Pharmacy Law | The Health Law Firm Blog

Florida Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

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

In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions reimbursed by Tricare over the last year.

In April 2015, just four months into the fiscal year, it was already determined that total costs for compound drug prescriptions filled for Tricare recipients were likely to come close to $1 billion. If the trend continues, the Defense Health Agency expects it may need to reallocate funds at the end of this year to cover the prescription drug benefit, which is currently set at $8.25 billion.

For more on this new screening process and its effect on compound medication prescriptions, click here.

With prescription drug costs at an all-time high, the government is cracking down on health care fraud. This includes the implementation of data mining for fraud detection and prevention.

It was during one of these routine mining expeditions of reimbursement data that the United States Attorney’s Office identified MediMix, a compounding pharmacy in Jacksonville, Florida, as the top-biller of compounding pain prescriptions. More importantly, upon further investigation, it was found that Ankit Desai, M.D. was the top referring physician for MediMix.

The significance in the correlation between the two is that, according to reports, Dr. Desai happens to be married to one of the top executives (Senior Vice President) of Medimix.

To read the press release on this story, click here.

Anti-Fraud Laws Prohibit Certain Physician Referrals.

Health care providers are generally prohibited from referring patients to another medical-related business in which they hold a financial interest of some kind, if there are payments made with federal funds.

The prohibition on certain physician referrals is established under Section 1395nn, 42 United States Code (otherwise known as the Stark Law). The Stark Law was specifically enacted to place limitations on physician referrals so as to avoid:

(1) conflicts of interests;

(2) self-referrals;

(3) overutilization of services;

(4) increased health care costs;

(5) a limit on competition by other medical providers;

(6) to prevent ineffective and unsafe treatment; and, ultimately-

(7) fraudulent practices.

Click here for more information on the most common Federal fraud and abuse laws in health care.

The Stakes are High for Non-Compliance.

MediMix reached a settlement agreement with the government which has avoided a determination of liability. However, the Jacksonville-based compounding pharmacy did not get off without a significant penalty. The settlement will cost MediMix an impressive $3,775,458.

Click here to read more about the government cracking down on what they determine to be “a significant threat to the [Department of Defense] DoD healthcare system.”

The FCA has been highly effective in exposing fraudulent practices of pharmaceutical companies. Whistleblower cases brought under the FCA have assisted the government in recovering more than $19 billion in stolen funds due to varying pricing, billing and marketing schemes.

Avoiding False Claims Violations.

Here are the most common pharmaceutical practices that can result in allegations of FCA violations:

(1) Off-label marketing of drugs;

(2) Illegal kickbacks;

(3) Inflating the price of pharmaceuticals;

(4) Best price fraud; and

(5) Pharmaceutical benefits manager fraud.

If you find yourself in a tricky situation with possible allegations of a FCA violation, it’s best to contact an experienced health attorney immediately to properly evaluate your case and inform you of your rights.

For more about your right to consult with a lawyer prior to speaking with an investigator, please read one of our previous blogs here.

Comments?
Are you currently engaged in a questionable financial relationship? Do you agree with the law on prohibiting certain referrals in which there is a financial interest? Why or why not? Please leave any thoughtful comments below.

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 please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Department of Justice, The United States Attorney’s Office, Middle District of Florida. Press release. “United States Settles False Claims Act Allegations Against Jacksonville-Based Compounding Pharmacy.” 1 June 2015. Web. 11 Sept. 2015.

Kime, Patricia. “Tricare to Start Screening Compound Medications Friday.” Military Times. A TEGNA Co., 1 May 2015. Web. 10 Sept. 2015.

“Pharmaceutical Fraud” Web blog post. False Claims Act Resource Center. Pietragallo Gordon Alfano Bosick & Raspanti, LLP, 2015. Web. 11 Sept. 2015.

Rumph, Alan, and Donna Lee Yesner. “When Referrals And Marriage Don’T Mix: MD, Pharmacy Settle Case.” Report on Medicare Compliance. Washington: Atlantic Information Services, Inc., 8 June 2015. Web. 11 Sept. 2015.

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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Keywords: False Claims Act defense attorney, FCA, pharmaceutical fraud, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistleblowers lawyer, FCA violations, fraud detection, data mining, financial interest in physician referrals, Stark Law, Department of Defense, DoD, Tricare fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, qui tam attorney, financial relationship with physician

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:19-04:00May 15, 2018|Categories: Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacy Audit, Pharmacy Law|Tags: False Claims Act defense attorney, stark law|Comments Off

Pharmacists: Talk to a Lawyer Before You Talk to an Investigator

By Christopher E. Brown, J.D.

In Florida, You DO NOT Have to Speak to an Investigator!

Despite mailing out hundreds of thousands of postcards and letters to pharmacists, throughout Florida, we continue to receive calls from new clients and from potential clients, after they have already spoken to and made critical harmful admissions against their own interests to investigators. In Florida, you do not have any duty to cooperate with any investigator who is investigating you. This extends to Department of Health (DOH) investigators (who are sometimes titled “Medical Quality Assurance Investigators” or “Medical Malpractice Investigators”), Drug Enforcement Administration (DEA) special agents, police officers, sheriff’s deputies, or criminal investigators of any type.

