Report on Medicare Compliance 29, no. 39 (November 2, 2020)

◆ Medtronic USA Inc., a medical device maker, has agreed to pay $8.1 million to settle allegations it violated the False Claims Act by paying kickbacks to induce South Dakota neurosurgeon Wilson Asfora, M.D., to use its SynchroMed II intrathecal infusion pumps, the Department of Justice said Oct. 29.^[1] According to the settlement,^[2] Medtronic knew that Asfora and his wife owned a restaurant in Sioux Falls called Carnaval Brazilian Grill. Asfora allegedly told Medtronic that business was slow and asked the device maker to pay for events there. “Contrary to Medtronic’s established written compliance policies, Medtronic agreed to Asfora’s request,” the settlement alleged. To “curry favor” with the neurosurgeon, Medtronic held 130 events at the restaurant, spending $87,000. Medtronic salespeople allegedly falsely said in expense reports that the events were for education or business information. After an internal review, Medtronic terminated or disciplined some salespeople involved. Medtronic also paid $1.1 million to settle allegations that it underreported payments to Asfora to CMS’s Open Payments program.

◆ CMS said Oct. 29 it has finalized permanent changes to telehealth in its 2021 home health prospective payment system regulation.^[3] Home health agencies will be able to use various kinds of telecommunications, “as long as any provision of remote patient monitoring or other services furnished via a telecommunications system or audio-only technology are included on the plan of care.” The technology must be related to the skilled services provided by the therapist, nurse or therapy assistant during the home health visit. The rule will be published in the Nov. 4 Federal Register.

1 Department of Justice, “Medtronic to Pay Over $9.2 Million To Settle Allegations of Improper Payments to South Dakota Neurosurgeon,” news release, October 29, 2020, https://bit.ly/3oFfCJK.
2 Department of Justice, “Settlement Agreement,” accessed October 30, 2020, https://bit.ly/2TDhCUB.
3 CMS, “Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update, Home Health Quality Reporting Program Requirements, and Home Infusion Therapy Services and Supplier Enrollment Requirements; and Home Health Value-Based Purchasing Model Data Submission Requirements,” proposed final rule, accessed October 30, 2020, https://bit.ly/2JhxsCp.

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