Emergency Suspension Order Issued to Florida Cardiologist for Performing Stem Cell Treatments

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
A Florida cardiologist recently had his medical license emergently suspended by the Florida Department of Health (DOH) for performing stem cell treatments. According to the emergency suspension order (ESO), the DOH had previously warned the doctor to stop performing these treatments in 2011. Now, his license is at risk of being revoked. To view the ESO click here.

Cardiologist's License Suspended by the DOH Because He Was Allegedly Performing Stem Cell Treatments.

The DOH ordered the emergency suspension of the cardiologist's medical license in March 2012. He is being accused of violating an emergency restriction order (ERO) against using stem cell treatments in Florida. He is also being accused of causing the death of a patient.
We want to be perfectly clear that these are just allegations being made by the DOH at this point in time. All persons are presumed to be innocent until found guilty in a court of law (or, in DOH licensure cases, in an administrative final order).

Stem Cell Treatment Allegedly Factor in Patient's Death.

According to the ESO, the doctor performed a stem cell treatment on a patient who had both pulmonary hypertension and pulmonary fibrosis. Both of these conditions restrict blood flow to the heart. According to the ESO, the stem cell treatment included harvesting adipose tissue from the patient's abdomen and concentrating stem cells from the tissue in a lab. The concentrated stem cells were then infused into the patient's bloodstream to help treat the patient's pulmonary hypertension and pulmonary fibrosis. Allegedly, the cardiologist's patient suffered a cardiac arrest and died during the treatment.

Doctor Now Awaits Administrative Hearing.

An administrative hearing regarding the doctor's license suspension is scheduled for June 2012.

To view the administrative complaint issued by the DOH, click here.

To see a diagram or flow chart of the procedures followed by the Florida Department of Health, click here.

For an explanation of the differences between a formal administrative hearing and an informal administrative hearing under the Florida Administrative Procedure Act, Chapter 120, Florida Statutes, click here.

For the Florida Administrative Procedure Act, Chapter 120, Florida Statutes, click here.

Contact Health Law Attorneys Experienced with Emergency Suspensions and Other Adverse DOH Actions.

The attorneys of The Health Law Firm are experienced in handling all types of DOH cases, including emergency suspensions, administrative complaints, investigations, administrative hearings, investigations, licensing issues, settlements and more. If you are currently facing adverse action by the DOH contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at http://www.thehealthlawfirm.com/.

Sources:

Fitzpatrick, David and Drew Griffin. "Florida Suspends Doctor Accused of Illegal Stem Cell Therapy." CNN. (Mar. 8, 2012). From:
http://www.cnn.com/2012/03/08/health/stem-cell-doctor-suspension/index.html

Miller, Reed. "Flouting Warning, Florida Stem-Cell Cardiologist has License Suspended." theheart.org. (Mar. 8, 2012). From:
http://www.theheart.org/article/1368039.do

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.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Cardinal Health and DEA Reach Settlement

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Cardinal Health has reached a settlement with the Drug Enforcement Administration (DEA) that suspends its shipments of controlled substances from its Florida distribution facility for two years. Cardinal will now supply controlled substances from its distribution center in Jackson, Mississippi.
DEA can Still Purse Civil Penalties, Despite Settlement.
The settlement was announced on May 15, 2012. It includes an Administrative Memorandum of Agreement (MOA), the terms of which will apply to all of Cardinal Health’s registered distribution facilities. The MOA will not prevent Cardinal Health from possible civil penalties related to the DEA's case against the pharmaceutical distributor.
The obligations in the MOA will remain in effect for five years unless the DEA agrees to an earlier termination. Some of the terms require Cardinal Health to improve anti-diversion procedures and keep track of narcotics distributions.
Click here to view the Memorandum of Agreement between Cardinal Health and the DEA.
Cardinal Health's History with the DEA.
On February 3, 2012, Cardinal Health's Florida distribution center was served with an Immediate Suspension Order (ISO) from the DEA. The ISO alleged that the distribution center did not maintain effective safeguards against the diversion of controlled substance, including oxycodone.
According to the DEA, Cardinal Health’s Florida facility shipped a large quantity of oxycodone to four Florida pharmacies. The DEA alleged that Cardinal Health did not ensure that these drugs only went to legitimate patients.
The February 2012 ISO was not the DEA’s first action against Cardinal Health’s Florida distribution center. In 2007, the DEA issued an ISO at the facility because it allegedly distributed hydrocodone to illegitimate internet pharmacies. That action, and similar DEA actions at other Cardinal Health facilities across the United States, resulted in a $34 million fine.
Cardinal Health has been operating under an Administrative MOA with the DEA since October 2008. This MOA required Cardinal Health to maintain a compliance program designed to detect and prevent the diversion of controlled substances (as required under the Controlled Substances Act).
According to the DEA, Cardinal Health did not comply with the terms of the October 2008 MOA, which is partly why the agency issued the February 2012 ISO.
Cardinal Health Pursues Litigation Against DEA.
Cardinal Health had filed litigation to challenge the DEA's decision to impose the ISO, shortly after it happened. Click here for a copy of the Complaint filed in Federal Court in Washington, D.C. Ultimately the federal courts ruled against Cardinal Health on February 29, 2012. For a copy of the Court's decision against Cardinal click here.
Click here to view other blogs regarding the Cardinal Health case.
Contact Health Law Attorneys Experienced with DEA Cases.
The Health Law Firm represents pharmacists, pharmacies, physicians and other health provders in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.thehealthlawfirm.com/.
Sources Include:
DEA Public Affairs. "DEA Suspends for Two Years Pharmaceutical Wholesale Distributor’s Ability to Sell Controlled Substances from Lakeland, Florida Facility." United States Drug Enforcement Administration. Press Release. (May 15, 2012). From
http://www.justice.gov/dea/pubs/pressrel/pr051512.html
Milford, Phil and Tom Schoenberg. "Cardinal DEA Settlement Calls for Two-Year Shipping Halt." Bloomberg. (May 15, 2012). From
http://www.bloomberg.com/news/2012-05-15/cardinal-dea-settlement-calls-for-two-year-shipping-halt.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.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

