Florida Pharmacy Owner to Serve 15 Years in Prison for $100 Million Billing Fraud Scheme

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

On April 26, 2018, the owner of several Florida pharmacies was sentenced to 15 years in prison and ordered to give up $54.5 million in restitution. Nicholas A. Borgesano Jr., owner of A to Z Pharmacies, pled guilty to his role in a $100 million scheme involving bogus insurance reimbursements for prescription drugs.

He pled guilty in November to charges of conspiracy to commit health care fraud and conspiracy to engage in monetary transactions in property derived from specified unlawful activity, according to the order. Click here to read more.

Health Care Billing Fraud Schemes. 

According to prosecutors, Borgesano was at the center of an alleged scheme in which the pharmacy owner used his six stores to peddle prescription compound medications. He would then submit fraudulent reimbursement claims to Medicare, Tricare and private insurance companies.

Borgesano and his co-conspirators are accused of manipulating billing codes in the reimbursement claims and submit claims for pharmaceutical ingredients they didn’t even have. Additionally, he used one of his pharmacies in Florida as the hub of operations and paid his co-conspirators through shell companies, checks and the purchase of assets, prosecutors said.

From the pharmacy owner and his group of conspirators, the U.S. Department of Justice (DOJ) has seized $7.6 million worth of property, including several luxury vehicles and a 50-foot racing boat, the DOJ said. To read more about the co-conspirators, click here to read the press release issued by the DOJ.

To read the judgement in full click here.

The expensive prescription medications and creams involved in this case have been targeted by prosecutors in a handful of other Florida suits alleging Medicare and Tricare fraud by pharmacy owners and others. Click here to read one of my prior blogs involving a similar case.


Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEADOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigationadministrative 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:

Greene, Kat. “Pharmacy Owner Gets 15 Years For Role In $100M Scheme.” Law360. (April 27, 2018). Web.

Manning, Margie. “New Port Richey pharmacy owner sentenced in $100 million fraud scheme.” Tampa Bay Business Journal. (April 26, 2018). 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 attorneyFCA legal counselFCA defense lawyer, Anti-Kickback Statute (AKSdefense attorneyFCA representation, legal representation for allegations of violating Anti-Kickback StatuteAKS representation, 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, FCA violations attorneyhealth care fraud representation, TRICARE fraud attorneyhealth law defense attorneyhealth care fraud defense attorney, The Health Law Firm, representation for health care fraud investigations, compounding pharmacy lawyer, prescription reimbursement representation, pharmacy defense attorneypharmacist defense lawter, representation for pharmacies, representation for pharmacistslegal representation for health care facilities, representation for health care professionals, legal defense of TRICARE providers, U.S. Department of Justice (DOJ) investigation representation, DOJ defense attorney, representation for DOJ matters, attorney reviews of The Health Law Firm, 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 © 2018 The Health Law Firm. All rights reserved.

37 Central Floridians Charged with Illicit Pharmaceutical Drug Trafficking

By Dr. Thu Pham, O.D., Law Clerk, The Health Law Firm

Attorney General Pam Bondi along with special agent Mark R. Trouville of the Drug Enforcement Administration (DEA) and Longwood Police Chief Troy Hickson announced, on June 20, 2012, the execution of 37 arrest warrants stemming from state drug charges.  The defendants all reside in Central Florida.

Click here to read the entire press release from the Florida Attorney General.

The Defendants’ Charged with Felonies.

The charges for the defendants ranged from first degree to third degree felonies.  The defendants have been charged with acts, such as conspiracy to traffic Oxycodone, solicitation to deliver Oxycodone, and possession of Hydromorphone with intent to sell or deliver. 

Law enforcement authorities have been able to apprehend 33 of the 37 charged.

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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.

Sources:

myfloridalegal.com. “DEA: 37 Charged in Longwood Local Impact Drug Trafficking Conspiracy.” AG. (June 20, 2012).  From Press Release: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/9E8D06F29BCB233B85257A230072572A.

Justice.gov. “Law Enforcement Dethrones “Queen” of Longwood, Florida.” DEA, Domestic Field Division. (June 20, 2012).  From Press Release: http://www.justice.gov/dea/pubs/states/newsrel/2012/mia062012.html

About the Author: Dr. Thu Pham, O.D., is a law clerk 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.

