Purpose of Florida E-FORCSE Prescription Database Not for Disciplinary or Criminal Prosecution Purposes Against Physicians, Pharmacists or Other Health Professionals

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

8 Indest-2008-5As you are no doubt aware now, Florida has an active prescription drug monitoring program (PDMP). It is called the “Electronic-Florida Online Reporting of Controlled Substances Evaluation” or “E-FORCSE.” More often it is referred to simply as the “prescription drug database” by Florida physicians.

The Florida Legislature adopted the E-FORCSE system in Florida by Section 893.055, Florida Statutes.

Section 893.055(7)(b), Florida Statutes, States Access to Program’s Database is Limited to Program Manager.

A pharmacy, prescriber, or dispenser shall have access to information in the prescription drug monitoring program’s database which relates to a patient of that pharmacy, prescriber, or dispenser in a manner established by the department as needed for the purpose of reviewing the patient’s controlled substance prescription history. Other access to the program’s database shall be limited to the program’s manager and to the designated program and support staff, who may act only at the direction of the program manager or, in the absence of the program manager, as authorized. Access by the program manager or such designated staff is for prescription drug program management only or for management of the program’s database and its system in support of the requirements of this section and in furtherance of the prescription drug monitoring program. Confidential and exempt information in the database shall be released only as provided in paragraph (c) and s. 893.0551. . . .

Data from E-FORCSE Not Intended to be Used to Bring Disciplinary Action Against Health Care Practitioners.

Most notably, it was not the intent of the Legislature for any state or federal agency to use the data from the E-FORCSE system primarily as evidence for the purpose of taking licensure or disciplinary action against physicians, dentists, pharmacists or other licensed health professionals.

Unfortunately, we have seen cases where, contrary to the Legislature’s intent, data from E-FORCSE has been recited in a case against a licensed health professional as an example of “substandard performance,” “falling below the standard of care,” or professional “negligence.” Additionally, we have been informed of the alleged use of the E-FORCSE system by state and federal law enforcement authorities in criminal investigations and prosecutions of licensed health professionals. However, the exact wording of Sections 893.055 and 893.0551, Florida Statutes, should be carefully analyzed in determining under what conditions access and use of the information are authorized.

Defending Against E-FORCSE Data’s Being Used Against a Health Care Practitioner.

If you are a physician, dentist or pharmacist, and data from E-FORCSE is used in or discussed in any complaint investigation, license investigation, Drug Enforcement Administration (DEA) investigation, criminal investigation, administrative complaint, charge sheet or indictment, you should ask your attorney to research the advisability of filing a motion to strike it. In addition, your attorney should also consider filing a motion in limine, before any major hearing or trial, to exclude all use or mention of the data and E-FORCSE system.

In addition, the attorney for the licensed health professional may explore the possibility of moving to exclude any and all information and evidence derived from the unauthorized use of the E-FORCSE databank under the “fruit of the poisonous tree” doctrine. To date, we have not seen any cases where this has been done.

Again the exact language of Sections 893.055 and 893.0551, Florida Statutes, should be consulted to determine whether access and use have been properly authorized.

Information on Florida’s Prescription Drug Monitoring Program from the Florida Department of Health.

The information below is taken from an informational pamphlet distributed by the Florida Department of Health (DOH) called “E-FORCSE; Florida’s Prescription Drug Monitoring Program.” It is available online, at http://www.e-forcse.com.

Florida’s Prescription Drug Monitoring Program Facts.

E-FORCSE will take in controlled substance dispensing data from pharmacies and health care practitioners, and will make the information available to all health care practitioners who can then use the database to guide their decisions when prescribing and dispensing certain highly-abused prescription drugs. With this information, health care practitioners may be able to identify patients who are “doctor shopping”—obtaining multiple prescriptions for the same controlled substance from multiple health care practitioners. Doctor shopping is a felony in Florida.

Who is Required to Report Controlled Substance Dispensing Information to E-FORCSE?

Any health care practitioner who has dispensed a controlled substance in schedule II, III and IV, as defined in section 893.03, Florida Statutes-like OxyContin, Percocet, Vicodine, etc., will be required to report to the database. This includes pharmacies licensed under chapter 465, Florida Statutes, (including mail order and Internet pharmacies that dispense controlled substances into Florida) and health care practitioners licensed under chapters 458, 459, 461, 462, 465, or 466, Florida Statutes.

Who is Not Required to Report Controlled Substance Dispensing Information to E-FORCSE?

