Colorado Judge Says Board of Pharmacy Must 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 and Audits.

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.

Clashing Over Patient Privacy and Data.

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 Court’s 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.

Contact Health Law Attorneys Experienced in Representing Nurses and Other Healthcare Professionals.

The Health Law Firm’s attorneys routinely provide legal representation to nurses, pharmacists, pharmacies, physicians, and other health providers. We provide legal representation for nurses in Board of Nursing investigations and complaints, DORA investigations and complaints, and Department of Health (DOH) investigations and complaints. We defend in state and federal administrative hearings, investigations, and litigation. We also represent health professionals in formal and informal administrative hearings. We have a great deal of experience in defending against DEA actions. We provide legal representation across the U.S., not just in Colorado, Florida, Louisiana, Virginia, and Washington, D.C.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 or (970) 416-7456 and visit our website at 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 |2024-03-14T09:59:57-04:00July 22, 2020|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Colorado Judge Says Board of Pharmacy Must Hand Over Patient Identifying Data to DEA

New Florida Law Allows Limited Pharmacist Medical Practice with Practice Agreements

Attorney Michael L. SmithBy Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law
A new Florida law allows pharmacists to practice medicine to a certain extent underwritten collaborative practice agreements with physicians who are licensed to practice medicine or osteopathic medicine in Florida. The new law, signed by Governor DeSantis, took effect on July 1, 2020. However, the initial 20-hour course required by the law has not been approved as of July 22, 2020. Also, the Florida Board of Pharmacy has not adopted the formulary of approved medicinal drugs that are required by the law, as of this writing on July 22, 2020.

What Pharmacists Need to Know About the New Law.

Pharmacists practicing under a collaborative practice agreement with a physician will be permitted to test, screen for, and treat some nonchronic health conditions. The nonchronic health conditions a pharmacist is permitted to treat under a collaborative practice agreement are influenza, streptococcus, lice, skin conditions, and minor infections.

Pharmacists will also be able to initiate, modify, or discontinue drug therapy for chronic health conditions under a written collaboration agreement with a physician. The chronic conditions a pharmacist will be able to treat are arthritis, asthma, COPD, type-2 diabetes, HIV or AIDS, and obesity. The collaborative practice agreement for chronic health conditions must be specific to a patient, or patients, of the supervising physician.

A pharmacist must be certified by the Florida Board of Pharmacy before practicing under a collaborative practice agreement. In order to be eligible for certification, the pharmacist must hold an unencumbered license to practice as a pharmacist in Florida. The pharmacist must also have a doctor of pharmacy degree or 5-years of experience as a licensed pharmacist.

Every pharmacist seeking certification to practice under a collaborative practice agreement will be required to complete an initial 20-hour course approved by the Board of Pharmacy, and complete additional continuing education hours for each license renewal. Pharmacists practicing under collaborative practice agreements will also be required to maintain professional liability coverage of at least $250,000.

Pharmacists will not be permitted to prescribe controlled substances. The new law requires the Florida Board of Pharmacy to adopt a formulary of medicinal drugs that pharmacists may prescribe under collaborative practice agreements with physicians.

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 our office now at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website www.TheHealthLawFirm.com.

About the Author: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He 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 Ave. 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

“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.

Federal Judge Says Colorado Board of Pharmacy Must 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.

Contact Health Law Attorneys Experienced in Representing Nurses and Other Healthcare Professionals.

The Health Law Firm’s attorneys routinely provide legal representation to nurses, pharmacists, pharmacies, physicians, and other health providers. We provide legal representation for nurses in Board of Nursing investigations and complaints, DORA investigations and complaints, and Department of Health (DOH) investigations and complaints. We defend in state and federal administrative hearings, investigations, and litigation. We also represent health professionals in formal and informal administrative hearings. We have a great deal of experience in defending against DEA actions. We provide legal representation across the U.S., not just in Colorado, Florida, Louisiana, Virginia, and Washington, D.C.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 or (970) 416-7456 and visit our website at 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 |2024-03-14T09:59:57-04:00July 1, 2020|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Federal Judge Says Colorado Board of Pharmacy Must Hand Over Patient Identifying Data to DEA

Emergency Order Allows Florida Pharmacists to Temporarily Order, 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 |2024-03-14T09:59:57-04:00June 24, 2020|Categories: Uncategorized|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Emergency Order Allows Florida Pharmacists to Temporarily Order, Administer COVID-19 Tests

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

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

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.

Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

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

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice or has to suffer the consequences of having no legal representation.

Administrative Proceedings Can be Complex.

In some cases, individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters, can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Legal Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases, it may even be possible to obtain a change in the forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing. Click here to read our blog on this matter and learn more.

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.

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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy and tagged Administrative Law Judge, administrative procedure act, administrative proceeding, ALJ, Board of Pharmacy, Board of Pharmacy hearing, defense attorney, defense lawyer, Department of Health, deposition coverage, disciplinary charges, disciplinary complaint, FAC, final hearing, Florida Administrative Code, formal hearing, health law firm, health professional, hearing representation, Informal hearing, last-minute deposition coverage, legal representation, legal representation for pharmacist, legal representation for pharmacy, local deposition coverage, negligence lawsuit, noticed of a deposition, pharmacist, pharmacy, professional liability insurance, rights for an appeal, Rules of Civil Procedure, Rules of Evidence, short notice of representation of pharmacy, short notice representation of pharmacist, subpoena, The Health Law Firm

“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.

Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

9 Indest-2008-6By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at a hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice, or has to suffer the consequences of having no legal representation.

Be Aware that Administrative Proceedings Can be Complex.

In some cases individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases it may even be possible to obtain a change in forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing.

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.

Comments?

Have you ever had an informal or formal hearing before the Board of Pharmacy? What was the experience like? Please leave any thoughtful comments below.

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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

 

“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 © 1996-2012 The Health Law Firm. All rights reserved.

 

 

 

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