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. A copy of a sample subpoena used by the DEA is on our website for reference here.


Not Just a Routine Audit, Inspection, or Investigation.

Beware the “Notice of Inspection of Controlled Premises” (DEA Form 82).   Although the DEA often treats it as one, it is not a search warrant.  Also, it is probably NOT a “Routine Inspection.”  IT WILL NOT TAKE ONLY 15 TO 20 MINUTES.

We have had several clients who have had to close down their businesses all day to try to accommodate the demands of the agents performing their “routine inspection.”  The DEA should not cause you to shut down or should not cause you to turn away patients.  It should not interfere with your patient services or your ability to provide them.  You can ask them to come back at a later date.

The DEA often refers to “routine audits” as “Accountability Investigations” and requires the pharmacy or registrant to be given certain rights in connection with it. For example, DEA Form 82 states you are given the following rights:

1.    The constitutional right not to have an administrative inspection without an Administrative Inspection Warrant (AIW),
2.    Has the right to refuse consent to such an inspection,
3.    Presented with a Notice of Inspection,
4.    Given consent voluntarily, without threats of any kind,
5.    May withdraw consent at any time during the course of the inspection, and
6.    Incriminating evidence may be seized and used in criminal prosecution.

Although the DEA agent may tell you that the site visit is “completely random,” do not believe it.  If the DEA agent has brought a list of records to obtain from you, try to keep a copy of it, as your lawyer may find it very useful later when they are defending you.


What to Do When Confronted with a DEA Inspection or Site Visit.

1.    Notify the owner right away.  If you are not the owner, don’t sign anything, give permission, or agree to anything. You probably have no authority to do so.

2.    Call your health lawyer and get them over immediately.  This is an emergency!

3.    Yes, you have the right to consult with your attorney;  do not believe them if they say you can’t (which they may do, believe it or not).

4.    Request photo identification from everyone to ensure the individuals are who they say they are.  No identification? No access. Federal agents, including DEA agents, will always have their photo ID.

5.    Obtain a business card from each person present.  DEA agents always carry business cards.  If they do not have one, you will have to write all contact information for that agent from their photo id card (or photocopy, if they will allow you to do so).

6.    Do the same as the above for anyone else the DEA brings, whether they claim to be a federal or state investigator, Department of Health investigator, or local police. Please note that our experience has been that the DEA and state agencies contend that they don’t go on joint inspections or investigations (however, we don’t believe this to be true).  Therefore, get all parties’ information at the very start, or you may never get it until they testify against you.

7.    DO NOT SIGN A VOLUNTARY AGREEMENT TO RELINQUISH YOUR DEA REGISTRATION.  Agents may try to pressure and intimidate you into signing one by telling you it will be easier if you sign it. They might even try to scare you by warnings of criminal prosecution unless you sign it.  Yes, you have the right to consult with an attorney before deciding whether or not to sign it (they may falsely tell you that you don’t). However, once you sign it, it is gone.  If you are a prescribing physician or health professional, your authority to prescribe is gone forever.  If you are a pharmacy/pharmacist, your ability to order or fill any controlled substances is forever gone. So go ahead and put a sign on the door that says “CLOSED-Out of Business.”

8.    Before the inspection begins, you should be given a form to read and sign. If not, request it. It will usually be a DEA Form 82 “Notice of Inspection of Controlled Premises” Form. Before the inspection, it should be read, explained, agreed to, and signed, not during or after.

9.    Read the form carefully. You have the right to fax it, scan and e-mail it, or call and read it to your attorney before you sign it. If it says you have the right to refuse the inspection, consider putting it off until a later date. Especially if you are busy and have patients you must serve.

10.    Obtain a copy of the form (inspection form or subpoena) at the beginning and keep it.  You will need this later.

11.    Obtain a complete, detailed receipt for any documents, prescriptions, or other items taken by the agents. Again, since this is not a search warrant, the DEA does not have the authority to take your only originals and leave you without a copy.

12.    You may or may not be in serious trouble and subject to future criminal charges or administrative action to revoke your DEA registration. Your attorney should be able to evaluate this and advise you. Don’t bother to ask the agents, as they will not tell you what is in your own best interest to know.

