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Florida Pharmacy Hit With FCA Suit for Illegal Kickback Scheme Targeting Tricare

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

On October 19, 2018, the federal government filed suit against a Florida pharmacy for allegations of illegal kickback schemes involving industry marketers. The U.S. Attorney’s Office for the Middle District of Florida alleges that Oldsmar Pharmacy was involved in illegal schemes that resulted in the federal Tricare program paying more than $21 million in reimbursements for prescriptions and False Claims Act (FCA) violations.

Suit Filed on Behalf of The Defense Health Agency (DHA).

The federal government filed the suit on behalf of the U.S. Department of Defense, including its Defense Health Agency (DHA). The DHA administers the Tricare program, which provides health insurance for active duty military personnel, military retirees and their dependents.

The government is seeking treble damages, civil penalties and restitution, based on its claims that the pharmacy submitted claims to Tricare for reimbursement for prescriptions of costly compound medications. The government claims that they knew were fraudulent under the FCA because of the kickbacks paid to marketers.

On October 18, 2018, the U.S. Department of Justice (DOJ) released a press release announcing the involvement of three military members in the scheme as sales representatives for Centurion Compounding, Inc. All three were indicted for paying kickbacks to Tricare beneficiaries to obtain prescriptions for compounded medications. You can learn more about this in the section below.21

Click here to read the DOJ’s press release.

Former Whistleblower Suit.

The lawsuit against Oldsmar Pharmacy and company President, Larry Smith, stems from a whistleblower suit filed in 2015 by Jennifer Silva and Jessica Robertson, former employees, according to the complaint.

The schemes allegedly occurred between September 2014 and February 2015 by Smith and Oldsmar and different pharmacy services administration organizations.

Tricare Reimbursements and Kickback Schemes.

According to the complaint, Centurion Compounding Inc., hired sales representatives as independent contractors who marketed costly compound medications to Tricare beneficiaries. Patients recruited by the sales reps were directed to send their prescriptions to Centurion, which then directed them to Oldsmar pharmacy.

From November 2014 to February 2015, Tricare paid about $18 million for approximately 4,000 claims for compound prescriptions as part of the kickback scheme, according to the federal government. Oldsmar paid Centurion more than $6.1 million in kickbacks, some of which was distributed to the individual sales representatives involved.

Additionally, prosecutors claim that pharmacy President, Larry Smith, entered into a second kickback scheme with several marketing companies. These companies published online advertisements offering free consultations for pain creams via telemedicine, without ever seeing a physician in person. In return, Oldsmar Pharmacy paid a 41 percent kickback to the marketers, the complaint alleges.

Click here to read the complaint in full.

The suit brings forward false or fraudulent claims; recovery of payments made by mistake by Tricare; and unjust enrichment. To learn more, click here to read one of my prior blogs on a similar case.

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 also represents both plaintiffs (whistle blowers or relators) and defendants in False Claims Act (whistle blower or qui tam) cases. 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:

Hale. Nathan. “Fla. Pharmacy Hit With False Claims Suit Over Kickbacks.” Law360. (October 19, 2018). Web.

Stringini, Mary. “St. Pete doctor pleads guilty to receiving kickbacks, BMW in $5.3 million pharmacy conspiracy.” ABC Action News. (March 8, 2018). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law 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 Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

KeyWords: Pharmacy legal representation, 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 representation, pharmacy representation, pharmacy defense attorney, pharmacist representation, pharmacist defense lawyer, TRICARE fraud attorney, The Health Law Firm, fraud investigations representation, health care fraud defense lawyer, compounding pharmacy lawyer, prescription reimbursement leagl representation, 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 © 2019 The Health Law Firm. All rights reserved.

The Most Common Cases The Health Law Firm Takes

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

One of the most common questions we get asked by doctors and lawyers alike, is about the types of cases our firm takes. They often mistake the practice of health law as medical malpractice defense. However, this is an incorrect assumption. Likewise, if we had a penny for every time we have heard “Yikes, an attorney! I hope I never need you,” we could close our doors and all retire.

As a general health law practice, we concentrate on both proactive and defensive legal issues and clients involved in the health care industry. To a certain extent our law firm does practically everything a physician, medical group, health facility or health care professional could need in the legal arena.

The types of cases we most commonly see are the following:

1. Sales, mergers and acquisitions of medical practices, health care clinics, and health facilities. We represent buyers, sellers and lenders at any stage of the process.

2. Contracts for medical and health care transactions. We prepare contracts, review contracts, negotiate contracts, help to terminate or break contracts, and we litigate contracts. We can be on either side of these transactions. Our litigation can take place in state court or federal court. We review and analyze quite a few employment contracts for medical residents and fellows going to new positions.

3. We research and prepare complex legal opinion letters on proposed health care transactions. The health care industry is the most regulated industry in the United States. There are complex layers of both federal and state laws and regulations as well as numerous federal and state agencies regulating it. Often, legal opinion letters are sought by purchasers and lenders for healthcare transactions for these reasons. We have several board certified health lawyers in our firm who have written dozens of these.

