Judge in Colorado 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.

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.

“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 © 2021 The Health Law Firm. All rights reserved.

By |2021-02-17T16:01:42-05:00April 13th, 2021|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Law in Florida 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.

“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 © 2021 The Health Law Firm. All rights reserved.

CVS Fined for Prescription Errors and Poor Staffing at Oklahoma Pharmacies

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 July 16, 2020, the Oklahoma State Board of Pharmacy fined CVS, the nationwide pharmacy chain, $125,000, after auditors found safety issues and “chaotic” scenes at four of its pharmacies. State regulators in Oklahoma cited and fined the nation’s largest retail pharmacy chain for conditions including inadequate staffing and errors made in filling prescriptions. Hopefully, this was isolated to the few stores involved.

Pharmacy Complaints.

In four separate administrative orders, the Oklahoma State Board of Pharmacy said that auditors responded to complaints at each of the pharmacies for issues including long waiting times, wrong information on prescription refills, and dosage mistakes. The state board inspected the four pharmacies from mid-2019 to early 2020. In one case, the complaint said the pharmacy had put someone on hold on multiple occasions, sometimes as long as an hour. In another case, a woman said that when she got her medication refilled, the name and other information on the bottle she received was for someone else.

The pharmacy chains have pushed back on customer and employees’ complaints, saying staffing is sufficient and errors are rare.

Pharmacy Audits.

On multiple occasions, state auditors visiting the pharmacies said they found understaffed facilities, with the phone continuously ringing, employees working around unopened (and, we assume, un-inventoried) delivery boxes, and long lines at the drive-through windows. According to the orders, one pharmacy stated that it was normal for them to be as much as two weeks behind in filling prescriptions as a result of understaffing. It should be noted that the audits took place predominantly before the COVID-19 crisis.

Additionally, in letters to state pharmacy boards and in interviews, pharmacists working for CVS allegedly admitted that they struggled to keep up with an increasing number of tasks including filling prescriptions, giving flu shots, tending the drive-through window, answering phones, and calling patients. According to the orders, many said they also struggled to meet corporate performance metrics that they characterized as excessive and unsafe.

As a routine customer of CVS Pharmacy (not in Oklahoma, of course), I can sympathize with the pharmacists, pharmacy technicians, and clerks. In many places, pharmacists are now being required to administer a laundry list of vaccinations (literally, ten different vaccinations), practice medicine to a limited scope, contact prescribing physicians, constantly order out-of-stock drugs, order diagnostic tests, and answer all sorts of customer questions. Now, with the COVID-19 pandemic, there is a steady flow of coronavirus tests to administer to customers at the drive-through window. I see first-hand how difficult it is for these front-line healthcare professionals to keep up on a daily basis.

The Oklahoma Board said it “strongly recommended” that CVS follow through on nearly a dozen recommendations for all of its Oklahoma pharmacies, including increased training for technicians and changes to how staffing needs were determined. Additionally, the Oklahoma Board advised eliminating tasks that might overburden pharmacists and removing some metrics they are required to meet. For example, phone calls pharmacists often must make could be outsourced to a corporate call center.

In a statement, CVS Pharmacy said it agreed with the Board to settle the matter to avoid the lengthy and costly hearing process. The orders specify that CVS neither admits to nor denies the violations. The company agreed to pay the fines and to make other efforts to address the problems without contesting the allegations.

While the fine of $125,000 is relatively small for CVS, as it’s the country’s fifth-largest company, the move did validate the concerns raised at multiple drugstore chains by pharmacists who say workplaces are putting the public at risk.

You can read all four orders in this case here: CVS Order – Bartlesville, CVS Order – Choctaw, CVS Order – Moore, and CVS Order – Owasso.

Visit our Areas of Practice page on our website to learn more about Board of Pharmacy Representation and how we can assist Pharmacists and Pharmacies in these types of cases.

