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.

Advertisements

Generic Drug Maker Ranbaxy Pleaded Guilty to Claims of Adulterated Drugs-Must Pay $500 Million Fine

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

Generic drug maker Ranbaxy USA Inc., pleaded guilty to drug safety violations and will be responsible for paying $500 million in criminal and civil fines, according to the Department of Justice (DOJ). The fines will resolve claims that the manufacturer sold inferior drugs and made false statements to the U.S. Food and Drug Administration (FDA) about manufacturing practices at two factories in India. This announcement was made by the DOJ on May 13, 2013. This settlement is the largest drug settlement to date involving a generic drug manufacturer and drug safety.

To read the entire press release from the DOJ, click here.

Ranbaxy USA Inc., is a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited. The entities listed in the settlement include: Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories, Inc., Ohm Laboratories, Inc., and Ranbaxy USA, Inc. (collectively “Ranbaxy”).

Criminal Fine and Forfeiture.

Ranbaxy admitted to not conducting proper safety and quality tests of several drugs manufactured at two of its plants in India, according to the DOJ. Under the settlement the company pleaded guilty to three felony counts of violating the federal drug safety law. Ranbaxy agreed to pay $150 million in criminal fines and forfeitures.

False Statements Made to FDA.

According to the DOJ, Ranbaxy also pleaded guilty to four felony counts of knowingly making false statements to the FDA in annual reports. To settle civil claims under the False Claims Act and related state laws, Ranbaxy agreed to pay $350 million. This fine was to resolve false claims that were submitted to government health care programs such as Medicare, Medicaid, TRICARE and the Department of Veterans Affairs. The settlement was entered into by all 50 states, the District of Columbia and the federal government.

Florida Will Receive $3 Million from Settlement.

According to the Florida Attorney General (AG), Florida will receive more than $3 million as a result of the settlement. AG Pam Bondi stated that the Medicaid Fraud Control Unit (MFCU) will not allow Florida taxpayers to pick up the tab for pharmaceutical companies that manufacture, distribute and sell adulterated pharmaceutical drugs.

Click here to read the settlement agreement between the State of Florida and Ranbaxy.

Example of Florida’s Civil Forfeiture Act.

This is an example of Medicaid fraud through the use of adulterated and “counterfeit” drugs, as well as the use of Florida’s Civil Forfeiture Act in a Medicaid case. To learn more on civil forfeiture and defending against seizures of property, click here for a previous blog.

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 this settlement agreement? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA.” Department of Justice. (May 13, 2013). From: http://www.justice.gov/opa/pr/2013/May/13-civ-542.html

Meale, Jenn. “Attorney General Bondi Enters $350 Million National Settlement with Ranbaxy Resolving Adulterated Drug Claims” Florida Office of the Attorney General. (May 14, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/505E50CA109D827885257B6B006BA668

Settlement Agreement between the State of Florida and Ranbaxy Laboratories Limited. Case No. 10-05-01. (May 14, 2013). From: http://www.thehealthlawfirm.com/uploads/Ranbaxy%20Settlement%20agreement.pdf

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.

Nation Rx Drug Abuse Summit Held in Central Florida-Leaders Share Struggles and Triumphs in “War Against Prescription Drugs”

11 Indest-2008-8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

From April 2 through April 4, 2013, the country’s leading experts on the prescription drug epidemic met in Central Florida for the National Rx Drug Abuse Summit, according to the Orlando Sentinel. National leaders including the White House drug czar, the director of the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) commissioner and Florida’s Attorney General (AG) shared ongoing challenges and strides each department has made in its fight against prescription drugs.

Good News in the War Against Prescription Drugs.

The Florida Department of Law Enforcement (FDLE) stated in its semi-annual report that oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. In the first half of 2012, there were 759 oxycodone-related deaths in Florida. That number is down from 1,058 during the same time period a year before.

A look at the national numbers shows that the number of people abusing prescription drugs is down. According to the White House drug czar, seven million people abused prescription drugs in 2010. By 2011, that number had dropped to 6.1 million. Studies also show prescription drug use among young adults ages 18 to 25 is also on the decline. To read the article from the Orlando Sentinel, click here.

Summit Focused on Need for More State Prescriptions Drug Monitoring Programs.

During the summit leaders spoke of the need to help state prescription drug monitoring programs succeed.

Just in March 2013, three states made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new regulations regarding the use of prescription drug monitoring programs. What this means is that whatever state you may be in, you should be aware that lawmakers are implementing similar programs and laws in their governments. To learn more, click here.

Drug Monitoring Programs Can Be Used as a Prosecution Tool.

Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool. Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

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 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Does the state where you are located have a prescription drug monitoring program? What do you think of these programs? Are they necessary? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “‘We Can Stop This Epidemic,’ CDC Boss Says at Rx-Drug Abuse Summit in Orlando.” Orlando Sentinel. (April 2, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-prescription-drug-abuse-summit-20130402,0,4693169.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.