Recommendations regarding the development of a model compliance plan for clinical laboratories

Medicare will only pay for tests that meet Medicare’s reasonable and necessary guidelines. Medicare may deny payment for a test that the physician believes is appropriate but does not meet Medicare’s definition of “medical necessity.”

The Office of the Inspector General (OIG) recommends that laboratories and laboratory companies take the following precautions to help ensure that requirements for medical necessity are met: 

• Standardize non-customized test offerings and use common, uniform requisition forms that require physicians to document the need for each test by inserting a diagnosis code
• Require physicians to order each chemistry test separately unless the test meets one or more of the following criteria:

The test is part of a CPT or HCPCS-defined automated multichannel test series.

The test is part of a CPT-defined clinically-relevant test grouping.

• The test is part of a profile that has been customized at the request of physician.
• The requisition should include a printed statement reiterating that physicians or other practitioners only order test that are medically necessary for the diagnosis or treatment of a patient, and not screening purposes. 

The OIG and other federal agencies charged with responsibility for enforcement of federal law have emphasized the importance of voluntarily developed and implemented compliance plans. In recent years, the OIG has been asked to supply guidance regarding essential elements of a model compliance plan. OIG’s “Model Compliance Plan for Clinical Laboratories” is available at: https://oig.hhs.gov/authorities/docs/cpglab.pdf