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

Attorney and Author George F. Indest III HeadshotBy 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:
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.
By |2024-04-09T13:21:22-04:00April 9, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Pharmacy Sues Claiming HHS Wrongly Terminated it from Federal PrEP Program

Pharmacy Technicians Allowed to Administer Immunizations After New Florida Legislation

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

On July 1, 2022, Florida passed HB 1209, allowing registered pharmacy technicians to administer immunizations to patients. The new law utilizes pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.” These pharmacy technicians will then be allowed to administer all vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC for international travel. Additionally, it includes vaccines authorized by the FDA under an emergency use authorization or by the Florida Board of Pharmacy in response to a state of emergency declared by the Governor.

This is a big step in medicine, once again broadening the ability of health professionals to provide more efficient and less expensive health care. In the past, properly qualified pharmacists were allowed to administer vaccines, but even then, there was a shortage.

Certification Requirements.

To become certified by the Florida Board of Pharmacy, a registered pharmacy technician must complete six hours of approved immunization-related training. As a renewal condition, an additional two hours of approved continuing education must be completed each cycle, according to the Board of Pharmacy website. For more information, click here.

In comparison, for certification, registered pharmacists must have 20 hours of education to administer vaccines. Registered pharmacist interns (persons with five years of college) who are also under the supervision of a certified pharmacist must take the same 20-hour immunization course that the pharmacists take to become certified to administer immunizations.

While this new Florida law seems to adopt a substantial lessening in training requirements, remember the 20-hour course allows pharmacists to administer vaccines independently. The six-hour course is for pharmacy technicians to administer vaccines under the pharmacist’s supervision. The technician certification program or programs authorized will have to be approved by the Florida Board of Pharmacy in consultation with the Florida Board of Medicine and the Florida Board of Osteopathic Medicine.

Stay Informed and Prepared.

The Board of Pharmacy has the authority to adopt rules to add new vaccines as added by the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), but it often takes many months to do so. Pharmacies and the pharmacists, pharmacist interns, and pharmacy technicians who are responsible need to monitor these situations closely.

Pharmacies should print a copy of the CDC adult immunization schedule, the CDC’s recommended vaccines for international travel, and the FDA’s list of vaccines with emergency use authorizations and have this readily available for its staff to review. They should also update this list at least once a month. This will help the pharmacy staff keep on top if either of these federal agencies, the CDC or the FDA, changes its list of immunizations. As we’ve seen from the COVID-19 pandemic, keeping track of vaccine schedules and emergency use authorization changes can be very confusing.

Click here to read Florida HB 1209 – Administration of Vaccines, in full.

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

We routinely provide 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 lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants, and other health professionals in investigations and at Board of Pharmacy hearings. Call our office now at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website www.TheHealthLawFirm.com.

Sources:

Dix, Martin. “A Jump Forward For Fla. Pharmacy Technicians’ Vax Authority.” Law360. (August 19, 2022). Web.

Sexton, Christine. “Checking the pulse of Florida health care news and policy.” Florida Politics. (August 16, 2022). Web.

Dix, Martin. “Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises.” Akerman. (July 28, 2022). Web.

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.

Attorney Positions with The Health Law Firm.  The Health Law Firm is always looking for qualified attorneys interested in health law practice. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: [email protected] or fax 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.

By |2024-03-14T09:59:12-04:00February 12, 2024|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Pharmacy Technicians Allowed to Administer Immunizations After New Florida Legislation

Florida Passes New Legislation That Allows Pharmacy Technicians to Administer Immunizations

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

On July 1, 2022, Florida passed HB 1209, allowing registered pharmacy technicians to administer immunizations to patients. The new law utilizes pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.” These pharmacy technicians will then be allowed to administer all vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC for international travel. Additionally, it includes vaccines authorized by the FDA under an emergency use authorization or by the Florida Board of Pharmacy in response to a state of emergency declared by the Governor.

This is a big step in medicine, once again broadening the ability of health professionals to provide more efficient and less expensive health care. In the past, properly qualified pharmacists were allowed to administer vaccines, but even then, there was a shortage.

Certification Requirements.

To become certified by the Florida Board of Pharmacy, a registered pharmacy technician must complete six hours of approved immunization-related training. As a renewal condition, an additional two hours of approved continuing education must be completed each cycle, according to the Board of Pharmacy website. For more information, click here.

In comparison, for certification, registered pharmacists must have 20 hours of education to administer vaccines. Registered pharmacist interns (persons with five years of college) who are also under the supervision of a certified pharmacist must take the same 20-hour immunization course that the pharmacists take to become certified to administer immunizations.

While this new Florida law seems to adopt a substantial lessening in training requirements, remember the 20-hour course allows pharmacists to administer vaccines independently. The six-hour course is for pharmacy technicians to administer vaccines under the pharmacist’s supervision. The technician certification program or programs authorized will have to be approved by the Florida Board of Pharmacy in consultation with the Florida Board of Medicine and the Florida Board of Osteopathic Medicine.

