Mental Health Counselors, Psychologists, Social Workers or Family Therapists - Purchase Professional Liability Insurance Before It’s Too Late

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

From our experience mental health counselors, psychologists, social workers and family therapists are at a high risk of having a client or patient file a complaint against them with their licensing board.

Many of their clients/patients have mental health problems, emotional problems or personality disorders; this is why they are seeing a therapist to begin with. If there is a disagreement between the therapist and the client/patient over treatment, diagnosis or other issues, this can easily result in that person filing a complaint.

We have also seen complaints filed when a therapist is retained to evaluate someone for a court proceeding, for vocational rehabilitation programs, for disability insurance and for other types of evaluations where the person is not the client or the patient of the therapist.


Types of Complaints.

Many complaints seem to arise out of situations in which the therapist has socialized with the client or patient. Socializing with a client or patient should be strictly avoided.

Divorces, custody disputes and other family law matters have resulted in an increase in the number of complaints filed against therapists.

If one parent disagrees with an evaluation in a child custody dispute, this may result in a complaint against the professional with the licensing board. We have experienced cases in which family law attorneys have suggested to their clients that they file such complaints in a misguided attempted to have that therapist disqualified from giving an opinion or intimidated into withdrawing.


Purchase Professional Liability Insurance Now.

Defending oneself in the investigation of a complaint against your license can be expensive and time consuming. There are two primary actions that can be taken to help alleviate the consequences of such actions by disgruntled clients/patients.

1. Be sure you have and maintain good professional liability insurance that provides professional license defense expense coverage of at least $25,000. You can easily spend this amount in legal fees to successfully defend yourself, even from a completely meritless complaint. This type of insurance is cheap and easy to obtain. Two insurers we know to provide this are Healthcare Providers Service Organization (HPSO) and Lloyd’s of London. Check with your insurance agents for others.

2. Immediately retain the services of an attorney who has experience with your type of case and with your professional board. Ask for numbers of cases and outcomes. Usually this will be a health law attorney or administrative law attorney, but make sure the attorney has experience with your board. Many states now recognize the legal specialty of health law. In these states, you want an attorney that is board certified in health law.

Do Not Wait, Hire an Experienced Attorney.

Hire an attorney as soon as you suspect there may be a complaint or an investigation. Do not attempt to do this yourself. Do not make any statement, oral or written, to any investigator until you consult with an attorney. The simplest statement can be used against you to help prove a charge resulting in discipline on your license.

Discipline is for life. Don’t take a chance.


Contact Health Law Attorneys Experienced Investigations of Mental Health Counselors, Psychologists, Social Workers and Family Therapists.

The attorneys of The Health Law Firm provide legal representation to mental health counselors, psychologists, social workers and family therapists in Department of Health (DOH) investigations, FBI 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?

Have you ever had a patient or client file a complaint against you with your licensing board? Do you have professional liability insurance? 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.

Be Sure To Review ABIM's New List of Overused and Unnecessary Medical Tests and Procedures

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

This year, seventeen (17) medical specialty societies added their names and recommendations to a list of medical procedures that are overused and often unnecessary. This updated list was released in February 2013, and includes ninety (90) new tests and procedures. The first version of the list was released in April 2012, with recommendations from nine (9) leading medical groups. It was created as part of the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign to help reduce healthcare spending and improve patient care.

An article I previously wrote on the first list was published in Medical Economics. Click here to read the entire article.


List Designed to Promote Education.
In 2011, the ABIM found that the United States spends more than $2.5 million a year on healthcare, which is more than $8,000 a person. Studies have suggested that the high cost of healthcare in the U.S. is driven largely by the price of tests and procedures.



The motive behind this list is to promote an educational dialogue between physicians and patients. These medical societies are urging patients to actively question their doctors when listed tests and procedures are recommended. It’s believed that reducing the amount of unnecessary tests and procedures will help decrease medical spending and medical costs.


Patient Protection.
This situation also may have the side effect of promoting additional litigation against doctors, healthcare clinics, and hospitals that provide the unnecessary tests and procedures. Many states have laws that prohibit unnecessary tests and procedures and sanction those who provide them. For instance, Section 766.111, Florida Statutes, which was enacted in 1985, states:

Engaging in unnecessary diagnostic testing; penalties:

1. No healthcare provider licensed pursuant to chapter 458 [medical doctors], chapter 459 [osteopathic physicians], chapter 460 [chiropractic physician], chapter 461 [podiatrist], or chapter 466 [dentist], shall order, procure, provide, or administer unnecessary diagnostic tests, which are not reasonably calculated to assist the healthcare provider in arriving at a diagnosis and treatment of a patient's condition.
2. A violation of this section shall be grounds for disciplinary action...
3. Any person who prevails in a suit brought against a healthcare provider predicated upon a violation of this section shall recover reasonable attorney's fees and costs.

This Florida law not only provides a private cause of action by a patient against a health provider who orders or furnishes such "unnecessary" diagnostic tests, but unlike other tort and medical malpractice statutes, it allows the prevailing party in such a case to recover attorney's fees and costs. This law may by itself promote litigation in the face of the lists of tests from the specialty groups.


Some Procedures and Tests That are Now Considered Unnecessary.
Some of the items the societies suggest avoiding include:

1. American Academy of Pediatrics (AAP): Antibiotics for apparent viral respiratory illnesses, such as sinusitis or bronchitis;



2. American Academy of Neurology (AAN): Electroencephalography for headaches;



3. American Academy of Ophthalmology (AAO): Antibiotics for pink eye;



4. American Society for Clinical Pathology (ASCP): Population-based screening for vitamin D deficiency;



5.  American Urological Association (AUA): Routine bone scans in men with a low risk of prostate cancer;



6 Society of Nuclear Medicine of Molecular Imaging (SNMMI): PET/CT scans for cancer screening in healthy individuals.

A number of recommendations were made by multiple groups.