“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 for Pharmacists

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.

We Will Work with Your Insurance Company.

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.

Finding a Healthcare Providers Service Organization (HPSO) Insurance Defense Lawyer

Patricia's Photos 013By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

We are sometimes told by the health professionals we represent especially pharmacists, licensed mental health counselors (LMHCs), advanced registered nurse practitioners (ARNPs), massage therapists and physical therapists that after they received a complaint regarding their license from the Florida Department of Health (DOH) they had difficulty finding an experienced attorney in Florida who would accept their professional liability insurance.  In this case, I am speaking specifically about Healthcare Providers Service Organization (HPSO) Insurance.

Benefits of HPSO Insurance.

The professionals who are covered by HPSO Insurance have excellent insurance coverage.  HPSO Insurance provides professional liability coverage that protects in the event of a lawsuit or negligence claim.  But much more often the professional receives a notice of an investigation, a subpoena for a deposition in someone else’s case, a demand because of an allegation of sexual harassment or sexual impropriety, a complaint because of a breach of medical records confidentiality or Health Insurance Portability and Accountability Act (HIPAA) Privacy complaint, or some other administrative type of action.

HPSO provides great coverage for these.  For example, HPSO currently reimburses up to $10,000 in legal fees and expenses just for representation of you at depositions.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your defense in a DOH or Agency for Health Care Administration (AHCA) notice of investigation or complaint.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your legal representation in defense of a complaint or investigation regarding breach of medical confidentiality.

If you are a pharmacist, own a pharmacy, are a massage therapist, own an assisted living facility (ALF), are a mental health counselor or a social worker, or you are one of the many other types of health care professionals who HPSO insures, it should be fairly easy to find experienced health lawyers to represent you, especially in Florida.

Our firm and our attorneys, including George F. Indest III, Michael L. Smith, Joanne Kenna, Carole C. Schriefer, Lance O. Leider, Christopher E. Brown and Danielle M. Murray, routinely represent licensed health care professionals, interns and students in all types of administrative investigations and hearings and in defending lawsuits and other actions that have been filed.  We also represent health facilities in license defense, survey complaints and administrative hearings.  We represent them throughout Florida, from Pensacola, to Jacksonville, to Key West.  We also occasionally represent them in other states, as well.  We accept HPSO Insurance assignments.

Free Legal Advice: Get Insurance Immediately.

It is very important for every health professional to carry insurance that covers any investigation, complaint or administrative hearing that might be filed or opened against your license.  You may think that you are covered for this by your employer, but you are not.  If your employer contradicts this, ask for a statement in writing that your employer will pay for your legal defense for any such matter arising during your employment.

What typically happens, especially in the case of a hospital employee, nursing home employee, pharmacy employee or corporate employee, is that the employer is the one who terminates the employee and then files a complaint with the DOH.  The DOH then opens an investigation against the health professional.  The employer is not going to pay your legal defense costs if the employer has reported you.

You may very well be out of work, out of money and face an investigation and complaint that could terminate your professional license and career.  You should not take this chance.  Insurance such as HPSO Insurance is inexpensive and reliable.  Buy it while you can afford it. After the actions have occurred, it is too late.

Find an Experience Health Law Attorney in the Event of an Investigation.

Also, you should immediately contact an experienced health law attorney if you are telephoned or visited by any investigator, or if you receive a letter advising you that an investigation has been opened regarding your care.  Call immediately for advice before you speak with an investigator or provide any documents or statements of any kind.

You cannot and should not seek “legal advice” on what to do from the investigator, from a DOH employee, from your professional board or from any attorney representing any of them.  They are not your friends.  They are on the side against you. You should definitely not take any advice from them.

Do Not Skimp on Insurance Coverage.

If you have good insurance, it will pay for your legal expenses from the very beginning, so use it.  However, beware of cheap insurance policies from professional associations that do not provide any coverage for disciplinary complaints and licensure investigations.  Always check to be sure this is covered.  Get it in writing.  With some companies you have to pay an extra premium to obtain this coverage.  With some insurers, they do not offer it, and you have to purchase a completely separate policy covering just this.  It is worth it!  Do it!

