Pharmacy Technicians Allowed to Administer Immunizations After New Florida Legislation

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

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

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

Certification Requirements.

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

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

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

Stay Informed and Prepared.

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

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

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

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

We routinely provide legal representation to pharmacists, pharmacies, and other health professionals who have received complaints against their licenses, notices of investigations, Medicare or Medicaid audits, Drug Enforcement Administration (DEA) audits, investigations, subpoenas, search warrants, and orders to show cause (OSC) or who are facing formal or informal administrative hearings.

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

Sources:

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

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

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free (888) 331-6620.

Attorney Positions with The Health Law Firm.  The Health Law Firm is always looking for qualified attorneys interested in health law practice. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: [email protected] or fax to: (407) 331-3030.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

By |2024-02-10T19:00:01-05:00February 12, 2024|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Florida Passes New Legislation That Allows Pharmacy Technicians to Administer Immunizations

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

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

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

Certification Requirements.

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

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

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

Stay Informed and Prepared.

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

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

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

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

We routinely provide legal representation to pharmacists, pharmacies, and other health professionals who have received complaints against their licenses, notices of investigations, Medicare or Medicaid audits, Drug Enforcement Administration (DEA) audits, investigations, subpoenas, search warrants, and orders to show cause (OSC) or who are facing formal or informal administrative hearings.

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

Sources:

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

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

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free (888) 331-6620.

Attorney Positions with The Health Law Firm.  The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: [email protected] or fax to: (407) 331-3030.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

 

 

 

 

 

 

By |2024-01-20T19:01:44-05:00January 22, 2024|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Florida Legislation Allows Pharmacy Technicians to Administer Immunizations

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

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

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

Certification Requirements.

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

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

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

Stay Informed and Prepared.

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

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

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

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

We routinely provide legal representation to pharmacists, pharmacies, and other health professionals who have received complaints against their licenses, notices of investigations, Medicare or Medicaid audits, Drug Enforcement Administration (DEA) audits, investigations, subpoenas, search warrants, and orders to show cause (OSC) or who are facing formal or informal administrative hearings.

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

Sources:

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

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

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free (888) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

 

 

 

 

 

 

By |2023-12-21T19:01:35-05:00December 23, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Miami, Florida Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

author headshot standing in dark suit with arms crossedBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.  The defendant was initially indicted on June 17, 2022, and charged with six counts of conspiracy and money laundering.  Unlike most of the fraud convictions we report on, this one was directed against the U.S. Food and Drug Administration (FDA) and involved adulterating and misbranding drugs.  The defendant pled guilty to only two counts: conspiracy to defraud the United States and conspiracy to commit money laundering.  Click here to view the press release from the U.S. Attorney’s Office, Southern District of Florida, to learn more about the arrest.

The Charges: Adulterated and Misbranded HIV Medications.

Prescription drug diversion is when prescription drugs are removed from regulated distribution channels and reintroduced into the wholesale market or otherwise illegally distributed.  These drugs can be acquired through theft, fraud, or patients who were prescribed the medication and intentionally did not consume them.
In this case, U.S. vs. Lazaro Hernandez,  the defendant would obtain prescribed drugs illegally, repackage them, falsify the documentation, and resell them to coconspirators through conspiracy wholesalers. To successfully divert the prescription medications, they got wholesale drug distributor licenses for LLC’s in Florida, New Jersey, Connecticut, and New York. These conspiracy wholesalers would purchase the diverted, adulterated, and misbranded drugs and documentation and sell them to pharmacies.
Adulteration occurs when any substance is added to or substituted, in part or in whole, or mixed with an approved drug.  Misbranding of a drug occurs when someone places a label on it that is false or misleading in any way, as defined in Title 21 U.S. Code sections 351(d) and 352 (a)(1).  In this case, the pharmacies billed health care benefit programs and dispensed adulterated and misbranded drugs to patients.  The pharmacies paid $232,800,000 for the diverted drugs between April 2019 and at least October 2021.

The six counts that the defendant was initially charged with include conspiracy to introduce adulterated and misbranded drugs and to defraud the United States, conspiracy to traffic pre-retail medical products with false documentation, conspiracy to commit money laundering, and three counts of money laundering.  The false documentation and money laundering charges were later dropped in the plea deal.

The Sentencing.

