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Florida Pharmacy Sues Claiming HHS Wrongly Terminated it from Federal PrEP Program

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On March 25, 2024, a pharmacy in Celebration, Florida, alleged HHS abruptly terminated it from a federal program that provides free access to preexposure prophylaxis HIV-prevention (PrEP) medication. Turner Brothers Inc., which does business as Turner Drugs, filed a motion in its lawsuit in the U.S. District Court for the District of Columbia for a temporary restraining order and preliminary injunction. In the motion, Turner Drugs asked a D.C. federal judge to force the U.S. Department of Health and Human Services (HHS) and two contractors to reinstate it to the program. To view the motion, click here.

The pharmacy says it is owed $3.1 million for nearly 1,500 already-approved prescriptions, but the payments have been withheld following its termination. The lawsuit accuses HHS, Mercalis Inc., and Pharmacy Data Management Inc. (PDMI) 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, in Celebration, Florida, is a pharmacy providing services to underprivileged patients that need access to free medications, including HIV medication. Turner Drugs was contracted with a Florida nonprofit, Advanced Health Access Inc., and Continuous Care LLC to operate free medical clinics. The pharmacy alleges in the motion that it was suddenly terminated from the “Ready, Set, PrEP” program on March 12, 2024. 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.

Details of the Lawsuit.

Even though Turner Drugs claims it has diligently complied with its contractual terms, on March 12, 2024, it was suddenly terminated from the program without warning or written notification. The pharmacy claims it first learned of the termination because its requests for PrEP prescription approvals were denied based on their “nonparticipation” in the program, much to its surprise!

The pharmacy later learned from an attorney at PDMI that it had been “blocked due to suspicious activity” and would be audited at a later date. The alleged suspicious activity was possibly due to Turner Drugs being acquired by Advancing Health as its in-house pharmacy. The pharmacy said this resulted in an uptick in Ready, Set, PrEP prescriptions.

“Turner Drugs [claims it] attempted to negotiate an amicable 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 to cooperate with 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 complaint in this case, click here.

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

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

The attorneys of The Health Law Firm routinely provide legal representation to pharmacists, pharmacies, physicians, medical clinics, and other health providers 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 lawyers of The Health Law Firm are experienced in complex healthcare litigation in both state court and federal court, and in both formal and informal administrative hearings, and represent pharmacists, physicians, physician assistants, nurse practitioners, and other health professionals in investigations and at Board of Pharmacy, Board of Medicine and Board of Nursing hearings. To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Sullivan, A. (March 25, 2024). Fla. pharmacy says it was cut from federal prep program. Law360. Retrieved from https://www.law360.com/health/articles/1817148?nl_pk=ab1e43aa-534e-4b86-8a5a-6b981ef7c33b&utm_source=newsletter&utm_medium=email&utm_campaign=health&utm_content=2024-03-26&read_main=1&nlsidx=0&nlaidx=13

Florida Health. “PrEP/PEP Program.” The Florida Department of Health. (August 15, 2024). https://www.floridahealth.gov/diseases-and-conditions/aids/PrEP/index.html

U.S. Department of Health and Human Services. “Ready, Set, PrEP: Find Out If You Qualify to Enroll for Free PrEP Medications.” https://readysetprep.hiv.gov/#how-to-enroll

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. www.TheHealthLawFirm.com 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.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.

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.

When the DEA Comes Knocking: 15 Tips If You Find Yourself Facing a “Routine” DEA Inspection

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

As the United States continues to open back up from the COVID-19 shutdown, the Drug Enforcement Agency (DEA) is resuming on-site routine inspections. Therefore, healthcare professionals must ensure compliance and regulatory efforts are in place.

This is part 1 of a 2-part blog series. Check back for part 2 of this blog series soon!

DEA Inspections and Site Visits: Subpoenas.