The Investigator is NOT Your Friend.

Let me state this as succinctly and clearly as possible. If you are being investigated, you will not be better off making a statement. You will not be better off explaining your side of the story. The investigator is not your friend. The investigator is not on your side. All you are doing is falling for a trick and helping the government to make a case against you.

Protect Yourself and Your License.

You have a right under the U.S. Constitution to not make any statement that may be used against you. This is so important that in criminal cases government investigators are required to advise you of this by reciting to you your Miranda rights.

However, in cases where you might have your pharmacy license revoked or have your DEA number revoked, the investigator is not required to advise you of your rights.

In a criminal case, there may be ways to have your statement thrown out. However, in a professional licensing case or other administrative case, it may be too late to avoid the damage. You may be the best witness the government has, and you may be the only witness the government needs to prove this case against you.

In the case where you could receive a $100 criminal fine, the investigators are required to read you your constitutional Miranda rights and to be sure that you understand them before you make a statement. However, in a case where you can lose your professional license, where you could lose your livelihood and ability to make a living, where you could lose everything you have worked so hard to obtain, they are not required to do this. You must protect yourself.

Many pharmacists, when confronted by an investigator, who will usually call at a very inconvenient time (to catch you by surprise) and will usually flash a badge (to intimidate you), will refuse to acknowledge the seriousness of the matter and will fall for the bait to “tell their side of the story.” This can be fatal to your defense and fatal to your license.

Do NOT Help the Investigators; Do NOT Admit to Anything.

In the absence of a statement by the suspect (in this case, let’s assume this is YOU), the government may have a very difficult time of proving that you have committed any offense. It may have other witnesses (who may not be around at the time of any hearing or trial). It may have a lot of physical evidence or documents. But it may be impossible for the government investigators to make any link between you and the evidence, unless you help the investigators do this. You would be surprised at how many pharmacists believe that they can just talk their way out of the situation; in reality, they are just giving evidence that is used to make the case against them.

Any evidence at all, just admitting that you were there, admitting that the documents are yours, admitting that the patient was yours, admitting that you worked at the pharmacy, admitting that filled the prescription, admitting that the property is yours, admitting that you were on duty at the time, admitting that you have taken a drug, admitting that you signed the form, can be a crucial piece of evidence that could not otherwise be proven without your own testimony.

Remember, this is the investigators’ job and profession. This is what they do full time, every day. And they are very good at it. They are 1,000 times better at getting you to admit the crucial elements of a disciplinary infraction than you are in “talking your way out of it.” They will not be convinced by any excuses you make. They do not have to be. They will not be the ones making the final decision against you. Theirs is the job of putting together the case against you. You will help them by talking to them, explaining why your decisions are correct, explaining why what you did is excusable, etc. It will not work. You will merely be giving them enough rope to hang you with.

How to Determine the Purpose of the Investigation.

Hint: If it is a Medicaid Fraud Control Unit (MFCU) special agent (investigator), you are probably under investigation for Medicaid fraud.

Hint: If it is an “auditor,” “surveyor” or “investigator” from an agency or company with “integrity” or “program integrity” in its name, they are probably investigating you for “lack of integrity,” i.e., false claims or fraud.

Hint: If it is a Drug Enforcement Administration (DEA) special agent (investigator) they are probably investigating you to prosecute you or to revoke your DEA registration for drug or prescribing violations.

Hint: If it is an Office of the Inspector General (OIG) special agent (investigator), you are probably under investigation for Medicare fraud or Medicare false claims.

Do Not Try to Talk Your Way Out of the Investigation; Do NOT Lie.

Do not believe for a second that you are smarter than the investigator. Do not believe for a second that you will convince the investigator (or anyone else) that there is a legal or medical justification for what you did or what they allege. If it were as simple as that, then why would there be an investigation and why would you be the one being investigated?

Additionally, do not believe for a second that you can lie your way out of it, either. Remember, if the government cannot prove the basic offense that it is investigating against you, it may be able to prove that you have committed perjury or lied to an investigator. In the case of a federal official or a federal investigation, merely making a false statement (oral or written) to an investigator is a criminal act. This is what Martha Stewart and many others have served time for in federal prisons.

These investigators are lied to all the time. They are usually better at detecting lies than a polygraph expert is. Furthermore, in most cases, you will be the very last person to be interviewed. Therefore, they will already know just about everything that can be used against you. If your statement contradicts in any way what others have told them, they will know you are the one who is lying. However, knowing something or suspecting something does not mean it will be something that can be proven in court or in an administrative hearing.

Consult a Lawyer Before You Do or Say ANYTHING.

It is much better to make no statement at all. Blame it on your attorney. Tell the investigator that your attorney will kill you if you were to talk to the investigator without your attorney being there ahead of time. “Speak to my attorney.” “My attorney can help you, I can’t.”

All you have to do is state “I must talk to my lawyer before I say anything.” “I will have my lawyer contact you.” “I cannot say anything until I talk to my lawyer.” “I want a lawyer.”

