Florida Toughens Up Drug Compounding Law for Out-of-State Pharmacies

Posted on October 6, 2014 by thehealthlawfirm

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

A new, stricter law on Florida’s compounding pharmacy industry took effect October 1, 2014.
The new law increases the restrictions for out-of-state compounding pharmacies and outsourcing facilities that ship medications into Florida. The law also gives the Florida Board of Pharmacy and Florida Department of Health (DOH) more power to oversee and penalize these companies. Click here to read the new law.

The law was enacted to increase the standards for compounding pharmacies that create medications that are supposed to be tailored to the needs of individual patients. In an effort to prevent another nationwide outbreak of fungal meningitis, similar efforts to tighten control on compounding pharmacies have been implemented by other states across the country. Click here to read a prior blog on the fungal meningitis outbreak.

The Lowdown on the New Law.

The bill requires an out-of-state compounding pharmacy or an outsourcing facility to obtain a nonresident sterile compounding permit before shipping products into Florida. Any currently-registered nonresident pharmacies must be permitted by February 28, 2015. However, all compounded sterile products shipped, mailed, delivered, or dispensed into the Sunshine State must meet Florida’s standards for sterile compounding.

The law establishes application and inspection requirements for the nonresident sterile compounding permit, as well as increased responsibilities for the Florida DOH and the Board of Pharmacy.

Under the law, the Florida DOH and Board of Pharmacy are given enhanced oversight for these out-of-state compounding pharmacies, including the authority to inspect a pharmacy or sterile compounding permittee; the cost of which is picked up by the pharmacy or permittee. The Board is authorized to discipline a nonresident pharmacy for conduct which causes or could cause serious injury, without waiting 180 days for the resident state to act. The Board is also authorized to discipline nonresident pharmacies and sterile compounding permittees for specified acts of noncompliance.

New Standards Triggered by Tainted Compounded Medications.

These new standards are being implemented two years after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. To read more: click here for the first blog and here for the second blog.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and the Board of Pharmacy, track pharmacies compounding sterile products.

Comments?

What do you think of the law to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? 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, 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 and visit our website at www.TheHealthLawFirm.com.

Sources:

Shedden, Mary. “Tougher Compounding Rules Finally Law.” Health News Florida. (September 30, 2014). From: http://bit.ly/1xBQtS0

Florida House Bill 7077

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 © 1996-2014 The Health Law Firm. All rights reserved.

Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

Posted on August 18, 2014 by thehealthlawfirm

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

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at a hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice, or has to suffer the consequences of having no legal representation.

Be Aware that Administrative Proceedings Can be Complex.

In some cases individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases it may even be possible to obtain a change in forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing.

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

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

Comments?

Have you ever had an informal or formal hearing before the Board of Pharmacy? What was the experience like? Please leave any thoughtful comments below.

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.

Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida

Posted on March 25, 2014 by thehealthlawfirm

By Lance O. Leider, J.D., The Health Law Firm

Beginning on October 1, 2014, out-of-state compounding pharmacies may be required to hold a compounded sterile product permit. That’s because the Regulated Industries Committee of the Florida Senate voted on March 13, 2014, to approve a bill increasing the restrictions on out-of-state compounding pharmacies that ship medications into Florida. These increased regulations would apply to around 300 compounding pharmacies shipping medicine to Florida.

The bill was introduced to increase standards for compounding pharmacies that create medications that are tailored to the needs of individual patients. Currently the bill is out for reference review. Considering that this is a hot issue in Florida and nationally, we expect the bill to pass.

Click here to read the entire bill.

Requirements Under the New Bill.

The bill requires out-of-state compounding pharmacies to hold a compounded sterile product permit to ship medications into Florida. Applications for the permit would be provided by the Board of Pharmacy. The bill also requires pharmacies to meet or exceed Florida’s sterile compounding standards. Under the bill, the Florida Department of Health (DOH) is responsible for inspecting out-of-state compounding pharmacies for compliance. The DOH would hold the authority to punish or revoke an out-of-state compounding pharmacy’s license for noncompliance. The pharmacy would be responsible for reimbursing the cost of the inspection.

If the bill passes, compounding pharmacies already shipping compounded sterile products into Florida may continue to do so, as long as the pharmacy receives a permit before January 31, 2015.

Permit Law for Florida Pharmacies that Compound Sterile Products.

Similarly, the Florida Board of Pharmacy promulgated a rule requiring a permit for pharmacies that compound sterile products in Florida. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit.

