HHS OIG Advisory Opinions: A Plain Guide for Medical Practices

Healthcare businesses regularly come up with arrangements that sound reasonable but brush against federal fraud and abuse law: a patient perk, a vendor deal, a marketing partnership, a fee that depends on referrals. When the answer is not clear, there is a formal way to ask the government before you act. It is called an advisory opinion, and it comes from the HHS Office of Inspector General (OIG).

This guide explains how the process works, what it costs, what protection you actually get, and what two 2026 opinions show about how OIG thinks.

What an advisory opinion is

An OIG advisory opinion is a written legal opinion on whether a specific arrangement could lead to OIG sanctions under the fraud and abuse laws OIG enforces. The process was created by HIPAA in 1996 (section 1128D of the Social Security Act), and the rules are in 42 CFR Part 1008.

Under those rules, OIG can address:

Whether an arrangement involves prohibited remuneration under the federal Anti-Kickback Statute.
Whether it fits a statutory exception or a regulatory safe harbor (the safe harbors are listed at 42 CFR 1001.952).
Whether something counts as an improper inducement to reduce or limit services to Medicare or Medicaid patients.
Whether an activity could lead to sanctions such as civil money penalties or exclusion, including under the beneficiary inducements law that limits gifts and perks to Medicare and Medicaid patients.

Two things are specifically off the table: OIG will not decide whether a price or payment is fair market value, and it will not decide whether someone is a bona fide employee.

Physician self-referral (Stark Law) questions are handled by a different agency. OIG's FAQ notes that those opinions come from the Centers for Medicare and Medicaid Services under separate rules.

Why this matters for a practice

The Anti-Kickback Statute makes it a crime to knowingly and willfully offer, pay, solicit or receive anything of value to induce or reward referrals of items or services paid for by federal health care programs. In its opinions OIG describes a violation as a felony punishable by up to $100,000 in fines and 10 years in prison, plus possible civil money penalties and exclusion from Medicare and Medicaid. Courts have read the law to apply if even one purpose of a payment is to induce referrals.

That is why everyday ideas, such as free services, refunds, waived fees, marketing deals and referral software, can raise questions when federal program patients are involved. Some states also have their own anti-kickback or fee-splitting laws, which can matter even for cash-pay businesses, so it is worth asking counsel about state rules too.

Who can request one

Under 42 CFR Part 1008:

The requestor must be a party to the arrangement.
The arrangement must be existing or one the requestor in good faith plans to carry out. It can be conditioned on getting a favorable opinion.
OIG will not answer hypotheticals, general questions of interpretation, or questions about what a third party is doing.
The request must include a full description of the arrangement, ownership information, and a signed certification that the information is true, correct and complete, made with knowledge of the federal false statements law. For a proposed arrangement, a second certification confirms the good-faith intent to proceed.

OIG asks for requests by email in PDF form and offers a voluntary request template. Its process page says the office will accept, reject or ask for more information within 10 business days.

Cost

There is no flat fee. The regulations require the requestor to pay OIG's actual cost of preparing the opinion, mainly staff time. You can ask for a written estimate and set a dollar trigger at which OIG pauses work until you approve going further. If you withdraw, you still owe costs incurred to that point.

OIG's FAQ estimates that the simplest requests cost roughly $5,000 to $8,000 and that more complex ones can run about $10,000 or more. Legal fees for preparing the request are a separate cost.

The 60-day clock has changed

The statute says OIG should issue an opinion within 60 days after it receives a request. For years, OIG's regulations started that clock only after OIG formally accepted a request and paused it while OIG gathered more information or waited on payments, so some requests took far longer.

In 2026, the U.S. Court of Appeals for the D.C. Circuit ruled in Vertex Pharmaceuticals v. HHS that the 60 days run from receipt of the request and that OIG's acceptance and tolling rules were invalid. OIG's FAQ now acknowledges the ruling and says it will otherwise continue to follow Part 1008. A complete request at submission is still the best way to avoid back-and-forth.

What protection you actually get

This is the part most often misunderstood, so it is worth being precise.

Only the requestor can rely on it. Each opinion states that it may not be relied on by anyone other than the requestor and applies only to the arrangement described. Other businesses can read opinions to understand OIG's reasoning, but they get no legal protection from someone else's opinion.
It binds HHS and the requestor, not other agencies. OIG's FAQ says the opinion does not bind other government departments.
It is only as good as the facts. OIG relies on the certified facts without investigating them. If material facts were not disclosed or later change, the opinion loses its force, and OIG can rescind, terminate or modify it.
Asking does not protect you. Requesting an opinion is not a shield against enforcement, and an unfavorable opinion is a published finding that the arrangement could generate prohibited remuneration.
Opinions are public. OIG posts issued opinions with identifying details redacted, and it may announce who requested an opinion and the outcome.

Two 2026 opinions worth knowing

As of late October 2026, OIG had posted 19 advisory opinions for the year. Two are especially relevant to practices.

AO 26-12: a refund warranty on a concierge program (favorable)

An orthopedic surgery provider offers an optional, self-pay concierge program for the year after surgery, with wellness coaching, a nutritional supplement program, a health monitoring app and recovery products. It proposed a written warranty: if a patient who followed the program needed revision surgery within two years, the provider would refund the concierge fees. Nothing else would be refunded or given.

OIG concluded, in an opinion issued May 22, 2026, that the arrangement would not generate prohibited remuneration under the Anti-Kickback Statute or the beneficiary inducements law, and that it would not impose sanctions. Commentators noted it as a provider-side use of warranty concepts that usually come up with manufacturers. For med spas and practices with membership or concierge programs, it is a useful example of how a narrowly defined, written guarantee was analyzed.

AO 26-15: paying for referral software (unfavorable)

A home health operator paid a software vendor subscription fees so it could receive electronic referrals from hospitals. Hospitals could see every agency in the region, but only paying subscribers could receive referrals electronically; the requestor said other agencies were, in practice, effectively shut out. The requestor also understood the fees were not based solely on the vendor's cost of providing the service.

In an opinion issued June 25, 2026, OIG concluded that the arrangement would generate prohibited remuneration under the Anti-Kickback Statute if the requisite intent were present. The lesson for any practice is that paying a vendor in a way tied to access to referrals of federal program patients deserves a careful legal review, even when the vendor calls it a software subscription.

A short checklist before you ask

Describe the arrangement in one page. Who pays whom, for what, how the amount is set and which patients are involved.
Ask whether federal program patients are involved. If Medicare, Medicaid or other federal programs are in the picture, the Anti-Kickback Statute and beneficiary inducement rules may apply.
Check the safe harbors with counsel. Many common arrangements can be structured to fit one.
Search published opinions. OIG's site lists opinions by year with short summaries.
Weigh cost and timing. Budget for OIG's fees plus legal fees, and remember the opinion protects only the requestor.
Decide whether to proceed, restructure or request. Counsel may recommend restructuring the arrangement instead of asking OIG.

Where NutriCove fits

NutriCove sets up AI automation for medical offices, such as AI receptionists, missed-call text back, follow-up and booking. We do not give legal advice or prepare advisory opinion requests. If you are adding automation and want it built with your compliance requirements in mind (our medical office page notes, for example, that GoHighLevel needs its HIPAA add-on and a signed business associate agreement before PHI goes in), see how we set it up for medical offices.

Sources

This article is general information, not legal or medical advice. Talk to a qualified attorney or licensed professional about your situation.