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

Our firm regularly represents pharmacists, massage therapists, mental health counselors, registered nurses, assisted living facilities, home health agencies, nurse practitioners, lab technicians, occupational therapists, physical therapists, social workers, physician assistants, psychologists and other health professionals in many different legal matters.

Services we provide include representation before your professional board, in DOH investigations, in administrative hearings, in civil litigation, in defense of malpractice claims, in professional licensing matters, in defense of allegations concerning HIPAA privacy violations and medical record breaches, in Drug Enforcement Administration (DEA) actions, and in many other matters.

We routinely represent physicians, dentists, nurse practitioners, and others in defending against malpractice claims, civil lawsuits, administrative complaints, peer review actions, DOH investigations, Medicare audits, Medicaid audits, and other matters. 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.  If allowed, 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.

We also defend health professionals and health facilities in general litigation matters and business litigation 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?

Do you have professional liability insurance? Why or why not. Please leave any thoughtful comments below.

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.

Two Pharmacists and One Dentist in Central Florida Arrested for Prescribing and Dispensing Prescription Drugs

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

The Lakeland Ledger reports that Polk County Sheriff’s Detectives arrested a dentist and two pharmacists on September 5, 2012, in three unrelated cases dealing with illegally prescribing and dispensing painkillers. The sheriff’s office said the three arrests are part of its efforts to target prescription drug abuse.

To read the entire Lakeland Ledger article, click here.

The Arrest of the Dentist’s Daughter Led to His Investigation and Arrest.

In May 2012, the dentist’s daughter was arrested for allegedly forging more than 500 hydrocodone prescriptions. That arrest led deputies and the Department of Health (DOH) to search the dentist’s clinic. According to the Lakeland Ledger article, out of 43 patient files randomly selected, 31 patients were being prescribed hydrocodone without any documentation.

The Polk County Sheriff’s Office stated that the dentist has been charged with knowingly overprescribing controlled narcotics.

To see the press release from the sheriff’s office on the dentist’s arrest, click here.

Both Pharmacists Caught by Undercover Detectives.

According to the Lakeland Ledger, the two pharmacists that were arrested allegedly illegally dispensed either oxycodone or hydrocodone to undercover detectives. The pharmacists have been charged with trafficking prescription painkillers.

Click here to see the press release on the pharmacists’ arrests from the Polk County Sheriff’s Office.

Arrests Part of Crack Down on Abuse of Prescription Drugs.

According to the Polk County Sheriff’s Office, these arrests are part of an ongoing investigation to target doctors and pharmacists that are improperly prescribing and dispensing prescription medications.

There is an article on our website on legal tips for physicians to manage pain patients. To read that piece, click here.

Criminal Arrest of Over-Prescribers May come From Many Different Agencies.

Physicians and pharmacists who are involved in schemes relating to overprescibing or trafficking in narcotics may be targeted by many different agencies. The local sheriff’s office or police department is just one of them.

We have represented physicians who have been the subjects of Drug Enforcement Administration (DEA) investigations. The DEA will often use undercover agents and informants to pose as patients, wired for audio recording. The DEA will often work with local law enforcement authorities and the Department of Health (DOH).

Other investigations and arrests may be initiated by a statewide prosecutor’s office, which is under the Attorney General. Still others have been initiated by the Medicaid Fraud Control Unit (MFCU) where Medicaid funds are used.

Contact Health Law Attorneys Experienced in Representing Health Care Providers in DOH Cases.

The Health Law Firm 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.

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.

Sources:

Malagon, Elvia. “Lakeland Dentist and Two Pharmacists Charged with Prescription Drug Violation.” The Lakeland Ledger. (September 5, 2012). From: http://www.theledger.com/article/20120905/NEWS/120909682?template=printart

Eleazer, Carrie. “PCSO Detectives Arrest Two Pharmacists from Trafficking in Prescription Drugs.” Polk County Sheriff’s Office. (September 5, 2012).  From: http://www.polksheriff.org/NewsRoom/Pages/09-05-2012PCSO%20DetectivesArrestTwoPharmacistsForTraffickinginPrescriptionDrugs.aspx

Eleazer, Carrie. “Dr. William Johnson of Sonrise Dental Clinic Arrested.” Polk County Sheriff’s Office. (September 5, 2012). From: http://www.polksheriff.org/NewsRoom/News%20Releases/Pages/09-05-2012.aspx

About the Authors: Danielle M. Murray 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.

