Physician Argues Definition of “Peer” at Formal Administrative Hearing

peer reviewFACTS: The Agency for Health Care Administration (“AHCA”) is responsible for administering Florida’s Medicaid program and conducting investigations and audits of paid claims to ascertain if Medicaid providers have been overpaid. With regard to investigations of physicians, section 409.9131, Florida Statutes, provides that AHCA must have a “peer” evaluate Medicaid claims before the initiation of formal proceedings by AHCA to recover overpayments. Section 409.9131(2)(c) defines a “peer” as “a Florida licensed physician who is, to the maximum extent possible, of the same specialty or subspecialty, licensed under the same chapter, and in active practice.” Section “109.9131(2)(a) deems a physician to be in “active practice” if he or she has “regularly provided medical care and treatment to patients within the past two years.”

Alfred Murciano, M.D., treats patients who are hospitalized in Level III neonatal intensive care units and pediatric intensive care units in Miami-Dade, Broward, and Palm Beach County hospitals. His practice is limited to pediatric infectious disease. He has been certified by the American Board of Pediatrics in two areas: General Pediatrics and Pediatric Infectious Diseases. AHCA initiated a review of Medicaid claims submitted by Dr. Murciano between September 1, 2008, and August 31, 2010, and referred those claims to Richard Keith O’Hern, M.D., for peer review. Dr. O’Hern practiced medicine for 37 years, and was engaged in a private general pediatric practice until he retired in December of 2012. During the course of his career, he was certified by the American Board of Pediatrics in General Pediatrics, completed a one-year infectious disease fellowship at the The University of Florida, and treated approximately 16,000 babies with infectious disease issues. However, he was never board certified in pediatric infectious diseases, and at the time he reviewed Dr. Murciano’s Medicaid claims, Dr. O’Hern would have been ineligible for board certification in pediatric infectious diseases. In addition, Dr. O’Hern would have been unable to treat Dr. Murciano’s hospitalized patients in Level III NICUs and PICUs.

After Dr. O’Hern’s review, AHCA issued a Final Agency Audit Report alleging Dr Murciano had been overpaid by $l,051.992.99, and that he was required to reimburse AHCA for the overpayment. In addition, AHCA stated it was seeking to impose a fine of $210,398.60.

OUTCOME: Dr. Murciano argued at the formal administrative hearing that Dr O’Hern was not a “peer” as that term is defined in section 409.9131(20)(c). The ALJ agreed and issued a Recommended Order on May 22, 2014, recommending that AHCA’s case be dismissed because it failed to satisfy a condition precedent to initiating formal proceedings. While recognizing that AHCA is not required to retain a reviewing physician with the exact credentials as the physician under review, the ALJ concluded Dr. O’Hern was not of the same specialty as Dr. Murciano.

On July 31, 2014, AHCA rendered a Partial Final Order rejecting the ALJ’s conclusion that Dr. O’Hern was not a “peer.” In the course of ruling that it has substantive jurisdiction over such conclusions and that its interpretation of section 409.9131(2)(c), Florida Statutes, is entitled to deference, AHCA stated that it interprets the statute “to mean that the peer must practice in the same area as Respondent, hold the same professional license as Respondent, and be in active practice like Respondent.” AHCA concluded that “Dr. O’Hern is indeed a ‘peer’ of Respondent under the Agency’s interpretation of Section 409.9131(2)(c), Florida Statutes, because he too has a Florida medical license, is a pediatrician and had an active practice at the time he reviewed Respondent’s records. That Dr. O’Hern did not hold the same certification as Respondent, or have a professional practice identical to Respondent in no way means he is not a ‘peer’ of Respondent.” AHCA’s rejection of the ALJ’s conclusion of law regarding Dr. O’Hern’s “peer” status caused AHCA to remand the case back to the ALJ to make the factual findings on the claimed overpayments that were not made in the Recommended Order because of the ALJ’s conclusion that Dr. O’Hern did not qualify as a “peer.”

