(Reproduced by permission from Medicare Focus, May 2000, Web Edition)

Medicare Part A Local Medical Review Policy
Lipid Profile and Cholesterol Testing

Policy Number:

A97-09 – Revised

Description

Lipoproteins are a class of heterogenous particles of varying sizes and densities, containing lipid and protein. These lipoproteins include cholesterol esters and free cholesterol, triglycerides, phospholipids, and A, C, and E apoproteins.

In most individuals, an elevated blood cholesterol constitutes an increased risk of developing coronary artery disease. Scientific evidence has established that lowering definitely elevated blood cholesterol (specifically LDL) will reduce the risk of heart attacks due to coronary heart disease (CHD). Elevated levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C) are associated with increased risk as are low levels of high-density lipoprotein cholesterol (HDL-C). Levels may be decreased by several factors, including diet and decreasing total fat in the diet.

LDL may be directly measured and fractionated into subparticles, all of which are in the LDL density range. These subparticles may reflect three density subtypes, Pattern A, Pattern B, and Pattern I (intermediate between pattern A and B).

Total cholesterol comprises all the cholesterol found in various lipoproteins. Patients can be stratified into three risk groups depending on total serum cholesterol levels.

·

Desirable Risk: Total Cholesterol <200

 

LDL Cholesterol <130

 

·

Borderline Risk: Total Cholesterol 200-239

 

LDL Cholesterol 130-159

 

·

High Risk: Total Cholesterol >240

 

LDL Cholesterol >160

Patients can be stratified into three risk groups depending on serum triglyceride levels.

·

Level of >599 mgm/dl = Abnormal high

·

Level of < 250 mgm/dl = Normal

·

Level of 250-500 mgm/dl = Has two times the risk for C-V disease

Type of Bill

12X, 13X, 14X, 22X, 23X, 24X, 28X, 71X, 72X, 73X, 83X, 85X

Revenue Codes

30X

Indications and Limitations of Coverage and/or Medical Necessity

Indications

These tests are indicated for the diagnosis and management of diseases and illnesses affecting lipid metabolism.

These tests will be covered at a combined frequency of up to three times a year for dietary therapy and four times a year for drug therapy. Documentation of the medical necessity for testing beyond this frequency must be in the patient's medical record.

Limitations

Screening tests are defined as those tests done in the course of an annual physical examination or as part of a routine physical checkup, without signs, symptoms or the presence of an illness. The panel covered by this local medical review policy when done as a screening test would not be a covered Medicare benefit.

CPT/HCPCS Code(s)

80061

Lipid panel [this panel must include the following:

   

·

Cholesterol, serum, total (82465)

·

Lipoprotein, direct measurement, high density cholesterol (HDL cholesterol) (83718)

·

Triglycerides (84478)].

82172

Apolipoprotein, each

82465

Cholesterol, serum, total

83715

Lipoprotein, blood; electrophoretic separation and quantitation

83716

Lipoprotein, blood; high resolution fractionation and quantitation of lipoprotein cholesterols (e.g., electrophoresis, nuclear magnetic resonance, ultracentrifugation)

83718

Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol)

83719

Lipoprotein, direct measurement; direct measurement VLDL cholesterol

83721

Lipoprotein, direct measurement; direct measurement LDL cholesterol

84478

Triglycerides

ICD-9-CM Codes That Support Medical Necessity

One of the following covered ICD-9-CM diagnosis codes must be linked to the appropriate procedure.

    The correct use of an ICD-9-CM code listed below does not guarantee coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this policy.