1. The American Academy of Family Physicians (AAFP) and the American College of Obstetricians and Gynecologists (ACOG): both urged against scheduling elective labor inducements or cesarean deliveries before 39 weeks. This action is associated with an increased risk of learning disabilities, respiratory issues and other possible problems in infants.



2. The American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS): both recommended against percutaneous feeding tubes in advanced dementia patients because studies have shown the tubes don’t result in better patient outcomes. Oral feeding is recommended instead.

The ABIM hopes to release a third list later in 2013, which will include thirteen (13) more healthcare societies.
A full list of the current recommendations can be found on the “Choosing Wisely” website.


Expect to See  More False Claims and Qui Tam Cases.
I believe that with this updated list will come more qui tam or “whistleblower” and false claims cases.
Qui tam cases have been brought under the federal False Claims Act for the recovery of Medicare payments from hospitals, physicians, medical groups, nursing homes, insurance companies, diagnostic testing facilities, clinical laboratories, radiology facilities and many other types of healthcare providers. These cases allege that a false claim was submitted to the government. If the test or procedure was unnecessary, then it seems almost axiomatic that a claim for it is false. The plaintiff bringing such cases receives a percentage of the recovery, which often amounts to millions of dollars in successful cases.

Most states now have similar false claims act or qui tam laws providing similar causes of action and recoveries to individual plaintiffs in the case of state Medicaid payments as well.

Because medical necessity is a requirement for practically every Medicare and Medicaid service, as well as most services paid by private health insurers, the lists provided by the specialty may very well be exhibit one in future lawsuits.


A Lawyer's Perspective.
I do not disagree with, and am not critical of, the specialties providing this valuable information to the public. If anything, such information makes for a more educated patient populace and provider group and serves to eliminate tests and procedures that have no proven medical efficacy.

A doctor should have the knowledge, skill, training, and confidence to know when such tests and procedures are not warranted. If a physician persists in ordering these tests solely for the means of increasing profits, he or she should be penalized. If not, the physician should be able to justify them.


Contact Experienced Health Law Attorneys.
 The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

 

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


Sound off.
Have you reviewed this new list of tests and procedures that have been deemed unnecessary? As a healthcare professional, what do you think of the list? How important is it for patients to be educated on their options for medical care? Please leave any thoughtful comments below.


Sources:
Levey, Noam. “Doctors List Overused Medical Treatments.” Lose Angeles Times. (February 20, 2013). From: http://www.latimes.com/health/la-na-medical-procedures-20130221,0,6234009.story
Indest III, George. “Beware Legal Ramifications of Unnecessary Tests.” Medical Economics. (July 25, 2013). From: http://medicaleconomics.modernmedicine.com/news/beware-legal-ramifications-unnecessary-tests
Lee, Jamie. “Choosing Wisely Campaign Expands List of Questionable Tests, Procedures.” Modern Healthcare. (February 231, 2013). From: http://bit.ly/YLFVtu
Pittman, David. “17 Doc Groups Add to ‘Overused’ Test List.” MedPage Today. (February 21, 2013). From: http://bit.ly/VAW2g6


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.

Lloyd’s of London (Lloyd’s) Attorneys, Lawyers and Defense Council in Florida

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


Often we learn after the fact that a health professional such as physicians, nurses, podiatrists, psychologists and other health professionals has received Lloyd’s of London Insurance, has had a legal problem, and has not been able to locate an attorney or law firm that accepts this type of insurance. We have offices in Florida and Colorado, but we have attorneys licensed in Florida, Colorado, Louisiana, the District of Columbia, Virginia and other states.

Additionally, we can provide legal advice and representation in license investigations and administrative proceedings in many other states.

If you have Lloyd’s of London Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it.

The Health Law Firm Will Work with Your Insurance Company.

Call us first. We can assist you in determining if your legal problem is covered by your insurance, and we can help you file a claim to have your legal defense expenses and costs covered. In most cases, we will accept the assignment of your insurance so that you do not have to worry about legal bills while your case is going on.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers 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.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. We will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company, if your insurance company will allow this. Many of these insurers will pay our firm to represent you in the legal defense of an investigation or complaint against your professional (nursing, medical, dental, psychology, mental health counselor) license or for an administrative hearing involving professional discipline.

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

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



The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Locating a Healthcare Providers Service Organization (HPSO) Insurance Defense Attorney in Florida

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
We are sometimes told by the health professionals we represent especially pharmacists, licensed mental health counselors (LMHCs), advanced registered nurse practitioners (ARNPs), massage therapists and physical therapists that after they received a complaint regarding their license from the Florida Department of Health (DOH) they had difficulty finding an experienced attorney in Florida who would accept their professional liability insurance.  In this case, I am speaking specifically about Healthcare Providers Service Organization (HPSO) Insurance.


HPSO Insurance Helps Cover Costly Legal Fees.
The professionals who are covered by HPSO Insurance have excellent insurance coverage.  HPSO Insurance provides professional liability coverage that protects in the event of a lawsuit or negligence claim.  But much more often the professional receives a notice of an investigation, a subpoena for a deposition in someone else's case, a demand because of an allegation of sexual harassment or sexual impropriety, a complaint because of a breach of medical records confidentiality or Health Insurance Portability and Accountability Act (HIPAA) Privacy complaint, or some other administrative type of action.
HPSO provides great coverage for these.  For example, HPSO currently reimburses up to $10,000 in legal fees and expenses just for representation of you at depositions.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your defense in a DOH or Agency for Health Care Administration (AHCA) notice of investigation or complaint.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your legal representation in defense of a complaint or investigation regarding breach of medical confidentiality.
If you are a pharmacist, own a pharmacy, are a massage therapist, own an assisted living facility (ALF), are a mental health counselor or a social worker, or you are one of the many other types of health care professionals who HPSO insures, it should be fairly easy to find experienced health lawyers to represent you, especially in Florida.
Our firm and our attorneys, including George F. Indest III, Michael L. Smith, Joanne Kenna, Carole C. Schriefer, Lance O. Leider and Christopher E. Brown represent licensed health care professionals, interns and students in all types of administrative investigations and hearings and in defending lawsuits and other actions that have been filed.  We also represent health facilities in license defense, survey complaints and administrative hearings.  We represent them throughout Florida, from Pensacola to Jacksonville, to Key West.  We also occasionally represent them in other states, as well.  We accept HPSO Insurance assignments.


