Implementing changes to the Social Security Act, the Office of the Inspector General of the Department of Health & Human Services (OIG) has issued regulations concerning the provision of advisory opinions on the subjects of (1) anti-kickback violations. (2) prohibited inducements to limit services, and (3) the basis for exclusion from Medicare and Medicaid for health care-related offenses.
A. Limitations Now that these regulations are in place, providers should understand that there are limits as to what questions may be asked and who may ask them. Requests may not be theoretical. A request must describe a factual situation relating to an existing arrangement or one in which the requester will certify that it is planning to engage. Not only may requests not be made anonymously, but a great deal of information about the requester and the arrangement must be divulged - information that is not guaranteed protection from redisclosure under the Freedom of Information Act.
Opinions may not be requested by anyone other than a party to the arrangement under scrutiny In other words, no one may request an opinion regarding another entity's activities. While opinions issued will be available to the general public, only the party to whom the opinion is issued may rely upon it.
Finally, the new regulations indicate that all requesters will be charged for opinions provided. The charges will be based on the costs to the government issuing the opinion, including fees paid to any outside consultants. There will be a minimum charge of $250.00, and the hourly rate for OIG staff time has been pegged at $86.00.
It does not appear that health care providers are lining up to be the first on their block to obtain an advisory opinion from the OIG. Questions about existing activities could raise the interest of the federal government in a way that would make paying for a negative opinion a dubious honor.
As there is no track record for the manner in which the OIG will respond to prospective requests for advice, many entities will likely wait to read the first few opinions to be published, before deciding whether to subject their activities to public scrutiny.
Interestingly, the report from the OIG is that the first opinion issued was "negotiated" with the requester to achieve a result that could be implemented. This sort of flexibility bodes well for the process.