Editor’s note: This is the first of a two-part series on billing for lab tests in physician offices.
The Clinical Laboratory Improvement Amendments (CLIA) program establishes quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with The Centers for Medicare & Medicaid Services and obtain CLIA certification.
CLIA was passed by Congress in 1988 to improve the quality of testing in all laboratories nationwide. These health assessment tests examine diagnoses, prevention and treatment of the human body. The basis of the complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity.
Waived tests: Waived tests include any test listed in the regulation process of categorizing and re-categorizing of tests; any test in which the manufacturer’s instructions allow inspections and random compliance checks; and tests cleared by the FDA for home usage. When billing for waived tests approved on or after Jan. 23, 1996, laboratories must use the QW modifier. It is not mandatory for tests approved before Jan. 23, 1996.
The specified tests that are listed in the FDA regulation as waived are:
- Dipstick or tablet reagent urinalysis, nonautomated, for the following:
- Bilirubin
- Glucose
- Hemoglobin
- Ketone
- Leukocytes
- Nitritew
- pH
- Protein
- Specific gravity
- Urobilinogen
- Fecal occult blood
- Erythrocyte sedimentation rate—nonautomated
- Hemoglobin-copper sulfate—nonautomated
- Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
- Spun microhematocrit
- Added 1/19/93. Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout
- Moderate & high-complexity tests: Moderate- and high-complexity tests must meet requirements for proficiency testing, patient test management, quality assurance/control and personnel. Waived tests are exempted from these requirements.
Proficiency testing evaluates the laboratory’s performance mandated by CLIA. Moderate and high complexity tests are required to enroll in an approved PT program for specialties in which certification is sought. Regulations create rules for PT providers that include sample problem solving, distribution, preparation, result reporting and records.
Patient test management must maintain and establish a system to ensure identification and reliability of specimens during the testing process and correct handing of the results. Requirements for the submission and handling, specimen referral, test applications, test records and reports are stipulated by the regulations.
Quality assurance/control ensures that every laboratory create quality control procedures that oversee and assess every test technique to guarantee precise and dependable results. Each laboratory must ascertain written policies and procedures for a QA program intended to oversee and assess the complete testing process.
Personnel requirements tie into the complexity of testing. The condition differs for personnel who execute moderate- and high-complexity testing and are identified individually. Define qualifications for a precise mixture of positions and accountability.
All laboratories must have one of the below CLIA certifications to perform clinical testing on specimens:
- Certificate of Waiver is issued to a laboratory to perform waived tests only.
- Certificate of Provider-Performed Microscopy Procedures is issued to a laboratory in which a mid-level practitioner, physician or dentist can perform microscopy procedures. Waived tests may also be performed.
- Certificate of Registration is issued to a laboratory that performs moderate and/or high complexity testing until it is determined by a survey to be in compliance with CLIA regulations.
- Certificate of Compliance is issued to a laboratory after an inspection determines that it is compliant with CLIA requirements.
- Certificate of Accreditation is issued to a laboratory on the basis of the accreditation of an organization approved by CMS.
Once the certification(s) is obtained, the physicians should evaluate which laboratory tests are covered. Medicare noncovered services should be accompanied by an Advanced Beneficiary Notice (ABN). If a physician has unassigned claims, the beneficiary or their representative must agree to be financially responsible for the noncovered services by applying their signature in the appropriate section. This ensures the physician services will be compensated by the beneficiary receiving the services. Assigned claims do not require a signature from the beneficiary or their representative; the physician can simply have a witness sign the form documenting the beneficiary’s refusal, and ABN will be effective.
ABNs are not required for such services as screening tests, cosmetic surgery and routine physicals. Nevertheless, physicians should be cautious in determining when to use an ABN, because some of the excluded categories could be covered under other circumstances. For example, when screenings, such as mammography, may prove unclear about whether it’s covered under Medicare, it’s better to acquire an ABN.
How to Apply for a CLIA Certificate of Waiver
Apply for a Certificate of Waiver via form CMS-116, which can be obtained on the CMS website at http://www.cms.gov/clia/cliaapp.asp or from your state health department. The application requests the following information to be complete:
- General Information—Provide information about your organization, including street address, name of director and federal tax identification number. Don’t fill out the CLIA identification number if this is an initial application.
- Type of Certificate Requested—Request a Certificate of Waiver.
- Type of Laboratory—Indicate the facility or setting in which you will perform the rapid test (e.g., community clinic, health fair, mobile laboratory [van]). If none of the categories applies to your setting, check “other.”
- Hours of Laboratory Testing—Indicate the times you plan to do testing.
- Multiple Sites—Indicate if you will be doing testing at more than one site. If you will have multiple sites, provide the number of sites and complete the remainder of this section. In general, a mobile van is considered a multiple site if it is not in a fixed location and moves from site to site for testing. The name and address of the testing site for that van would be the same as the organization it operates under or the physical location where the van is housed.
- Waived Testing—Estimate the number of tests you will be performing annually.
- Non-Waived Tests—Skip this section if you are performing a waived test only.
- Type of Control—Check the type of organization for which you are making this application—private nonprofit, for-profit, government).
- Director Affiliation with Other Laboratories—Provide the name and address of other laboratories that your director also directs. CLIA regulations allow a director to direct a maximum of five laboratories.
- Individuals Involved in Laboratory Testing—Indicate the total number of individuals who are directing, supervising, consulting or testing. Include counselors only if they will perform or supervise testing.
- Consent & Signature—Carefully read the consent information at the bottom of p. 4 before signing and dating.
The Certificate of Waiver application should be forwarded to the address of the local state agency in which the testing will be performed. CMS has a list of these agencies at http://cms.hhs.gov/clia/ssa-map.asp. You can also contact your state agency for assistance in filling out the application. You will need to submit a fee of $150 with the application.
The Certificate of Waiver is valid for two years. A renewal application will need to be completed and sent to the state agency no less than nine months before the certificate’s expiration date. Many states have additional regulations that apply to laboratory testing, and some require separate applications to the state agency. Before applying, consider the pertinent requirements and the best method for receiving the authority for testing, including contacting your state health department and your local CMS inspector for guidance. CLIA contacts can be found at http://cms.hhs.gov/clia/ssa-map.asp.
For more information or questions on CLIA testing or coding for lab services, contact Melesia Tillman at [email protected] or (404) 633-3777 x820.