13.    If you don’t have an attorney who is experienced in health law and DEA defense,  get one NOW.  You should begin preparing now.  It often takes the DEA a year or more to work up charges against you.  Once you are served with charges, you will only have a very short time to prepare your defense.  It is a completely unfair system for the subject of charges as the government will have longer to prepare its case against you than you have to prepare your defense.  Take advantage of the time you have. Do not waste it.

14.    Be polite and do not argue with a DEA agent.

15.    Do not volunteer information, but never tell a lie. Making a false statement to any federal agent is a felony criminal offense. A subpoena for documents is not an authorization to interrogate you.  A search warrant is not an authorization to interrogate you.

Lastly, don’t forget to check back to read part 2 of this blog series.

Please remember: This blog’s statements are opinions based on our experience.  If you do not agree with it, then you are probably the DEA.

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

The attorneys of The Health Law Firm provide legal representation to physicians, pharmacists, pharmacies, medical groups, nurses, nurse practitioners, CRNAs, dentists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in 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.


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.


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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 © 2022 The Health Law Firm. All rights reserved.

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 of your most important constitutional rights?


Don’t Get Fooled By What the DEA Agents Tell You.

The DEA has the reputation (and, in my experience, deservedly so) of making false statements to individuals about what will happen to them or not happen to them if they do not “Cooperate” with the DEA by giving up their rights.

Often they will handcuff the pharmacist or the physician who is the subject of their raid, search warrant, or subpoena as a method of intimidating them. Then they will threaten the person by arresting them and jailing them immediately if they do not sign a “voluntary” relinquishment of their DEA registration. Yet once you do this, your DEA registration is gone, and you will most likely never get one again.

We have even had the report from a physician recently where the DEA agents, during executing a search warrant (not an arrest warrant, by the way), of having the doctor sign a document waiving her right to having a grand jury hearing on any charges she may have been facing. The threat was that she needed to waive her rights or be arrested on the spot and taken to jail. She signed without consulting an attorney.

If you are a pharmacist or pain management physician, or you own or operate a pain management practice, or if you prescribe or dispense opioids, you must have the name and phone number of a good health lawyer and a good criminal lawyer on hand and post at all times! It is only a matter of time before you need to use it.

Have this information in your wallet and taped to every telephone and computer in your office. But use it right away. Call your attorney right away. Your attorney will come over or brief you on what to do or not do.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH, and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law, as well as licensed health professionals who are also attorneys.

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

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

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 © 2022 The Health Law Firm. All rights reserved.

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 of your most important constitutional rights?


Don’t be fooled by what the DEA agents tell you.

The DEA has the reputation (and, in my experience, deservedly so) of making false statements to individuals about what will happen to them or not happen to them if they do not “Cooperate” with the DEA by giving up their rights.

Often they will handcuff the pharmacist or the physician who is the subject of their raid, search warrant, or subpoena as a method of intimidating them. Then they will threaten the person by arresting them and jailing them immediately if they do not sign a “voluntary” relinquishment of their DEA registration. Yet once you do this, your DEA registration is gone, and you will most likely never get one again.

We have even had the report from a physician recently where the DEA agents, during executing a search warrant (not an arrest warrant, by the way), of having the doctor sign a document waiving her right to having a grand jury hearing on any charges she may have been facing. The threat was that she needed to waive her rights or be arrested on the spot and taken to jail. She signed without consulting an attorney.

If you are a pharmacist or pain management physician, or you own or operate a pain management practice, or if you prescribe or dispense opioids, you must have the name and phone number of a good health lawyer and a good criminal lawyer on hand and post at all times! It is only a matter of time before you need to use it.

Have this information in your wallet and taped to every telephone and computer in your office. But use it right away. Call your attorney right away. Your attorney will come over or brief you on what to do or not do.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH, and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law, as well as licensed health professionals who are also attorneys.

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

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

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 © 2022 The Health Law Firm. All rights reserved.

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 sample subpoena used by the DEA is on our website for reference here.

Not Just a Routine Audit, Inspection, or Investigation.

Beware the “Notice of Inspection of Controlled Premises” (DEA Form 82).   Although the DEA often treats it as one, it is not a search warrant.  Also, it is probably NOT a “Routine Inspection.”  IT WILL NOT TAKE ONLY 15 TO 20 MINUTES.

