is known as the good cholesterol, however, not all HDL is beneficial. HDL subfractions (lipoprotein AI (LpAI) and lipoprotein AI/AII (LpAI/AII) and/or HDL3 and HDL2) have also been used for risk prediction. However, studies have not shown superiority of HDL subspecies over HDL cholesterol in CHD risk assessments. Angiotensin gene (AGT) or CardiaRisk: This test analyzes angiotensin gene polymorphisms which have been associated with cardiovascular disease risk and some forms of hypertension. Certain AGT polymorphisms have been associated with responsiveness of blood pressure to ACE inhibitor therapy and sodium reduction. Therefore, analysis of the AGT gene may beneficial in helping to predict how patients will respond to certain antihypertensive interventions. CardiaRisk is a lab test done at Myriad Genetics Laboratories that analyzes the angiotensinogen gene. II. Criteria: CWQI HCS-0015 A. Moda Health covers the following tests for preventive cholesterol screening when the member has benefits available: total cholesterol, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), VLDL (very low density lipoprotein), and triglycerides. B. Moda Health will cover hs-crp as a medical diagnostic only. hs-crp is considered investigational and will not be covered when performed as a routine screening test. C. Other laboratory tests for assessing coronary heart disease are considered investigational for screening, diagnosing, or managing coronary heart disease. However, Moda Health will allow limited coverage of specific tests under the following circumstances for 1 or more of the following: a. Lipoprotein (a) and hs-crp will be covered for young individuals who have unexplained coronary artery disease and lack traditional risk factors. b. Lipoprotein (a) will be covered for members with the diagnosis of complex lipid disorder with familial hyperlipidemia, such as Familial Lp (a) hyperlipidemia. c. Homocysteine will be covered for members undergoing workup or management of suspected homocystinurias or for a hypercoagulable workup (i.e. members with unexplained deep vein thrombosis or recurrent thrombosis). D. Apolipoprotein B will be covered for members undergoing management of lipoprotein abnormalities and who have 1 or more of the following: a. Diabetes; or b. Coronary heart disease; or c. Member is a smoker; or d. Member has a family history of premature coronary heart disease Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 2/9
III. Information Submitted with the Prior Authorization Request: 1. Documentation from the ordering physician supporting one of the above listed indications. 2. When performed as a routine screening, these tests are considered investigational and will not be covered. Prevailing medical literature does not support the use of these tests for screening of coronary heart disease. IV. CPT or HCPC codes covered: Codes Description 80061 Lipid panel 82465 Cholesterol, serum or whole blood, total 83695 Lipoprotein (a) 83718 Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol) 83721 Lipoprotein, direct measurement; LDL cholesterol 84478 Triglycerides 86141 C-reactive protein, high sensitivity (hscrp) V. Annual Review History Review Date Revisions Effective Date 03/2013 Annual Review: Added table with review date, revisions, 04/03/2013 and effective date. 06/2014 Annual Review: No change 06/2014 9/2015 Removed ICD-9 codes, added ICD-10 9/26/2015 9/2016 Annual Review: Minor change added age for 9/28/2016 Apolipoprotein B. 08/2017 Annual Review: Included itemized list of codes approved for Homocyteine 08/23/2017 VI. References 1. American Association for Clinical Chemistry (AACC). ApoE genotyping. Lab Tests Online. Washington, DC: AACC; July 22, 2009. Accessed on May 18, 2011 at: http://www.labtestsonline.org/understanding/analytes/apoe/test.html. 2. Berkeley Heart Lab. Accessed on May 18, 2011 at: www.berkeleyheartlab.com 3. Clarke R, Peden JF, Hopewell JC, et al; PROCARDIS Consortium. Genetic variants associated with Lp(a) lipoprotein level and coronary disease. N Engl J Med. 2009;361(26):2518-2528. Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 3/9
