Wachler & Associates Health Law BlogNew FAQs Expand OIG Guidance
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently announced that it is offering a new frequently asked question (FAQ) process to provide informal feedback to healthcare providers regarding an expanded set of topics. OIG already offers FAQs and responses on a number of topics, including advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions. During the beginning of the COVID-19 public health emergency (PHE), OIG also implemented a FAQ process to provide informal guidance on certain arrangements that are directly connected to the PHE and that implicate OIG’s administrative enforcement authorities. Now, OIG is expanding its informal guidance umbrella even further.
The topics that OIG is expanding its informal guidance to cover include the following:
- General questions regarding the Federal Anti-Kickback Statute, the civil monetary penalty (CMP) provision prohibiting certain remuneration to Medicare and State healthcare program beneficiaries (Beneficiary Inducements CMP), and OIG’s administrative enforcement authorities in connection with these statutes.
- Inquiries regarding the general application of the Federal Anti-Kickback Statute and Beneficiary Inducements CMP to a type of arrangement that may implicate these statutes.
- Questions regarding compliance
- OIG’s Health Care Fraud Self-Disclosure Protocol.
In addition to these expanded topics listed above, OIG also reviews and considers general questions related to topics covered by certain of its FAQ pages existing as of March 2023, specifically: (1) advisory opinions, (2) exclusions, and (3) its whistleblower protection coordinator function.
Providers should be mindful that any guidance OIG furnishes through its FAQ process is non-binding on itself or any other Federal agency. Further, OIG is likely to provide general guidance, rather than specific guidance regarding or a complete analysis of a particular arrangement or set of circumstances. However, an OIG informal inquiry may be a valuable part of a complete analysis, depending on the circumstances. For providers seeking to obtain a binding, legal opinion, the OIG advisory process remains available. Regarding FAQs, OIG may choose not to answer certain questions, and it may alter or modify questions that are submitted to the agency. Also, any information submitted to OIG through the FAQ process may become available to the public, although OIG has stated that it will not provide identifying information about the submitting party.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in healthcare law and regulation. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.