Click here to read more on this permit.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and U.S. Food and Drug Administration (FDA), track pharmacies compounding sterile products.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

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 bill to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? Please leave any thoughtful comments below.

Sources:

The News Service of Florida. “Pharmacy Bill, FL Budge Taking Shape.” WUSF News. (March 14, 2014). From: http://wusfnews.wusf.usf.edu/post/pharmacy-bill-fl-budget-taking-shape

Palombo, Jessica. “After Federal Compounding Pharmacy Crackdown, Fla. Panel Passes Extra Restrictions.” WFSU News. (February 12, 2014). From: http://news.wfsu.org/post/after-federal-compounding-pharmacy-crackdown-fla-panel-passes-extra-restrictions

About the Author: Lance O. Leider 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, Florida 32714, Phone: (407) 331-6620.

Central Florida Doctor’s Home and Offices Raided Over Alleged Improper Prescribing Practices

Posted on November 11, 2013 by thehealthlawfirm

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

In a joint operation, law enforcement officials raided the home and two offices of a Central Florida physician on November 8, 2013, according to the Osceola County Sheriff’s Office. The Osceola County Sheriff’s Office alleges that the doctor is being investigated for improper prescribing practices. According to the press release, this is not the first time the physician has been under investigation.

The raid was a collective effort between the Osceola County Investigative Bureau (OCIB), Florida Department of Health (DOH), Drug Enforcement Administration (DEA), Florida Department of Law Enforcement (FDLE), and the Metropolitan Bureau of Investigation (MBI).

Physician Not Arrested After Raid.

On November 8, 2013, law enforcement agents searched the physician’s home and his offices in Kissimmee, Florida and Orlando, Florida. The Florida DOH also issued an emergency order restricting the doctor’s privilege to prescribe narcotics. The physician was not arrested.

The physician was allegedly the target of two separate Florida DOH complaints in June 2013. Both complaints alleged the physician wrote prescriptions for painkillers to patients who did not have a medical need for the drugs. Click here to read the two previous complaints.

Doctor Previously Blacklisted by CVS.

According to an Orlando Sentinel article, this physician was previously placed on a CVS document referred to as the “blacklist.” This list identifies Central Florida’s top physicians prescribing oxycodone. When the list was released, the pharmacy chain notified the physicians that CVS pharmacists would no longer fill their patients’ prescriptions. This blacklist was an effort by CVS to step up internal efforts to combat the nation’s prescription drug abuse epidemic. So far, CVS has released two blacklists, one was released in November 2011, and the second list was released in August 2013. You can read more about the two lists on our blog. Click here for part one, and click here for part two.

To read the Orlando Sentinel article, click here.

Florida Losing War on Prescription Drug Abuse.

Despite the aggressive “war on prescription drugs” the Sunshine State reportedly ranks eleventh highest nationally in drug overdose deaths.

I have represented a number of physicians who have been accused of “overprescribing.” Some of these were criminal investigations by local law enforcement authorities, such as a county sheriff’s office. Some were investigations by the DEA. Some were investigations by the state licensing agency such as the Florida DOH. To read a previous blog, “Legal Tips for Physicians to Manage Pain Patients,” click here.

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

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, dentists, pharmacists, 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 (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Do you think Florida’s war on prescription drug abuse is working? Please leave any thoughtful comments below.

Sources:

Lizasuain, Twis. “Dr. Ibem Borges Investigated for Over Prescribing Drugs.” Osceola County Sheriff’s Public and Medica Relations. (November 8, 2013).

Pavuk, Amy. “Agents Raid Home, Offices of Central Florida Physician Suspected of Improper Prescribing Practices.” Orlando Sentinel. (November 8, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-doctor-ibem-borges-raid-20131108,0,735835.story

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 25 Biggest Mistakes Pharmacists Make After Being Notified of a Department of Health Complaint

Posted on December 27, 2012 by thehealthlawfirm

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

The investigation of a complaint which could lead to the revocation of a pharmacist’s license to practice and the assessment of tens of thousands of dollars in fines, usually starts with a simple letter from the Department of Health (DOH). This is a very serious legal matter and it should be treated as such by the pharmacist who receives it. Yet, in many cases, attorneys are consulted by pharmacists after the entire investigation is over, and they have attempted to represent themselves throughout the case. Often, the mistakes that have been made severely compromise an attorney’s ability to achieve a favorable result for the pharmacist.

