On December 4, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion No. 17-07 regarding a proposed pilot program involving a health technology collaboration funded by a pharmaceutical manufacturer and administered amongst a trade association, Medicare Advantage plan, health system, and vendor responsible for creating the electronic interface. The pilot program seeks to test whether certain minor improvements in technology involved in medication therapy management (MTM) services provided by a Medicare Advantage (MA) plan can help decrease hospital readmissions for MA plan beneficiaries who were admitted to the hospital with one of the five diagnoses that are eligible conditions under the Hospital Readmission Reduction Program (HRRP): pneumonia; congestive heart failure; acute myocardial infarction; chronic obstructive pulmonary disease; and elective total hip or knee arthroplasty. The pharmaceutical manufacturer submitted a request for the OIG’s feedback on whether the pilot program implicated prohibited conduct under the federal anti-kickback statute.

In analyzing the pilot program, the OIG highlighted the following key elements of the proposed arrangement in its opinion:

• The pharmaceutical manufacturer would fund the pilot program (but would not have access to any data or the electronic interface used in the program) and manufactures only two products to treat or prevent any of the eligible conditions subject to the program.
• MA plan pharmacists would have real-time electronic access to certain discharge information for qualifying MA plan beneficiaries to conduct MTM services. The pharmacists would not be prompted to use certain drugs or formularies throughout the pilot.
• The hospital system would identify and engage administrators, quality officers, discharge planners, and would ensure sufficient resources to identify and recruit patients to participate in the pilot.
• The vendor would establish and monitor the electronic interface to be used by the pilot program participants.
• The trade association would contribute management services and oversight and would establish evaluation tools to ensure that the pilot program was operating according to the outlined plans.

The OIG reasoned that, although the pilot program could potentially implicate certain aspects of the federal anti-kickback statute, the arrangement presents minimal risk to patients or federal healthcare programs for a number of reasons. First, there are safeguards to reduce the risk that the manufacturer’s involvement would influence prescribing or formulary decisions; for example, the pilot program materials would be unbranded and would not promote the manufacturer funding the program. Second, the pilot program would unlikely lead to increased costs or overutilization of federally reimbursable services because increased costs would work counter to the MA plan’s interests. Third, nothing in the pilot program would prompt the MA plan pharmacists to select one product over another. Fourth, the pilot program would be unlikely to have a negative impact on patient quality of care since one of the underlying goals of the program is to reduce hospital readmissions. And, last, the pilot program is limited in the number of patients (approximately 200), scope (to only the five HRRP diagnoses), and monetary investment (funding would not exceed $257,000 and would be distributed across states in the pilot).