Tag Archives: attorney

Guilty Plea to Research Misconduct Results in 4 1/2 Year Prison Sentence

By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

MS_smDong-Pyou Han, a former Iowa State University scientist was sentenced to four-and-a-half (4 ½)  years in prison on Wednesday July 1, 2015, for falsifying his research results concerning the effectiveness of an experimental HIV vaccine.  A plea agreement also required Han to pay $7.2 million in restitution to the National Institutes of Health (NIH), which funded the research.  Han was testing the experimental HIV vaccine on rabbits.  He spiked the rabbit blood with human antibodies to make it falsely appear the experimental vaccine caused the rabbits to develop antibodies to HIV.
Click here to the entire AP article.

What is Research Misconduct?

“Research misconduct” is intentional fabrication, falsification, or plagiarism during the course of clinical research. It is not honest differences of opinion or differences in the interpretation of data.  In Han’s case, the test results were fabricated in order to fraudulently secure millions of dollars in grants from the NIH.

Click here to read one of our blogs on the ABCs of IRBs.  For more resources, visit the Research Misconduct Website at National Institutes of Health.

Han’s Attorney Requests Probation, Not Prison.

According to an AP article, Han was represented by a federal public defender who asked the court to sentence Han to probation rather than prison.  The public defender argued that Han already lost his ability to work as a scientist and would most likely be deported to his native South Korea.  Instead, the judge in this case sentenced Han to four-and-a-half years (4 ½)  in prison.

Prison Sentences Unusual for Research Misconduct Cases.

Research misconduct investigations do not often result in prison sentences.  Most often, the sanction imposed on a scientist found to have committed research misconduct is a requirement to retract published articles, research or reports, and the loss of their research positions.  When NIH funding is involved, a prohibition on conducting any future NIH-funded research for a period of time is also often imposed.  A finding of research misconduct usually ends the research career of a scientist or physician.  However, when the fraud is blatant or when it involves a large amount of grant money, criminal prosecution may follow.

Contact Health Law Attorneys Experienced with Research Misconduct.

The attorneys of The Health Law Firm provide legal representation to doctors and other scientists involved in research in addition to representing healthcare providers in numerous other 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?

Have you ever heard of research misconduct? Do you think the scientist received a fair punishment for his research misconduct? Please leave any thoughtful comments below.

Sources:

Pitt, David. “Ex-Iowa State Scientist Gets Prison for Faking HIV Research” Associated Press. (July 1, 2015). From:

http://abcnews.go.com/Technology/wireStory/iowa-state-scientist-prison-faking-aids-research-32161935

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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

KeyWords: research misconduct, attorney, research fraud defense, misconduct in science, clinical investigation fraud defense attorney, National Institutes for Health, NIH, fraud defense lawyer, medical investigation, clinical research fraud, clinical trials, grant fraud, institutional review board investigation, IRB, misconduct in science committee, MISC, defense counsel, data falsification, researcher’s attorney

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.

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.

CMS Extends Waivers under the ACO Shared Savings Program

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

On November 2, 2011, the Centers for Medicare and Medicaid Services (CMS) promulgated the interim final rule on fraud and abuse waivers for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program. The interim rule can be found at 76 Fed. Reg. 67801. The waiver was granted pursuant to the agency’s authority under the Affordable Care Act, specifically, 42 U.S.C. § 1899(f).

You can read our prior blog postings on the ACO waiver programs here.

Normally, interim final rules are only permitted to remain in effect for a maximum of three years (see 69 Fed. Reg. 78422). CMS regulations require the agency to publish a final rule within three years of a proposed or interim final rule. As the interim final rule is set to expire on November 2, 2014, the agency took advantage of the procedure that allows it to extend the life of the rule for an additional year by publishing a notice explaining the reasons why the regular timeline was not met.

Explanation for the Extension.

CMS stated that it is in the process of preparing a final rule, and allowing the interim final rule to expire would create a great deal of legal uncertainty for ACOs currently participating in the Shared Savings Program. According to CMS, this uncertainty has the potential to disrupt ongoing ACO business, plans, and operations.

Ultimately, CMS has learned through the course of its operation of the Shared Savings Program that certain modifications to the program are necessary. Although these modifications are not yet defined completely, CMS nevertheless believed the prudent course of action was to maintain the status quo during the rule making process.

Check back with us for updates on the process and any further information as the final rule is developed.

Comments?

Have you considered joining an ACO? Why or why not? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced With Healthcare Business Practices.

The Health Law Firm routinely represents physician groups and practices with issues involving establishing, licensing, selling, merging, and intergroup affiliation. If you are considering establishing an ACO or have been approached to become a participant in one, you can contact The Health Law Firm at (407) 331-6620 or (850) 439-1001 or you can visit our website at http://www.TheHealthLawFirm.com.

About the Author: 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. http://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 © 1996-2014 The Health Law Firm. All rights reserved.