“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.

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.

Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his wife to fungal meningitis filed the first lawsuit against a Nashville outpatient clinic. It’s believed hundreds of people were injected at the same clinic with the tainted steroids. The man is now seeking $12.5 million in damages.

Click here to read the entire article from The Tennessean.

This lawsuit is just one in what is expected to be a series of lawsuits, in not just Tennessee, but across the country.

Compounding Pharmacy Allegedly Behind the Meningitis Outbreak is Out of Business.

The meningitis outbreak was at a peak in the fall of 2012. Contaminated steroid injections were allegedly made at the New England Compounding Center (NECC) in Framingham, Massachusetts. NECC is accused of shipping thousands of vials of tainted drugs across the country. There are allegedly 45 deaths nationwide from the steroids. The company shut down in October 2012, and filed for bankruptcy in December, according to an article in American Medical News.

Tennessee Complaint Alleges Outpatient Clinic Put Money Before Patients.

The man suing the Nashville outpatient clinic believes, among other things, that officials at the clinic put the company’s bottom line before patient care. The lawsuit specifically alleges:

1. The outpatient clinic ignored important information when it chose NECC to purchase thousands of vials of steroids,
2. That clinic officials failed to properly notify the victim that she had been injected with a potentially contaminated steroid,
3. That clinic officials failed to recommend the victim should receive treatment,
4. The clinic chose to purchase drugs from NECC because it was a cheaper than the safer alternatives.

Click here to read the entire complaint.

The Responsibility of Doctors and Clinics.

Negligence is the most common claim used against doctors in cases of defective medication. The assumption is that the physician breached the standard of care because he or she knew or should have known that NECC was not meeting applicable standards in compounding the medications. Another legal theory is that the physician should have known that certain medications should not have been compounded, but rather obtained directly from a manufacturer. I believe the liability of physicians and clinics might be established to the extent that the physicians were aware that the steroids distributed by NECC violated regulations on compounding prescription medications.

It’s imperative physicians and clinics are sure of the credentials of all vendors and suppliers.

I was recently quoted in an American Medical News article about physicians and clinics that are entangled in tainted drugs lawsuits. To read the entire article, click here.

Florida Compounding Pharmacy No Stranger to Fungal Outbreaks.

Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

Pharmacists Need to Obtain Good Professional Liability Insurance.

Many pharmacists, especially those who work for state agencies, large hospitals, pharmacy chains or other large institutions, scrimp on their purchase of professional liability insurance. Many mistakenly believe their employer will cover any legal defense expenses. This is not true and is often found out too late.

A pharmacist should always carry his/her own professional negligence insurance. It is inexpensive and can cover many types of legal actions other than just civil negligence cases. Always, always, always be sure your insurance includes at least $25,000 in professional license defense coverage. Get this in writing!

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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.

Comments?

What do you think about the lawsuits against these doctors and clinics? Who do you think should be help responsible: the compounding pharmacy that shipped the contaminated steroids, or the doctors and clinics that administered the steroid shots? Please leave any thoughtful comments below.

Sources:

Roche Jr., Walter. “Meningitis Outbreak: Victim’s Husband Sues Saint Thomas Clinic.” The Tennessean. (January 31, 2013). From: http://www.tennessean.com/apps/pbcs.dll/article?AID=2013301300211&nclick_check=1

Wayne A. Reed v. Saint Thomas Outpatient Neurosurgical Center. Case Number 13C-417. Complaint. (January 29, 2013). From: http://www.thehealthlawfirm.com/uploads/Reed%20v.%20St.%20Thomas%20Outpatient.pdf

Gallegos, Alicia. “Physicians Entangled in Tainted Drugs Lawsuits.” American Medical News. (February 11, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_PhysicianLawsuits.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

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.

Two Central Florida CVS Pharmacies Get Controlled Substance Licenses Pulled by Drug Enforcement Administration (DEA)

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

The U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida, on September 12, 2012, according to a number of sources. The two pharmacies will no longer be able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision is in response to a government crackdown on the distribution of painkillers. Sanford is in Seminole County, a suburb of the greater Orlando area.