If you are not the one being investigated, then there is no good reason why the investigator would want you to make a statement before you consulted with your attorney. What is the rush?

Then you must also avoid the old trick of the investigator telling you “If you don’t have anything to hide, why would you need a lawyer?” Please don’t fall for this trick, either. This is America. Smart people and rich people spend a lot of money on attorneys and other professionals to represent them and advise them. There is a good reason why they do this.

Far too often the pharmacist only calls us after he has given a statement. This is usually too late to avoid much of the damage that will have been be caused.

Everything above applies to oral statements or written statements. Do not make either. Contact a lawyer as soon as possible, preferably before making any statement, no matter how simple, defensive, self-serving or innocuous you may think it to be.

Think of this as an intelligence test. Are you smart enough to follow this guidance and avoid this type of mistake?

Contact Health Law Attorneys Experienced with Investigations of Pharmacists.

The attorneys of The Health Law Firm provide legal representation to pharmacists in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) 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.

About the Author: Christopher E. Brown, J.D. 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2024-03-14T10:01:05-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: criminal charges, D.O., dea, DEA investigation, DEA number, department of health, doh, FBI, investigation, license revoked, Medicaid investigation, Medicare investigation, pharmacist, pharmacist investigation, pharmacy investigation, physician, quality assurance|2 Comments

Food and Drug Administration (FDA) Recalls Products from Two Different Compounding Pharmacies

By Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

All Products from Med Prep Consulting Recalled.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Products from Georgia Compounding Pharmacy Allegedly Causing Eye Infections.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Franck’s Compounding Pharmacy in Florida Caused Fungal Growth.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Compounding Pharmacies Under the Microscope.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding pharmacies, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Deficiencies That are Common in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recent blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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 please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer 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 Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:11-04:00May 15, 2018|Categories: Compounding pharmacy, Department of Health, Pharmacist, Pharmacy, Pharmacy Law|Tags: administrative complaints, administrative law, attorney administrative law, Board of Pharmacy, Centers for Disease Control and Prevention (CDC), common deficiencies in pharmacy inspection, compounding pharmacy, defense attorney, defense lawyer, Department of Health (DOH), DOH hearing, DOH hearing attorney, drug recall, Florida compounding pharmacy, legal defense for administrative complaints, licensing issues, meningitis, meningitis outbreak, pharmacist, pharmacy, pharmacy attorney, pharmacy investigation, pharmacy lawyer, product recall, U.S. Food and Drug Administration (FDA)|Comments Off

How to Prepare for an Informal Hearing Before the Florida Board of Pharmacy

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

If you are scheduled to appear for an informal hearing before the Florida Board of Pharmacy, there are a number of facts that you will want to know in order to be properly prepared. This article will cover many of them.

Limited Circumstances for Informal Administrative Hearing.

First, you should understand that you will only be at an informal hearing in which you appear before the Board of Pharmacy itself for a very limited number of reasons. These will include the following:

1. If you completed an election of rights (EOR) form and agreed that you did not intend to dispute any material facts alleged against you from the administrative complaint (AC) in the case.

2. If you entered into a settlement agreement (or “stipulation”) (similar to a plea bargain in a criminal case) in which you agreed to accept discipline against your license.

3. You failed to submit any election of rights (EOR) form and failed to file a petition for a formal hearing in a timely manner, and, therefore, you have waived your right to a formal hearing.

There are a few other circumstances in which there may be an informal hearing before the Board, such as motions to modify a final order, motion to lift a suspension of a license, appearance in accordance with an earlier order, petition for a declaratory statement, or other administrative matters. This article only discusses those directly relating to disciplinary action as indicated above.

What an Informal Administrative Hearing Is Not.

1. An informal administrative hearing is not an opportunity for you to tell your side of the story. You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

2. An informal administrative hearing is not an opportunity for you to prove that you are innocent of the charges. You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

3. An informal administrative hearing is not an opportunity for you to introduce documents or evidence to show that someone else committed the offenses charged and you did not. You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

4. An informal administrative hearing is not an opportunity for you to argue that you should not be in the board’s impaired practitioners program (either the Professionals Resource Network (PRN) or the intervention Project for Nurses (IPN)) because you have completed a different program or that you do not have a problem. These are the only programs recognized and used and you have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

Formal Administrative Hearing vs. Informal Hearing.

If you desire to contest the facts alleged against you then you must state this in writing. If the material facts in a case are challenged by you, then the Board or the Department of Health (DOH) (note: all professional boards are under the Department of Health in Florida) must forward your case to the Division of Administrative Hearings (DOAH) where a neutral, objective administrative law judge (ALJ) will be appointed to hold a formal hearing in your case. This is the only way that exists for you to prove that the facts alleged against you are incorrect or that you are not guilty of the charges made against you. In fact, you do not even have to do anything in such a case. The Department of Health has the burden of proof and it has to prove the charges against you and the material facts alleged against you by clear and convincing evidence. Often, it is unable to do this at a formal administrative hearing.