We have had several clients who have had to close down their businesses all day to try to accommodate the demands of the agents performing their “routine inspection.”  The DEA should not cause you to shut down or should not cause you to turn away patients.  It should not interfere with your patient services or your ability to provide them.  You can ask them to come back at a later date.

The DEA often refers to “routine audits” as “Accountability Investigations” and requires the pharmacy or registrant to be given certain rights in connection with it. For example, DEA Form 82 states you are given the following rights:

1.    The constitutional right not to have an administrative inspection without an Administrative Inspection Warrant (AIW),
2.    Has the right to refuse consent to such an inspection,
3.    Presented with a Notice of Inspection,
4.    Given consent voluntarily, without threats of any kind,
5.    May withdraw consent at any time during the course of the inspection, and
6.    Incriminating evidence may be seized and used in criminal prosecution.

Although the DEA agent may tell you that the site visit is “completely random,” do not believe it.  If the DEA agent has brought a list of records to obtain from you, try to keep a copy of it, as your lawyer may find it very useful later when they are defending you.


What to Do When Confronted with a DEA Inspection or Site Visit.

1.    Notify the owner right away.  If you are not the owner, don’t sign anything, give permission, or agree to anything. You probably have no authority to do so.

2.    Call your health lawyer and get them over immediately.  This is an emergency!

3.    Yes, you have the right to consult with your attorney;  do not believe them if they say you can’t (which they may do, believe it or not).

4.    Request photo identification from everyone to ensure the individuals are who they say they are.  No identification? No access. Federal agents, including DEA agents, will always have their photo ID.

5.    Obtain a business card from each person present.  DEA agents always carry business cards.  If they do not have one, you will have to write all contact information for that agent from their photo id card (or photocopy, if they will allow you to do so).

6.    Do the same as the above for anyone else the DEA brings, whether they claim to be a federal or state investigator, Department of Health investigator, or local police. Please note that our experience has been that the DEA and state agencies contend that they don’t go on joint inspections or investigations (however, we don’t believe this to be true).  Therefore, get all parties’ information at the very start, or you may never get it until they testify against you.

7.    DO NOT SIGN A VOLUNTARY AGREEMENT TO RELINQUISH YOUR DEA REGISTRATION.  Agents may try to pressure and intimidate you into signing one by telling you it will be easier if you sign it. They might even try to scare you by warnings of criminal prosecution unless you sign it.  Yes, you have the right to consult with an attorney before deciding whether or not to sign it (they may falsely tell you that you don’t). However, once you sign it, it is gone.  If you are a prescribing physician or health professional, your authority to prescribe is gone forever.  If you are a pharmacy/pharmacist, your ability to order or fill any controlled substances is forever gone. So go ahead and put a sign on the door that says “CLOSED-Out of Business.”

8.    Before the inspection begins, you should be given a form to read and sign. If not, request it. It will usually be a DEA Form 82 “Notice of Inspection of Controlled Premises” Form. Before the inspection, it should be read, explained, agreed to, and signed, not during or after.

9.    Read the form carefully. You have the right to fax it, scan and e-mail it, or call and read it to your attorney before you sign it. If it says you have the right to refuse the inspection, consider putting it off until a later date. Especially if you are busy and have patients you must serve.

10.    Obtain a copy of the form (inspection form or subpoena) at the beginning and keep it.  You will need this later.

11.    Obtain a complete, detailed receipt for any documents, prescriptions, or other items taken by the agents. Again, since this is not a search warrant, the DEA does not have the authority to take your only originals and leave you without a copy.

12.    You may or may not be in serious trouble and subject to future criminal charges or administrative action to revoke your DEA registration. Your attorney should be able to evaluate this and advise you. Don’t bother to ask the agents, as they will not tell you what is in your own best interest to know.

13.    If you don’t have an attorney who is experienced in health law and DEA defense,  get one NOW.  You should begin preparing now.  It often takes the DEA a year or more to work up charges against you.  Once you are served with charges, you will only have a very short time to prepare your defense.  It is a completely unfair system for the subject of charges as the government will have longer to prepare its case against you than you have to prepare your defense.  Take advantage of the time you have. Do not waste it.

