Letter Suspending Corporate Integrity Agreement Obligations Between Ra Medical Systems and HHS OIG

Contract Categories: Business Finance › Waiver Agreements
Summary

This letter from the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services notifies Ra Medical Systems, Inc. that its obligations under a Corporate Integrity Agreement (CIA) are suspended. The suspension is due to the completion of a transaction with Catheter Precision, after which neither company will perform certain government-related functions covered by the CIA. The suspension will last until the CIA term ends, unless either company resumes those activities.

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EX-10.16-1 3 rmed-ex10161_639.htm EX-10.16-1 rmed-ex10161_639.htm

Exhibit 10.16.1

 

MEREDITH WILLIAMS, SENIOR COUNSEL ADMINISTRATIVE & CIVIL REMEDIES BRANCH OFFICE OF COUNSEL TO THE INSPECTOR GENERAL

330 INDEPENDENCE AVE SW WASHINGTON, DC 20201

 

January 11, 2023

 

VIA EMAIL

Will McGuire

Chief Executive Officer

Ra Medical Systems

5857 Owens Ave., Suite 300

Carlsbad, CA 92009

 

Re:Suspension of Corporate Integrity Agreement

 

Dear Will:

 

The purpose of this letter is to notify Ra Medical Systems, Inc. (RMS) that its obligations under the Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services are suspended.

 

It is our understanding that the proposed transaction between RMS and Catheter Precision (CP) has been finalized. This suspension of RMS’s obligations is based upon the representations made to the OIG that, following the closing of the transaction, referenced in OIG’s letters dated   August 12, 2022 and December 20, 2022, neither RMS nor CP will engage in Covered Functions (as defined in the CIA) with respect to the RMS Government Reimbursed Products that were subject to the CIA. The CIA will remain suspended until the end of the CIA term, unless either RMS or CP resume engaging in Covered Functions with respect to the RMS Government Reimbursed Products that were subject to the CIA.

 

If you have any questions, please contact me at ###-###-#### or by email at ***@***.

 

Sincerely,

 

/s/ Meredith Williams

Meredith Williams Senior Counsel