The Place of work of Inspector Basic (“OIG”) inside the U.S. Division of Well being and Human Services and products (“HHS”) is accountable for detecting and combating fraud, waste, and abuse in federal well being care methods. The OIG has authority to put into effect the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Financial Penalty legislation (“CMPL”). One of the vital ways in which the OIG makes use of its enforcement authority is throughout the issuance of advisory critiques. 

Upon request from well being care suppliers and others, the OIG periodically problems advisory critiques in regards to the software of fraud and abuse regulations to present or proposed trade preparations. Whilst advisory critiques aren’t binding, the OIG has said a celebration that receives a positive advisory opinion is secure from OIG-imposed administrative sanctions, only if the association is performed according to the info submitted to the OIG.

In 2022, the OIG issued 21 new advisory critiques referring to preparations and changed two of its present critiques. Nearly all of the advisory critiques concerned preparations that the OIG made up our minds would generate prohibited remuneration, however offered minimum possibility of fraud and abuse. Whilst the OIG cautioned that a number of proposed preparations offered greater than a minimum possibility of fraud and abuse, it indicated that it might handiest impose sanctions because of violations of the AKS beneath two of the preparations.

This publish supplies an evidence of the OIG’s evaluation procedure, a abstract of the OIG’s 2022 advisory critiques, and an outline of the OIG’s new FAQ procedure.

OIG Assessment Procedure

Asking for an advisory opinion from the OIG calls for the requestor to explain an present or proposed association, supply related info, and certify that each one data equipped is correct and correct to the most productive of the requestor’s wisdom. As soon as the OIG has finished its evaluation, it problems an advisory opinion that gives steering on how the proposed or present association might implicate the AKS or CMPL.

The OIG usually supplies the requestor with a chance to talk about the advisory opinion ahead of it’s issued, so to facilitate the OIG’s evaluation and research of the association.[1] Moreover, the requestor is afforded the chance to withdraw the request for an advisory opinion ahead of it’s issued.[2] Alternatively, advisory critiques that aren’t withdrawn are required through legislation to be made to be had to the general public.

Abstract of 2022 OIG Advisory Reviews

For ease of reference, we have now integrated for every advisory opinion the important thing info of the proposed association, the OIG’s research, and its final resolution within the [attached chart].

OIG’s New FAQs Procedure

Along with its present advisory opinion procedure, on March 23, 2023, the OIG launched a new FAQs procedure to permit stakeholders to post questions and obtain comments from the OIG on problems historically reserved for the advisory opinion procedure. The OIG already supplies FAQs referring to advisory critiques, self-disclosures, company integrity agreements, and exclusions. In the beginning of the COVID-19 public well being emergency (“PHE”), the OIG additionally carried out COVID-19 FAQs to offer non-binding steering explaining the OIG’s view on sure preparations which can be without delay attached to the PHE and implicate the OIG’s administrative enforcement government.

Thru its new procedure, the OIG has expanded the subjects it considers for FAQs submitted through the well being care group. In particular, the brand new FAQ subjects the OIG will imagine come with: (1) basic questions referring to AKS and the OIG’s administrative enforcement government, (2) inquiries in regards to the basic software of the AKS and CMPL to one of those association that can implicate those statutes, (3) questions referring to compliance issues, and (4) the OIG’s Well being Care Fraud Self-Disclosure Protocol. Moreover, the OIG may even evaluation and imagine basic questions coated through sure of its FAQ pages, particularly advisory critiques, exclusions, and its whistleblower coverage coordinator serve as.

The OIG has presented that after “suitable and really helpful,” it is going to factor formal, non-binding comments in keeping with decided on inquiries in regards to the above-described subjects in an FAQ reaction. Along with the brand new FAQ procedure, stakeholders are reminded that they are able to use the OIG advisory opinion procedure to hunt a proper, binding criminal opinion about an association that implicates or might implicate the AKS or CMPL.

FOOTNOTES

[1] HHS-OIG Advisory Opinion FAQs, to be had at https://oig.hhs.gov/faqs/advisory-opinion-faqs/ (remaining visited Apr. 10, 2023).

[2] Identity.