Deeper Than the Headlines: March 2019 OIG Advisory Opinion

The OIG’s newest published Advisory Opinion (AO) was posted in March of 2019. Whenever the OIG posts an AO it’s a good idea to review it. These are great opportunities to examine the OIG’s thought process.

BACKGROUND

“Requestor” is a nonprofit medical center that provides a range of inpatient and outpatient hospital-based services.

The “Clinic” is an affiliate of Requestor that offers primary care and certain specialty services at several facilities located in the geographic region that Requestor serves. The requestor and the Clinic are under the sole control of the “Health System”, an integrated health system operating in three states.

Requestor has developed a program to provide free, in-home follow-up care to certain patients who it certifies are at higher risk of admission or readmission to a hospital. Under the Current Arrangement, Requestor offers in-home care to patients with congestive heart failure (“CHF”) who qualify for participation, and under the Proposed Arrangement, Requestor would expand the program to qualifying patients with chronic obstructive pulmonary disease (“COPD”).

According to Requestor, the goals of both Arrangements are to increase patient compliance with discharge plans, improve patient health and reduce hospital inpatient admissions and readmissions.

Eligibility Requirements

Clinical nurse leaders screen patients to determine if they meet the following eligibility criteria for the Current Arrangement. First, a patient must have CHF and be (i) currently admitted as an inpatient to Requestor, or (ii) a patient of Requestor’s “CHF Center”, a part of Requestor’s outpatient cardiology department, who was admitted as an inpatient to Requestor within the previous 30 days. Second, the clinical nurse leader must identify the patient as high risk for hospital inpatient readmission using a risk assessment tool utilized throughout the industry to predict the risk of unplanned readmission or emergency department visits subsequent to a hospital discharge. Third, the patient must have arranged to receive follow-up care at the CHF Center. If a patient does not plan to seek follow-up care, intends to receive follow-up services elsewhere, or expresses uncertainty about where he or she will receive follow-up care, the patient is not informed of the Current Arrangement. Fourth, the patient must be willing to enroll in the Current Arrangement after consultation with the clinical nurse leader. Finally, the patient must be discharged to—or reside at—a personal residence or an assisted living facility (“ALF”) in the Health System’s service area.

The Proposed Arrangement generally would have the same eligibility requirements as the Current Arrangement. Instead of screening patients with CHF who are admitted as an inpatient to Requestor or who are a patient of the CHF Center, however, clinical nurse leaders would screen patients with COPD who have presented for care at Requestor or at one of the Clinic facilities. Second, the patient must be identified by a clinical nurse leader as (i) high risk for hospital inpatient readmission, using the assessment tool described above, or (ii) high risk for hospital inpatient admission, using a predictive analytics tool. Third, the patient must have arranged to receive follow-up care at Requestor or a Clinic facility. As in the Current Arrangement, if a patient does not plan to seek follow-up care, intends to receive follow-up services elsewhere, or expresses uncertainty about where he or she will receive follow-up care, the patient would not be informed of the Proposed Arrangement. Fourth, as in the Current Arrangement, the patient must be willing to enroll in the Proposed Arrangement after consultation with the clinical nurse leader. Finally, as in the Current Arrangement, the patient must be  discharged to—or reside at—a personal residence or an ALF in the Health System’s service area. Requestor offers the Current Arrangement and would offer the Proposed Arrangement to any patient who meets the eligibility criteria, regardless of the patient’s health insurance status or his or her ability to pay for medical services. Requestor certified that it does not, and would not, advertise or market the Arrangements to the public. Further, Requestor does not, and would not, publicize the Arrangements on its website.

Program Services

Under the Arrangements, patients who meet all eligibility criteria and who choose to participate receive two visits from a community paramedic each week for approximately 30 days following enrollment. Each visit takes place in the patient’s home or ALF and lasts approximately 60 minutes, during which time the community paramedic may perform some or all of the following activities (collectively, the “Services”): i. Review the patient’s medication; ii. Assess the patient’s need for follow-up appointments; iii. Monitor the patient’s compliance with the discharge plan of care or the patient’s disease management; iv. Perform a home safety inspection; and v. Perform a physical assessment, which may include checking the patient’s pulse and blood pressure, listening to the patient’s lungs and heart, checking any wounds, running an electrocardiogram, drawing blood and running blood tests using a portable blood analyzer, or administering medication. The community paramedic uses a clinical protocol to deliver interventions and to assess whether a referral for follow-up care is necessary. The community paramedic documents all activities and interventions he or she performs during the course of the visit in the patient’s electronic medical record. If a patient requires care that falls outside the community paramedic’s scope of practice, the community paramedic directs the patient to follow up with his or her established provider. For urgent but non-life-threatening medical needs, the community paramedic calls the patient’s established provider, and such provider follows up with the patient as he or she deems appropriate. Requestor certified that in many cases Requestor or the Clinic is the patient’s established provider. 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 contacts Requestor or the Clinic, as applicable, to determine if Requestor or the Clinic can address any immediate needs, but Requestor explained that the patient may obtain care from the provider of his or her choice, and the community paramedic informs the patient of this fact.

Requestor certified that this approach fosters integrated care delivery for patients and improves patients’ adherence to their treatment plans, which is particularly important for patients with chronic diseases. Requestor and the Clinic bill, and would bill, for any follow-up services they provide outside the scope of the Arrangements at the same rate that they would bill for such services if the patient were not participating in the Arrangements. Requestor certified that it employs, on either a full-time or part-time basis, the community paramedics who provide the Services. Neither Requestor nor the Clinic compensates or would compensate, any employee or contractor based on the number of patients who enroll in the Arrangements. Further, all costs associated with the community-paramedic visits (e.g., supplies, vehicle use, equipment) provided under the Arrangements are and would be, allocated to Requestor. With one exception, Requestor certified that the Services provided under the Arrangements are not covered or reimbursed by Federal health care programs when performed by a community paramedic. Specifically, one Medicaid program in the Health System’s service area reimburses for community-paramedic services that Requestor certified are similar to the Services, but Requestor certified that it does not, and would not, bill this Medicaid program for the Services provided under the Arrangements. Neither patients nor any payors are or would be, billed for the Services, and Requestor does not, and would not shift any costs related to the Current Arrangement or the Proposed Arrangement to Medicare, Medicaid, other payors, or individuals.

OIG’s Opinion

Based on the facts certified in the request for an advisory opinion and supplemental submissions, OIG concluded that, although the Current Arrangement and the Proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward referrals of Federal health care program business was present, the OIG will not, and would not, respectively, impose administrative sanctions in connection with the Current Arrangement or the Proposed Arrangement.

In addition, the OIG will not, and would not, respectively, impose administrative sanctions in connection with the Current Arrangement or the Proposed Arrangement. This opinion is limited to the Arrangements and, therefore, OIG expressed no opinion about any ancillary agreements or arrangements disclosed or referenced in the request for an advisory opinion or supplemental submissions. As always, the OIG reiterated that this opinion may not be relied on by any persons other than the requestor of this opinion. Those of you interested in the legal analysis can read it in the Advisory Opinion itself.