 

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

We routinely provide defense for pharmacists, pharmacies, and pharmacy technicians; defense to complaints filed against their licenses; defense to complaints filed by patients; defense in litigation against pharmacists, pharmacies, and technicians; legal representation and defense to DEA and Board of Pharmacy audits, investigations, and subpoenas; legal representation in depositions in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals. We have experience in dealing with HIPAA privacy complaints, audits, and investigations. We have experience in defending in Medicare, Medicaid, Tricare, and health insurance audits. We accept most professional liability insurance that pharmacists carry.

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: 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2021 The Health Law Firm. All rights reserved.

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.

“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 © 2021 The Health Law Firm. All rights reserved.

Board of Pharmacy Must Hand Over Patient Identifying Data to DEA in Colorado

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.

“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 © 2021 The Health Law Firm. All rights reserved.

By |2021-02-17T15:53:15-05:00February 24th, 2021|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

CVS Fined for Prescription Errors and Poor Staffing at Oklahoma Pharmacies

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 July 16, 2020, the Oklahoma State Board of Pharmacy fined CVS, the nationwide pharmacy chain, $125,000, after auditors found safety issues and “chaotic” scenes at four of its pharmacies. State regulators in Oklahoma cited and fined the nation’s largest retail pharmacy chain for conditions including inadequate staffing and errors made in filling prescriptions. Hopefully, this was isolated to the few stores involved.

Pharmacy Complaints.

In four separate administrative orders, the Oklahoma State Board of Pharmacy said that auditors responded to complaints at each of the pharmacies for issues including long waiting times, wrong information on prescription refills, and dosage mistakes. The state board inspected the four pharmacies from mid-2019 to early 2020. In one case, the complaint said the pharmacy had put someone on hold on multiple occasions, sometimes as long as an hour. In another case, a woman said that when she got her medication refilled, the name and other information on the bottle she received was for someone else.

The pharmacy chains have pushed back on customer and employees’ complaints, saying staffing is sufficient and errors are rare.

Pharmacy Audits.

On multiple occasions, state auditors visiting the pharmacies said they found understaffed facilities, with the phone continuously ringing, employees working around unopened (and, we assume, un-inventoried) delivery boxes, and long lines at the drive-through windows. According to the orders, one pharmacy stated that it was normal for them to be as much as two weeks behind in filling prescriptions as a result of understaffing. It should be noted that the audits took place predominantly before the COVID-19 crisis.

Additionally, in letters to state pharmacy boards and in interviews, pharmacists working for CVS allegedly admitted that they struggled to keep up with an increasing number of tasks including filling prescriptions, giving flu shots, tending the drive-through window, answering phones, and calling patients. According to the orders, many said they also struggled to meet corporate performance metrics that they characterized as excessive and unsafe.

As a routine customer of CVS Pharmacy (not in Oklahoma, of course), I can sympathize with the pharmacists, pharmacy technicians, and clerks. In many places, pharmacists are now being required to administer a laundry list of vaccinations (literally, ten different vaccinations), practice medicine to a limited scope, contact prescribing physicians, constantly order out-of-stock drugs, order diagnostic tests, and answer all sorts of customer questions. Now, with the COVID-19 pandemic, there is a steady flow of coronavirus tests to administer to customers at the drive-through window. I see first-hand how difficult it is for these front-line healthcare professionals to keep up on a daily basis.

The Oklahoma Board said it “strongly recommended” that CVS follow through on nearly a dozen recommendations for all of its Oklahoma pharmacies, including increased training for technicians and changes to how staffing needs were determined. Additionally, the Oklahoma Board advised eliminating tasks that might overburden pharmacists and removing some metrics they are required to meet. For example, phone calls pharmacists often must make could be outsourced to a corporate call center.

In a statement, CVS Pharmacy said it agreed with the Board to settle the matter to avoid the lengthy and costly hearing process. The orders specify that CVS neither admits to nor denies the violations. The company agreed to pay the fines and to make other efforts to address the problems without contesting the allegations.

While the fine of $125,000 is relatively small for CVS, as it’s the country’s fifth-largest company, the move did validate the concerns raised at multiple drugstore chains by pharmacists who say workplaces are putting the public at risk.

