The Workplace of Inspector Common (“OIG”) inside the U.S. Division of Well being and Human Providers (“HHS”) is accountable for detecting and stopping fraud, waste, and abuse in federal well being care applications. The OIG has authority to implement the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Financial Penalty legislation (“CMPL”). One of many ways in which the OIG makes use of its enforcement authority is thru the issuance of advisory opinions.
Upon request from well being care suppliers and others, the OIG periodically points advisory opinions in regards to the software of fraud and abuse legal guidelines to current or proposed enterprise preparations. Whereas advisory opinions aren’t binding, the OIG has said a celebration that receives a positive advisory opinion is protected against OIG-imposed administrative sanctions, supplied that the association is performed in accordance with the information submitted to the OIG.
In 2022, the OIG issued 21 new advisory opinions concerning preparations and modified two of its current opinions. The vast majority of the advisory opinions concerned preparations that the OIG decided would generate prohibited remuneration, however introduced minimal threat of fraud and abuse. Whereas the OIG cautioned that a number of proposed preparations introduced greater than a minimal threat of fraud and abuse, it indicated that it could solely impose sanctions resulting from violations of the AKS beneath two of the preparations.
This put up gives an evidence of the OIG’s assessment course of, a abstract of the OIG’s 2022 advisory opinions, and an summary of the OIG’s new FAQ course of.
OIG Overview Course of
Requesting an advisory opinion from the OIG requires the requestor to explain an current or proposed association, present related information, and certify that every one info supplied is true and correct to the most effective of the requestor’s data. As soon as the OIG has accomplished its assessment, it points an advisory opinion that gives steerage on how the proposed or current association could implicate the AKS or CMPL.
The OIG usually gives the requestor with a possibility to debate the advisory opinion earlier than it’s issued, in order to facilitate the OIG’s assessment and evaluation of the association. Moreover, the requestor is afforded the chance to withdraw the request for an advisory opinion earlier than it’s issued. Nevertheless, advisory opinions that aren’t withdrawn are required by legislation to be made accessible to the general public.
Abstract of 2022 OIG Advisory Opinions
For ease of reference, we’ve included for every advisory opinion the important thing information of the proposed association, the OIG’s evaluation, and its final dedication within the [attached chart].
OIG’s New FAQs Course of
Along with its current advisory opinion course of, on March 23, 2023, the OIG launched a new FAQs course of to permit stakeholders to submit questions and obtain suggestions from the OIG on points historically reserved for the advisory opinion course of. The OIG already gives FAQs concerning advisory opinions, self-disclosures, company integrity agreements, and exclusions. Firstly of the COVID-19 public well being emergency (“PHE”), the OIG additionally carried out COVID-19 FAQs to supply non-binding steerage explaining the OIG’s view on sure preparations which are immediately linked to the PHE and implicate the OIG’s administrative enforcement authorities.
By its new course of, the OIG has expanded the matters it considers for FAQs submitted by the well being care group. Particularly, the brand new FAQ matters the OIG will take into account embody: (1) basic questions concerning AKS and the OIG’s administrative enforcement authorities, (2) inquiries concerning the final software of the AKS and CMPL to a sort of association that will implicate these statutes, (3) questions concerning compliance concerns, and (4) the OIG’s Well being Care Fraud Self-Disclosure Protocol. Moreover, the OIG will even assessment and take into account basic questions lined by sure of its FAQ pages, particularly advisory opinions, exclusions, and its whistleblower safety coordinator perform.
The OIG has supplied that when “applicable and useful,” it should problem formal, non-binding suggestions in response to chose inquiries concerning the above-described matters in an FAQ response. Along with the brand new FAQ course of, stakeholders are reminded that they will use the OIG advisory opinion course of to hunt a proper, binding authorized opinion about an association that implicates or could implicate the AKS or CMPL.