A new advisory issued by the Department of Health and Human Services that weighs the risks of a real-time data-sharing pilot provides a glimpse into how the agency plans to regulate innovative partnerships that could potentially violate the Anti-Kickback Statute.
The HHS Office of Inspector General advisory (PDF), which redacts the names of the organizations involved, includes a pharmaceutical manufacturer, a Medicare Advantage plan, a hospital system and an EHR vendor. The proposed collaboration, coordinated by a trade association, would provide pharmacists on the MA plan with real-time discharge data from the hospital's EHR system to improve medication management.
The advisory offers some insight into how the OIG evaluates potential kickbacks or overutilization associated with data-sharing partnerships and gives healthcare organizations a stronger legal foothold when setting up collaborative relationships to advance value-based care, attorney Matthew Fisher told FierceHealthcare.
According to the facts described by the pharmaceutical company that requested the advisory opinion from OIG, the pilot would focus on five discharge diagnoses included in the Centers for Medicaid & Medicare Services (CMS) Hospital Readmissions Reduction Program: pneumonia, congestive heart failure, heart attack, chronic obstructive pulmonary disease and joint replacements.
RELATED: Patient-generated data could be the missing piece to new payment models for drugs and devices
Through an interface developed by the hospital’s EHR vendor, the pharmacists would access to real-time data from the patient’s medical record to coordinate follow-up care with the patient and adjust medications as needed.
The OIG ruled that although the proposed pilot could “potentially generate prohibited remuneration” under the Anti-Kickback Statute, the agency would not impose administrative sanctions.
Although limited to the circumstances described in the advisory, the opinion offers a framework for collaborations that rely on real-time data-sharing among multiple industry partners.
“It shows the industry that when sufficient safeguards are included in the structure of innovative partnerships, OIG will find that they pose a low risk under the Anti-Kickback Statute,” Jill Wright, an attorney at Foley & Lardner, LLP in Washington, D.C., said in an email to FierceHealthcare. Wright previously worked as a senior counsel for the OIG specializing in anti-kickback laws and quality of care issues.
There were important caveats in the OIG’s analysis. For example, allowing the pharmaceutical manufacturer to provide free technology could induce pharmacists to make favorable drug recommendations. But several safeguards lowered the risks, including the fact that the pharmaceutical company would not have access to the data or the interface and the pilot would have no bearing on drug formulary recommendations.
“We caution that we likely would reach a different conclusion with respect to the risk presented by this type of arrangement under different facts, such as if a manufacturer sponsor made or marketed more drugs to treat eligible conditions, the manufacturer branded any of the information being presented to [medication therapy management] pharmacists during the Pilot Program, or if the interface was designed to recommend one drug over another,” the OIG wrote.
RELATED: In a new pharmacy initiative, Sutter Health reimagines its approach to real-time analytics
The OIG also raised concerns that the EHR vendor’s interface would provide independent value by reducing administrative burdens for the MA plan and its pharmacists. But the watchdog agency ultimately ruled the pilot presented minimal risk since it was limited to 200 participants and was designed to improve quality and reduce unnecessary readmissions.
“The MA plan as the payer has a strong incentive to ensure that its patients receive the most appropriate and cost-effective treatment, which would reduce the risk of overutilization,” Wright says.
Fisher, a partner at Mirick O’Connell who chairs the firm’s Health Law Group, said the OIG’s advisory opinions are “extremely important” to industry and attorneys trying to navigate the complexities of the Anti-Kickback Statute. Although the agency’s analysis is limited to the specifics outlined in the request, the advisory could encourage collaboration and “start breaking down barriers that often exist between different healthcare segments.”