You can read all four orders in this case here: CVS Order – Bartlesville, CVS Order – Choctaw, CVS Order – Moore, and CVS Order – Owasso.

Visit our Areas of Practice page on our website to learn more about Board of Pharmacy Representation and how we can assist Pharmacists and Pharmacies in these types of cases.

 

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

We routinely provide defense for pharmacists, pharmacies, and pharmacy technicians; defense to complaints filed against their licenses; defense to complaints filed by patients; defense in litigation against pharmacists, pharmacies, and technicians; legal representation and defense to DEA and Board of Pharmacy audits, investigations, and subpoenas; legal representation in depositions in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals. We have experience in dealing with HIPAA privacy complaints, audits, and investigations. We have experience in defending in Medicare, Medicaid, Tricare, and health insurance audits. We accept most professional liability insurance that pharmacists carry.

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: 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2021 The Health Law Firm. All rights reserved.

Two FL Pill Mill Owners Get Prison Time For Illegal Distribution Of Opioids

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

On October 7, 2020, two owners of a medical practice in Tampa, Florida, were sentenced to federal prison time for their roles in the illegal distribution of opioids. U.S. District Judge Mary S. Scriven sentenced Ernest Gonzalez to 46 months and Rosa Colon to 24 months in federal prison for conspiracy to distribute and dispense controlled substances for no legitimate medical purpose.

Plot to Illegally Distribute Controlled Substances.

According to court documents, Gonzalez served as the president and owner of Health and Pain Center (HPC), a Tampa pain management clinic. In June 2011, he transferred his executive title and ownership of HPC to Colon. The Drug Enforcement Administration (DEA) obtained a warrant in October 2016, while both were active participants of the administration and management of HPC.

The two owners allegedly hired physicians at HPC, who routinely prescribed controlled substances to patients eeking pain mediciations. Federal authorities always allege that such prescriptions are “outside the scope of professional (medical) practice.” Additionally, the owners are alleged to have participated and facilitated the physicians’ illegal prescribing practices by instructing employees to overlook failed urinalysis screens that help to detect drug abusers.

According to court papers, the owners also obtained MRI studies and other documents that the physicians used to justify the high volume of opioid prescriptions. According to court documents, the owners operated HPC as a cash-only business with little to no medical equipment on-site and staff with no medical training.

The owners pled guilty on September 11, 2018. It is unclear as to why they were not sentenced until October 7, 2020. As part of their sentences, the court entered money judgments of $47,780.96 against Gonzalez and $765,356.76 against Colon. This was in addition to the prison time stated above.

The facts above are typical of those in other state and federal prosecutions against physicians, pharmacists, and clinic owners. If you are a physician who is working for a clinic owned by non-physicians, you need to be very careful that you are working for a legitimate organization. If you are being pressured to write prescriptions for narcotics for patients, you need to be very careful about what you do and why you do it. Often physicians who work for pill mills just bury their heads in the sand and rationalize why they are writing and refilling the same prescriptions for opioids month after month.

For the past ten years, in Florida, the DEA, the Department of Health, the state Attorney General, and multi-jurisdictional task forces have been targeting physicians who write prescriptions for narcotics and pharmacies that fill such prescriptions. There are very few left. The cross-hairs of the regulators and law enforcement are now targeting those who are involved in only very small quantities. Watch out, it could be you next!

View the press release issued by the U.S. Attorney’s Office for the Middle District of Florida.

Read my prior blog and learn more about pill mills, here.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases, and board of pharmacy case, Department of Health (DOH) investigations, and Department of Regulatory Agencies (DORA) investigations, regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA or a state licensing board, contact one of our attorneys by calling (407) 331-6620 or toll-free at (888) 331-6620. You can also visit our website for more information at www.TheHealthLawFirm.com.


Sources:

“Tampa Pill Mill Owners Sentenced To Prison For Illegal Distribution Of Opioids.” Tampa Free Press. (October 11, 2020). Web.