College Student Drinks Urine to Survive After Being Forgotten by DEA

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Drug Enforcement Administration (DEA) left a California college student in a small holding cell for five days without food, water, or a toilet. He believes that the DEA forgot about him.

He was taken by agents during a late April 2012 drug raid on his friend's house in which nine people were arrested.

DEA Abandons Student in Cell; Student Left to Drink His Own Urine to Survive.
According to a law enforcement official who has reviewed this case, the student was never arrested, was not going to be charged with a crime and should have been released.
Instead, he was left handcuffed and placed back in a 5-by-10-foot cell, where he remained for several days with no food or water. The student says that he yelled and tried shoving his clothes under the door so that someone would realize that he was there. Eventually, he said he had to drink his own urine after being without water. He suffered from dehydration and allegedly began to hallucinate.
DEA Left Methamphetamine in Student's Holding Cell.
The abandoned student reportedly stated that he broke his own glasses and began carving "Sorry Mom" into his arm but stopped after the "S." Additionally, he ingested a white powder DEA agents said was accidentally left in the cell and was later identified as methamphetamine.
Numerous media accounts of this event have been published including by the Associated Press and Delaware Online. An apology was issued by the DEA.
When he was eventually found, paramedics took him to a hospital. He spent three days in intensive care and five days total at the hospital before leaving.
DEA Apologizes to the Student.
The DEA has acknowledged that the student was accidentally left in the cell and has issued an apology. The agency is investigating how this incident happened.
Student Seeks Up to $20 Million in Compensation.
The student's attorney has sent a five page demand letter to the DEA's general counsel in Washington D.C., which calls the student's treatment "torture." The letter also requests that all federal agencies preserve any evidence related to the case, including video, interview notes and written reports.
The student is seeking up to $20 million in compensation for the incident.
Perseverance of Engineering Students.
I believe this incident, which is horrendous and never should have happened illustrates the perseverance of engineering students. Not to make light of the situation, Survivorman could not have done better. One wonders how such an event could happen in our country.
Contact Health Law Attorneys Experienced with DEA Cases.
The attorneys of The Health Law Firm are experienced in handling DEA cases. If you are currently being investigated or facing other adverse action by the DEA contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at www.TheHealthLawFirm.com.
Sources Include:
Associated Press. "Calif. Man Forgotten in Cell Says He Drank Urine." Delaware Online. (May 2, 2012). From
http://www.delawareonline.com/viewart/20120502/NEWS01/120502037/Calif-man-forgotten-cell-says-he-drank-urine
Caldwell, Alicia. "DEA Apologizes to College Student Left in Cell." Delaware Online. (May 2, 2012). From
http://www.delawareonline.com/viewart/20120502/NEWS01/120502047/DEA-apologizes-college-student-left-cell
Gastaldo, Evann. "Student Forgotten in DEA Cell Wants $20M." Newser. (May 3, 2012). From
http://www.newser.com/story/145323/student-forgotten-in-dea-cell-wants-20m.html
McDonald, Jeff. "Abandoned DEA detainee seeks $20 million." UT San Diego. (May 2, 2012). From
http://www.utsandiego.com/news/2012/may/02/abandoned-dea-detainee-seeks-20-million/
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.

