Avera LabNet - Newsletter

Avera Health Lab News
Fall 1997 Vol. 1, Issue 1

New Recommendations for Diabetes Testing.
An international Expert Committee, convened under the auspices of the American Diabetes Association, has made several recommendations concerning the diagnosis of diabetes. Diabetes is a group of diseases that result from defects in the body's ability to produce and/or use insulin as needed. Currently diabetes is the fourth-leading cause of death by disease in the United States.

The Expert Committee states that diabetes can be diagnosed in any one of three ways, confirmed by any one of the three on a different day. However, the Committee clearly stated that the fasting glucose option is the preferred test because of its convenience, acceptability to patients, and lower cost (compared to the glucose tolerance test.) The tests for diagnosis of diabetes are:

A fasting plasma glucose of >=126 mg/dl (following a fast of at least 8 hours)
A casual plasma glucose (taken any time of day regardless of food intake) >=200 mg/dl accompanied by the classic diabetes symptoms of increased urination, increased thirst, and unexplained weight loss.
An oral glucose tolerance test value of >=200 mg/dl in the two-hour sample.

The Committee also notes that, while useful for monitoring known diabetic patients, finger-prick glucose tests and hemoglobin Alc (glycated hemoglobin) tests are not recommended for diagnosis of the disease.

The Committee recommends that all adults age 45 and over should be tested for diabetes. If the initial test is normal, it may be repeated in three-year intervals. Earlier and more frequent testing my be necessary for patients who:

are obese (>20% above ideal weight)
have a first-degree relative with diabetes
are members of a high-risk ethnic group
were diagnosed with gestational diabetes or delivered a baby weighing more than nine pounds.
have an HDL <=35 mg/dl and/or a triglyceride >= 250 mg/dl
on previous testing, had a fasting glucose >= 110 mg/dl but <126 mg/dl

In addition, the Committee recommended eliminating the categories of "insulin-dependent diabetes mellitus" (IDDM) and "non-insulin-dependent diabetes mellitus" (NIDDM), as these classifications are based on treatment and not the underlying etiology of the disease. Type I diabetes (formerly IDDM) is a disease characterized by destruction of pancreatic beta cells which produce insulin, usually leading to absolute insulin deficiency. Type 2 diabetes (formerly NIDDM) is caused by insulin resistance combined with relative insulin deficiency. It typically occurs in overweight, sedentary people over 45 with a family history of diabetes.

The Committee emphasized that earlier diagnosis and treatment does not imply earlier implementation of drug therapy, as type 2 diabetes is often effectively treated with lifestyle changes such as a healthier diet and regular exercise. It is hoped that these recommendations will enable earlier diagnosis and treatment, resulting in fewer of the serious complications caused by the disease.

Medicare Part B Updates.

Physicians to provide labs with diagnosis codes and/or ABNs.

In a recent issue of the South Dakota Medicare B Newsletter, physicians were strongly encouraged to provide ICD-9-CM diagnosis codes to laboratories when ordering tests. Clinical laboratory tests that are submitted with a covered diagnosis to substantiate the medical necessity of the test(s) are denied. Although Medicare does not currently require ordering physicians to submit this information to laboratories, they are urged to do so to help expedite payment of claims submitted by clinical laboratories for their patients. Without documentation of a covered diagnosis, the lab will not be paid for its services.

If there is reason to believe that reimbursement for the test(s) may be denied because of failure to meet the medical necessity criteria, a signed Advance Beneficiary Notice (ABN) should be forwarded to the laboratory with the specimen. The laboratory needs a valid ABN in order to bill the beneficiary for the denied tests. If ordering physicians are unsure of the medical necessity criteria for a specific test, please reference the bulletin index mailed along with the April 1997 Medicare B News, or contact your reference lab for further information.

Orders for more than 19 Automated Multichannel Tests.

The AMA's CPT Manual lists fourteen codes (80002-80019) that are used to bill for combinations of clinical chemistry tests selected from a list of nineteen tests. The following HCPCS codes are used to bill for a combination of more than nineteen tests.

G0058, Automated Multichannel test; 20 clinical chemistry tests
G0059, Automated Multichannel test; 21 clinical chemistry tests
G0060, Automated Multichannel test; 22 clinical chemistry tests

Medicare allows payment only for tests that are medically necessary. Since it is very rare for any patient to have a condition(s) that would create the medical necessity of a battery of more than nineteen chemistry tests, the only legitimate justification for performing these tests would be for purposes of screening. Therefore, as screening tests the carrier for South Dakota Medicare Part B considers these three HCPCS codes to be outside the scope of Medicare coverage. Accordingly, the carrier will deny all claims for HCPCS codes G0058, G0059, and G0060. If the provider believes that these tests are medically necessary, the denial may be appealed with supporting documentation.

Please note: These updates are in effect for laboratory claims reimbursed by Medicare Part B (paid by a carrier), such as those submitted by McKennan Regional Laboratory. The above information may or may not apply to laboratory claims that are reimbursed by Medicare Part A (paid by an intermediary), such as those submitted by Queen of Peace and St. Luke's Midland. If you have any questions on the Medicare requirements for your laboratory orders, please contact the specific laboratory performing your testing.

Medicare Part A Updates.

Local Medical Review Policy Updates.

Several additions have been made to the ICD-9-CM codes covered by the policy. To the WBC policy, the following codes have been added: 789.0 for abdominal pain, V58.69 for long ten-n (current) use of high risk medications and 780.6 for fever of unknown origin. The diagnosis 786.09, shortness of breath, has been added to the CBC Local Medical Review Policy (LMRP). Revisions to the CBC policy are as follows: 1,37.00-139.8 should be 137.0-139.8; 200.0-200.9 should be 200.0-208.91; 460-466.1 should be 460466.19.

