In the first of a two-part series, we will take a closer look at billing for laboratory tests in physician offices. As we venture into this arena, we will attempt to cover basic steps to assist nurse practitioners and physician assistants in office compliance as well as efficient coding and reimbursement.

The Clinical Laboratory Improvement Amendments (CLIA) establish quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. These amendments require 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 and Medicaid Services (CMS) and obtain CLIA certification.
The complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity.
Waived tests include any test listed in the FDA regulation as well as any test in which the manufacturer instructions allow inspections and random compliance checks. (See “A Guide To Waived Tests.") When billing for waived tests, laboratories or facilities must use a QW modifier.

What You Should Know About Moderate And High Complexity Tests
Moderate and high complexity tests must meet requirements for proficiency testing, patient test management, quality assurance/control and personnel.

Proficiency testing evaluates the laboratory’s performance as mandated by the CLIA. Moderate and high complexity tests are required for enrollment in an approved physical therapy (PT) program for specialties in which one is seeking certification. Regulations create rules for PT providers that include sample problem solving, distribution, preparation, result reporting and records.

In regard to patient test management, the testing facility 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/facility must create quality control procedures that oversee and assess every test technique to guarantee precise and dependable results. Each laboratory/facility must ascertain written policies and procedures for a quality assurance program that is intended to oversee and assess the complete testing process.

A Guide To Waived Tests

Personnel requirements tie into the complexity of testing. These requirements differ for personnel who execute moderate and high complexity testing, and are identified individually. Qualifications require a precise mixture of positions and define accountability for people who fill the position.

Key Certifications For Performing Clinical Testing
All laboratories/testing facilities must have one of the following certifications from CLIA in order to perform clinical testing on specimens.

A Certificate of Waiver is issued to a laboratory/facility to perform waived tests only.
A Certificate of Provider-Performed Microscopy Procedures is issued to a laboratory in which a mid-level practitioner, physician or dentist can perform microscopy procedures. One may also perform waived tests.
A Certificate of Registration is issued to a laboratory that performs moderate and/or high complexity testing until it is later determined to be in compliance with CLIA regulations.
A Certificate of Compliance is issued to a laboratory after an inspection determines that it is compliant with CLIA requirements.
A Certificate of Accreditation is issued to a laboratory based on the accreditation of an organization approved by CMS.

How To Apply For A CLIA Certificate Of Waiver
Obtaining a Certificate of Waiver is usually a straightforward process. One may get an application (form CMS-116) from the CMS Web site at http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf or from your state health department.

The application requests the following information: general information about your organization/facility; the type of certificate you are requesting; the type of laboratory/facility; the hours of laboratory/facility testing; whether testing will be conducted at multiple sites; an estimate of the annual number of waived tests one expects to perform; the type of organization (government, non-profit, for profit); whether the facility director is affiliated with other laboratories/facilities; and the number of individuals involved in laboratory testing.
One can forward the Certificate of Waiver application to the address of the local state agency. The Centers for Medicare and Medicaid Services has a list of these agencies by state at http://www.cms.hhs.gov/CLIA/downloads/CLIA.SA.pdf. You can also contact your local 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. One will need to complete a renewal application and send it to the state agency no less than nine months before the certificate's expiration date.

Why ABNs Are Essential Before Conducting Tests
Once the facility has obtained specific certification(s), clinicians should evaluate which laboratory tests are covered tests. When it comes to Medicare non-covered services, one should always obtain a signed Advanced Beneficiary Notice (ABN). This form ensures that the physician services will be compensated by the beneficiary receiving the services. The ABN requires that if a physician has unassigned claims, the beneficiary or his or her representative must agree to be financially responsible for the non-covered services.

Assigned claims do not require a signature from the beneficiary or his or her representative. The clinician can simply have a witness sign the form documenting the beneficiary’s refusal and the ABN will be effective.
Advanced beneficiary notices are not required for services such as screening tests, cosmetic surgery and routine physicals. Nevertheless, clinicians should be cautious in determining when to use an ABN since some of the excluded categories could be covered under other circumstances. For example, when it is unclear whether screenings such as mammography are covered under Medicare, it is better to acquire an ABN.

In Summary
Many states have additional regulations that apply to laboratory testing. Some also require separate applications to the state agency. Before applying, you should consider the pertinent requirements and best method for receiving the authority for testing, including contacting your state health department and your local CMS inspector for guidance.

As we noted earlier, one may find the CLIA contacts for all states at the following Web site: http://www.cms.hhs.gov/CLIA/downloads/CLIA.SA.pdf.

Editor’s note: For previous “Coding Corner” columns, please visit the archives at www.arthritispractitioner.com