Diagnosis Definition for HCPCS 80061, 82465, 83715, 83718, 83719, 83721, 84478:
Revised per Medicare Focus, October 2000, pg. 29

Disorders of Thyroid Gland
240.0-246.9


Diseases of Other Endocrine Glands
250.00-250.93
255.0
Nutritional Deficiencies

260
261
262
263.0
263.1
263.8
263.9
Other Metabolic and Immunity Disorders

270.0
271.1
272.0
272.1
272.2
272.3
272.4
272.5
272.6
272.7
272.8
272.9
277.7 Revised per Medicare Focus December, 2001
Neurotic Disorders, Personality Disorders, and Other Nonpsychotic Mental Disorders

303.90-303.92
Disorders of the Eye and Adnexa

362.13
362.82
379.22
Diseases of the Ear and Mastoid

388.00
Hypertensive Disease

401.0-405.99
Ischemic Heart Disease

410.00-410.92
411.0-411.1
411.81
411.89
412
413.0-413.9
414.00-414.03
414.04-414.05 Revised per Medicare Focus August, 2001
414.10-414.19
414.8-414.9
Arthropathies and Related Disorders

713.0
Other Forms of Heart Disease

427.0-427.9
428.0-428.9
429.2
Cerebrovascular Disease

431-437.9
438.0 Revised per Medicare Focus March, 2002
Diseases of Arteries, Arterioles, and Capillaries

440.0-440.9
441.00-441.9
443.0-448.9
Noninfectious Enteritis and Colitis

557.1
Other Diseases of Digestive System

570-573.9
574.00-574.51
575.2
575.6
576.2
576.8
577.0-577.9
579.3
579.8
Nephritis, Nephrotic Syndrome, and Nephrosis

581.0-581.9
584.5
588.1
588.8
Complications Mainly Related to Pregnancy

646.70-646.73
648.10-648.14
Other Inflammatory Conditions of Skin and Subcutaneous Tissue

696.0
696.1
Congenital Anomalies

746.85
751.61
Other Conditions Originating in the Perinatal Period

764.10-764.19
Symptoms

786.50
Persons With Potential Health Hazards Related To Personal and Family History

V12.2
Persons Encountering Health Services For Specific Procedures and Aftercar
e
V58.69
Persons Encountering Health Services In Other Circumstances

V67.51

Diagnosis Definition for HCPCS 83716:

Ischemic Heart Disease
410.00-414.05
414.8-414.9
Other Forms of Heart Disease

429.2
Cerebrovascular Disease

433.00-437.1
437.8-437.9
Diseases of Arteries, Arterioles, and Capillaries

440.0-440.9
443.9

HCPCS Section and Benefit Category

Pathology and Laboratory

HCFA National Coverage Policy

In the event that a national policy is established, the national policy will take precedence over
local policy.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be reasonable and medically necessary, i.e., reasonable and necessary are those tests used in the diagnosis and management of illness or injury or to improve the function of a malformed body part.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine
physical examinations.

Reasons for Denial

Tests performed during annual physical examinations or other routine screening situations without signs, symptoms or illness will result in denial as a non-covered benefit. In this circumstance one of the following ICD-9-CM diagnosis codes must be linked to the procedure code: V70.0-V70.9, V82.9.

Apolipoprotein (82172) has been determined to be unnecessary for appropriate patient monitoring in cases of hyperlipoproteinemia, and is considered to be a screening test and therefore noncovered by Medicare.

Note:

LDL cholesterol = [total cholesterol - HDL cholesterol - (triglycerides/5)].
Revised per Medicare Focus, October 2000, pg. 29

Measured LDL (CPT code 83721) should only be used with documented Triglycerides greater than 400. Otherwise use a calculation method that is not reimbursable.

A multichannel chemistry profile will not be allowed when it is performed to measure cholesterol or triglycerides only.

The addition of a HDL-cholesterol to a chemistry profile to provide the basic three components of a lipid profile is acceptable if performed as a part of coronary artery evaluation or ongoing monitoring of vascular disease.

Most follow-up may be done with a total cholesterol (CPT code 82465). Triglycerides (CPT code 84478) may be obtained if lipid fraction is also elevated or if the patient is prescribed drugs (i.e., thiazide diuretics, beta blockers, estrogens, glucocorticoids, and tamoxifen) that may raise the triglyceride level. Need for a full lipid profile (CPT code 80061) will depend on the clinical circumstances of the individual patient.