Use of Modifiers on Medicare Lab Claims.

The GA and QP modifiers have been designed to allow laboratories to indicate that there is a valid ABN on file for the test(s) ordered (GA) or that the tests have been ordered individually (QP). However, the fiscal intermediary is not able, at this time, to accept claims containing these modifiers. Therefore, they cannot be used until the system is able to accept them.

Please note: These updates are in effect for laboratory claims reimbursed by Medicare Part A (paid by an intermediary), such as those submitted by Queen of Peace and St. Luke's Midland. The above information may or may not apply to laboratory claims that are reimbursed by Medicare Part B (paid by a carrier), such as those submitted by McKennan Regional Laboratory. If you have any questions on the Medicare requirements for your laboratory orders, please contact the specific laboratory performing your testing.

Vaginitis DNA Probes Offered at McKennan.
McKennan Hospital and Regional Laboratory recently began offering a vaginitis DNA probe for the diagnosis of vaginitis/vaginosis caused by Gardnerella vaginalis, Candida species, and Trichomonas vaginalis. Vaginitis is one of the most common problems in clinical medicine. Bacterial vaginitis complications can be especially significant in pregnant women, resulting in increased obstetrical complications. Trichomoniasis is a non-reportable sexually transmitted disease.

Traditionally, laboratory diagnosis of these conditions was made by microscopic examination of vaginal discharge, Gram stain, or culture. The Affirm BPIII Microbial Identification Test is based on the principles of nucleic acid hybridization. Specimen collection is a critical step. All samples must be collected using the materials provided in the kit. Separate swabs should be used for other tests. The total time between placing the swab into the collection tube and processing the specimen should be no longer than I hour at room temperature or 4 hours if stored at 2-8' C. Results may be affected by improper handling. A negative result does not exclude the possibility of vaginitis/vaginosis. Positive results must be evaluated in light of clinical signs and symptoms.

Queen of Peace Adds to Test Menu.
Due to increased demand, Queen of Peace Laboratory will be performing lactic acid levels in-house effective October 1, 1997. These will be available 24 hours/day on a STAT, urgent or routine basis. Lactic acid assays will be performed on the Dimension clinical chemistry system using an enzymatic method for the quantitative measurement of lactic acid in plasma and cerebrospinal fluid. Lactic acid test results may be used as an aid in the diagnosis and treatment of lactic acidosis.

In response to needs created for exposure follow-ups, HIV- I and hepatitis testing will also be performed in-house. The HIV-1 assay is a screening test for the rapid detection of antibodies to HIV-1 in plasma or serum. HIV-1 testing will be performed daily at approximately 10:00 am with results available by noon. The hepatitis assays added to the test menu include HBsAg, HBsAb, HCV, HAVAB-M, and HBcAb-M. All hepatitis testing will be performed Monday, Wednesday, and Friday with results available midafternoon. With the exception of exposure follow-ups, all testing will be performed on a routine basis only.

New Cardiac Markers at McKennan.
As of August 27^th, McKennan Hospital and Regional Laboratory has two new tests for the evaluation of acute chest pain. Troponin I and myoglobin have been added to the traditional diagnostic tests of CK, CKMB, and the EKG. Both new assays are available on a STAT basis.

Myoglobin is present in the cytoplasm of skeletal and cardiac muscle cells. Any muscle damage will release this protein from the affected cells. In cardiac damage, serum myoglobin levels may be elevated within three hours of the onset of chest pain. Myoglobin levels peak in 8-12 hours and fall to normal within 24-36 hours. Serum myoglobin is not specific for cardiac damage, as it can be elevated in any condition that results in muscle damage. Assays every two hours are suggested, and if myoglobin does not double within a two-hour period cardiac damage can be ruled out with 98% assurance. Serum is the specimen of choice. Specimens that will not be tested within 8 hours should be frozen at -20'C. Normal values are <70 ng/ml.

Cardiac Troponin I is one of three structural proteins located on the contractile apparatus of cardiac muscle. This protein is not found in any other tissue, making the assay very specific for myocardial damage. Troponin I is elevated within 3-4 hours, peaks in 12-16 hours, and stays elevated for 5-9 days. Myocardial damage is unlikely if serial troponin levels do not rise over 0. 15 ng/ml after 12 hours from onset of chest pain. Any condition resulting in myocardial damage can potentially elevate cardic troponin levels, including unstable angina, congestive heart failure, myocarditis, and cardiac surgery or invasive testing. Serum is the specimen of choice. Avoid collecting specimens in heparin. Samples that will not be run within 8 hours should be frozen at -200C. Normal values are < 0.05 ng/ml.

Question of the Quarter:

Q: What is microalbumin and why is its measurement significant in patients with diabetes?

A: Microalbumin is the term frequently used for the small amounts of albumin excreted by the kidney in the early stages of nephropathy. The term "microalbumin' may be misleading in that it implies presence of a smaller protein that is different than albumin; actually it refers to an excretion rate of albumin greater than normal but less than previously detectable levels. The presence of increased urinary albumin excretion (microalbuminuria) is a marker of microvascular disease, and is highly predictive of diabetic nephropathy, end-stage renal disease, and proliferative retinopathy in Type 1 diabetes. Identifying patients early in the progression of nephropathy can allow the physician to treat those at risk for progressive renal damage by controlling blood glucose and hypertension. Administration of angiotensin-converting enzyme inhibitors may also help to slow the progression to end-stage renal disease.