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Seven Things To Know When You Receive A Notice Of Investigation From The Department Of Health

FL Pharmacy Alleges Wrongful HHS PrEP Program Termination

On March 25, 2024, a Florida-based pharmacy alleged in a lawsuit it filed that the U.S. Department of Health and Human Services (HHS) abruptly cut it off from a federal program. This program provides free access to pre-exposure prophylaxis HIV-prevention (PrEP) medication for HIV patients. Turner Drugs filed a motion in the U.S. District Court for the District of Columbia for a temporary restraining order and a preliminary injunction. In its motion, Turner Drugs asked a D.C. federal judge to force HHS and two contractors to reinstate it to the program.

The pharmacy says it is owed $3.1 million for nearly 1,500 already-approved prescriptions, but the payments to it have been withheld following the termination. The lawsuit accuses HHS, Mercalis, Inc., and Pharmacy Data Management, Inc. (PDMI) (two contractors of HHS), of breaching a contractual obligation to give participating pharmacies 40 days to fix any alleged breach before terminating them. Additionally, the suit contends the allegedly overdue payments constitute a breach of contract.

The “Ready, Set, PrEP” Program. 

Turner Drugs is a Florida-based pharmacy providing services to underprivileged populations that need access to free medications, including HIV medications. The drug company is contracted with a Florida nonprofit corporation, Advanced Health Access, Inc., and Continuous Care, LLC, to operate free medical clinics.  The pharmacy alleges in its motion that it was suddenly terminated from the “Ready, Set, PrEP” program on March 12, 2024, without advance notice. The national program provides people without prescription drug coverage access to HIV-prevention medication as part of an HHS initiative to end the HIV epidemic in the United States.  You may have seen the advertisements on TV.

For more information on the “ready, Set, prEP” program, click here.

Details of the Lawsuit.

Turner Drugs stated that even though it had diligently complied with its contractual terms, on March 12, 2024, it was suddenly terminated from the program without warning or written notification. The pharmacy first learned of the termination because its requests for PrEP prescription approvals were denied based on the pharmacy’s alleged “non-participation” in the program. The pharmacy later learned from an attorney with contractor PDMI that it had been “blocked due to suspicious activity” and would be audited. The alleged suspicious activity was potentially due to Turner Drugs being acquired by Advancing Health as its in-house pharmacy. The pharmacy said this resulted in an increase in Ready, Set, PrEP prescriptions, which would be a “red flag” for HHS, if it was an unexplained, very large one.
“Turner Drugs stated that it attempted to negotiate a resolution by responding to an audit of prescriptions in only one day, offering to make all its records and procedures available to defendants for inspection, and offering to cooperate with the defendants in any other manner they might request,” the complaint states. When the defendants made no attempt to explain the alleged “suspicious activities” and no resolution could be reached, Turner Drugs claims it had “little choice but to prepare” the lawsuit and the motion and file them.

To view the motion in full, click here.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

The Health Law Firm routinely provides legal representation to pharmacists, pharmacies, and other health professionals who have received complaints against their licenses, notices of investigations, Medicare or Medicaid audits, Drug Enforcement Administration (DEA) audits, investigations. Subpoenas, search warrants, and orders to show cause (OSC) or who are facing formal or informal administrative hearings.

The Health Law Firm’s lawyers are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants, and other health professionals in investigations and Board of Pharmacy hearings. To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website.


Sullivan, A. (March 25, 2024). Fla. pharmacy says it was cut from federal prep program. Law360.
Florida Health. “PrEP/PEP Program.” The Florida Department of Health. (August 15, 2024).
U.S. Department of Health and Human Services. “Ready, Set, PrEP: Find Out If You Qualify to Enroll for Free PrEP Medications”.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free (888) 331-6620.

Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to [email protected] or fax them to (407) 331-3030.

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Copyright © 2024 George F. Indest III, The Health Law Firm. All rights reserved. No part of this work may be reproduced in any way in any medium without the written permission of the copyright owner. The author of this work reserves the right to have his name associated with any use or publication of this work or any part of it.
By George F. Indest III, J.D., M.P.A., LL.M.

By George F. Indest III, J.D., M.P.A., LL.M.

Board Certified by The Florida Bar in Health Law

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