G2 Compliance Corner

Pennsylvania recently passed a law prohibiting leasing or renting space in a physician office or placing phlebotomists in an office. Can a lab lease or rent space from a physician in other states specifically for placing a phlebotomist in the office?

The federal physician self-referral law, also known as the Stark law, and the anti-kickback statute include exceptions or safe harbors for renting space from physicians or other referral sources. Many states now also have laws or regulations covering the same situation, but each state law may have different criteria (see the Perspectives article beginning on page 5). In the case of placing a phlebotomist, as opposed to setting up a new drawing station, Stark presents the more problematic exception criteria because it includes a criterion that says the agreement would be commercially reasonable even if no referrals were made between the lessee and the lessor, in addition to all of the usual requirements such as a written agreement, fair market value of the lease payment, and value or volume of referrals.

If the phlebotomist is only drawing specimens for the physician leasing the space to the laboratory, and the physician stops referring specimens, it is unlikely that this criterion would be met. The test of other referrals would include more than cosmetic representations that patients from other physicians use the draw site; it would require proof of those referrals and the draw site would have to meet any criteria the lab uses to financially justify the cost of the space in any other situation. Under Stark, the requirements of all the criteria must be met in order for the exception to apply.

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