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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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.

Two Florida Doctors Convicted of Money Laundering Stemming from Pill Mill Operation in Broward and Palm Beach Counties

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two South Florida doctors faced life in prison and fines up to $2 million each because nine (9) of their patients allegedly died of drug overdoses, according to the Drug Enforcement Administration (DEA). However, on July 30, 2013, a jury acquitted Cynthia Cadet, M.D., and Joseph Castronuovo, M.D., of causing the deaths of their patients. The doctors were convicted of money laundering for their role in a conspiracy involving the chain of pain clinics they worked at, according to the DEA. The doctors still face up to ten (10) years in jail for the money laundering charges, as well as forfeiture of the money made while working at the clinics. Sentencing for the doctors is set for November 4, 2013, according to the DEA.

Click here to read the press release from the DEA.

The two doctors were arrested as part of a four (4) year operation targeting a string of South Florida pain clinics. The operation, also known as “Oxy Alley,” resulted in racketeering charges against 32 people in 2010.

Defense Attorneys Argued Doctors Appropriately Examined and Diagnosed Patients.

In the case against the two doctors, prosecutors depicted the pain management clinics where the two doctors worked to be pill mills for addicts. According to an article on Reuters, prosecutors stated that addicts and distributors would come from all over the country and pay cash to be prescribed hundreds of prescription pills at a time.

Defense attorneys argued both doctors were unaware of the conspiracy and were practicing medicine in line with state standards, which allows licensed physicians to distribute opioid pain pills without fear of punishment. An expert on pain management testified that specifically Dr. Cadet’s files showed no evidence of misconduct

According to Reuters, the two clinics where the doctors worked disbursed more than 20 million oxycodone tablets between 2008 and 2010.

To read the entire article from Reuters, click here.

Legal Tips to Manage Pain Patients.

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 Department of Health (DOH).

In several cases the investigation began when the patient died of a drug overdose (in several of these cases it was unclear whether it was a suicide by the patient or an accidental overdose). In each of these cases, there was an angry, upset family member who blamed the physicians for the patient’s death. In each case, the physician I represented had no idea what the patient was going to do.

Anytime there is a death that may have been drug related, local law enforcement authorities will usually do a thorough investigation and will usually seize any prescription medications for the patient that they can find. This may result in the prescribing physician becoming the target of a homicide investigation.

To read a previous blog listing some ideas on how physicians might protect themselves from drug-seeking patients, click here.

Florida Ranks Eleventh in Nation for Prescription Drug Abuse Deaths.

Despite the aggressive “war on prescription drugs,” the stings on pill mills and Florida’s prescription drug monitoring program, the Sunshine State reportedly ranks eleventh highest nationally in drug overdose deaths. According to an article in the Orlando Sentinel, in 1999, the number of drug-overdose deaths, most from prescription drugs, was 6.4 deaths per 100,000 Florida residents. In 2013, that number is reportedly 16.4 deaths per 100,000 Florida residents.

According to the Orlando Sentinel, states were ranked by investigating ten (10) different strategies that appear effective in curbing prescription drug abuse. Florida was found to be using seven (7) of the ten (10) strategies. The article did not list the strategies that were reviewed.

Click here to read the entire article from the Orlando Sentinel.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling DEA cases. If you are currently being investigated or facing other adverse action by the DEA contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at www.TheHealthLawFirm.com.

Comments?

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

Sources:

Jameson, Marni. “Florida Ranks 11th in Nation for Prescription-Drug Abuse Death.” Orlando Sentinel. (October 10, 2013). From: http://www.orlandosentinel.com/features/blogs/vital-signs/os-prescription-drug-abuse-florida,0,2078034.post

Drug Enforcement Administration. “Jury Convicts Two Doctors of Conspiracy to Commit Money Laundering Resulting from Pill Mill Operation in Broward and Palm Beach Counties.” Drug Enforcement Administration. (August 1, 2013). From: http://www.justice.gov/dea/divisions/mia/2013/mia080113a.shtml

Fagenson, Zachary. “Florida Pain Doctors Convicted of Money Laundering.” Reuters. (July 30, 2013). From: http://www.reuters.com/article/2013/07/31/us-florida-pillmills-doctors-idUSBRE96U01D20130731

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.

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

10 Indest-2008-7By 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.

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.

Two Orlando-Area Pharmacists Arrested on Charges of Allegedly Trafficking Drugs

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two Orlando-area pharmacists were arrested on June 4, 2013, allegedly in connection to trafficking oxycodone, according to a number of local media sources. An Orlando Sentinel article states that the pharmacists are also co-owners of an Orlando pharmacy that was raided by the Metropolitan Bureau of Investigation (MBI).

This is the fourth pharmacy in the Orlando area in which a pharmacist has been arrested as a result of an MBI investigation into alleged forgery and drug trafficking operations, according to the Orlando Sentinel.

I want to point out that these are just allegations made against the pharmacists at this point in time and nothing has been proven by the state.

Pharmacists Allegedly Filling Fake Prescriptions for Drug Traffickers.