A health care practitioner who:

– Administers a controlled substance directly to a patient if the amount is adequate to treat the patient during that particular treatment session;
– Administers a controlled substance to a patient or resident receiving care as a patient, at a hospital, nursing home, ambulatory surgical center, hospice or intermediate care facility for the developmentally disabled;
– Administers or dispenses a controlled substance in the health care system of the Florida Department of Corrections;
– Administers a controlled substance in the emergency room of a licensed hospital;
– Administers or dispenses a controlled substance to a patient under the age of 16; and
– Dispenses a one-time, 72-hour re-supply of a controlled substance.

How Can E-FORCSE Help Improve a Patient’s Standard of Care?

– It allows the health care practitioners to choose and prescribe controlled substances that will not negatively interact with medicines prescribed by other health care practitioners.
– Pharmacists can determine for their patients if their health care practitioners have prescribed controlled substances that might negatively interact when used together.
– Health care practitioners can determine if their patient has had multiple prescriptions for the same drugs from multiple health care practitioners. This identifies those patients potentially engaged in the crime of doctor shopping. When health care practitioners intervene, they can help their patients find treatment.

How Can E-FORCSE Help Improve the Public Health of Florida?

Health care practitioners can identify a potentially illegal diversion pattern for drugs when they request and receive a Patient Activity Report (PAR). A PAR can alert health care practitioners to doctor shopping. In addition, this information can assist law enforcement, medical regulatory boards and the Attorney General’s Medicaid Fraud Control Unit (MFCU) with active investigations into criminal activity regarding controlled prescription drugs.

Who Has Access to the Information Stored in E-FORCSE?

A health care practitioner who is subject to licensure or regulation by the DOH under chapter 458, chapter 459, chapter 461, chapter 462, chapter 464, chapter 465, or chapter 466, Florida Statutes, will have direct access to their specific patient’s information. Other direct access to information will be limited to the E-FORCSE program manager and designated staff for the purpose of program management.

Indirect access may be requested by the following organizations upon being verified and authenticated by E-FORCSE staff.

– DOH or appropriate health care regulatory boards who are involved in a specific investigation involving a designated individual for one or more prescribed controlled substances;
– The Attorney General (AG) for Medicaid fraud cases involving prescribed controlled substances; and
– A law enforcement agency during active investigations regarding potential criminal activity, fraud or theft of prescribed controlled substances.

Are Health Care Practitioners Required to Access E-FORCSE Before Prescribing a Controlled Substance?

Health care practitioners will not be required to access E-FORCSE before prescribing a controlled substance. It will be voluntary; however, physicians are encouraged to use it as a tool to improve patient care.

Is E-FORCSE Compliant with the Federal Health Insurance Portability and Accountability Act (HIPAA)?

Yes, in addition to meeting the federal HIPAA requirements, E-FORCSE will meet all required DOH security requirements.

What is the Penalty for Disclosure of Confidential Information in the E-FORCSE Database?

A health care practitioner or other individual who has access to the information in the E-FORCSE database who discloses confidential information will be committing a third-degree felony.

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, pain management doctors, 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 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a health care practitioner, do you use E-FORCSE? Why or why not? 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.

KeyWords: prescription drug monitoring program, PDMP, Florida prescription drug monitoring program, Electronic-Florida Online Reporting Controlled Substance Evaluation, E-FORCSE, E-FORCSE data, prescription database, physician, doctor, pharmacist, dentist, health care professional, health care provider, health care practitioner, Florida Legislature, prescriber, cases against licensed health care professionals, substandard performance, falling below the standard of care, professional negligence, criminal investigation, criminal investigation of a physician, prosecution of health care professional, prosecution of physician, compliant investigation, license investigation, Drug Enforcement Administration, DEA, DEA investigation, administrative complain, charge sheet or indictment, defense attorney, defense lawyer, Florida defense attorney, Florida defense lawyer, Florida Department of Health, DOH, doctor shopping, controlled substance, Attorney General, AG, Medicaid Fraud Control Unit (MFCU), dispensing controlled substances, reporting to E-FORCSE, who can access E-FORCSE, Health Insurance Portability and Accountability Act, HIPAA, E-FORCSE HIPAA compliant, health law firm, The Health Law Firm

“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.

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

8 Indest-2008-5By 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.

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

Lance Leider headshotBy 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.

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 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.

 

“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.

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

4 Indest-2009-3By 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 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.

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

1 Indest-2008-1By 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.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

 

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.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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.

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:

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.

“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.