Food and Drug Administration (FDA) Recalls Products from Two Different Compounding Pharmacies

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

All Products from Med Prep Consulting Recalled.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Products from Georgia Compounding Pharmacy Allegedly Causing Eye Infections.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Franck’s Compounding Pharmacy in Florida  Caused Fungal Growth.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Compounding Pharmacies Under the Microscope.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding pharmacies, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Deficiencies That are Common in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recent blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

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.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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.

What Nurses Need to Know about Florida Law and HIV Testing

indest9By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Section 381.004, Florida Statutes, provides for an increased level of protection of medical records that contain human immunodeficiency virus (HIV) test results. The super confidentiality requirements imposed by Florida law are viewed as the precautions which must be taken both before an HIV test can be performed and after the HIV test is performed to ensure patient confidentiality.

Pre-Test Requirements.

The administration of an HIV test requires the informed consent of the patient for whom the HIV results will be obtained. No person in Florida may order an HIV test without first obtaining the informed consent of the person upon whom the test is being performed. Section 381.004(3)(a), Florida Statutes. Consent need not be in writing if the medical record documents that consent was given. Section 381.004(3)(a), Florida Statutes. Informed consent must be preceded by an explanation of the right to confidential treatment of information identifying the subject of the test and the results of the test to the extent provided by law. Information must also be provided on the fact that a positive HIV test result will be reported to the county health department with sufficient information to identify the test subject and on the availability and location of sites at which anonymous testing is performed.

Post-Test Requirements.

Notification – Once an HIV test has been administered, there are a number of statutorily prescribed steps that a health care professional must follow. All reasonable efforts must be made to notify the test subject of his or her test result. Section 381.004(3)(c), Florida Statutes. Notification of a person with a positive test result will include information on the availability of appropriate medical and support services, the importance of notifying partners who may have been exposed, and preventing the transmission of HIV. When testing occurs in a hospital emergency department, detention facility, or other facility and the test subject has been released before being notified of positive test results, informing the county health department for that department to notify the test subject fulfills this responsibility. No test result shall be determined as positive, and no positive test result shall be revealed to any person, without corroborating or confirmatory tests being conducted except in the following situations:

1. Preliminary test results may be released to licensed physicians or the

medical or nonmedical personnel subject to the significant exposure for purposes of
subparagraphs (3)(h)10., 11., and 12.

2. Preliminary test results may be released to health care providers and to the
person tested when decisions about medical care or treatment of, or recommendation to, the person tested and, in the case of an intrapartum or postpartum woman, when care, treatment, or recommendations regarding her newborn, cannot await the results of confirmatory testing. Positive preliminary HIV test results shall not be characterized to the patient as a diagnosis of HIV infection. Justification for the use of preliminary test results must be documented in the medical record by the health care provider who ordered the test. This subparagraph does not authorize the release of preliminary test results for the purpose of routine identification of HIV-infected individuals or when HIV testing is incidental to the preliminary diagnosis or care of a patient. Corroborating or confirmatory testing must be conducted as followup to a positive preliminary test. Results shall be communicated to the patient according to statute regardless of the outcome. Except as provided in this section, test results are confidential and exempt from the provisions of Section. 119.07(1), Florida Statutes. Section 381.004(3)(d), Florida Statutes.

Confidentiality.

Once an HIV test has been performed and the results have been obtained, confidentiality must be preserved. The identity of any person upon whom a test has been performed and test results must be held confidential. Section 381.004(3)(e), Florida Statutes. No person who has obtained or has knowledge of an HIV test result may disclose or be compelled to disclose the identity of any person upon whom a test is performed, or the results of such a test in a manner which permits identification of the subject of the test,
except for the following reasons:

1. Patient Release. Consent for disclosure by the subject may be obtained in
a “legally effective release.” Section 381.004(3)(e)(1-2), Florida Statutes.

2. Authorized agents or employees of providers and facilities. Personnel
within a single facility or provider are authorized to disclose to each other
on a “need to know” basis.

3. Health care consultation. Health care providers that are not employees of
the same provider or facility may disclose HIV test results to each other
without the subject’s consent, provided they are involved in the care or
treatment of the test subject and the consultation is for the purpose of the
patient’s diagnosis or treatment. 381.004(3)(e)(4), Florida Statutes.