The government recommended a sentence of 188 to 235 months, which aligns with the defendant’s criminal history and total offense level (calculated in accordance with federal statutes and regulations), while the defense argued for a lesser amount of time due to the allegedly “secondary” role the defendant played in the fraud.  The judge sentenced the defendant to 180 months. Also included in the sentence was a forfeiture of all proceeds from the scam and restitution in an amount that has yet to be determined.

This lower-than-recommended prison sentence came after the defendant spoke about his gambling addiction, which allegedly led him to participate in the fraud. Also, two of his 47 character references addressed the court in person.  The judge was swayed to give him a lower sentence as a result. View the indictment in the case in full here.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to pharmacists, pharmacy facilities, physicians, nurse practitioners, CRNAs, dentists, psychologists, mental health professionals, nurses, and other health providers in Department of Health (DOH) investigations and hearings, Drug Enforcement Administration (DEA) investigations, audits and hearings, Food and Drug Administration (FDA) investigations and hearings, FBI investigations, Medicare/Medicaid investigations, audits and hearings, and many other actions involving defense of health professionals and providers.

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

Sources:

Minsky, David. “Fla. Man Sentenced To 15 Years In Prison Over HIV Drug Fraud.” Law360. (June 16, 2023). Web.

Becker, Zoey. “In fraud case targeting HIV meds, Florida man gets 15 years in prison.” FiercePharma. (June 21, 2023). 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 Avenue, Suite 1000, Altamonte Springs, FL 32714.  Phone:  (407) 331-6620;  Toll-Free: (888) 331-6620.

Current Open Positions with The Health Law Firm.  The Health Law Firm always seeks qualified individuals interested in health law.  Its main office is in the Orlando, Florida, area.  If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to:  [email protected] or fax them to (407) 331-3030.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2023 The Health Law Firm. All rights reserved.
By |2023-06-26T11:30:16-04:00August 22, 2023|Categories: Mental Health Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Florida Man Sentenced to 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

author headshot standing in dark suit with arms crossedBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.  The defendant was initially indicted on June 17, 2022, and charged with six counts of conspiracy and money laundering.  Unlike most of the fraud convictions we report on, this one was directed against the U.S. Food and Drug Administration (FDA) and involved adulterating and misbranding drugs.  The defendant pled guilty to only two counts: conspiracy to defraud the United States and conspiracy to commit money laundering.  Click here to view the press release from the U.S. Attorney’s Office, Southern District of Florida, to learn more about the arrest.


The Charges: Adulterated and Misbranded HIV Medications.

Prescription drug diversion is when prescription drugs are removed from regulated distribution channels and reintroduced into the wholesale market or otherwise illegally distributed.  These drugs can be acquired through theft, fraud, or patients who were prescribed the medication and intentionally did not consume them.
In this case, U.S. vs. Lazaro Hernandez,  the defendant would obtain prescribed drugs illegally, repackage them, falsify the documentation, and resell them to coconspirators through conspiracy wholesalers. To successfully divert the prescription medications, they got wholesale drug distributor licenses for LLC’s in Florida, New Jersey, Connecticut, and New York. These conspiracy wholesalers would purchase the diverted, adulterated, and misbranded drugs and documentation and sell them to pharmacies.
Adulteration occurs when any substance is added to or substituted, in part or in whole, or mixed with an approved drug.  Misbranding of a drug occurs when someone places a label on it that is false or misleading in any way, as defined in Title 21 U.S. Code sections 351(d) and 352 (a)(1).  In this case, the pharmacies billed health care benefit programs and dispensed adulterated and misbranded drugs to patients.  The pharmacies paid $232,800,000 for the diverted drugs between April 2019 and at least October 2021.

The six counts that the defendant was initially charged with include conspiracy to introduce adulterated and misbranded drugs and to defraud the United States, conspiracy to traffic pre-retail medical products with false documentation, conspiracy to commit money laundering, and three counts of money laundering.  The false documentation and money laundering charges were later dropped in the plea deal.

The Sentencing.

The government recommended a sentence of 188 to 235 months, which aligns with the defendant’s criminal history and total offense level (calculated in accordance with federal statutes and regulations), while the defense argued for a lesser amount of time due to the allegedly “secondary” role the defendant played in the fraud.  The judge sentenced the defendant to 180 months. Also included in the sentence was a forfeiture of all proceeds from the scam and restitution in an amount that has yet to be determined.

