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|Quidel's QuickVue(R) Influenza Test Receives Specific Reimbursement Code Just in Time for Flu Season|
New 2002 Code Streamlines Billing Process
SAN DIEGO, Jan. 14 /PRNewswire-FirstCall/ -- Quidel Corporation (Nasdaq: QDEL) today announced that its QuickVue(R) Influenza test received a new billing code for 2002 from the Centers for Medicare and Medicaid Services (CMS).
CMS sent all carriers and intermediaries a Change Request, Transmittal AB-01-187, on December 18, 2001, updating the CLIA-Waived Test list to include Quidel's QuickVue Influenza test billable under a new Current Procedural Terminology (CPT) code in 2002. This test was previously approved by the U.S. Food and Drug Administration (FDA) as a waived test under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
This Change Request states, "CPT code 87804 is a new code for 2002 that was developed for Infectious agent antigen detection by immunoassay with direct optical observation; Influenza. Hence, the CPT code 87804QW replaces the CPT code 87899QW for the Quidel QuickVue Influenza test."
The effective date of this CMS transmittal is for services delivered after January 1, 2002.
"The new 87804QW code should alleviate many of the reimbursement issues encountered with the old code as the 87804QW code is specific for our QuickVue Influenza test. The 87899QW code was a 'not otherwise specified' code that created some billing problems with some carriers across the country. We appreciate this timely decision by CMS as we are currently entering the height of the flu season and this development should streamline billing for busy physicians," stated S. Wayne Kay, President and CEO of Quidel.
According to the United States Centers for Disease Control and Prevention (CDC), each year in the U.S. 20,000 people die and over 100,000 are hospitalized from influenza complications. "Rapid diagnosis and immediate intervention in patients presenting with a flu-like illness is paramount in order to decrease the morbidity and mortality associated with influenza," added S. Wayne Kay.
The QuickVue Influenza test is the only 3-step, 1-reagent, 10-minute flu test with less than 30-seconds hands-on time currently available. The test is the first CLIA-waived flu test and can be stored at room temperature. An important product improvement for the 2001-2002 flu season is an extended 2-year shelf life from date of manufacture.
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 established national quality standards for most laboratories that perform testing on human specimens to ensure the reliability of test results regardless of where the test is performed. CLIA-regulated laboratories must meet specified quality standards to be eligible for payment from the Medicare and Medicaid programs. Diagnostic test systems are classified into one of three CLIA regulatory categories based on their potential risk to public health. Waived tests are the lowest regulated category and those most used in physician offices.
Quidel Corporation discovers, develops, manufactures and markets rapid point-of-care diagnostic tests for detection of medical conditions and illnesses. These products provide accurate, rapid and cost-effective diagnostic information for acute and chronic conditions associated with women's health, in areas such as reproduction and diseases of the elderly. Quidel also provides point-of-care diagnostics for infectious diseases, including influenza A and B, strep throat, H. pylori infection, chlamydia, infectious mononucleosis and bacterial vaginosis. Quidel's products are sold to healthcare professionals for use in physicians' offices, clinical laboratories and pharmacies, and to consumers through organizations that provide private label, store brand products. These tests provide diagnostic information to enable rapid treatment and improve health outcomes, lower costs and increase patient satisfaction. For more information, please visit Quidel's Web site at www.quidel.com .
This press release contains forward-looking statements regarding Quidel's future activities within the meaning of the federal securities laws. These forward-looking statements involve material risks and uncertainties. Many possible factors could affect the future results and performance of Quidel's products, such that actual results and performance may differ materially. If Quidel's products fail to perform as expected, or if there is lower consumer demand for these products than expected, Quidel's financial condition and operating results may be materially and adversely affected. Quidel's financial condition and operating results may also be materially and adversely affected by a number of other factors, including, without limitation, seasonality, adverse changes (both domestically and internationally) in competitive and economic conditions, actions by the Company's distributors, manufacturing and production delays or difficulties and adverse actions or delays in product reviews by the FDA. Please see the discussion of these and other factors in Quidel's annual report on Form 10-K and subsequent quarterly reports on Form 10-Q.