Otero, Sebastian. “Tampa pill mill owners sentenced to prison for illegal distribution of opioids.” ABC 7 WWSB. (October 8, 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 the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

“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.

 

Non-physician Pill Mill Owners in Tampa Sentenced To Prison Time For Illegal Distribution Of Opioids

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

On October 7, 2020, two owners of a medical practice in Tampa, Florida, were sentenced to federal prison time for their roles in the illegal distribution of opioids. U.S. District Judge Mary S. Scriven sentenced Ernest Gonzalez to 46 months and Rosa Colon to 24 months in federal prison for conspiracy to distribute and dispense controlled substances for no legitimate medical purpose.

Plot to Illegally Distribute Controlled Substances.

According to court documents, Gonzalez served as the president and owner of Health and Pain Center (HPC), a Tampa pain management clinic. In June 2011, he transferred his executive title and ownership of HPC to Colon. The Drug Enforcement Administration (DEA) obtained a warrant in October 2016, while both were active participants of the administration and management of HPC.

The two owners allegedly hired physicians at HPC, who routinely prescribed controlled substances to patients eeking pain mediciations. Federal authorities always allege that such prescriptions are “outside the scope of professional (medical) practice.” Additionally, the owners are alleged to have participated and facilitated the physicians’ illegal prescribing practices by instructing employees to overlook failed urinalysis screens that help to detect drug abusers.

According to court papers, the owners also obtained MRI studies and other documents that the physicians used to justify the high volume of opioid prescriptions. According to court documents, the owners operated HPC as a cash-only business with little to no medical equipment on-site and staff with no medical training.

The owners pled guilty on September 11, 2018. It is unclear as to why they were not sentenced until October 7, 2020. As part of their sentences, the court entered money judgments of $47,780.96 against Gonzalez and $765,356.76 against Colon. This was in addition to the prison time stated above.

The facts above are typical of those in other state and federal prosecutions against physicians, pharmacists, and clinic owners. If you are a physician who is working for a clinic owned by non-physicians, you need to be very careful that you are working for a legitimate organization. If you are being pressured to write prescriptions for narcotics for patients, you need to be very careful about what you do and why you do it. Often physicians who work for pill mills just bury their heads in the sand and rationalize why they are writing and refilling the same prescriptions for opioids month after month.

For the past ten years, in Florida, the DEA, the Department of Health, the state Attorney General, and multi-jurisdictional task forces have been targeting physicians who write prescriptions for narcotics and pharmacies that fill such prescriptions. There are very few left. The cross-hairs of the regulators and law enforcement are now targeting those who are involved in only very small quantities. Watch out, it could be you next!

View the press release issued by the U.S. Attorney’s Office for the Middle District of Florida.

Read my prior blog and learn more about pill mills, here.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases, and board of pharmacy case, Department of Health (DOH) investigations, and Department of Regulatory Agencies (DORA) investigations, regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA or a state licensing board, contact one of our attorneys by calling (407) 331-6620 or toll-free at (888) 331-6620. You can also visit our website for more information at www.TheHealthLawFirm.com.


Sources:

“Tampa Pill Mill Owners Sentenced To Prison For Illegal Distribution Of Opioids.” Tampa Free Press. (October 11, 2020). Web.

Otero, Sebastian. “Tampa pill mill owners sentenced to prison for illegal distribution of opioids.” ABC 7 WWSB. (October 8, 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 the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

“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.

 

CVS Fined for Prescription Errors and Poor Staffing at Oklahoma Pharmacies

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 July 16, 2020, the Oklahoma State Board of Pharmacy fined CVS, the nationwide pharmacy chain, $125,000, after auditors found safety issues and “chaotic” scenes at four of its pharmacies. State regulators in Oklahoma cited and fined the nation’s largest retail pharmacy chain for conditions including inadequate staffing and errors made in filling prescriptions. Hopefully, this was isolated to the few stores involved.

Pharmacy Complaints.

