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More Guidance About “Guidance”: HHS-OIG’s Equivocal Responses to FAQs Regarding Its Administrative Enforcement Authority During the COVID-19 Crisis Provide Little Actual Guidance

May 1, 2020 - Scott R. Landau

On April 24, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued responses to frequently asked questions (“FAQs”) regarding application of its administrative enforcement authority (under the Antikickback Statute (“AKS”) and the Civil Monetary Penalties law (“CMP”)) to certain COVID-19 related financial arrangements. With all due respect to OIG, its responses here were so cumbersome and equivocal that they failed to give healthcare providers the clarity and assurances they need to nimbly and creatively provide efficient patient services in this constantly-evolving regulatory environment.

OIG’s Specific Responses to FAQs

OIG’s stated purpose in responding to the FAQs was to “ensure that health care providers have the regulatory flexibility necessary to adequately respond to COVID-19 concerns.”  While this is a laudable and important goal, many of OIG’s responses to questions submitted by stakeholders are simply too convoluted and oblique to provide actual meaningful guidance.

For example, in response to a question regarding whether mental health and substance use disorder providers can accept donations to “fund cell phones, service or data plans” for patients who are financially needy for purposes of furnishing medically necessary services during the COVID-19 outbreak, OIG offered a lengthy and meandering response regarding the importance of technology and the fact that different relationships between donors, providers, and patients present different fraud and abuse risks, among other things. Ultimately, and with multiple caveats, OIG went on to state that the proposed arrangement “likely presents a sufficiently low risk of fraud and abuse” so long as the arrangement complied with 8 specific “safeguards” enumerated in the response.  OIG further cautioned that its response related only to the “financial relationship” between the provider and the patient, and that risks that may arise regarding financial relationships between donor and provider needed to be “separately assessed.”

Similarly, in response to another question regarding whether or not providers can furnish services “for free or at a reduced rate” to “assist skilled nursing facilities (SNFs) or other long-term care providers that are facing staffing shortages,” OIG again recited the history of its “longstanding” guidance that the provision of free goods or services to actual or potential referral sources may violate the AKS. Following this lengthy, punctation-less walk back in time, OIG eventually, indirectly, and equivocally concluded that “we believe that these circumstances likely would present a low risk of fraud and abuse” under the AKS and CMP so long as the services complied with 6 additional “safeguards” that would need to be followed.

And again, in response to a query as to whether hospitals can provide access to their web-based telehealth platforms for free to independent physicians on their medical staffs so they can furnish telehealth during the COVID-19 emergency period, instead of just responding “yes,” OIG again engaged in a lengthy recital of its longtime guidance before disguising its equivocal response (that the arrangement would present a “low risk” of fraud and abuse assuming implementation of 6 additional safeguards) in the middle of a lengthy paragraph.

While we recognize (as discussed below) that these FAQ responses constitute only “informal” and non-binding guidance, they are far from a beacon of clarity, and in many cases raise additional questions to which the answers remain unknown.

Further Caveats and Limitations on OIG’s Responses to the FAQs

Federal agency guidance often contains overarching caveats and limitations. OIG’s responses to the FAQs follow this form, and in addition to the specific caveats and limitations included in each response, they also contained multiple” “blanket limitations as well.

Most notably, OIG cautioned that: (1) its specific responses to the FAQs; and (2) responses to inquiries and questions submitted via email and outside of the formal advisory opinion process generally, constitutes “informal feedback” that “does not bind or obligate HHS, the U.S. Department of Justice, or any other agency.” Here, OIG reminded parties that the “advisory opinion process” remains available for parties seeking more formal, binding guidance, and that favorable answers provided in “informal feedback” in response to questions submitted via email will not result in “prospective immunity or protection from OIG administrative sanctions . . . or protection under Federal criminal law.” Though ostensibly “cold comfort” for providers seeking guidance in a pinch, we believe that the government would be hard-pressed to seek sanctions and/or prosecute COVID-19 related arrangements upon which OIG had previously favorably opined, even if only equivocally, in “informal,” non-binding guidance like this..

OIG further cautioned that its FAQ responses apply only to arrangements in existence “solely” during the time period subject to the COVID-19 Declaration, and that it may take “different” positions on arrangements that are “the same or similar that existed before the effective date of the COVID-19 Declaration or after the time” the declaration ends. In other words, while OIG may exercise its discretion not to enforce the AKS and/or CMP regarding certain arrangements in place during the COVID-19 crisis, those very same arrangements may still be subject to enforcement if they were in place before the crisis began or if they remain in place after it ends.

Additionally, OIG noted here that it is expressing no opinions regarding the application of any federal or state laws or rules other than the AKS and CMP, including but not limited to the Stark law. OIG further cautioned that its FAQ responses should not be read as opining on the liability of any party under the Federal False Claims Act or federal criminal laws regarding improper billing, claims submission, cost reporting, or “related” conduct. In other words, OIG’s “guidance” here relates only to its enforcement authority (and its discretion to exercise such authority) under the AKS and the CMP.

With those caveats in mind, OIG still invites the health care community to submit inquiries regarding the application of OIG’s enforcement authority under the AKS and the CMP during the COVID-19 crisis to [email protected]. OIG asks that all submissions provide “sufficient facts to allow for an understanding of the key parties and terms of the arrangements at issue,” and will continue to respond to questions submitted and update the FAQ site as it responds to additional questions.

Final Thoughts

We understand that OIG cannot issue full-throated, binding commentary outside of the formal “advisory opinion” process. That said, the length of OIG’ responses to the FAQs combined with their unusually high level (even for a government agency) of equivocation significantly diminishes their utility to front-line healthcare providers – who in this time of crisis need  straightforward guidance so that they can most efficiently and effectively deliver patient care services. While issuing FAQ responses like these certainly creates work for attorneys like us (who then have to interpret it for our provider clients), it gives little direct, practicalguidance to providers, and thus cannot enable them to be as nimble as possible during these current emergent circumstances.    All that said, if you still wish to submit questions to OIG regarding COVID-19 related arrangements through the “informal” submission process, we will be happy to assist you. Please contact us at [email protected] for more information.