DEA agents are often pushy, demanding, and intimidating. They will try to use subpoenas (which are merely requests for documents that afford you at least ten days to produce the requested documents) as search warrants. THEY ARE NOT. They will try to use an administrative subpoena to obtain documents and get your testimony immediately. YOU DO NOT HAVE TO PRODUCE THEM RIGHT AWAY. A copy of a sample subpoena used by the DEA is on our website for reference here.

Not Just a Routine Audit, Inspection, or Investigation.

Beware the “Notice of Inspection of Controlled Premises” (DEA Form 82). Although the DEA often treats it as one, it is not a search warrant. Also, it is probably NOT a “Routine Inspection.” IT WILL NOT TAKE ONLY 15 TO 20 MINUTES.

We have had several clients who have had to close down their businesses all day to try to accommodate the demands of the agents performing their “routine inspection.” The DEA should not cause you to shut down or should not cause you to turn away patients. It should not interfere with your patient services or your ability to provide them. You can ask them to come back at a later date.

The DEA often refers to “routine audits” as “Accountability Investigations” and requires the pharmacy or registrant to be given certain rights in connection with it. For example, DEA Form 82 states you are given the following rights:

1.    The constitutional right not to have an administrative inspection without an Administrative Inspection Warrant (AIW),
2.    Has the right to refuse consent to such an inspection,
3.    Presented with a Notice of Inspection,
4.    Given consent voluntarily, without threats of any kind,
5.    May withdraw consent at any time during the course of the inspection, and
6.    Incriminating evidence may be seized and used in criminal prosecution.

Although the DEA agent may tell you that the site visit is “completely random,” do not believe it. If the DEA agent has brought a list of records to obtain from you, try to keep a copy of it, as your lawyer may find it very useful later when they are defending you.

What to Do When Confronted with a DEA Inspection or Site Visit.

1.    Notify the owner right away. If you are not the owner, don’t sign anything, give permission, or agree to anything. You probably have no authority to do so.

2.    Call your health lawyer and get them over immediately. This is an emergency!

3.    Yes, you have the right to consult with your attorney; do not believe them if they say you can’t (which they may do, believe it or not).

4.    Request photo identification from everyone to ensure the individuals are who they say they are. No identification? No access. Federal agents, including DEA agents, will always have their photo ID.

5.    Obtain a business card from each person present. DEA agents always carry business cards. If they do not have one, you will have to write all contact information for that agent from their photo id card (or photocopy, if they will allow you to do so).

6.    Do the same as the above for anyone else the DEA brings, whether they claim to be a federal or state investigator, Department of Health investigator, or local police. Please note that our experience has been that the DEA and state agencies contend that they don’t go on joint inspections or investigations (however, we don’t believe this to be true). Therefore, get all parties’ information at the very start, or you may never get it until they testify against you.

7.    DO NOT SIGN A VOLUNTARY AGREEMENT TO RELINQUISH YOUR DEA REGISTRATION. Agents may try to pressure and intimidate you into signing one by telling you it will be easier if you sign it. They might even try to scare you by warnings of criminal prosecution unless you sign it. Yes, you have the right to consult with an attorney before deciding whether or not to sign it (they may falsely tell you that you don’t). However, once you sign it, it is gone. If you are a prescribing physician or health professional, your authority to prescribe is gone forever. If you are a pharmacy/pharmacist, your ability to order or fill any controlled substances is forever gone. So go ahead and put a sign on the door that says “CLOSED-Out of Business.”

8.    Before the inspection begins, you should be given a form to read and sign. If not, request it. It will usually be a DEA Form 82 “Notice of Inspection of Controlled Premises” Form. Before the inspection, it should be read, explained, agreed to, and signed, not during or after.

9.    Read the form carefully. You have the right to fax it, scan and e-mail it, or call and read it to your attorney before you sign it. If it says you have the right to refuse the inspection, consider putting it off until a later date. Especially if you are busy and have patients you must serve.

10.    Obtain a copy of the form (inspection form or subpoena) at the beginning and keep it. You will need this later.

11.    Obtain a complete, detailed receipt for any documents, prescriptions, or other items taken by the agents. Again, since this is not a search warrant, the DEA does not have the authority to take your only originals and leave you without a copy.