In four separate administrative orders, the Oklahoma State Board of Pharmacy said that auditors responded to complaints at each of the pharmacies for issues including long waiting times, wrong information on prescription refills, and dosage mistakes. The state board inspected the four pharmacies from mid-2019 to early 2020. In one case, the complaint said the pharmacy had put someone on hold on multiple occasions, sometimes as long as an hour. In another case, a woman said that when she got her medication refilled, the name and other information on the bottle she received was for someone else.

The pharmacy chains have pushed back on customer and employees’ complaints, saying staffing is sufficient and errors are rare.

Pharmacy Audits.

On multiple occasions, state auditors visiting the pharmacies said they found understaffed facilities, with the phone continuously ringing, employees working around unopened (and, we assume, un-inventoried) delivery boxes, and long lines at the drive-through windows. According to the orders, one pharmacy stated that it was normal for them to be as much as two weeks behind in filling prescriptions as a result of understaffing. It should be noted that the audits took place predominantly before the COVID-19 crisis.

Additionally, in letters to state pharmacy boards and in interviews, pharmacists working for CVS allegedly admitted that they struggled to keep up with an increasing number of tasks including filling prescriptions, giving flu shots, tending the drive-through window, answering phones, and calling patients. According to the orders, many said they also struggled to meet corporate performance metrics that they characterized as excessive and unsafe.

As a routine customer of CVS Pharmacy (not in Oklahoma, of course), I can sympathize with the pharmacists, pharmacy technicians, and clerks. In many places, pharmacists are now being required to administer a laundry list of vaccinations (literally, ten different vaccinations), practice medicine to a limited scope, contact prescribing physicians, constantly order out-of-stock drugs, order diagnostic tests, and answer all sorts of customer questions. Now, with the COVID-19 pandemic, there is a steady flow of coronavirus tests to administer to customers at the drive-through window. I see first-hand how difficult it is for these front-line healthcare professionals to keep up on a daily basis.

The Oklahoma Board said it “strongly recommended” that CVS follow through on nearly a dozen recommendations for all of its Oklahoma pharmacies, including increased training for technicians and changes to how staffing needs were determined. Additionally, the Oklahoma Board advised eliminating tasks that might overburden pharmacists and removing some metrics they are required to meet. For example, phone calls pharmacists often must make could be outsourced to a corporate call center.

In a statement, CVS Pharmacy said it agreed with the Board to settle the matter to avoid the lengthy and costly hearing process. The orders specify that CVS neither admits to nor denies the violations. The company agreed to pay the fines and to make other efforts to address the problems without contesting the allegations.

While the fine of $125,000 is relatively small for CVS, as it’s the country’s fifth-largest company, the move did validate the concerns raised at multiple drugstore chains by pharmacists who say workplaces are putting the public at risk.

You can read all four orders in this case here: CVS Order – Bartlesville, CVS Order – Choctaw, CVS Order – Moore, and CVS Order – Owasso.

Visit our Areas of Practice page on our website to learn more about Board of Pharmacy Representation and how we can assist Pharmacists and Pharmacies in these types of cases.

 

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

We routinely provide defense for pharmacists, pharmacies, and pharmacy technicians; defense to complaints filed against their licenses; defense to complaints filed by patients; defense in litigation against pharmacists, pharmacies, and technicians; legal representation and defense to DEA and Board of Pharmacy audits, investigations, and subpoenas; legal representation in depositions in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals. We have experience in dealing with HIPAA privacy complaints, audits, and investigations. We have experience in defending in Medicare, Medicaid, Tricare, and health insurance audits. We accept most professional liability insurance that pharmacists carry.

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: 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or Toll-Free: (888) 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.

Colorado Board of Pharmacy Must Give DEA Patient Identifying Data Says Federal Judge

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.

Clashing 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 Pharmacists and Other Healthcare Professionals.

The Health Law Firm’s attorneys routinely provide legal representation to mental healthcare professionals, 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.

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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2020 The Health Law Firm. All rights reserved.

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