On March 6, 2019, the U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a favorable advisory opinion that allows a nonprofit medical center (“Center”) to offer free, in-home follow-up care after a recent hospital admission for qualifying patients (the “In-Home Program”). In Advisory Opinion No. 19-03, the OIG concluded that although services furnished to qualifying patients under the In-Home Program would constitute remuneration to patients under the Anti-Kickback Statute (AKS) and the Civil Monetary Penalties law (CMP), the OIG would not impose sanctions on the Provider due to the low-risk nature of the In-Home Program.
The Provider furnishes a range of inpatient and outpatient hospital-based services, and currently offers in-home care to qualifying high-risk patients suffering from congestive heart failure (CHF) who (i) are currently admitted as inpatients of the Provider or (ii) were admitted within the previous 30 days and are being treated by the Provider’s outpatient cardiology department (“Current Arrangement”). Under the Current Arrangement, a clinical nurse leader must determine that the patient is a high risk for inpatient readmission using an industry-standard risk assessment tool, the patient must be willing to enroll in the program after consultation with the clinical nurse leader, the patient must seek follow-up care at the Provider’s CHF center, and the patient must live in the Provider’s service area.
Under the In-Home Program, the Provider proposes to expand the Current Arrangement to patients with chronic obstructive pulmonary disease (COPD). A clinical nurse leader would similarly screen COPD patients who have requested care at Provider or at a facility affiliated with Provider, and patients ineligible for the In-Home Program would not be informed of it. The In-Home Program would be offered to any patient meeting the eligibility criteria, regardless of insurance status or ability to pay, and the arrangement would not be marketed publicly. Patients that agree to participate in the In-Home Program receive two 60-minute visits per week from a community paramedic over the course of a month, during which visits the paramedic may perform some or all of the following services:
- Review the patient’s medication;
- Assess the patient’s need for follow-up appointments;
- Monitor the patient’s compliance with his/her discharge plan or disease management;
- Perform a home safety inspection; and/or
- Perform a physical assessment of the patient, which could include checking the patient’s pulse and blood pressure, listening to the patient’s lungs/heart, checking wounds, performing an electrocardiogram, drawing blood and running tests using a portable blood analyzer, or administering medication.
The paramedic follows a clinical protocol to deliver interventions, and to assess whether follow-up care may be necessary, and all activities and interventions during the course of the visit are documented in the patient’s medical record. Where the patient requires care that exceeds the paramedic’s scope of practice, the paramedic will direct the patient to follow up with his/her established provider. the paramedic records all activities and intervenes as he or she sees fit. If a patient requires outstanding care beyond the paramedic’s scope of practice, the paramedic directs the patient to follow up with their established health care provider. Where the patient’s established provider is affiliated with the Provider, the paramedic will contact the Provider or one of its affiliates to determine whether the patient’s immediate needs can be addressed, but the patient is informed of his/her option to obtain follow-up care from a provider of choice.
Under the In-Home Program, the paramedic would be an employee of the Provider, and no compensation would be paid based on the number of patients that enroll in the In-Home Program. Moreover, all costs associated with the in-home visits would be allocated to the Provider, and no payors would be billed for services furnished under the In-Home Program.
In response, the OIG noted that the In-Home Program provides a “significant benefit to patients in the form of free health care services and care management furnished in their home” that therefore constitutes remuneration to the patients, who may include federal health care program beneficiaries. The OIG further concluded that such remuneration could influence a patient to choose the Provider or one of its affiliates to obtain health care items or services that are reimbursed under federal health care programs, and participating patients may be more likely to seek reimbursable treatment related to CHF or COPD from the Provider as a result of the In-Home Program. The In-Home Program thus implicates both the beneficiary inducement civil monetary penalty law (Beneficiary Inducement CMP), as well as the Anti-Kickback Statute (AKS).
The OIG then determined that the exception to the Beneficiary Inducement CMP for promoting access to care would not apply to the In-Home Program, because the arrangement ultimately would not promote a patient’s access to care, and does not clearly remove barriers that may prevent patients from obtaining care.
Nonetheless, the OIG concluded that it would exercise discretion and not impose sanctions under the Beneficiary Inducement CMP or the AKS. The OIG based this decision, inter alia, on the following factors: (i) the In-Home Program’s benefits and safeguards outweigh any risk of improper patient steering; (ii) the In-Home Program is unlikely to result in increased costs through overutilization or inappropriate utilization; (iii) there is low risk that the In-Home Program would interfere with clinical decision-making, including because no compensation would be tied to the number of enrolled patients; (iv) the In-Home Program would not be publicly marketed; and (v) the scope and duration of the in-home visits “appear reasonably tailored to accomplish… goals of increasing patient compliance with discharge plans, improving patient health, and reducing hospital inpatient admissions and readmissions.”
This favorable opinion from the OIG provides additional guidance to health care providers on safeguards that can be incorporated into patient wellness and value-based care programs that may lower the risk of scrutiny under fraud and abuse laws. Providers and their counsel would be well-advised to closely review the OIG’s analysis in connection with their own programs targeting high-risk patient populations.
As the OIG has emphasized, Advisory Opinions are issued only to the requestor(s) of the opinion, and have no application to, and cannot be relied upon by, any other individual or entity, nor may they be introduced into evidence by anyone other than the requestors to prove the individual or entity did not violate the Civil Monetary Penalties Law, the Anti-Kickback Statute, or any other law.