Florida Pain Clinics Can Expect More Bullying From Law Enforcement

Florida pain clinics really began to feel the impact of becoming law enforcement’s newest target about one year ago. This was based in part on televison “magazine” shows and investigative reporters’ shows and articles publicizing many abuses by patients who were “doctor shopping” and physicians who were allegedly “over-prescribing.”

More regulations were enacted, and lawmakers approved severe penalties for doctors accused of over-prescribing, including prison sentences. Most physicians were banned from dispensing drugs in their offices, and the governor created a Florida drug “strike team” whose mission was to eliminate any pain clinics that were found to be suspicious. The Florida Surgeon General and the Board of Medicine made announcements about the “crackdown” on “over-prescribing.”

According to the Orlando Sentinel, since the implementation of the new pain management and prescribing laws, the Florida strike force has made thousands of arrests and seized millions of pills in an effort to curb alleged over-prescribing and prescription drug abuse.

Now, after a year of strict regulations and punishments for Florida’s pain management physicians, pain clinics, pharmacists and pharmacies, the state is continuing to attack the pain management profession. While the planned measures aren’t as harsh as those that began a year ago, such as installing prescription drop boxes at police stations, they continue to place a stigma on the practice of pain management – a medical subspecialty with the purpose of alleviating the pain of suffering patients.

In addition, patients with true medical need for prescription pain medications are finding it increasingly difficult to even locate a physician to treat them, given the stigma and the possibility of arrest and prosecution. Medical ethicists have commented on this problem, an issue that will become increasingly problematic for the foreseeable future.

If you work in the pain management industry (physician, pharmacist, pain clinic, pharmacy, etc.) and feel that your medical license, pharmacy license, or business is at risk or is under investigation by the Drug Enforcement Administration (DEA) or Florida Department of Health (DOH), please visit our website at www.TheHealthLawFirm.com for more information about this.

Orlando Health Attorney Featured in Latest Issue of Medical Economics

Orlando, Fla. – March 15, 2012 - George F. Indest III, President and Managing Partner of The Health Law Firm, shares his knowledge of health law in the March 14 issue of Medical Economics. Mr. Indest was interviewed and quoted for an article concerning legal advice for primary care physicians who prescribe painkillers. In the article he provided information based on his experience in defending physicians charged with over-prescribing with the DEA and Florida DOH, Board of Medicine.

The article, “5 ways to avoid over-prescribing allegations,” includes tips written by Mr. Indest for physicians to follow if they practice pain management. The article can be read in its entirety here.

Mr. Indest is a well-known attorney specializing in the representation of health professionals and health care providers throughout Florida. His practice encompasses all aspects of health law, including pain management and pain medicine physician and clinic defense, defense of professional licensing cases, representation in investigations, defense in credentialing matters, Medicare and Medicaid audits, formation of corporations and limited liability companies (LLCs), Board of Medicine hearings, peer review actions, clinical privileges hearings, representation of medical students, and other matters of health care law and legal representation of health care professionals.

In 1999, Mr. Indest started The Health Law Firm, which has three Florida offices in Altamonte Springs, Orlando, and Pensacola. A former Navy JAG Corps attorney, he has practiced law for over 30 years.

For more information about The Health Law Firm visit http://www.thehealthlawfirm.com.

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About The Health Law Firm
The Health Law Firm was established in 1999, bringing together a team of experienced attorneys with decades of work in the legal and healthcare fields. With offices in Altamonte Springs, Orlando and Pensacola, Florida, the firm represents healthcare providers, including hospitals, nursing homes, physicians, dentists, mental health professionals and other licensed health professionals and entities. For more information about The Health Law Firm, visit http://www.thehealthlawfirm.com.

For additional information contact:
Kara Large
Office: (407) 331-6620, ext. 219
Cell: (407) 921-4322

The DEA Attacks Legitimate Pharmaceutical Distributors, Starting with CVS Pharmacy and Cardinal Health

Earlier in February 2012, the DEA accused both CVS Pharmacy, one of the nation’s largest drug store chains, and Cardinal Health, one of the nation’s largest legitimate distributors of pharmaceuticals, of endangering the public by selling excessive amounts of oxycodone to four Florida pharmacies. For Cardinal Health, the charges came in an immediate suspension order served Feb. 3, 2012, when the DEA suspended Cardinal’s license to distribute controlled substances from its Lakeland, Florida location, which serves four states, according to USA Today. Lakeland is located between Orlando and Tampa.

