On March 10, 2017, the Office of Inspector General (“OIG”) posted Advisory Opinion 17-01. The Advisory Opinion is available here. The OIG issued this favorable opinion on a proposal by an Academic Medical Center, including a Level I trauma center (together the “Center”), to provide free or reduced-cost lodging and meals to certain financially needy patients residing in rural or underserved areas. Specifically, the Center proposed that qualifying patients, including potentially Federal health care program beneficiaries, presenting for care would receive:
(i) a single room for free or at reduced cost at a modest hotel for one night before and up to two nights after hospital treatment; and
(ii) hospital cafeteria meals for free or at reduced cost, up to a value of $15.00 per overnight stay.
The Center’s goal with the proposed arrangement is to improve the access of qualifying patients to services they may not be able to otherwise obtain locally. To qualify, patients must meet the requirements listed on Page 3 of the Advisory Opinion. Insurance status will not be a consideration for eligibility, and the amount of assistance provided to a qualifying patient would be based on a financial need-based sliding scale under the Center’s written financial assistance policies. (See Page 4 of the Advisory Opinion). Moreover, the benefits would not be provided in the form of cash, cash equivalents, or other payment; and there would be no limit on the amount of times a qualifying patient could receive the free or reduced-cost lodging and meals as proposed. The Center estimates that 100 to 200 patients would qualify annually.
The OIG concluded that the proposal would not constitute grounds for sanctions under the Beneficiary Inducements Civil Monetary Penalties Law because it satisfies the requirements of the Promotes Access to Care Exception (“CMP Exception”). Nor would the Center be subject to administrative sanctions under Federal Anti-Kickback Statute (“FAKS”) in connection with the proposal.
The OIG analyzed the CMP Exception in two prongs: (1) Promotes Access to Care and (2) Low Risk of Harm.
(1) Promotes Access to Care. The OIG states that its interpretation of “promotes access to care” encompasses giving patients the tools needed to remove socioeconomic, educational, geographic, mobility or other barriers that prevent them from receiving preventive and other necessary care, or from following through on a treatment plan. It found that the Center’s proposal would improve a beneficiary’s ability to obtain items and services payable under Medicare and Medicaid by removing certain socioeconomic and geographic barriers.
(a) The proposed access to lodging near the hospital prior to treatment would enable a qualifying patient to attend early morning treatments or evaluations required prior to treatment. The proposed access to lodging post-treatment would make follow-up care more accessible by eliminating lengthy painful and exhaustive round-trip travel.
(b) The free or reduced-cost hospital cafeteria meals would ensure qualifying patients can afford the meals before, during, or after treatment.
As alluded to in Spengler Nathanson’s January 24, 2017 Alert, this then shows that services not solely clinical in nature may be found to promote access to care, and thus meet this portion of the CMP Exception.
(2) Low Risk of Harm. The CMP Exception requires the item or service also to pose a low risk of harm to Medicare and Medicaid beneficiaries and the Medicare and Medicaid programs by: (i) being unlikely to interfere with, or skew, clinical decision making; (ii) being unlikely to increase costs to beneficiaries and the programs through overutilization or inappropriate utilization; and (iii) not raising patient safety or quality-of-care concerns. The proposal here met all three elements.
(a) It is unlikely to interfere with clinical decision-making because the Center would not condition eligibility on receipt of a particular service provided by the Center; and it would not provide remuneration to any clinician to encourage them to refer qualifying patients.
(b) It is unlikely to increase costs to Federal health care programs because the Center would not shift costs to a Federal health care program and would not report any of the proposal’s costs on its costs reports or claims. Moreover, qualifying patients are only identified after they have scheduled services, and the Center will not advertise or market this to patients. Finally, the small fraction of total patients that would receive these benefits shows that the proposal is meant to facilitate access to care and reduce risks, rather than lead to medically unnecessary or inappropriate care.
(c) It would not raise safety or quality-of-care concerns because it removes logistical and financial obstacles for qualifying patients to obtain necessary treatments. It does not encourage patients to seek out unnecessary or poor quality care.
The proposed free or reduced-cost lodging and meals, therefore, satisfy this CMP Exception in full and do not constitute “remuneration” thereunder. Although the items and services would be “remuneration” under the FAKS, the OIG would not impose administrative sanctions under the anti-kickback statute for the same reasons cited above.
Application of an Advisory Opinion is limited. Yet the OIG’s general analysis and factors considered in Advisory Opinion 17-01 can be instructive for systems looking for ways to improve access to care for more patients.
If you have questions about this Alert, please contact Karl Strauss at email@example.com or (419) 252-6250.