4. We represent health professionals and health facilities in Medicare audits, including fraud audits by the Zone Program Integrity Contractors (ZPICs) and by Recovery Audit Contractors (RACs). This includes representation in the appellate process, including requests for reconsideration, request for redetermination, and federal administrative law judge hearings. Preparation of the response to the audit request, completion of the audit questionnaire, response to the preliminary audit report (PAR), and defense of any repayments demanded, through administrative hearings before federal administrative law judges and appeals if necessary.

5. We represent health professionals and health facilities in Medicaid audits, including fraud audits by the zone program integrity contractors (ZPICs). This includes preparation of the initial response to the audit request, completion of the audit questionnaire, response to the preliminary audit report (PAR), and defense of any repayments demanded, through administrative hearings and appeals if necessary.

6. If there has been an action by the Centers for Medicare & Medicaid Services (CMS) to terminate the Medicare provider’s billing privileges, we aggressively represent them to have the decision reversed and have them reinstated. This includes filing requests for reconsideration and corrective action plans (CAPs). We have been very successful in obtaining relief for our clients.

7. We have represented a number of clinical investigators, primarily physicians, and defensive charges of research fraud, misconduct in science, manipulation of data, manipulating outcomes, in research investigations, and other similar proceedings brought by their institutions or and investigation review board. Whether it is at the initiation of such an investigation or in later hearings and appeals, we have navigated a number of principal investigators through these processes.

8. Our firm has represented a number of medical students, residents and fellow, including foreign medical graduates, in cases brought by the National Board of Medical Examiners (NBME), the United States Medical Licensing Examination (USMLE), and the Educational Commission for Foreign Medical Graduates (ECFMG) in cases where there is an allegation of “irregular behavior” and rules violations through the hearing process and in appeals as necessary.

9. We represent physicians and other health professionals in hospital medical staff peer review proceedings and hearings. Whether it’s the initial application for clinical privileges and medical staff membership or action being taken to revoke or limit clinical privileges, we have been involved representing physicians and other health professionals at all levels. We have also done similar work for physicians in actions initiated by HMOs, professional associations, certification bodies, and other organizations. This is an area where a physician truly needs a health lawyer experienced in this type of proceeding.
10. “Disruptive physician” defense is another area where a doctor really needs an attorney who knows what he or she is doing. When your hospital or medical staff is attempting to place the label on you “disruptive physician,” you are really in trouble. This is an area in which careful navigation is required to prevent actions that result in such a label. Other wise, the physician can be pigeon-holed for life, placed into disruptive physician programs requiring years, if not a lifetime, of close monitoring and can even have discipline commenced against his or her medical license. We can assist you in taking actions to avoid having this happen.

11. When you receive a Medicare, Department of Health and Human Services (HHS), or Office of the Inspector General (OIG) subpoena or civil investigative demand (CID), you know there is serious trouble for someone in the works. We help you to respond promptly and professionally and attempt to keep you from becoming the target of serious federal investigations.

12. We represent physicians, nurses, dentists, psychologists and other licensed health professionals in responding to Department of Health (DOH) letters of investigation. Many physicians, nurses, dentists and other licensed health professionals do not understand that when they receive a letter from the Department of Health complaints advising them that they are under investigation for a complaint that is been made against them, this is a very serious matter. There is nothing that is “routine” about this. This means that there is an investigation that has been opened against your license that could ultimately result in disciplinary action being taken against you. Any disciplinary action taken against you will be on your license forever. This is the time to obtain an attorney. This is not a time to attempt to represent yourself. You should not ever speak with the investigator or provide a statement to the investigator; this is something only your attorney should do and only if it is determined to be advisable considering the facts of the case. We have represented hundreds of licensed health professionals in such investigations and in subsequent disciplinary hearings.

13. We also represent health professionals and others who have been excluded from the Medicare program and placed on the Office of Inspector General (OIG) List of Excluded Individuals and Entities (LEIE). We have represented a number of healthcare professionals in completing and submitting applications to be removed from the LEIE and reinstated to the Medicare program.

14. We routinely counsel and represent physicians, dentists, psychologists, mental health counselors, and other health professionals in referrals to the Professionals Resource Network (PRN) for evaluation. We have found that often the health professional will not actually have any type of substance abuse problem or mental health issue. However, one referred for an evaluation to the PRN can wind up in a five year contract or even a lifetime contract for monitoring containing many mandatory requirements in order to continue practicing his/her profession and a lot of expenses associated with meeting such requirements.

15. We also routinely counsel and represent nurses and nurse practitioners (ARNPs), including certified registered nurse anesthetists (CRNAs) in similar referrals to the Intervention Project for Nurses (IPN). We have found that often the nurse will not actually have any type of substance abuse problem or mental health issue. However, one referred for an evaluation to the IPN can wind up in a five year contract or even a lifetime monitoring contract containing many mandatory requirements in order to continue practicing his/her profession and a lot of expenses associated with meeting such requirements.