4. Department of Health. The Department may share HIV test results “in
accordance with rules for reporting and controlling the spread of disease,
as permitted by state law.” 381.004(3)(e)(5), Florida Statutes.

5. Transfer of body parts. Health care facilities and providers who transfer
body parts and semen, for the purposes of artificial insemination, may
disclose HIV test results to each other. 381.0041, Florida Statutes.

6. Health facility staff committees may disclose HIV test results for the
purposes of conducting program monitoring, program evaluation, or
service reviews pursuant to Chapters 395 and 766, Florida Statutes.

7. Research. HIV test results may be disclosed to authorized medical and
epidemiological researchers who are then prohibited from disclosing any
identifying characteristics or information regarding test subjects. Section
381.004(3)(e)(8), Florida Statutes.

8. Court Orders. Subpoenas are not sufficient under Florida law for the
release of HIV test results. A court order must be obtained and this
process is not easily accomplished. A “compelling need” must be
demonstrated by the individual seeking the results and the court must
balance this need against the test subject’s privacy rights as well as
public’s interests in privacy.

9. Workers’ Compensation. An administrative law judge of compensation
claims of the Division of Workers’ Compensation may authorize
disclosure of HIV test results, but only upon a finding that the person
seeking the test results has demonstrated a compelling need for the results.

10. Custodians of Children. Under Section 381.004(3)(e)(11), Florida
Statutes, there are three classes of persons allowed access to HIV test
results:

a. Department personnel and other employees “directly
involved in the placement, care, control or custody” of
the tested child who demonstrate a need to know;

b. Adoptive parents of the tested subject; or

c. An adult custodian, relative or other person responsible
for the child’s welfare if the parent or legal guardian
cannot be reasonably located and informed of the test
result.

Oral Disclosure.

Oral disclosure of HIV test results shall be accompanied by oral notice and followed by a written notice within 10 days. This written notice shall include the following statement: “This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is NOT sufficient for this purpose.” Section 381.004(3)(f).

Penalties.

Any violation of this section by a facility or a licensed health care provider is grounds for
disciplinary action contained in the facility’s or professional’s respective licensing chapter. Any person who violates the confidentiality provisions commits a misdemeanor of the first degree. Any person who obtains information that identifies an individual who has a sexually transmissible disease, including human immunodeficiency virus or acquired immunodeficiency syndrome, who knew or should have known the nature of the information and maliciously, or for monetary gain, disseminates this information or otherwise makes this information known to any other person, except by providing it either to a physician or to a nurse employed by the department or to a law enforcement agency, commits a felony of the third degree. Section 381.004(6), Florida Statutes

Conclusion.

The use of tests designed to reveal a condition indicative of human immunodeficiency virus infection is a valuable tool in protecting the public health. Many members of the public are deterred from seeking such testing because they misunderstand the nature of the test or fear that test results will be disclosed without their consent. The laws imposed on the super confidentiality of HIV testing are intended to benefit the public health and the public will be benefited by the nursing profession, when those nurses serve by facilitating informed, voluntary, and confidential use of tests designed to detect human immunodeficiency virus infection.

Contact Health Law Attorneys Experienced in Representing Nurses.

The Health Law Firm’s attorneys routinely represent nurses in Department of Health (DOH) investigations, Department of Justice (DOJ) investigations, in appearances before the Board of Nursing in licensing matters and in many other legal matters. We represent nurses across the U.S., and throughout Florida.

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.

Recall Alert: FDA Warns Steroid Injections Compounded by Tennessee Pharmacy May Be Contaminated

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

The U.S. Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida.

To read the press release from the FDA, click here.

Steroid Injections Recalled.

According to an article in the Associated Press, officials have not yet confirmed the products are contaminated. The FDA is treating all sterile products from Main Street Family Pharmacy as if they were contaminated as a precaution. The pharmacy has agreed to recall all of its sterile products. Click here to read the Associated Press article.

The injections in question allegedly contain the same drug at the center of the October 2012, deadly fungal meningitis outbreak. More than 55 people, including five in Florida were killed and 740 others were sickened after receiving contaminated injections from a Massachusetts compounding pharmacy. I previously blogged about that outbreak. To read more, click here.

Patients in North Carolina and Illinois Allegedly Reacted to Injections.

