Tag Archives: whistle-blower

“Doctor of Death” Trial Could Ignite Stricter Oversight in the Healthcare Industry

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

On paper, one Detroit-area oncologist appeared to be a wildly successful professional with impeccable medical credentials. According to his medical practice’s website, he went to medical school at Cornell Medical College, did an internal medicine residency at Maimonides Medical Center in Brooklyn, New York, and then completed a medical oncology fellowship at Memorial Sloan-Kettering Cancer Center, a very well-respected facility. The oncologist ran a professional practice of seven locations with a total of 60 employees.

However, on September 24, 2014, his reputation and accolades faded when he pleaded guilty to intentionally and wrongfully diagnosing healthy patients with cancer. He also admitted to giving these patients chemotherapy solely for the purpose of making a profit.

For healthcare professionals, this act is an obvious violation of the oath they took to serve their patients and to do no harm. But, if this oncologist is found guilty, you can be assured that oncologists, physicians, dentists, and all other healthcare professionals will be under a microscope to help ensure that something this egregious and dishonest does not happen again.

Allegations Against the Oncologist.

The details of the allegations, obtained from various employee whistleblowers, range from the mundane to the horrific. In the Federal Bureau of Investigation’s (FBI) complaint against the oncologist, there are dozens of examples of his wrongdoing described. The activities of which the doctor is accused include:

– Administration of unnecessary chemotherapy to patients in remission;
– Deliberate misdiagnosis of patients as having cancer to justify unnecessary cancer treatment;
– Administration of chemotherapy to end-of-life patients who would not benefit from the treatment;
– Deliberate misdiagnosis of patients without cancer to justify expensive testing;
– Fabrication of other diagnoses such as anemia and fatigue to justify unnecessary hematology treatments; and
– Distribution of controlled substances to patients without medical necessity.

There is also an issue of Medicare fraud. For the past six years, the doctor is accused of seeing a large number of patients per day. He would then bill every patient at the highest possible billing code, even though he allegedly only spent a few minutes with each patient. The amount of money related to the doctor’s Medicare fraud scheme is a staggering $35 million.

Click here to read the FBI’s complaint against the oncologist.

Charges.

The oncologist is facing a an abundance of legal issues. In all, the oncologist pleaded guilty in U.S. District Court to 13 counts of healthcare fraud, one count of conspiracy to pay or receive kickbacks and two counts of money laundering. He will be sentenced in February 2015 and faces up to 175 years in prison.

Other Healthcare Providers Could Pay for Oncologist’s Greed.

If the oncologist is found guilty, the aftereffects will surely be felt throughout the industry. For example, healthcare providers will need to more closely watch their Medicare billing. Any reimbursement submitted to Medicare will be under tight scrutiny. Keep in mind that Medicare pays close attention to the percentage of patients billed at each level. If a physician bills for every patient at the highest level, it’s going to send up a huge red flag. If you or your practice is being audited, click here for some tips on responding to a Medicare audit.

On top of the extensive healthcare fraud charges, the oncologist allegedly misled, endangered, and injured his patients. He betrayed the trust and privilege given to him as a physician by society, all in the name of greed. According to an article in The Washington Post, more than one patient died under the care of the oncologist. These families are now left to figure out whether their loved ones actually had cancer and died of chemotherapy complications, or whether they died of an actual cancerous ailment.

It’s crucial to remember that cutting corners to make a profit as a healthcare professional leads to great ramifications. Once a healthcare professional’s license and reputation are questioned, it is not an industry one can easily get back into.

Comments?

In your opinion, what is the worst offense this oncologist allegedly committed? Explain. 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 http://www.TheHealthLawFirm.com.

Sources:

Sullivan, Gail. “‘Death Doctor’ Who Profited from Unnecessary Chemotherapy for Fake Cancers Could Resume Practice in 5 Years.” The Washington Post. (October 1, 2014). From: http://www.washingtonpost.com/news/morning-mix/wp/2014/10/01/death-doctor-who-profited-from-unnecessary-chemotherapy-for-fake-cancers-could-resume-practice-in-three-years/

“Prominent Michigan Cancer Doctor Pleads Guilty: ‘I Knew That It Was Medically Unnecessary’.” The Inquisitr. (September 24, 2014). From: http://www.inquisitr.com/1485160/prominent-michigan-cancer-doctor-pleads-guilty-i-knew-that-it-was-medically-unnecessary/

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

“The 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.

Consequences of Clinical Research Fraud and Misconduct

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

Medical and clinical researchers, whether in an academic community or in a practice setting, spend years on clinical trials and investigations in hopes of contributing to their respective fields. Many of these researchers, however, find themselves defending their reputation after being accused of research fraud or research misconduct.


