Federal Judge Refuses to Dismiss Florida Compounding Pharmacy’s FCA Suit

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

On December 4, 2017, a Florida federal judge refused to dismiss the federal government’s False Claims Act (FCA) suit against a compounding pharmacy. RS Compounding LLC and its owner, Renier Gobea, are accused of overbilling Tricare for prescriptions. The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner.

Judge Finds Claims Are Sufficiently Stated.

According to U.S. District Judge Virginia M. Hernandez Covington, the government adequately pled its claims that RS and Gobea had knowingly charged Tricare prices well in excess of what it charged cash payors for substantially the same drugs. “The United States’ amended complaint in partial intervention sufficiently states claims for unjust enrichment and violation of the FCA,” the judge said.

The government had also adequately backed its allegations that RS knew it had been overpaid but had made no attempt to refund the difference to Tricare, according to the judge.

Additionally, Judge Covington rejected the owner’s argument that claims against him personally should be dropped from the case pointing to his “extensive involvement” in RS’s operations and his profit-taking from the company.

The Relator’s FCA Suit.

The relator McKenzie Stepe, a former RS sales representative, originally filed her complaint in December 2013. She accused RS and Gobea of charging Tricare, Medicare and Medicaid excessively high rates for certain compounded drugs. Those drugs, all mixtures containing the anesthetic ketamine, were charged to the government at prices of between $400 and $3,000 per bottle when the equivalent rate for an uninsured cash payer was between $15 and $45 a bottle.

The relator’s complaint was dismissed in November 2017, based on what Judge Covington said was a lack of firsthand knowledge to support her claims, but with leave to file an amended complaint by December 7, 2017.

To read the court’s order in full, click here.

To learn about a similar case involving a Florida compounding pharmacy, click here to read one of my prior blogs.

 

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s 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.

Sources:

Wilson, Daniel. “Fla. Compounding Pharmacy Can’t Escape Tricare FCA Suit.” Law360. (December 4, 2017). Web.

Raymond, Nate. “Florida compounding pharmacy must face U.S. fraud suit – judge.” Reuters. (December 4, 2017). Web.

KeyWords: False Claims Act defense attorney, FCA legal counsel, TRICARE false claims legal defense attorney, TRICARE physician representation, legal representation violating False Claims Act, pharmaceutical fraud lawyer, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistle blower lawyer, FCA violations, fraud detection, financial interest in physician referrals, TRICARE fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, consumer reports of health care fraud, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, legal defense of military physicians, legal defense of TRICARE providers, attorney reviews of The Health Law Firm, Veterans Administration (VA) physician defense attorney, The Health Law Firm attorney reviews, legal representation for pharmacies, legal representation for pharmacists, health law defense attorney, legal representation for health care professionals

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.

 

Florida-Based Compounding Pharmacy Violated False Claims Act by Overcharging Tricare, Feds Claim

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

On July 3, 2017, a compounding pharmacy based in Tampa, Florida, charged Tricare at least 2,000 percent more for drugs than it charged cash payers, according to the government. Teh government claimed that the Florida pharmacy acted in violation of the False Claims Act (FCA), as it intervened in a whistleblower’s suit.

The government claimed that RS Compounding LLC and its owner, Renier Gobea, knew it was illegal to provide discounts to cash payers but not the government. However, the company still went through with a scheme to do it, the partial-intervention complaint says. Prosecutors are seeking triple damages and civil penalties.

The False Claims Act provisions in Tricare cases are a little different from those in Medicare cases. In Tricare cases, recovery can be had for any “fraud, waste or abuse.” It is not limited to just fraud or false claims. Abusive claims can lead to recoveries by the government and by whistle blowers.

The Whistleblower Suit.

The suit was brought forward by former sales representative McKenzie Stepe. She filed her whistleblower suit in December 2013. Stepe’s suit alleges that RS Compounding used the average wholesale price in place of the lower acquisition cost when reporting what it paid for drugs. Additionally, the company then reported the usual and customary cost of the compounded drug to be equal to the average wholesale price, and as a result the government paid more for the drug that it needed to when reimbursing RS Compounding, the complaint says.

Between January 1, 2012, and January 31, 2014, the company was charging cash customers less without telling the government, according to the complaint.

Click here to read the complaint in full.

Unfortunately, this is not the first time a Florida pharmacy has allegedly defrauded government programs such as Tricare through compounding activities. The Tricare program is a health care program that provides benefits for U.S. military personnel, their defendants and retired military personnel.

Click here to read one of my prior blogs on a similar case against Tricare.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s 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.
Sources:

Kass, Dani. “Fla. Compounding Pharmacy Ripped Off Tricare, Feds Claim.” Law360. (July 3, 2017). Web.

“Florida Compounding Pharmacy Ripped Off Tricare.” Law of Compounding Medication. (July 4, 2017). Web.

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.

