OIG Offers Advisory Opinions on COVID-19-Related Arrangements, But …

A blue door with two small holes in it.

The COVID-19 pandemic has resulted in a unique set of circumstances for many healthcare providers. Delivering quality patient care, while at the same time trying to navigate existing laws and regulations, has many providers questioning whether the arrangements they are making in response to this public health emergency will not get them into trouble with healthcare regulators.

For example, will a clinical lab run afoul of the Anti-kickback Statute (AKS) if it provides free COVID-19 antibody testing to federal healthcare program beneficiaries. Or, can a physician group provide protective face masks at no, or a reduce cost, to a nursing home where it provides care if the nursing home is experiencing a shortage.

To answer these and other concerns, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) recently announced it was accepting inquiries from the healthcare community regarding the application of its administrative enforcement authorities.

As we have previously written about, the OIG generally issues advisory opinions offering individual healthcare providers with guidance on whether their proposed arrangement would violate the AKS or civil monetary penalty (CMP) provision prohibiting inducements to beneficiaries (Beneficiary Inducement CMP). The advisory opinions are specific to the requestor, though they may be seen as a form of guidance for others.

With regard to inquiries relating to COVID-19 and the public health emergency, HHS has said that while the process to obtain an opinion is the same “responses to COVID-19 inquires differ from advisory opinions which are legally binding on HHS and the requesting party or parties. FAQs in response to a COVID-19 inquiry are mere informal opinions, and according to the OIG, are not binding on HHS, the Department of Justice, or any other agency. Moreover, the COVID-19 FAQs apply only to arrangements in existence during the PHE.â€

In the FAQ, the OIG provided informal feedback on a number of proposed arrangements specific to the COVID-19 pandemic. The most recent among them was issued Aug. 4 pertaining to COVID-19 testing.

Can clinical labs offer free COVID-19 antibody tests to federal healthcare program beneficiaries who are contemporaneously receiving other medically necessary blood tests during the COVID-19 public health emergency? Such an arrangement could be seen as an inducement because the clinical laboratory would be providing something of value for free to beneficiaries who could self-refer to the laboratory for items and services reimbursable by a federal healthcare program.

OIG stated, in its opinion, such an arrangement “offers the possibility of substantial public health benefits through the identification of additional potential convalescent plasma donors and valuable public health information and data and would pose a sufficiently low risk of fraud and abuse, provided the proposed arrangement,†so long as the requestor put into place a number of stated safeguards.

OIG makes it clear that “any favorable answer will not result in prospective immunity or protection from OIG administrative sanctions or prospective immunity or protection under federal criminal law.â€

In addition OIG states that “any answer provided is not intended to be, and should not be construed as, a determination that an arrangement complies with the physician self-referral law or satisfies a statutory or regulatory exception or waiver to that law.â€

As always, it’s best to consult with a qualified healthcare attorney to determine whether any arrangements under consideration will not violate federal or state healthcare laws. The Health Law Offices of Anthony C. Vitale can assist you with questions you may have about business arrangements. For more information, you can contact us at 305-358-4500 or send us an email to info@vitalehealthlaw.com and let’s discuss how we might be able to assist you.

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The Health Law Offices of Anthony C. Vitale