4. Contois JH, McConnell JP, Sethi AA, et al.; AACC Lipoproteins and Vascular Diseases Division Working Group on Best Practices. Apolipoprotein B and cardiovascular disease risk: Position statement from the AACC Lipoproteins and Vascular Diseases Division Working Group on Best Practices. Clin Chem. 2009;55(3):407-419. 5. Cooper GR, Wilson PWF, Myers GL, et al. Lipoprotein (a) and cardiovascular disease risk. In: Emerging biomarkers for primary prevention of cardiovascular disease and stroke. Laboratory Medicine Practice Guidelines. G. Meyers, ed. Product ID 5660. Washington, DC: National Academy of Clinical Biochemistry; 2009 6. C-reactive protein as a predictor for atherosclerotic progression and recurrent cardiac events. Hayes Alert. January 2005; 8(1):3-4. 7. Danesh J, Wheeler J, Hirschfield G, et al. C-reactive protein and other circulating markers of inflammation in the prediction of coronary heart disease. The New England Journal of Medicine. April 2004; 350(14):1387-1397. 8. Does C-reactive protein predict cardiovascular risk better than LDL? Hayes Alert; Dec. 2002; 5(12). 9. Durga J, van Tits L, Schouten E, et al. Effect of lowering of homocysteine levels on inflammatory markers: A randomized controlled trial. Arch Intern Med. June 27, 2005; 165:1388-1394. 10. Emerging Risk Factors Collaboration; Kaptoge S, Di Angelantonio E, Lowe G, et al. C-reactive protein concentration and risk of coronary heart disease, stroke, and mortality: An individual participant meta-analysis. Lancet. 2010;375(9709):132-140. 11. Grundy, et al. AHA/ACC Scientific statement: assessment of cardiovascular risk by use of multiple-risk-factor assessment equations. J. American College of Cardiology. 1999: 34:1348-59. 12. Guthrie RM. Counseling patients about lipid management. Part 1. What are the goals of therapy? Medical World Communications. May 2003. 13. Lp-PLA(2) Studies Collaboration; Thompson A, Gao P, Orfei L, et al. Lipoprotein-associated phospholipase A(2) and risk of coronary disease, stroke, and mortality: Collaborative analysis of 32 prospective studies. Lancet. 2010; 375(9725):1536-1544. 14. McQueen MJ, Hawken S, Wang X, et al,; INTERHEART study investigators. Lipids, lipoproteins, and apolipoproteins as risk markers of myocardial infarction in 52 countries (the INTERHEART study): A case-control study. Lancet. 2008; 372(9634):224-233. 15. Nontraditional markers of cardiovascular risk. Diabetes Forum. 2002; 1(2). 16. Pai J, Pischon T, Ma J, et al. Inflammatory markers and the risk of coronary heart disease in men and women. The New England Journal of Medicine. December 2004; 351(25):2599-2610. 17. Pearson TA, et al. Markers of inflammation and cardiovascular disease. American Heart Association 2003. 18. Ridker P, Block P. CRP in 2005. Expert opinions. Cardiosource American College of Cardiology. July 2005. Accessed on May 18, 2011 at: www.cardiosource.com. 19. Ridker P, Hennekens C, Buring J. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. The New England Journal of Medicine. March 2000; 342:836-843. 20. Risk Factors for Atherosclerotic Disease, A Textbook of Cardiovascular Medicine, 6th ed., 2001, Ch. 31. 21. U.S. Preventive Services Task Force (USPSTF). Using nontraditional risk factors in coronary heart disease risk assessment. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); October 2009. Assessed on May 18, 2011 at: http://www.ahrq.gov/clinic/uspstf/uspscoronaryhd.htm Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 4/9
22. Physician Advisors Appendix 1 Applicable ICD10 codes approved for Homocysteine test: Codes Description E72.11 Homocystinuria T81.718D Embolism of cardiac prosthetic devices, implants and grafts, sequelae T82.818D Embolism of vascular prosthetic devices, implants and grafts, subsequent encounter T82.817A Embolism of cardiac prosthetic devices, implants and grafts, initial encounter I26.90 Septic pulmonary embolism without acute cor pulmonale I26.99 Other pulmonary embolism without acute cor pulmonale I26.01 Septic pulmonary embolism with acute cor pulmonale I26.02 Saddle embolus of pulmonary artery with acute cor pulmonale I26.92 Saddle embolus of pulmonary artery without acute cor pulmonale I26.09 Other pulmonary embolism with acute cor pulmonale I74.01 Saddle embolus of abdominal aorta I74.19 Embolism and thrombosis of other parts of aorta I74.10 Embolism and thrombosis of unspecified parts of aorta I74.09 Other arterial embolism and thrombosis of abdominal aorta I74.11 Embolism and thrombosis of thoracic aorta I74.2 Embolism and thrombosis of arteries of the upper extremities I74.4 Embolism and thrombosis of arteries of extremities, unspecified I74.3 Embolism and thrombosis of arteries of the lower extremities I74.5 Embolism and thrombosis of iliac artery I74.8 Embolism and thrombosis of other arteries I74.9 Embolism and thrombosis of unspecified artery I82.403 Acute embolism and thrombosis of unspecified deep veins of lower, bilateral I82.409 Acute embolism and thrombosis of unspecified deep veins of unspecified lower I82.402 Acute embolism and thrombosis of unspecified deep veins of left lower I82.401 Acute embolism and thrombosis of unspecified deep veins of right lower I82.4Y3 Acute embolism and thrombosis of unspecified deep veins of proximal lower, bilateral I82.412 Acute embolism and thrombosis of left femoral vein I82.413 Acute embolism and thrombosis of femoral vein, bilateral I82.433 Acute embolism and thrombosis of popliteal vein, bilateral I82.423 Acute embolism and thrombosis of iliac vein, bilateral I82.429 Acute embolism and thrombosis of unspecified iliac vein Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 5/9