On August 18, 2014, the ALJ issued an Order respectfully declining AHCA’s remand. AHCA then filed a Petition for writ of Mandamus in the First District Court of Appeal, asking the court to direct the ALA to accept the remand and to enter findings of fact and conclusions of law with regard to each overpayment claim. The court assigned case number 1D14-3836 to AHCA’s Petition, and the case is pending.
Source:

AHCA v. Alfred Murciano, M.D., DOAH Case No. 13-0795MPI (Recommended Order May 22, 2014), AHCA Rendition No. 14-687-FOF-MDO (Partial Final Order July 31, 2014)
About the Author: The forgoing case summary was prepared by and appeared in the DOAH case notes of the Administrative Law Section newsletter, Vol. 36, No. 2 (Dec. 2014), a publication of the Administrative Law Section of The Florida Bar.

Two More Compounding Pharmacies Recall Drugs

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.

Recall Upgraded in New Jersey.

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.

Eye Infections from Georgia Compounding Pharmacy Products.

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.

Florida Compounding Pharmacy in Hot Water Due to 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.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, 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.

Common Deficiencies We See 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 recently 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.

Trial Court Must Hold Evidentiary Hearing to Determine Disputed Facts in Public Records Act Suit

10 Indest-2008-7Edited by George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in the Legal Specialty of Health Law

An interesting summary of a Florida appellate case from Florida’s First District Court of Appeal recently came across my desk. Florida has a very broad Public Records Act and Sunshine Act. We are often involved in suing state agencies for force disclosure of documents and information.

The following is from a summary that was originally published in the newsletter of the Florida Bar’s Administrative Law Section.

Clay Cnty. Ed. Ass’n u. Clay Cnty. Sch. Bd., 144 So. 3d 708 (Fla. 1st DCA 2014).

After requesting various public records related to the Clay County School Board’s operation, and receiving only some of the responsive documents, the Clay County Education Association (CCEA) filed a petition for a writ of mandamus with the circuit court to compel production of the records. In unsworn defenses to the complaint, the school board stated that it had already produced the documents, did not have the information in the requested format, or that the requested documents did not exist. The circuit court granted the school board’s motion to dismiss the complaint, and the CCEA appealed.

The First District Court of Appeal reversed, finding that CCEA’s petition for writ of mandamus was legally sufficient. The complaint alleged a violation of a clear legal right and breach of an indisputable legal duty, thereby showing a prima facie basis for relief.

The appellate court also concluded that the circuit court erred by failing to hold an evidentiary hearing to resolve disputed issues of fact, which CCEA requested. The school board’s defenses likewise created issues of fact that should have been grounds for a priority bearing under section 119.01, Florida Statutes.

Additional Comments.

This case is important for several reasons. It took place in the First District Court of Appeal. Since most Florida agencies are located in Tallahassee, most Public Records Act cases are filed there. Additionally this shows that the Florida Appellate Courts will require trial courts to actually have evidentiary hearings and trials when there are facts in contention between the parties, which is good for citizens.

Contact The Health Law Firm Attorneys Experienced in Administrative Law.

The attorneys of The Health Law Firm represent clients in administrative and civil litigation (both state and federal) throughout the state and in other states as permitted by their rules. We also represent clients in cases involving the Florida Public Records Act, the Sunshine Act, the Federal Freedom of Information Act (FOIA) and the Privacy Act. Our attorneys are available to provide emergency hearing coverage, administrative hearing representation, emergency board representation (Board of Medicine, Board of Dentistry, Board of Nursing, Board of Osteopathic Medicine, Board of Pharmacy, Board of Psychology, Board of Licensed Clinical Social Work, Marriage & Family Therapy & Mental Health Counseling and other professional boards), as well as the Agency for Health Care Administration, emergency deposition coverage and other litigation coverage on short notice. Should you need local counsel or just coverage for a hearing or deposition, we are available; contact us.

Source: The original case summary discussed above was originally published in the Administrative Law Section Newsletter, Vol. 34, No. 2 (Dec. 2014), a publication of The Administrative Law Section of the Florida Bar.

 

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 © 1999-2015 The Health Law Firm. All rights reserved.

Tips for Medical Students and Medical Residents Accused of Irregular Behavior on the USMLE

Patricia's Photos 013By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

We frequently receive calls for consultations from students who receive a letter from the National Board of Medical Examiners (NBME) accusing the medical student or medical resident of “Irregular Behavior” on the United States Medical Licensing Examination (USMLE). In many cases these are graduates of foreign medical schools who have applied through the Examination Committee for Foreign Medical Graduates (ECFMG).

Irregular behavior can consist of many different things before, during or after taking the USMLE.  What you must know is that, in effect, you are being accused of cheating.