Stay Informed and Prepared.

The Board of Pharmacy has the authority to adopt rules to add new vaccines as added by the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), but it often takes many months to do so. Pharmacies and the pharmacists, pharmacist interns, and pharmacy technicians who are responsible need to monitor these situations closely.

Pharmacies should print a copy of the CDC adult immunization schedule, the CDC’s recommended vaccines for international travel, and the FDA’s list of vaccines with emergency use authorizations and have this readily available for its staff to review. They should also update this list at least once a month. This will help the pharmacy staff keep on top if either of these federal agencies, the CDC or the FDA, changes its list of immunizations. As we’ve seen from the COVID-19 pandemic, keeping track of vaccine schedules and emergency use authorization changes can be very confusing.

Click here to read Florida HB 1209 – Administration of Vaccines, in full.

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

We routinely provide 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 lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants, and other health professionals in investigations and at Board of Pharmacy hearings. Call our office now at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website www.TheHealthLawFirm.com.

Sources:

Dix, Martin. “A Jump Forward For Fla. Pharmacy Technicians’ Vax Authority.” Law360. (August 19, 2022). Web.

Sexton, Christine. “Checking the pulse of Florida health care news and policy.” Florida Politics. (August 16, 2022). Web.

Dix, Martin. “Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises.” Akerman. (July 28, 2022). Web.

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.

Attorney Positions with The Health Law Firm.  The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: [email protected] or fax 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.

 

 

 

 

 

 

By |2024-03-14T09:59:13-04:00January 22, 2024|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Passes New Legislation That Allows Pharmacy Technicians to Administer Immunizations

Florida Legislation Allows Pharmacy Technicians to Administer Immunizations

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

On July 1, 2022, Florida passed HB 1209, allowing registered pharmacy technicians to administer immunizations to patients. The new law utilizes pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.” These pharmacy technicians will then be allowed to administer all vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC for international travel. Additionally, it includes vaccines authorized by the FDA under an emergency use authorization or by the Florida Board of Pharmacy in response to a state of emergency declared by the Governor.

This is a big step in medicine, once again broadening the ability of health professionals to provide more efficient and less expensive health care. In the past, properly qualified pharmacists were allowed to administer vaccines, but even then, there was a shortage.

Certification Requirements.

To become certified by the Florida Board of Pharmacy, a registered pharmacy technician must complete six hours of approved immunization-related training. As a renewal condition, an additional two hours of approved continuing education must be completed each cycle, according to the Board of Pharmacy website. For more information, click here.

In comparison, for certification, registered pharmacists must have 20 hours of education to administer vaccines. Registered pharmacist interns (persons with five years of college) who are also under the supervision of a certified pharmacist must take the same 20-hour immunization course that the pharmacists take to become certified to administer immunizations.

While this new Florida law seems to adopt a substantial lessening in training requirements, remember the 20-hour course allows pharmacists to administer vaccines independently. The six-hour course is for pharmacy technicians to administer vaccines under the pharmacist’s supervision. The technician certification program or programs authorized will have to be approved by the Florida Board of Pharmacy in consultation with the Florida Board of Medicine and the Florida Board of Osteopathic Medicine.

Stay Informed and Prepared.

The Board of Pharmacy has the authority to adopt rules to add new vaccines as added by the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), but it often takes many months to do so. Pharmacies and the pharmacists, pharmacist interns, and pharmacy technicians who are responsible need to monitor these situations closely.

Pharmacies should print a copy of the CDC adult immunization schedule, the CDC’s recommended vaccines for international travel, and the FDA’s list of vaccines with emergency use authorizations and have this readily available for its staff to review. They should also update this list at least once a month. This will help the pharmacy staff keep on top if either of these federal agencies, the CDC or the FDA, changes its list of immunizations. As we’ve seen from the COVID-19 pandemic, keeping track of vaccine schedules and emergency use authorization changes can be very confusing.

Click here to read Florida HB 1209 – Administration of Vaccines, in full.

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

We routinely provide 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 lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants, and other health professionals in investigations and at Board of Pharmacy hearings. Call our office now at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website www.TheHealthLawFirm.com.

Sources:

Dix, Martin. “A Jump Forward For Fla. Pharmacy Technicians’ Vax Authority.” Law360. (August 19, 2022). Web.

Sexton, Christine. “Checking the pulse of Florida health care news and policy.” Florida Politics. (August 16, 2022). Web.

Dix, Martin. “Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises.” Akerman. (July 28, 2022). Web.

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.

“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.

 

 

 

 

 

 

By |2024-03-14T09:59:15-04:00December 23, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Legislation Allows Pharmacy Technicians to Administer Immunizations
Go to Top