Federal authorities have allegedly identified seven cases of patients who have suffered complications after being injected with the potentially contaminated medications. There are five cases in Illinois and two cases in North Carolina. The Illinois patients supposedly have skin infections and one patient in North Carolina allegedly suffered from a fungal infection.

Florida Department of Health Working to Contain Allegedly Tainted Injections Statewide.

According to the Florida Department of Health (DOH), at least three Florida facilities received the drugs under investigation. Two of the facilities are in Melbourne, Florida, and one is in Chipley, Florida. The Florida DOH says it is not aware of any local cases of infections from these drugs.

To read the press release from the Florida DOH, click here.

Previous Florida Case of Contaminated Medication.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Congress Debating on Giving Authority Over Compounding Pharmacies to FDA.

Currently, compounding pharmacies are regulated by state pharmacy boards. There is currently legislation moving through Congress that would give the FDA direct authority over the compounding manufacturers. The goal is to prevent any national outbreaks tied to compounded medications.

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.

Sound Off.

Do you think each state should be responsible for regulating compounding pharmacies, or do you think the FDA should be responsible? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “FL Got Drugs Linked to New Outbreak.” Health News Florida. (May 24, 2013). From: http://health.wusf.usf.edu/post/fl-got-drugs-linked-new-outbreak

Kelly, Christopher. “FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections from Main Street Family Pharmacy in Tennessee.” Food and Drug Administration (May 24, 2013). From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm

Stobbe, Mike and Loller, Travis. “FDA Warns of Infections Tied to Tennessee Pharmacy.” The Associated Press. (May 24, 2013). From: http://www.npr.org/templates/story/story.php?storyId=186473297

Florida Department of Health. “The Florida Department of Health Partners with Federal and State Health Organizations to Ward of Adverse Reactions Associated with Steroid Injections.” Florida Department of Health. (May 24, 2013). From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2013/05/052413CDCinfection.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.

Florida Nurse Allegedly Filled Fake Prescriptions for Painkillers

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Central Florida nurse is in trouble with the law for allegedly writing fake prescriptions and illegally obtaining painkillers for herself, according to the Orlando NBC affiliate, WESH television. The nurse was allegedly arrested during the week of December 31, 2012. She is accused of trafficking in oxycodone and trying to fill forged prescriptions.

Click here to read the WESH article.

Pharmacist Did Not Fall For Fake Prescription.

According to an Orlando Sentinel article, a pharmacist, who was suspicious of one of the prescriptions the nurse tried to fill, called the doctor listed on the prescription. The doctor informed the pharmacist that she (the doctor) was the nurse’s employer, and the nurse was not a patient. It was then discovered that the nurse used the names of two doctors at her place of employment. She had stolen the prescriptions to obtain painkillers for herself.

A search of Florida’s Prescription Drug Monitoring Database allegedly showed that the nurse had obtained dozens of prescriptions for controlled substances for herself in the past year.

To read the article from the Orlando Sentinel, click here.

Check the Department of Health (DOH) Website for a Health Provider’s License Status. 

According to the Department of Health (DOH) the nurse’s license is currently suspended. A complaint on the nurse’s record also shows that in December 2009, the nurse admitted to stealing pain medication from her patients.

Preventing Employees from Stealing.

I recently wrote an article for Medical Economics on how to prevent or detect employee embezzlement in the medical or dental office. It contains valuable information for any small health care practice owner. Topics discussed in the article include: how to recognize embezzlement warning signs, steps to take to safeguard your assets, and the proper way to take action against a suspected embezzler. To read it in its entirety, click here.

I have also written a number of blogs on abuses with narcotics. See my blog on a fake prescription ring busted in Osceola County, and a Drug Enforcement Administration (DEA) arrest of a doctor allegedly on crack cocaine charges, for example.

Contact Health Law Attorneys Experienced in Representing Nurses.

The Health Law Firm’s attorneys routinely represent nurses in Department of Health (DOH) investigations, Department of Justice (DOJ) investigations, in appearances before the Board of Nursing in licensing matters and in many other legal matters. We represent nurses across the U.S., and throughout Florida.

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

Comments?

