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.
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New Changes to HHS Regulatory Process: Secretary Must Sign All Agency Rulemaking

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

In a September 15, 2020 memorandum, the current Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, barred the Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations. The memo establishes that the Secretary must sign all agency rulemaking. This new policy affects all rules coming from all HHS agencies and offices, the department said, including the FDA, Centers for Medicare & Medicaid Services (CMS), and Office for Civil Rights. It doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

How long this policy stands after President-elect Biden is sworn in is anybody’s guess. It is my guess that it won’t last long.

Why Make the Changes?

According to HHS, the new regulation-making procedures are to ensure consistency within HHS, compliance with congressional intent, the need to minimize the risk of litigation, and to provide public accountability. HHS regulations have been challenged in court based on the argument that officials who signed new regulations did not have the proper authority to do so.

The memo attempts to rationalize the change in the face of critics who claim that the move could negatively affect public trust in approval of COVID-19 vaccines and the entire approval process.

Rulemaking Process Before and After the Memo.

Before the policy change, the law and established departmental procedure required that all new regulations go through departmental and White House clearance and receive the Secretary’s approval. The regulations were typically signed by the Secretary and by the head of the agency involved. In some instances, other officials to whom authority had been delegated signed the new regulations.

Now, all HHS regulations will still go through departmental and White House clearance and will continue to be approved by the Secretary. But, the change effectively bars the FDA and other health agencies from signing off on any new regulations regarding the nation’s food, medicine, and other products under the HHS umbrella. The HHS Secretary himself must now sign all final regulations.

HHS released the following statement on this action:

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him.”

Click here to read the HHS Statement on Regulatory Process.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

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

Sources:

Stein, Shira. “HHS Secretary to Sign All Rules in Bid to Stem Litigation.” Bloomberg Law. (September 21, 2020). Web.

Keller and Heckman LLP. “A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules.” National Law Review. (September 21, 2020). 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 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.

 

“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 © 2020 The Health Law Firm. All rights reserved.

HHS Makes Changes to Regulatory Process for Rulemaking

George Indest Headshot

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

In a September 15, 2020 memorandum, the current Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, barred the Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations. The memo establishes that the Secretary must sign all agency rulemaking. This new policy affects all rules coming from all HHS agencies and offices, the department said, including the FDA, Centers for Medicare & Medicaid Services (CMS), and Office for Civil Rights. It doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

How long this policy stands after President-elect Biden is sworn in is anybody’s guess. It is my guess that it won’t last long.

Why Make the Changes?

According to HHS, the new regulation-making procedures are to ensure consistency within HHS, compliance with congressional intent, the need to minimize the risk of litigation, and to provide public accountability. HHS regulations have been challenged in court based on the argument that officials who signed new regulations did not have the proper authority to do so.

The memo attempts to rationalize the change in the face of critics who claim that the move could negatively affect public trust in approval of COVID-19 vaccines and the entire approval process.

Rulemaking Process Before and After the Memo.

Before the policy change, the law and established departmental procedure required that all new regulations go through departmental and White House clearance and receive the Secretary’s approval. The regulations were typically signed by the Secretary and by the head of the agency involved. In some instances, other officials to whom authority had been delegated signed the new regulations.

Now, all HHS regulations will still go through departmental and White House clearance and will continue to be approved by the Secretary. But, the change effectively bars the FDA and other health agencies from signing off on any new regulations regarding the nation’s food, medicine, and other products under the HHS umbrella. The HHS Secretary himself must now sign all final regulations.

HHS released the following statement on this action:

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him.”

Click here to read the HHS Statement on Regulatory Process.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

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

Sources:

Stein, Shira. “HHS Secretary to Sign All Rules in Bid to Stem Litigation.” Bloomberg Law. (September 21, 2020). Web.

Keller and Heckman LLP. “A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules.” National Law Review. (September 21, 2020). 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 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.

 

“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 © 2020 The Health Law Firm. All rights reserved.

HHS Changes Regulatory Process: Secretary Must Sign All Agency Rulemaking

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

In a September 15, 2020 memorandum, the current Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, barred the Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations. The memo establishes that the Secretary must sign all agency rulemaking. This new policy affects all rules coming from all HHS agencies and offices, the department said, including the FDA, Centers for Medicare & Medicaid Services (CMS), and Office for Civil Rights. It doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

How long this policy stands after President-elect Biden is sworn in is anybody’s guess. It is my guess that it won’t last long.

Why Make the Changes?

According to HHS, the new regulation-making procedures are to ensure consistency within HHS, compliance with congressional intent, the need to minimize the risk of litigation, and to provide public accountability. HHS regulations have been challenged in court based on the argument that officials who signed new regulations did not have the proper authority to do so.

The memo attempts to rationalize the change in the face of critics who claim that the move could negatively affect public trust in approval of COVID-19 vaccines and the entire approval process.

Rulemaking Process Before and After the Memo.

Before the policy change, the law and established departmental procedure required that all new regulations go through departmental and White House clearance and receive the Secretary’s approval. The regulations were typically signed by the Secretary and by the head of the agency involved. In some instances, other officials to whom authority had been delegated signed the new regulations.

Now, all HHS regulations will still go through departmental and White House clearance and will continue to be approved by the Secretary. But, the change effectively bars the FDA and other health agencies from signing off on any new regulations regarding the nation’s food, medicine, and other products under the HHS umbrella. The HHS Secretary himself must now sign all final regulations.

HHS released the following statement on this action:

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him.”

Click here to read the HHS Statement on Regulatory Process.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

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

Sources:

Stein, Shira. “HHS Secretary to Sign All Rules in Bid to Stem Litigation.” Bloomberg Law. (September 21, 2020). Web.

Keller and Heckman LLP. “A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules.” National Law Review. (September 21, 2020). 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 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.

 

“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 © 2020 The Health Law Firm. All rights reserved.

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