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In Brief: Florida Pain Management Clinic Laws

Every health profession has its own set of rules and regulations. This week, we’re examining Florida laws under which pain management clinics operate.

Because Florida has one of the worst drug trafficking problems in the country, law enforcement is making sure that punishments for any violations are severe. For example, if a patient dies of drug overdose and the prescriber is found to be responsible, he or she can be charged with homicide, which was the case for a Palm Beach County pain management physician (see this New York Times article).

The DEA, Florida Department of Health and Florida law enforcement are watching pain management clinics very closely in order to keep Florida’s drug trafficking problem under control. Make sure that your clinic abides by the following legislation, in order to prevent any interference with your practice.

The 2011 Florida Statutes

Section 458.3265, F.S.:

Definition of Pain Management Clinic:

Pain-management clinic” or “clinic” means any publicly or privately owned facility:
(I) That advertises in any medium for any type of pain-management services; or
(II) Where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic nonmalignant pain.

Registration:

Every pain-management clinic must register with the Florida Department of Health UNLESS:

1. That clinic is licensed as a facility pursuant to chapter 395;

2. The majority of the physicians who provide services in the clinic primarily provide surgical services;

3. The clinic is owned by a publicly held corporation whose shares are traded on a national exchange or on the over-the-counter market and whose total assets at the end of the corporation’s most recent fiscal quarter exceeded $50 million;

4. The clinic is affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows;

5. The clinic does not prescribe controlled substances for the treatment of pain;

6. The clinic is owned by a corporate entity exempt from federal taxation under 26 U.S.C. s. 501(c)(3);

7. The clinic is wholly owned and operated by one or more board-certified anesthesiologists, physiatrists, or neurologists; or

8. The clinic is wholly owned and operated by one or more board-certified medical specialists who have also completed fellowships in pain medicine approved by the Accreditation Council for Graduate Medical Education, or who are also board-certified in pain medicine by a board approved by the American Board of Medical Specialties and perform interventional pain procedures of the type routinely billed using surgical codes.

Physician Responsibilities:

1. A physician may not practice medicine in a pain-management clinic, if the pain-management clinic is not registered with the department. Any physician who qualifies to practice medicine in a pain-management clinic pursuant to rules adopted by the Board of Medicine as of July 1, 2012, may continue to practice medicine in a pain-management clinic as long as the physician continues to meet the qualifications set forth in the board rules. A physician who violates this paragraph is subject to disciplinary action by his or her appropriate medical regulatory board.

2. A person may not dispense any medication on the premises of a registered pain-management clinic unless he or she is a physician licensed under this chapter or chapter 459.

3. A physician, a physician assistant, or an advanced registered nurse practitioner must perform a physical examination of a patient on the same day that the physician prescribes a controlled substance to a patient at a pain-management clinic. If the physician prescribes more than a 72-hour dose of controlled substances for the treatment of chronic nonmalignant pain, the physician must document in the patient’s record the reason for prescribing that quantity.

4. A physician authorized to prescribe controlled substances who practices at a pain-management clinic is responsible for maintaining the control and security of his or her prescription blanks and any other method used for prescribing controlled substance pain medication. The physician shall comply with the requirements for counterfeit-resistant prescription blanks in s. 893.065 and the rules adopted pursuant to that section. The physician shall notify, in writing, the department within 24 hours following any theft or loss of a prescription blank or breach of any other method for prescribing pain medication.

5. The designated physician of a pain-management clinic shall notify the applicable board in writing of the date of termination of employment within 10 days after terminating his or her employment with a pain-management clinic that is required to be registered. Each physician practicing in a pain-management clinic shall advise the Board of Medicine, in writing, within 10 calendar days after beginning or ending his or her practice at a pain-management clinic.

6. Each physician practicing in a pain-management clinic is responsible for ensuring compliance with facility and physical operations requirements

Inspection:

1. The department shall inspect the pain-management clinic annually, including a review of the patient records, to ensure that it complies with this section and the rules of the Board of Medicine.