Don't Wait to get Insurance.
It is very important for every health professional to carry insurance that covers any investigation, complaint or administrative hearing that might be filed or opened against your license.  You may think that you are covered for this by your employer, but you are not.  If your employer contradicts this, ask for a statement in writing that your employer will pay for your legal defense for any such matter arising during your employment.
What typically happens, especially in the case of a hospital employee, nursing home employee, pharmacy employee or corporate employee, is that the employer is the one who terminates the employee and then files a complaint with the DOH.  The DOH then opens an investigation against the health professional.  The employer is not going to pay your legal defense costs if the employer has reported you.
You may very well be out of work, out of money and face an investigation and complaint that could terminate your professional license and career.  You should not take this chance.  Insurance such as HPSO Insurance is inexpensive and reliable.  Buy it while you can afford it. After the actions have occurred, it is too late.


If You are Contacted by an Investigator, Call a Health Law Attorney First.
Also, you should immediately contact an experienced health law attorney if you are telephoned or visited by any investigator, or if you receive a letter advising you that an investigation has been opened regarding your care.  Call immediately for advice before you speak with an investigator or provide any documents or statements of any kind.
You cannot and should not seek "legal advice" on what to do from the investigator, from a DOH employee, from your professional board or from any attorney representing any of them.  They are not your friends.  They are on the side against you. You should definitely not take any advice from them.


Don't be Cheap When it Comes to Insurance Policies.
If you have good insurance, it will pay for your legal expenses from the very beginning, so use it.  However, beware of cheap insurance policies from professional associations that do not provide any coverage for disciplinary complaints and licensure investigations.  Always check to be sure this is covered.  Get it in writing.  With some companies you have to pay an extra premium to obtain this coverage.  With some insurers, they do not offer it, and you have to purchase a completely separate policy covering just this.  It is worth it!  Do it!


Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.
Our firm regularly represents physicians, dentists, nurse practitioners, pharmacists, massage therapists, mental health counselors, registered nurses (RNs), assisted living facilities (ALFs), home health agencies, nurse practitioners, lab technicians, occupational therapists, physical therapists, social workers, physician assistants, psychologists and other health professionals in many different legal matters.
Services we provide include representation before your professional board in DOH investigations, in administrative hearings, in civil litigation, in defense of malpractice claims, in professional licensing matters, in defense of allegations concerning HIPAA privacy violations and medical record breaches, in Drug Enforcement Administration (DEA) actions, and in many other matters.
In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company.  If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.
We also defend health professionals and health facilities in general litigation matters and business litigation matters.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


Comments?
Do you have professional liability insurance? Why or why not. 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.

A Majority of all Medicare Claims for Breast-Cancer Drug Were Billed Incorrectly

By Lance O. Leider, 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

It’s no surprise that the government is aggressively pursuing Medicare fraud. Recently, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), made a surprising discovery. An audit uncovered that more than three-quarters (3/4) of all Medicare claims for the breast-cancer drug Herceptin were billed incorrectly, according to Modern Healthcare. This was found during an audit conducted on physicians and hospitals from around the country between January 1, 2008, and December 31, 2010.

To read the entire Modern Healthcare article, click here.


Audit Results Not Uncommon.

Three different audits were released to the public by the HHS OIG. All of these audits showed roughly the same information. Health care providers have been billing Medicare for full multiuse vials of the drug Herceptin, when patients actually only need a smaller portion. Medicare does not pay healthcare providers for any part of the drug that is discarded, because it can be preserved for up to 28 days and reused. The auditors suggest that payment from Medicare for an entire multiuse vial is likely to be incorrect. We saw a similar situation with the drug Avastin and Lucentis being used by ophthalmologists several years ago.

The results of the audits were released in January 2013. One audit found eighty-five percent (85%) of 1,073 Herceptin vials used in Ohio and Kentucky were billed incorrectly. In Illinois, Indiana, Michigan and Wisconsin, the government auditors found that seventy-eight (78%) of 713 claims investigated were wrong. The overpayment amount was around $682,000, for these audits.


Florida Overcharged Amost 80% of Bills.

According to the report, HHS auditors found overcharges in seventy-eight percent (78%) of bills for 1,330 vitals of Herceptin submitted to First Coast Service Options, Inc. This company serves as the Medicare Administrative Contractor (MAC) for HHS District Nine, which primarily includes providers in Florida, Puerto Rico, and the U.S. Virgin Islands. The overcharges for Herceptin were $1,325,409.

In the report, the government recommends that First Coast Service Options, Inc., do a number of things. The first is to recover the more than one million dollars in overpayments. It’s also recommended that First Coast Service Options, Inc., implement system edits that review multiuse vial drugs that are billed with units of service equivalent to the dosage of an entire vial. The government also suggests that these audit results be used as an educational tool for teaching correct billing practices to physicians and hospitals.

Click here to read the entire report on District Nine.


Responding to a Medicare Audit.

Remember, there is no such thing as a “routine” Medicare audit. The fact is that if you find yourself or your practice at the center of a Medicare audit, there is some item you have claimed as a Medicare provider or the amount of claims Medicare has paid in a certain category that has caused the audit. We’ve come up with a list of actions that we use and recommend you take when responding to a Medicare audit. Click here to view that list.


Don't Wait Until It's Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Investigations.


The best time to respond to and defeat an allegation of overpayment is at the very beginning. That is why it is essential that you obtain qualified counsel to help you through the process. The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.


