As the industry eagerly awaits the outcome of the “Regulatory Sprint to Coordinated Care”—the multi-pronged, inter-agency initiative within the Department of Health and Human Services (HHS) to identify and remove barriers to care coordination and value-based healthcare—the Office of Inspector General’s (OIG) latest advisory opinion shows the watchdog’s cautious embrace of just the sort of care coordination arrangement that prompted the need for regulatory reform.

On March 6, 2019, the OIG published Advisory Opinion No. 19-03, a favorable opinion concerning a nonprofit medical center’s proposal to provide post-discharge care to patients with certain conditions. The OIG concluded that, although the arrangement could generate prohibited remuneration under the Anti-Kickback Statute and the Civil Monetary Penalties Law, the OIG would not impose administrative sanctions. Healthcare providers evaluating care coordination and disease management initiatives should review the opinion and carefully consider the OIG’s reasoning.

Proposed Arrangements

The advisory opinion addresses the medical center’s program of providing free, in-home follow-up care to certain patients in an effort to increase patient compliance with discharge plans, improve patient health, and reduce hospital admissions and readmissions. The medical center that requested the opinion had already begun a program of providing in-home care to patients with congestive heart failure (CHF) who qualify for participation, and it sought to expand the program to qualifying patients with chronic obstructive pulmonary disease (COPD).

Eligibility for the program would be limited to individuals who (1) have a qualifying diagnosis, (2) currently are or recently were admitted as inpatients, (3) have been identified by treating clinicians as high risk for readmission, (4) have scheduled follow-up care at the requestor’s facilities, and (5) live in a residence or assisted living facility within the medical center’s service area. Eligibility would not be based on patient’s insurance coverage or ability to pay for future services.

Patients enrolled in the program would receive two visits per week from a community paramedic employed by the medical center for approximately 30 days. Each visit would take place in the patient’s home or assisted living facility and involve some or all of the following: medication review; assessment of patient’s need for follow-up appointments; monitoring compliance with discharge or disease management plan; completion of a home safety inspection; and completion of a physical assessment that includes checking pulse and blood pressure, examining heart and lung functioning, checking any wounds, performing an electrocardiogram, conducting blood tests, and administering medication. The community paramedic would use clinical protocols to deliver these interventions and to assess whether a referral for follow-up care was necessary.

If a patient requires care unrelated to his or her CHF or COPD for which he or she has no established provider, the community paramedic would contact the medical center to determine if it could address any immediate needs, but the paramedic would inform the patient that he or she could obtain care from the provider of his or her choice. The medical center would bill for any follow-up services it provides outside the scope of the program, and it would do so at the same rate for such services if the patient were not participating in the program.

OIG Analysis

The OIG began its analysis by stating that the follow-up care services constitute a significant benefit to patients and would, therefore, constitute remuneration for purposes of the federal fraud and abuse laws. The OIG further noted that although the program would be limited to patients who had already selected the requesting medical center for follow-up care, the provision of the program services at no charge could still influence patients to seek out the medical center or its affiliates for unrelated services covered under federal healthcare programs. Because of that possibility, the OIG determined that the arrangement would implicate the beneficiary inducement provision of the Civil Monetary Penalties Law, which prohibits offering or transferring remuneration to certain beneficiaries where the offeror or transferor knows or should know doing so is likely to influence the beneficiary to order certain services, as well as the Anti-Kickback Statute.

The OIG then considered the potential application of the so-called “access to care” exception to the beneficiary inducement provision of the Civil Monetary Penalties Law. The access to care exception excludes from the definition of “remuneration” certain remuneration that improves a beneficiary’s ability to obtain healthcare items or services and that poses a low risk of harm to patients and federal healthcare programs. While the OIG cited its own previous commentary that “some forms of remuneration that remove impediments to compliance with a treatment plan” and some types of post-discharge support can promote access to care, it concluded that the access to care exception did not protect the “full suite” of services offered under the medical center’s program. In doing so, the OIG specifically cited the home safety assessment performed by the community paramedic as not improving the patient’s ability to obtain healthcare items or services or otherwise removing an obstacle that prevents the patient from receiving care.

Nevertheless, the OIG ultimately concluded that, “in an exercise of [its] discretion,” it would not impose administrative sanctions on the medical center. The OIG cited five factors in reaching this conclusion:

  1. The benefits to the patient would, in the OIG’s view, outweigh any risk of inappropriate patient steering that the law was designed to prevent. The OIG noted that the risk that the remuneration will induce patients to choose the medical center for CHF- or COPD-related services is negligible because patients already have made this selection. The OIG also noted that the program included safeguards to protect patient choice in the event that additional care was needed.
  2. The program would be unlikely to lead to increased costs to federal healthcare programs, as the program services would not be reimbursed by federal healthcare programs. Furthermore, any increase in utilization of other healthcare 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 a reduction in unnecessary inpatient admissions.
  3. The medical center certified that it does not and would not compensate any employee or contractor based on the number of patients who enroll in the program, removing any incentive that might interfere with clinical decision-making.
  4. The medical center also certified that it does not, and would not, advertise or market the program to the public, including through its website.
  5. Lastly, the scope and duration of the services provided by the community paramedics appeared, in the OIG’s view, to be “reasonably tailored” to accomplish the medical center’s goals of increasing patient compliance with discharge plans, improving patient health, and reducing hospital inpatient admissions and readmissions.

Key Takeaways

While Advisory Opinion No. 19-03 is, like every OIG advisory opinion, limited in scope to the specific arrangement at issue and permitted to be relied upon only by the requesting party, it offers valuable guidance to healthcare providers that have implemented or are considering implementing care coordination initiatives, particularly for chronic conditions.

The opinion was written in full view of the ongoing Regulatory Sprint to Coordinated Care. Indeed, the OIG cited its 2018 Request for Information on the Anti-Kickback Statute and Civil Monetary Penalties Law, acknowledging the broad reach of the laws and the barriers the laws pose to arrangements that improve care coordination. It remains to be seen what will come of the Regulatory Sprint, but this advisory opinion demonstrates the OIG’s willingness to critically evaluate innovative care management arrangements and exercise enforcement discretion where they pose sufficiently low risk and further the aims of value-based purchasing.

It should be noted that the opinion concerns a program aimed at two diagnoses, CHF and COPD, which previously have been recognized as warranting special treatment. Both conditions are among those that are tracked in the Medicare Hospital Readmissions Reduction Program, a value-based purchasing program that reduces payments to hospitals with excessive readmissions. The OIG has in the past observed that hospitals “may need to become more engaged in patients’ care during the post discharge period” to carry out the goals of this program (see Advisory Opinion No. 13-10). While it is important to consider this context, it is also worth noting that the OIG’s stated rationale would seem to apply with equal force to similar arrangements involving other chronic conditions.

Lastly, this advisory opinion appears to be the first time the OIG has expressly concluded that the “access to care” exception is not available to protect a particular arrangement. In prior guidance, the OIG has either found the exception to apply or been noncommittal. While this opinion does not offer much in the way of substantive analysis—and provides what some may find to be an unnecessarily restrictive interpretation of the exception—the fact that the OIG found the exception not to apply is noteworthy.