2. During an onsite inspection, the department shall make a reasonable attempt to discuss each violation with the owner or designated physician of the pain-management clinic before issuing a formal written notification.

3. Any action taken to correct a violation shall be documented in writing by the owner or designated physician of the pain-management clinic and verified by followup visits by departmental personnel.

Penalties and Enforcement:

1. The department may impose an administrative fine on the clinic of up to $5,000 per violation for violating the requirements of this section; chapter 499, the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug Abuse Prevention and Control Act; chapter 893, the Florida Comprehensive Drug Abuse Prevention and Control Act; or the rules of the department. In determining whether a penalty is to be imposed, and in fixing the amount of the fine, the department shall consider the following factors:

  • The gravity of the violation, including the probability that death or serious physical or emotional harm to a patient has resulted, or could have resulted, from the pain-management clinic’s actions or the actions of the physician, the severity of the action or potential harm, and the extent to which the provisions of the applicable laws or rules were violated.
  • What actions, if any, the owner or designated physician took to correct the violations.
  • Whether there were any previous violations at the pain-management clinic.
  • The financial benefits that the pain-management clinic derived from committing or continuing to commit the violation.

2. Each day a violation continues after the date fixed for termination of the violation as ordered by the department constitutes an additional, separate, and distinct violation.

3. The department may impose a fine and, in the case of an owner-operated pain-management clinic, revoke or deny a pain-management clinic’s registration, if the clinic’s designated physician knowingly and intentionally misrepresents actions taken to correct a violation.

4. An owner or designated physician of a pain-management clinic who concurrently operates an unregistered pain-management clinic is subject to an administrative fine of $5,000 per day.

5. If the owner of a pain-management clinic that requires registration fails to apply to register the clinic upon a change of ownership and operates the clinic under the new ownership, the owner is subject to a fine of $5,000.

For more information about Florida pain management clinics, visit www.TheHealthLawFirm.com.

Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak

The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S.

The CDC reports that eye drops and injections traced back to the lab caused the infections. These ophthalmic products contained multiple fungal and bacterial species, according to the CDC. The products have now been recalled, but were in use for over a year before the recall. The CDC has also issued a warning to avoid any product labeled sterile from Franck’s.

The patients impacted by the contaminated products had all undergone some type of eye procedure in which the Franck’s products were used. 23 patients have allegedly suffered some vision loss as a result of the infection.

The Florida Department of Health (DOH) has stated that it cannot divulge if Franck’s or any other pharmacy is being investigated at this time. If the pharmacy is believed to pose an immediate threat to patient safety, the DOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.

Franck’s has released a statement saying that the pharmacy is fully cooperating with the DOH and FDA. Franck’s says it is currently cooperating to conduct product recalls and will assist in post-recall inspections to prevent future occurrences.

This is not the first time that this Central Florida pharmacy has made headlines. In 2009, the pharmacy was blamed for the deaths of over twenty polo horses in south Florida. This was also allegedly caused by a contaminated compound. Because of this case, the FDA tried to stop Franck’s from compounding veterinary products.

However, Franck’s won in U.S. District Court when United States v. Franck’s Lab, Inc. was decided in December 2011. In this case, the federal court ruled that the FDA does not have the authority to regulate the practice of pharmacists compounding veterinary prescriptions from bulk substances. The decision in favor of the pharmacy can be found here.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. It’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

Sources Include:

Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012). From
http://www.foxnews.com/health/2012/05/04/cdc-links-eye-infections-to-troubled-florida-pharmacy/#ixzz1tvHCA4yg

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012). From:
http://www.cbsnews.com/8301-504763_162-57427915-10391704/rare-fungal-eye-infections-tied-to-fla-pharmacy-cdc-warns/

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012) From
http://www.gainesville.com/article/20120503/ARTICLES/120509811?tc=ar

United States v. Franck’s Lab, Inc., No. 5:10-cv-147-Oc-32TBS (M.D. Fla., Sept. 12, 2011).

