Avera Health Lab News
Sept/Oct 1999 Vol. 3, Issue 4

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FETAL FIBRONECTIN TESTING TO BE OFFERED.
Preterm delivery is a serious complication of pregnancy and a contributing factor in up to 70% of all neonatal deaths and many long-term childhood disabilities. Fetal Fibronectin is a reliable diagnostic test for the identification of women who are at risk of preterm labor. Preterm labor is often misdiagnosed, leading to billions of dollars in health care expenses annually from unnecessary hospital admissions, pharmacy and diagnostic procedures.

The Adzea fFn test detects fetal fibronectin protein, a clinically proven, direct biochemical marker for assessing the risk of preterm delivery in pregnant women. The use of fFn has been heralded by the OB/GYN community as the first safe, non-invasive and objective tool to identify risk for preterm delivery.

The rapid fFn test employs a single-use dry chemistry immunoassay procedure. Results are available within 1 hour of collection. The CPT code for the procedure is 82731. Specimens must be collected using the Adeza Fetal Fibronectin kits. Specimens that are not tested immediately after collection must be stored refrigerated at 2 to 8 degrees C and assayed within three days of collection to avoid degradation of the analyte. Do not expose to temperatures beyond what is recommended. Frozen specimens are stable for twelve months.

Testing will be available at both Avera McKennan and Avera St. Luke's Laboratories soon. Please contact the client services department at these facilities for collection kits and further details.

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MEDICARE REIMBURSEMENT FOR TROPONIN I CLARIFICATIONS.
Some facilities have experienced denials of Medicare claims for troponin and CK testing performed on the same day. The September Newsline should clarify billing matters on these tests. The latest information we have is that troponins and CKs will be allowed on the same day.

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GIARDIA ANTIGEN.
The ova and parasite exam has traditionally been ordered when evaluating patients with diarrhea. Other than Giardia lamblia, intestinal parasites are extremely rare in the patient population of this area. For example, since the institution of Giardia antigen testing at Avera McKennan Hospital Laboratory in January of 1993, no intestinal parasites other than Giardia lamblia have been identified in patients that did not meet the O&P criteria. Giardia antigen testing is highly sensitive and specific. For most patients, being evaluated for diarrhea, Giardia antigen is the most cost-effective test. In patients who are recent immigrants, have traveled outside the U.S. or for which there is other reason to suspect a parasite other than Giardia lamblia the ova and parasite exam may be appropriate.

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AVERA HEALTH HOSPITALS RECEIVE JCAHO REACCREDITATION.
Avera Sacred Heart, Avera Queen of Peace, Avera St. Luke's and Avera McKennan were recently re-accredited by JCAHO, the largest national hospital accrediting organization. All four hospitals received praise for their compassion and respect for patients, emphasis on quality improvement and competent employees.

Congratulations to all the hard working employees of these sister hospitals!

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LOCAL MEDICAL REVIEW REMINDERS FOR PHYSICIANS.

SUBJECT: LIPID PROFILE/CHOLESTEROL TESTING.
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 elevated blood cholesterol (specifically LDL) will reduce the risk of heart attack 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 fat in the diet.

Total cholesterol comprises all the cholesterol found in various lipoproteins.

There are three groups at risk based on 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 >1 60

There are three groups at risk based on triglyceride levels:

Triglyceride of >599 mgm/dl = Abnormal high

Triglyceride of <250 mg/dl = Normal

Triglyceride of 250-500 mgm/dl = Has two times the risk of cardiovascular disease.

Indications and Limitations of Coverage: Testing 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. Testing beyond this must be documented in the patient's medical record to support medical necessity.

Reasons for Non-Coverage: Any diagnosis which is not listed in the covered ICD-9 diagnosis section of model policy #96.24.

Under all other conditions, lipid profile/cholesterol testing is considered screening and is therefore not covered. A family history alone does not indicate medical necessity. Routine screening and prophylactic testing are not allowed for payment purposes in the Medicare program. These are non-covered services which means that while such use may represent good medical practice, this type of testing cannot be reimbursed by Medicare. Only those services which directly relate to disease, injury or malfunctioning body parts-are covered by Medicare.

Measured LDL (83721) should only be used with documented triglycerides >400.

The addition of an HDL cholesterol to a chemistry profile to provide the basic three components of a lipid protein (total cholesterol, triglycerides, and HDL) is acceptable if performed as part of coronary artery evaluation or ongoing monitoring of vascular disease.

Most follow-up may be done with total cholesterol (83465). Triglycerides (84478) may be obtained if this lipid fraction is also elevated or if the patient is put on drugs (i.e. thiazide diuretics, beta blockers, estrogens, glucocorticoids, and tamoxifen) which may raise the triglyceride level. Need for a full lipid profile (80061) will depend on the clinical circumstances of the individual patient.