Why Researchers are Accused of Misconduct.

Although accusations of research fraud and misconduct have been present for decades, the number of complaints is on the rise, according to the FDA. In many cases, the researcher accused of such misconduct may actually be the victim of one or more unscrupulous individuals who make the complaint for his or her own ulterior motives. Some researchers may be targeted by an academic institution or the government. Other cases may involve a “whistle blower” who may just have misunderstood the situation.

Researchers Face Many Difference Accusations.

The most common accusations against researchers include: manipulating or concocting research data, failing to disclose financial interest or not properly disclosing conflict of interest, plagiarizing, failing to present data that contradicts one’s own previous research, overlooking the use of flawed data, and circumventing certain minor aspects of human-subject requirements. Researchers also face an enormous amount of pressure from funding sources. That influence on a researcher can lead to these accusations: changing the design, methodology or results of a study to meet a funding source’s expectations, ignoring details or cutting corners to meet a deadline, fabricating, falsifying or mishandling of data to gain some form of reward or benefit.

A Person and Professional Reputation can be Tarnished.

An accusation, even if later proven to be unfounded, may unfairly tarnish the personal and professional reputation of the researcher, cause the researcher to lose grants, bonuses and promotions, his or her employment may be terminated, or may even face criminal prosecution for fraud, theft or other applicable crimes.

To learn more on clinical research fraud and misconduct, click here.

Well-Known Cases of Research Fraud and Misconduct.

One of the most notorious recent cases of research misconduct involved a stem cell researcher in South Korea who claimed to have cloned human embryonic stem cells. However, the researcher was later accused of fabricating crucial data and charged with fraud and embezzlement. The fraud charges were eventually cleared, but not before the researcher’s reputation was destroyed.

From 1992 to 2002 a former research professor in Vermont falsified and fabricated data in numerous federal grant applications and academic articles. He used two million dollars in government grants – taxpayer money – for studies to perpetrate his fraud. He pled guilty to falsifying 17 grant applications to the National Institutes of Health (NIH) and fabricating data in 10 of his papers. He was ordered to serve one year and a day in federal prison, permanently barred from ever receiving more federal research grants, and ordered to write letters of retraction and correction to a number of scientific journals.

A prominent Massachusetts anesthesiologist admitted to fabricating 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked. This data used in the studies was published in several anesthesiology journals between 1996 and 2008. This doctor was sentenced to six months in prison, followed by three years of supervised release. He was ordered to pay a $5,000 fine, forfeit $50,000 to the government and make $360,000 in restitution to pharmaceutical companies. The plea deal effectively ended his career as a physician.

Visit the Office of Research Integrity (ORI) website to learn more on research fraud and misconduct.

Contact Health Law Attorneys Experienced in Clinical Research Fraud and Misconduct.

The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians and clinicians who are the subject of clinical research fraud and misconduct. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers, investigators and “whistle blowers” who report such matters including those who become the victim or reprisals and retaliation by the person against whom the report is made.

Don’t wait. Obtain the advice and counsel of experienced attorneys who are familiar with such matters and can assist you before it is too late.

If you are facing research misconduct or research fraud accusations, please visit our website for more information at www.TheHealthLawFirm.com or call The Health Law Firm at (407) 331-6620 or (850) 439-1001.

Sources:

“Grantee Misconduct: Dr. Eric T. Poehlman.” National Institutes of Health. (March 7, 2012). From: http://www.nih.gov/news/granteemisconduct.htm

Arak, Joel. “Menopause Doc Fudged Data.” CBS Evening News. (February 11, 2009). From: http://www.cbsnews.com/2100-18563_162-703359.html

Interlandi, Jeneen. “An Unwelcome Discovery.” The New York Times. (October 22, 2006). From: http://www.nytimes.com/2006/10/22/magazine/22sciencefraud.html?pagewanted=all

Winstein, Keith and Armstrong, David. “Top Pain Scientist Fabricated Data in Studies, Hospital Says.” The Wall Street Journal. (March 11, 2009). From: http://online.wsj.com/article/SB123672510903888207.html

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.

Michael L. Smith, J.D., R.R.T.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.

$24 Million Medicaid Fraud Scheme Alleged by Connecticut Attorney General

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

Connecticut’s Attorney General, George Jepsen, alleges that 28 individuals, dental practices and corporations were involved in a $24 million Medicaid fraud scheme. He filed a civil action  on May 31, 2012. It is the first case the state has initiated under the Connecticut False Claims Act. The Connecticut False Claims Act gives the state the ability to seek compensation for taxpayers from those who submit false claims for reimbursements they are not eligible to receive. To view the Connecticut False Claims Act, click here.