Cardinal immediately challenged the suspension in federal court denying the charges. The DEA’s suspension was temporarily lifted and a hearing was scheduled in the federal district court in Washington, D.C. In preparation for the hearing, the DEA and Cardinal filed hundreds of pages of documents that provide a look into how prescription painkillers have infiltrated the black market. We are attempting to obtain copies of some of these so that we can share them with other interested attorneys and individuals.

As reported in various media sources, the investigation into Cardinal’s operation began after a Cardinal investigator became aware of a rumor that a local pharmacy was selling oxycodone by the pill for cash. This Florida pharmacy was reported to be one of Cardinal’s biggest customers.

Over the next two years, Cardinal employees allegedly visited the same pharmacy at least four more times. Each time, they noted the following suspicious signs: Customers paid cash, oxycodone was the top seller, and young people came into the pharmacy in groups to have their prescriptions filled. The pharmacy allegedly dispensed 462,776 oxycodone pills over a two month period — which is what the DEA states is approximately seven times what the average pharmacy dispenses in a year. Additionally the pharmacy allegedly asked Cardinal for more. Cardinal filled the order for more oxycodone but terminated the pharmacy as a customer.

By the time Cardinal cut the pharmacy off in October 2011, police had arrested at least three doctors who were associated with or had their patients’ prescriptions filled at the pharmacy.  Law enforcement officials charged them with trafficking in oxycodone, racketeering and over-prescribing narcotics.

Then, in early February 2012, the DEA reportedly suspended the DEA registrations (sometimes called “DEA numbers” or “DEA licenses”) of four of Cardinal’s largest Florida customers. These suspensions demonstrate the DEA’s strategy to combat the country’s prescription drug abuse problem at the highest levels, regardless of the size or reputation of the company. After years of attacking doctors who dispense drugs from pain clinics, DEA agents are now targeting the legitimate pharmaceutical distributers — the top of the legitimate drug supply chain.

The number of overdose deaths involving prescription pain medications allegedly now exceeds deaths from heroin and cocaine combined, which motivates state and federal agents to be more aggressive in fighting against misuse of drugs.

Under the federal Controlled Substances Act, the DEA regulates every link in the supply chain for controlled substances such as oxycodone and hydrocodone, including manufacturers, distributors, doctors and pharmacies. According to the DEA, approximately 1.4 million entities have DEA registrations to handle controlled pharmaceuticals. The law requires pharmaceutical distributors, like Cardinal Health, to have systems to detect suspicious orders, which must then be reported to the DEA.  Additionally, federal regulations require that any thefts, losses or shortages of controlled medications be reported to the DEA.

In court documents filed in response to Cardinal’s challenge, the DEA said Cardinal ignored “red flags” raised to detect suspicious orders. However, Cardinal argues that volume alone is not enough to determine whether a pharmacy is diverting the drugs, because it does not account for a pharmacy’s location, the age and health of the population, and the proximity to hospitals, nursing homes and cancer centers.

The DEA routinely cites the volumes of drugs a pharmacy fills or the numbers of tablets of a certain type of medication for which a doctor writes prescriptions.  This is also a factor the DEA uses in cases we have seen where it seeks to suspend or revoke the DEA registrations of physicians and pharmacies in administrative cases.  However, some judges have expressed a reluctance to admit such “bean counting” or naked numbers as being irrelevant, when not supported by testimony or evidence placing the numbers into context with other factors, such as the physician’s practice, patient mix, standards of treatment, severity of illness, etc.

In the federal court case now pending, Cardinal has stated in papers filed that it has a “robust” detection system and has cut off more than 330 pharmacies, including 140 pharmacies located in Florida, over the past four years that it decided posed an unreasonable risk of diversion.

In a news article posted late on February 29, 2012, the Associated Press advised that federal Judge Reggie Walton had ruled against Cardinal Health earlier in the day.  Apparently Cardinal Health had originally obtained a “stay” (sometimes referred to as a “temporary restraining order” or “temporary injunction”) against the DEA’s suspension order.  However, after a hearing held on February 29 in which Cardinal Health sought an injunction against the DEA’s enforcement of its suspension, Judge Walton announced a decision form the bench.  He reportedly refused to grant Cardinal Health an injunction against the DEA, apparently agreeing with the DEA’s position.

This battle between Cardinal Health and the DEA is an important one as it demonstrates the DEA continued efforts to attempt to exert more control over pain clinics, pain management physicians, pharmacists, pharmacies, and now, pharmaceutical distributors. If you believe that the DEA is investigating you, your facility, your company or if you want to learn more about the legal implications of pain management, visit our website to learn more.