However, because of the technicalities of evidentiary law and administrative law, we do not recommend that a nonlawyer attempt to represent himself or herself at such hearings. You can make technical mistakes (such as answering requests for admissions incorrectly) that severely compromise any defense you may have. We recommend that you always retain the services of an experienced health lawyer in any such matter.

What to Do If You Find That You Are at an Informal Hearing and That You Do Desire to Contest the Material Facts of the Case (And Your Guilt or Innocence).

If you have been scheduled for an informal administrative hearing and you decide that you do desire to challenge the material facts alleged against you in the administrative complaint (AC), file a written objection to proceeding at the informal hearing. State that you have discovered that there are material facts that you do desire to challenge and that you desire that the proceedings be converted to a formal hearing. File this with the Clerk of the administrative agency you are before (usually the department of health or the Agency for Health Care Administration (AHCA) and also send a copy to the opposing attorney and the executive director of the Board. Do this as early as possible and keep proof that you have actually and filed the written request.

If you are already at the informal hearing when you discover this, object to the proceedings on the record and ask to have the informal hearing be converted to a formal hearing where you may contest the material facts. State this as many times as reasonably possible.

Preparing for an Informal Hearing.

Since you are not contesting the facts alleged against you, if you are going to an informal hearing be sure you do the following:

1. Be sure you know where the hearing is going to be held. Try to stay the night before in the same hotel as the hearing will be held. You will usually have to make these reservations early in order to get a room.

2. Attend a Board meeting that occurs before the one at which your case is scheduled. This will give you a feeling for the procedures that will be followed, will help to make you less nervous when you appear, and you can obtain continuing education units for doing so (be sure to sign in and sign out). Be sure to attend one of the days when the disciplinary hearings are held.

3. Dress professionally for the appearance. This may be the most important event in your professional career. For men, this means a suit and tie or, at least, a dark coat, dark slacks and a necktie. For women, a professional business suit or the equivalent is in order. Do not dress as if you are going to the park, the beach or out on a date. Do not wear sexually provocative or revealing clothing.

4. Check the agenda that is published on line a day or two before the scheduled hearing to make sure that your case is still scheduled for the date and time on the hearing notice. Informal hearings may be moved around on the schedule. Make sure you are there at the earliest time on the hearing notice or agenda.

5. Listen to questions asked of you by Board members and attempt to answer them directly and succinctly. You will be placed under oath for the proceeding and there will be a court reporter present as well as audio recording devices to take everything down.

6. Do not argue with the Board members or lose your temper. This is not the time or place to let this happen. If you have such tendencies, then you should have an attorney there with you who can intercept some of the questions and can make defensive arguments (to the extent that they may be permitted) for you.

7. You may introduce documents and evidence in mitigation. However, you have agreed that the material facts alleged are true, so you may not contest these. In effect, you have plead guilty and you are just arguing about how much punishment (discipline) and what kind of punishment you should receive.

8. If you do intend to introduce documents and evidence in mitigation, be sure you know what the mitigating factors are (these are published in a separate board rule in the Florida Administrative Code for each professional board). These may include, for example, the fact that there was no patient harm, that there was no monetary loss, that restitution has been made, the length of time the professional has been practicing, the absence of any prior discipline, etc. You should submit these far ahead of time with a notice of filing, so that they are sent out to the board members with the other materials in your file. This is another reason to have experienced counsel represent you at the informal hearing.

9. Be prepared to take responsibility for your actions. If you are not prepared to take responsibility, then this means you must believe you are innocent and you should be at a formal hearing, not an informal one.

10. Be prepared to explain what went wrong, why it went wrong, and what remedial measures you have taken to prevent a recurrence of this type of event in the future. Show that you have learned from this experience and that you are not going to make the same mistake again.

11. It is our advice to always retain the services of an experienced attorney to represent you at such hearings. Often your professional liability insurance will cover this. If you have professional liability insurance, be sure that it contains a rider or addendum that provides coverage for professional license defense matters and administrative hearings. You need at least $25,000 to $50,000 in coverage for this type of defense. If necessary, you should contact your insurer or insurance agent and have the limits increased for a small additional premium.

Other Little Known Facts to Remember.

Professional licensing matters are considered to be “penal” or “quasi-criminal” in nature. Therefore, you have your Fifth Amendment rights in relation to being required to give evidence against yourself. You cannot be compelled to do this in such matters. However, since it is an administrative proceeding and not a criminal proceeding, there is no requirement that the licensee be advised of this by a DOH investigator or attorney.

If you enter into a settlement agreement and attend the informal hearing to approve it, nothing you say or testify to at this hearing can later be used against you. This is because you are involved in an attempt to negotiate and settle (or compromise) the claims being made against you. It is a general rule of law that nothing the parties say in such settlement proceedings can later be used as evidence if the settlement agreement is not approved. The law tries to promote settlements among parties to any dispute in this way.

It is true that on occasion the Board will examine a case on an informal hearing and will decide to dismiss it. This is rare, but it does happen. Sometimes, it will be a tactical decision on the part of you and your attorney to elect to go to an informal hearing with the hope that the Board may examine the case and decide to dismiss it. However, you cannot count on this happening.

Don’t Wait Too Late; Consult with an Experienced Health Law Attorney Early.