As a health professional how do you keep tabs on your important office supplies? How would you handle an employee stealing from your office? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Nurse Charged with Stealing Scripts, Illegally Obtaining Painkillers.” Orlando Sentinel. (January 3, 2013). From: http://articles.orlandosentinel.com/2013-01-02/news/os-nurse-arrested-prescription-drugs-20130102_1_fake-prescriptions-prescription-sheets-cvs

WESH-TV. “Nurse Accused of Illegally Obtaining Painkillers.” WESH. (January 3, 2013). From: http://www.wesh.com/news/central-florida/seminole-county/Nurse-accused-of-illegally-obtaining-painkillers/-/17597106/17995906/-/dmj2se/-/index.html?absolute=true

 

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.

The Collateral Effects of Discipline on Your Nursing License

indest1By George F. Indest, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A. A case involving an arrest or a conviction involving alcohol abuse (DUI/public Intoxication) or drugs (possession, diversion, theft, trafficking) will probably result in an emergency suspension order (ESO) until the entire licensure case is complete.

B. Client may be required to be evaluated and probably enrolled in the Impaired Nurses Program (IPN) (for nurses only) or the Professionals Resource Network (PRN) (for all other licensed health professionals), which is usually at least a five year contract.

C. Action to revoke, suspend or take other action against the clinical privileges and medical staff membership of those licensed health professionals who may have such in a hospital, ambulatory surgical center, skilled nursing facility, or staff model HMO or clinic. This will usually be advance registered nurse practitioners (ARNPs) and certified registered nurse anesthetists.

D. Mandatory report to the National Practitioner Data Base (NPDB) (Note: Healthcare Integrity and Protection Data Bank or HIPDB recently folded into NPDB) which remains there for 50 years.

E. Must be reported to and included in the Department of Health (DOH) profile that is available to the public online (for those having one), and remains for at least 10 years.

F. Any other states or jurisdictions in which the client has a license will also initiate action against him or her in that jurisdiction. (Note: I have had two clients who had licenses in seven other states).

G. The Office of Inspector General (OIG) of Department of Health and Human Services (HHS) will take action to exclude the provider from the Medicare Program. If this occurs (and most of these offenses require mandatory exclusion) the provider will be placed on the List of Excluded Individuals and Entities (LEIE) maintained by the HHS OIG.

H. If the above occurs, the provider is also automatically “debarred” or prohibited from participating in any capacity in any federal contracting and is placed on the U.S. General Services Administration’s (GSA’s) debarment list.

I. The U.S. Drug Enforcement Administration (DEA) will act to revoke the professional’s DEA registration if he or she has one.

J. The certified health professional’s certify organization will act to revoke his or her certification.

K. Third party payors (health insurance companies, HMOs, etc.) will terminate the professional’s contract or panel membership with that organization.

L. Any profile maintained by a national organization or federation (e.g., American Medical Association physician profile or Federation of State Boards of Physical Therapy profile) will include the conviction.

M. Regardless of any of the above, any facility licensed by AHCA (hospitals, skilled nursing facilities (SNFs), public health clinics, public health clinics, group homes for the developmentally disabled, etc.) that are required to perform background screenings on their employees will result in AHCA notifying the facility and the professional that he or she is disqualified from employment.
Contact Health Law Attorneys Experienced in Representing Nurses.

The Health Law Firm’s attorneys routinely represent nurses in Department of Health Investigations, before the Board of Nursing, in appearances before the Board of Nursing in licensing matters, and in administrative hearings.

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.

The Government’s Use of Civil Forfeiture to Combat Health Care Fraud and Pill Mills in Florida

CEB Blog Label2By Christopher E. Brown, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Recently we have seen government prosecutors and agencies, including the Medicaid Fraud Control Unit (MFCU), the U.S. Attorney General’s (AG) Office, and local sheriff and police departments use the Florida Contraband Forfeiture Act against health professionals and health facilities in health-related cases.

A prompt, aggressive defense to these actions may recover the property or funds seized and, more importantly, a good defense can be used to help resolve any pending criminal charges.

Civil Forfeiture of Property is Used to Fight Alleged Criminal Activity.