Sources for this article included; the Orlando Sentinel, Boston Globe, Associated Press, USA Today and Florida Today.

Suspected Florida Pill Mills Continue to Attract Investigations

According to the Orlando Sentinel, some of the worst alleged pill mills in Florida are located in Orlando. At a small pain clinic near downtown Orlando and an affiliated office, one doctor prescribed more oxycodone during a three-month period in 2010 than all doctors in the state of California combined. Details about the clinic from former employees span a nearly 200-page affidavit filed in Orange County Circuit Court in the racketeering case against doctors and management of this pain clinic. The documents offer a rare glimpse inside the investigation.

In this case, agents examined bank records, Crimeline tips and records from the Medical Examiner’s Office. Additionally, FDLE and Metropolitan Bureau of Investigation agents gathered prescribing data from the U.S. Drug Enforcement Administration, pulled state corporation filings and viewed Department of Health records. Agents obtained the prescribing histories for 75 patients who got their drugs at Walgreens and found that 64 had criminal records. Of those, 42 have been arrested for drug-related crimes.

In addition to exploring paper trails, agents and investigators employed more-traditional law enforcement tactics, including undercover investigations. Posed as patients, undercover MBI agents were prescribed painkillers with little or no medical assessment. While waiting for their turns to see the doctors in the clinics, they overheard patients in the lobby talk about selling drugs.

Undercover agents said there were other indications that this pain clinic was a pill mill. There were long lines outside; armed security guards; and signs that warned patients they needed to bring empty pill bottles and posted what medications were available and a price list for the pills. The pain clinics were a cash business. Insurance was not accepted, and employees told agents the price per visit ranged from $160 to $350.

The original target of this investigation was one of the doctors at the pain clinic, but as agents gathered intelligence, it became clear they needed to learn more about the owners and management.

According to the investigation, the management recruited doctors to work at the clinics, but court documents show they had a problem retaining them. A man who used to work at a nearby business told agents that one of the owners complained to him that doctors were quitting and suggested he would hire the man to pretend to be a doctor at the clinic. 

The investigation of this pain clinic resulted in the arrest of the owners and doctor involved in allegedly overprescribing narcotics. As federal, state, and local agencies continue their mission to eradicate pill mills, more pain clinics will be involved in investigations.

If you are concerned about your pain clinic, or if you are a doctor practicing pain management at a pain clinic, please call us today at (407) 331-6620 or (850) 439-1001.

CVS Refuses to Fill Prescriptions For Some Florida Doctors

The crack down on Florida pill mills continues with CVS pharmacies notifying some doctors that they no longer will fill their prescriptions for certain narcotic medications.

According to Health News Florida, this new policy appears to be limited to Florida, but CVS has not clearly stated what is being used to determine which doctors can have their prescriptions filled for which drugs (though oxycodone definitely appears to be a target).

The Florida Academy of Pain Management, released a letter via email alert that was sent by CVS to a Central Florida physician. The physician who received the letter had never been disciplined by state medical regulators and had extensive pain management training. The email alert, stated that CVS appears to “have initiated an internal program where they are profiling physicians’ controlled substance prescribing habits and possibly their patients’ prescriptions.”

A spokesperson for CVS said that the company is refusing to fill prescriptions for a “small number of Florida physicians” and is supporting measures by federal and state law enforcement officials to “keep controlled substances out of the wrong hands.”

While some pain physicians have not received a letter, they have been told by patients that they are being analyzed by CVS for writing prescriptions for narcotics, especially a specific combination of medications with high potential for abuse — oxycodone, Xanax and Soma. This trio has been widely prescribed at pill mills.

Although the actions taken by CVS may be extreme, other pharmacies and pharmacists are increasingly hesitant about filling certain prescriptions. With pain killers now responsible for more than seven overdose deaths a day in Florida, there is reason to be cautious, and pharmacists are professionally obligated not to fill prescriptions they find questionable.

However, stricter regulations on pain clinics, pain management physicians and prescription writing has left patients who face real pain unable to obtain necessary medication. Legitimate patients are being punished for the actions of a small group of corrupt practitioners.

Florida must find a way to get out of the Catch-22 in which the state is currently entangled. Yes, prescription drug abuse is a problem, but so is the real pain faced by many patients.

For more information on legal matters concerning pain clinics and pain management physicians, visit www.TheHealthLawFirm.com.

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.