"Dealing with fraud and abuse issues is akin to visiting Alice in Wonderland," says attorney Jeff Baird, chairman of the health care group at Brown & Fortunato. "What is down is up, what is up is down, and every day we descend through the proverbial rabbit hole. This is particularly true when a DME company desires to enter into a business arrangement with a referral source such as a physician, hospital or long-term care facility.
"The challenge," continues Baird, "is that when a DME company 'does business with' a referral source, kickback issues invariably arise. The Medicare anti-kickback statute states that a kickback may occur when a provider gives anything of value to a person/entity in exchange for referring a Medicare patient or in exchange for 'arranging for the referral of' a Medicare patient.
"The anti-kickback statute is broadly worded and, arguably, it can apply to almost any type of arrangement between a provider and a referral source," Baird says. "When designing a business arrangement with a referral source, the prudent DME company will be careful to avoid violating the anti-kickback statute. It can do so by fitting the arrangement (or substantially fitting the arrangement) within one of the safe harbors to the anti-kickback statute."
An even more conservative approach, according to Baird, "is for the DME company to submit a request to the OIG for an advisory opinion."
Check his explanation in the following Q&A.
Question: In laymen's terms, what is a request for an OIG advisory opinion?
Answer: The Office of Inspector General is an agency within the Department of Health and Human Services. CMS, which administers the Medicare program, also falls within HHS. The purpose of the OIG is two-fold: to educate health care providers on how to avoid fraud and investigate alleged fraudulent activities.
If you go to Google and type in "Office of Inspector General," you will land on the OIG's official website. One of the links on the website leads you to published advisory opinions. Any health care provider, including a DME company, can submit a detailed letter to the OIG that describes an existing or proposed arrangement with a referral source.
The requestor will ask the OIG to give its opinion as to whether or not the arrangement violates the anti-kickback statute. The OIG will review the arrangement and then say one of three things: "Absolutely not!" or "Looks OK" or "We don't particularly like it but would not be inclined to bring an enforcement action."
Question: Is a published advisory opinion "the law?"
Answer: No, it is not the law, but the provider would be foolish to act contrary to a published opinion. It is likely that the Department of Justice, the NSC and the courts will take the same position as set out in the advisory opinion.
Question: Does an OIG advisory opinion address other potentially fraudulent issues such as the Stark physician self-referral statute, the telephone solicitation statute, the beneficiary inducement statute and the False Claims Act?
Answer: No. An advisory opinion only addresses whether remuneration, in an arrangement proposed by the requestor, constitutes illegal remuneration in violation of the anti-kickback statute.
Question: Is the published advisory opinion binding on providers other than the requestor?
Answer: No. The opinion is binding only on the requestor. However, other providers that are involved in the same or a similar arrangement should take notice of the advisory opinion and adhere to its guidance.
Question: Will the requestor have the ability to talk informally to the OIG before it issues the opinion? Will the requestor have the right to withdraw the advisory opinion request?
Answer: Yes to both questions. The requestor may have informal discussions with the OIG regarding the advisory opinion request. If the OIG expresses concerns about the arrangement, then the requestor will have the opportunity to modify the arrangement so as to address the OIG's concerns. If it appears that the OIG simply does not like the arrangement, then the requestor will have the right to withdraw the advisory opinion request.
Question: Who is the advisory opinion request addressed to?
Answer: Chief, Industry Guidance Branch; Department of Health and Human Services; Office of Inspector General; Office of Counsel to the Inspector General; Room 5527, Cohen Building; 330 Independence Ave, S.W.; Washington, D.C. 20201.
Question: How many originals and how many copies must be submitted?
Answer: Original and two copies.
Question: What information must be included in the advisory opinion request?
Answer: (1) To the extent known to the requestor, the identities, including the names and addresses, of the requestor and of all other actual and potential parties to the arrangement, that are the subject of the request for the advisory opinion.
(2) The name, title, address, and daytime telephone number of a contact person who will be available to discuss the request for an advisory opinion with the OIG on behalf of the requestor.
(3) A declaration of the subject category or categories for which the advisory opinion is requested.
(4) A complete and specific description of all relevant information bearing on the arrangement. This description includes: (a) for existing arrangements, complete copies of all operative documents; (b) for proposed arrangements, complete copies of all operative documents, if possible, and otherwise descriptions of proposed terms, drafts, or models of documents sufficient to permit the OIG to render an informed opinion; (c) detailed statements of all collateral or oral understandings; (d) if applicable, a designation of trade secrets or confidential commercial or financial information; (e) a signed certification by the requestor; (f) a declaration regarding whether an advisory opinion request (regarding Stark) will be submitted to CMS; and (g) each requestor's Taxpayer Identification Number.
Jeffrey S. Baird, Esq., is chairman of the Health Care Group at Brown & Fortunato, P.C., a law firm based in Amarillo, Texas. He represents pharmacies, infusion companies, home medical equipment companies and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization. He can be reached at 806/345-6320 or jbaird@bf-law.com.
