Emergency Order Allows Florida Pharmacists to Order and Administer COVID-19 Tests

Headshot of The Health Law Firm's attorney George F. Indest IIIBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On April 24, 2020, Florida Gov. Ron DeSantis announced he would expand the opportunities for people to obtain COVID-19 tests by allowing licensed pharmacists to order and administer them. For purposes of preparing for, responding to, and mitigating any effect of COVID-19, Emergency Order 20-006 was filed, suspending section 483.813, Florida Statutes. You can click on the link to read the entire Order.

According to the Order, it was necessary to waive certain statutes and rules of the Florida DOH in order to effectively respond to the emergency caused by COVID-19. Section 483.813, Florida Statutes, requires a pharmacist to be separately licensed to perform a clinical laboratory test. Additionally, section 465.003(13), Florida Statutes, has provisions that prohibit a pharmacist from ordering, administering, or reporting the results of COVID-19 tests, including serology tests, authorized by the United States Food & Drug Administration (FDA). The Emergency Order temporarily sidesteps the law to allow pharmacists to perform these functions.

This suspension of the applicable law applies until the expiration of Executive Order 20-52.

The full version of the Emergency Order may be found on the Florida Board of Pharmacy’s website here as well as on our website here.

It’s important to remember that as with all new guidance and policy changes, it is essential to understand how these changes fit into the existing regulatory frameworks that govern the health care industry.

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

We routinely provide deposition coverage to pharmacists, pharmacies, and other health professionals being deposed in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals.

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 now or visit our website www.TheHealthLawFirm.com.

Sources:

Gross, J. Samantha. “Florida pharmacists to be allowed to issue COVID-19 tests, DeSantis says.” Miami Herald. (April 24, 2020). Web.

“Pharmacists Authorized to Order and Administer COVID-19 Testing.” The National Law Review. (April 20,2020). 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 Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Florida Board of Pharmacy defense representation, legal defense for pharmacists, pharmacist defense lawyer, Board of Pharmacy defense lawyer, Board of Pharmacy hearing legal representation, pharmacy license disciplinary charges defense attorney, legal representation for pharmacist, legal representation for pharmacy, pharmacy defense lawyer, pharmacy audit defense representation, pharmacy audit defense attorney, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, The Health Law Firm, administrative hearing defense attorney, DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, DEA hearing defense attorney, reviews of The Health Law Firm, The Health Law Firm attorney reviews, DEA order to show cause (OSC) defense attorney, Drug Enforcement Administration (DEA) defense attorney, Drug Enforcement Administration (DEA) investigation defense attorney, Drug Enforcement Administration (DEA) subpoena defense lawyer, Drug Enforcement Administration (DEA) inspection defense attorney, Drug Enforcement Administration (DEA) hearing defense attorney, Drug Enforcement Administration (DEA) order to show cause (OTSC) defense lawyer

“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.

By |2024-03-14T09:59:58-04:00June 3, 2020|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Emergency Order Allows Florida Pharmacists to Order and Administer COVID-19 Tests
Read More

Colorado Board of Pharmacy Ordered to Hand Over Patient Identifying Data to DEA

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On April 22, 2020, a federal judge ordered the Colorado Board of Pharmacy to give the U.S. Drug Enforcement Administration (DEA) prescription drug monitoring program data on two pharmacies that the DEA is investigating. The data includes patient identifying information of more than 14,000 patients. The state must turn over the data by May 15, 2020, according to the order.

Pharmacy Investigations.

Citing concerns about the two pharmacies’ handling of controlled-substance prescriptions, the DEA issued subpoenas under the Controlled Substances Act in 2019. The DEA requested the information as part of an investigation into whether the two unnamed pharmacies broke the law in dispensing opioids and other drugs.

Clash Over Patient Privacy.

The DEA’s requested information is kept under the state’s Prescription Drug Monitoring Program or PDMP. For controlled-substance prescriptions, Colorado pharmacies and pharmacists are required by state law to report information that includes the names of patients, their doctors, and pharmacies.

Colorado state officials refused to release the data citing patient privacy concerns. The DEA’s “overly broad, undifferentiated demand for access would violate the Fourth Amendment right to privacy guaranteed to more than 14,000 patients whose medical data is at issue,” the state said.

According to the order, the Colorado statute allows the prescription-monitoring data to be disclosed but only to specific recipients including in response to law enforcement subpoenas. However, the state argued that the Colorado statute only applies to a “bona fide investigation of a specific individual.”

To read about a similar case involving a DEA investigation into pharmacy prescription practices, click here to read my prior blog.