12.    You may or may not be in serious trouble and subject to future criminal charges or administrative action to revoke your DEA registration. Your attorney should be able to evaluate this and advise you. Don’t bother to ask the agents, as they will not tell you what is in your own best interest to know.

13.    If you don’t have an attorney who is experienced in health law and DEA defense, get one NOW. You should begin preparing now. It often takes the DEA a year or more to work up charges against you. Once you are served with charges, you will only have a very short time to prepare your defense. It is a completely unfair system for the subject of charges as the government will have longer to prepare its case against you than you have to prepare your defense. Take advantage of the time you have. Do not waste it.

14.    Be polite and do not argue with a DEA agent.

15.    Do not volunteer information, but never tell a lie. Making a false statement to any federal agent is a felony criminal offense. A subpoena for documents is not an authorization to interrogate you. A search warrant is not an authorization to interrogate you.

Lastly, don’t forget to check back to read part 2 of this blog series.

Please remember: This blog’s statements are opinions based on our experience. If you do not agree with it, then you are probably the DEA.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, pharmacists, pharmacies, medical groups, nurses, nurse practitioners, CRNAs, dentists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

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. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. 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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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

What You Need to Know Right Now If the DEA is Knocking on Your Door!

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Is the Drug Enforcement Administration (DEA) knocking at your door or, even worse, going through your files inside your office?

If so, this is what you need to know right now!

YES, you do have the right to call your attorney. Call your attorney right now. If you cannot, ask one of your employees or spouse to call your attorney. Get your attorney involved right now!

NO, do not sign a document to relinquish or voluntarily give up your DEA registration number. If you do so, this will probably be the biggest mistake you make in your life.

NO, do not sign a document waiving your right to a grand jury investigation before the DEA is authorized to charge you. Why would you voluntarily give up one of your most important constitutional rights?

Don’t Get Fooled By What the DEA Agents Tell You.

The DEA has the reputation (and, in my experience, deservedly so) of making false statements to individuals about what will happen to them or not happen to them if they do not “Cooperate” with the DEA by giving up their rights.

Often they will handcuff the pharmacist or the physician who is the subject of their raid, search warrant, or subpoena as a method of intimidating them. Then they will threaten the person by arresting them and jailing them immediately if they do not sign a “voluntary” relinquishment of their DEA registration. Yet once you do this, your DEA registration is gone, and you will most likely never get one again.

We have even had the report from a physician recently where the DEA agents, during executing a search warrant (not an arrest warrant, by the way), of having the doctor sign a document waiving her right to having a grand jury hearing on any charges she may have been facing. The threat was that she needed to waive her rights or be arrested on the spot and taken to jail. She signed without consulting an attorney.

If you are a pharmacist or pain management physician, or you own or operate a pain management practice, or if you prescribe or dispense opioids, you must have the name and phone number of a good health lawyer and a good criminal lawyer on hand and post at all times! It is only a matter of time before you need to use it.

Have this information in your wallet and taped to every telephone and computer in your office. But use it right away. Call your attorney right away. Your attorney will come over or brief you on what to do or not do.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH, and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law, as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, call (407) 331-6620 or toll-free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

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. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620. 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.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

Is the DEA Knocking on Your Door? What You Need to Know Right Now!

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Is the Drug Enforcement Administration (DEA) knocking at your door or, even worse, going through your files inside your office?

This is what you need to know right now!

YES, you do have the right to call your attorney. Call your attorney right now. If you cannot, ask one of your employees or spouse to call your attorney. Get your attorney involved right now!

NO, do not sign a document to relinquish or voluntarily give up your DEA registration number. If you do so, this will probably be the biggest mistake you make of your life.

NO, do not sign a document waiving your right to a grand jury investigation before the DEA is authorized to charge you. Why would you want to voluntarily give up one of your most important constitutional rights?

Don’t be fooled by what the DEA agents tell you.