HHS On Track to Allow Sharing of Patient Data With Pharmacists

By advisory opinion issued on December 4, 2017, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) has announced that some pharmacists will now be given access to patient discharge data as part of a new pilot program designed to combat readmission rates and to create more effective post-discharge care plans for patients.

Under the pilot program, drug manufacturers (who have to meet specified requirements to participate) would each work with a trade association, a Medicare Advantage plan and a hospital system. Pharmacists employed by the Medicare Advantage plan would then have real-time electronic access to selected discharge information for that Medicare Advantage plan’s beneficiaries. The pharmacists who will be involved in this pilot program will be providing medication therapy management services, which involves a combination of therapies that use drugs, that do not use drugs, and that focus on lifestyle modifications associated with specific diseases.

For the pilot program’s inception, the focus will be on patients admitted to hospitals due to pneumonia, congestive heart failure, acute myocardial infarction, chronic obstructive pulmonary disease, and elective total hip or knee arthroplasty – diagnoses that are tracked by the Hospital Readmission Reduction Program. Furthermore, it will be the responsibility of the drug manufacturers to develop the electronic interface that will then relay the patient discharge data from the hospital’s electronic medical record system to the participating pharmacists.

Soon after the advisory opinion was issued, an unnamed U.S. drug manufacturer that is part of the pilot program requested an agency investigation into whether the program violated any of the anti-kickback laws. The manufacturer’s stated fear is that the program may lead to pharmacists recommending the manufacturer’s products. The OIG responded that it will continue with the pilot program despite the small chance of the program violating anti-kickback laws. In the advisory opinion, the OIG stated that while the pilot program was underway, it would not impose administrative sanctions against those partaking in the pilot program for what would otherwise be anti-kickback violations.

Currently, the pilot program and its accompanying safe harbor from anti-kickback sanctions is only available to the entities currently taking part in the program. Time will tell if the OIG will allow other entities access to the program moving forward, and it will be interesting to see how the program changes and how OIG addresses the anti-kickback concerns for the long-term. It is also yet to be seen how HIPAA may affect the program, should it continue as is.

The advisory opinion can be found here: https://oig.hhs.gov/fraud/docs/advisoryopinions/2017/AdvOpn17-07.pdf