The Decision.

U.S. District Judge Raymond P. Moore denied Colorado’s objections to the DEA’s subpoenas for the prescription data including patients’ information such as names, birth dates, and addresses. The judge said the DEA has shown that the requested information is relevant and needed for the ongoing investigation of the two pharmacies, and no warrant is needed to obtain it. The order directs the Colorado Board of Pharmacy and Patty Salazar, Executive Director of the Colorado Department of Regulatory Agencies (DORA) to provide the data to the DEA no later than May 15, 2020.

To read the court’s order in full, click here.

For more information, click here to read the press release issued from the United States Attorney’s Office for the District of Colorado.

States Must Act to Protect the Integrity of Such Programs.

State prescription drug monitoring programs (PDMPs) were sold to pharmacists and physicians based on a promise that they were solely for the purpose of protecting patients from overdoses and preventing “doctor shopping” by dishonest, drug-seeking patients. Inherent in these programs was the promise that they would not be used for the purpose of prosecuting or charging physicians or pharmacists, in criminal proceedings or administrative proceedings, based on their contents. Most of the state laws that authorized the creation of PDMPs specifically forbid their use in such cases. This was required in order to get physicians and state medical societies to buy off on them.

Yet here we are. We see this over and over. the Federal government and federal agencies obtaining copies of these reports from the state and using them as direct evidence against physicians, pharmacists, nurse practitioners, and pharmacies, despite the prohibition of the state statutes.

Moreover, not only does this subvert the purpose behind creating such databases, but then it runs afoul of the Fifth Amendment of the U.S. Constitution and similar provisions of most state constitutions. The doctor or pharmacist is required by law to report the prescriptions to the PDMP, but then the federal agency turns right around and uses it as evidence against the individual who reported it.

The feds take the position: “We do not care why you, the state, authorized it or what its purpose was supposed to be. If we want to take that information and use it for something else, something that was specifically prohibited by the state, then we will do it.”

Until state pharmacy associations and medical associations do something to tighten up the state legislation that created the PDMPs, this situation is not likely to change. The feds will continue to use the state PDMPs to prosecute and to take administrative actions to revoke the DEA registrations of physicians, pharmacists, pharmacies, and other health professionals.

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

We routinely provide legal representation to pharmacists, pharmacies, physicians and other health providers. We defend in state and federal administrative hearings, investigations, and litigation. We represent health professionals in formal and informal administrative hearings. We have a great deal of experience in defending against DEA actions.

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 now or visit our website www.TheHealthLawFirm.com.

Sources:

Zegers, Kelly. “Colo. Must Give DEA Pharmacy Data With Patient Info.” Law360. (April 20, 2020). Web.

Ingold, John. “Why the DEA is suing Colorado’s pharmacy board as part of an opioid investigation.” The Colorado Sun. (November 11, 2019). Web.

Pazanowski, Mary Ann. “Colorado Pharmacy Board Must Give DEA Patient-Identifying Info.” Bloomberg Law. (April 22, 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 Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, DEA hearing defense attorney, reviews of The Health Law Firm, The Health Law Firm attorney reviews, DEA order to show cause (OSC) defense attorney, Drug Enforcement Administration (DEA) defense attorney, Drug Enforcement Administration (DEA) investigation defense attorney, Drug Enforcement Administration (DEA) subpoena defense lawyer, Drug Enforcement Administration (DEA) inspection defense attorney, Drug Enforcement Administration (DEA) hearing defense attorney, Drug Enforcement Administration (DEA) order to show cause (OTSC) defense lawyer, DORA defense attorney, Department of Health defense attorney, Florida Board of Pharmacy defense legal representation, legal defense for pharmacists, pharmacist defense lawyer, board of pharmacy defense lawyer, board of pharmacy hearing legal representation, pharmacy license disciplinary charges defense attorney, legal representation for pharmacist, legal representation for pharmacy, pharmacy defense lawyer, pharmacy audit defense representation, pharmacy audit defense attorney, board representation for pharmacists, board representation for pharmacies, board representation for physicians, board of pharmacy investigation representation, legal representation for board investigations, The Health Law Firm, administrative hearing defense attorney

“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.

By |2024-03-14T09:59:58-04:00June 3, 2020|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Colorado Board of Pharmacy Ordered to Hand Over Patient Identifying Data to DEA
Read More

Walgreens Agrees to Pay $7.5 Million To End Lawsuit Over Unlicensed Pharmacist

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 February 4, 2020, Walgreens agreed to pay $7.5 million to settle allegations that for more than a decade it let an unlicensed pharmacist handle hundreds of thousands of prescriptions. The pharmacy giant settled with authorities after an employee was criminally charged with impersonating a pharmacist in California. Prosecutors said that from 2006 through 2017, she used the license numbers of other registered pharmacists to dispense more than 745,000 prescriptions at Walgreens stores.

