Federal regulators are frowning on a proposed business arrangement in which an independent allergy-services laboratory would have been able to flip through a physician's patient files to find potential new business.
Feds reject proposed arrangement involving doc office, allergy lab
An advisory opinion from the HHS office of inspector general (PDF) found that a laboratory for allergy testing and immunotherapy could have criminal liability under the anti-kickback provisions of the Social Security Act if it executed its proposed business arrangement.
Specifically, the lab proposed to sign an exclusive contract with a physician's office to set up lab space inside the office and perform all of the doctor's allergy and immunotherapy testing. The lab would receive 60% of the total fees for the work, and would be allowed to peruse patient files to find candidates for lab services.
The inspector general's office took issue with two aspects of the arrangement. First, inspectors wrote that “percentage compensation arrangements are inherently problematic” because they can be used as a vehicle to induce more business than a flat fee would. Secondly, the inspector's office said that allowing lab personnel to look at patient files could encourage the doctor to order medically unnecessary tests.
As in all such advisory opinions, the HHS officials omitted the names of the lab that requested the opinion.
Although the lab officials said the arrangement was crafted to fit with a safe-harbor exception to the Stark physician self-referral laws, inspectors noted the Stark exceptions have no bearing on the anti-kickback law. Inspectors also noted that they could offer no opinion on whether allowing the lab to view patient files would violate patient-confidentiality laws.
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