This lower-than-recommended prison sentence came after the defendant spoke about his gambling addiction, which allegedly led him to participate in the fraud. Also, two of his 47 character references addressed the court in person.  The judge was swayed to give him a lower sentence as a result. View the indictment in the case in full here.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to pharmacists, pharmacy facilities, physicians, nurse practitioners, CRNAs, dentists, psychologists, mental health professionals, nurses, and other health providers in Department of Health (DOH) investigations and hearings, Drug Enforcement Administration (DEA) investigations, audits and hearings, Food and Drug Administration (FDA) investigations and hearings, FBI investigations, Medicare/Medicaid investigations, audits and hearings, and many other actions involving defense of health professionals and providers.

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

Sources:

Minsky, David. “Fla. Man Sentenced To 15 Years In Prison Over HIV Drug Fraud.” Law360. (June 16, 2023). Web.

Becker, Zoey. “In fraud case targeting HIV meds, Florida man gets 15 years in prison.” FiercePharma. (June 21, 2023). 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 Avenue, Suite 1000, Altamonte Springs, FL 32714.  Phone:  (407) 331-6620;  Toll-Free: (888) 331-6620.

Current Open Positions with The Health Law Firm.  The Health Law Firm always seeks qualified individuals interested in health law.  Its main office is in the Orlando, Florida, area.  If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to:  [email protected] or fax them to (407) 331-3030.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2023 The Health Law Firm. All rights reserved.
By |2023-06-26T11:23:47-04:00August 8, 2023|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Miami Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

author headshot standing in dark suit with arms crossedBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.  The defendant was initially indicted on June 17, 2022, and charged with six counts of conspiracy and money laundering.  Unlike most of the fraud convictions we report on, this one was directed against the U.S. Food and Drug Administration (FDA) and involved adulterating and misbranding drugs.  The defendant pled guilty to only two counts: conspiracy to defraud the United States and conspiracy to commit money laundering.  Click here to view the press release from the U.S. Attorney’s Office, Southern District of Florida, to learn more about the arrest

The Charges: Adulterated and Misbranded HIV Medications.

Prescription drug diversion is when prescription drugs are removed from regulated distribution channels and reintroduced into the wholesale market or otherwise illegally distributed.  These drugs can be acquired through theft, fraud, or patients who were prescribed the medication and intentionally did not consume them.
In this case, U.S. vs. Lazaro Hernandez,  the defendant would obtain prescribed drugs illegally, repackage them, falsify the documentation, and resell them to coconspirators through conspiracy wholesalers. To successfully divert the prescription medications, they got wholesale drug distributor licenses for LLC’s in Florida, New Jersey, Connecticut, and New York. These conspiracy wholesalers would purchase the diverted, adulterated, and misbranded drugs and documentation and sell them to pharmacies.
Adulteration occurs when any substance is added to or substituted, in part or in whole, or mixed with an approved drug.  Misbranding of a drug occurs when someone places a label on it that is false or misleading in any way, as defined in Title 21 U.S. Code sections 351(d) and 352 (a)(1).  In this case, the pharmacies billed health care benefit programs and dispensed adulterated and misbranded drugs to patients.  The pharmacies paid $232,800,000 for the diverted drugs between April 2019 and at least October 2021.

The six counts that the defendant was initially charged with include conspiracy to introduce adulterated and misbranded drugs and to defraud the United States, conspiracy to traffic pre-retail medical products with false documentation, conspiracy to commit money laundering, and three counts of money laundering.  The false documentation and money laundering charges were later dropped in the plea deal.

The Sentencing.

The government recommended a sentence of 188 to 235 months, which aligns with the defendant’s criminal history and total offense level (calculated in accordance with federal statutes and regulations), while the defense argued for a lesser amount of time due to the allegedly “secondary” role the defendant played in the fraud.  The judge sentenced the defendant to 180 months. Also included in the sentence was a forfeiture of all proceeds from the scam and restitution in an amount that has yet to be determined.

This lower-than-recommended prison sentence came after the defendant spoke about his gambling addiction, which allegedly led him to participate in the fraud. Also, two of his 47 character references addressed the court in person.  The judge was swayed to give him a lower sentence as a result. View the indictment in the case in full here.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to pharmacists, pharmacy facilities, physicians, nurse practitioners, CRNAs, dentists, psychologists, mental health professionals, nurses, and other health providers in Department of Health (DOH) investigations and hearings, Drug Enforcement Administration (DEA) investigations, audits and hearings, Food and Drug Administration (FDA) investigations and hearings, FBI investigations, Medicare/Medicaid investigations, audits and hearings, and many other actions involving defense of health professionals and providers.

