By Rose Willis
The “Registry Arrangements” that concern the OIG involves payments from labs to physicians for certain specified duties such as submitting patient data to be incorporated into the Registry, answering patient questions about the Registry and reviewing Registry reports. The OIG’s primary concern is that the arrangements may induce physicians to order medically unnecessary or duplicative tests from such offering labs in lieu of from other potentially superior laboratories.
- The physician’s compensation should not be tied to the physician’s frequency of performance of the tests, nor should it be set as a per-patient or other basis that takes into account the value or volume of referrals.
- Compensation should be fair market value for the physician’s efforts in collecting and reporting data.
- The laboratory should not pay or collect data for its Registry from only physicians who were selected on the basis of their prior or anticipated referral volume, rather than their specialty, sub-specialty, or other relevant attribute.
- Physicians should support all compensation paid pursuant to Registry Arrangements with documentation, submitted in a timely manner, memorializing their efforts.
Registry Collection and Billing Practices
- The laboratory should not collect comparative data for the Registry from, and bill for, multiple tests that may be duplicative (e.g., two or more tests performed using different methodologies that are intended to provide the same clinical information) or that otherwise are not reasonable and necessary.
- The Registry Arrangements should not be offered only for tests (or disease states associated with tests) for which the lab has obtained patents or that the lab exclusively performs.
- The lab should not collect data only from tests it performs if such tests are performed by multiple labs.
- Tests associated with the Registry Arrangement should not be presented on the offering laboratory’s requisition in a manner that makes it more difficult for the ordering physician to make an independent medical necessity decision with regard to each test for which the laboratory will bill (e.g., disease-related panels).