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012). From
http://www.wftv.com/news/news/local/ocala-pharmacy-blamed-dozens-people-suffering-visi/nNWCR/

Nurses Rx: Medication Administration

From George Indest’s Nursing Law Manual

Nurses face a busy schedule often including a long list of patients and extensive work hours. As a result, they can become overworked and overtired, which may lead to mistakes when carrying out essential job duties like administering medication. An Institute of Medicine (IOM) report titled To Err is Human: Building a Safer Health System (IOM, Dec. 1999) states the deaths from medication errors that take place both in and out of hospitals, more than 7,000 annually, exceed those from workplace injuries. In a separate report, investigation by the Chicago-Tribune states that since 1995, at least 1,720 hospital patients have died and 9,548 others have been injured because of mistakes made by RN’s across the country (Associated Press, Sept. 10, 2000).

Because nurses are usually the front-line health care providers who are required to administer medications prescribed by physicians (and often the most potent medications to critically ill patients), they must be especially careful in their procedures and practices to avoid one of the many types of common medication errors. The most common types of medication errors include:

1. similar sounding medication name;

2. administration without a prescription;

3. the wrong medication;

4. the wrong dosage;

5. negligent injection;

6. failure to note an order change;

7. failure to administer medication;

8. failure to discontinue medication;

9. use of an unsterile needle;

10. the wrong patient;

11. allergic reactions; and

12. failure to assure patient taking medications.

Nurses are required to handle and administer a vast variety of drugs that are prescribed by physicians and dispensed by an organization’s pharmacy. Medications may range from aspirin to esoteric drugs that are administered through intravenous solutions. These medications must be administered in the prescribed manner and dose to prevent serious harm to patients.

There are a variety of ways to ensure that, as a nurse, you are helping to prevent medication errors within your facility. Use this checklist from George Indest’s Nursing Law Manual in order to maintain safe administration procedures.

Nurses are exempted from the various pharmacy statutes when administering a medication on the oral or written order of a physician. However, the improper administration of medications can lead to malpractice suits.

ADMINISTRATION OF CONTROLLED MEDICATIONS WITHOUT A PRESCRIPTION

A nurse should never administer prescription medications without a valid prescription or order from a physician. In effect, doing that constitutes practicing medicine without a medical license and is beyond the scope of a nurse’s license. Administering medications without approval may give rise to legal liability and disciplinary action against the nurse.

ADMINISTERING THE WRONG MEDICATION

The injection of the wrong medication into a patient can lead to civil liability or to a charge of substandard nursing care made to the Department of Health. A nurse who prepares medication for a physician is liable for the preparation of that medication. A physician can blame a nurse who fails to prepare the medication properly in order to escape liability.

In the case of Ambercrombie v. Roof, a solution was prepared by a nurse employee and injected into the patient by a physician, 28 N.E. 2d 772 (Ohio 1940). The physician made no examination of the fluid, and the patient suffered permanent injuries as a result of the infection. An action was brought against the physician for malpractice. The patient claimed that the fluid injected into her was alcohol and that the physician should have recognized its distinctive odor. The court, in finding for the physician, stated that the physician was not responsible for the misuse of drugs prepared by the hospital, unless the ordinarily prudent use of his faculties would have prevented injury to the patient.

GIVING THE WRONG DOSAGE

A nurse is responsible for making an inquiry if there is uncertainty about the accuracy of a physician’s medication order in a patient’s record. A nurse who is in doubt about a physician’s orders should contact that physician and seek clarification of their order.

WRONG ROUTE

The nurse in Fleming v Baptist General Convention, 742 P.2d 1087 (Okla. 1987), negligently injected the patient with a solution of Talwin and Atarax subcutaneously, rather than intramuscularly. The patient suffered tissue necrosis as a result of the improper injection. The suit against the hospital was successful. On appeal, the court held that the jury’s verdict for the plaintiff found adequate support in the testimony of the plaintiff’s expert witness on the issues of nursing negligence and causation.