Examples of What The USMLE Defines  as “Irregular Behavior.”

Examples of the types of conduct which we have seen before include:

–  Attending a commercial USMLE preparation course that provides some of the actual examination questions.

–  Soliciting information on the contents or questions on the examination.

–  Using a cell phone during the examination.

–  Talking with another person during the examination.

–  Sharing information on the types of questions or cases that were on your examination with another person or on a blog over the internet.

These are just a few.  For more examples, please see an article I wrote on this by clicking here.

When Accused of Irregular Behavior Don’t Do  The Following.

We have represented students accused of irregular behavior by consulting with them before and after USMLE hearings and on appealing the results. We have represented a number of examinees at the hearings held before the NBME at its headquarters in Philadelphia, Pennsylvania.

From our experience in such cases, the following are the errors that most of you will make when accused by the USMLE of irregular behavior.

1.  You will fail to obtain an attorney experienced with such cases immediately upon receipt of a letter from the NBME accusing you of irregular behavior.  Take this as a formal charge accusing you of, in effect, cheating.  THIS IS SERIOUS.

2.  You will telephone, write or e-mail the NBME and explain “your side of the story.”  This will be full of admissions that will help prove the case against you and you will not even understand this.  (Please note that under U.S. law any statements you make, oral or written, can be used as evidence against you in any civil, criminal or administrative proceeding.  This is not the case with statements that your attorney makes on your behalf.)

3.  If you submit documents or statements to the NBME in support of your case, these will not be well-organized, well-labeled and in a form simple and easy to understand.  In many instances, you will not even understand the legal issues you are facing or how to refute them.

4.  You will fail to request or attend in person the hearing before the NBME Committee on Irregular Behavior (“The Committee”) in Philadelphia, Pennsylvania.

5.  You will fail to take an attorney experienced in such medical administrative hearings to represent you at The Committee hearing in Philadelphia.

6.  You will not know how to properly present your evidence or present your own position to The Committee, if you do attend the hearing.

7.  You will not know when or what kind of witnesses, including expert witnesses, you need to use to prove issues in your case before The Committee.

8.  You will fail to understand and correctly respond to the questions that the many different Committee members (usually 15 or more) will ask you during the hearing.

9.  You will fail to correctly follow all procedures in order to preserve your rights in the proceedings.

10.  You will falsely believe that if you lose at The Committee hearing you can win on appeal or somehow sue in court and prove you are right; this is almost never correct.  You will have only one chance at proving your case and this is at The Committee hearing in Philadelphia.

11.  You will incorrectly believe that even if you are only suspended from taking the USMLE again for a short period of time, this will have no effect on your education or career.  (Note:  Your USMLE transcript will note this fact and this will probably prevent you from ever getting into a good residency program.  See #1 above.)

 

This Is a Serious Matter, Don’t Think Otherwise.

You and your family have invested tens of thousands, if not hundreds of thousands of dollars, on your education so that you can become a physician.  You have spent years of sacrifice and studying in order to become a physician.  This is not the time to be cheap and to think that the cost of hiring an experienced legal counsel is too high.  You could lose everything you and your family has invested in this. Do not be “penny wise and pound foolish.”  You will need professional help if you are to get through this successfully.  If you don’t care about these matters or you don’t believe this is a serious matter worthy of an investment for attorney’s fees, then go ahead and ignore this advice.

If you are not reading this until after you have lost the case and been found to have committed “irregular behavior” by the USMLE Committee on Irregular Behavior, I am sorry for you, but it is probably too late to do anything about it.

Contact Experienced Health Law Attorneys Today.

The attorneys of The Health Law Firm provide legal representation to medical students, residents, interns and fellows in academic disputes, graduate medical education (GME) hearings, contract negotiations, license applications, board certification applications and hearings, credential hearings, and civil and administrative litigations.

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

Comments?

Have you faced The Committee? What was the experience like? 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.

Chinese Nationals Indicted in Alleged U.S. Test-Taking Scheme

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

Fifteen Chinese citizens living in the United States reportedly conspired to take college entrance exams for others so they could obtain student visas, according to the Associated Press. The frauds allegedly took standardized exams including the Scholastic Aptitude Test (SAT), the Graduate Record Examination (GRE), and the Test of English as a Foreign Language (TOEFL).

