On March 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) announced a new, expanded frequently asked questions (FAQs) process. Although OIG has long maintained FAQs on topics such as exclusion authorities, it has addressed only a limited range of issues. Under the new process, stakeholders may now submit questions related to subjects traditionally reserved for the formal advisory opinion process, including the federal Anti-Kickback Statute (AKS) and the civil monetary penalty (CMP) provision prohibiting certain remuneration to Medicare and state health care program beneficiaries (Beneficiary Inducements CMP).
OIG also published several new FAQs, including FAQs concerning the treatment of gift cards, whether the AKS applies to EHR vendor arrangements and entities under common ownership, and how OIG analyzes the fraud and abuse risks of physician investments in ambulatory surgery centers when not all physician-investors meet the safe harbor’s “one-third practice income test.”
This alert provides an overview of the expanded FAQ process. In subsequent alerts, we will explore the substance of some of the new FAQs described above.
Historically, OIG has published FAQs on topics such as advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions to address various procedural issues. For example, such FAQs address what information an advisory opinion request should include and what penalties OIG may impose for a provider’s failure to comply with its corporate integrity agreement but do not address how OIG interprets the AKS, the Beneficiary Inducements CMP, or its other enforcement authorities.
At the beginning of the COVID-19 public health emergency (PHE), OIG implemented an FAQ process to provide timely, non-binding guidance explaining how OIG’s administrative enforcement authorities would apply to certain arrangements during the PHE. Through that FAQ process, OIG offered flexibilities with respect to certain arrangements that were directly connected to the PHE to allow healthcare providers to focus on delivering needed patient care. With the PHE ending on May 11, 2023, the COVID-19 FAQs soon will no longer apply.
In late 2021, OIG published a Request for Information (RFI) in the Federal Register as part of its modernization initiative, seeking stakeholder input regarding the agency’s public resources and other guidance. Among other things, OIG noted that it has received feedback that the advisory opinion process is too restrictive, slow, and cumbersome and sought input on how to balance the value of including a detailed analysis in each opinion with the value of a more expeditious approach that does not include a detailed legal analysis. OIG’s new FAQ categories respond to these criticisms, allowing new flexibilities.
New FAQ Categories
OIG’s new FAQ process is designed to improve the timeliness and utility of its guidance and offers a new avenue for insight regarding how OIG analyzes particular arrangements outside of the advisory opinion process. The new categories of FAQs include:
- General applicability of the AKS and Beneficiary Inducements CMP.
- OIG’s administrative enforcement authorities in connection with the AKS and Beneficiary Inducements CMP.
- Application of the AKS and the Beneficiary Inducements CMP to certain types of arrangements.
- Compliance considerations.
- OIG’s Health Care Fraud Self-Disclosure Protocol.
OIG requests that FAQ submissions provide sufficient background information and facts to allow for an understanding of the question. For example, if stakeholders submit an inquiry regarding a specific type of arrangement, OIG seeks information critical to understanding the arrangement, such as the key parties and the arrangement’s general terms. Where OIG considers it “appropriate and beneficial,” it will issue informal, non-binding feedback in response to selected inquiries in the form of FAQs, subject to a number of caveats discussed below.
OIG will choose which questions it answers and may modify the question to deliver “a more useful or meaningful response” and “to ensure generality in any response.”
Additional limitations apply to OIG’s FAQs, including:
- FAQs do not bind or obligate OIG, HHS, the Department of Justice, or any other agency.
- If OIG publishes a response, it may (but is not obligated to) notify the party that submitted the question.
- FAQs do not confer prospective immunity from OIG administrative sanctions.
As one would expect, OIG will express no opinion with respect to the application of any federal, state, or local statute, rule, regulation, ordinance, or other law that may apply to the question answered, including, without limitation, the physician self-referral law (the Stark Law). Likewise, OIG will express no opinion regarding the liability of any party under the federal False Claims Act, federal criminal law or other legal authorities relating to any improper billing, claims submission, cost reporting, or related conduct.
While OIG will not provide identifying information about the party that submitted a question in any public response, it cautions that certain information related to an FAQ submission may be disclosed in response to a Freedom of Information Act request.
Drawing on its success with the PHE FAQ process and in response to stakeholder comments to its RFI, OIG’s expansion of the FAQ process offers a new pathway for providing more rapid industry guidance. OIG’s expansion of this informal guidance process allows stakeholders to present OIG with innovative questions outside of the formal advisory opinion process. Stakeholders may find this new FAQ process helpful, particularly as healthcare models rapidly shift to value-based care, although the fact that OIG is not obligated to respond may limit utility.
It is unclear how OIG will exercise its discretion to respond to inquiries made under the new process. Moreover, OIG is clear that the FAQs are not binding on any agency, including OIG, leaving some doubt as to the value of FAQs in the enforcement or whistleblower context. Additionally, unlike an advisory opinion—where requestors can withdraw a request if OIG is planning to issue unfavorable guidance—FAQ submissions lack that mechanism. Because OIG will be surgical in issuing FAQs, some responses may throw into question certain existing business practices without the needed context observed in an advisory opinion, regulatory preamble, or a special fraud alert. Indeed, like the agency’s special fraud alerts, OIG may use the FAQ process to quash certain trends without the benefit of added context or dialogue while reserving “favorable” guidance for crises such as the opioid epidemic.
With no requirement to respond to any FAQ, some questions may go unanswered. Other stakeholders may collaborate to submit the same question to encourage a response, potentially inundating the agency. Stakeholders should carefully consider the costs and benefits of approaching OIG for this type of one-sided guidance on complicated fraud and abuse issues.
While the new process might allow stakeholders to seek helpful clarification on misunderstood preamble and certain historic guidance documents, formal advisory opinions remain the only means of obtaining binding, conclusive guidance from the agency with the benefit of correspondence with regulators on the specific facts and circumstances of an arrangement.
Please contact the authors if you have questions about the new FAQ process and how it could affect your business.