FAILURE TO NOTE AN ORDER CHANGE

A nurse’s failure to review a patient’s record before administering a medication, to ascertain whether an order has been modified, may render a nurse liable for negligence.

FAILURE TO ADMINISTER MEDICATION

In Kallenberg v. Beth Israel Hospital, 357 N.Y. S.2d 508 (N.Y. App. Div. 1974), a patient died after her third cerebral hemorrhage because of the failure of the physicians and staff to administer necessary medications. When the patient was admitted to the hospital, her physician determined that she should be given a ceratin drug to reduce her blood pressure and make her condition operable. For some unexplained reason, the drug was not administered. The patient’s blood pressure rose, and after a hemorrhage, she died. The jury found the hospital and physicians negligent in failing to administer the drug and ruled that the negligence had caused the patient’s death. The appellate court found that the jury had sufficient evidence to decide that the negligent treatment had been the cause of the patient’s death.

FAILURE TO DISCONTINUE A MEDICATION

A health care organization will be held liable if a nurse continues to inject a solution into a patient after noticing its ill effects. Once something is observed to be wrong with the administration of the medication, the nurse has a duty to discontinue its use.

NONSTERILE NEEDLE

The blood donor in Brown v. Shannon West Texas Memorial Hospital, 222 S.W. 2d 248 (Tex. 1949), sought to recover from a serious injury allegedly caused by the use of a nonsterile needle. The court held that the burden of proof was on the plaintiff to show, by competent evidence, that the needle was contaminated when used and that it was the proximate cause of the alleged injury. The mere proof, said the court, that infection followed the use of the needle or that the infection possible could be attributed to the use of an unsterile needle was insufficient. If the plaintiff had been able to prove the needle was not sterile, then the plaintiff would have recovered damages.

WRONG PATIENT

It is of utmost importance to check each patient’s name bracelet before administering any medication. To ensure that the patient’s identity corresponds to the name on the patient’s bracelet, the nurse should address the patient by name when approaching the patient’s bedside to administer any medication. Especially in nursing homes and hospitals where there may be more than one patient in a room, this is exceptionally important. Should the nurse unwittingly administer one patient’s medication to a different patient, the attending physician should be notified and appropriate documentation placed on the patient’s chart.

ALLERGIC REACTIONS

Any adverse reactions to a medication should be charted on the patient’s medical record. The attending physician and the facility’s pharmacy should be advised as to the patient’s allergic reaction.

FAILURE TO MONITOR AND ENSURE PATIENT TAKING MEDICATIONS

A nurse normally has a duty to monitor and ensure that a patient is taking their medications. A failure to perform this act can lead to nursing negligence on the part of the nurse.

THE “SEVEN RIGHTS” OF PATIENT MEDICATION

There is a checklist every nurse should learn called the “Seven Rights of Medication.” If this checklist is memorized and followed in every case, medication errors would be significantly reduced or eliminated altogether. Every nurse and nursing student should memorize this list and go through it in her mind every time a patient is administered a medication by the nurse.

Always check for and confirm:

1. The right medication;

2. The right patient;

3. The right dose;

4. The right time;

5. The right route;

6. The right reason; and

7. The right documentation;

The nurse may be the last wall of defense to protect a patient from a medication error. The nurse should avoid at all costs, being rushed, tired, inattentive, sloppy, or lazy. Guard at every turn against medication errors. For more information about nursing law, or to read more from the Nursing Law Manual, visit www.TheHealthLawFirm.com.

Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

Franck’s Pharmacy Urges Physicians to Assist in Recall Efforts.

Franck’s Pharmacy is seeking the assistance of physicians in alerting patients who may be impacted by the recall. Franck’s Pharmacy is also advising physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Any adverse events should be reported to Franck’s Pharmacy and the FDA’s MedWatch program.

