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.

CVS Blacklists Second Set of Doctors Accused of Overprescribing Painkillers

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

CVS is again stepping up its own internal efforts to combat the nation’s prescription drug abuse epidemic. According to Reuters, the second largest retail pharmacy chain announced it is cutting off access to the most powerful painkillers for more than 36 doctors and health care providers around the country. The Drug Enforcement Administration (DEA) has been keeping a close eye on CVS over the past few years. According to Reuters, CVS began revoking the dispensing privileges of certain providers back in 2011. CVS disclosed this round of suspensions on August 21, 2013.

To read the article from Reuters, click here.

CVS Closely Analyzed Prescription Practices of Health Care Providers Before Suspending Dispensing Privileges.

CVS said the suspension followed an analysis of prescriptions brought to its drugstores from March 2010 through January 2012, for painkillers such as oxycondone, hydrocodone, and methadone, according to Reuters. CVS said it first identified several dozen health care providers, from its database of nearly one million, with “extreme” patters of prescribing high-risk drugs. CVS allegedly compared their prescription rates to other providers in the same specialty and geographic region, the ages of the patients, and the number of patients paying with cash for the drugs.

After analyzing the results, CVS said the company’s stores and mail-order pharmacy will no longer dispense controlled substances for 36 providers who it said could not justify their prescribing habits, according to the Orlando Sentinel. CVS did not disclose the names or location of the physicians blacklisted this time around.

Click here to read the Orlando Sentinel article.

Second Time CVS Has Blacked Listed Specific Doctors.

In November 2011, at least 22 Central Florida doctors received an unsigned letter from CVS telling them that the company’s pharmacists would no longer fill prescriptions they write for painkillers and other powerful drugs. The letter was called a “blacklist” and was criticized as discriminatory. One Orlando doctor tried to fight back with legal action, claiming that CVS basically called him a criminal. To read more on the previous blacklist, click here to read my blog.

So far, we have not heard of any legal action pending against CVS from providers recently added to the blacklist.

DEA Previously Pulled Controlled Substance Licenses from Two Sanford, Florida, CVS Pharmacies.

As previously stated, the DEA has had its eyes on CVS for a while. You may remember that in September 2012, the DEA revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. I previously wrote about this, click here to read that blog.

Who is Responsible for the Prescription Drug Epidemic?

The act of prescribing powerful, and sometimes deadly, addictive drugs inappropriately for a health care provider’s personal gain has grown. It’s argued that pharmacies have a role to play in the oversight of controlled substance prescriptions. Pharmacists, as well as physicians and all health care providers, have an ethical (and legal duty) to ensure that a prescription for a controlled substance is appropriate.

Contact Health Law Attorneys Experienced with DEA Cases.

The Health Law Firm represents physicians, pharmacists, pharmacies, 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.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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

Comments?

What do you think of CVS’ ban on filling controlled substance prescriptions from certain doctors? Do you think this will help with the national prescription drug abuse epidemic? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “CVS Cracks Down on Doctors with ‘Extreme Patters’ of Prescribing High-Risk Drugs.” Orlando Sentinel. (August 29, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-cvs-crackdown-doctors-20130829,0,5193527.story?dssReturn

Wohl, Jessica. “CVS Cuts Access to Opiod Pain-Killers for Suspect Doctors.” Reuters. (August 21, 2013). From: http://www.reuters.com/article/2013/08/21/us-cvscaremark-painkillers-idUSBRE97K17120130821

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.

Central Florida Doctor’s Home and Offices Raided Over Alleged Improper Prescribing Practices

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In a joint operation, law enforcement officials raided the home and two offices of a Central Florida physician on November 8, 2013, according to the Osceola County Sheriff’s Office. The Osceola County Sheriff’s Office alleges that the doctor is being investigated for improper prescribing practices. According to the press release, this is not the first time the physician has been under investigation.

The raid was a collective effort between the Osceola County Investigative Bureau (OCIB), Florida Department of Health (DOH), Drug Enforcement Administration (DEA), Florida Department of Law Enforcement (FDLE), and the Metropolitan Bureau of Investigation (MBI).

Physician Not Arrested After Raid.

On November 8, 2013, law enforcement agents searched the physician’s home and his offices in Kissimmee, Florida and Orlando, Florida. The Florida DOH also issued an emergency order restricting the doctor’s privilege to prescribe narcotics. The physician was not arrested.

The physician was allegedly the target of two separate Florida DOH complaints in June 2013. Both complaints alleged the physician wrote prescriptions for painkillers to patients who did not have a medical need for the drugs. Click here to read the two previous complaints.

Doctor Previously Blacklisted by CVS.

According to an Orlando Sentinel article, this physician was previously placed on a CVS document referred to as the “blacklist.” This list identifies Central Florida’s top physicians prescribing oxycodone. When the list was released, the pharmacy chain notified the physicians that CVS pharmacists would no longer fill their patients’ prescriptions. This blacklist was an effort by CVS to step up internal efforts to combat the nation’s prescription drug abuse epidemic. So far, CVS has released two blacklists, one was released in November 2011, and the second list was released in August 2013. You can read more about the two lists on our blog. Click here for part one, and click here for part two.

