A compliance program is intended to assist the clinical laboratory in developing effective internal controls that promote adherence to applicable federal and state law, and the program requirements of federal, state and local health plans. There are seven elements that a clinical laboratory needs to commit to in order to have an effective compliance program. It can not be stressed enough the importance of documentation and recordkeeping. A laboratory should be able to produce or obtain documentation to support the medical necessity of the service they are providing and billing for. Laboratories are in a unique position to educate physician clients concerning medical necessity issues.
Billing is also an important part of the documentation process.
It is imperative that the code used to bill accurately describes the service ordered and performed. For detailed information on Compliance issues contact a Technical Consultant at one of the ALN Regional Service Centers. Refer to catalog, price list, or call client services. Individual laboratories must be able to produce, upon request, the documentation necessary to support medical necessity of the laboratory service provided and billed to federal or private healthcare programs. This documentation should come from treating physician, authorized person on physician's staff, or other individual authorized by law to order tests.