Lipid profile (CPT code 80061) and Hepatic panel (CPT code 80076) testing will be reimbursed for patients with severe psoriasis that has not responded to conventional therapy and for which the retinoid estretinate has been prescribed and who have developed hyperlipidemia or hepatic toxicity. Specific examples include erythrodermia and generalized pustular type and psoriasis associated with arthritis. These two panels will be allowed at a frequency in keeping with medical necessity and appropriate medical practice acceptable to the carrier's medical review.

Claims not meeting the coverage criteria as stated in the Indications section of this policy will be denied. Services will always be denied which are considered:

·

experimental; or

·

cosmetic; or

·

routine screening; or

·

a program exclusion; or

·

never medically necessary; or

·

otherwise not covered.

Non-covered ICD-9-CM Diagnosis Codes

Any code not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this policy.

Codes that are never covered:

V70.0-V70.9
V82.9

Sources of Information

·

Bierman EL. Atherosclerosis and Other Forms of Arteriosclerosis. Harrison's Principles of Internal Medicine, 13th edition (Editors Isselbacher KJ, Braunwald E, Wilson JD, Martin JB, Fauci AS, Kasper DL) McGraw-Hill, New York 1994:2058-2069.

·

Brown MS and Goldstein JL. The Hyperlipoproteinemias and Other Disorders of Lipid Metabolism. Harrison's Principles of Internal Medicine, 13th edition. (Editors Isselbacher KJ, Braunwald E, Wilson JD, Martin JB, Fauci AS, Kasper DL) McGraw-Hill, New York 1994: 1106-1116.

·

Executive Summary of the National Cholesterol Education Program Expert Panel – Second Report on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, (Adult Treatment Panel II). National Institutes of Health, National Heart, Lung, and Blood Institute. NIH publication No. 93-3095, Bethesda, July 1993, September 1993.

·

Farmer JA and Gotto Jr AM. Risk Factors for Coronary Artery Disease. Heart Disease, A Textbook of Cardiovascular Medicine, 4th edition, (Editor Braunwald E) WB Saunders, Philadelphia, 1992:1125-1160.

·

Laboratory Test Handbook, 2nd edition

·

Other carriers' existing local medical review policies

·

Carrier Medical Director (CMD) Clinical Laboratory Workgroup

Coding Guidelines

All claims for these tests must be submitted with an ICD-9-CM diagnosis code. Failure to do so may result in denial or delay in claim processing.

When a lipid profile (CPT code 80061) is performed, separate billing for individual test components (CPT codes 82465, 83718, 84478) will not be allowed on the same day.

When CPT 83716 (Lipoprotein, blood; high resolution fractionation and quantitation of lipoprotein cholesterols (e.g., electrophoresis, nuclear magnetic resonance, ultracentrifugation)) is performed, separate billing for 83718, 83719, 83721 will not be allowed on the same day. If it is reasonable and necessary (medically necessary) to perform these direct measurements on the same day as 83716, modifier 59 should be used and medical records supporting the medical necessity should be sent with the claim.

After the initial definition of the cholesterol abnormality, follow-up testing during the treatment of hypercholesterolemia is usually done with a total cholesterol (CPT code 82465). Follow-up testing with a lipid profile (CPT code 80061) would be appropriate at less frequent intervals, (refer to the "Limitations" section of this policy for frequency). For example, in patients with borderline high cholesterol who are not being treated or in patients who are stable on dietary and/or drug therapy, performing a lipid profile yearly is reasonable.

In patients with significantly elevated cholesterol levels who are being aggressively managed with drug therapy, a lipid profile may be reasonable every three to four months until the clinical condition has stabilized. More frequent use of lipid profiles or use of other lipid fraction tests to follow the course of treatment needs to be individually justified.

Report the principal diagnosis (Form Locator 67) to your highest degree of certainty. Secondary diagnosis codes (Form Locator 68-75) should include the patient’s presenting symptoms and any other medical conditions that may effect the patient’s care (Refer to the May 1999 issue of Medicare Focus).