The complaint seeks restitution, treble damages and civil penalties as well as a permanent injunction against the unlawful acts and practices alleged in the complaint. To view the complaint, click here.

Accused Individual Allegedly Found Ways to Bill Medicaid for Services, Despite Being Excluded from Medicare and Medicaid Programs.

According to the complaint, one of the individuals involved in the alleged fraud scheme was previously convicted of a felony in another state for submitting false health care claims. He was then permanently excluded by the U.S. Department of Health and Human Services (DHHS) from participation in Medicare and Medicaid, as a result of his conviction. Any entity with which he serves as an employee, administrator, operator or in any other capacity, were also excluded from state healthcare programs.

The state alleges that, despite the exclusion, he established a number of dental practices in Connecticut that were operated by practicing dentists who billed Medicaid for services.

Allegedly, the excluded individual was actively involved in managing the practices and received millions of dollars in Medicaid reimbursements. The dental providers allegedly knew of the exclusion and did not disclose it on enrollment and re-enrollment forms for the Connecticut Medical Assistance Program.

Florida Has Similar False Claims Act.

Florida has a Medicaid False Claims Act similar to the one that Connecticut has. Florida’s Medicaid False Claims Act can be found here. However, in Florida, a separate provision of the state’s Medicaid law provides an award to a whistle-blower of up to 25% of any recovery. This is in Section 409.9203, Florida Statutes. In addition, Florida has a law that allows civil recovery for criminal acts such as Medicaid fraud, which is sometimes used by the Florida Attorney General and private individuals to recover money lost as a result of certain criminal conduct. For the Florida Civil Remedies for Criminal Actions law, click here.

As a general rule state false claims acts are modeled after the federal False Claims Act used to pursue Medicare fraud. For the federal Medicare Fraud False Claims Act, 31 U.S.C. § 3729, click here.

Contact Health Law Attorneys Experienced in Handling Medicaid and Medicare Fraud Cases.

The Health Law Firm’s attorneys routinely represent physicians, dentists, nurses, medical groups, clinics, pharmacies, durable medical equipment (DME) suppliers, home health agencies, nursing homes and other healthcare providers in Medicaid and Medicare investigations, audits, hearings and recovery actions. In addition The Health Law Firm represents health providers in Medicare exclusion actions and in being reinstated to the Medicare Program or being removed from the exclusion list.

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

Sources:

Rees, Nick. “Jepsen alleges $24M Medicaid fraud.” Legal Newsline. (June 4, 2012). From: http://www.legalnewsline.com/news/contentview.asp?c=236342

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.

2010 District Ruling for $44.9 Million in Tuomey Overturned by U.S. Appeals Court

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

Tuomey Reversed

The 4th U.S. Circuit Court of Appeals overturned a federal district judge’s 2010 decision for Tuomey Healthcare System on March 30, 2012. (U.S. ex rel. Drakeford v. Tuomey Health. Sys., Inc., 4th Cir., No. 10-1819 (Mar. 30, 2012)) The lower court’s decision ordered Toumey Healthcare System to pay $44.9 million for allegedly violating the Stark Law. (42 U.S.C. § 1395nn) The appeals court decided that the 2010 district ruling denied Tuomey its Seventh Amendment right to a jury trial. 

A physician initiated a qui tam or whistle-blower suit against Toumey under the False Claims Act in 2005. The suit was later picked up and prosecuted by the U.S. Department of Justice. In the False Claims Act complaints filed in the U.S. District Court in Columbia, S.C., the whistle-blower and the U.S. Department of Justice (DOJ) alleged that Tuomey had contracts with physicians that were illegally overpaid by Tuomey. This was alleged to be in exchange for their exclusively referring patients to Tuomey’s hospital, thus violating the Stark Law. Billings for referrals from those physicians allegedly constituted false claims as a result of this.

Novel Theory Used to Obtain Large Recovery

This was a novel theory to pursue in a qui tam or whistle-blower case because it was not based directly on submission of false claims. Instead it put forth the theory that the claims were false because they violated the anti-referral provisions of the Stark Act.

In March 2010, a jury found that Tuomey had not violated the False Claims Act but did find Tuomey guilty of committing Stark Law violations. (Note: The Stark Act does not establish a private cause of action for plaintiff to recover civil damages.) This jury verdict was set aside by the judge and a new trial regarding the False Claims Act allegations was granted. Under the lower court’s decision, Tuomey was still required to repay the government $44.9 million in Medicare payments that were allegedly received through physician contracts that violated the Stark Law.  This was the part of the verdict that was not set aside by the trial court.

