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Health and Human Service’s Office of Inspector General issued an advisory opinion in December of 2017 indicating that Pharma support of a program to conduct MTM post discharge would not violate anti-kickback rules. The permission was outlined in an advisory opinion by OIG.

An undisclosed drug manufacturer requested that the OIG (the agency responsible for investigating fraud) issue an opinion as to whether their support of an post discharge MTM program violated any anti-kickback laws since the program could lead to pharmacists recommending the drug company’s products.

The drug maker, teaming with the American Academy of Managed Care Pharmacists (AMCP), would support the creation of a data exchange interface between a Medicare Advantage plan and a hospital system.  Pharmacists employed by the Medicare Advantage plan would receive real-time electronic access to patient discharge information for that plan’s beneficiaries. The receipt of discharge information would trigger the pharmacist to medication therapy management services.  The pilot would focus on patients admitted to the hospital with one of the five diagnoses that are tracked under the Hospital Readmission Reduction Program: pneumonia, congestive heart failure, acute myocardial infarction, chronic obstructive pulmonary disease, and elective total hip or knee arthroplasty.

As described the pilot would not require the MTM pharmacists to recommend the drug makers products, limit the program to patients using the drug makers products or provide access of patient level data to the drug maker.  As such, the HHS’ OIG opinion stated that it was approving the program as there was a small chance of violating kickback laws.  “Based on the facts certified in your request for an advisory opinion and supplemental submissions, we conclude that, although the proposed arrangement could potentially generate prohibited remuneration under the anti-kickback statute … the OIG would not impose administrative sanctions,” the agency said in the advisory opinion notice.

For now, the approval for the pilot is only for the unnamed parties outlined in this proposal. It’s unclear if other parties looking to also implement the same experiment could get expedited approval from the HHS OIG to move forward.  Violation of kickback laws constitutes a felony punishable by a maximum fine of $25,000, imprisonment up to five years, or both. Conviction could also lead to automatic exclusion from the Medicare and Medicaid programs.

As always I am happy to discuss your medication therapy management program.  CSS supports health plans, ACOs, integrated care delivery systems, pharmacists and physician groups to design, implement and manage medication management programs.  Feel free to reach out by phone or e-mail.

Jim Notaro

716.541.0273 x101

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