The Test-Taking Conspiracy.

According to BBC News, the scheme reportedly took place between 2011 and 2015, mainly in western Pennsylvania. Six individuals named in the indictment were identified as students who supposedly paid up to $6,000 to have other individuals, also charged, take the tests. The test-takers purportedly “impersonated others, and those others were able to use the fraudulent test scores to obtain F1 visas,” U.S. Attorney for the Western District of Pennsylvania David Hickton told the Associated Press. The individuals allegedly used fake passports that contained the students’ personal information, but a picture of the test-taker substituted for the student.

Testing Services Cooperate with the Investigation.

Princeton, New Jersey-based Educational Testing Service and the New York-based College Board are cooperating with the investigation, according to Hickton. “Their actions are consistent with the College Board’s commitment to identify and stop illegal activity that undermines the integrity of our exams and the hard work of students around the world,” College Board vice president Stacy Caldwell told the Associated Press. Educational Testing Service administers the SAT, GRE, and TOEFL exams, while the College Board oversees SAT registration.

Offenders Expected to Receive More Than Just a Slap on the Wrist.

The charges against the suspects include conspiracy, counterfeiting passports, mail and wire fraud, BBC News reported. The defendants, both male and female ranging in age from 19 to 26, could face up to 20 years in prison if convicted. According to BBC’s report, Special Agent in Charge of Homeland Security Investigations of Philadelphia John Kelleghan believes “these students were not only cheating their way into the university, they were also cheating their way through our nation’s immigration system.”

Due to the ongoing investigation, a final number has not yet been released documenting an exact number of suspects believed to be involved in the ruse.

Is There Similar Activity Going On in Medical Testing for NBME, USMLE or ECFMG Administered Tests?

There have been somewhat similar alleged test-taking fraudulent activities involving medical testing. From time to time we are consulted by individuals who have been caught using fraudulent documents to attempt to take the USMLE Step exams. We are also aware of allegations that there have been compromises of actual examinations involving foreign nationals. For example, see the blog I wrote on the Optima scandal.

On the whole, the NBME, USMLE, and ECFMG and their testing centers do an excellent job in screening out fraudulent test takers. It would be foolish for anyone who ever hoped to be a practicing physician to try to perpetrate a fraud in taking these tests.

Comments?

What are your thoughts on these allegations? Do you feel standardized testing should be monitored more heavily to prevent test-taking fraud from occurring? Please leave any thoughtful comments below.

Contact Experienced Health Law Attorneys.

The attorneys of The Health Law Firm provide legal representation to medical, dental, chiropractic, other professional students, residents, interns and fellows in academic disputes, contract negotiations, license applications, board certification applications and hearings, credential hearings, and civil and administrative litigations.

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

Sources:

“Chinese Nationals Accused of Taking SATs for Others.” BBC News. (May 28 2015). From:

http://www.bbc.com/news/world-us-canada-32921737

Mandak, Joe. “Feds Indict 15 Chinese in Alleged College Test-Taking Scheme.” The Associated Press. (May 28, 2015). From:

http://abcnews.go.com/US/wireStory/feds-indict-15-chinese-alleged-college-test-taking-31366456

About the Author: George F. Indest III, J.D., M.P.A., LL.M. is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone (407) 331-6620.

KeyWords: medical students, standardized tests, irregular behavior, fraud, defense attorney, legal representation, criminal proceeding, administrative law, health law, health care attorney, health care lawyer, defense lawyer, GME, graduate medical education, Step exams, medical interns, medical residents, ECFMG lawyer, USMLE attorney, foreign medical graduate attorney, legal counsel, legal advocate

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries

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

A Colorado surgeon allegedly faces 14 counts of unprofessional conduct associated with the use a robotic arm used during surgeries, according to the formal administrative complaint. The Colorado Medical Board filed the complaint on April 2, 2013, alleging that from 2008 until 2010, the surgeon cut and tore blood vessels, left sponges and other instruments inside of patients, injured patients through padding and positioning, subjected some patients to overly long surgeries and had to abort kidney donation procedures because of mistakes. The surgeon is also accused of not documenting the mistakes in patient charts.

According to the Colorado Board of Medicine’s administrative complaint, the surgeon was using the da Vinci robot, manufactured by Intuitive Surgical, Inc., for surgeries.

Click here to read the formal complaint from the Colorado Medical Board.