A Phony Pharmacist.

According to the lawsuit, Kim Thien Le worked for Walgreens for more than 15 years, first as an intern and then a pharmacist, despite never having her license. Le allegedly used the license of another person with the same first name to dispense more than 100,000 prescriptions for dangerous controlled substances. By using the license numbers of legitimate pharmacists, she was able to illegally impersonate and dispense highly regulated controlled substances, including prescription opioids such as fentanyl, oxycodone, hydrocodone, morphine, and codeine.

State Pharmacy Audit.

California state authorities discovered that she did not have a license during a pharmacy board audit in 2017. In California, as in most states, working as a pharmacist or pharmacist intern without a license from the state Board of Pharmacy is a crime. Le was criminally charged by the state with three felonies: false personation, identity theft, and obtaining money, labor or property by false pretenses. To read California Attorney General’s press release on this case, click here.

In a public statement, the Santa Clara County District Attorney’s Office announced the lawsuit against Walgreens alleging the company failed to properly safeguard against an unlicensed employee working for it as a pharmacist. Click here to view the press release in full.

The settlement also requires Walgreens to ensure licensure compliance by implementing a verification program, posting proof of licensure, conducting annual audits, and submitting an annual compliance report.

To read about a similar case involving overprescribing in Florida, click here to read one of my prior blogs.

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

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

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 now or visit our website www.TheHealthLawFirm.com.

Sources:

“Walgreens to pay $7.5M in settlement over phony pharmacist.” AP News. (February 3, 2020). Web.

Zaveri, Mihir. “A Fake Pharmacist, 745,000 Prescriptions and a $7.5 Million Settlement.” The New York Times. (February 4, 2020). Web.

Clough, Craig. “Walgreens To Pay $7.5M To End Suit Over Fake Pharmacist.” Law360. (February 4, 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 Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Florida Board of Pharmacy defense representation, legal defense for pharmacists, pharmacist defense lawyer, Board of Pharmacy defense lawyer, Board of Pharmacy hearing legal representation, pharmacy license disciplinary charges defense attorney, legal representation for pharmacist, legal representation for pharmacy, pharmacy defense lawyer, pharmacy audit defense representation, pharmacy audit defense attorney, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, The Health Law Firm, administrative hearing defense attorney, DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, DEA hearing defense attorney, reviews of The Health Law Firm, The Health Law Firm attorney reviews, DEA order to show cause (OSC) defense attorney, Drug Enforcement Administration (DEA) defense attorney, Drug Enforcement Administration (DEA) investigation defense attorney, Drug Enforcement Administration (DEA) subpoena defense lawyer, Drug Enforcement Administration (DEA) inspection defense attorney, Drug Enforcement Administration (DEA) hearing defense attorney, Drug Enforcement Administration (DEA) order to show cause (OTSC) defense lawyer

“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.

By |2024-03-14T10:00:03-04:00March 6, 2020|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |6 Comments
Read More

Alaska Board of Pharmacy Sends Letter to its Pharmacists Sending Mixed Signals Over Filling Opioid Prescriptions (Part 1 of a 2 part series)

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

The “Opioid Crisis” in the U.S.

We all know that there is an “opioid crisis” in the U.S. It is probably prevalent in every state. In Florida we have been suffering under it for the past ten to fifteen years. So it is nothing new to Florida. Government regulators including, but not limited to the Florida Department of Health (DOH), Florida Attorney General (AG), different State’s Attorneys’ (prosecutors) offices, multi-jurisdictional task forces, local law enforcement agencies, the U.S. Drug Enforcement Administration (DEA) and the Department of Justice (DOJ), along with federal prosecutors, have been involved in ongoing efforts in Florida for the past fifteen years or so, to shut down “pill mills” and attempt to eliminate the “opioid crisis.” Florida was, unfortunately, leading this trend.

The “Opioid Crisis;” Nothing New in Florida.

During this same period of time, my firm and I have been involved in defending physicians and pharmacists in criminal, civil, and administrative actions seeking to prosecute them, revoke their licenses, revoke their DEA registrations, terminate them from Medicaid participation, levy fines on them and other punitive actions. Florida was also, unfortunately, leading this trend.

So our opinions and comments in this blog, Part 1, and its Part 2, are informed by long years of experience with something that is old news in Florida, but may be new news in other states.