Do not wait until action has been taken against you to consult with an experienced attorney in these matters. Few cases are won on appeal. It is much easier to win your case when there is proper time to prepare and you have requested a formal hearing so that you may actually dispute the facts being alleged against you.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing pharmacists, pharmacies and pharmacy technicians in investigations and at Board of Pharmacy hearings. Call now or visit our website 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

By The Health Law Firm|2024-03-14T10:01:38-04:00May 15, 2018|Categories: Florida Board of Pharmacy, Pharmacy Law|Tags: administrative charges, administrative complaint, Administrative Hearing, Department of Health (DOH) Investigation, disciplinary action, disputed issues of material fact, election of rights (EOR) form, final order, formal administrative hearing, Informal hearing, mitigating factors, pharmacist, pharmacy, Professionals Resource Network (PRN), settlement agreement|Comments Off

37 Central Floridians Charged with Illicit Pharmaceutical Drug Trafficking

By Dr. Thu Pham, O.D., Law Clerk, The Health Law Firm

Attorney General Pam Bondi along with special agent Mark R. Trouville of the Drug Enforcement Administration (DEA) and Longwood Police Chief Troy Hickson announced, on June 20, 2012, the execution of 37 arrest warrants stemming from state drug charges. The defendants all reside in Central Florida.

Click here to read the entire press release from the Florida Attorney General.

The Defendants’ Charged with Felonies.

The charges for the defendants ranged from first degree to third degree felonies. The defendants have been charged with acts, such as conspiracy to traffic Oxycodone, solicitation to deliver Oxycodone, and possession of Hydromorphone with intent to sell or deliver.

Law enforcement authorities have been able to apprehend 33 of the 37 charged.

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) 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.

Sources:

myfloridalegal.com. “DEA: 37 Charged in Longwood Local Impact Drug Trafficking Conspiracy.” AG. (June 20, 2012). From Press Release: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/9E8D06F29BCB233B85257A230072572A.

Justice.gov. “Law Enforcement Dethrones “Queen” of Longwood, Florida.” DEA, Domestic Field Division. (June 20, 2012). From Press Release: http://www.justice.gov/dea/pubs/states/newsrel/2012/mia062012.html

About the Author: Dr. Thu Pham, O.D., is a law clerk 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2024-03-14T10:01:05-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: administrative law, Attorney General (AG), Central Florida, conspiracy, controlled substances, DEA investigation, DEA raid, defense attorney, defense lawyer, drug charges, Drug Enforcement Agency (DEA), drug trafficking, felonies, investigation, pharmaceutical, pharmacist, pharmacy, prescription drug trafficking|Comments Off

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council for Pharmacists

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

Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to locate an attorney or law firm that accepts this type of insurance. We have offices in Florida and Colorado, but we have attorneys licensed in Florida, Colorado, Louisiana, the District of Columbia, Virginia and other states.

Additionally, we can provide legal advice and representation in license investigations and administrative proceedings in many other states.

If you have HPSO Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it. Contact us, and we will help you.

We Will Work with Your Insurance Company.

Call us first. We can assist you in determining if your legal problem is covered by your insurance, and we can help you file a claim to have your legal defense expenses and costs covered. In most cases, we will accept the assignment of your insurance so that you do not have to worry about legal bills while your case is going on.

Contact Experienced Health Law Attorneys That Will Work with Insurance Companies.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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. 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, if your insurance company will allow this. Many of these insurers will pay our firm to represent you in the legal defense of an investigation or complaint against your professional (nursing, medical, dental, psychology, mental health counselor) license or for an administrative hearing involving professional discipline.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

By The Health Law Firm|2024-03-14T10:01:12-04:00May 15, 2018|Categories: Insurance, Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: administrative law, administrative proceedings, attorney, complaint against a health care professional, complaint against a health care provider, doctor, health attorney, health care lawyer, health care professional, health care provider, health law, health law attorney, Healthcare Providers Service Organization (HPSO) Insurance, insurance, investigation of a health care professional, investigation of a health care provider, legal bills, legal defense expenses, mental health counselor, pharmacist, physician, professional discipline, professional liability insurance, psychologist|Comments Off

South Florida Man Pleads Guilty to Fraudulently Working as a Pharmacist

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

On July 24, 2012, a 49-year-old man from Ruskin in South Fla., pleaded guilty in federal court to fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ) in a press release.

Fake Pharmacist was Working at Central Florida Pharmacies.

Prosecutors said this man worked at pharmacies throughout Central Florida, including CVS pharmacy and Walgreens. According to the Orlando Sentinel, while working at one of the pharmacies, he gave a customer the incorrect medication, causing that person to suffer a severe reaction and stroke.

Alleged Identity Theft to Obtain Pharmacist License.

Allegedly, the man fraudulently obtained a pharmacist license in September of 2000 from the State Department of Health (DOH) by using the name, date of birth, Social Security number and pharmacy education information of a licensed pharmacist.

The fake pharmacist was able to renew the license and was allegedly receiving paychecks from pharmacies through the mail.

Will The Real Pharmacist Please Stand Up?