To read the Orlando Sentinel article, click here.

Florida Losing War on Prescription Drug Abuse.

Despite the aggressive “war on prescription drugs” the Sunshine State reportedly ranks eleventh highest nationally in drug overdose deaths.

I have represented a number of physicians who have been accused of “overprescribing.” Some of these were criminal investigations by local law enforcement authorities, such as a county sheriff’s office. Some were investigations by the DEA. Some were investigations by the state licensing agency such as the Florida DOH. To read a previous blog, “Legal Tips for Physicians to Manage Pain Patients,” click here.

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 Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

Do you think Florida’s war on prescription drug abuse is working? Please leave any thoughtful comments below.

Sources:

Lizasuain, Twis. “Dr. Ibem Borges Investigated for Over Prescribing Drugs.” Osceola County Sheriff’s Public and Medica Relations. (November 8, 2013).

Pavuk, Amy. “Agents Raid Home, Offices of Central Florida Physician Suspected of Improper Prescribing Practices.” Orlando Sentinel. (November 8, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-doctor-ibem-borges-raid-20131108,0,735835.story

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.

Florida HB 0653 Signed Into Law; Effective 2/1/2012

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

The Florida Legislature unanimously passed HB 653 which relaxes some of the draconian exclusions enacted under SB 1986, which went into effect on July 1, 2009. SB 1986, which added provisions to Chapter 456, Florida Statutes, among others, prevented numerous healthcare providers from obtaining or renewing licenses based on prior criminal convictions, which could have occurred decades earlier.

HB 653 has been passed unanimously by the Florida Legislature and has been signed by the Governor to be effective July 1, 2012. It has been signed into law as Chapter 2012-64, Florida Laws and amends Section 456.0635(5), Florida Statutes (2012).

Under HB 653, the professional boards within the Department of Health (such as the Board of Medicine, Board of Nursing, Board of Psychology, Board of Massage Therapy, etc.) now will, if signed by the Governor, only prohibit the renewal or granting of a health professional’s license, certificate or registration, if the individual:

1. Has been convicted of, or entered a plea of guilty or no contest to, regardless of adjudication, a felony under Chapters 409 (Medicaid offenses), 817 (theft or fraud) or 893 (drug offenses), Florida Statutes, or similar laws in other jurisdictions, unless the individual successfully completed a drug court program for the felony and provides proof that the plea was withdrawn or the charges were dismissed, or unless the sentence and any related period of probation for such conviction or plea ended:

– For first and second degree felonies, more than fifteen (15) years before the date of application;

– For third degree felonies, more than ten (10) years before the date of application, except for third degree felonies under Section 893.13(6)(a), Florida Statutes; and

– For third degree felonies under Section 893.13(6)(a), Florida Statutes, more than five (5) years before the date of application.

2. Has been convicted of, or entered a plea of guilty or no contest to, regardless of adjudication, a felony under 21 U.S.C. Sections 801-970 or 42 U.S.C. Sections 1395-1396 (federal Medicare & Medicaid offenses), unless the sentence and any subsequent period of probation for such convictions or plea ended more than fifteen (15) years before the date of application; or

3. Is listed on the OIG’s list of excluded individuals and entities.

This new legislation has the effect of reducing the period of time a health professional may be prohibited from holding a license because of a conviction for one of the enumerated felonies. Under the current law, there is a fifteen (15) year prohibition for all enumerated offenses. The new legislation, if signed, will reduce the period to as little as five (5) years for drug offenses.

However, it also broadens the reach of the current Florida law by including, for the first time, convictions under “similar laws in other jurisdictions.” This may now “catch” many to whom the Florida law did not previously apply.

HB 653 also allows individuals previously denied renewals under SB 1986 who at are now eligible for renewal to obtain a license without retaking and passing their examinations.

The latter requirement above, number 3, may present a “catch 22” for many health professionals. Usually, if a licensed health professional is convicted of a felony, loses his/her license or is denied renewal of a health professional’s license, this is reported to the National Practitioner Data Bank (NPDB). The NPDB now includes reports previously made to the Healthcare Integrity and Protection Data Bank (HIPDB). If this occurs, in most cases the Office of Inspector General (OIG) commences action to exclude the professional from the Medicare Program. This automatically places the health provider’s name on the OIG’s List of Excluded Individuals and Entities (LEIE). Therefore, most licensed health professionals, even if they are no longer prohibited from holding a license under numbers 1 and 2 above, may still be prohibited because of requirement number 3 above.

Doubtless, this lacuna (gap) in this legislation will require additional corrective legislation in the future.

To view a summary of HB 653, click here.

To view the Bill Analysis of HB 653 from the Health and Human Services Quality Subcommittee, click here.

To view the Bill Analysis of HB 653 from the Health Care Appropriations Subcommittee, click here.

To view the Bill Analysis of HB 653 from the Health and Human Services Committee, click here.

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.

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