What are the criteria for including a test on HFHS Lab Formulary?

Typically, for each test on the menu, HFHS Lab Formulary committee evaluates the following criteria:

1. Is there a specific assay classification and recommendation for use from FDA, CMS and/or other regulatory bodies?
2. Is there a clinical consensus (e.g. widely accepted national guidelines) about the test?
3. Is there a significant impact on diagnostic certainty and/or choice of therapy?
4. Is there intellectual property (e.g. undisclosed proprietary algorithms) that precludes the possibility of performing the same/similar test in-house or comparing with other testing options?
5. Is there a significant gap in reimbursement versus the reference laboratory charge for the test?

What kind of information is considered by HFHS Lab Formulary?

The HFHS Lab Formulary is developed and updated quarterly by MLFC. This committee comprises of a diverse group of clinical experts and leaders drawn from across the HFHS.

The first step of evaluation requires a formal request/review by the Clinical Evaluation and Assessment Committee (CETAC). Comprised of predominantly Pathology experts, the CETAC reviews the medical literature concerning the test's effectiveness and current use in diagnosis and/or therapy, along with the financial aspects (test charge, reimbursement, estimated annual volume) to determine which tests should be included on our formularies. The medical information reviewed is from a variety of nationally recognized sources such as Medline, other databases, reference laboratories, medical professional associations, and peer-reviewed journals.

A crucial part of this discussion is the participation of a 'clinical champion'- a clinician who has domain expertise in the management of the condition in question. The clinical champion provides direction and information on downstream medical and operational benefits for our patients. Based on all the information, CETAC makes a Tier determination for each test.

The next step of evaluation requires a formal review of CETAC determination by members of the MLFC. This second level review ensures that CETAC determination can be independently verified and endorsed by HFHS leadership. MLFC is provider-led and may choose to invite other clinical experts to evaluate CETAC determination. Additions or removal of tests from the HF Lab Formulary s that were approved by MLFC are promptly listed on the electronic lab user guide (eLUG).

Overall the HFHS Lab Formulary reviews and updates the test menu regularly to ensure that our tests continue to remain medically efficacious and cost effective. We can help you maximize the diagnostic and treatment quality while keeping testing costs lower.