Feds File Two Lawsuits Against Novartis for Allegedly Giving Kickback to Pharmacists and Physicians

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

Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by NPC to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe NPC products that were reimbursed by federal health care programs.

Click here to read the entire press release from the DOJ.

Doctors and Pharmacists Allegedly Paid to Prescribe.

Both lawsuits allege NPC violated the Anti-Kickback Statute. In the April 23, 2013, complaint against NPC the lawsuit alleges the company gave kickbacks, in the form of rebates and discounts to pharmacies in exchange for the pharmacies’ cooperation in switching patients from competitors’ drugs to NPC products.

The April 26, 2013, lawsuit accuses NPC of paying doctors to speak about certain drugs at events that were allegedly social occasions. Many of the programs were allegedly held in circumstances in which it would be impossible to have a presentation. According to the DOJ, this included fishing trips off the Florida coast and meetings in Hooters restaurants. NPC is also accused of treating health care professionals to expensive dinners. The payments and dinners were apparently kickbacks to the doctors for writing prescriptions for NPC drugs.

Doctors in the Sunshine State Allegedly Involved.

The lawsuit alleges at least six Florida doctors of participating in the bogus conferences and taking thousands of dollars in kickbacks, according to the Tampa Bay Times. The doctors are not named or charged in the civil lawsuit.

To read the allegations listed in the lawsuit against Florida doctors, click here for the Tampa Bay Times article.

Novartis Claims Discounts and Physician Speaker Programs Were Legitimate.

In a press release, NPC disputes all of the government’s allegations. The pharmaceutical company states that discounts and rebates by pharmaceutical companies are a customary and legal procedure, as recognized by the government. It also addresses the physician speaker programs by saying the programs are also acceptable practices designed to inform physicians about the uses of different types of medicines. Click here to read the entire press release from NPC.

Kickbacks and The Law.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Whistleblower or Qui Tam Lawsuits Can Results in a Big Pay Day.

The original complaint against NPC was allegedly filed under the qui tam, or whistleblower, provisions of the False Claims Act by a former sales representative.

Individuals working in the health care industry, whether for hospitals, pharmacies, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities.  Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog series on whistleblower/qui tam lawsuits I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit, and more. Click here to read the first part of this blog, and click here for the second part.

The Health Law Firm Lawyers are Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm represent plaintiffs, patients, 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.

Sound Off.

Have you head about these two lawsuits? What are your thoughts? Please leave any thoughtful comments below.

Sources:

Masow, Julie. “Novartis Pharmaceuticals Corporation Disputes Allegations in Two US Government Lawsuits and Looks Forward to a Fair Discussion of the Facts.” Novartis Pharmaceuticals. (April 26, 2013). From: http://www.pharma.us.novartis.com/newsroom/pressreleases/137176.shtml

Davis, Brittany Alana. “Lawsuit: Pharmaceutical Company Gave Kickbacks to Florida Doctors.” Tampa Bay Times. (May 3, 2013). From: http://www.tampabay.com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133

Department of Justice. “United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs.” Department of Justice. (April 26, 2013). From: http://www.justice.gov/opa/pr/2013/April/13-civ-481.html

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.
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Crackdown in the Supply of Prescription Medications Drive Floridians to Heroin

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

For the past three years, Florida lawmakers and officials have waged war against prescription drug abuse. At the peak of the pill abuse epidemic, seven people a day reportedly died of a prescription drug overdose in Florida. As the Sunshine State became known as painkiller capital of America, officials worked quickly to enact legislation against prescription drugs, develop and monitor the statewide prescription drug monitoring database, and crackdown on prescription drug abusers and pill mills. Flash forward to summer 2013, prescription pills are harder to come by and more expensive, therefore making them less appealing to addicts. However, that does not mean the war is over. Now addicts are finding their replacement fix in heroin, according to the Miami Herald.

Click here to read the entire article from The Miami Herald.

Oxycodone-Related Deaths Down, While Heroin Numbers Rise in Florida.

According to the Florida Department of Law Enforcement’s (FDLE) semi-annual report, oxycodone-related deaths dropped statewide between January and June of 2012, compared to the same period of time in 2011. I previously wrote a blog on the decline of oxycodone-related deaths in Florida. To read that blog, click here.

Now that oxycodone-related deaths are down, heroin numbers are on the rise. According to the Florida Medical Examiners Commission, from July 2010 to June 2011, there were 45 heroin-related deaths statewide. From July 2011 to June 2012, the number jumped to 77 heroin-related deaths. The FDLE is seeing the same trend. In the first three months of 2013, heroin-related charges totaled 948 and in the same three months in 2012, that number was 772.

Florida Officials Try to Fight Heroin.

Lawmakers took dramatic actions to reduce the supply of prescription drugs on the streets. According to the Miami Herald, lawmakers are now trying to fight heroin before it takes off.

Broward County’s substance abuse commission and the Sanford-Brown Institute hosted a workshop to share the news about the growing heroin trend. The commission’s board of governors has formed a task force to put together an anti-heroin campaign. The group is also publicizing the 911 Good Samaritan Act. This Act protects callers from prosecution for possessing or ingesting low-level controlled substances under some circumstances.