For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Comments?

Why do you think hospitals and physicians incorrectly bill for Herceptin? Are audits like these necessary? Please leave any thoughtful comments below.


Sources:

Carlson, Joe. “OIG Finds Widespread Herceptin Overcharges.” Modern Healthcare. (January 21, 2013). From: http://www.modernhealthcare.com/article/20130121/NEWS/301219959/oig-finds-widespread-herceptin-overcharges

Jarmon, Glorida. “The Medicare Contractor’s Payments to Providers in Jurisdiction 9 for Full Vials of Herceptin were often Incorrect.” Office of Inspector General (January 2013). From: http://www.thehealthlawfirm.com/uploads/Herceptin%20FL%20Overcharges.pdf


About the Authors: Lance O. Leider 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.

Don't Land on the Office for Civil Rights’ “Wall of Shame”

By George F. Indest, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
As of February 2013, there are 537 cases listed on the Office for Civil Rights’ (OCR) “Wall of Shame.” These are breaches of unsecured health information affecting 500 or more individuals. The reports of these breaches of patient confidentiality are required by the Health Information Technology for Economic and Clinical Health (HITECH) Act.
The OCR continuously updates this list of breaches on its website. These breaches include a brief summary of each case that OCR has investigated and closed, as well as the names of private practice providers who have reported breaches of unsecured health information to the OCR.
Click here to see the OCR’s “Wall of Shame.”


Most Breaches on the “Wall of Shame” Involve Laptops and Portable Devices.
Six healthcare organizations listed on the “Wall of Shame” reported security breaches that involved one million or more patient records. Among the largest breaches reported was one by the TRICARE Management Activity, which reported 4.9 million records lost when back up tapes for computer systems went missing. Another major breach involved WellPoint, the largest managed health care company in the Blue Cross and Blue Shield Association. The company reported 31,700 of its customer records were compromised during a three-year time frame. The breach was believed to be caused by an unauthorized hack into a network server.
According to an article in Modern Healthcare, a majority of the breaches on the “Wall of Shame” involve laptops, backup disks and other portable devices that were stolen. These devices contained patient information and were not encrypted. Had the files been protected by encryption, these organizations would not have landed on the list.
Click here to read the article from Modern Healthcare.


New HIPAA and HITECH Rules.

The OCR under the U.S. Department of Health and Humans Services (HHS) recently released stronger rules and protections governing patient privacy. On January 17, 2013, the HHS announced the omnibus rule to strengthen the privacy and security protection established under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. These changes also improve the HITECH Act by making it clear when breaches must be reported to the OCR. Once reported, the breaches are then placed on the “Wall of Shame.” It’s important to review these changes, as to stay off the list. Click here to learn more on the new HIPAA rules.


It's In Your Best Interest to Get a HIPAA Risk Assessment.

Since the HIPAA laws have changed, you need to edit your privacy forms and procedures. Many health providers simply don't have the time to re-review their policies and revise documents. A HIPAA risk assessment is a thorough review and analysis of areas where you may have risk of violating the HIPAA laws.  Federal regulations require that covered entities have this assessment done. To learn more on HIPAA risk assessments, click here.


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 www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.


Sound Off.
Have you ever heard of the “Wall of Shame? What do you think of this list? Please leave any thoughtful comments below.


Sources:
Modern Healthcare. “Hoping for ‘Progress’ on Health Data Breaches.” Modern Healthcare. (January 8, 2013). From: http://www.modernhealthcare.com/article/20130108/BLOGS02/301089998/joe-blog-sad-sign-of-progress-in-health-data-breaches
Mearian, Lucas. “‘Wall of Shame’ Exposes 21M Medical Record Breaches.” Computerworld. (August 7, 2012). From: http://www.computerworld.com/s/article/9230028/_Wall_of_Shame_exposes_21M_medical_record_breaches


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. 

Stryker Orthopaedics Facing Dozens of Hip Implant Lawsuits

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

As of February 2013, more than 80 lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey against Stryker Orthopaedics. Patients are claiming the company’s Rejuvenate and ABG II modular-neck femoral hip systems are defective, according to a number of news sources. The case is on track to becoming one of the largest mass-tort litigations in the country.

In July 2012, Stryker issued a voluntary recall of the Rejuvenate and ABG II modular-neck femoral hip systems. (Click here to see the press release from Stryker.) The company is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on patients who had implants installed. The letters state that Stryker will compensate patients for any tests or work that has to be done.
Click here to read a letter from Stryker to a surgeon.

Unfortunately, for some, this notice is too late. Hundreds of patients are already experiencing pain from the Stryker hip implants, which has forced them to have the implants removed. Even after surgery some patients alleged they have permanent damage and are demanding compensation.

Early Lawsuit Filed from Florida Patient.
According to the Palm Beach Post, one of the first lawsuits against Stryker came from a Boca Raton retiree. Her hip replacement came with a promise to last for decades. The device allegedly failed within months. Click here to read the patient’s entire story.

According to Drug Watch, most patients who received Stryker’s devices allegedly suffered from muscle, nerve and bone damage as the metallic components of the device rub against each other, causing metallic elements to be released into the body and be absorbed into the blood stream and body tissue. To read the entire article from Drug Watch, click here.


More Lawsuits to Come - Contact an Experienced Health Lawyer.
Since the implants were recently recalled, it’s expected that there are many more cases out there.
Many of the people who have already filed lawsuits claim Stryker marketed and sold a defective device and failed to warn the public, among other issues.

If you or a family member received a Stryker Rejuvenate or ABG II hip implant and suffered complications, you don’t have to face the medical issues alone. Contact an experienced attorney that is board certified in health law. Before you talk about settling, call an attorney.

Stryker Lawsuits Similar to DePuy.