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

Sources:

Minsky, David. “Fla. Man Sentenced To 15 Years In Prison Over HIV Drug Fraud.” Law360. (June 16, 2023). Web.

Becker, Zoey. “In fraud case targeting HIV meds, Florida man gets 15 years in prison.” FiercePharma. (June 21, 2023). 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 Avenue, Suite 1000, Altamonte Springs, FL 32714.  Phone:  (407) 331-6620;  Toll-Free: (888) 331-6620.

Current Open Positions with The Health Law Firm.  The Health Law Firm always seeks qualified individuals interested in health law.  Its main office is in the Orlando, Florida, area.  If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to:  [email protected] or fax them to (407) 331-3030.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2023 The Health Law Firm. All rights reserved.
By |2023-06-26T11:18:27-04:00July 17, 2023|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Florida Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

author headshot standing in dark suit with arms crossedBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.  The defendant was initially indicted on June 17, 2022, and charged with six counts of conspiracy and money laundering.  Unlike most of the fraud convictions we report on, this one was directed against the U.S. Food and Drug Administration (FDA) and involved adulterating and misbranding drugs.  The defendant pled guilty to only two counts: conspiracy to defraud the United States and conspiracy to commit money laundering.  Click here to view the press release from the U.S. Attorney’s Office, Southern District of Florida, to learn more about the arrest


The Charges: Adulterated and Misbranded HIV Medications.

Prescription drug diversion is when prescription drugs are removed from regulated distribution channels and reintroduced into the wholesale market or otherwise illegally distributed.  These drugs can be acquired through theft, fraud, or patients who were prescribed the medication and intentionally did not consume them.
In this case, U.S. vs. Lazaro Hernandez,  the defendant would obtain prescribed drugs illegally, repackage them, falsify the documentation, and resell them to coconspirators through conspiracy wholesalers. To successfully divert the prescription medications, they got wholesale drug distributor licenses for LLC’s in Florida, New Jersey, Connecticut, and New York. These conspiracy wholesalers would purchase the diverted, adulterated, and misbranded drugs and documentation and sell them to pharmacies.
Adulteration occurs when any substance is added to or substituted, in part or in whole, or mixed with an approved drug.  Misbranding of a drug occurs when someone places a label on it that is false or misleading in any way, as defined in Title 21 U.S. Code sections 351(d) and 352 (a)(1).  In this case, the pharmacies billed health care benefit programs and dispensed adulterated and misbranded drugs to patients.  The pharmacies paid $232,800,000 for the diverted drugs between April 2019 and at least October 2021.
The six counts that the defendant was initially charged with include conspiracy to introduce adulterated and misbranded drugs and to defraud the United States, conspiracy to traffic pre-retail medical products with false documentation, conspiracy to commit money laundering, and three counts of money laundering.  The false documentation and money laundering charges were later dropped in the plea deal.

The Sentencing.

The government recommended a sentence of 188 to 235 months, which aligns with the defendant’s criminal history and total offense level (calculated in accordance with federal statutes and regulations), while the defense argued for a lesser amount of time due to the allegedly “secondary” role the defendant played in the fraud.  The judge sentenced the defendant to 180 months. Also included in the sentence was a forfeiture of all proceeds from the scam and restitution in an amount that has yet to be determined.
This lower-than-recommended prison sentence came after the defendant spoke about his gambling addiction, which allegedly led him to participate in the fraud. Also, two of his 47 character references addressed the court in person.  The judge was swayed to give him a lower sentence as a result. View the indictment in the case in full here.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to pharmacists, pharmacy facilities, physicians, nurse practitioners, CRNAs, dentists, psychologists, mental health professionals, nurses, and other health providers in Department of Health (DOH) investigations and hearings, Drug Enforcement Administration (DEA) investigations, audits and hearings, Food and Drug Administration (FDA) investigations and hearings, FBI investigations, Medicare/Medicaid investigations, audits and hearings, and many other actions involving defense of health professionals and providers.
To contact The Health Law Firm, please call (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Minsky, David. “Fla. Man Sentenced To 15 Years In Prison Over HIV Drug Fraud.” Law360. (June 16, 2023). Web.
Becker, Zoey. “In fraud case targeting HIV meds, Florida man gets 15 years in prison.” FiercePharma. (June 21, 2023). 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 Avenue, Suite 1000, Altamonte Springs, FL 32714.  Phone:  (407) 331-6620;  Toll-Free: (888) 331-6620.

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