To see the court records from this case, click here.

We’ve been following this story and previously blogged on this topic in our blogs on February 10, 2012, February 29, 2012, and March 7, 2012.

DEA Believed the Two Pharmacies Filled an Inappropriate Number of Prescriptions for Oxycodone.

According to an article from Reuters, the DEA believed the stores, located on Orlando Drive and West First Street, in Sanford, were allegedly filling an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances.

In the same article, CVS argued that the large number of oxycodone and other prescription painkillers from the two stores is due to that fact that the two locations are busy stores, with one store open 24 hours a day. The DEA apparently did not accept this justification.

Click here to read the entire article from Reuters.

Same Two CVS Pharmacies were Raided in February 2012.

Back in February of 2012, the DEA raided the same two Sanford CVS pharmacies. The DEA called the pharmacies an “imminent danger” to the public and filed immediate suspension orders against both stores. I previously wrote a blog about the emergency suspension order and the subsequent request from CVS for a restraining order against the DEA. Click here to read the blog.

DEA Fights Prescription Drug Epidemic.

In a press release, a special agent in charge of the DEA’s Miami Division said the final order reflects “the continued commitment of the DEA to identify and bring to light the diversion of controlled substance pharmaceutical drugs.”

To see the entire press release from the DEA, click here.

According to the Orlando Sentinel, the major newspaper in Orange County and Seminole County, this measure is thought to be the first of its kind against a national retail pharmacy chain.

In my personal opinion, if the large retail giants can’t survive such an attack, the small independent pharmacies stand little chance.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, 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:

Reuters. “U.S. Revoking 2 CVS Stores’ Controlled Substance Licenses” Thomson Reuter. (September 12, 2012). From: http://www.reuters.com/article/2012/09/12/us-usa-drugstores-cvs-idUSBRE88B0KN20120912

Pavuk, Amy. “Two Sanford CVS Pharmacies Banned from Selling Oxycodone, Other Controlled Substances.” Orlando Sentinel. (September 12, 2012). From: http://articles.orlandosentinel.com/2012-09-12/news/os-sanford-cvs-caremark-revoke-drugs-20120912_1_revokes-prescription-drug-abuse-oxycodone-and-other-prescription

Holiday CVS, L.L.C., v. Eric H. Holder, JR., et al., No. 12-5072 United States Court of Appeals for the District of Columbia Circuit. (September 11, 2012), available at http://www.thehealthlawfirm.com/uploads/CVS%20License%20Revoked.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.

“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.

Supreme Court to Determine if Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers are Legal

7 Indest-2008-4By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Supreme Court is currently looking into whether brand name drug manufacturers may pay generic drug manufacturers to keep the generic drugs off the market. These payments, often called pay-for-delay, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court’s decision may be worth billions to pharmaceutical companies and consumers.

In January 2013, the American Medical Association (AMA) teamed up with the American Association of Retired Persons (AARP) and other organizations seeking to eliminate pay-for-delay agreements. The groups filed a friend-of-the-court brief in the Supreme Court case.

Click here to read the friend-of-the-court brief.

History of Pay-For-Delay Agreements.

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

The Impact of Pay-For-Delay Agreements.

It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs.

According to an article on National Public Radio (NPR), the number of pay-for-delay agreements is increasing. Click here to read the entire NPR article.

Legalized Extortion Causes Patients to Pay High Drug Prices.

This type of legalized extortion does nothing more than drive up drug prices for all patients by keeping generic drugs off the market. On the other hand, it vastly increases the profits made by big name pharmacy companies who are able to derive even more money from expired patents.

AMA Fights to Get Rid of Pay-for-Delay Agreements.

According to a press release, AMA, AARP, the National Legislative Association for Prescription Drug Prices and the U.S. Public Interest Research Groups all signed onto the friend-of-the-court brief filed in the Supreme Court.

The AMA is concerned that pay-for-delay agreements extend patent monopolies, increase health care costs and restrict doctors’ ability to treat patients. To read the entire press release from the AMA, click here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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.

Comments?