According to an article in The Records, similar mass-tort cases in New Jersey include hundreds of lawsuits filed against DePuy Orthopaedics. More than 2,500 plaintiffs in that case alleged similar complaints due to a metallic hip part. DePuy’s product, ASR, was recalled by the company in August 2010. The cases being heard involve potentially hundreds of millions of dollars in settlements or verdicts. Click here to read the entire article from The Records.


Contact Experienced Health Law Attorneys.
If you or a family member received a Stryker Rejuvenate or ABG hip implant and suffered complications you don’t have to face the medical issues alone. Our attorneys are available seven days a week to answer your questions. We can help you decide whether filing a lawsuit is the right option for you. Our 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?
Did you or someone you know have a Stryker Rejuvenate or ABG II modular-neck femoral hip implant? What has been your experience? Did you know about the recall? Are you in need of legal assistance? Please leave comments below.


Sources:
Markos, Kibret. “Mahwah-based Stryker Orthopaedics Faces Hip Implant Lawsuits.” The Records. (February 28, 2013). From: http://www.northjersey.com/mahwah/Over_80_lawsuits_on_hip_implants_filed_against_Mahwah-based_Stryker_Orthopaedics_.html?c=y&page=3

Singer, Stacey. “Artificial Hips Corrode, Poisoning Some Patients, Local Lawsuits Say.” The Palm Beach Post. (January 27, 2013) From: http://www.palmbeachpost.com/news/lifestyles/health/artificial-hips-corrode-poisoning-some-patients-lo/nT7jf/

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.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.

Department of Health and Human Services Introduces HIPAA Omnibus Rule

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

With the popularity of electronic health records (EHRs), social media and everything in between, the U.S. Department of Health and Human Services (HHS) has released stronger rules and protections governing patient privacy. On January 17, 2013, the HHS announced the omnibus rule to strengthen the privacy and security protection established under the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

Click here to read the entire 563-page rule.
Now, I can’t say that I’ve had enough free time to read the entire document yet, but I can tell you about the major parts of the omnibus rule, and what it means for healthcare providers.


Protecting a Patient's Information During Data Exchanges.
HHS is expanding the government’s jurisdiction over healthcare providers, health plans and other entities that process health insurance claims to include their contractors and subcontractors with whom providers share protected health information. As the industry embraces new care delivery models, including accountable care organizations (ACOs) and integrated delivery systems, data is exchanged between physicians, hospitals and additional providers to improve care and reduce costs. This all has to be done while keeping patient data safe. According to the HHS, some of the largest breaches involve business associates and not the covered entities themselves.

The government is committed to doing more HIPAA compliance audits and collecting more fines.  The fines the government collects will help to fund the audit process. Because of this rule, we will see audits of business associates and their subcontractors, not just covered entities.

Under the new rule, penalties have been increased for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation.


Don’t Land on the Office for Civil Rights’ “Wall of Shame.”
The changes also improve the Health Information Technology for Economic and Clinical Health (HITECH) breach notification requirements by making it clear when breaches must be reported to the Office for Civil Rights (OCR), according to the HHS.

Once reported to the OCR, the breaches are then placed on what is commonly known in the healthcare industry as the “Wall of Shame.” It’s a comprehensive list of privacy breaches each affecting more than 500 people. We’re currently working on a “Wall of Shame” blog, so more on that later.


Take Notes of New Regulations Regarding Patient Information in Marketing.
One part of the final rule also sets new regulations for how patient information can be used for marketing and fundraising. It ensures that such information cannot be sold without a patient’s permission. According to an article in Fierce Healthcare, this provision is a huge win for patient advocates and privacy groups who blast hospitals for mining patient data to target affluent or privately insured patients. Hospitals using health and demographic data from patients’ records to target advertising could be in hot water.

Click here to read the entire Fierce Healthcare article.


If You are Unsure of Your Policies and Procedures, Get a HIPAA Risk Assessment.
Since the HIPAA laws have changed, you need to edit your privacy forms and procedures. Many health providers simply don't have the time to re-review their policies and revise documents. A HIPAA risk assessment is a thorough review and analysis of areas where you may have risk of violating the HIPAA laws.  Federal regulations require that covered entities have this assessment done. A HIPAA risk assessment can significantly reduce, if not entirely eliminate, your exposure to regulatory and litigation sanctions.

When the OCR auditor comes to visit your office to check for HIPAA compliance, they will ask for your risk assessment. Do you have one? Does your staff know who your HIPAA compliance officer is? Call an experienced health law attorney to complete a risk assessment of your practice today. To learn more on HIPAA risk assessments, click here to read a blog we wrote.


Update Notice of Privacy Practices.
Healthcare providers, now is the time to revise your Notice of Privacy. The final rule will be effective on March 26, 2013. Covered entities and their business associates will have until September 21, 2013, to comply.


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 www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.


What Do You Think?
What do you think about the new HIPAA rules? Do you think these updates were necessary? Do you think it will be difficult for health professionals to comply? Please leave any thoughtful comments below.


Sources:
HHS Press Office. “New Rule Protects Patient Privacy, Secures Health Information.” U.S. Department of Health and Human Services. (January 17, 2013). From: http://www.hhs.gov/news/press/2013pres/01/20130117b.html
Struck, Kathleen. “HIPAA Rules Fortify Patient Privacy.” MedPage Today. (January 21, 2013). From: http://www.medpagetoday.com/PracticeManagement/InformationTechnology/36940
Conn, Joseph. “New Rule: Hospital, Physician Partners Face Penalties for Privacy Leaks.” Modern Healthcare. (January 17, 2013). From: http://www.modernhealthcare.com/article/20130117/NEWS/301179957/new-rule-hospital-physician-partners-face-penalties-for-privacy&utm_source=home&utm_medium=web&utm_campaign=most-popular-box
Caramenico, Alicia. “New HIPAA Rule a Delicate Balance Between Privacy, Sharing.” Fierce Healthcare. (January 18, 2013). From: http://www.fiercehealthcare.com/story/new-hipaa-rule-delicate-balance-between-privacy-sharing/2013-01-18

About the Authors: 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.