I82.422 Acute embolism and thrombosis of left iliac vein I82.4Y2 Acute embolism and thrombosis of unspecified deep veins of left proximal lower I82.419 Acute embolism and thrombosis of unspecified femoral vein I82.432 Acute embolism and thrombosis of left popliteal vein I82.411 Acute embolism and thrombosis of right femoral vein I82.4Y9 Acute embolism and thrombosis of unspecified deep veins of unspecified proximal lower I82.431 Acute embolism and thrombosis of right popliteal vein I82.4Y1 Acute embolism and thrombosis of unspecified deep veins of right proximal lower I82.439 Acute embolism and thrombosis of unspecified popliteal vein I82.421 Acute embolism and thrombosis of right iliac vein I82.493 Acute embolism and thrombosis of other specified deep vein of lower, bilateral I82.449 Acute embolism and thrombosis of other specified deep vein of lower, bilateral I82.449 Acute embolism and thrombosis of unspecified tibial vein I82.4Z3 Acute embolism and thrombosis of unspecified deep veins of distal lower, bilateral I82.492 Acute embolism and thrombosis of other specified deep vein of left lower I82.442 Acute embolism and thrombosis of left tibial vein I82.4Z9 I82.4Z1 Acute embolism and thrombosis of unspecified deep veins of unspecified distal lower Acute embolism and thrombosis of unspecified deep veins of right distal lower I82.443 Acute embolism and thrombosis of tibial vein, bilateral I82.441 Acute embolism and thrombosis of right tibial vein I82.499 Acute embolism and thrombosis of other specified deep vein of unspecified lower I82.491 Acute embolism and thrombosis of other specified deep vein of right lower I82.502 Chronic embolism and thrombosis of unspecified deep veins of left lower I82.509 Chronic embolism and thrombosis of unspecified deep veins of unspecified lower I82.592 Chronic embolism and thrombosis of other specified deep vein of left lower I82.501 Chronic embolism and thrombosis of unspecified deep veins of right lower I82.599 Chronic embolism and thrombosis of other specified deep vein of unspecified lower I82.511 Chronic embolism and thrombosis of right femoral vein I82.529 Chronic embolism and thrombosis of unspecified iliac vein Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 6/9
I82.5Y9 Chronic embolism and thrombosis of unspecified deep veins of unspecified proximal lower I82.533 Chronic embolism and thrombosis of popliteal vein, bilateral I82.5Y3 Chronic embolism and thrombosis of unspecified deep veins of proximal lower, bilateral I82.513 Chronic embolism and thrombosis of femoral vein, bilateral I82.523 Chronic embolism and thrombosis of iliac vein, bilateral I82.531 Chronic embolism and thrombosis of right popliteal vein I82.519 Chronic embolism and thrombosis of unspecified femoral vein I82.5Y2 Chronic embolism and thrombosis of unspecified deep veins of left proximal lower I82.539 Chronic embolism and thrombosis of unspecified popliteal vein I82.522 Chronic embolism and thrombosis of left iliac vein I82.532 Chronic embolism and thrombosis of left popliteal vein I82.521 Chronic embolism and thrombosis of right iliac vein I82.512 Chronic embolism and thrombosis of left femoral vein I82.5Y1 I82.5Z9 I82.5Z1 I82.5Z2 Chronic embolism and thrombosis of unspecified deep veins of right proximal lower Chronic embolism and thrombosis of unspecified deep veins of unspecified distal lower Chronic embolism and thrombosis of unspecified deep veins of right distal lower Chronic embolism and thrombosis of unspecified deep veins of left distal lower I82.543 Chronic embolism and thrombosis of tibial vein, bilateral I82.542 Chronic embolism and thrombosis of left tibial vein I82.549 Chronic embolism and thrombosis of unspecified tibial vein I82.541 Chronic embolism and thrombosis of right tibial vein I82.5Z3 Chronic embolism and thrombosis of unspecified deep veins of distal lower, bilateral I82.813 Embolism and thrombosis of superficial veins of lower extremities, bilateral I82.811 Embolism and thrombosis of superficial veins of right lower extremities