Franck’s Pharmacy Ceases Production of Sterile Compounds.

Franck’s Pharmacy also announced that it will stop producing sterile compounds at its Ocala lab facility for the present. Franck’s Pharmacy made the announcement via e-mail on May 23, 2012. The e-mail also confirmed that several employees had been laid off. Allegedly, these employees were terminated due to the sterile compounding shutdown. Franck’s Pharmacy will continue to compound non-sterile human and veterinary medicine.

Franck’s Pharmacy Recently Linked to Eye Infection Outbreak.

Franck’s Pharmacy decided to cease sterile compounding after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used. For additional information on this, click here.

Prior Deaths of 30 Polo Ponies.

In an earlier unfortunate incident in 2009, Franck’s Pharmacy’s compounding of veterinarian prescriptions allegedly led to the deaths of approximately 30 expensive polo ponies here in Florida. Click here for details. In the aftermath of that case, the FDA attempted to prevent Franck’s Pharmacy from any further compounding of pharmaceuticals for veterinary purposes. The FDA eventually lost the case heard by the U.S. District Court, Middle District of Florida, which ruled in favor of Franck’s Pharmacy. The decision can be seen here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

Sources Include:

Franck, Paul. “Urgent: Compounding Prescriptions Recall.” Franck’s Pharmacy. Press Release. (May 23, 2012). From
http://www.francks.com/

Medina, Carlos E. “Franck’s Ceases Sterile Compounding Service.” Ocala.com. (May 23, 2012) From
http://www.ocala.com/article/20120523/ARTICLES/120529872/-1/entertainment02?template/

Benchmark: DEA Conduct Resulted in Dismissed Charges

In light of the DEA‘s recent focus on Florida’s prescription drug trafficking problem, we wanted to discuss a former case in which the DEA‘s actions resulted in a favorable outcome for alleged drug dealers.

According to the Daily Journal, in 2004, U.S. District Judge Florence-Marie Cooper dismissed charges against three alleged methamphetamine dealers after an attorney to one of the defendants argued that the informant improperly relied on a “subinformant” to set up drug transactions in order for DEA agents to bust suspected dealers. According to the attorney, the informant used the intermediary to protect himself and the DEA from entrapment claims. Because of this, defense attorneys could not derive from the primary witness how the drug sale was arranged.

The attorney claimed that the subinformant contacted old friends and acquaintances in low-income areas and informed them of money to be made if they could find a large amount of methamphetamine for a prospective buyer. The informant posed as the buyer. By repeatedly calling these individuals to find a source for the methamphetamine transactions, the subinformant would turn the case over to the informant right before the transaction took place.

In this case, the DEA provided evidence only of the final interactions between the informant and the defendants. The attorney wanted to show that the entrapment actually occurred earlier, when the subinformant allegedly pressured the defendants to complete the methamphetamine deal.

In laying out the subinformant scheme in his discovery motion, the attorney cited phone records between the subinformant and the defendants in his case and in two other methamphetamine cases, U.S v. Parra, 03-CR- 121, and U.S. v. Corcuera, 03-CR-24. In the three cases, the subinformant had regular and frequent contact with the defendants, but the informant had very little or no contact with the defendants before the arrests.

Cooper agreed that the informant used an underling to keep the defense from analyzing the details of the drug deal. According to Cooper, using an intermediary to do the actual work assigned to the informant, allows the DEA to protect itself from inspection and from any charges of improper conduct.

“A law enforcement agency must not be allowed to shield itself from accountability by hiring someone outside of law enforcement who is free to violate citizens’ rights.” U.S. v. Alvarez, 02-CR-355.

With a subinformant, there is no requirement to monitor their actions. The DEA doesn’t tape, keep records or provide discovery for subinformants. The DEA has a history of failing to regulate its informants, including the nationwide Andrew Chambers scandal. An internal investigation launched by the DEA in 2000 revealed that Chambers repeatedly lied under oath over a 16-year period in which he earned almost $2 million to help bust drug felons.