DEA's "Cases Against Doctors" List Available Online

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

Did you know that the Drug Enforcement Administration (DEA) has a public list of physicians with DEA registrations that have been arrested and prosecuted? On the DEA's website, there is a list of all investigations of physician registrants in which the DEA was involved that resulted in the arrest and prosecution of the registrant which was updated and released on April 3, 2012.

The list includes:
• The name of the physician;
• The physician's city/state;
• Date of arrest/conviction;
• Judicial status;
• Conviction;
• Status of the physician's DEA registration; and
• Remarks regarding the physician's case.
Click here to view a copy of the most recent list (last updated on April 3, 2012).
We cannot vouch for the validity of the information on the DEA's list. We just know it was published.
Contact Health Law Attorneys Experienced in Handling DEA Cases.
The attorneys of The Health Law Firm are experienced in representing health care providers in DEA cases. If you are currently being investigated or facing other adverse action by the DEA contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at http://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.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Informal Hearings Before the Florida Board of Pharmacy

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

If you are scheduled to appear for an informal hearing before the Florida Board of Pharmacy, there are a number of facts that you will want to know in order to be properly prepared.  This article will cover many of them.

Limited Circumstances for Informal Administrative Hearing

First, you should understand that you will only be at an informal hearing in which you appear before the Board of Pharmacy itself for a very limited number of reasons.  These will include the following:

1.  If you completed an election of rights (EOR) form and agreed that you did not intend to dispute any material facts alleged against you from the administrative complaint (AC) in the case.

2.  If you entered into a settlement agreement (or "stipulation") (similar to a plea bargain in a criminal case) in which you agreed to accept discipline against your license.

3.  You failed to submit any election of rights (EOR) form and failed to file a petition for a formal hearing in a timely manner, and, therefore, you have waived your right to a formal hearing.
There are a few other circumstances in which there may be an informal hearing before the Board of Pharmacy, such as motions to modify a final order, motion to lift a suspension of a license, appearance in accordance with an earlier order, petition for a declaratory statement, or other administrative matters.  This article only discusses those directly relating to disciplinary action as indicated above.

What an Informal Administrative Hearing Is Not.
1.  An informal administrative hearing is not an opportunity for you to tell your side of the story.  You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

2.  An informal administrative hearing is not an opportunity for you to prove that you are innocent of the charges.  You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

3.  An informal administrative hearing is not an opportunity for you to introduce documents or evidence to show that someone else committed the offenses charged and you did not.  You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.
4.  An informal administrative hearing is not an opportunity for you to argue that you should not be in the board's impaired practitioners program (the Professionals Resource Network (PRN)) because you have completed a different program or that you do not have a problem.  These are the only programs recognized and used and you have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

Board of Pharmacy Formal Administrative Hearing vs. Informal Hearing.
If you desire to contest the facts alleged against you then you must state this in writing.  If the material facts in a case are challenged by you, then the Board of Pharmacy or the Department of Health (DOH) (note:  all professional boards are under the Department of Health in Florida) must forward your case to the Division of Administrative Hearings (DOAH) where a neutral, objective administrative law judge (ALJ) will be appointed to hold a formal hearing in your case.  This is the only way that exists for you to prove that the facts alleged against you are incorrect or that you are not guilty of the charges made against you.  In fact, you do not even have to do anything in such a case.  The Department of Health has the burden of proof and it has to prove the charges against you and the material facts alleged against you by clear and convincing evidence.  Often, it is unable to do this at a formal administrative hearing.
However, because of the technicalities of evidentiary law and administrative law, we do not recommend that a nonlawyer attempt to represent himself or herself at such hearings.  You can make technical mistakes (such as answering requests for admissions incorrectly) that severely compromise any defense you may have.  We recommend that you always retain the services of an experienced health lawyer in any such matter.

What to Do If You Find That You Are at an Informal Hearing and Decide to Contest the Material Facts of the Case (And Your Guilt or Innocence).
If you have been scheduled for an informal administrative hearing and you decide that you do desire to challenge the material facts alleged against you in the administrative complaint (AC), file a written objection to proceeding at the informal hearing.  State that you have discovered that there are material facts that you do desire to challenge and that you desire that the proceedings be converted to a formal hearing.  File this with the Clerk of the administrative agency you are before (usually the department of health or the Agency for Health Care Administration (AHCA) and also send a copy to the opposing attorney and the executive director of the Board of Pharmacy.  Do this as early as possible and keep proof that you have actually and filed the written request.
If you are already at the informal hearing when you discover this, object to the proceedings on the record and ask to have the informal hearing be converted to a formal hearing where you may contest the material facts.  State this as many times as reasonably possible.