I82.812 Embolism and thrombosis of superficial veins of left lower extremities I82.819 Embolism and thrombosis of superficial veins of unspecified lower extremities I82.711 Chronic embolism and thrombosis of superficial veins of right upper I82.712 Chronic embolism and thrombosis of superficial veins of left upper I82.713 Chronic embolism and thrombosis of superficial veins of upper, bilateral I82.719 Chronic embolism and thrombosis of superficial veins of unspecified upper I82.729 Chronic embolism and thrombosis of deep veins of unspecified upper I82.723 Chronic embolism and thrombosis of deep veins of upper, bilateral I82.721 Chronic embolism and thrombosis of deep veins of right upper I82.722 Chronic embolism and thrombosis of deep veins of left upper I82.701 Chronic embolism and thrombosis of unspecified veins of left upper Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 7/9
I82.703 Chronic embolism and thrombosis of unspecified veins of upper, bilateral I82.702 Chronic embolism and thrombosis of unspecified veins of left upper I82.709 Chronic embolism and thrombosis of unspecified veins of unspecified upper I82.A22 Chronic embolism and thrombosis of left axillary vein I82.A23 Chronic embolism and thrombosis of axillary vein, bilateral I82.A21 Chronic embolism and thrombosis of right axillary vein I82.A29 Chronic embolism and thrombosis of unspecified axillary vein I82.B22 Chronic embolism and thrombosis of left subclavian vein I82.B23 Chronic embolism and thrombosis of subclavian vein, bilateral I82.B21 Chronic embolism and thrombosis of right subclavian vein I82.B29 Chronic embolism and thrombosis of unspecified subclavian vein I82.C22 Chronic embolism and thrombosis of left internal jugular vein I82.C21 Chronic embolism and thrombosis of right internal jugular vein I82.C23 Chronic embolism and thrombosis of internal jugular vein, bilateral I82.C29 Chronic embolism and thrombosis of unspecified internal jugular vein I82.291 Chronic embolism and thrombosis of other thoracic veins I82.211 Chronic embolism and thrombosis of superior vena cava I82.91 Chronic embolism and thrombosis of unspecified vein I82.891 Chronic embolism and thrombosis of other specified veins I82.613 Acute embolism and thrombosis of superficial veins of upper, bilateral I82.611 Acute embolism and thrombosis of superficial veins of right upper I82.619 Acute embolism and thrombosis of deep veins of unspecified upper I82.612 Acute embolism and thrombosis of superficial veins of left upper I82.629 Acute embolism and thrombosis of deep veins of unspecified upper I82.621 Acute embolism and thrombosis of deep veins of right upper I82.623 Acute embolism and thrombosis of deep veins of upper, bilateral I82.622 Acute embolism and thrombosis of deep veins of left upper I82.602 Acute embolism and thrombosis of unspecified veins of left upper I82.601 Acute embolism and thrombosis of unspecified veins of right upper I82.609 Acute embolism and thrombosis of unspecified veins of unspecified upper I82.603 Acute embolism and thrombosis of unspecified veins of upper, bilateral I82.A11 Acute embolism and thrombosis of right axillary vein I82.A13 Acute embolism and thrombosis of axillary vein, bilateral I82.A12 Acute embolism and thrombosis of left axillary vein I82.A19 Acute embolism and thrombosis of left subclavian vein I82.B12 Acute embolism and thrombosis of left subclavian vein I82.B13 Acute embolism and thrombosis of subclavian vein, bilateral I82.B11 Acute embolism and thrombosis of right subclavian vein I82.B19 Acute embolism and thrombosis of unspecified subclavian vein I82.C19 Acute embolism and thrombosis of unspecified internal jugular vein I82.C11 Acute embolism and thrombosis of right internal jugular vein Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 8/9
I82.C12 Acute embolism and thrombosis of left internal jugular vein I82.C13 Acute embolism and thrombosis of internal jugular vein, bilateral I82.210 Acute embolism and thrombosis of superior vena cava I82.290 Acute embolism and thrombosis of other thoracic veins I82.90 Acute embolism and thrombosis of unspecified vein Appendix 2 Centers for Medicare and Medicaid Services (CMS) Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, 50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan. Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): Jurisdiction(s): 5, 8 NCD/LCD Document (s): NCD/LCD Document (s): Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor F (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC Moda Health Medical Necessity Criteria Cardiac Disease Screening Lipid Profile Page 9/9