Deeper Than the Headlines: Need some advice? Don’t forget to check out the OIG’s Advisory Opinions

We all could use some advice every now and then, especially in the world of healthcare compliance. It’s one thing to know the generalities of fraud and abuse laws or regulations, but applying that understanding to a specific context can be frustrating for some folks.

Why Take Advantage of the OIG Advisory Opinion?

One way to gain a better understanding of how the OIG might look at a certain situation or set of facts as they relate to fraud and abuse laws, is to submit a request for an OIG Advisory Opinion.

In fact, in accordance with the Social Security Act, the OIG will issue advisory opinions about the application of the OIG’s fraud and abuse authorities to the requesting party’s existing or proposed business arrangement. The good thing is that the law requires that these advisory opinions be made available to the public. The OIG meets this requirement by posting the opinions on their website.

According to the OIG, “One purpose of the advisory opinion process is to provide meaningful advice on the application of the anti-kickback statute and other OIG sanction statutes in specific factual situations. Please note, however, that advisory opinions are binding and may legally be relied upon only by the requestor. Since each opinion will apply legal standards to a set of facts involving certain known persons who provide specific statements about key factual issues, no third-parties are bound nor may they legally rely on these advisory opinions.”

Even with this disclaimer, the advisory opinions often provided a glimpse into the mind of those interpreting and enforcing fraud and abuse laws. The oldest opinion is from 1997 and is now 20 years old. The most recent opinion was posted in September of 2017. Keep in mind that more recent opinions can change conclusions of past opinions so make sure to read any of the references to more recent opinions when applicable.

September 2017 Advisory Opinion

The September opinion involves “a retail pharmacy chain’s proposal to allow Federal healthcare program beneficiaries to participate in a paid membership program that includes discounts on certain prescriptions and clinic services (the “Proposed Arrangement”).”

The written opinion outlines the fact and context and analyzes whether the proposed arrangement “would constitute grounds for the imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, section 1128A(a)(5) of the Social Security Act (the “Act”), or under the exclusion authority at section 1128(b)(7) of the Act, or the civil monetary penalty provision at section 1128A(a)(7) of the Act, as those sections relate to the commission of acts described in section 1128B(b) of the Act, the Federal anti-kickback statute.”

For this particular request, the OIG concluded that “the Proposed Arrangement would not constitute grounds for the imposition of civil monetary…and although the Proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward referrals of Federal health care program business were present, the Office of Inspector General (“OIG”) would not impose administrative sanctions…in connection with the Proposed Arrangement.”

Such a favorable outcome is not always the case. Sometimes the OIG concludes the arrangement would violate the law given the specific facts and context. These opinions can be just as insightful for compliance officers and legal counsel who are trying to identify and apply the boundaries of general fraud and abuse statutes to specific, real-life situations and circumstances that might not appear to show a black and white line at first review.

Common Topics: Waiving Co-Payments and Free Services for Patients

A common topic in advisory opinions is the waiving or reducing of co-payments or patient responsibility amounts. For example, a July 2017 opinion discussed “a hospital outpatient facility’s proposal to reduce or waive, on a non-routine, unadvertised basis, cost-sharing amounts owed by financially needy Medicare beneficiaries for items and services furnished in connection with a clinical research study.”

Another common topic is the providing of free services to patients. For example, a March 2017 opinion was written about a hospital system’s proposal to provide free or reduced-cost lodging and meals to certain financially needy patients. While in 2015 three different opinions were published for the following scenarios:

• a plan to offer free van shuttle service to certain medical facilities in an integrated health system
• a home health provider's policy to offer free introductory visits to patients who have chosen it as their home health provider
• a program to provide a drug for free for a limited time to patients who experience a delay in the insurance approval process

As you can imagine the facts and scenarios can be as varied as the day is long. Again, while the opinion is only formally applicable to the party requesting the opinion, reading the opinions will give you a glimpse into the mind of the OIG.