News Story #16983

The latest CD offering from Equal Diagnostics of Exton, Pa., may not come with a hip-hop sound for dancing, but it does offer upbeat information about soon-to-be implemented national Medicare coverage policies on lipid testing reimbursement. Designed for the PC, the 25-minute Lipid Testing Reimbursement

Update outlines the medical reasons for using a direct rather than calculated LDL cholesterol test and how current and future reimbursement policies align with lipid testing. The CD includes three sections: Real Measure, Right Decisions; National Lipid Coverage Policy; and Reference Documents.

The goal of the CD is to assist laboratorians in planning and implementing testing procedures. Lipid testing, policies for lipid testing, and the alignment of these national coverage policies with the National Cholesterol Educational Program (NCEP) recommendations for lipid testing are reviewed with the laboratorian in mind. It includes expert physician analysis, the impact of reimbursement on the laboratory and the changing role of direct LDL testing.

Since the late 1980s, a large body of epidemiological research has shown a significant link between elevated cholesterol levels and coronary heart disease risk. In fact, reducing LDL cholesterol levels is a primary target identified by NCEP and the American Heart Association (AHA) for reducing the morbidity and mortality associated with coronary disease.

Since its introduction in 1972, cholesterol test results for LDL levels have been determined by the Friedwald formula, which uses a calculation involving total cholesterol, HDL cholesterol and triglyceride results to calculate the LDL level rather than an actual measurement. Despite its widespread use, the Friedwald method has three limitations. First, the additive variability of the three assays can skew results. Also, it requires patients to fast, and it is not accurate for patient with triglycerides over 400. Fortunately, there are new homogeneous assays that directly measure LDL, require no patient fasting and provide accurate values even when triglycerides are over 400.

NCEP guidelines
NCEP guidelines recommend that cholesterol be monitored by the measurement of direct LDL cholesterol. The recent availability of simple, direct, homogeneous assays for LDL cholesterol assessment makes the monitoring of LDL cholesterol possible. The new Medicare coverage policy for lipid testing is now more aligned with the NCEP guidelines.

The national coverage policy was developed over 14 months by HCFA and a 19-member committee representing medical care providers, laboratories and diagnostics industry manufacturers. When fully implemented, all Medicare contractors will adopt these coverage policies.

The national coverage policy rules for the 23 clinical lab testing groups. which comprise 60 percent of all clinical lab tests paid for by Medicare, is almost complete.

New policies affect tests
The new policies will affect the lipid panel, total cholesterol, HDL cholesterol, direct LDL cholesterol, and triglycerides tests. The Lipid Testing Reimbursement Update CD helps lab managers prepare for changes, determine coverage, and comply with testing recommendations. (See chart below).

Lipoproteins, a class of heterogeneous particles of varying sizes and densities containing lipid and protein, include cholesterol esters and free cholesterol, triglycerides, phospholipids and A, C, and E apoproteins. A total cholesterol encompasses all the cholesterol found in various lipoproteins.

Blood cholesterol levels are affected by a person’s age, sex, weight, diet, exercise habits, genetics, family history, medications and alcohol and tobacco use. Chronic disorders such as hypothyroidism, obstructive liver disease, pancreatic disease (including diabetes) and kidney disease also have an impact.

LDL equates with risk
In most individuals, an elevated blood cholesterol level constitutes an increased risk for developing coronary artery disease. Levels of total cholesterol and cholesterol fractions such as low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) are useful in assessing and monitoring treatment for patients who have or are at-risk for cardiovascular diseases. In a 1993 report, certain levels of these cholesterol components were categorized as “desirable,” “borderline” or “high-risk” by the National Heart, Lung and Blood Institute. In the years since, these categories have served as a foundation for the evaluation and treatment of patients with hyper-lipidemia. Therapy to reduce these risk parameters includes a low-fat diet, regular exercise and medication.

Monitors anti-lipid therapy
When monitoring long term anti-lipid dietary or pharmacological therapy in patients with borderline high total or LDL cholesterol levels, it is reasonable to perform an annual lipid panel (CPT code 80061) while measuring serum total cholesterol (CPT code 82465) and measured LDL (CPT code 83721) during interim visits. That holds only if the patient does not have hyper-triglyceridemia.

In addition, any single component of the panel or a measured LDL may be reasonable and necessary up to six times the first year for monitoring dietary or pharmacological therapy. More frequent total cholesterol, HDL cholesterol, LDL cholesterol and triglyceride testing may be indicated if the patient shows marked elevations or if there are any changes to anti-lipid therapy due to inadequate patient response. LDL cholesterol or total cholesterol may be measured three times yearly after treatment goals have been achieved. Electrophoresis or other quantification of lipoproteins (CPT codes 83715 and 83716) may be indicated if the patient has a primary disorder of lipoid metabolism.

The national coverage policy indicates that when monitoring anti-lipid, dietary, or pharmacological therapy on a patient with a high total cholesterol or high LDL, it may be appropriate to run a lipid panel once in the first year. This should be followed by six additional tests from the components of the lipid panel or the direct LDL test for the rest of the year. In subsequent years, it is appropriate to run the lipid panel and three additional tests from the component list or the direct LDL test.

Bottom line reimbursement
The bottom line is that laboratories can be reimbursed for one lipid panel in year one of a patient’s therapy. After that, one test must be chosen for subsequent visits. Thus, any one of the above cholesterol tests can be reimbursed up to six times in year one and three times in subsequent years.

The new lipid policy includes a list of ICD-9-CM codes that will be covered. Medicare Policy continues to be that, unless authorized by law, it will not pay for the screening of patients.

Final rules are expected to be published in the Federal Register by the end of the first quarter of 2001. The effective date of the new coverage policies will be one year from that publication date. However, Medicare contractors may adopt the new coverage policies as soon as they can make the appropriate changes to their systems.

For information about Equal Diagnostics or to order a free CD, call 800-999-6578 or select Reader Service No. 260 on the reader service card.

Brenda Kan is technical support director at Equal Diagnostics.