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: PAlexander@TheHealthLawFirm.com 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.

2022-10-14T00:15:49-04:00November 18th, 2022|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: PAlexander@TheHealthLawFirm.com 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.

 

 

 

 

 

 

2022-10-14T00:08:21-04:00October 28th, 2022|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.

 

 

 

 

 

 

2022-09-28T10:23:19-04:00September 28th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Feds Charge Three People For Multi-Million Dollar Scheme to Defraud Medicare, HIPAA Violations

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

In October 2020, Massachusetts federal prosecutors charged three people for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient data and sold it to the purported mastermind, who used it to submit $109 million in false claims.

The two individuals who allegedly obtained the patient information were both located in Florida, wouldn’t ya know. They were each charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Fraudulently Collecting & Using Private Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries. Using a prepared script, they allegedly asked the patients they called if they would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.”

The call centers would then collect information, including the patient’s name, address, insurance number, Medicare number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who filed fraudulent Medicare claims for DME that were never prescribed and not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. Click here to view the criminal information in this case.

Read the DOJ’s press release on this case for additional information.

Also, you can read one of my prior blogs on a similar case in Florida.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare Issues Now.

The attorneys of The Health Law Firm represent durable medical equipment (DME) suppliers and other health care providers in Medicare audits, ZPIC audits, MAC audits, and RAC audits throughout Florida and across the U.S. They also health care providers in qui tam or False Claims Act (whistleblower) litigation and in other complex medical litigation. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, and termination from the Medicare or Medicaid programs, They represent health care providers in formal and informal administrative hearings, federal or state.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 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 Avenue, 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 © 2021 The Health Law

2021-02-24T10:55:49-05:00May 19th, 2021|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

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

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.

2021-02-17T16:04:11-05:00May 4th, 2021|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Feds Charge Three For Role in Multi-Million Dollar Scheme to Defraud Medicare, HIPAA Violations

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

In October 2020, Massachusetts federal prosecutors charged three people for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient data and sold it to the purported mastermind, who used it to submit $109 million in false claims.

The two individuals who allegedly obtained the patient information were both located in Florida, wouldn’t ya know. They were each charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Fraudulently Collecting & Using Private Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries. Using a prepared script, they allegedly asked the patients they called if they would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.”

The call centers would then collect information, including the patient’s name, address, insurance number, Medicare number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who filed fraudulent Medicare claims for DME that were never prescribed and not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. Click here to view the criminal information in this case.

Read the DOJ’s press release on this case for additional information.

Also, you can read one of my prior blogs on a similar case in Florida.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare Issues Now.

The attorneys of The Health Law Firm represent durable medical equipment (DME) suppliers and other health care providers in Medicare audits, ZPIC audits, MAC audits, and RAC audits throughout Florida and across the U.S. They also health care providers in qui tam or False Claims Act (whistleblower) litigation and in other complex medical litigation. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, and termination from the Medicare or Medicaid programs, They represent health care providers in formal and informal administrative hearings, federal or state.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 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 Avenue, 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 © 2021 The Health Law

2021-02-24T10:52:53-05:00April 28th, 2021|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Certifying Emotional Support Animals and Protecting Your Professional License, Part 1 of 2

Attorney Amanda I. ForbesBy Amanda I. Forbes, J.D., and George F. Indest III, J.D., M.P.A., LL.M., Board Certified in Health Law

In today’s stress-filed world if you are a mental health counselor or other professional counselor, it is likely that you will encounter a client seeking to obtain an Emotional Support Animal (ESA)
designation letter from you. Providing such a letter may cause you to face complaints, licensing, and disciplinary actions driven by hostile landlords, homeowners associations, and business establishments that do not want any sort of animals on their premises. Often cases wind up in civil litigation. The client may also try to retaliate against you, should the client be the victim of legal problems because of attempting to keep an ESA and not understanding the legal ramifications.

However, you, as an experienced, licensed mental health professional must know what to do and not to do to protect your license and your career.

This is part 1 of 2 in a blog series regarding Emotional Support Animals. Click here for part two. We also intend to do a follow-up blog series on working animals and how they are legally distinguished from ESAs.

Here are some tips to keep in mind should you decide to provide an ESA recommendation letter:

1. You must develop and document a properly established therapist-client relationship with the client prior to writing a recommendation–do whatever you would normally do for any other client seeking your help who walks in the door.

2. Confirm the actual, true identity of the client to be sure you know with whom you are dealing. Request and obtain at least two different forms of photo ID, one including a driver’s license for the equivalent. Check and verify the name and address on the Internet or with directory assistance. (I have a personal rule of thumb: “If you can’t find a person on the Internet, then he is a fake and does not exist”).

3. Obtain the client’s complete mental health history and medical history, requesting and obtaining other treater’s records just as you would do for any other client/patient.

4. If the client has been referred to you by another provider, especially one in a different medical or health specialty, request a written referral documenting the need for the referral to you.

5. Adequately and thoroughly make and document any decision that an ESA will benefit the client and help in treating any mental health symptoms. Be thorough and document it.

6. Assign a code from the Diagnostic and Statistical Manual, ed. 5 (DSM-5 ), to the patient, or obtain one from the patient’s regular treating psychiatrist, psychologist, or mental health therapist.

7. The most important element involved is to show that there is an actual medical necessity for the client to have an ESA or that there will be a therapeutic benefit for the client to have the ESA. If you cannot justify and document this, then do not approve the request.

