OIG eases its rules for advisory opinions
Attorneys for providers — but not trade associations — will be able to obtain advisory opinions for their clients under final regs just put out by OIG. The regs, published in the July 16 Federal Register, will also make it easier for providers to get opinions on whether their actions violate the anti-kickback statute.
The changes are in response to public comment on the interim advisory opinion rules that OIG published in February 1997. In particular, the agency received several letters complaining that the existing rules only allowed the parties to an arrangement to request an opinion. Technically, that meant only providers could make such requests. OIG now will specifically allow attorneys to request opinions on behalf of clients, as long as their clients themselves are eligible to ask for an opinion.
But this generosity won’t extend to trade associations, which some critics say should be able to request opinions that would apply to all of their members on various national issues. OIG says this would be unfeasible because a given opinion is only binding upon the party that receives it. "It is unlikely that a party could precisely duplicate an approved arrangement," the agency notes. "Invariably, there would be differences, some of which might be significant." OIG cites the same rationale for not issuing model advisory opinions that providers could use as a template. Regulators do promise, however, that providers will be able to obtain guidance from upcoming fraud alerts as well as safe harbor regulations that promise immunity from prosecution under the anti-kickback statute.
The agency is not budging from its policy of requiring all parties to an arrangement to be identified in the request, despite complaints that it’s not always practical to list every one. But whether some of the parties are in a position to affect referrals, for example, could have a bearing on the agency’s decision, replies OIG. However, the final rule does allow a small escape hatch by noting that in a case involving managed care, or pricing for thousands of customers, it may not be feasible to list all parties. Providers can state in their request why they can’t list every party. Nor will requests need to include provider ID numbers.
There won’t be much relief, either, for providers who are financially deterred from asking for an opinion. OIG has not specified a fee schedule, except for a mandatory $250 initial deposit, though requestors can specify a maximum dollar threshold beyond which OIG would cease processing the case. "Many commentors suggested that the solution to this dilemma would be for the OIG to provide a fee estimate based on an initial review of the request," the agency notes. But OIG claims that it hasn’t been issuing opinions long enough to devise a fee schedule. However, regulators will offer a "non-binding, good faith estimate" to any provider that asks for one.
Note: OIG says most of the 14 opinions it has already issued have cost $1,500 to $3,000, with some priced even lower. Other changes in the advisory opinion process include:
- The Stark connection. HCFA is gearing up to meet a Balanced Budget Act requirement that it provide advisory opinions for the Stark self-referral laws. OIG now expects requests for an anti-kickback advisory to mention if there is a request for a Stark advisory on the same arrangement.
- Specific statutes. OIG can issue opinions regarding Section 1128 of the Social Security Act, which covers everything from kickbacks to doing business with excluded parties. Providers requesting opinions should now specify which part of Section 1128 their request addresses. Providers who want a ruling as to all aspects can expect both the process to take longer and OIG to ask for additional information.
- Documents. Descriptions of documents can now be submitted in lieu of the actual items. In addition, only those portions of a document relevant to the request need be filed.
- Grace periods. Providers will be given time to change their operations if OIG later rescinds or modifies an opinion.