Disruptive Physicians: Nobody Likes a Nuisance

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

Identifying and eliminating disruptive physicians has become a paramount concern of many hospitals and healthcare systems. Disruptive physicians hinder the safe and orderly operation of a healthcare facility and are considered a threat to the safety of patients. Disruptive behavior can impact staff morale and can increase the risk of liability to all employers.

A recent New York case demonstrates this. According to a journal for surgeons, a New York doctor is being held responsible for an ongoing worker’s compensation bill as the result of a violent outburst he directed toward a physician assistant (PA). The physician allegedly lost his temper during an open-heart surgery when the physician assistant accidentally suctioned some heart tissue. The physician allegedly threatened that he would “throw the physician assistant through the wall” if it happened again.

The physician assistant has claimed that the threat deeply affected her ability to perform her job, as well as put the patient’s safety at risk. A psychologist diagnosed the PA with post traumatic stress disorder (PTSD) caused by the incident. Unable to work because of the trauma allegedly caused by the disruptive physician, the PA now reportedly collects $2,415 a week in workers’ compensation.

To read the full article from Outpatient Surgery, click here.

Implications of Disruptive Behavior.

Disruptive behavior from a physician can lead to dire consequences for both the physician and his or her employer. Lawsuits and liabilities, such as those in the New York case discussed above, can detract from a safe, cooperative, and professional healthcare environment.

Disruptive behavior can negatively affect the quality of patient care. Hospitals claim that this happens because of conduct that:

–    Disrupts or impedes the operations of the hospital;

–    Adversely affects the ability of others on the healthcare team to do their jobs;

–    Creates an unprofessional or hostile work environment for hospital employees;

–    Interferes with coworkers’ ability to practice competently;

–    Prevents effective communications among healthcare providers and staff;

–    Disrupts the continuity of care a patient receives; and

–    Adversely affect the community’s confidence in the hospital’s ability to provide quality patient care.

Being accused of being a disruptive physician may lead to adverse action against clinical privileges, action to drop the physician from insurance panels, consequential action by the state medical board or licensing authority, loss of specialty certification, termination of employment contracts and other various consequences.

What Conduct May Cause One to be Labeled a Disruptive Physician?

A hospital’s creed, ethical statement, or code of conduct, as well as Joint Commission Standards, and medical staff bylaws can define what constitutes disruptive behavior. Case reports, hospital policies and actual cases in which we have defended physicians demonstrate the types of acts that can be used to label a person as “disruptive.” Disruptive behavior includes, but is not limited to:

–    Verbal attacks that are personal, irrelevant to hospital operations, or exceed the bounds of professional conduct;

–    Shouting, yelling, or the use of profanity;

–    Verbally demeaning, rude or insulting conduct, including exhibiting signs of disdain or disgust;

–    Inappropriate physical conduct, such as pushing, shoving, grabbing, hitting, making obscene gestures, or throwing objects;

–    Inappropriate comments or illustrations made in patient medical records or other official documents, impugning the quality of care in hospital facilities, or attacking particular medical staff members, personnel, or policies;

–    Belittling remarks about the patient care provided by the hospital or any healthcare provider in the presence or vicinity of patients or their families;

–    Non-constructive criticism that is addressed to the recipient in such a way as to intimidate, undermine confidence, belittle, or imply stupidity or incompetence;

–    Refusal to accept, or disparaging or disgruntled acceptance of, medical staff assignments;

–    Inappropriately noisy or loud behavior in patient areas;

–    Making sexual or racial jokes;

–    Physically touching another professional, nurse or staff member, especially those of the opposite sex;

–    Making sexually suggestive remarks;

–    Commenting on another person’s body parts;

–    Threatening violence to another;

–    Throwing surgical equipment, medical supplies, charts, or anything else at or around anyone else; or

–    Other disruptive, abusive, or unprofessional behavior.

I previously wrote a two-part blog series detailing the types of conduct considered disruptive, as well as the consequences associated with disruptive behavior and how you as a physician can avoid such pitfalls. To read part one of the blog series, click here. To read part two of the blog series, click here.

Physicians: Proactively Educate Yourself.

It’s wise to review your hospital’s or institution’s policies on disruptive behavior. Arming yourself with the knowledge necessary to avoid such accusations is imperative in protecting your reputation and career.

No one lives in a glass house, but pretend you do. Someone can always observe your actions in the office or hospital. Once you have been labeled a disruptive physician, others may be closely, at times, scrutinizing you for anything you may do wrong. You will make yourself a target for possible false allegations and accusations. The healthcare industry is a demanding and stressful field. It’s understandable that potential outbursts can occur; control yourself and don’t let them.

Comments?

Have you ever been accused of being a disruptive physician? Have you ever been around one? What are some proactive tactics physicians can take to prevent any outbursts or behavioral conduct that would be deemed as disruptive? Please leave any thoughtful comments below.

