When your family physician (FP) performs laboratory tests such as urinalysis and rapid strep tests in the office, you may not know what requirements you have to meet and what added filing steps you have to take.
You can, however, report in-office tests with confidence if you know these fundamentals: 1. What Is CLIA? CMS is responsible for implementing the Clinical Laboratory Improvement Amendments (CLIA). These amendments established quality standards for all laboratory testing.
Impact: Laboratories, including in-office labs, have to apply for various levels of CLIA certification. Most FPs have the lowest level of certification, which is "waived status." 2. What Is Waived Status? The CDC or FDA deems certain tests so simple that little risk of error exists. Therefore, a physician may perform the procedures in his office without obtaining a higher-level certificate, says Lorna Powell, CCS-P, owner of Quality Medical Management in Elk City, Okla. "You call these tests waived-status tests."
Watch out: You still need a certificate to perform "waived" tests. The law requires that all laboratories have a certificate and obtain a CLIA number. "You can apply for a certificate of waiver (COW) through CMS for a $150 fee," Powell says.
Private-payer alert: Even though Medicare oversees CLIA, you still need a certificate when billing third-party payers. 3. What Tests Qualify for Waived Status? CLIA considers some glucose and cholesterol testing methods waived, as well as pregnancy tests. FPs can also perform fecal occult blood tests (FOBT) and simple dipstick urinalysis, Powell says.
Real-world coding: Wondering what tests other FP offices are performing? "We report 81002 (Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy), 81025 (Urine pregnancy test, by visual color comparison methods), 82270 (Blood, occult, by peroxidase activity [e.g., guaiac], qualitative; feces, 1-3 simultaneous determinations), 82962 (Glucose, blood by glucose monitoring device[s] cleared by the FDA specifically for home use) and 87804 (Infectious agent antigen detection by immunoassay with direct optical observation; Influenza)," says Michael Clark, coder at Providence Family Medicine in Providence, Utah.
When Clark's office performs a rapid strep test, he uses 87880 (Infectious agent detection by immunoassay with direct optical observation; Streptococcus, group A]). "It's the only CLIA-waived strep test," he says.
Tool: For a free list of the current CLIA-waived tests, you can e-mail firstname.lastname@example.org 4. What Special Filing Rules Should I Follow? When your office performs a waived test, code based on these guidelines:
1. Report the appropriate CPT test code.
2. Append the procedure code with modifier -QW (CLIA waived test).
3. Link the CPT code to the ICD-9 diagnosis code.
4. Record your CLIA number on the claim form.