Preparing for an Informal Hearing Before the Board of Pharmacy.
Since you are not contesting the facts alleged against you, if you are going to an informal hearing be sure you do the following:
1.  Be sure you know where the hearing is going to be held.  Try to stay the night before in the same hotel as the hearing will be held.  You will usually have to make these reservations early in order to get a room.

2.  Attend a Board of Pharmacy meeting that occurs before the one at which your case is scheduled.  This will give you a feeling for the procedures that will be followed, will help to make you less nervous when you appear, and you can obtain continuing education units for doing so (be sure to sign in and sign out).  Be sure to attend one of the days when the disciplinary hearings are held.

3.  Dress professionally for the appearance.  This may be the most important event in your professional career.  For men, this means a suit and tie or, at least, a dark coat, dark slacks and a necktie.  For women, a professional business suit or the equivalent is in order.  Do not dress as if you are going to the park, the beach or out on a date.  Do not wear sexually provocative or revealing clothing.

4.  Check the agenda that is published on line a day or two before the scheduled hearing to make sure that your case is still scheduled for the date and time on the hearing notice.  Informal hearings may be moved around on the schedule.  Make sure you are there at the earliest time on the hearing notice or agenda.

5.  Listen to questions asked of you by Board of Pharmacy members and attempt to answer them directly and succinctly.  You will be placed under oath for the proceeding and there will be a court reporter present as well as audio recording devices to take everything down.

6.  Do not argue with the Board members or lose your temper.  This is not the time or place to let this happen.  If you have such tendencies, then you should have an attorney there with you who can intercept some of the questions and can make defensive arguments (to the extent that they may be permitted) for you.

7.  You may introduce documents and evidence in mitigation.  However, you have agreed that the material facts alleged are true, so you may not contest these.  In effect, you have plead guilty and you are just arguing about how much punishment (discipline) and what kind of punishment you should receive.

8.  If you do intend to introduce documents and evidence in mitigation, be sure you know what the mitigating factors are (these are published in a separate board rule in the Florida Administrative Code for each professional board).  These may include, for example, the fact that there was no patient harm, that there was no monetary loss, that restitution has been made, the length of time the professional has been practicing, the absence of any prior discipline, etc.  You should submit these far ahead of time with a notice of filing, so that they are sent out to the board members with the other materials in your file.  This is another reason to have experienced counsel represent you at the informal hearing.

9.  Be prepared to take responsibility for your actions.  If you are not prepared to take responsibility, then this means you must believe you are innocent and you should be at a formal hearing, not an informal one.

10.  Be prepared to explain what went wrong, why it went wrong, and what remedial measures you have taken to prevent a recurrence of this type of event in the future.  Show that you have learned from this experience and that you are not going to make the same mistake again.

11.  It is our advice to always retain the services of an experienced attorney to represent you at such hearings.  Often your professional liability insurance will cover this.  If you have professional liability insurance, be sure that it contains a rider or addendum that provides coverage for professional license defense matters and administrative hearings.  You need at least $25,000 to $50,000 in coverage for this type of defense.  If necessary, you should contact your insurer or insurance agent and have the limits increased for a small additional premium.

Other Little Known Facts About Board of Pharmacy Proceedings to Remember.
Professional licensing matters are considered to be "penal" or "quasi-criminal" in nature.  Therefore, you have your Fifth Amendment rights in relation to being required to give evidence against yourself.  You cannot be compelled to do this in such matters.  However, since it is an administrative proceeding and not a criminal proceeding, there is no requirement that the licensee be advised of this by a DOH investigator or attorney.
If you enter into a settlement agreement and attend the informal hearing to approve it, nothing you say or testify to at this hearing can later be used against you.  This is because you are involved in an attempt to negotiate and settle (or compromise) the claims being made against you.  It is a general rule of law that nothing the parties say in such settlement proceedings can later be used as evidence if the settlement agreement is not approved.  The law tries to promote settlements among parties to any dispute in this way.
It is true that on occasion the Board will examine a case on an informal hearing and will decide to dismiss it.  This is rare, but it does happen.  Sometimes, it will be a tactical decision on the part of you and your attorney to elect to go to an informal hearing with the hope that the Board of Pharmacy may examine the case and decide to dismiss it.  However, you cannot count on this happening.