14.    Be polite and do not argue with a DEA agent.

15.    Do not volunteer information, but never tell a lie. Making a false statement to any federal agent is a felony criminal offense. A subpoena for documents is not an authorization to interrogate you.  A search warrant is not an authorization to interrogate you.

Lastly, don’t forget to check back to read part 2 of this blog series.

Please remember: This blog’s statements are opinions based on our experience.  If you do not agree with it, then you are probably the DEA.

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

The attorneys of The Health Law Firm provide legal representation to physicians, pharmacists, pharmacies, medical groups, nurses, nurse practitioners, CRNAs, dentists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in 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.


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.


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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 © 2022 The Health Law Firm. All rights reserved.

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 90 minutes, the Supreme Court heard oral arguments from both sides, struggling with the exact wording of the Controlled Substances Act (CSA), the clarity of the relevant federal regulation, and the proposition that a doctor who lacked subjective criminal intent could nevertheless go to jail for a substantial period of time, up to life imprisonment.

The two physicians whose cases are being considered are Xiulu Ruan, who was sentenced to 21 years in prison in 2017 for allegedly running a “pill mill,” and Shakeel Kahn, who was sentenced to 25 years in prison in 2019 for crimes including drug distribution of controlled drugs resulting in the death of a patient. The court consolidated their cases for the Supreme Court’s hearing.

Controversial Legal Standards Used to Convict.

The legal standard in question centers heavily on a disputed sentence in the Controlled Substances Act (CSA) that says, “Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally” to distribute controlled substances. The central question is how juries should assess the intentions of a doctor accused of prescribing narcotic painkillers outside “the usual course of his professional practice.”

The U.S. Department of Justice (DOJ) argued that the criminal intent standard is an objective one — or an “honest effort” to comply with professional norms. On the other hand, the attorneys for the doctors who were prosecuted argue that the standard must be subjective; that is did the doctor subjectively believe they were not prescribed for a legitimate medical purpose. This distinction gives rise to whether there is merely a violation of regulation as opposed to a crime having been committed.

Throughout the oral arguments, various justices seemed to cast doubt on whether deviating from mainstream standards on opioid prescribing is sufficient to throw physicians in jail, which could result in years or life in prison. In some states, this might even result in a death sentence, pretty drastic for what would otherwise be medical negligence.

How This Ruling Will Impact Future Prosecutions.

This case and the upcoming ruling raise alarms for healthcare providers and advocates for pain patients. Many fear that the ruling could enable even more aggressive prosecutions of opioid prescribers. They warn that such a decision could discourage doctors from providing opioids even when they’re fully warranted. In addition, the outcome could affect civil litigation accusing large pharmaceutical companies of recklessly selling prescription narcotics.

After hearing the oral arguments, the Supreme Court seemed likely to demand more substantial proof of intentional wrongdoing when the DOJ prosecutes opioid prescribers. A decision from the High Court is expected by late June 2022. The cases are Ruan v. U.S., case number 20-1410, and Kahn v. U.S., case number 21-5261, in the Supreme Court of the United States.

We will definitely keep you posted on the outcome of this case.

Click here to read one of my blogs about controlled substances and compliance.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in different cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and administrative hearings at both the state and federal levels.

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

Sources:

Overley, Jeff. “High Court Poised To Make DOJ’s Job Harder In Opioid Cases.” Law360. (March 1, 2022.) Web.

Gluck, Abby. “In opioids “pill mill” case, justices grapple with physician intent.” SCOTUS Blog. (March 2, 2022). Web.

Joseph, Andrew. “Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court.” STAT News. (February 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 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 |2024-03-14T09:59:20-04:00September 18, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |1 Comment

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 |2024-03-14T09:59:23-04:00August 22, 2023|Categories: Mental Health Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Miami, Florida Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

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 |2024-03-14T09:59:24-04:00August 8, 2023|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Man Sentenced to 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

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 |2024-03-14T09:59:25-04:00July 17, 2023|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Miami Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

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 |2024-03-14T09:59:27-04:00June 26, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

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.

By |2024-03-14T09:59:40-04:00May 4, 2021|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Colorado Board of Pharmacy Must Hand Over Patient Identifying Data to DEA Says Judge
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