The Ultimate Results of Such Crackdowns.

The war on prescription drug abuse took away the supply, but not the demand. Since the crackdown we have seen the largest legitimate pharmacy chains in the state and nation not allowed to fill prescriptions for painkillers. Click here to read a blog on a Walgreens distribution center that was served with an immediate suspension order from the Drug Enforcement Administration (DEA). To read a blog on the DEA pulling the controlled substance licenses from two Central Florida CVS pharmacies.

This has left some patients in dire straits. They are suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

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.

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 about the increase in heroin use? Is one drug more dangerous than another? Please leave any thoughtful comments below.

Sources:

Burch, Audra. “As Pill Mills Fade Away, Heroin Fills the Void.” The Miami Herald. (May 11, 2013). From: http://www.miamiherald.com/2013/05/11/3392908/as-prescription-pills-fade-heroin.html

Gillen, Michele. “Dangerous Drug Creating New Addicts.” WBFS. (May 22, 2013). From: http://miami.cbslocal.com/2013/05/22/dangerous-drug-creating-new-addicts/

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.

Nation Rx Drug Abuse Summit Held in Central Florida-Leaders Share Struggles and Triumphs in “War Against Prescription Drugs”

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

From April 2 through April 4, 2013, the country’s leading experts on the prescription drug epidemic met in Central Florida for the National Rx Drug Abuse Summit, according to the Orlando Sentinel. National leaders including the White House drug czar, the director of the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) commissioner and Florida’s Attorney General (AG) shared ongoing challenges and strides each department has made in its fight against prescription drugs.

Good News in the War Against Prescription Drugs.

The Florida Department of Law Enforcement (FDLE) stated in its semi-annual report that oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. In the first half of 2012, there were 759 oxycodone-related deaths in Florida. That number is down from 1,058 during the same time period a year before.

A look at the national numbers shows that the number of people abusing prescription drugs is down. According to the White House drug czar, seven million people abused prescription drugs in 2010. By 2011, that number had dropped to 6.1 million. Studies also show prescription drug use among young adults ages 18 to 25 is also on the decline. To read the article from the Orlando Sentinel, click here.

Summit Focused on Need for More State Prescriptions Drug Monitoring Programs.

During the summit leaders spoke of the need to help state prescription drug monitoring programs succeed.

Just in March 2013, three states made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new regulations regarding the use of prescription drug monitoring programs. What this means is that whatever state you may be in, you should be aware that lawmakers are implementing similar programs and laws in their governments. To learn more, click here.

Drug Monitoring Programs Can Be Used as a Prosecution Tool.

Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool. Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

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

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

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

Comments?

Does the state where you are located have a prescription drug monitoring program? What do you think of these programs? Are they necessary? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “‘We Can Stop This Epidemic,’ CDC Boss Says at Rx-Drug Abuse Summit in Orlando.” Orlando Sentinel. (April 2, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-prescription-drug-abuse-summit-20130402,0,4693169.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 Pharmacy Owner Admits to $23 Million Health Care Fraud Scheme

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A co-owner and operator of three Miami-area pharmacies pleaded guilty on December 6, 2012, for his part in a $23 million health care fraud scheme. The pharmacy owner allegedly admitted in the Florida Southern Federal District Court to one count of conspiracy to commit health care fraud and one count of conspiracy to pay illegal health care kickbacks, according to a Department of Justice (DOJ) press release.

Click here to read the entire press release from the DOJ.

Pharmacy Owner and Co-Conspirators Used a Network of Beneficiaries to Bill Medicare and Medicaid.

According to court documents, the pharmacy owner allegedly admitted to paying illegal kickbacks to an unnamed number of co-conspirators in return for Medicare and Medicaid beneficiary information. That information was then used to submit fraudulent claims. A majority of the beneficiaries referred to the owner’s pharmacies reportedly resided at assisted living facilities (ALFs) in Miami.

The court documents state that the pharmacy owner also allegedly paid kickbacks to physicians in exchange for prescription referrals which were also billed to Medicare.

Unused and Partially Used Medications Were Also Allegedly Used in Scheme.

As part of the scheme, the pharmacy owner allegedly instructed drivers working for his pharmacies to pick up unused medications from ALFs around Miami. The medications were then allegedly placed back into pill bottles. Unused and partially used medications were billed back to Medicare and Medicaid, according to court documents.

Click here to read the court documents on this case.

The pharmacy owner and his co-conspirators allegedly submitted more than $23 million in false and fraudulent claims to Medicare and Florida Medicaid programs.

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

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?

What do you think of this case? Is the Miami area just a hotbed for Medicare and Medicaid schemes? Please leave any thoughtful comment below.

Sources:

United States of America v. Jose Carlos Morales. Case Number 12-23374, Preliminary Injunction and Supporting Memorandum of Law. (September 14, 2012). From: http://www.thehealthlawfirm.com/uploads/USA%20v%20Morales.pdf

Department of Justice. “Pharmacy Owner Pleads Guilty in Miami for Role in $23 Million Health Care Fraud Scheme.” Department of Justice . (December 6, 2012). From: http://www.justice.gov/opa/pr/2012/December/12-crm-1461.html

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.