Reconsiderations and Appeals - Claims resubmitted with a different diagnosis code must include medical record documentation to justify the diagnosis code change. Submission with diagnoses other than those listed in the "ICD-9-CM Codes That Support Medical Necessity" section of this policy, will be individually reviewed by this Intermediary for medical necessity.

Documentation Requirements

Documentation supporting the medical necessity of this item, such as ICD-9-CM codes, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.

All coverage criteria must be documented in the patient’s medical record and made available to Medicare upon request. This information should be generally submitted on reconsideration only (or with the claim if the services are unusual or if denial is anticipated).

ICD-9-CM diagnosis codes are required on claim.

If documentation is requested for review, submit the following:

·

History and Physical

·

Physician orders/progress notes

·

Nurses notes

·

Medication sheet indicating the name of drug, the dosage and route administered

·

Diagnosis/reason for drug

·

Test results

·

Itemization of charges

Submission of ICD-9-CM diagnosis other than those listed as covered in this policy must be supported by written medical necessity documentation. Claims submission of diagnosis outside this guideline must have accompanying written medical necessity documentation. The ordering physician must clearly document in the patient's clinical record conformity to this policy and/or support the medical necessity for deviation. The treatment plan, if the patient is being treated for those conditions listed above, must be in the patient's medical record.

Direct LDL measurement [Physicians' Current Procedural Terminology (CPT) code 83721] will only be reimbursed with accompanying documentation of triglycerides greater than or equal to 400 mg/dl.

The medical necessity for additional special lipoprotein analyses (CPT codes 83715, 83716, 83719, 83721) must be documented in the patient's medical record.

Comments

Patients with documented vascular disease are candidates for aggressive lipid lowering treatment. Treatment includes smoking cessation, diet adjustment, fiber supplements, "statin," drugs, "fibrates," and/or nicotinic acid in large doses. LDL subparticle measurements will distinguish patients with more of the larger and less dense LDL subparticles (Pattern A) from patients with more of the smaller and denser LDL subparticles (Pattern B). LDL subparticle measurement may be necessary to select the most effective therapy for patients when the standard lipid profile (TC, HDL, LDL, T) is within the statistically normal range:

·

a triglyceride value between 70 mg/dl and 250 mg/dl; and

·

an HDL cholesterol value over 35 mg/dl; but

·

less than 55 mg/dl for men and women without estrogen, or

·

65 mg/dl for women with endogenous or exogenous estrogen (pre-menopausal or HRT).

Pattern B (smaller/more dense) patients may be more responsive to "fibrates" and/or niacin, and less responsive to "statin" drugs in regard to small dense LDL reduction. Patients who have LDL subtype Pattern A (larger/less dense) may be more responsive to "statin" drugs and less responsive to "fibrates" and/or niacin.

Medicare will cover 83716 when needed to determine the most effective lipid lowering pharmacologic therapy in patients with vascular disease who have standard lipid profiles within the statistically normal range, and for whom an LDL goal of below 100 mg/dl is established.

This group of laboratory tests is among the subjects of negotiated rulemaking with the Health Care Financing Administration (HCFA). When the final rules are published and effective, this local medical review policy will be revised.

The Local Medical Review Policy Lipid Profile and Cholesterol Testing was published in the July 1997 issue of the Medicare Focus. This Local Medical Review Policy replaces the policy previously published in the July 1997 issue of Medicare Focus.

This policy should be interpreted to incorporate future changes in the ICD-9-CM or CPT/HCPCS coding systems such that its original intent and scope will not be substantively changed.

CPT only © 1999 American Medical Association. All Rights Reserved.

All International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes and descriptions are copyright © 1998 Medicode, Inc.

 

Original

Revised

Start Date of Comment Period

April 8, 1997

January 25, 2000

Start Date of Notice Period

July 1, 1997

May 1, 2000

Original Effective Date

August 1, 1999

 

Revised Effective Date

 

June 1, 2000

Approval

This policy does not reflect the sole opinion of the Intermediary/Medical Director. Although the final decision rests with the Intermediary, this policy was developed in conjunction with the other Intermediaries and other Intermediary policies.