 

Lance O. Leider 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.

 

"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.

Is It Legal to Require a Flu Shot for Health Professionals?

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

The warnings have been loud and clear from the Centers for Disease Control and Prevention (CDC). This influenza season is off to an early and serious start. With that in mind, a number of states are requiring all health professionals in the state to receive the flu vaccination. Some of those opposed to getting vaccinated are being fired by hospitals and health facilities. Because of this, a controversy is arising between employee rights and patient safety, according to a number of news sources.

Click here to read more on this year’s flu season from the CDC.


Hospitals Want to Keep Patients Safe and Healthy.
In December 2010, the Department of Health and Human Services (DHHS) announced a 10-year agenda to improve the nation’s health. It’s called Healthy People 2020. A part of this agenda calls for a ninety percent (90%) average vaccination rate of health professionals. Click here to read the press release on the Healthy People 2020 initiative from the DHHS.

According to an American Medical News article, there’s a push in the medical community to meet this goal as soon as possible. The CDC states that as of November 18, 2011, close to eighty-four percent (84%) of doctors in the U.S. had been immunized against influenza. The CDC is praising these doctors for this high number, hoping other health professionals and the public will follow suit.

The safety of patients is the chief reason for the mandate. In an ABC News article, one Indiana hospital said that it implemented the mandatory vaccine in September of 2012, to promote patient safety. Of the hospital’s 26,000 employees statewide, ninety-five percent (95%) have complied.


Some Employees Fired for Refusing to Get a Flu Shot.
A large majority of employees at the Indiana hospital complied with the mandate; however, 1,300 employees did not. According to ABC News, eight employees, including at least three veteran nurses, were allegedly fired because they refused to get a flu vaccine.

The fired nurses are standing their ground, saying they should have the right to refuse the flu vaccine. One nurse had filed two medical exemption requests, a religious exemption request and two appeals. All were denied by the hospital. To read more on this story from ABC News, click here.

In October 2012, Rhode Island mandated immunizations for all health care workers who have patient contact. On December 6, 2012, a health care worker union filed a federal lawsuit against the Rhode Island Department of Health (DOH) to prevent it from implementing the regulations, according to a Fierce Healthcare article. Click here to read the entire Fierce Healthcare article.


How Groups are Fighting Back.

The attorney representing the Indiana nurses, who were fired, states that his clients had the right to refuse their flu shots. He argues Title VII of the Civil Rights Act of 1964 prohibits religious discrimination against employees. The attorney is suggesting religion is legally broad under the First Amendment, so it can include any strongly held belief. According to a Chicago Tribune article, in 2009 New York mandated flu shots for all health workers, during the H1N1 outbreak. Unions fought the issue in court, and the state has since relaxed the rule.


Flu Shots in Florida.
I’ve recently received calls from several local health care professionals working in different Florida hospitals, regarding refusing flu shots and other vaccinations. I’ve also read the news stories about Tampa General Hospital and Moffitt Cancer Center in Tampa requiring employees to receive the influenza vaccine. According to the news articles, the two Tampa health facilities require employees who refuse the flu shot to wear surgical masks.

However, the states and hospitals may not back down in this case. The issue may have to be decided by the courts. I promise to write more on this topic later.


Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.
At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings.

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


What Do You Think?
What do you think of mandated flu shots for health care workers? Is receiving a flu shot mandatory at your job? As a health care professional, do you think it is important to receive a flu shot? Is there enough medical evidence to justify firing health care professionals for not receiving the flu shot? Please leave any thoughtful comments below.


Sources:
Lupkin, Sydney. “Nurses Fire for Refusing Flu Shot.” ABC News. (January 3, 2013). From: http://abcnews.go.com/Health/indiana-hospital-fires-nurses-refusing-flu-shot/story?id=18116967
Moyer, Christine. “More Physicians on Track to get Flu Shots.” American Medical News. (December 14, 2012). From: http://www.ama-assn.org/amednews/2012/12/10/hlsb1214.htm
Cheung-Larivee, Karen. “Health Unions Sue Over Mandated Flu Shots.” Fierce Healthcare. (December 10, 2012). From: http://www.fiercehealthcare.com/story/health-unions-sue-over-mandated-flu-shots/2012-12-10


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.

Part 2 - Burden of Proof in Professional Licensing Disciplinary Cases

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

I am often asked about the burden of proof that must be met by the state Department of Health (DOH)  in professional licensing disciplinary cases.  This could be a complaint against a physician, dentists, mental health counselor, nurse, psychologist, pharmacist or anyone else.  It also includes, for example, engineers, general contractors, school teachers, architects, cosmetologists, or any other professional holding a professional license in Florida.  However, since we routinely represent health professionals, I will continue to concentrate on those licenses by the state DOH in this blog.

Click here to read part one.


Fifth Amendment Protection Against Self-Incrimination Applies.
Because potential license revocation proceedings are penal in nature, a respondent or license holder in such an investigation or administrative hearing has the right to remain silent under the Fifth Amendment of the United States Constitution and under the Florida Constitution.
Otherwise, this would defeat the spirit and intent of the constitutional protections guaranteed by the Fifth and Fourteenth Amendments to the United State Constitution.  See, State v. Caballero, 396 So. 2d 1210, 1213 (Fla. 3d DCA 1981) ("A coerced confession offends due process of law.");  Dickerson v. U.S., 530 U.S. 428, 434, 120 S. Ct. 2326, 2331 (2000) ("We have never abandoned this due process jurisprudence, and thus continue to exclude confessions that were obtained involuntarily");  Chambers v. State of Fla., 309 U.S. 227, 228, 60 S. Ct. 472, 473 (1940) ("[U]se by a state of an improperly obtained confession may constitute a denial of due process of law as guaranteed in the Fourteenth Amendment");  and Barnes v. Merrill, 2002 WL 1313123 (D. Me. 2002) ("Involuntary statements are inadmissible under the Fifth Amendment requirement that no person can be compelled to be a witness against himself in a criminal case.").
For Florida cases on point, see, Chancellor Media Whiteco Outdoor v. Fla. Dep't of Transport., 26 Fla. L. Weekly D627 (Fla. 5th DCA March 2, 2001), substitute opinion entered on rehearing, 795 So. 2d 991, 26 Fla. L. Weekly D1894 (Fla. 5th DCA July 30, 2001).  See also, State ex rel. Vining v. Fla. Real Estate Comm'n, 281 So.2d 487, 491 (Fla. 1973);  Best Pool & Spa Service Co., Inc. v. Romanik, 622 So. 2d 65, 66 (Fla. 4th DCA 1993) ("We agree that requiring Kassover to answer . . . questions does violate his right against self-incrimination which applies not only to criminal matters but also administrative proceedings such as licensing").