These are the 25 biggest mistakes we see in the pharmacy cases we are called upon to defend after a DOH investigation has been initiated:

1. Failing to keep a current, valid address on file with the DOH (as required by law), which may seriously delay the receipt of the Uniform Complaint (notice of investigation), letters, and other important correspondence related to the investigation.

2. Contacting the DOH investigator and providing him/her an oral statement or oral interview. (Note: There is no legal requirement to do this.)

3. Making a written statement in response to the “invitation” extended by the DOH investigator to do so. (Note: There is no legal requirement to do this.)

4. Failing to carefully review the complaint to make sure it has been sent to the correct pharmacist. (Note: Check name and license number).

5. Failing to ascertain whether or not the investigation is on the “Fast Track” which may then result in an emergency suspension order (ESO) suspending the pharmacist’s license until all proceedings are concluded. (Note: This will usually be the case if there are allegations regarding drug abuse, alcohol abuse, sexual contact with a patient, mental health issues, or failure to comply with PRN instructions.)

6. Providing a copy of the pharmacist’s curriculum vitae (CV) or resume to the investigator because the investigator requested them to do so. (Note: There is no legal requirement to do this.)

7.Believing that if they “just explain it,” the investigation will be closed and the case dropped.

8. Failing to submit a timely objection to a DOH subpoena when there are valid grounds to do so.

9. Failing to forward a complete copy of the patient medical record when subpoenaed by the DOH investigator as part of the investigation, when no objection is going to be filed.

10. Delegating the task of providing a complete copy of the patient medical record to office staff, resulting in an incomplete or partial copy being provided.

11. Failing to keep an exact copy of any medical records, documents, letters or statements provided to the investigator.

12. Believing that the investigator has knowledge or experience in medical procedures or health care matters or procedures being investigated.

13. Believing that the investigator is merely attempting to ascertain the truth of the matter and this will result in the matter being dismissed.

14. Failing to check to see if their medical malpractice insurance carrier will pay the legal fees to defend them in this investigation.

15. Talking to DOH investigators, staff or attorneys, in the mistaken belief that they are capable of doing so without providing information that can and will be used against them.

16. Believing that because they haven’t heard anything for six months or more the matter has “gone away.” The matter does not ever just go away.

17. Failing to submit a written request to the investigator at the beginning of the investigation for a copy of the complete investigation report and file and then following up with additional requests until it is received.

18. Failing to wisely use the time while the investigation is proceeding to interview witnesses, obtain witness statements, conduct research, obtain experts, and perform other tasks that may assist defending the case.

19. Failing to exercise the right of submitting documents, statements, and expert opinions to rebut the findings made in the investigation report before the case is submitted to the Probable Cause Panel of your licensing board for a decision.

20. Taking legal advice from their colleagues regarding what they should do (or not do) in defending themselves in the investigation.

21. Retaining “consultants” or other non-lawyer personnel to represent them.

22. Believing that the case is indefensible so there is no reason to even try to have it dismissed by the Probable Cause Panel.

23. Attempting to defend themselves.

24. Believing that because they know someone with the Department of Health or a state legislator, that influence can be exerted to have the case dismissed.

25. Failing to immediately retain the services of a health care attorney who is experienced in such matters to represent them, to communicate with the DOH investigator for them, and to prepare and submit materials to the Probable Cause Panel.

Bonus Point: 26. Communicating with the Department of Health about the pending case.

Not every case will require submission of materials to the Probable Cause Panel after the investigation is received and reviewed. There will be a few where the allegations made are not “legally sufficient” and do not constitute an offense for which the pharmacist may be disciplined.

In other cases, an experienced health care attorney may be successful in obtaining a commitment from the DOH attorney to recommend a dismissal to the Probable Cause Panel. In other cases (usually the most serious ones), for tactical reasons, the experienced health care attorney may recommend that you waive your right to have the case submitted to the Probable Cause Panel and that you proceed directly to an administrative hearing. The key to a successful outcome in all of these cases is to obtain the assistance of a health care lawyer who is experienced in appearing before the Board of Pharmacy in such cases and does so on a regular basis.

Contact Health Law Attorneys Experienced with Department of Health Investigations of Pharmacists.

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.

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.

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.

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

Posted on August 31, 2012 by thehealthlawfirm

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.

South Florida Man Pleads Guilty to Fraudulently Working as a Pharmacist

Posted on August 28, 2012 by thehealthlawfirm

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.

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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.

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