The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has authority to enforce the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty law (“CMPL”). One of the ways that the OIG utilizes its enforcement authority is through the issuance of advisory opinions.
Upon request from health care providers and others, the OIG periodically issues advisory opinions concerning the application of fraud and abuse laws to existing or proposed business arrangements. While advisory opinions are not binding, the OIG has stated a party that receives a favorable advisory opinion is protected from OIG-imposed administrative sanctions, provided that the arrangement is conducted in accordance with the facts submitted to the OIG.
In 2022, the OIG issued 21 new advisory opinions regarding arrangements and modified two of its existing opinions. The majority of the advisory opinions involved arrangements that the OIG determined would generate prohibited remuneration, but presented minimal risk of fraud and abuse. While the OIG cautioned that several proposed arrangements presented more than a minimal risk of fraud and abuse, it indicated that it would only impose sanctions due to violations of the AKS under two of the arrangements.
This post provides an explanation of the OIG’s review process, a summary of the OIG’s 2022 advisory opinions, and an overview of the OIG’s new FAQ process.
OIG Review Process
Requesting an advisory opinion from the OIG requires the requestor to describe an existing or proposed arrangement, provide relevant facts, and certify that all information provided is true and accurate to the best of the requestor’s knowledge. Once the OIG has completed its review, it issues an advisory opinion that provides guidance on how the proposed or existing arrangement may implicate the AKS or CMPL.
The OIG typically provides the requestor with an opportunity to discuss the advisory opinion before it is issued, so as to facilitate the OIG’s review and analysis of the arrangement.[1] Additionally, the requestor is afforded the opportunity to withdraw the request for an advisory opinion before it is issued.[2] However, advisory opinions that are not withdrawn are required by law to be made available to the public.
Summary of 2022 OIG Advisory Opinions
For ease of reference, we have included for each advisory opinion the key facts of the proposed arrangement, the OIG’s analysis, and its ultimate determination in the [attached chart].
OIG’s New FAQs Process
In addition to its existing advisory opinion process, on March 23, 2023, the OIG released a new FAQs process to allow stakeholders to submit questions and receive feedback from the OIG on issues traditionally reserved for the advisory opinion process. The OIG already provides FAQs regarding advisory opinions, self-disclosures, corporate integrity agreements, and exclusions. At the beginning of the COVID-19 public health emergency (“PHE”), the OIG also implemented COVID-19 FAQs to provide non-binding guidance explaining the OIG’s view on certain arrangements that are directly connected to the PHE and implicate the OIG’s administrative enforcement authorities.
Through its new process, the OIG has expanded the topics it considers for FAQs submitted by the health care community. Specifically, the new FAQ topics the OIG will consider include: (1) general questions regarding AKS and the OIG’s administrative enforcement authorities, (2) inquiries regarding the general application of the AKS and CMPL to a type of arrangement that may implicate these statutes, (3) questions regarding compliance considerations, and (4) the OIG’s Health Care Fraud Self-Disclosure Protocol. Additionally, the OIG will also review and consider general questions covered by certain of its FAQ pages, namely advisory opinions, exclusions, and its whistleblower protection coordinator function.
The OIG has offered that when “appropriate and beneficial,” it will issue formal, non-binding feedback in response to selected inquiries regarding the above-described topics in an FAQ response. In addition to the new FAQ process, stakeholders are reminded that they can use the OIG advisory opinion process to seek a formal, binding legal opinion about an arrangement that implicates or may implicate the AKS or CMPL.
FOOTNOTES
[1] HHS-OIG Advisory Opinion FAQs, available at https://oig.hhs.gov/faqs/advisory-opinion-faqs/ (last visited Apr. 10, 2023).
[2] Id.