Advisory Opinion Process
Pursuant to section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104–101, codified at section 1128D of the Social Security Act (Act), the Secretary must publish advisory opinions regarding the application of the Federal anti-kickback statute and the safe harbor provisions, as well as certain other administrative sanction authorities, to parties’ proposed or existing arrangements.
Through the advisory opinion process, the OIG issues written advisory opinions with regard to:
- What constitutes prohibited remuneration under the Federal anti-kickback statute;
- Whether an arrangement or proposed arrangement satisfies the criteria in section 1128B(b)(3) of the Act, or established by regulation (i.e., safe harbors), for activities which do not result in prohibited remuneration;
- What constitutes an inducement to reduce or limit services to Medicare or Medicaid program beneficiaries under section 1128A(b) of the Act; and
- Whether an activity or proposed activity constitutes grounds for the imposition of sanctions under sections 1128, 1128A or 1128B of the Act.
While the goal of the advisory opinion process is to offer meaningful advice to the requestors of advisory opinions, these advisory opinions are binding and may legally be relied upon only by such requestors. We publish the redacted form of each issued advisory opinion on the OIG website for informational purposes only; no third parties are bound by or may legally rely upon these advisory opinions.
The current regulations governing the advisory opinion process are codified in part 1008 of title 42 of the Code of Federal Regulations.
To implement and interpret section 1128D of the Act, the OIG issued an interim final rule with comment period in 1997. OIG, Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG, 62 Fed. Reg. 7350 (Feb. 19, 1997). We revised and clarified our regulations in a final rule issued in 1998. OIG, Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG, 63 Fed. Reg. 38,311 (July 16, 1998).
In 2008, we revised certain procedural requirements for submitting payments for advisory opinion costs. OIG, Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by OIG, 73 Fed. Reg. 15,937 (Mar. 26, 2008); see also OIG, Office of Inspector General; Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG, 73 Fed. Reg. 40,982 (July 17, 2008).
In January 2022, we issued a final rule governing the procedures for the submission of advisory opinion requests to, and the issuance of advisory opinions by, OIG. In conjunction with the final rule, OIG issued a related enforcement policy statement.
Advisory Opinion FAQs
To address common questions that we receive from potential or actual requestors, the OIG has developed a list of frequently asked questions about the advisory opinion process. If you have a question about the advisory opinion process, please review these frequently asked questions first; if you still have questions about the process after reviewing these materials, you may call (202) 619-0335 and ask to speak to a member of the Industry Guidance Branch.
Submit a request
Advisory opinion requests must be submitted in PDF format to OIGAdvisoryOpinions@oig.hhs.gov. Although not required, we encourage requestors to use the OIG Advisory Opinion Request Template to prepare advisory opinion requests. This template helps to ensure that requestors include information required by OIG as part of the advisory opinion process, as well as information that is optional. You will receive an initial response to your advisory opinion request that accepts, rejects, or seeks additional information regarding the request within 10 business days of submitting your request.