However, even if informants were regulated it wouldn’t prevent subinformants from negotiating the transactions that entrap individuals.

These investigative measures by the DEA are also being used in operations directed at Florida pain clinics. In an effort to rid the state of pill mills, the DEA is using every tool to bust clinics, physicians and pharmacists that might be involved in a suspicious pain clinic.

For more information about legal matters concerning pain clinics, visit www.TheHealthLawFirm.com.

411-PAIN Settles with Florida Attorney General

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

Florida Attorney General Pam Bondi announced that her office has reached a settlement with 411-PAIN. The settlement requires 411-PAIN to pay $550,000 and change its advertising practices for allegedly making misrepresentations to consumers. 411-PAIN is a Florida-based attorney and chiropractic referral service.

411-PAIN Allegedly Misrepresented Consumer Entitlements.

The Attorney General pursued action against 411-PAIN for the company’s alleged violation of Florida’s Deceptive and Unfair Trade Practices Act, Chapter 501, Part II, Florida Statutes. To view Florida’s Deceptive and Unfair Trade Practices Act, click here.

Allegedly, the company misrepresented that consumers could be entitled to $100,000 or more for injuries and lost wages as a result of accidents. The company also allegedly misrepresented that consumers could be entitled to more than $10,000 in personal injury protection compensation or benefits for injuries and lost wages. The alleged misrepresentations were made through the company’s advertising.

Additionally, 411-PAIN was accused of falsely stating that police officers require consumers to call 411-PAIN after calling emergency services following an auto accident. This was allegedly conveyed through the company’s advertisements which used actors dressed as police officers. The advertisements allegedly did not feature a disclosure that the individuals in the commercials were actors and not actual law enforcement officers.

Attorney Services Allegedly Misrepresented by 411-PAIN.

411-Pain also allegedly misrepresented attorney services to consumers. The company is accused of stating that consumers would be referred to a “qualified” attorney or “specialized” attorney who specializes in the type of injury or accident they sustained, when no such attorney specialization exists in Florida.

Settlement Restricts the Company’s Advertising.

The settlement reached by the state in Broward Circuit Court prohibits 411-PAIN from
 • Promising any monetary compensation in its ads; 
 • Saying it’s referring victims to a “specialized attorney;” 
 • Using images of law enforcement officers to suggest that officials are directing consumers to use 411-Pain after calling 911, unless the officer is labeled as a “paid actor.”

To view the full settlement, click here.

Sources:

Cohen, Bryan. “Florida AG Settles with 411-PAIN.” Legal Newsline. (June 5, 2012). From:
http://www.legalnewsline.com/news/contentview.asp?c=236354

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.

Florida’s Pill Mills Still a Target

Last week, the DEA announced the results of enforcement efforts directed at Florida’s illegal prescription drug distributors.

According to the DEA, more than 100 individuals have been arrested in operations targeting pill mills in Florida, and the DEA, as well as Florida law enforcement, will continue to investigate and prosecute pain clinics, pharmacies and physicians who are contributing to Florida’s prescription drug trafficking epidemic.

Operation Pill Nation I, initiated in February 2011 in South Florida, has resulted in the arrest of 47 people, including 17 doctors and five clinic owners, and the seizure of more than $18.9 million in cash and assets. Furthermore, over 70 doctors, six pharmacy owners and five DEA Registered Controlled Substance Distributors have been stripped of their DEA registrations.

Operation Pill Nation II has resulted in enforcement actions against 22 individuals and one pharmacy allegedly involved in the illegal distribution of prescription drugs.

The DEA also announced the addition of a third Tactical Diversion Squad in Florida. Based in Orlando, this new group will be responsible for investigating prescription drug diversion in Central Florida.

According to the Orlando Sentinel, this new squad was created solely to investigate the illegal use and distribution of prescription drugs in the Orlando area. Currently, the Orlando squad is investigating doctors and pharmacies, their first case involves a Winter Park pharmacy.

