Medicare Compliance & Reimbursement

Strict federal guidelines must be followed for compliance.

Laboratories that perform tests for a local optometrist or ophthalmologist may be in for a shock.

In a letter to state survey agencies in late September, the Centers for Medicare and Medicaid Services announced that doctors of optometry and ophthalmology could serve as lab directors under CLIA.

This guidance "clears a path for optometrists or ophthalmologists to develop their own in-house labs," says Nancy Grove, a surveyor with the CLIA Laboratory Program of the University of Iowa Hygienic Laboratory in Iowa City.

Eye physicians wanting to direct their own labs makes sense. "It's one-stop shopping for patients and ensures a quick turnaround," points out Margaret Knapp, a CLIA expert with Knapp Frazer Consulting in California. And the payoff for keeping lab tests in-house is greater than it would be for an optometrist or ophthalmologist to work with an independent lab, she says.

But whether optometrists or ophthalmologists would actually benefit from creating an in-house lab remains to be seen, Knapp says. CMS' letter outlined very concise guidelines for an eye doc's participation:

• Optometrists and/or ophthalmologists may direct labs that conduct only moderate complexity tests.

• Optometrists can serve as lab directors for tests  performed only in their specialty areas.

• Optometrists must obtain 20 continuing medical education credits to serve as lab directors for tests performed outside their specialty areas.

• Ophthalmologists with an MD degree can serve as a lab director only if they have at least one year of experience directing or supervising a moderate-complexity lab or have obtained at least 20 CMEs in lab practice. And each state's optometry board will interpret the guidance differently, asserts Rochelle Leemhuis-Stewart, executive consultant with rpl Laboratory Solutions in Riverside, CA.

For instance, in California, optometrists cannot even order a test if they aren't able to treat for what the result would tell them.

Even if a state allows optometrists or ophthalmologists to dispense antibiotics or otherwise treat patients' ailments, most of the tests they would perform (such as a culture and sensitivity) fall under high-complexity testing, Leemhuis-Stewart notes.