Florida Courts Require Higher Standard for Administrative Licensure Cases.
In Florida, the courts have adopted and have required the “clear and convincing” standard to be used in any case involving a professional license, finding that such action by the state is punitive or penal in nature and affects a substantial right of the respondent.  The key Florida cases that discuss this are two Florida Supreme Court cases, Florida Bar v. Rayman, 238 So. 2d 594 (Fla. 1970) and Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).  See also, Kozerowitz v. Fla. Real Estate Comm'n, 289 So. 2d 391 (Fla. 1974).

Any case in which a state administrative agency seeks a penalty, a fine or action affecting the status of a professional license, would require the application of a "clear and convincing standard."  An action to revoke a professional license is definitely considered to be penal.  So too is an action which results in the loss of income, such as by suspending a license (so there is no professional income), a fine, or an order to refund professional fees.  McDonald v. Dep't of Prof. Reg., Bd. of Pilot Commissioners, 582 So. 2d 660 (1st DCA 1991).

Although these are all Florida cases, if you read them and follow their rationale, they go back to basic constitutional principles of due process of law and the taking away of rights or property without due process.
For example, in one case in which I defended a nursing home's license, the state had evidence that contradicted itself.  There were certain facts at issue and the state put forth two different sets of facts.  The state could not prove either set of facts by "clear and convincing evidence."  Therefore, by law, the administrative law judge had to rule in favor of the license holder.


Penal Statutes, Such as Professional Discipline Statutes and Professional Practice Acts Must Be Narrowly Interpreted.
A statute is unconstitutionally void for vagueness if it fails to give a personal of ordinary intelligence fair notice of what conduct is forbidden by the Statute.  Papachristou v. City of Jacksonville, 405 U.S. 156, 92 S. Ct. 839, 31 L. Ed. 2d  110 (1972).  United States v. Harriss, 347 U.S. 612, 74 S. Ct. 808, 98 L. Ed. 989, (1954).  Criminal statutes must be written with sufficient specificity so that citizens are given fair warning of the offending conduct, and law enforcement officers are prevented from engaging in arbitrary and erratic enforcement activity.  Papachristou; Thornhill v. Alabama, 310 U.S. 88, 60 S. Ct. 736, 84 L. Ed. 1093 (1940); Lanzetta v. New Jersey, 306 U.S. 451, 59  S. Ct. 618, 83 L. Ed. 888 (1939). 

Florida case law has long upheld this principle of the common law as well.  Statutes must be written well enough so as to provide fair notice to ordinary citizens as to their exact meaning.  State v. Warren, 558 So. 2d 55 (Fla. 5th DCA 1990),  aff’d. Warren v. State 16 Fla., L. Week 28 (Fla. 1991).


When First Notified of a Pending Investigation Seek the Advice of an Experienced Health Law Attorney.
When you receive any notice, by telephone, by mail, by hand delivery or by information passed along by your employer, that an investigation has been opened against your professional license, immediately contact an attorney experienced in such matters.  Do not talk to the investigator.  Do not talk to the prosecuting attorney.  Do not call the state agency and ask for advice on what you should do. Do not send a written statement explaining your side of the story.

You have important constitutional rights that protect you.  But you have to exercise the common sense required to use these rights.  Part of this is by obtaining competent legal counsel who can advise you and protect your rights.  Again, we remind you that unless an attorney routinely handles this type of case, he or she may be unfamiliar with what your rights are in such a situation or how to handle it.


Contact Experienced Health Law Attorneys.
At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings.

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

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

"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Part 1 - Burden of Proof in Professional Licensing Disciplinary Cases

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

I am often asked about the burden of proof that must be met by the state Department of Health (DOH) in professional licensing disciplinary cases.  This could be a complaint against a physician, dentists, mental health counselor, nurse, psychologist, pharmacist or anyone else.  It also includes, for example, engineers, general contractors, school teachers, architects, cosmetologists, or any other professional holding a professional license in Florida.  However, since we routinely represent health professionals, I will concentrate on those licenses by the state DOH in this blog.


Overview.
What few people (even attorneys) know is that cases which involve discipline against a professional's license are treated as "punitive" or "penal" cases.  This means the standards applied to them, at least in Florida, are the same that are applied to criminal cases.

Therefore, if the statute that is being charged is unclear or ambiguous, the courts apply a "strict scrutiny" standard.  If the language of the statute does not clearly prohibit the acts being charged or is unclear about being covered by the statute, then there should be a ruling in favor of the one charged.

Additionally, rights that apply in criminal cases, such as the right to have an attorney and the right to not be compelled to be a witness against oneself found in the Fifth Amendment of the U.S. Constitution, also apply to administrative cases involving discipline against a license holder.

The state has a higher burden of proof in an administrative licensure case, as well.  The burden of proof that applies in a civil case, "preponderance of the evidence" (also described as the greater weight of the evidence, the preponderance of the evidence or more than fifty percent), does not apply in administrative discipline cases.  Instead a higher burden, "clear and convincing evidence" applies.  Therefore, if the evidence supports the license holder's position, just as much as it supports the state's case, the state loses.