Howell Branch Road’s The Medicine Shoppe is under investigation. It’s pharmacist is accused of  providing more than 15,000 oxycodone pills that were illegally distributed.

Coinciding with the DEA’s announcements, was the investigation of Tampa pill mills. DEA agents, and Florida state and local law enforcement executed six search warrants and served two immediate suspension orders to a doctor and a pharmacy in Tampa. Immediate suspension orders revoke authority to dispense or prescribe controlled substances.

Earlier this year, the DEA commissioned a pill mill hotline in Florida. This 24-hour pill mill tip line and e-mail address allow the public to provide information on suspicious pain clinics. Additionally, laws targeting pill mills were passed that makes it much more difficult to dispense narcotics at a clinic. However, the DEA’s raids will continue in order to eradicate Florida’s pill mill problem.

For more information on Florida pain clinics and the laws and legal matters that impact them, visit www.TheHealthLawFirm.com.

George Indest is an attorney, board certified by the Florida Bar in Health Law, who represents health care professionals and providers, including pain management clinics and pain management physicians.

Settlement Reached in GlaxoSmithKline Healthcare Fraud Case

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

GlaxoSmithKline (GSK), a prescription drug manufacturer, will pay $3 billion in fines to resolve allegations of healthcare fraud. The settlement was announced by federal prosecutors on July 1, 2012, and in a press release from the Florida Attorney General on July 2, 2012. This is the largest healthcare fraud settlement in U.S. history.

Settlement Resolves Allegations Against GSK Related to Healthcare Fraud.

The settlement resolves allegations that GSK:

  • Marketed the depression drug Paxil for off-label uses, such as use by children and adolescents; 
  • Marketed the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages; 
  • Marketed the asthma drug Advair for off-label uses, including first-line use for asthma;
  • Marketed the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions; 
  • Marketed the nausea drug Zofran for off-label uses, including pregnancy-related nausea; 
  • Made false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
  • Offered kickbacks to healthcare professionals to induce them to promote and prescribe certain prescription drugs; and
  • Submitted incorrect pricing data for various prescription drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.

GSK Will Also Plead Guilty to Criminal Charges as Part of Settlement.

As part of the settlement, GSK has will plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (FDCA). Allegedly, GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs contained labels that were not in accordance with their FDA approvals. Additionally, GSK allegedly failed to report certain clinical data regarding Avandia to the FDA.

Florida to Receive Over $56 Million In Settlement.

Florida will receive more than $56 million as part of the settlement with GSK. Florida Attorney General, Pam Bondi, announced the state’s participation in the settlement on July 2, 2012.

Settlement Stems From Whistleblower Actions.

The settlement is based on four qui tam, or whistleblower, actions brought by individuals pursuant to state and federal false claims. To view the federal False Claims Act, click here. A National Association of Medicaid Fraud Control Units team, along with several other federal agencies, investigated the matter and conducted settlement negotiations with the defendants. Florida’s civil investigation was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is part of the Medicaid Fraud Control Unit.

Contact Health Law Attorneys Experienced in Healthcare Fraud Cases.

The Health Law Firm represents physicians, medical practices, pharmacists, pharmacies, and other health providers in healthcare fraud cases, including investigations, regulatory matters, litigation, and audits involving government health programs (Medicare, Medicaid, TRICARE).

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

Sources Include:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Historic Healthcare Fraud Settlement.” Florida Office of the Attorney General. (July 2, 2012). Press Release. From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/E494FDADFF113AC885257A2F0068F790

Schmidt, Michael S. and Katie Thomas. “GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement.” New York Times. (July 2, 2012). From: http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

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.