However, according to the opinion of the appeals court, when the district court set aside the jury’s verdict, it specifically ordered that the new trial would encompass the whole False Claims Act matter, including whether Tuomey had violated the Stark Law. This nullified the jury’s interrogatory answer (part of the verdict it returned) regarding the Stark Law. Thus, when the district court ordered Tuomey to repay the government for violating the Stark Law, it denied Tuomey of its right to a jury trial.

Two Major Stark Issues Discussed

The appeals court also addressed two major Stark Law issues that were raised on appeal and are likely to recur on remand. The first issue is whether the facility component of the services performed by the physicians, for which Tuomey billed a facility fee to Medicare, constituted a “referral” within the meaning of the Stark Law. The court used the Health Care Financing Administration’s (now the Centers for Medicare and Medicaid Services) final rule on referrals (66 Fed. Reg. 856, 941, Jan. 4, 2001) to conclude that the facility/technical component of the physician’s personally performed services does constitute a referral.

The second issue was the correct standard to use. Having decided that the physicians were making referrals to Tuomey, the appeals court then examined if an arrangement that takes into account anticipated referrals violate the Stark Act’s “volume or value standards.” The “volume or value standards” require that compensation must be calculated in a way that does not take into account the volume or value of referrals between the parties.

Fair Market Value Standard

Additionally, Stark Act requires that whatever financial relationship exists reflects “fair market value.” Stark defines “fair market value” as compensation that “has not been determined in any manner that takes into account the volume or value of anticipated or actual referrals”(42 C.F.R. § 411.351). Thus, the court concluded that compensation based on the volume or value of anticipated referrals does implicate the volume or value standard. The court left it to the jury to decide if Tuomey’s contracts violated the fair market value standard.

$50 Million May be Returned to Tuomey

The government has 45 days from the date of the decision to request a rehearing. If it doesn’t, the matter goes back to the South Carolina federal district court where it was originally decided. Tuomey can then request the money that it had set aside to pay the government back, $50 million according to it, to be released to the health system.

Tuomey Issues Press Release

In a press release dated March 31, 2012 (Press Release), signed by Jay Cox, its President and Chief Executive Officer (CEO), Tuomey Healthcare System stated:

The 4th Circuit has issued an opinion in favor of Tuomey on our appeal. We are pleased that the 4th Circuit Court has decided that the District Court’s judgment violated Tuomey’s Seventh Amendment right to a jury trial, and vacated (reversed) the $50 million judgment against Tuomey Healthcare System.

*          *          *

As the Court of Appeals said in the opinion: “The whole case, including the issues of fact at the former trial is open for hearing and determination.” This includes the incorrect finding by the first jury that Tuomey violated the Stark Law. Again, we are pleased with this news and we will keep you posted as we learn more.

Setback to Plaintiff’s Qui Tam Bar?

The original decision in Tuomey had encouraged plaintiff’s attorneys who take whistle-blower cases in health care matters and had alarmed health care systems across the country.  Although this does not eliminate the ability to use Stark Act violations as the basis for False Claims Act recoveries, it does indicate that the courts will require strict pleading, proof and procedural rules before it does allow this.

Sources Include:

Blesch, Gregg, “Appeals Court Overturns Order for S.C. Hospital to Pay $45 Million in Stark Case,” Modern Healthcare (Apr. 1, 2012). From:
http://www.modernhealthcare.com/article/20120401/NEWS/304019973/appeals-court-overturns-order-for-s-c-hospital-to-pay-45-million-in#

Cheung, Karen M., “Federal Appeals Court Overturns $45M Stark Ruling,” FierceHealthcare (Apr. 2, 2012). From:
http://www.fiercehealthcare.com/story/federal-appeals-court-overturns-45m-stark-ruling/2012-04-02

Cox, Jay, “Federal Case Update,” Tuomey Healthcare System Press Release (Mar. 31, 2012).

Cox, Jay, “Federal Case Update,” Tuomey Healthcare System Press Release (Mar. 31, 2012). From: http://www.tuomey.com/Articles/federal_case_update.aspx

Davis, Caralyn, “Stark Violations: Tuomey Healthcare in South Carolina Ordered to Pay $50 Million,” FierceHealthcare (June 9, 2012). From: http://www.fiercehealthfinance.com/story/stark-violations-tuomey-healthcare-s-c-ordered-pay-50-million/2010-06-09

HHS, “Medicare and Medicaid Programs: Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships,” 66 Fed. Reg. 856, 941 (Jan. 4, 2001). From:  http://www.gpo.gov/fdsys/pkg/FR-2001-01-04/pdf/01-4.pdf

U.S. ex rel. Drakeford v. Tuomey Health.Sys., Inc., 4th Cir., No. 10-1819 (Mar. 30, 2012). From: http://pacer.ca4.uscourts.gov/opinion.pdf/101819.P.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.