On July 5, 2022, OIG posted Advisory Opinion No. 22-15, regarding a proposal by two universities to provide medical care and financial assistance to veterans with mild-to-moderate traumatic brain injuries and associated physical and psychological health conditions. The requestors, groups within two academic medical centers, proposed to use donations to cover: (i) specialized care furnished to veterans who meet certain criteria; and (ii) certain out-of-pocket expenses related to that specialized care. OIG determined that it would not impose administrative sanctions in connection with the Anti-Kickback Statute (AKS) or the Beneficiary Inducements Civil Monetary Penalty (CMP) provision.

The Proposed Arrangements

The requestors are two universities. University A brings the request on behalf of the University A School of Medicine, a component of an academic medical center employing University A physicians and non-physician practitioners and operates an “Institute”, and on behalf of the University A Management Entity, a nonprofit corporation that provides support for the education, research, and patient care mission, including business management services to the University A School of Medicine. University B brings the request on behalf of the University B Medical Group. University B employs physicians and non-physician practitioners of the University B Medical Group, which is a component of an academic medical center and operates the “Center”. University B Medical Group and University A Management Entity are enrolled in Federal health care programs.

The Institute and Center (collectively, the Clinical Programs) are interdisciplinary programs designed to provide intensive outpatient treatment and specialty care to United States military service veterans with mild-to-moderate traumatic brain injuries (TBI) and associated physical and psychological health conditions connected to their military service, including post-traumatic stress (PTS). The Clinical Programs use the same interdisciplinary model of care that is used in the Department of Defense’s Intrepid Spirit Centers, but the Intrepid Centers are only available to active-duty service members. The Clinical Programs are designed to assist veterans with TBI and PTS who have unmet health needs due to the lack of access to specialty care for veterans with TBI in their communities. Although veterans may be able to find some aspects of treatment in their communities, the Requestors represented that the interdisciplinary care model is not otherwise available to veterans.

The Clinical Programs

The Proposed Arrangement would provide intensive outpatient treatment to qualified veterans through the Clinical Programs using an interdisciplinary care model. The Clinical Programs will assess initial eligibility to confirm (i) the potential patient’s veteran status; and (ii) that medical records show either a TBI diagnosis or a history of head injury that could have led to TBI or post-concussion syndrome (“head injury”). The eligibility review would also assess whether the veteran is psychiatrically stable and has no indication of unmanaged substance use disorder. If the potential patient meets the initial eligibility criteria, the veteran would participate in a 3-4 day in-person evaluation at a Clinical Program site. Based on this evaluation, specialists at the Clinical Program would collectively determine whether the intensive outpatient program is appropriate for the veteran on a case-by-case basis. If the veteran is approved, then the veteran would return for 3 weeks of intensive outpatient interdisciplinary treatment provided or coordinated by clinicians at one of the Clinical Programs. After the three-week program, case managers at the Clinical Programs would continue to follow up with the veteran for one year or longer, as needed, to assist the veteran with navigating resources for follow-up treatment and other services.

The Proposed Arrangement only includes medically necessary care and other ancillary services that are integral to the veteran’s specific intensive outpatient treatment program. If the veteran requires treatment or services that are related to the TBI, Head Injury or PTS but are not directly provided by the Clinical Program, then the Clinical Program would make arrangements with a third party for the services, and the cost of the services would be covered by the Clinical Program. If the veteran requires treatment or services unrelated to the TBI, Head Injury or PTS the Clinical Program would refer the patient elsewhere for treatment, but the unrelated treatment costs would not be covered by the Clinical Program.

Funding for Clinical Programs

Requestors propose to use charitable donations to cover the expenses that veterans would incur while receiving evaluation and treatment by the Clinical Programs, including out-of-pocket costs for treatment related to the veteran’s TBI, Head Injury or PTS and travel-related expenses to ensure that the veterans and their families incur no out-of-pocket expenses for participation in the Clinical Program regardless of ability to pay or any potential insurance status. Many offered services would not be covered by insurance, so without the financial support, veterans and their families would be left with large out-of-pocket expenses. Requestors will not advertise the availability of financial assistance.
Requestors would use charitable donations to provide three types of assistance:

• All out-of-pocket costs for treatment by the Clinical Programs and by third parties for the treatment related to the veteran’s TBI, Head Injury, or PTS diagnosis. For veterans without insurance, Requestors would cover all costs. For veterans with insurance, Requestors would cover all cost sharing and the cost of non-covered services. If a third-party provides services, the Requestors would instruct the third party to bill the Clinical Programs rather than the veteran or any payor.
• The cost of travel, modest lodging, and meals for in-person evaluation and treatment for the veteran, and as needed, a companion.
• The cost of travel for the veteran’s family for the last week of intensive outpatient treatment. The family’s in-person attendance is necessary to plan to meet the veteran’s future needs.

Funds for financial assistance will be raised from donors. The donors would be individuals and organizations that support veterans’ needs but would not be individuals or entities in the health care industry or entities that manufacture or furnish items or render services billable to Federal healthcare programs. Even with financial assistance, Requestors would sustain financial losses because the donor support is not expected to cover all of Requestors’ costs.

OIG Determination

OIG advised that the proposal would implicate both the AKS and the Beneficiary Inducements CMP provision. No exception or safe harbor covers the proposed conduct. However, OIG determined that, because of the unique circumstances present in the Proposed Arrangement, the Proposed Arrangement presents a minimal risk of fraud and abuse under the AKS and OIG will exercise its discretion and not impose sanctions under the Beneficiary Inducements CMP. OIG identified a number of factors supporting this decision:

• The Proposed Arrangement is unlikely to increase costs inappropriately for the federal healthcare programs and could result in overall cost savings because some services provided are not covered, and others will be provided by third parties would not be billed to the federal healthcare program. Requestors also certified that they would only provide medically necessary care and other ancillary services integral to the veteran’s treatment.
• Donors are not involved in the health care industry and do not render services or furnish items billable to a federal healthcare program. Donors would not have an interest in veterans receiving any particular items or services.
• There is a low risk that the Proposed Arrangement would induce veterans to receive any services from Requestors outside of those offered through the Clinical Programs. The Proposed Arrangement is designed to enable veteran access to the services of the Clinical Programs, not other covered services that are not a part of the Clinical Programs.
• Requestors will not advertise the availability of financial assistance, but all veterans will receive financial assistance regardless of insurance status or need.
• The Proposed Arrangement is unlikely to result in “leapfrogging” concerns where an arrangement would result in the bypassing of other providers equipped to provide quality medical care. To Requestors’ knowledge no other entities provide a similar, coordinated suite of services.

The Advisory Opinion may not be relied upon by anyone other than the Requestor. A copy of Advisory Opinion 22-15 is available here.