On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge support to patients. The OIG determined that it would not impose sanctions under either the Civil Monetary Penalties law (“CMPL”) or the federal health care program Anti-Kickback Statute (“AKS”), offering some comfort to providers who seek to implement – or who have already implemented – similar programs. However, the OIG’s assertion that the proposed program would not fall within the “promotes access to care” exception to the CMPL indicates a potentially worrisome and narrow interpretation of a facially broad statutory exception.

Proposed Arrangement

The requestor of the AO is a nonprofit medical center that offers free, in-home follow-up services to patients with congestive heart failure (“CHF”) and that sought to expand these services to certain patients with chronic obstructive pulmonary disease (“COPD”). The goal of the in-home follow-up care program is to increase patient compliance with discharge plans, improve patient health, and reduce unnecessary hospital inpatient admissions and readmissions, thereby decreasing unnecessary utilization of services and accordant costs to the federal health care programs.

The medical center would limit the program to patients who have a current or recent inpatient admission, have been identified by treating clinicians as at high risk for readmission, have scheduled follow-up care at the requestor’s facilities, and who live in a residence or assisted living facility within the hospital’s service area. Patients’ health insurance status or ability to pay would not be a criterion for eligibility. The program’s in-home services would be provided by a community paramedic employed by the requestor; the paramedic would visit a patient twice a week and provide (and document) services such as reviewing medications, monitoring the patient’s compliance with discharge plans of care or disease management, inspecting home safety, performing physical assessments, and evaluating the need for follow-up care, whether or not to be provided by the requestor.

OIG’s Analysis

The OIG opined that the program would provide a “significant benefit to patients.” While the OIG noted that the program would be limited to patients who had already selected the requestor for follow-up care for their COPD or CHF, the OIG determined that the provision of free support services could still influence patients to seek out the requestor for other services covered under federal health care programs, thus implicating the CMPL.

The OIG further determined that the proposed arrangement would not qualify for the “promotes access to care” exception to the CMPL. Citing to its own 2016 rulemaking commentary that “some forms of remuneration that remove impediments to compliance with a treatment plan” and certain types of post-discharge support would comply with the exception, the OIG stated that it did “not believe that the full suite of Services offered under the Arrangements promotes a patient’s access to care.” In particular, the OIG stated that it “fail[ed] to see how [home safety assessments would] remove[] socioeconomic, educational, geographic, or other barriers that could prevent the patient from receiving care.” Having found that one component of the proposed program would not promote access to items and services paid for by a federal health care program, the OIG did not address whether other elements of the proposed program might – in its view – succeed or fail to remove such barriers.

However, the OIG ultimately determined that it would not subject the proposed program to administrative sanctions because the “benefits outweigh any risk of inappropriate patient steering.” In making this determination, the OIG was persuaded by a number of factors:

• The risk that the proposed program would influence patients to select the requestor to provide other services would be negligible, as only patients who had already selected the requestor for follow-up care related to their COPD or CHF would be eligible for enrollment in the program and patients could choose any provider for other services while enrolled in the program.

• The program would be unlikely to increase costs to the federal health care programs, as the services provided through the program would not be reimbursed by federal health care programs. Further, any increase in utilization of other health care services resulting from the program would likely reflect only appropriate utilization from patients receiving medically necessary care, and the success of the program would result in overall savings due to improved health and reduced unnecessary inpatient admissions.

• The requestor certified that no employees or contractors would be compensated based on the number of patients who enroll in the program, and therefore the program would be unlikely to skew clinical decision making.

• The requestor certified that it would not advertise or market the program to the public and would not publicize the program on its website.

• The “scope and duration” of the services to be provided as part of the program appeared “reasonably tailored to accomplish” the goals of increasing patient compliance with discharge plans, improving patient health, and reducing unnecessary hospital inpatient admissions and readmissions.

Takeaways

The AO offers important guidance and reassurance to the many health care providers who have implemented or are considering implementing post-discharge and similar support service programs that aim to improve patient health outcomes. However, the AO pertains to a proposed arrangement relating to patients with particular diagnoses, CHF and COPD, for which readmissions are tracked and potentially penalized under the Hospital Readmissions Reduction Program. The OIG has previously recognized that “[t]o effectively carry out the goals of the HRRP, hospitals may need to become more engaged in patients’ care during the post discharge period.” OIG AO No. 13-10 (Aug. 16, 2013); see also OIG AO No. 17-07 (Dec. 11, 2017). It is not clear whether the OIG would have had the same reaction to a proposed post-discharge support program that would apply to a wider range of diagnoses.

The OIG was explicit that the proposed arrangement would not satisfy the “promotes access to care” exception to the CMP law. Rather, it noted that it would not impose sanctions “in an exercise of [its] discretion.” While this application of discretion may indicate a generally favorable attitude toward programs that – like the proposed program – contribute to better patient outcomes and coordination of care, such a discretionary approach may make it difficult for providers to reliably predict the risk associated with programs they are considering. The OIG’s narrow interpretation of the “promotes access to care” exception – dismissing its application to the entire program based on one program element’s inability to promote access to care with no analysis of the impact on such barriers of other program elements – contributes to this difficulty.

Despite the potential breadth of the statutory exception for arrangements that promote access to care, in whole or in part, the OIG’s narrower focus leaves the status of post-discharge support programs unnecessarily uncertain. Given the long-recognized import of such support programs in improving health outcomes, the introduction of this type of uncertainty is unfortunate and may be counterproductive.