As a health care professional, how do you feel about pay-for-delay agreements? Please leave any thoughtful comments below.

Sources:

Mills, Robert. “AMA Joins Other Groups Seeking to Overturn Pay-for-Delay Drug Agreement.” American Medical Association. (January 30, 2013). From: http://www.ama-assn.org/ama/pub/news/news/2013-01-30-amicus-brief-ftc-vs-watson-pharmaceuticals.page

Federal Trade Commission v. Watson Pharmaceuticals, Inc. Case Number 12-416. Brief for AARP, American Medical Association, National Legislative Association for Prescription Drug Prices and U.S. Public Interest Research Groups as Amici Curiae in Support of Petitioner. January 29, 2013. From: http://www.thehealthlawfirm.com/uploads/2013-01-29-amicus-brief-ftc-vs-watson-pharmaceuticals.pdf

Purvis, Leigh. “Pay-for-Delay Agreements and Prescription Drug Costs.” AARP. (May 13, 2013.) From: http://blog.aarp.org/2013/05/13/pay-for-delay-agreements-and-prescription-drug-costs/

Totenberg, Nina. “Supreme Court Hears ‘Pay to Delay’ Pharmaceutical Case.” National Public Radio. (March 25, 2013). From: http://www.npr.org/2013/03/25/175043758/supreme-court-hears-pay-to-delay-pharmaceutical-case

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’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company

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

The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement is in response to allegations of misrepresenting the regulatory status of an ointment used to treat skin conditions and submitting false Medicaid claims. Florida’s Medicaid program will receive almost $900,000 of the settlement.

Click here to see the press release from the AG’s office.

Pharmaceutical Company Allegedly Submitted False Claims to Medicaid.

According to the Department of Justice (DOJ), Healthpoint launched the ointment for the treatment of nursing home patients with bed sores. The settlement resolves allegations that Healthpoint marketed the ointment, Xenaderm, without the approval of the Food and Drug Administration (FDA) by modeling it on a pre-1962 drug that the FDA never reviewed. The DOJ states that the main ingredient in Xenaderm was determined by the FDA to be less-than-effective for its intended use. The government contends those determinations render the ointment ineligible for Medicaid reimbursements. Healthpoint is accused of knowingly submitting false claims to Medicaid programs.

To read the press release on the settlement from the DOJ, click here.

The settlement is th result of litigation by the United States Attorney’s Office for the District of Massachusetts, the DOJ and fifteen (15) states, including Florida.

Responding to a Medicaid Audit.

Should you find yourself, your facility or your health practice the subject of a Medicaid audit by your state Medicaid agency or audit contractor, there are a few things you should know.

The most important thing is that just because you are being audited, it does not mean that you or your business has done anything wrong. State and federal governments conduct audits for many different reasons. Typical ones include: special audits of high-fraud geographic areas, auditing of particular billing codes, randomly selected provider auditing, and complaints of possible fraud.

Click here to see a complete list of steps you should take in order to compile and provide a set of records that will best serve to help you avoid any liability at the conclusion of the audit process.


Contact Health Law Attorneys Experienced in Handling Medicaid Audits, Investigations and other Legal Proceedings.


Medicaid fraud is a serious crime and is vigorously investigated by the state MFCU, the Agency for Healthcare Administration (AHCA), the Zone Program Integrity Contractors (ZPICs), the FBI, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health attorney familiar with medical billing and audits today. Often Medicaid fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.

The Health Law Firm’s attorneys routinely represent physicians, dentists, orthodontists, medical groups, clinics, pharmacies, assisted living facilities (AFLs), home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions. We also represent health professionals and others who know of Medicare and Medicaid fraud to file whistleblower and qui tam cases.

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 this settlement agreement? Please leave any thoughtful comments below.

Sources:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Settlement with Pharmaceutical Company.” Florida Office of the Attorney General. (February 25, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/D69C285712F6FF9185257B1D004D275D

Department of Justice. “Healthpoint Ltd. to Pay up to $48 Million for False Medicaid and Medicare Claims for Unapproved Prescription Drug.” Department of Justice. (December 6, 2013). From: http://www.justice.gov/opa/pr/2012/December/12-civ-1459.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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