Don't Wair Until it is Too Late;  Consult with an Experienced Health Law Attorney.
Do not wait until action has been taken against you to consult with an experienced attorney in these matters.  Few cases are won on appeal.  It is much easier to win your case when there is proper time to prepare and you have requested a formal hearing so that you may actually dispute the facts being alleged against you.

The attorneys of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing pharmacists, pharmacies and pharmacy techs in investigations and at Board of Pharmacy hearings.  Call now or visit our website http://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.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Internet Calendar Postings at the Center of Alleged HIPAA Privacy Violation Settlement

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

A physician group has reached a settlement with the United States Department of Health and Human Services (HHS) Office for Civil Rights (OCR) over alleged Health Insurance Portability and Accountability Act of 1996 (HIPAA) violations. The settlement was reached on April 17, 2012. It requires Phoenix Cardiac Surgery (PCS) to pay OCR $100,000. PCS is also required enter into a one-year corrective action plan (CAP). The Resolution Agreement and Corrective Action Plan can be viewed here.

HIPAA Complaint Resulted from Internet Calendar Postings.
OCR's investigation of PCS was launched after a complaint was received in 2009. Click here to view a HIPAA complaint that you can file online. The complaint alleged that PSC disclosed protected health information (PHI) on patients on the Internet. After investigating the complaint, the OCR alleged that PCS violated the HIPAA privacy and security rules.

According to the OCR, PCS posted clinical and surgical appointments on a publicly accessible, Internet calendar. The OCR also alleged that PCS employees e-mailed protected health information to their personal e-mail accounts. Furthermore, PCS allegedly did not have adequate administrative, physical and technical safeguards in place to protect patient data. The OCR alleged that PCS did not appoint a security officer as required by HIPAA or perform an accurate and thorough risk assessment, also required by HIPAA. The CAP required by the settlement will require PCS to implement policies to ensure full compliance with HIPAA's privacy and security rules.

Are You In Compliance with HIPAA?

The Health Insurance Portability and Accountability Act of 1996, sometimes referred to as the Kennedy-Kassenbaum Act, was enacted into law as Public Law (P.L.) 104-191, 110 Stat. 1936. Among its many different provisions, it included basic minimums to ensure the privacy of personal medical information. Its main privacy provisions are codified in federal law in different sections of the U.S. Code.

Health Providers Must be Cautious When Working With Electronic Health Information.
This case provides a good example of the downside of information technology (IT). While electronic health information assists in increasing accessibility and efficiency, it can also increase a practice's risk of violating HIPAA's Privacy Rule and Security Rule. All medical practices that utilize electronic health information need to ensure that they have effective IT security, education, policies and procedures in place to protect themselves from HIPAA's violations.

Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at http://www.thehealthlawfirm.com/ or call (407) 331-6620 or (850) 439-1001.

Sources Include:

HHS Press Office. "HHS Settles Case with Phoenix Cardiac Surgery for Lack of HIPAA Safeguards." U.S. Department of Health and Human Services. (Apr. 17, 2012). Press Release. From http://www.hhs.gov/news/press/2012pres/04/20120417a.html

Lewis, Nicole. "Online Calendar Mistakes Cost Doctors Group $100,000." Information Week. (Apr. 23, 2012). From http://www.informationweek.com/news/healthcare/security-privacy/232900727

Sterling, Robyn. "HHS Settlement for Lack of HIPAA Safeguards." Proskauer Privacy Law Blog. (Apr. 25, 2012). From http://www.jdsupra.com/post/documentViewer.aspx?fid=e548966a-d7eb-4f47-a0af-de15db487dbb/

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. http://www.thehealthlawfirm.com/ The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Florida Pain Clinics Continue to be a Target for Law Enforcement

Florida pain clinics began to really feel the impact of becoming law enforcement's newest target about a 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."
Regulations increased, and lawmakers enacted 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 http://www.thehealthlawfirm.com/ for more information about this.

Preparing for an Informal Board of Medicine Hearing

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

If you are scheduled to appear for an informal hearing before the Florida Board of Medicine, there are many facts that you will want to know to be properly prepared. 
Limited Circumstances for Informal Administrative Hearing

First, you should understand that you will only be at an informal hearing in which you appear before the Board of Medicine itself for a very limited number of reasons.  These will include the following:

1.  If you completed an election of rights (EOR) form and agreed that you did not intend to dispute any material facts alleged against you from the administrative complaint (AC) in the case.

2.  If you entered into a settlement agreement (or "stipulation") (similar to a plea bargain in a criminal case) in which you agreed to accept discipline against your license.