8. Evaluate the ESA, preferably by an in-person meeting or tele-health conference, and determine that it will benefit the client, be sure to document this evaluation and comment on the weight, height, aggressiveness, and character of the ESA. It is most helpful to have a form the ESA’s veterinarian will complete, sign, and return to you for confirmation of this information and, perhaps, an indication that the animal is suitable in character. Keep this in your record.

9. Thoroughly document the above in your chart on the client.

10. Have a thorough knowledge of your state’s laws and professional licensing board’s regulations concerning ESAs. You might review past disciplinary cases in which counselors have received discipline relating to ESAs in your state.

Warning About Organizations that Target Mental Health Counselors, Psychoanalysts, and Professional Counselors Who Approve Emotional Support Animals.

Those mental health counselors, social workers, professional counselors, and therapists who are involved in the certification or approval of emotional support animals and working animals should be advised that there are a number of organizations and individuals out there who seek out and target those who certify or approve such animals. These organizations and individuals see many cases of abuse and improper certifications being used. They see individuals who appear to have no real medical need for such an animal “purchasing” such certifications. They view them as a merely “privileged” individual who merely buys such certification for their pet just so that can take the pet everywhere and garner attention for themselves.

Sometimes these organizations and individuals even pretend to be a patient seeking certification of an emotional support animal or a working animal. They do often contact counselors using fake names and pretending to be fake patients to see how far the therapist will go without even having a real patient. Then they file a complaint with the therapist’s professional board in an attempt to have disciplinary action taken against their license.

Therefore, it is imperative that you follow the tips mentioned in this article.

Guidance from the American Counseling Association:

The American Counseling Association (ACA) published a position paper titled: Emotional Support Animals-Human Animal Interactions in Counseling Interest Network Position Statement.

In that position paper the ACA stated:

As Licensed Professional Counselors, the assessment of DSM-5 diagnoses for human clients is within the scope of practice; however, the added practices of animal behavior, behavior assessment or Human-Animal Interventions are (most often) not. Emotional Support Animal may, in some specific circumstances, provide benefits to humans to minimize identified symptoms often associated with a DSM 5 diagnoses; however, because of the potential risks and unanticipated outcomes, the HAIC strongly suggests that counselors abstain from writing letters for persons seeking counseling or assessments for the sole purpose of obtaining an ESA recommendation letter.

Click here to read the ACA letter in full.

However, if the counselor already has an existing treating relationship with a client and the counselor is considering writing an ESA recommendation letter, then the ASA recommends:

[T]he counselor must have a thorough knowledge of the local, state, and federal laws and policies surrounding ESAs and appropriate knowledge, skills, and attitudes with the subject of therapeutic human-animal interactions before writing such a letter.

Click here to learn more.

The ACA also cautions:

The ACA’s Code of Ethics C.2.e Consultations on Ethical Obligations includes “taking reasonable steps with other counselors, the ACA Ethics and Professional Standards Department, or related professionals when they have questions regarding their ethical obligations or professional practice.” This may include working with animal trainers, behaviorists, or veterinary behaviorists to ensure that the clinician remains within their scope of practice. Since there is no overarching licensing or accrediting body for this matter, nor are there federal or state mandates at this time, the onus is on the clinician to ensure ethical practice.

https://www.unh.edu/sites/default/files/departments/student_accessibility_services_/aca.final_version_esa14556_002.pdf. (Emphasis added).

Don’t forget to read part 2 in this blog series to learn more.

Contact Health Law Attorneys Experienced Investigations of Mental Health Counselors, Psychologists, Social Workers, and Family Therapists.

The attorneys of The Health Law Firm provide legal representation to mental health counselors, psychologists, social workers, and family therapists in Department of Health (DOH) investigations, FBI investigations and other types of investigations of health professionals and providers. To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.

We also defend health professionals and health facilities in general litigation matters and business litigation matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 or Toll-Free: (888) 331-6620, and visit our website at www.TheHealthLawFirm.com.

GEORGE F. INDEST III, J.D., M.P.A., LL.M.About the Authors: Amanda I. Forbes, practices health law with The Health Law Firm in its Altamonte Springs, Florida, office. George F. Indest III, J.D., M.P.A., LL.M., is Board Certified in Health Law by The Florida Bar and is licensed in Louisiana, Florida, and the District of Columbia. He is President and Managing Partner of The Health Law Firm. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com. The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll Free: (888) 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 © 2021 The Health Law Firm. All rights reserved.

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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.

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

Three People Charged For $109 Million Scheme to Defraud Medicare & HIPAA Violations

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

In October 2020, Massachusetts federal prosecutors charged three people for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient data and sold it to the purported mastermind, who used it to submit $109 million in false claims.

The two individuals who allegedly obtained the patient information were both located in Florida, wouldn’t ya know. They were each charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Fraudulently Collecting & Using Private Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries. Using a prepared script, they allegedly asked the patients they called if they would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.”

The call centers would then collect information, including the patient’s name, address, insurance number, Medicare number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who filed fraudulent Medicare claims for DME that were never prescribed and not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. Click here to view the criminal information in this case.

Read the DOJ’s press release on this case for additional information.

Also, you can read one of my prior blogs on a similar case in Florida.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare Issues Now.

The attorneys of The Health Law Firm represent durable medical equipment (DME) suppliers and other health care providers in Medicare audits, ZPIC audits, MAC audits, and RAC audits throughout Florida and across the U.S. They also health care providers in qui tam or False Claims Act (whistleblower) litigation and in other complex medical litigation. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, and termination from the Medicare or Medicaid programs, They represent health care providers in formal and informal administrative hearings, federal or state.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 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 Avenue, 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 © 2021 The Health Law

2021-02-24T10:50:35-05:00April 7th, 2021|Categories: Mental Health 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.

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