OIG Publishes FAQs Addressing Application of Its Administrative Enforcement Authorities During the COVID-19 Public Health Emergency

FAQs and OIG's Responses

Acknowledging the need during the COVID-19 outbreak for health care providers to furnish services through modalities other than in-person visits, and the fact that some vulnerable patient populations may not own or have access to needed technology or data to facilitate these services, the OIG determined that the provision of a cell phone, service or data plan, or both (Telecommunications Technologies) by a mental health or substance disorder provider to a patient likely presents a sufficiently low risk of fraud and abuse so long as certain safeguards apply.  Among other things, the provider cannot market the availability of the Telecommunications Technologies or make the offer to new patients. 

Observations:

• The OIG sidestepped the question actually posed by refusing to comment on the fraud and abuse risks that might arise with respect to any financial relationships between the donors and providers.  Instead, the OIG addressed the issue of whether providers could provide Telecommunications Technologies to needy patients.
• While the OIG is willing to be somewhat flexible, it was not willing to go so far as to allow providers to use the Telecommunications Technologies as marketing tools.
• The OIG acknowledged that the parties might be able to structure this arrangement to meet the Promotes Access to Care exception to the Beneficiary Inducement CMPL (we previously blogged on this exception and a related OIG advisory opinion), but that no parallel AKS exception or safe harbor exists.

The OIG concluded that, under the unique circumstances of the COVID-19 outbreak, an oncology practice could provide modest in-kind transportation assistance that does not otherwise meet the conditions of the existing AKS safe harbor for local transportation to established patients.

In its response, the OIG laid out three requirements that would ensure that such transportation assistance is sufficiently low risk, including that the assistance is provided by an “eligible entity” to an “established patient” as those terms are defined by the existing local transportation AKS safe harbor, 42 U.S.C. § 1001.952(bb).

Observations:

• As in the FAQ above, the OIG also articulated three safeguards that the eligible entity must meet in order to ensure that the transportation assistance presents a sufficiently low risk of fraud and abuse, including prohibitions on marketing of these services and on paying drivers on a per-beneficiary basis.
• Surprisingly, the OIG broadened its response beyond the original facts presented by recognizing that many physicians (beyond oncologists) prescribe extended courses of treatment to beneficiaries who use public transportation to access care and that those physicians might also wish to provide transportation assistance to their patients to mitigate the effects of office closures caused by the COVID-19 outbreak or increased risk of exposure to the virus.  The OIG specifically mentioned physicians providing chemotherapy, dialysis, radiation therapy, cardio/pulmonary rehabilitation treatment or behavioral health services.

While OIG emphasized that its longstanding guidance makes clear that, depending on the facts and circumstances, the provision of free goods or services to an actual or potential referral source may violate the AKS and Beneficiary Inducement CMPL, it recognized that there are scenarios where health care providers could work together to fill critical gaps caused by COVID-19 and provide necessary care to vulnerable beneficiaries receiving care in a SNF or other long-term-care facility.

For example, a hospice vendor already providing services to some SNF patients could furnish basic care needs (not to exceed the scope of applicable facility and staff licensure) for free to patients who are not hospice clients to help mitigate SNF staffing shortages, or dentists or podiatrists who otherwise are not practicing at full capacity during the public health emergency could offer their services for free or at a reduced rate to SNF patients on a temporary basis.

Observations:

• Given that this scenario involves the provision of something for free to a potential referral source, it is not surprising that the limitations imposed by the OIG focused on limiting the scope, purpose, and duration of these services.
• Compliance with the OIG’s guidance could be difficult to execute.  The parties would need to (1) carefully document the necessity of the services and the existence of a staffing shortage directly related to COVID-19; and (2) be sure to cease providing the services as soon as the COVID-19 public health emergency has ended.

The OIG recognized that given the unique and exigent circumstances resulting from the COVID-19 outbreak, free access to a hospital’s telehealth platform by physicians on its medical staff would present a low risk of fraud and abuse under the AKS and could improve beneficiaries’ access to telehealth services, provided four particular conditions are met. 

Observations:

• Like the FAQ immediately above, this scenario involves the provision of something for free to a potential referral source.  Not surprisingly, the OIG’s conditions for this FAQ include that platform access (1) is not conditioned on the physician’s past or anticipated volume or value of referrals to, or business generated for the hospital, and (2) is provided only when necessary as a result of the COVID-19 outbreak and during the period subject to the PHE Declaration.
• The OIG took the additional step of pointing parties to recent guidance published by the Office of Civil Rights regarding the use of audio or video communication technology to furnish telehealth services during the COVID-19 public health emergency: Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency.