On July 5, 2022, the OIG released Advisory Opinion #22-15 regarding a proposal by two universities to provide medical care and financial assistance to veterans with mild to moderate traumatic brain injury and mental health issues. associated physical and psychological health. The applicants, grouped within two academic medical centers, proposed to use the donations to cover: (i) specialized care provided to veterans who meet certain criteria; and (ii) certain disbursements related to such specialized care. The OIG has determined that it will not impose administrative penalties under the Anti-Kribery Act (AKS) or the Civil Monetary Penalty (CMP) provision relating to beneficiary inducements.
The proposed arrangements
The applicants are two universities. University A submits the application on behalf of University A’s medical school, a component of an academic medical center employing physicians and non-physician practitioners from University A and operates an “institute”, and at the name of the managing entity of University A, a non-profit organization. company that provides support for the education, research, and patient care mission, including business management services to University A’s medical school. University B submits the application on behalf of the University B Medical Group. University B employs physicians and non-physician practitioners from University B Medical Group, which is part of a University Medical Center and operates the “Centre”. University B’s medical group and University A’s 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 specialized care to U.S. military service veterans with mild to moderate traumatic brain injury and physical and associated psychological issues related to their military service, including post-traumatic stress (PTS). Clinical programs use the same interdisciplinary model of care used at Department of Defense Intrepid Spirit Centers, but Intrepid Centers are only available to active duty service members. Clinical programs are designed to help veterans with TBI and PTS who have unmet health needs due to the lack of access to specialized care for veterans with TBI in their communities. Although veterans may be able to find some aspects of treatment in their communities, requesters indicated that the interdisciplinary care model is not otherwise available to veterans.
The proposed arrangement would provide intensive outpatient treatment to qualified veterans through clinical programs using an interdisciplinary care model. Clinical programs will assess initial eligibility to confirm (i) the potential patient’s veteran status; and (ii) medical records indicate either a diagnosis of TBI or a history of head trauma that could have resulted in TBI or post-concussion syndrome (“Head Injury”). The eligibility review would also assess whether the veteran is psychiatrically stable and has no indication of an unmanaged substance use disorder. If the prospective patient meets the initial eligibility criteria, the veteran will participate in a 3-4 day in-person assessment at a clinical program site. Based on this assessment, the clinical program specialists would collectively determine if the intensive outpatient program is appropriate for the veteran on a case-by-case basis. If the Veteran is approved, then the Veteran will return for 3 weeks of outpatient intensive interdisciplinary treatment provided or coordinated by clinicians at one of the clinical programs. After the three-week program, clinical program case managers would continue to follow the veteran for a year or more, as needed, to help the veteran navigate resources for follow-up treatment and other services.
The proposed arrangement includes only medically necessary care and other ancillary services that are an integral part of the veteran’s specific intensive outpatient treatment program. If the Veteran requires treatment or services related to TBI, Head Injury, or PTS but not directly provided by the Clinical Program, then the Clinical Program would arrange with a third party to the services, and the cost of the services would be covered by the clinical program. If the veteran requires treatment or services unrelated to TBI, TBI, or PTSD, the clinical program will refer the patient to other treatment, but unrelated treatment costs will not be covered by the clinical program.
Funding of clinical programs
Plaintiffs propose to use charitable donations to cover expenses veterans would incur during evaluation and treatment through clinical programs, including out-of-pocket costs for treatment related to TBI, head injury or veteran’s TPS and travel-related expenses to ensure that veterans and their families do not incur any out-of-pocket costs to participate in the clinical program, regardless of their ability to pay or any potential insurance status . Many services offered would not be covered by insurance, so without the financial support, veterans and their families would be left with significant out-of-pocket expenses. Applicants will not advertise the availability of financial assistance.
The applicants would use the charitable donations to provide three types of assistance:
- All reimbursable costs for treatment by clinical programs and by third parties for treatment related to the Veteran’s diagnosis of TBI, head injury or PTS. For veterans without insurance, applicants would cover all costs. For insured veterans, claimants would cover all shared expenses and the cost of uncovered services. If a third party is providing services, claimants would ask the third party to bill for the clinical programs rather than the veteran or any payer.
- The cost of travel, modest accommodations and meals for the in-person assessment and treatment of the veteran and, if necessary, a companion.
- Veteran’s family travel expenses for the final week of intensive outpatient treatment. In-person family presence is necessary to plan for and meet the Veteran’s future needs.
Funds for financial assistance will be collected from donors. Donors would be individuals and organizations that meet the needs of veterans, but would not be individuals or entities in the health care industry or entities that manufacture or supply items or render billable services to health care programs. federal health. Even with financial assistance, applicants would suffer financial losses as donor support is not expected to cover all applicants’ costs.
The OIG indicated that the proposal would involve both the AKS and the beneficiary incentive provision of the CMP. No exception or safe harbor covers the proposed conduct. However, the OIG has determined that due to the unique circumstances present in the proposed arrangement, the proposed arrangement presents minimal risk of fraud and abuse under the AKS and the OIG will exercise its discretion and will not impose sanctions under the CMP on inducements to beneficiaries. The OIG identified a number of factors in support of this decision:
- The proposed arrangement is unlikely to inappropriately increase costs for federal health care programs and could result in overall savings, as some services provided are not covered and others will be provided by third parties that would not be billed to the federal health care program. The plaintiffs also certified that they would provide only 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 provide billable items to any federal health care program. Donors would have no interest in veterans receiving particular items or services.
- There is a low risk that the proposed arrangement will incentivize veterans to receive services from claimants other than those offered through clinical programs. The proposed arrangement is designed to allow veterans access to clinical program services, not other covered services that are not part of the clinical programs.
- Applicants 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 give rise to “overshoot” concerns where an arrangement would cause other providers equipped to provide quality medical care to be bypassed. To the knowledge of the applicants, no other entity provides a suite of similar coordinated services.
The advisory opinion cannot be invoked by anyone other than the applicant. A copy of Advisory Opinion 22-15 is available here.