Local authorities began investigating the South Florida man after a legitimate pharmacist in Arizona reported that his identity had been stolen.

The legitimate pharmacist first learned in 2007 that someone was using his identity in Florida when the Internal Revenue Service (IRS) contacted him about undeclared earnings. He had never worked in Florida and learned someone was posing as him and working as a pharmacist under his name, according to the court records.

To see the full press release on this case, click here.

A Long List of Charges Could Mean Prison Time.

The fraudulent pharmacist pled guilty to mail fraud, aggravated identity theft, and money laundering in Orlando. He faces up to 20 years in federal prison for the mail fraud charge, 10 years for the money laundering charge, and a minimum of two years for any other sentence for the aggravated identity theft charge, the Justice release said.

The Federal Bureau of Investigation (FBI) and the Drug Enforcement Administration (DEA) investigated the case with assistance from the Florida Department of Health’s Division of Medical Quality Assurance.

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

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

Sources:

FBI.gov. “Pharmacist Impersonator Charged with Mail Fraud, Identity Theft, and Money Laundering.” FBI, Tampa Division. (July 24, 2012). From Press Release: http://www.fbi.gov/tampa/press-releases/2012/pharmacist-impersonator-pleads-guilty-to-mail-fraud-identity-theft-and-money-laundering

TBO.com. “Ruskin Man Admits Identity Theft in Fake Pharmacist Case.” Tampa Bay Online. (July, 24, 2012). From: http://www2.tbo.com/news/health-4-you/2012/jul/24/ruskin-man-admits-identity-theft-in-fake-pharmacis-ar-440248/

Pavuk, Amy. “Feds: Man Stole Pharmacist’s Identity, Worked at Pharmacies Across Metro Orlando.” Orlando Sentinel. (July 24, 2012). From: http://articles.orlandosentinel.com/2012-07-24/news/os-pharmacist-stolen-identity-20120724_1_pharmacies-illinois-court-federal-court

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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

By The Health Law Firm|2024-03-14T10:01:38-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: criminal charges, dea, DEA investigation, DEA number, department of health, Department of Justice, doh, DOJ, FBI, identity theft, investigation, legal defense for pharmacists, legal representation for pharmacists, license revoked, pharmacies, pharmacy investigation, quality assurance|Comments Off

Two Pharmacists and One Dentist in Central Florida Arrested for Prescribing and Dispensing Prescription Drugs

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

The Lakeland Ledger reports that Polk County Sheriff’s Detectives arrested a dentist and two pharmacists on September 5, 2012, in three unrelated cases dealing with illegally prescribing and dispensing painkillers. The sheriff’s office said the three arrests are part of its efforts to target prescription drug abuse.

To read the entire Lakeland Ledger article, click here.

The Arrest of the Dentist’s Daughter Led to His Investigation and Arrest.

In May 2012, the dentist’s daughter was arrested for allegedly forging more than 500 hydrocodone prescriptions. That arrest led deputies and the Department of Health (DOH) to search the dentist’s clinic. According to the Lakeland Ledger article, out of 43 patient files randomly selected, 31 patients were being prescribed hydrocodone without any documentation.

The Polk County Sheriff’s Office stated that the dentist has been charged with knowingly overprescribing controlled narcotics.

To see the press release from the sheriff’s office on the dentist’s arrest, click here.

Both Pharmacists Caught by Undercover Detectives.

According to the Lakeland Ledger, the two pharmacists that were arrested allegedly illegally dispensed either oxycodone or hydrocodone to undercover detectives. The pharmacists have been charged with trafficking prescription painkillers.

Click here to see the press release on the pharmacists’ arrests from the Polk County Sheriff’s Office.

Arrests Part of Crack Down on Abuse of Prescription Drugs.

According to the Polk County Sheriff’s Office, these arrests are part of an ongoing investigation to target doctors and pharmacists that are improperly prescribing and dispensing prescription medications.

There is an article on our website on legal tips for physicians to manage pain patients. To read that piece, click here.

Criminal Arrest of Over-Prescribers May come From Many Different Agencies.

Physicians and pharmacists who are involved in schemes relating to overprescibing or trafficking in narcotics may be targeted by many different agencies. The local sheriff’s office or police department is just one of them.

We have represented physicians who have been the subjects of Drug Enforcement Administration (DEA) investigations. The DEA will often use undercover agents and informants to pose as patients, wired for audio recording. The DEA will often work with local law enforcement authorities and the Department of Health (DOH).

Other investigations and arrests may be initiated by a statewide prosecutor’s office, which is under the Attorney General. Still others have been initiated by the Medicaid Fraud Control Unit (MFCU) where Medicaid funds are used.

Contact Health Law Attorneys Experienced in Representing Health Care Providers in DOH Cases.

The Health Law Firm represents pharmacists, pharmacies, physicians, nurses, and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.

