When the DEA Comes Knocking: 15 Tips If You Find Yourself Facing a “Routine” DEA Inspection

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

As the United States continues to open back up from the COVID-19 shutdown, the Drug Enforcement Agency (DEA) is resuming on-site routine inspections.  Therefore, healthcare professionals must ensure compliance and regulatory efforts are in place.

This is part 1 of a 2-part blog series. Check back for part 2 of this blog series soon!


DEA Inspections and Site Visits:  Subpoenas.

DEA agents are often pushy, demanding, and intimidating.  They will try to use subpoenas (which are merely requests for documents that afford you at least ten days to produce the requested documents) as search warrants.  THEY ARE NOT.  They will try to use an administrative subpoena to obtain documents and get your testimony immediately. YOU DO NOT HAVE TO PRODUCE THEM RIGHT AWAY. […]

By |2024-03-19T20:00:14-04:00March 21, 2024|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on When the DEA Comes Knocking: 15 Tips If You Find Yourself Facing a “Routine” DEA Inspection

What You Need to Know Right Now If the DEA is Knocking on Your Door!

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

Is the Drug Enforcement Administration (DEA) knocking at your door or, even worse, going through your files inside your office?

If so, this is what you need to know right now!

YES, you do have the right to call your attorney. Call your attorney right now. If you cannot, ask one of your employees or spouse to call your attorney. Get your attorney involved right now!

NO, do not sign a document to relinquish or voluntarily give up your DEA registration number. If you do so, this will probably be the biggest mistake you make in your life.

NO, do not sign a document waiving your right to a grand jury investigation before the DEA is authorized to charge you. Why would you voluntarily give up one […]

By |2024-03-14T20:00:41-04:00March 16, 2024|Categories: Medical Education Law Blog, Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on What You Need to Know Right Now If the DEA is Knocking on Your Door!

Is the DEA Knocking on Your Door? What You Need to Know Right Now!

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

Is the Drug Enforcement Administration (DEA) knocking at your door or, even worse, going through your files inside your office?

This is what you need to know right now!

YES, you do have the right to call your attorney. Call your attorney right now. If you cannot, ask one of your employees or spouse to call your attorney. Get your attorney involved right now!

NO, do not sign a document to relinquish or voluntarily give up your DEA registration number. If you do so, this will probably be the biggest mistake you make of your life.

NO, do not sign a document waiving your right to a grand jury investigation before the DEA is authorized to charge you. Why would you want to voluntarily give up one […]

By |2024-03-14T09:59:11-04:00March 2, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Is the DEA Knocking on Your Door? What You Need to Know Right Now!

When the DEA Comes Knocking: 15 Tips For a “Routine” DEA Inspection

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

As the United States continues to open back up from the COVID-19 shutdown, the Drug Enforcement Agency (DEA) is resuming on-site routine inspections.  Therefore, healthcare professionals must ensure compliance and regulatory efforts are in place.

This is part 1 of a 2-part blog series. Check back for part 2 of this blog series soon!

DEA Inspections and Site Visits:  Subpoenas.

DEA agents are often pushy, demanding, and intimidating.  They will try to use subpoenas (which are merely requests for documents that afford you at least ten days to produce the requested documents) as search warrants.  THEY ARE NOT.  They will try to use an administrative subpoena to obtain documents and get your testimony immediately. YOU DO NOT HAVE TO PRODUCE THEM RIGHT AWAY. A copy of a […]

By |2024-03-14T09:59:11-04:00February 22, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on When the DEA Comes Knocking: 15 Tips For a “Routine” DEA Inspection

From the archives: Supreme Court Explores Doctor Intent in “Pill Mill” Criminal Prosecutions Under the Controlled Substances Act

Previously published on June 24, 2022
Attorney & Author HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Physicians and other healthcare professionals usually have broad scope to prescribe most drugs, including potentially dangerous ones. However, over the past decade, many limits, often imposed arbitrarily through criminal prosecutions or drastic administrative sanctions, have been used to impose limits.

The question was recently put before the U.S. Supreme Court as to how far a physician’s judgment can be allowed to go in the context of prescribing controlled substances before it becomes criminal. This was in the context of criminal prosecution of a physician for allegedly over-prescribing.

On March 1, 2022, the U.S. Supreme Court confronted the question of whether good faith is a defense for a doctor criminally prosecuted for unlawful distribution of controlled substances. For nearly […]

By |2024-03-14T09:59:20-04:00September 18, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |1 Comment

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

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

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

Plot to Illegally Distribute Controlled Substances.

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

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

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

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

Plot to Illegally Distribute Controlled Substances.

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

Physician Gets 40 Years For Illegally Prescribing More Than Half a Million Opioid Doses

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On October 2, 2019, a Virginia doctor received a 40-year prison sentence for illegally prescribing more than half a million opioid pills over 19 months. The U.S. District Court for the Western District of Virginia handed down the sentence to Joel Smithers, who was reported to have operated a “pill mill” out of Virginia, according to authorities. In addition to prison time, he was given an $86,000 fine and will serve three years of supervised release upon the completion of his prison time, according to court documents.

The sentence is lighter than it could have been. He was facing up to life in prison and a fine of more than $200 million, according to officials at the U.S. Justice Department. Click here to view the court’s […]

By |2024-03-14T10:00:06-04:00December 26, 2019|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Physician Gets 40 Years For Illegally Prescribing More Than Half a Million Opioid Doses

Florida’s New E-Prescribing Law: How It May Affect You and Your Career

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
In 2019, Florida’s Governor Ron DeSantis signed House Bill 831 (2019), Electronic Prescribing, into law. The new bill provides important requirements for prescribers to generate and transmit all prescriptions electronically upon their license renewal or by July 1, 2021, whichever is earlier. The bill will go into effect on January 1, 2020.

Summary of New Law, HB 831.

The new law applies to any health care practitioner who is licensed by law to prescribe a medicinal drug. The law, HB 831 sets forth the following general rule for prescribing:

If you are licensed to prescribe a medicinal drug, and you:

(1) Maintain a system of electronic health records; or

(2) Are an owner, employee or contractor of a licensed healthcare facility […]

Florida Compounding Pharmacy Reaches $21 Million Settlement to End FCA Kickback Suit

George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On September 19, 2019, a Florida compounding pharmacy reached a $21.4 million settlement with the U.S. Department of Justice (DOJ) in the Southern District of Florida to resolve claims they orchestrated a $70 million kickback scheme. Diabetic Care Rx LLC, which does business as Patient Care America, and private equity firm Riordan Lewis & Haden Inc. agreed to pay to bring the False Claims Act (FCA) lawsuit to a close.

According to the DOJ, the Florida pharmacy, two executives and the private equity firm schemed to recruit beneficiaries of Tricare for medically unnecessary prescriptions such as expensive pain creams.

Details of the Case.

The DOJ claimed PCA used marketers to help recruit beneficiaries of Tricare. They allegedly paid kickbacks to solicit medically unnecessary prescriptions for expensive compounded drugs […]

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