Medicare CLIA not all tests are covered
Physicians are allowed to perform only a limited number of lab tests since 1991. To do so, application for a Clinical Laboratory Improvement Amendment (CLIA) waiver is required. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing to ensure quality. The waiver allows physicians to perform certain test that CMS considers to be so simple that there is very little risk of error in performing and interpreting them. The provider has to enroll in the Medicare CLIA program, pay a fee, and follow the manufacturers? instructions when performing the test. There are approximately 80 tests under this waiver.
To apply for the appropriate certification one needs to fill out the CMS-116 form and provide the following information about their facility:
- Facility name
- Address, City, State, Zip Code
- Phone number
- Tax ID number
- Hours of operation
- Type of certificate needed
- Number of tests performed annually
? The number on patient volume anticipated in a year?s time must be based, if it is a new practice,
? An established practice could run a utilization report
- Director of the facility
? This could be the physician, medical director, or dept. chairman
It should be noted that Medicare does not cover all CLIA tests.
CMS also has specific guidelines as to which laboratory tests are covered for Medicare beneficiaries. The provider is required to have the patient sign an Advance Beneficiary Notice (ABN), when a test is ordered that is not a covered benefit. This notice specifies the test is not covered and that the patient is aware that he or she will be responsible for payment of the testing. Advance Beneficiary Notices are required for any service provided that is not a covered benefit of Medicare.