The United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently announced a quicker way to answer questions from the healthcare and pharmaceutical industries on the Anti-Kickback Statute. The HHS OIG Frequently Asked Questions (FAQ) program was expanded to cover new topics, including Anti-Kickback Statute enforcement, civil monetary penalties, and general compliance considerations. OIG also noted that the agency “reviews and considers general questions related to topics covered by certain of its FAQ pages…namely: (1) advisory opinions, (2) exclusions, and (3) its whistleblower protection coordinator function.
In the new FAQ process, HHS OIG “will issue information, non-binding feedback in response to selected inquiries regarding the above-described topics in the form of an FAQ response.” To submit an FAQ for non-binding feedback, you can email the email address included on the FAQ page here.
This marks a change from the prior operation, where companies could only get HHS OIG guidance on the new FAQ topics through formal advisory opinions. The formal advisory opinion process is much longer and labor-intensive than seeking information from the FAQ program. HHS OIG is hoping that the new FAQ program will allow the agency to issue more guidance to companies at a faster pace.
HHS OIG has long tried to find ways to modernize and make their processes more efficient. By offering FAQs during the COVID-19 pandemic, the agency became more confident in its ability to answer enforcement questions in such a manner.
FAQ Limitations
As this process is quicker (and hopefully more efficient) than the current formal advisory opinion process, there are some limitations. One, as mentioned above, is that the FAQ responses do not “bind of obligate OIG, HHS, the Department of Justice, or any other agency.”
Along those same lines, answers provided in the FAQ section of HHS OIG’s website “do not confer prospective immunity from OIG administrative sanctions on any party,” including the party that submits the FAQ.
The FAQ responses will also not include any opinion with respect to the application of any law, statute, rule, regulation, or ordinance that may apply to the question, including the Stark Law. FAQ responses will also not provide an opinion regarding liability of any party under the Federal False Claims Act, federal criminal law, or other areas relating to improper billing, claims submission, cost reporting, or other related conduct.
Submitting an Inquiry
When emailing your proposed FAQ, HHS OIG recommends you include “sufficient background and facts,” so the agency can best understand the question. OIG provides the example of an inquiry regarding a type of arrangement – be sure to “including information critical to understanding the type of arrangement, such as the key types of parties and the general terms of the arrangement.”
When responding to your inquiry, HHS OIG may revise the question to “ensure generality.” HHS OIG also reserves the right to not respond to a particular question.
HHS OIG will not provide any identifying information about the party that submits a question, but such information may be made available in accordance with 5 U.S.C. § 552, and as such, HHS OIG recommends you not submit any protected health information.
Formal Advisory Opinion Process Remains Available
The advent of the FAQ process does not supplant the formal advisory opinion process, and that process remains available to any interested parties. The formal advisory opinions from OIG will continue to be legally binding on HHS. Therefore, if weight in the court system is an important factor in obtaining an answer from HHS OIG on a topic, a formal advisory opinion may be recommended.