This complaint was filed around the same time as the U.S. Food and Drug Administration (FDA) launched a review of the robotic procedures.

A Number of Patients Speak Out On Surgeries.

The complaint lists 11 patient cases allegedly mishandled by the surgeon.

In one case, a 22-year-old woman wanted to donate a kidney to her brother. She was informed by the surgeon that the robot was the “gold standard” for kidney removals and transplants. During the surgery, the surgeon allegedly injured the patient’s aorta. To stop the bleeding, the surgeon allegedly converted to an open surgery, then aborted the kidney removal. After the attempted surgery, the patient allegedly went into post-operative distress and an X-ray showed a sponge that had been left inside the patient. The patient also alleges she was left with nerve damage after being improperly padded.

In another case, the surgeon allegedly used the robot on an 86-year-old man with metastatic cancer. The surgeon allegedly injured the patient’s aorta, and the robot arm moved when it should not have, causing another tear. The patient suffered kidney failure after the operation, and the family withdrew the patient’s life support.

Surgeon Suspended for Performing Robotic Surgeries.

In the complaint, the Colorado Medical Board is asking an administrative law judge to discipline the surgeon’s license to practice medicine. An article in The Denver Post states that the surgeon had his robotic-surgery privileges suspended for three months in 2010. The hospital would not say whether or not the surgeon received new training before allowing him to use the robotic arm after his suspension.

To read the entire article from The Denver Post, click here.

FDA and Other Medical Societies Leery of Robotic Procedures.

In March 2013, the FDA began interviewing surgeons about issues with the robotic surgery units, according to Fierce Health IT. The agency is allegedly trying to figure out why there has been an uptick in adverse event reports, including damaged organs and device failures, and whether these are a result of error or design problems.

For a list of other sources discussing possible adverse outcomes from robotic surgery, please see “references” below.

The American Congress of Obstetricians and Gynecologists and the Massachusetts Quality and Patient Safety Division are also warning health care professionals about the risks associated with robotic surgeries, according to Fierce Health IT. The American Congress of Obstetricians and Gynecologists said that these types of surgeries should not be the first or second choice for women undergoing routine hysterectomies. The Massachusetts Quality and Patient Safety Division sent a letter advising doctors of the safety concerns regarding robotic surgery.

Click here to read the entire article from Fierce Health IT.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

As a health care professional, does your facility use robotic arm surgeries? Do you believe they are the safer option? Do you think the FDA should take a closer look at these machines? Please leave any thoughtful comments below.

Sources:

Booth, Michael. “Colorado Charges Doctor in Problem-Plagued Robo-Surgeries at Porter.” The Denver Post. (April 10, 2013). From: http://www.denverpost.com/breakingnews/ci_22998041/colorado-charges-doctor-botched-robo-surgeries-at-porter

Hall, Susan. “Robo-Surgery Mistakes Land Physician in Hot Water.” Fierce Health IT. (April 15, 2013). From: http://www.fiercehealthit.com/story/robo-surgery-mistakes-land-physician-hot-water/2013-04-15

Colorado Medical Board v. Warren J. Kortz, M.D. Case Number ME 2013. Formal Complaint (April 2, 2013). From:http://www.thehealthlawfirm.com/uploads/Colo%20v.%20Warren%20Kortz%20MD.pdf

Gold, Ashley. “Health Officials Warn Complications Robotic Surgeries.” Fierce Health IT. (March 26, 2013). From: http://www.fiercehealthit.com/story/health-officials-warn-complications-robotic-surgeries/2013-03-26

Hall, Susan. “OBGYN Group: Robotic Surgeries Not Best Choice for Routine Hysterectomies.” (March 15, 2013). From: http://www.fiercehealthit.com/story/obgyn-group-robotic-surgery-not-best-choice-routine-hysterectomies/2013-03-15

Garde, Damian. “FDA Echoes Questions Over Intuitives’s Surgical Robot.” Fierce Medical Devices. (March 1, 2013). From: http://www.fiercemedicaldevices.com/story/fda-echoes-questions-over-intuitives-surgical-robot/2013-03-01

Bird, Julie. Much of Robo-Surgery Marketing ‘Unsubstantiated.’” Fierce Health IT. (July, 24, 2012). From”
http://www.fiercehealthit.com/story/much-robotic-surgery-marketing-unsubstantiated/2012-07-24

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.