The civil forfeiture of property has become a popular tool for state and federal agencies to combat alleged criminal activity.  In Florida, the Florida Contraband Forfeiture Act, Sections 932.701 through 932.706, Florida Statues permits the government to seize personal property if there is probable cause to believe that property is either an instrumentality or the proceeds of criminal activity. In federal cases, such as Medicare fraud cases, the Federal Forfeiture Act can be found at 18 U.S.C. §983.Typically, a forfeiture action begins when personal property is seized as a result of a violation or arrest.  The owner of the personal property is then entitled to a notice within five (5) days of the seizure.

Remember If You Are The Subject of a Seizure, Ask For:

1.  An inventory of the seized items.

2.  A Receipt.

3.  The business cards or names, addresses, titles and phone numbers of each official or agent involved.

What is The Adversarial Preliminary Hearing?

Your most important right after a seizure is the right to an adversarial preliminary hearing.  This request must be made in writing within fifteen (15) calendar days of receipt of the notice. Sometimes the notice is given at the time the property is seized; it is important not to lose or misplace it.

When an adversarial preliminary hearing is held, the Court will review the verified affidavit and any other supporting documents and take testimony to determine whether there is probable cause to believe that the seized property was used, is being used, was attempted to be used, or was intended to be used in violation of the Florida Contraband Forfeiture Act.

While the burden of proof at this initial stage favors the government, the adversarial preliminary hearing is one of the fastest and most effective ways to fight for the return of the property and assert any defenses that exist in the case.  Even if unsuccessful at this hearing, the property owner is still entitled to a later civil forfeiture trial in which the government must prove by a preponderance of the evidence that the property was used in the commission of or obtained through the proceeds of criminal activity. Often it is unable to do this and far more defenses are available for use at the trial.

The key to success in civil forfeiture actions is to immediately consult with an experienced attorney after the property has been seized. Your best defense is to act as quickly as possible.

Use of Adversarial Preliminary Hearing to Obtain Information for Defense.

The Adversarial Preliminary Hearing is also a tool by which a defendant can obtain early, detailed discovery on his or her case. During the hearing the law enforcement authorities will be required to testify under oath and produce any documentary evidence. This can prove invaluable to the criminal defense attorney in later criminal proceedings.

Did the Government Exceed the Bounds of Propriety?

Although the government would contend otherwise, we believe the main purpose in the government’s use of civil forfeitures is to shut down the alleged criminal and make it so he or she cannot hire an attorney to defend the person(s) accused. This does, unfortunately, often work.

However, there are defenses and often the government exceeds the bounds of propriety in its overzealousness. We have successfully defended, for example, cases in which:

–  A sheriff’s office seized a spouse’s personal car for which she had traded in her old car.

–  A teenage daughter’s college account that had in it only money she had earned from her part-time job.

–  Money from a business owner’s purse which had been given to her by her mother to pay for her hospital labor and delivery charges.

–  Money from a roll-over IRA account which had been invested long before any criminal activity was alleged to have occurred.

–  Money from a family member’s account which had come from social security payments made for that person.

Every Person Should File a Claim.

If a spouse or other family member has an interest in the property, especially if that person is named on the account or title, that person should file a separate claim for return of the property and demand a Preliminary Adversarial Hearing. Even if the initial hearing is not successful in achieving an early return of the property, such defenses should prevail at the trial of the case.

Contact Health Law Attorneys Experienced in Civil Forfeiture Cases.

The Health Law Firm routinely represents physicians, nurses, pharmacists, dentists, mental health counselors and other health providers in investigations, regulatory matters, licensing issues, litigation, civil forfeitures, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), 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.

What Do You Think?

What do you think of the Civil Forfeiture Act being used against health care professionals and health facilities? Please leave any thoughtful comments below.
About the Authors: Christopher E. Brown, J.D., is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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.

Traveling Nurses Must Have Appropriate Professional Liability Insurance

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

We are often asked what we consider to be the biggest problem that a nurse has in defending herself in a complaint against her license.  In our opinion, it is not having the financial resources to retain the services of an experienced attorney to defend her.  Because of this, we believe that any nurse, especially traveling nurses working at a hospital, skilled nursing facility, home health agency, assisted living facility, medical group, or any other organization must have her own personal professional liability policy that provides ample insurance coverage for professional license defense expenses.

Most Complaints Made Against Nurses are Filed by Employers.