Know Your Constitutional Rights.

The Fifth Amendment of the United States Constitution provides individuals protection against self-incrimination, stating:

No person . . . shall be compelled in any criminal case to be a witness against himself, nor be deprived of life, liberty, or property, without due process of law. . . .

Note that in Florida, as in most states, a professional license is considered to be a property right which cannot be taken by the state without due process of law.
Article I, Section 9 of the Constitution of Florida also provides similar protections stating:

No person shall be deprived of life, liberty or property without due process of law . . . or be compelled in any criminal matter to be a witness against oneself.

In addition, case law in Florida has upheld as a protected right the individual's ability to practice a profession of choice if otherwise so qualified.  To take away this right requires due process of law and reviewing courts will apply a strict scrutiny standard.

Under some states’ constitutions or state statutes there is a right to work or a right to practice the profession of one’s choice;  this further lends credibility to an argument that agency actions which take away this substantial right should require a greater burden than that required in a mere civil case (i.e., preponderance of the evidence”).  However, even without such a provision in the state constitution, a professional license (or the right to practice a profession) is a substantial right and to take it away should require a higher burden of proof (e.g., clear and convincing).

Cases that are "Penal" Receive A Higher Degree of Protection.

The law is settled through U.S. Supreme Court cases that “penal statutes are to be construed strictly, Commissioner v. Acker, 361.U.S. 87, 80 S. Ct. 144, 4. L. Ed. 2d 127 (1959), Fed'l Comm. Comm’n v. Am.  Broadcasting Co., 347  U.S. 284, 296.  One “is not to be subjected to a penalty unless the words of the statute plainly impose it,” Keppel v. Tiffin Savings Bank, 197 U.S. 356, 362.  See, e.g., Tiffany v. National Bank of Missouri, 18 Wall. 409, 410;  Elliott v. RR Co., 99 U.S. 573, 576.

Penal statutes must be construed narrowly and are interpreted against the state.  Any part or term that is vague will not be enforced or will be stricken.  Warren v. State,  16 Fla. L. Week 1346 (Fla. 1991).  Accord, Riley v. Georgia,  219 Ga. 345, 133 S.E. 2d 367 (Ga. 1963);  State v. Morrison, 25 N.J. Super. 534, 96 A. 2d 723 (Essex Cty. Ct., N.J., 1953);  U.S. v. Ortiz, 24 M.J. 164 (CMA 1987), at 168.


Florida Courts Apply Criminal Law Rights and Protections to Cases Involving Administrative Penalties.

The Florida Supreme Court has affirmatively extended the proscription against self-incrimination to any administrative proceeding of a "penal" character.  This could be one in which the state seeks revocation or suspension of a license or one in which the state seeks a fine on a licensee.  Kozerowitz v. Fla. Real Estate Comm'n, 289 So. 2d 391 (Fla. 1974).
Any administrative proceeding in which the state seeks to inflict a penalty against the license or the licensee would invoke these rights.  An action to revoke a professional license is penal.  So, too, is an action which results in the loss of income or a fine.


Check Blog for More on the Burden of Proof.

Be sure to check our blog regularly to learn more on the burden of proof in administrative cases involving discipline of professional licenses. Part two of this blog series will be posted soon.


Contact The Health Law Firm. We are Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.
The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Know 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.

Department of Justice Settles Lawsuit with Specialty Pharmacy in California

By Lance O. Leider, J.D., and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Department of Justice (DOJ) announced on December 27, 2012, that a specialty pharmacy, based in San Diego, California, has agreed to pay a $11.4 million settlement. That payment is to resolve allegations that the company used kickbacks to persuade doctors to write prescription for its products. The allegations came from a whistleblower lawsuit filed by a former employee.
Click here to read the press release from the DOJ.


Pharmacy Allegedly Used Expensive Kickbacks to Boost Business with Physicians.
An article in Modern Healthcare states that the specialty pharmacy allegedly used tickets to sporting events, concerts, plays, spa outings, golf games and ski trips to bribe physicians to write prescriptions for its products. The company also had representatives schedule paid “preceptorships,” where the reps would follow physicians in their offices in an attempt to increase prescriptions written for their products.
To read the Modern Healthcare article, click here.


How the Lawsuit was Settled.
The specialty pharmacy company agreed to a forfeiture of $1.4 million to resolve the anti-kickback statue allegations. It will also pay $9.9 million to resolve false claims allegations, according to the DOJ. Representatives with the DOJ said that by entering the deferred prosecution agreement the company was able to avoid criminal and civil liability for the kickback and false claims violations.


Former Employee Receives $1.7 Million for Filing Lawsuit.
According to the DOJ, the settlement resolves a False Claims Act lawsuit that was filed by a former sales representative for the specialty pharmacy. As part of the resolution, that whistleblower will receive $1.7 million.
Whistleblowers stand to gain substantial amounts, sometimes as much as thirty percent (30%), of the amount the government recovers under the False Claims Act (31 U.S.C. Sect. 3730). Such awards encourage employees and contractors to come forward and report fraud. You can learn more on the False Claims Act on the DOJ website.


Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.
Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

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


What Do You Think?
What do you think of the settlement agreement? As a health professional are you tempted with kickbacks? Please leave any thoughtful comments below.


Sources:
Department of Justice. “Victory Pharma Inc. of San Diego Pays $11.4 Million to Resolve Kickback Allegations in Connection with Promotion of Its Drugs.” Department of Justice. (December 27, 2012). From: http://www.justice.gov/opa/pr/2012/December/12-civ-1547.html

Kutscher, Beth. “$11.4 Million Settlement in Pharma Kickback Case.” Modern Healthcare. (December 27, 2012). From: http://www.modernhealthcare.com/article/20121227/NEWS/312279957/


About the Authors: Lance O. Leider 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.