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In the Balanced Budget Act of 1997, Congress authorized the Health Care Financing Administration (HCFA) to issue written advisory opinions on whether a referral relating to a designated health service was prohibited by the Stark laws.
Under this system, health care providers would submit a request for an advisory opinion, outlining in detail their proposal for a particular arrangement. HCFA would then analyze the arrangement with regard to the physician self-referral laws and determine if it was legal.
This advisory opinion process, however, was placed on hold while HCFA concentrated its staff resources on crafting the final Stark rules, Phase I of which was issued last January. Meanwhile, some 30 written requests for opinions on the Stark statute await a response from HCFA. The question is, will HCFA resume its Stark advisory process or drop this service?
If HCFA stops providing advisory comments, then the Department of Health and Human Services’ Office of Inspector General (OIG) becomes the only government agency providers can turn to for these kinds of advisory opinions. This option, however, sends a chill down the back of most physicians who believe the OIG errs on the side of regulatory rigidity when it comes to the Stark statute.