Home Health & Hospice Week

Compliance :

FIND OUTWHEN THE OIG ADVISORY PROCESS WORKS FOR YOU -- AND WHEN IT DOESN'T

Tip: Make your request before implementing policies.

You've most likely heard about the OIG's "advisory opinions," but in addition to knowing how the OIG rules on other provider's situations, it's a good idea to know when this process could help you -- and what the rules are.

What is it: If you think one of your home care organization's actions might be in violation of the law (such as anti-kickback or Stark laws), you can ask the HHS Office of Inspector General to analyze your case and make a determination regarding the legality of your arrangement. That opinion is the advisory opinion, which will let you know whether you are potentially in violation of the law.

What it doesn't cover: The OIG will not address topics such as "model arrangements" or general questions of interpretation, among other issues,in advisory opinions, it says on its Web site.

How to request one: If you'd like to ask the OIG to issue an advisory opinion on your situation,you should gather the required materials (including two copies of your request, your contact information,and an initial $250 fee, among other items) and submit them to the OIG's Washington office. (For a full list of required items and the address where you should send them, visit the OIG's Web site at www.oig.hhs.gov/fraud/advisoryopinions/aofaq.asp.)

Prep your documents: Before you create your advisory opinion request, you should consider asking a health care attorney for advice, says attorney Mark Rogers with The Rogers Law Firm in Boston. "The attorney should be able to provide an opinion as to whether the arrangement creates any potential fraud and abuse liability exposure for the parties involved in the arrangement," Rogers says. "Based upon the uniqueness of the arrangement, the attorney should be able to provide guidance as towhether an advisory opinion request is appropriate."

If you do request an advisory opinion, the attorney "should at the very least review the request to determine that it includes the pertinent facts about the arrangement, Rogers says. "A complete description about the arrangement is necessary in order for the OIG to provide the advisory opinion."

Request before implementing: If you think you would benefit from an advisory opinion, file your request before you begin performing the questionable action. "The advisory opinion process is designed to yield reviews of proposed arrangements,"points out attorney David C. Harlow with The Harlow Group in Newton, Mass.

Advisory Opinion Process Will Cost You

Providers often worry about whether the OIG could use the information in an advisory opinion request to impose penalties on the practice.

Reality: "If your advisory opinion concerns a proposed arrangement and the OIG issues an unfavorable opinion, the OIG generally assumes that the requester will not go through with the proposed arrangement," says attorney Mark Wachlin, a former OIG staffer who now practices with Dilworth Paxson in Philadelphia.

If your advisory opinion involves an existing arrangement and the opinion will be unfavorable, the OIG will normally call and inform you. "The requester will then usually withdraw the advisory opinion request," Wachlin says.

"The regulations governing the advisory opinion process expressly state that in the event of withdrawal, the 'OIG reserves the right to retain any request for an advisory opinion, documents and other information submitted to it under these procedures,and to use them for any government purpose,'"Wachlin says. "In the final rule published in the Federal Register, 63 FR 38311, several commenters asked whether the 'any governmental purpose' language means that the OIG can use information submitted with requests as a basis for investigation."

The OIG responded as follows: "Our primary purpose under these regulations is to gather and assess information in order to render informed advisory opinions. However, the anti-kickback statute is a criminal statute, and therefore review of arrangements that potentially implicate the statute requires heightened scrutiny. As a law enforcement agency,the OIG cannot ignore information lawfully obtained to further legitimate governmental purposes."

Outcome: If the OIG issued an unfavorable opinion regarding an existing practice, it could pursue the requester or refer the matter to the Department of Justice, Wachlin says. "It is not,however, customary for this to occur. Indeed, in my three-plus years at the OIG, I do not ever recall such a situation occurring."

Consider Financial Impact

If you request an advisory opinion, you won't get an answer overnight -- and it won't be inexpensive. "Getting an advisory opinion is not a straightforward and simple thing -- there is a huge checklist of items that must be included with your request and the initial $250 fee," Harlow notes.

First, you'll pay your attorney to prepare, review, and/or submit your request. Then, after you submit it, the OIG might recommend that its independent expert review it, "and they'll engage what could be a big consulting firm or a healthcare economics firm and that cost is passed along to you," Harlow says. "Plus, they charge for staff time reviewing your case."

Keep in mind: You can set a "trigger amount," which means the OIG will contact you if they've surpassed a particular dollar amount.

Timeliness: The OIG is supposed to respond to your request within 60 days, but that doesn't necessarily start the day you submit your paperwork. "The process could easily take six months or longer," Harlow says.

Alternative: In some cases, you might review previous advisory opinions and structure your arrangement to fit one that the OIG has already blessed, Harlow says. "Whether you want to follow this path could depend on your risk tolerance," Harlow advises. "The stakes are high--and include being barred from the Medicare program -- so you don't want to guess wrong."