From the DOH: Attention Pain-Management Clinics

From the Florida Department of Health:

Florida law requires pain-management clinics report specific data to the Board of Medicine.  The designated physician shall report on a quarterly basis the following data:

a.  The number of new and repeat patients seen and treated at the clinic who are prescribed controlled substance medications for the treatment of chronic, nonmalignant pain.

b.  The number of patients discharged due to drug abuse.

c.  The number of patients discharged due to drug diversion.

d.  The number of patients treated at the pain clinic whose domicile is located somewhere other

OSTEOPATHIC PHYSICIANS:
Your next reporting period is the month of October and you will be reporting for the period July 1, 2011 – September 30, 2011.

ALLOPATHIC PHYSICIANS:
Your first reporting period is the month of October and you will be reporting for the period July 1, 2011 – September 30, 2011.
New Service Available for Data Reporting

We have now made data reporting easy for you with an online service.  Simply follow these steps:

  • Go to http://www.doh.state.fl.us/mqa/index.html
  • Click on Login on the right side of the screen
  • The Designated Physician will login under his/her user id and pass code (same one used to renew medical license).  If the physician does not remember the user name or password, have him/her go to the login web page.  From there, the physician will select Get Login Help.  If the physician is still unable to get logged in, then have him/her call (850) 488-0595 for assistance.
  • Once logged in, select the clinic data will be reported for and follow the online instructions to input the data.
  • Be sure to print your submission when prompted.

Recent changes to Section 458.3265 and Section 459.0137(2)(e), Florida Statutes, which became effective July 1,2011, require Medical and Osteopathic physicians to advise the Board of Medicine within 10 calendar days of beginning or ending practice at a pain-management clinic.

We have made this easy for your physicians.  By going to www.doh.state.fl.us/mqa physicians can login to Medical Quality Assurance Online Services and create a relationship with your clinic.

Simply have the physician login using his/her user name and password (same one used to renew the medical license ).  If the physician does not remember the user name or password, have him/her go to the login web page.  From there, the physician will select Get Login Help.  If the physician is still unable to get logged in, then have him/her call (850) 488-0595 for assistance.

Once logged in, follow these instructions to establish the relationship between the physician and the pain-management clinic:

  • Select Maintain Related Licenses from the list on the left hand side of the screen
  • Complete the online instructions for adding (or deleting) relationships
  • Be sure to print the page when you are done for your records

At any time, the physician may use the View Relationship Summary located on the same web page to see a list of all relationships.

The DEA’s War on Pain Management

The Health Law Firm George F. Indest III HeadshotWithin the last few years, raids on pain management clinics, as well as pharmacies, have been increasingly commonplace. The doctors, pharmacists, nurses and other health care professionals involved are carted away in handcuffs and must defend their practice.

According to the St. Petersburg Times, a South Florida pain management clinic has recently been shut down under emergency action by the Florida Department of Health (DOH). Several health care professionals at the clinic were arrested, their licenses revoked.

In this instance, the charges against these health care employees are not completely unwarranted. Patients confessed to authorities that members of the clinic knew they were shopping for drugs, and an employee revealed that he was asked to recruit patients by promising powerful drugs.

However, it is not uncommon for a pain management clinic or related practice to face investigation, especially in Florida. Federal and state agencies are doing everything and anything they can to prevent drug farming, which means a crackdown on health care providers. Dubbed “Operation Pill Nation,” this strict enforcement means more worries for health care professionals, who now must monitor patient needs under the DEA’s close watch.

If your medical practice specializes in pain management or a similar area, have a plan in place in the event that the DEA comes knocking on your door. Be aware of health lawyers that are familiar with these cases and can defend you in the event of a DEA raid. These proceedings are often very complicated, and you’ll want an experienced team of health law attorneys to properly defend you from criminal charges.

At The Health Law Firm, our team of lawyers specialize in the representation of doctors, nurses, pharmacists, physicians assistants, nurse practitioners and other health care professionals involved in Department of Health, Diversion Control and Drug Enforcement Administration in Florida and throughout the United States. For more information about our knowledge in the practice of health law and DEA cases read our article on Pain Management and the DEA.

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