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.

Administrative Final Orders Must State Findings of Fact Based on the Evidence Presented

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

Following is a summary of a recent appellate case on an issue relevant to health law:

Borges v. Dep’t of Health, 143 So. 3d 1185 (Fla. 3d DCA 2014).
Gustavo Borges (Borges) appealed a final order of the Florida Board of Dentistry that revoked his license to practice dentistry based on a conviction of the knowing receipt of child pornography under a federal statute.

At hearing, eight lay witnesses and four expert witnesses testified. In the recommended order’s discussion of the evidence presented, which was the basis for the Board’s final order, the administrative law judge (ALJ) discussed the testimony of only one witness-Borges-after concluding that a statement by Borges constituted a concession that established that his conviction was related to his ability to practice dentistry. No other testimony was discussed in the order, or even acknowledged.

On appeal, the appellate court concluded that the ALJ’s recommended order adopted by the Board did not comply with one of the requirements of section 120.57, Florida Statutes-that an ALJ’s order must contain “express findings of fact.” The court was quick to point out that, while the findings of fact did not have to address the testimony of every witness (i.e., all twelve here), the order must at least address the factual controversies at issue to the extent they are relevant to the disposition, or address why the testimony is irrelevant. Having failed to do so in this case, the appellate court reversed and remanded.

The case summary above was originally published in the Administrative Law Section Newsletter, Vol. 34, No. 2 (Dec. 2014), a publication of The Administrative Law Section of The Florida Bar.

Editor’s Comments on Case Summary.

This case demonstrates an important concept in administrative law. This is, an administrative law judge is required to discuss the evidence presented at the hearing and make specific findings of fact based on that evidence. Failing to do this in the recommended order (RO) can lead to reversal by an appellate court.


Comments?

Do you think the appellate court should have reversed? Do you think it was important to discuss all testimonies in this case? Please leave any thoughtful comments below.


Contact Health Law Attorneys Experienced in Handling Licensure Matters.

If you have been arrested, it is strongly recommended that you retain an experienced healthcare attorney who can advise you as to the effects a potential outcome could have on your license.

The attorneys of The Health Law Firm routinely represent physicians, pharmacists, nurses, and other healthcare practitioners in licensure matters. We frequently consult with criminal defense attorneys regarding defense strategies tailored to minimizing criminal sanctions while preserving the practitioner’s license.

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.

KeyWords: Criminal law, license, defense attorney, health law, health care attorney, health care lawyer, health investigation, medical license, conviction, desntist, dentist criminal charges, Department of Health, DOH, professional license, federal statutes, license disciplined, license revoked, health attorney, finding of guilt, adjudication withheld, diversion program, DOH conviction, adjudication, discipline, criminal trial, defense lawyer, ALJ, administrative law judge, administrative law, appellate court, administrative orders, Florida Board of Dentistry, Board of Dentistry, dentistry, statutes, testimony

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

At Board of Nursing Hearing, Each Aggravating Factor Must be Supported by “Competent Substantial Evidence” or Discipline Is reversible on Appeal

The foregoing case summary was prepared by Mary F. Smallwood, Esquire, of The Administrative Law Section of The Florida Bar.

The Department of Health, Board of Nursing (“Board”) filed charges against Fernandez for administering medication to a person who was not his patient. The facts demonstrated that Fernandez had visited a friend in the hospital and administered a drug prescribed for one of his home health care patients. After an administrative hearing, the Board found that five aggravating circumstances justified an upward departure in the penalty provided for the Board’s guidelines to license revocation.

On appeal, the court reversed. While it found support for four of the aggravating circumstances cited by the Board, it held that one of the circumstances was not supported by competent substantial evidence. Specifically, the Board had determined that Fernandez’ actions had caused damage to the patient. The court found the only support for this determination was testimony in the hearing transcript that the court characterized as “speculation.” Since the court concluded that it was unclear whether the Board would have revoked Fernandez’ license absent the determination of damage to the patient, it reversed in part and remanded for the Board to reconsider the penalty without the unsupported aggravating circumstance.

Source:

Fernandez v. Department of Health, 120 So. 3d 117 (Fla. 4th DCA 2013) (Opinion filed August 14, 2013).

About the Author: The foregoing 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, Col. 36, No. 2 (Dec. 2013).

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