3.  You failed to submit any election of rights (EOR) form and failed to file a petition for a formal hearing in a timely manner, and, therefore, you have waived your right to a formal hearing.
There are a few other circumstances in which there may be an informal hearing before the Board, such as motions to modify a final order, motion to lift a suspension of a license, appearance in accordance with an earlier order, petition for a declaratory statement, or other administrative matters.  This article only discusses those directly relating to disciplinary action as indicated above.

What an Informal Administrative Hearing Is Not
1.  An informal administrative hearing is not an opportunity for you to tell your side of the story.  You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

2.  An informal administrative hearing is not an opportunity for you to prove that you are innocent of the charges.  You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

3.  An informal administrative hearing is not an opportunity for you to introduce documents or evidence to show that someone else committed the offenses charged and you did not.  You have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.
4.  An informal administrative hearing is not an opportunity for you to argue that you should not be in the board's impaired practitioners program (either the Professionals Resource Network (PRN) or the intervention Project for Nurses (IPN)) because you have completed a different program or that you do not have a problem.  These are the only programs recognized and used and you have agreed that there are no disputed material facts in the case or you would not be at an informal hearing.

Formal Administrative Hearing vs. Informal Hearing
If you desire to contest the facts alleged against you then you must state this in writing.  If the material facts in a case are challenged by you, then the Board or the Department of Health (DOH) (note:  all professional boards are under the Department of Health in Florida) must forward your case to the Division of Administrative Hearings (DOAH) where a neutral, objective administrative law judge (ALJ) will be appointed to hold a formal hearing in your case.  This is the only way that exists for you to prove that the facts alleged against you are incorrect or that you are not guilty of the charges made against you.  In fact, you do not even have to do anything in such a case.  The Department of Health has the burden of proof and it has to prove the charges against you and the material facts alleged against you by clear and convincing evidence.  Often, it is unable to do this at a formal administrative hearing.
However, because of the technicalities of evidentiary law and administrative law, we do not recommend that a nonlawyer attempt to represent himself or herself at such hearings.  You can make technical mistakes (such as answering requests for admissions incorrectly) that severely compromise any defense you may have.  We recommend that you always retain the services of an experienced health lawyer in any such matter.

What to Do If You Find That You Are at an Informal Hearing and That You Do Desire to Contest the Material Facts of the Case (And Your Guilt or Innocence)
If you have been scheduled for an informal administrative hearing and you decide that you do desire to challenge the material facts alleged against you in the administrative complaint (AC), file a written objection to proceeding at the informal hearing.  State that you have discovered that there are material facts that you do desire to challenge and that you desire that the proceedings be converted to a formal hearing.  File this with the Clerk of the administrative agency you are before (usually the department of health or the Agency for Health Care Administration (AHCA) and also send a copy to the opposing attorney and the executive director of the Board.  Do this as early as possible and keep proof that you have actually and filed the written request.

If you are already at the informal hearing when you discover this, object to the proceedings on the record and ask to have the informal hearing be converted to a formal hearing where you may contest the material facts.  State this as many times as reasonably possible.

Preparing for an Informal Hearing
Since you are not contesting the facts alleged against you, if you are going to an informal hearing be sure you do the following:
1.  Be sure you know where the hearing is going to be held.  Try to stay the night before in the same hotel as the hearing will be held.  You will usually have to make these reservations early in order to get a room.

2.  Attend a Board meeting that occurs before the one at which your case is scheduled.  This will give you a feeling for the procedures that will be followed, will help to make you less nervous when you appear, and you can obtain continuing education units for doing so (be sure to sign in and sign out).  Be sure to attend one of the days when the disciplinary hearings are held.

3.  Dress professionally for the appearance.  This may be the most important event in your professional career.  For men, this means a suit and tie or, at least, a dark coat, dark slacks and a necktie.  For women, a professional business suit or the equivalent is in order.  Do not dress as if you are going to the park, the beach or out on a date.  Do not wear sexually provocative or revealing clothing.

4.  Check the agenda that is published on line a day or two before the scheduled hearing to make sure that your case is still scheduled for the date and time on the hearing notice.  Informal hearings may be moved around on the schedule.  Make sure you are there at the earliest time on the hearing notice or agenda.

5.  Listen to questions asked of you by Board members and attempt to answer them directly and succinctly.  You will be placed under oath for the proceeding and there will be a court reporter present as well as audio recording devices to take everything down.

6.  Do not argue with the Board members or lose your temper.  This is not the time or place to let this happen.  If you have such tendencies, then you should have an attorney there with you who can intercept some of the questions and can make defensive arguments (to the extent that they may be permitted) for you.

