Recently the Health Care Financing Administration ("HCFA") issued proposed regulations interpreting the Stark law. The Stark law originally prohibited physicians from referring Medicare beneficiaries for clinical laboratory services to entities in which they or members of their immediate family had a financial interest ("Stark I"). It also prohibited entities from making a claim for payment under the Medicare program for clinical laboratory services furnished pursuant to a prohibited referral.
In 1993, Congress amended the Stark law to expand the self-referral ban to include many additional health care services and to apply aspects of the ban to Medicaid beneficiaries ("Stark II"). Some of Stark IIbs provisions were made retroactive to January 1, 1992. In August 1995, HCFA published the Stark I final regulations. While these regulations applied only to referrals for clinical laboratory services, the Stark I final regulations also applied to those provisions in Stark which applied retroactively to clinical laboratory services as of January 1, 1992. Consequently, it was expected that many interpretations in the Stark final regulations would apply to the other designated health services as well.
With some exceptions, the proposed Stark regulations reflect that many of the interpretations in the Stark I final regulations do indeed apply to the remaining designated health services. The preamble to the proposed regulations indicates that any comments received in connection with the proposed rule, as well as those that were received in response to the Stark I final regulations, will be considered in connection with publication of the Stark II final regulations. Accordingly, when examining the Stark law and regulations, both the Stark I final regulations and the Stark II proposed regulations should be considered in conjunction with each other. Additionally, the proposed Stark II regulations, are only just that, proposed, and do not have the force and affect of law, while the Stark I final regulations do have this force and affect.