KeyWords: False Claims Act defense attorney, FCA legal counsel, Anti-Kickback Statute (AKS) defense attorney, legal representation for allegations of violating Anti-Kickback Statute, TRICARE false claims legal defense attorney, TRICARE physician representation, legal representation violating False Claims Act, pharmaceutical fraud lawyer, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistle blower lawyer, FCA violations, fraud detection, financial interest in physician referrals, TRICARE fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, consumer reports of health care fraud, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, legal defense of military physicians, legal defense of TRICARE providers, attorney reviews of The Health Law Firm, Veterans Administration (VA) physician defense attorney, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2017 The Health Law Firm. All rights reserved.

 

Florida Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

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

In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions reimbursed by Tricare over the last year.

In April 2015, just four months into the fiscal year, it was already determined that total costs for compound drug prescriptions filled for Tricare recipients were likely to come close to $1 billion. If the trend continues, the Defense Health Agency expects it may need to reallocate funds at the end of this year to cover the prescription drug benefit, which is currently set at $8.25 billion.

For more on this new screening process and its effect on compound medication prescriptions, click here.

With prescription drug costs at an all-time high, the government is cracking down on health care fraud. This includes the implementation of data mining for fraud detection and prevention.

It was during one of these routine mining expeditions of reimbursement data that the United States Attorney’s Office identified MediMix, a compounding pharmacy in Jacksonville, Florida, as the top-biller of compounding pain prescriptions. More importantly, upon further investigation, it was found that Ankit Desai, M.D. was the top referring physician for MediMix.

The significance in the correlation between the two is that, according to reports, Dr. Desai happens to be married to one of the top executives (Senior Vice President) of Medimix.

To read the press release on this story, click here.

Anti-Fraud Laws Prohibit Certain Physician Referrals.

Health care providers are generally prohibited from referring patients to another medical-related business in which they hold a financial interest of some kind, if there are payments made with federal funds.

The prohibition on certain physician referrals is established under Section 1395nn, 42 United States Code (otherwise known as the Stark Law). The Stark Law was specifically enacted to place limitations on physician referrals so as to avoid:

(1) conflicts of interests;

(2) self-referrals;

(3) overutilization of services;

(4) increased health care costs;

(5) a limit on competition by other medical providers;

(6) to prevent ineffective and unsafe treatment; and, ultimately-

(7) fraudulent practices.

Click here for more information on the most common Federal fraud and abuse laws in health care.

The Stakes are High for Non-Compliance.

MediMix reached a settlement agreement with the government which has avoided a determination of liability. However, the Jacksonville-based compounding pharmacy did not get off without a significant penalty. The settlement will cost MediMix an impressive $3,775,458.

Click here to read more about the government cracking down on what they determine to be “a significant threat to the [Department of Defense] DoD healthcare system.”

The FCA has been highly effective in exposing fraudulent practices of pharmaceutical companies. Whistleblower cases brought under the FCA have assisted the government in recovering more than $19 billion in stolen funds due to varying pricing, billing and marketing schemes.

To read more about the importance of complying with Stark and other anti-fraud laws, read one of our previous blogs here.

Avoiding False Claims Violations.

Here are the most common pharmaceutical practices that can result in allegations of FCA violations:

(1) Off-label marketing of drugs;

(2) Illegal kickbacks;

(3) Inflating the price of pharmaceuticals;

(4) Best price fraud; and

(5) Pharmaceutical benefits manager fraud.

If you find yourself in a tricky situation with possible allegations of a FCA violation, it’s best to contact an experienced health attorney immediately to properly evaluate your case and inform you of your rights.

For more about your right to consult with a lawyer prior to speaking with an investigator, please read one of our previous blogs here.

Comments?
Are you currently engaged in a questionable financial relationship? Do you agree with the law on prohibiting certain referrals in which there is a financial interest? Why or why not? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s 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.

Sources:

Department of Justice, The United States Attorney’s Office, Middle District of Florida. Press release. “United States Settles False Claims Act Allegations Against Jacksonville-Based Compounding Pharmacy.” 1 June 2015. Web. 11 Sept. 2015.

Kime, Patricia. “Tricare to Start Screening Compound Medications Friday.” Military Times. A TEGNA Co., 1 May 2015. Web. 10 Sept. 2015.

“Pharmaceutical Fraud” Web blog post. False Claims Act Resource Center. Pietragallo Gordon Alfano Bosick & Raspanti, LLP, 2015. Web. 11 Sept. 2015.

Rumph, Alan, and Donna Lee Yesner. “When Referrals And Marriage Don’T Mix: MD, Pharmacy Settle Case.” Report on Medicare Compliance. Washington: Atlantic Information Services, Inc., 8 June 2015. Web. 11 Sept. 2015.

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.

Keywords: False Claims Act defense attorney, FCA, pharmaceutical fraud, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistleblowers lawyer, FCA violations, fraud detection, data mining, financial interest in physician referrals, Stark Law, Department of Defense, DoD, Tricare fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, qui tam attorney, financial relationship with physician

“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.