In our experience, most of the complaints filed against nurse professionals come from employers.  In many cases, a patient will complain to the employer and the employer will file the complaint.  In others, the employer initiates the complaint because of substandard performance, documentation problems, allegations of theft or drug diversion, allegations of falsification of documents or records, etc.  When this happens, in most cases the employer terminates the nurse.  This is why we say that a nurse must have her own professional liability insurance policy.

We see a great many more complaints filed against a nurse’s license that she then must defend, than we ever see civil claims for damages.

Many nurses work under the incorrect assumption that they are “insured” by their employer or their agency or that their employer’s or agency’s insurance covers them.  This is a fallacy, especially when it comes to defending against a complaint made against one’s nursing license.  If your employer or agency is the one that files the complaint against you, you don’t really think that your employer or agency is going to cover the legal expenses associated with your defense, do you?

Some hospitals and health organizations are notorious about firing nurses who have any discrepancies in drug counts or who have documentation errors.  This often results in a complaint to the Department of Health (DOH) against the nurse’s license.

Furthermore, we are all aware of the phenomenon with the traveling nurse, the person who is no longer there, getting all of the blame for any problem or incident that come up.  The ones that are still at the facility, the ones who are conducting the investigation on the incident, are far less likely to find blame with their friends and colleagues who are still there.

Just when you need it the most, you may find yourself out of a job, with no income, and no money to pay for a legal defense.  This may ultimately lead to your losing your nursing license and your ability to ever work as a health professional again.

If You Don’t Have Personal Professional Liability Insurance-Get It.

Professional liability insurance policies for nurses are very cheap.  Often policies are only about ten dollars a month.  Usual limits of coverage for this small premium payment are one million dollars of coverage for civil suits and $25,000 or more coverage for professional license defense.

But wait, it is not as simple as just purchasing the first professional liability insurance policy you find.  Many professional liability insurance policies do not offer license defense coverage.  Or, if they do, it is limited to only complaints where there is also the threat that a patient is going to sue for money.  Still others provide such low limits of coverage for license defense expenses (e.g., $5,000 or $10,000) that it is not worth the money paid for it, while others do not allow you to choose your own attorney.

Insurance Companies We Recommend.

We usually tout insurance companies such as that provided by Nurses Service Organization (NSO) and Healthcare Professionals Service Organization (HPSO) as providing great bang for the buck.  But here lately, we’ve been seeing (and hearing) more and more about CPH & Associates insurance.  Not only does it provide one million dollars in coverage if you are sued in a civil court, but it also provides up to $35,000 in coverage for professional license defense.  Additionally, for a very small additional payment, with CPH & Associates Insurance you can increase that coverage to $100,000 for professional license defense.  The other company we hear good things about is Lloyd’s of London.

If you have a complaint filed against your nursing license and you have to prove your innocence through a formal administrative hearing (trial), this can be very, very expensive.  Additionally, if you lose at this level, you may have to appeal the results to a higher court.  These expenses can easily cost $75,000, even if you win.  And you are not ever assured that you will get any of this money paid back to you, even if you are innocent and you win the case.  Inexpensive insurance coverage is the only thing that makes since.  Buy it!

In Conclusion.

We urge all nurses, especially traveling nurses, to purchase and maintain their own personal professional liability insurance policy.  It’s tax deductible.  But check to make sure you have coverage for professional license defense, even when there is no claim for damages expected from a patient.  Additionally, pay the extra premium to purchase a higher limit of coverage for professional license defense cases, or buy a second insurance policy for this additional coverage.

Contact Health Law Attorneys Experienced in Representing Nurses.

The Health Law Firm’s attorneys routinely represent nurses in Department of Health (DOH) investigations, in appearances before the Board of Nursing in licensing matters and in many other legal matters. We represent nurses across the U.S., and throughout Florida.

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 have personal professional liability insurance? Will you consider purchasing a personal policy now? 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.

“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.

Florida Woman Arrested for Allegedly Posing as a Nurse, Giving Botox Injections-For Second Time

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

A Boca Raton, Florida, woman was arrested on June 21, 2013, after authorities say she posed as a nurse and offered Botox injections. The fake nurse has been charged with unlicensed practice of a health care professional. If found guilty, the phony nurse could be sentenced to up to five years in jail. This was a joint investigation between the Florida Department of Health (DOH) Investigative Services Unit, the City of Boca Raton Police Department and the Florida Department of Corrections.