7.  You may introduce documents and evidence in mitigation.  However, you have agreed that the material facts alleged are true, so you may not contest these.  In effect, you have plead guilty and you are just arguing about how much punishment (discipline) and what kind of punishment you should receive.

8.  If you do intend to introduce documents and evidence in mitigation, be sure you know what the mitigating factors are (these are published in a separate board rule in the Florida Administrative Code for each professional board).  These may include, for example, the fact that there was no patient harm, that there was no monetary loss, that restitution has been made, the length of time the professional has been practicing, the absence of any prior discipline, etc.  You should submit these far ahead of time with a notice of filing, so that they are sent out to the board members with the other materials in your file.  This is another reason to have experienced counsel represent you at the informal hearing.

9.  Be prepared to take responsibility for your actions.  If you are not prepared to take responsibility, then this means you must believe you are innocent and you should be at a formal hearing, not an informal one.

10.  Be prepared to explain what went wrong, why it went wrong, and what remedial measures you have taken to prevent a recurrence of this type of event in the future.  Show that you have learned from this experience and that you are not going to make the same mistake again.

11.  It is our advice to always retain the services of an experienced attorney to represent you at such hearings.  Often your professional liability insurance will cover this.  If you have professional liability insurance, be sure that it contains a rider or addendum that provides coverage for professional license defense matters and administrative hearings.  You need at least $25,000 to $50,000 in coverage for this type of defense.  If necessary, you should contact your insurer or insurance agent and have the limits increased for a small additional premium.
Other Little Known Facts to Remember
Professional licensing matters are considered to be "penal" or "quasi-criminal" in nature.  Therefore, you have your Fifth Amendment rights in relation to being required to give evidence against yourself.  You cannot be compelled to do this in such matters.  However, since it is an administrative proceeding and not a criminal proceeding, there is no requirement that the licensee be advised of this by a DOH investigator or attorney.
If you enter into a settlement agreement and attend the informal hearing to approve it, nothing you say or testify to at this hearing can later be used against you.  This is because you are involved in an attempt to negotiate and settle (or compromise) the claims being made against you.  It is a general rule of law that nothing the parties say in such settlement proceedings can later be used as evidence if the settlement agreement is not approved.  The law tries to promote settlements among parties to any dispute in this way.
It is true that on occasion the Board will examine a case on an informal hearing and will decide to dismiss it.  This is rare, but it does happen.  Sometimes, it will be a tactical decision on the part of you and your attorney to elect to go to an informal hearing with the hope that the Board may examine the case and decide to dismiss it.  However, you cannot count on this happening.

Don't Wait Too Late;  Consult with an Experienced Health Law Attorney Early
Do not wait until action has been taken against you to consult with an experienced attorney in these matters.  Few cases are won on appeal.  It is much easier to win your case when there is proper time to prepare and you have requested a formal hearing so that you may actually dispute the facts being alleged against you.
The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians in investigations and at Board of Medicine hearings.  Call now or visit our website 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. 

Over 100 Medical Professionals Arrested During Medicare Fraud Bust

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
More than 100 doctors, nurses and other licensed health professionals were arrested for alleged involvement in Medicare fraud on May 2, 2012. The arrests were made by federal agents in seven cities nationwide, but more than half took place in South Florida.
This multi-agency attack on medical professionals involved law enforcement agents from the Federal Bureau of Investigation (FBI), Department of Health and Human Services-Office of Inspector General (HHS-OIG), Medicaid Fraud Control Units (MFCU) and other state and local law enforcement agencies. In addition to arresting over 100 health professionals, these agents also executed 20 search warrants in connection with ongoing Medicare fraud investigations.
Some of the charges against the medical professionals include conspiracy to commit health care fraud, health care fraud, violations of the anti-kickback statutes and money laundering. The charges are based on a variety of alleged Medicare fraud schemes involving medical treatments and services such as home health care, mental health services, physical and occupational therapy, durable medical equipment (DME), mental health counseling and ambulance services. These alleged Medicare fraud schemes resulted in a combined $452 million in false billings.
HHS also took other administrative action against 52 other health providers. These providers were tracked down through data analysis and are also accused of Medicare fraud. Because of the Affordable Care Act, HHS will be able to suspend payments to these providers the entire time until the investigations are completed.
Because of the severe state budget shortfalls and the federal deficit, we are seeing a tremendous increase in both Medicare and Medicaid fraud initiatives. If you are being accused of Medicare or Medicaid fraud, it is extremely important to retain an experienced health attorney immediately.
Don't Wait; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now
The Health Law Firm's attorneys routinely represent physicians and other healthcare professionals in Medicare and Medicaid investigations, audits and recovery actions. They also represent physicians and health professionals in actions initiated by the Medicaid Fraud Control Units (MFCUs), in False Claims Act cases, in actions initiated by the state to exclude or terminate from the Medicaid Program or by the HHS OIG to exclude from the Medicare Program.
Call now at (407) 331-6620 or (850) 439-1001 or visit our website http://www.thehealthlawfirm.com/.
Sources Include:
Weaver, Jay. "Feds Arrest More Than 100 Medicare Fraud Suspects in South Florida, Nationwide." Miami Herald. (May 02, 2012). From
http://www.miamiherald.com/2012/05/02/2779369/feds-arrest-about-100-medicare.html
U.S. Department of Justice, Office of Public Affairs. "Medicare Fraud Strike Force Charges 107 Individuals for Approximately $452 Million in False Billing." U.S. Department of Justice. Press Release. (May 02, 2012). From http://www.justice.gov/opa/pr/2012/May/12-ag-568.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.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