Lipid profile (80061) and hepatic panel (80058) testing will be reimbursed with severe psoriasis which 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.

After the initial definition of the cholesterol abnormality, follow-up testing during the treatment of hypercholesterol is usually done with a total cholesterol. Follow-up testing with a lipid profile would be appropriate at less frequent intervals (refer to indications and limitations section 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 would be reasonable.

In patients with significantly elevated cholesterol levels who are being aggressively managed with drug therapy, a lipid profile may be reasonable every 3-4 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 would need to be individually justified.

Documentation: Submission of ICD-9 codes other than those listed as covered in policy #96.24 must be supported by written medical necessity documentation. Claim submissions 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, must be in the patient's medical record. Direct LDL measurement will only be reimbursed with accompanying documentation of triglycerides >400. Note: These guidelines apply to laboratory claims reimbursed by Medicare Part A (paid by an intermediary) and claims reimbursed by Medicare Part B (paid by a carrier).

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SUBJECT: FOLIC ACID, SERUM CPT CODE: 82746
Description:
Folic acid, also known as folate, is a B-complex vitamin which serves as a carrier of onecarbon groups in many metabolic reactions. As a tetra-hydrofolate, it is required in the synthesis and catabolism of several amino acids, the formation of creatine and choline, the methylation of RNAS, the synthesis of purines, and the synthesis of DNA. Folic acid deficiency is usually nutritional in origin, and results in megaloblastic anemia. Unlike vitamin Bl 2 deficiency, folic acid deficiency does not cause neuropathy.

Indications and Limitations of Coverage: Serum folic acid testing is indicated when a macrocytic anemia is suspected using blood indices, especially when the Mean Corpuscular Volume (MCV) is above 1 00 fl.

Serum folic acid levels are generally indicated in the evaluation of megaloblastic anemias whose cause is unknown, and in the setting of nutritional deficiency status, alcoholism, pregnancy, and malabsorption. Therapy with certain drugs, especially dehydrofolate reductase inhibitors such as methotrexate and trimthoprim, can result in folic acid deficiency and may be an indication to determine serum folic acid levels.

Except in malabsorptive states where periodic serum folic acid determinations may help in monitoring disease severity, sequential testing of folic acid is usually unnecessary, as response to treatment can be ascertained through increase in hemoglobin, hematrocrit or decrease in macrocytosis/megaloblastosis.

Reasons for Denial: Medicare does not cover routine screening studies.

Non-covered ICD-9 codes: Any diagnostic code not listed in the covered ICD-9 diagnosis section of model policy #97.13.

Documentation Requirements: Medical records should document signs and symptoms to substantiate medical necessity.

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SUBJECT- VITAMIN B12 (CYANOCOBALAMIN) CHEMISTRY TEST. CPT CODE: 82607
Description:
The serum cyanocobalamin is a quantitative analysis of serum vitamin B12 levels. It is generally indicated in the evaluation of megaloblastic anemias whose cause is unknown and in patients with malabsorptive states.

Inadequate intake is rarely the cause of B12 deficiency, it occurs most commonly where there is damage to the stomach, ileum, or pancreas or the enterohepatic circulation of vitamin B12 is impaired.

Indications and Limitations of Coverage:

A. Vitamin B12 testing is indicated when a macrocytic anemia is suspected using blood indices, especially when the Mean Corpuscular Volume (MCV) is increased above 1 00 f 1.

B. Yesting is indicated only for megaloblastic anemias, and in dementias or neuropathies thought to be secondary to B12 deficiencies. Sequential testing is usually unnecessary to monitor the effects of vitamin B12 therapy. Since cyanocobalamin is given to treat the macrocytic anemia, tests normally used to monitor anemia such as hemoglobin or hemtocrit should be used.

Reasons for Denial.

A. Cyanocobalamin testing is usually not necessary to monitor vitamin Bl 2 therapy.

B. Medicare does not cover routine screening.

Non-covered ICD-9 codes: Any diagnostic code not listed in the covered ICD-9 diagnosis section of model policy #97.12.

Documentation requirements: Medical records should indicate signs and symptoms to substantiate medical necessity.

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FROM THE EDITOR...
Congratulations to the Iowa and North Dakota Societies for Clinical Laboratory Science on the awards won at the ASCLS Annual Meeting and Clinical Laboratory Exposition in New Orleans. Both won membership awards and the Iowa society's newsletter won first place in the Constituent Society Publication category. Our state societies are a great resource and it's nice to see them receive well-deserved recognition.

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