We comply with all applicable laws and regulations, including the Clinical Laboratory Improvement Amendments (CLIA), through the development of laboratory-specific practice guidelines. Several regulatory agencies monitor our laboratories for compliance, including the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA).
Our active compliance plan follows the outline of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS/OIG) program. Below are some of the specific activities associated with this government compliance program of which you should be aware:
- Medicare regulations limit which tests can be billed to that are medically necessary for diagnosis or treatment of a patient. Each request must include the appropriate medical necessity codes.
- Most screening tests that are billed to Medicare will be denied reimbursement, save for a few specifically identified exemptions. Medicare may not pay for non-FDA-approved tests or tests that are identified as "for research only".
- Each individual test component within the Organ and Disease Related Panels must meet the criteria of medical necessity.
- If all component tests within a panel do not meet the criteria of medical necessity, please order individual tests or a more appropriate panel.
- When it appears likely that a test will not be paid for by Medicare, the patient should be informed and asked to sign an Advance Beneficiary Notice (ABN). This indicates that the patient is aware that Medicare will likely not pay for the test and has agreed to be responsible for any non-reimbursed charges.
- A reflex test is a specific laboratory test in which an abnormal result causes one or more additional tests to be automatically ordered, resulted and billed.
- The reflex test is reviewed and approved by Wake Forest Baptist Health each year. A full list of these tests is available below.
By contracting with Wake Forest Baptist Health Diagnostic Laboratories, your organization agrees to comply with all regulations related to anti-kick-back statutes, CLIA proficiency testing, CPT-4 coding, diagnosis coding, patient confidentiality and professional courtesy, as well as any additional regulatory requirements not listed here.
Some of our specific practice guidelines include:
Analyte Specific Reagents
Analyte specific reagents (ASRs) are reagents of chemicals or antibodies that may be considered "active ingredients". They are purchased by clinical laboratories to develop in-house tests for the diagnosis and management of various conditions. To meet FDA regulations, we include a disclaimer on results from those tests developed at Wake Forest Baptist Health Diagnostic Laboratories using ASRs.
In order to complete requested genetic testing, we may require additional patient information and/or patient consent documentation. If any necessary information is missing, we will contact the submitting organization to obtain the required documentation before beginning testing.
Wake Forest Baptist Health Diagnostics Laboratories is committed to maintaining the confidentiality of all patient information and complying with all privacy, security and electronic transaction code requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Any services that require joint efforts with other laboratories will be conducted in accordance with HIPAA and the College of American Pathologists (CAP).
To ensure HIPAA compliance for the release of patient results, we have adopted the following regulations:
- In order to release result information by phone or e-mail, the patient must sign a HIPAA release form.
- Because federal regulations restrict the release of test results to the ordering physician or healthcare providers responsible for the patient's care, any third parties requesting results - including the patient - will be directed to contact the ordering facility.