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, dentists, pharmacists, psychologists and other health providers in accusations of disruptive behavior, 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.

Source:

Burger, Jim. “Doc Threatens Physician’s Assistant During Open Heart Surgery: I’m Going to Put Your Through the Wall.” Outpatient Surgery. (July 14, 2014). From: http://www.outpatientsurgery.net/surgical-facility-administration/legal-and-regulatory/doc-threatens-physician-s-assistant-during-open-heart-surgery-i-m-going-to-put-you-through-the-wall–07-14-14

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 © 1996-2014 The Health Law Firm. All rights reserved.

Agency Attorney Prosecuting Case Should Not Also Be in Position of Advising The Agency; Possible Bias Denies Due Process

McAlpin appealed an order of the Criminal Justice Standards and Training Commission (“Commission”) suspending his law enforcement certification for eighteen months. The Commission filed an administrative complaint alleging misconduct during the course of a criminal investigation. A formal administrative hearing was held and a recommended order was issued.

At the Commission hearing to consider the recommended order, the attorney who prosecuted the case against McAlpin was present and offered advice to the Commission. The Commission’s staff had prepared a memorandum to the Commission recommending an increase in the recommended penalty to revocation of McAlpin’s license. It was not clear who prepared the staff memorandum. However, it was clear the prosecuting attorney had prepared exceptions to the recommended order for the agency.

On appeal, the court reversed and remanded for a new Commission hearing. While the Commission did not ultimately adopt the agency’s recommendation of an increased penalty, the court held that the staff attorney’s enhanced access to the Commission undermined the Commission’s function as an unbiased reviewer of the recommended order.

The court did note that it was not inherently inappropriate to consolidate investigative, prosecutorial and adjudicatory authority in a single agency. Each case must be considered on its unique factual background.

Source:

McAlpin v. Criminal Justice Standards and Training Comm’n, 120 So. 3d 1260 (Fla. 1st DCA 2013)(Opinion filed September 13, 2013).

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

 

MedPAC Wants to Hold Accountable Care Organizations More Accountable

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

As the Centers for Medicare and Medicaid Services (CMS) prepares to designate the next class of accountable care organizations (ACOs), the agency sought the advice and input of the Medicare Payment Advisory Commission (MedPAC) on how to proceed.  MedPAC is an independent Congressional Agency established to advise the U.S. Congress on issues affecting Medicare.

Click here to read our previous blog on the background and purpose of ACOs.

MedPAC Suggests All Medicare Shared Savings Program ACOs Join the Two-Sided Risk Model.

In response to the request from the CMS, MedPAC reiterated its previous position that it would like to see all Medicare ACOs take on greater financial risk.  As it presently stands, some Medicare-contracted ACOs do not share in the risks associated with the ACOs patients’ healthcare costs exceeding certain target ranges.  Even though those ACOs do not bear any financial risk if the goals are not met, they nevertheless stand to benefit if they are.

MedPAC found that the one-sided risk model being used by most Medicare Shared Savings Program (MSSP) ACOs to be insufficient to reach the goals of the MSSP.

Specifically, MedPAC wants to see all MSSP ACOs in the two-sided risk model.  That model requires the ACO to reimburse Medicare for some of the costs which exceeded the target ranges. This pressure is important to note because only 13 of the 32 Pioneer ACOs generated enough savings to Medicare to qualify for MSSP savings payments.

Understand an ACO Agreement Before You Sign.

As we see more and more physicians being approached to join or form ACOs, it is crucial to understand exactly what type of arrangement you are getting into.

Many ACO contracts we see are simply for participation as a provider in the organization.  However, some of the contracts we see require that the physician make a financial investment in the ACO or otherwise require that the physician pay a “pro rata” share of any penalty assessed by CMS.

Current ACO participation and recruiting is something akin to the gold rush of the nineteenth century.  Everyone is rushing to stake a claim in fear of being left out.  Be careful about what kind of an agreement you sign and be sure that you understand the long-term consequences of tying your practice to an as-yet unproven model. To read our previous blog on the first year pioneer ACO results, click here.

If you are approached to join an ACO, or are considering signing a participation agreement/contract with one, make sure to read the contract carefully and consult with an experienced healthcare attorney.

Contact Health Law Attorneys Experienced With Healthcare Business Practices.

The Health Law Firm routinely represents physician groups and practices with issues involving establishing, licensing, selling, merging, and intergroup affiliation.  If you are considering establishing an ACO or have been approached to become a participant in one, you can contact The Health Law Firm at (407) 331-6620 or (850) 439-1001 or you can visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of MedPAC’s position on ACOs? Have you considered joining an ACO? Why or why not? Please leave any thoughtful comments below.

About the Author: 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.

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council in Florida

10 Indest-2008-7By 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 a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) 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 HPSO Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it. Contact us, and we will help you.

Don’t Worry About Legal Bills While Your Case is Going On.

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 That Will Work with Insurance Companies.

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.