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When HCFA released Phase I of the Stark II final rule on Jan. 3, most of its provisions were scheduled to go into effect on Jan. 4, 2002, with regulations relating to referrals to home health agencies going into place Feb. 5, 2001. However, on Jan. 20, the Bush administration released a memorandum postponing the effective date of regulations that have been published in the Federal Register — including the Stark II final rule — for 60 days. In turn, on Feb.1, the Health Care Financing Administration (HCFA) announced that the home health provision would take effect April 6 instead of Feb. 5.
Until final word comes down from HCFA, most observers now believe the final Stark II effective date will probably be March 5, 2002, 60 days after the originally stated effective date. Meanwhile, there’s also speculation that, to cut down on the confusion, Congress might intervene and implement the new rules sooner than the current year-plus waiting period. Until this implementation date is settled, providers must remember that their actions are still being judged by the stricter Stark I standards.
This distinction is especially important to physicians who make referrals to clinical laboratories with which they have financial relationships, notes William H. Maruca, an attorney with Kabala & Geeseman in Pittsburgh.
Under Stark I, it is illegal for physicians to refer Medicare patients to clinical laboratories in which the physicians have a financial or compensation interest. According to a statement released by HCFA: "Until the effective date of these new final regulations, the August 1995 final rule covering referrals for clinical laboratory services remains in full force and effect with respect to clinical laboratory services referrals and claims for services."
As such, a physician’s office lab must technically satisfy the Stark I on-site supervision requirements and must meet the Stark definition of group practice, even though those standards have been loosened in Phase I of the Stark II final regulation, warns Maruca.
"In reality, it is highly unlikely that HCFA, the Justice Department, or the OIG would take any enforcement action against a physician or lab who was in compliance with the new regulations [Stark II final rule] but not the old ones [Stark I final rule] in 2001, but that does not prevent qui tam whistleblower plaintiffs from including Stark counts in false claims lawsuit," Maruca cautions.