The Corporate Practice of Medicine in Florida

Florida has no laws or court decisions that prohibit the corporate practice of medicine. As a general rule, physicians and other health care providers may be employed by or contracted by corporations and other business owned and controlled by non-physicians. This can be seen in a number of different cases.

In Rush v. City of St. Petersburg, 205 So.2d 11 (Fla. 2d DCA 1967),⁹ the Florida Court of Appeal held that the City of St. Petersburg had not practiced medicine because it had not interfered with the physician-patient relationship, thus acknowledging that a physician could be legally employed by a nonphysician business.

The decision of a Florida federal bankruptcy court in the case of In re Urban² also indicates that a corporation may lawfully employ a physician to engage in a medical practice. In the Urban case, creditors attempted to void a physician's transfer of shares in two corporations arguing that the purpose of the corporations was to conduct medical practices in violation of state law prohibitions. The corporations argued that they were not conducting a medical practice, but were employing physicians to engage in the practice of medicine. The bankruptcy court agreed that there was no legal basis to void the transfer of shares. The court seemed to accept the difference between a corporation's practicing medicine and the employment of a physician to practice medicine. This distinction appears to allow the utilization of the corporate form to employ the physician as long as the physician makes all significant medical decisions involving patient care.

The Florida Board of Medicine has published several declaratory statements also indicating that there is no prohibition in Florida on the practice of medicine by physicians as corporate employees.³
Florida laws do allow for licensed health care professionals to operate as professional service corporations (designated by the initials "P.A." in Florida) and as professional limited liability companies ("PLC").⁴
If the physician (or any other professional, for that matter) chooses to operate as a professional service corporation or professional limited liability company, he must remember that only persons in that same profession may serve as shareholders (or "members" in the case of a limited liability corporation), officers or directors of the corporation.⁵ However, there is no prohibition on a health care provider's forming and operating his or her medical practice as a regular business corporation (usually designated by the abbreviation "Inc.") or as a regular limited liability company ("LLC").

SUMMARY OF FLORIDA LAW REGARDING CORPORATE PRACTICE OF MEDICINE:

• Florida law does not prohibit the corporate practice of medicine, but does prohibit "fee-splitting" by health care professional.
  
• Florida does prohibit the corporate practice of dentistry and optometry.

For more information about corporate medicine in Florida, please visit our webiste at http://www.thehealthlawfirm.com/.


Sources:


1.  Rush v. City of St. Petersburg, 205 So.2d 11 (Fla. 2d DCA 1967).

2.  In re Urban, 138 B.R. 632 (Fla. M.D. 1992).

3.  See In re John W Lister, M.D., 9 EA.L.R. 6299(1987) and In re Conrad Goulet, M.D., Florida Board of Medicine Case No. 89-BOM-01 (1989).

4.  See Chapter 621, Fla. Stat. (2002).
5.  Florida law defines "members of the same profession" very narrowly in this regard. Thus, a professional service corporation composed of doctors of medicine (M.D.'s) cannot legally allow any other profession, including doctors of osteopathic medicine (D.O.'s) or doctors of chiropractic medicine (D.C.'s) to be owners, officers or directors of the same P.A. Likewise, a professional service corporation composed of doctors of chiropractic medicine (D.C.'s) cannot legally allow any other profession, including doctors of osteopathic medicine (D.O.'s) or doctors of medicine (M.D.'s) to be owners, officers or directors of the same P.A. It goes without saying that layperson, including family members can never legally be owners, officers or directors in the same P.A.

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.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.