According to the Orlando Sentinel, MBI agents said the pharmacists had been under investigation since 2011. They are accused of accepting fraudulent forged prescriptions from drug-trafficking ringleaders. The drug traffickers would allegedly print off hundreds of fake prescriptions for pain medications, which were then taken to be filled at pharmacies around Central Florida.

To read the entire Orlando Sentinel article, click here.

Prescriptions Allegedly Full of Red Flags.

According to a WESH-TV report, the arrests were based on evidence of illegally selling pain medications to a local drug trafficking organization under circumstances in which there could be no reasonable good faith belief of a medical necessity. After reviewing the case, a Florida Department of Health (DOH) expert pharmacist said there were nine red flags that should have indicated that the prescriptions filled by the two arrested pharmacists were forged.

Click here to watch a report on the arrests from WESH-TV.

The Result of Crackdowns on Florida Pill Mills.

According to the director of Orange County’s Office for a Drug Free Community, the number of pill mills in Orange County, Florida, has dropped from 60 in 2010, to 23 clinics in June 2013. The number of oxycodone-related deaths are down in Florida as well. Click here to read a blog on that. However, with prescription pills harder to come by and more expensive, addicts are finding their replacement fix in heroin. To read a blog on the fight against heroin in Florida, click here.

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.

Comments?

What do you think of these pharmacy raids around Central Florida? As a pharmacist, what safeguards do you have in place so you do not fall under investigation? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Agents Raid South Orange Pharmacy, Arrest Pair.” Orlando Sentinel. (June 4, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-jr-pharmacy-raid-arrests-20130604,0,2706542.story

McDaniel, Dave. “Pharmacists Arrested on Trafficking Charges.” WESH TV. (June 4, 2013). From: http://www.wesh.com/news/central-florida/orange-county/pharmacists-arrested-on-trafficking-charges/-/12978032/20414548/-/13bxurx/-/index.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.

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

11 Indest-2008-8By 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.

Crackdown in the Supply of Prescription Medications Drive Floridians to Heroin

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

For the past three years, Florida lawmakers and officials have waged war against prescription drug abuse. At the peak of the pill abuse epidemic, seven people a day reportedly died of a prescription drug overdose in Florida. As the Sunshine State became known as painkiller capital of America, officials worked quickly to enact legislation against prescription drugs, develop and monitor the statewide prescription drug monitoring database, and crackdown on prescription drug abusers and pill mills. Flash forward to summer 2013, prescription pills are harder to come by and more expensive, therefore making them less appealing to addicts. However, that does not mean the war is over. Now addicts are finding their replacement fix in heroin, according to the Miami Herald.

Click here to read the entire article from The Miami Herald.

Oxycodone-Related Deaths Down, While Heroin Numbers Rise in Florida.

According to the Florida Department of Law Enforcement’s (FDLE) semi-annual report, oxycodone-related deaths dropped statewide between January and June of 2012, compared to the same period of time in 2011. I previously wrote a blog on the decline of oxycodone-related deaths in Florida. To read that blog, click here.

Now that oxycodone-related deaths are down, heroin numbers are on the rise. According to the Florida Medical Examiners Commission, from July 2010 to June 2011, there were 45 heroin-related deaths statewide. From July 2011 to June 2012, the number jumped to 77 heroin-related deaths. The FDLE is seeing the same trend. In the first three months of 2013, heroin-related charges totaled 948 and in the same three months in 2012, that number was 772.

Florida Officials Try to Fight Heroin.

Lawmakers took dramatic actions to reduce the supply of prescription drugs on the streets. According to the Miami Herald, lawmakers are now trying to fight heroin before it takes off.

Broward County’s substance abuse commission and the Sanford-Brown Institute hosted a workshop to share the news about the growing heroin trend. The commission’s board of governors has formed a task force to put together an anti-heroin campaign. The group is also publicizing the 911 Good Samaritan Act. This Act protects callers from prosecution for possessing or ingesting low-level controlled substances under some circumstances.

The Ultimate Results of Such Crackdowns.

The war on prescription drug abuse took away the supply, but not the demand. Since the crackdown we have seen the largest legitimate pharmacy chains in the state and nation not allowed to fill prescriptions for painkillers. Click here to read a blog on a Walgreens distribution center that was served with an immediate suspension order from the Drug Enforcement Administration (DEA). To read a blog on the DEA pulling the controlled substance licenses from two Central Florida CVS pharmacies.

This has left some patients in dire straits. They are 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.

Contact Experienced Health Law Attorneys.

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.

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 about the increase in heroin use? Is one drug more dangerous than another? Please leave any thoughtful comments below.

Sources:

Burch, Audra. “As Pill Mills Fade Away, Heroin Fills the Void.” The Miami Herald. (May 11, 2013). From: http://www.miamiherald.com/2013/05/11/3392908/as-prescription-pills-fade-heroin.html

Gillen, Michele. “Dangerous Drug Creating New Addicts.” WBFS. (May 22, 2013). From: http://miami.cbslocal.com/2013/05/22/dangerous-drug-creating-new-addicts/

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.