Alaska Sends out its Warning to Pharmacists to Keep Filling Prescriptions for Opioids.

On January 23, 2019, the Chairman of the Alaska Board of Pharmacy sent out an open letter to Alaska pharmacists, discussing the negative effect on patient health that has arisen in response to the fact that many pharmacists have stopped filling prescriptions for opioids. From its tone, it warns pharmacists to keep filling such prescriptions under threat of possible disciplinary action against their licenses, at least that is my interpretation of it. Here is a copy you can read for yourself, click here.

The two-page letter begins by stating:

The [Alaska] Board of Pharmacy has had an influx of communication concerning patients not able to get controlled substance prescriptions filled for various reasons, even when signs of forgery or fraudulence were not presented.

The letter continues stating:

As a professional reminder, failing to practice pharmacy using reasonable knowledge, skill, competence, and safety for the public may result in disciplinary actions under Alaska statute and regulation. These laws are: AS [Alaska Statutes] 08.80.261 DISCIPLINARY ACTIONS.

It then continues, quoting and citing other statutes and administrative codes under which a pharmacist could be charged for refusing to fill an opioid prescription for a patient.

Chilling? Mixed Signals? You be the Judge!

The problem I have is where is the state board of pharmacy (in any state, not just Alaska), when the DEA comes in to the pharmacy with its search warrants and arrest warrants? Where is the state board of pharmacy when the raid by local police/sheriff/multi-jurisdictional task force comes into the pharmacy? Where is the state board of pharmacy when the U.S. Attorney’s Office indicts and prosecutes the pharmacist? Where is the state board of pharmacy when the DEA issues its Order to Show Cause (OTSC) why the pharmacy’s or pharmacist’s DEA registration should not be revoked.

The state board of pharmacy is usually the one providing the expert witnesses to testify against the pharmacist or pharmacy, that’s where. The state board of pharmacy is standing by ready to take disciplinary action against the pharmacist or pharmacy, after the other government agencies get finished.

If pharmacists and pharmacies are refusing to fill prescriptions for opioids, which is something that I advise my clients to do, if they can afford to do so, then that is a smart move, until state agencies, including the state boards of pharmacy, take action to help them out of this predicament. The pharmacists are caught on the horns of a dilemma: face federal and state criminal prosecutions and actions by the DEA for filling opioid prescriptions; or face possible administrative actions by the state board of pharmacy for not filling opioid prescriptions. My advice is to choose the latter as it is much easier to defend a state administrative action, especially if you are not trying to do so from a federal prison somewhere.

The cost of defending a DEA action to revoke a DEA registration is prohibitive if done correctly, even if the pharmacist is completely innocent of any wrongdoing. The goal of these proceedings, despite the innocence of the pharmacist or pharmacy, is to put them out of business, and it almost always succeeds! Click here to read one of my prior blogs about DEA investigations of health care professionals.

To read my additional opinions on the types of actions that can be taken by states and state agencies to address the issues which the Alaska Board letter attempts to address, please see Part 2 of this blog. To read more on pill mill cases in the state of Florida, click here.

To learn more on administrative and informal hearings before the Florida Board of Pharmacy, click here to read one of my prior blogs.

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 also represents both plaintiffs (whistle blowers or relators) and defendants in False Claims Act (whistle blower or qui tam) cases. 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 please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with 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, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pharmacists, legal representation for pharmacies, pharmacy defense attorney, pharmacist defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, administrative hearing defense attorney, representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, Drug Enforcement Administration (DEA) hearing defense attorney, DEA investigation attorney, Drug Enforcement Administration (DEA) hearing legal representation, Drug Enforcement Administration (DEA) investigation legal defense attorney representation, representation for DEA investigations against pharmacists and physicians, legal representation for pill mill allegations, legal representation for allegations of over prescribing, lawyer providing representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews, defense for Drug Enforcement Administration (DEA) Order to Show Cause (OTSC), responding to Drug Enforcement Administration (DEA) Order to Show Cause (OTSC), Drug Enforcement Administration (DEA) Order to Show Cause (OTSC) attorney and legal defense

“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 © 2019 The Health Law Firm. All rights reserved.

By |2024-03-14T10:00:17-04:00February 6, 2019|Categories: Uncategorized|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Alaska Board of Pharmacy Sends Letter to its Pharmacists Sending Mixed Signals Over Filling Opioid Prescriptions (Part 1 of a 2 part series)
Read More
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A.
The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.
FacebookInstagramLinkedInTwitterYouTube
Toggle Sliding Bar Area
Go to Top