If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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

Sources:

Malagon, Elvia. “Lakeland Dentist and Two Pharmacists Charged with Prescription Drug Violation.” The Lakeland Ledger. (September 5, 2012). From: http://www.theledger.com/article/20120905/NEWS/120909682?template=printart

Eleazer, Carrie. “PCSO Detectives Arrest Two Pharmacists from Trafficking in Prescription Drugs.” Polk County Sheriff’s Office. (September 5, 2012). From: http://www.polksheriff.org/NewsRoom/Pages/09-05-2012PCSO%20DetectivesArrestTwoPharmacistsForTraffickinginPrescriptionDrugs.aspx

Eleazer, Carrie. “Dr. William Johnson of Sonrise Dental Clinic Arrested.” Polk County Sheriff’s Office. (September 5, 2012). From: http://www.polksheriff.org/NewsRoom/News%20Releases/Pages/09-05-2012.aspx

About the Authors: Danielle M. Murray 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

By The Health Law Firm|2024-03-14T10:01:05-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy Law, Trafficking Prescription Painkillers|Tags: defense attorney, dentist defense, Department of Health (DOH) Investigation, Drug Enforcement Administration (DEA) investigation, Florida prescription drug abuse, Florida prescription drug crackdown, Medicaid Fraud Control Unit (MFCU) investigation, overprescribing pain medication, prescription drug trafficking. pharmacist defense, prescription drugs, undercover agents|Comments Off

Feds File Two Lawsuits Against Novartis for Allegedly Giving Kickback to Pharmacists and Physicians

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

Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by NPC to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe NPC products that were reimbursed by federal health care programs.

Click here to read the entire press release from the DOJ.

Doctors and Pharmacists Allegedly Paid to Prescribe.

Both lawsuits allege NPC violated the Anti-Kickback Statute. In the April 23, 2013, complaint against NPC the lawsuit alleges the company gave kickbacks, in the form of rebates and discounts to pharmacies in exchange for the pharmacies’ cooperation in switching patients from competitors’ drugs to NPC products.

The April 26, 2013, lawsuit accuses NPC of paying doctors to speak about certain drugs at events that were allegedly social occasions. Many of the programs were allegedly held in circumstances in which it would be impossible to have a presentation. According to the DOJ, this included fishing trips off the Florida coast and meetings in Hooters restaurants. NPC is also accused of treating health care professionals to expensive dinners. The payments and dinners were apparently kickbacks to the doctors for writing prescriptions for NPC drugs.

Doctors in the Sunshine State Allegedly Involved.

The lawsuit alleges at least six Florida doctors of participating in the bogus conferences and taking thousands of dollars in kickbacks, according to the Tampa Bay Times. The doctors are not named or charged in the civil lawsuit.

To read the allegations listed in the lawsuit against Florida doctors, click here for the Tampa Bay Times article.

Novartis Claims Discounts and Physician Speaker Programs Were Legitimate.

In a press release, NPC disputes all of the government’s allegations. The pharmaceutical company states that discounts and rebates by pharmaceutical companies are a customary and legal procedure, as recognized by the government. It also addresses the physician speaker programs by saying the programs are also acceptable practices designed to inform physicians about the uses of different types of medicines. Click here to read the entire press release from NPC.

Kickbacks and The Law.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Whistleblower or Qui Tam Lawsuits Can Results in a Big Pay Day.

The original complaint against NPC was allegedly filed under the qui tam, or whistleblower, provisions of the False Claims Act by a former sales representative.

Individuals working in the health care industry, whether for hospitals, pharmacies, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities. Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog series on whistleblower/qui tam lawsuits I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit, and more. Click here to read the first part of this blog, and click here for the second part.

The Health Law Firm Lawyers are Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm represent plaintiffs, patients, health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

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

Sound Off.

Have you head about these two lawsuits? What are your thoughts? Please leave any thoughtful comments below.

Sources:

Masow, Julie. “Novartis Pharmaceuticals Corporation Disputes Allegations in Two US Government Lawsuits and Looks Forward to a Fair Discussion of the Facts.” Novartis Pharmaceuticals. (April 26, 2013). From: http://www.pharma.us.novartis.com/newsroom/pressreleases/137176.shtml

Davis, Brittany Alana. “Lawsuit: Pharmaceutical Company Gave Kickbacks to Florida Doctors.” Tampa Bay Times. (May 3, 2013). From: http://www.tampabay.com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133

Department of Justice. “United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs.” Department of Justice. (April 26, 2013). From: http://www.justice.gov/opa/pr/2013/April/13-civ-481.html

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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:12-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law, Whistleblower|Tags: anti-kickback statute, attorney's fees, CHAMPUS, defense attorney, defense lawyer, Department of Justice (DOJ), doctor, doctor kickbacks, false billing, false claims, false claims act, Florida health care attorney, Florida health care lawyer, health law, hospital, kickbacks, legal representation, medicaid, medicaid audit, Medicaid false claims, Medicaid fraud, medical group, medicare, medicare audit, Medicare false claims, Medicare fraud, Novartis Pharmaceuticals Corporation (NPC), pharmacist, pharmacy, physician, qui taim, qui tam relator, qui tam suits, the health law firm, TRICARE, unnecessary procedures, Veterans Administration, whistleblower, whistleblower attorney, whistleblower lawyer, whistleblower protection|Comments Off

Drug Enforcement Agency (DEA) Serves Up Immediate Suspension Order for Walgreens Distribution Center

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

On September 14, 2012, the Drug Enforcement Agency (DEA) blocked the Walgreens distribution center in Jupiter, Florida, from shipping oxycodone and other controlled drugs to its pharmacies in Florida and the East Coast with an immediate suspension order, according to the DEA. In the press release, the DEA called the Walgreens distribution facility an “imminent danger” to the public.