To read the press release from the DOH, click here.

Undercover Agents Visited Fake Nurse at her Place of Business.

According to The Palm Beach Post, officials began their investigation of the fake nurse on June 6, 2013, after receiving an anonymous tip. Local police officials and the DOH set up an undercover sting. Days later an undercover agent scheduled a Botox appointment with the phony nurse and then visited the office. Hours later, investigators allegedly arrested the fake nurse.

Click here to read the entire article from The Palm Beach Post.

According to the DOH, this is not the first time she has claimed to be a nurse and got caught. The same phony nurse was allegedly previous arrested for unlicensed activity in Palm Beach, Florida, according to DOH authorities.

Verifying the License of a Health Care Professional.

This particular woman allegedly claimed to be an operating room nurse and on the website Groupon.com she allegedly claimed to be a surgical nurse.

The DOH has several resources to fight unlicensed activity. Patients are encouraged to check the DOH’s website to verify the license information of their health care providers. Complaints can also be filed calling the DOH. Click here to view the DOH’s website.

Practicing Without a License Is a Crime.

Practicing medicine without a license is a crime. Additionally, so is helping someone practice medicine without a license. As a practitioner, you may be asked to supervise or join a practice. Remember, your license may be at stake with any wrongdoing by your subordinates. Before you join a practice or agree to supervise others, check first with the DOH that the other providers are legitimate. You can verify a license for free on the DOH’s website.

Remember, a license to practice medicine in Venezuela, Cuba, or anywhere else, is just that: a license to practice in that country. It does not allow a person to practice medicine in the United States.

More Stories on Fake Physicians and Other Health Professionals to Come.

In the future on this blog, we will continue to include additional articles on fake doctors and health professionals.

To see a blog on a fake South Florida dentist and the damage he inflicted on a teenage girl, click here. To read a blog on an infamous Florida teen impersonating a physician assistant (PA), click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

Contact a Health Law Attorney Experienced in Representing Health Care Providers in DOH Cases.

If you find yourself working for or supervising someone that does not have a valid Florida license, your own license may be at risk. If and when the Department of Health (DOH) becomes involved, do not sign anything, do not speak to the investigators and do not make any statements. Contact an experienced health law attorney immediately to review your case.

The Health Law Firm represents physicians, nurses, dentists, pharmacists, pharmacies and other health care providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Agency (DEA), Department of Health (DOH), and other law enforcement agencies. If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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 are your thoughts on this story? Please leave any thoughtful comments below.

Sources:

Florida Department of Health. “Joint Investigation Leads to Arrest in Palm Beach County.” Florida Department of Health. (June 21, 2013). From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2013/05/062113Goldman.pdf

Alcantara, Chris. “Woman Arrested a Second Time for Allegedly Posing as Nurse, Offering Botox Injections in Boca Raton.” The Palm Beach Post. (June 22, 2013). From: http://www.palmbeachpost.com/news/news/crime-law/woman-arrested-a-second-time-for-allegedly-posing-/nYSDh/

Entin, Brian. “Sheri Goldman: Boca Woman Arrested After Police Say She Offered Botox, Told People She was a Nurse.” WPTV. (June 21, 2013). From: http://www.wptv.com/dpp/news/region_s_palm_beach_county/boca_raton/boca-woman-arrested-after-police-say-she-offered-botox-and-told-people-she-was-a-nurse

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.

Other Options Must Be Considered Before Emergency Suspension Order Will Be Upheld

The Department of Health (“DOH”) issued an emergency order suspending Burton’s license to practice nursing.

On appeal, the court quashed the emergency order. It held that DOH had failed to examine other disciplinary options available to it short of suspension. While recognizing DOH might be able to support license suspension as an appropriate penalty, it held that Burton was entitled to a hearing to contest the charges.

In the dissenting opinion, Judge Osterhaus cited numerous findings in the DOH order that supported suspension.

Source:

Burton v. Department of Health, 116 So. 3d 1285 (Fla. 1st DCA 2013) (Opinion filed July 24, 2013).

About the Author: The forgoing case summary was prepared by Mary F. Smallwood, Esquire, of the Administrative Law Section of The Florida Bar. It originally appeared in the Administrative Law Section newsletter, Vol. 35, No. 2 (Dec. 2013).

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