To see the entire press release from the DEA, click here.

Back in April 2012, the DEA served an administrative inspection warrant at the same facility, as well as its six top retail Walgreens pharmacies in Florida. To see my blog post on that story, click here.

DEA Named the Distribution Center “Largest Distributor of Oxycodone Products in Florida.”

The DEA said the Jupiter distribution center has been “the single largest distributor of oxycodone products in Florida” since 2009. The DEA issued the suspension order because it believes Walgreens failed to maintain proper controls to ensure its retailers didn’t dispense drugs to addicts and drug dealers.

The order only applies to the Jupiter distribution center and only suspends the distribution of controlled substances.

Whether or not bath salts fall into this category is unclear. The Florida Legislature recently banned the sale of bath salts and 90 other substances to help stop the big face-eating zombie outbreak in Florida. See my blog on bath salts and the zombie outbreak in Florida.

Recently, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. The two stores are accused of dispensing an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances. There is a blog on this story on our website, click here to read it.

Six Walgreens Pharmacies Allegedly Purchased Millions of Oxycodone Pills.

According to a USA Today article, six of Walgreens’ Florida pharmacies allegedly ordered more than a million oxycodone pills a year. One pharmacy in Oviedo, Florida, went from ordering more than 80,000 oxycodone pills in 2009, to nearly 1.7 million in 2011.

Click here to read the USA Today article.

DEA Continues to Fight Prescription Drug Abuse in Florida.

According to the DEA, this is an effort to curb Florida’s prescription drug epidemic. Special Agent Mark Trouville, with the DEA’s Miami Division, said all DEA licensees “have an obligation to ensure that medications are getting into the hands of legitimate patients. When they choose to look the other way, patients suffer and drug dealers prosper.”

Neither Agent Trouville nor the DEA was, apparently, requested to comment on the bath salts ban and its effect on the zombie outbreak, however.

Meaningless Numbers Used for Shock and Awe.

I really do not see why the public or our elected representatives are shocked and awed by the meaningless numbers and statistics used in connection with these matters. The fact that Walgreens, the biggest pharmacy retailer in Florida, might distribute over a million oxycodone pills in a year, is a meaningless statistic by itself. If a doctor prescribes a pain management patient a prescription for three (3) pills a day, that is approximately 90 pills per month or 1,080 pills per year. If Walgreens has only 1,000 patients with such a prescription in a year throughout the entire state of Florida, that is in excess of one million (1,000,000) pills per year. I would venture to guess that many single Walgreens retail stores have more than 1,000 customers per day, much less all Walgreens stores throughout Florida.

My point is that any such statistics are meaningless out of context and are only meant to sound huge of one doesn’t stop and think about it.

Another concern is that many, if not the vast majority of the Walgreens customers who now will not be able to get their prescriptions filled, are legitimate pain management patients with legitimate prescriptions written by legitimate physicians.

Crackdowns Leave Pain Patients to Suffer.

I am constantly being contacted by patients who are in dire straits, suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

If the largest legitimate chains of pharmacies in the state and nation are not allowed to fill these prescriptions, where will these suffering patients turn? Are these actions driving our citizens into the hands of shady independent pharmacies that have fewer safeguards and less accountability? Are these actions driving our citizens to seek out illegal drug dealers and turn to illegal drugs to cope with their legitimate medical problems? I hope not.

Thank you. I will get off my soapbox now.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, 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 please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Leinwand, Donna. “DEA Inspects Walgreens for Oxycodone Probe.” USA Today. (September 15, 2012). From: http://www.usatoday.com/news/nation/story/2012/09/14/walgreens-and-oxycodone/57782912/1

Pavuk, Amy. “DEA Blocks Controlled-Substance Distribution at Florida Walgreens Facility.” Orlando Sentinel. (September 14, 2012). From: http://articles.orlandosentinel.com/2012-09-14/news/os-walgreens-dea-suspension-20120914_1_distribution-center-dea-miami-field-division

DEA. “DEA Serves a Suspension Order on Walgreens Distribution Center in Jupiter, Florida.” DEA.gov. (September 14, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia091412.shtml

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., Altamonte Springs, FL 32714, Phone: (407) 331-6620. He does not own stock in Walgreens or any other pharmacy.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:39-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pain Management, Pharmacist, Pharmacy, Pharmacy Law|Tags: administrative hearings, controlled substance licenses, DEA defense attorney, DEA defense lawyer, DEA raid, defense attorney, Drug Enforcement Administration (DEA) administrative law attorney, emergency suspension order, Immediate Suspension Order, investigation, pharmacist, pharmacy, pharmacy investigation, prescription drug trafficking, registration, revoked license|Comments Off