16. We have been involved in a number of qui tam or whistle blower cases, either representing the whistle blower or representing an employer or institution that is being accused of wrongdoing. Whether this is pursuant to the Federal False Claims Act (FCA), a state false claims act or a private whistle blower act, we are experienced in investigating, prosecuting, defending, and litigating such cases in state or federal court.

17. Our firm represents physicians, pharmacists, health professionals and health facilities in administrative litigation against the Drug Enforcement Administration (DEA), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the Agency for Health Care Administration (AHCA) and the Department of Health, among other agencies. Whether the government agency is seeking to recover civil monetary penalties (CMP), attempting to recover large Medicare overpayments, seeking to revoke your DEA registration or seeking to discipline your medical license, we have experience in litigating such matters in these administrative tribunals. This can make the difference between a favorable outcome or a devastating outcome.

18. We represent Veterans Administration (VA) physicians, Army physicians, Navy physicians, Air Force physicians, and Indian Health Service physicians, in employment disputes, peer review investigations and hearings, clinical privileging investigations and hearings, and decisions to report to the National Practitioner Data Bank (NPDB).

19. Reporting a conviction for Driving under the influence (DUI) or some other criminal offense is required by most state licensing agencies. We are experienced in making such reports when required and in such a manner that a subsequent investigation and discipline on the professional license is often avoided.

20. Complex litigation involving health professionals is another area in which we routinely practice. Whether the matter involves a dispute between the shareholders of a medical clinic or practice, restraints on trade, allegations of false claims and fraud, the enforcement or avoidance of restrictive covenants (or covenants-not-to-compete), employment, pay and bonus disputes, ownership of practices or facilities, or any other of a number of different situations, we represent either side in state court or federal court.

21. Because of our experience in mental health law, we have come to represent individuals who have been incorrectly confined in mental health facilities in Florida because of allegations of impairment, drug abuse, mental health issues and other issues in which the person is initially though to be a threat to himself or to others. Both law enforcement authorities and medical personnel are being trained to take fewer chances with an individual acting unusual who may tend to hurt herself or someone else. They often tend to err to the side of ordering confinement under the Florida Mental Health Act (also known as the “Baker Act”). When this happens, the individual may be set for a long stay unless he or she has assistance in navigating the way out. We help doing this as quickly and expeditiously as possible.
22. We routinely representing physicians, pharmacists, nurses, dentists and other licensed health professionals in attempting to avoid or in disputing or in appealing adverse National Practitioner Data Bank (NPDB) Reports. There are only limited grounds for doing this so the professional needs to obtain counsel as early in the process as possible.

23. Any type of subpoena or search warrant from a government agency or law enforcement organization seeking your patient records can herald an investigation into false claims, over-prescribing, or other serious possible charges, criminal, civil or administrative. Our representation seeks to determine the reasons for this as early in the process as feasible and to protect your rights and limit your exposure as much as possible.

24. There are many, many other types of cases which we have experience with. To see some of these others, please visit our website.

As the business of health care grows, our law firm also grows. We are always seeking to expand our areas of practice within the health law field. Be sure to check back regularly for updates.

For more information on various health law topics and how The Health Law Firm can help you, visit our YouTube page to watch our video blogs.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in Centers for Medicare and Medicaid Services (CMS) investigations, Medicare Audit defense, 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.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law 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 Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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“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 © 2019 The Health Law Firm. All rights reserved.

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FDA Releases Draft Guidance to Revamp Drug Indication and Usage Labels

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

On July 6, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance outlining its recommendations for how drug companies should word the indications and usage sections on a drug’s label. The new guidance aims to increase readability and reduce redundant information on indications and usage.

Drug Indication Label.

Prescribers can expect to see revamped drug labels with clearer descriptions of the conditions and patient populations for which an FDA-approved drug is indicated. Also, described in the guidance are circumstances when it might be appropriate for an indication to be either broader or narrower than the parameters of the clinical studies that backed its approval.

In addition to suggesting what information labels should include, the draft guidance also indicates what should be omitted to avoid unnecessary clutter the label.

The FDA hopes this guidance will give health care providers more precise information on which conditions a drug is approved to treat and, therefore, help identify the correct treatment options for patients. To read the FDA’s draft guidance in full, click here.

Contact Health Law Attorneys Experienced in the Representation 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.

Sources:

Gever, John. “Drug Labels to Get FDA Revamp.” MedPage Today. (July 6, 2018). Web.

Field, Emily. “FDA Releases Draft Guidance On Drug Indication Labeling.” Law360. (July 6, 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: Food and Drug Administration (FDA) defense attorney, representation for FDA matters, legal representation for health care professionals, representation for prescribers, pharmacy representation, legal representation for pharmacies, pharmacy defense lawyer, pharmacist representation, legal representation for pharmacists, pharmacist defense attorney, health care compliance lawyer, health law defense attorney, The Health Law Firm reviews, reviews of The Health Law Firm attorneys

“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 © 2018 The Health Law Firm. All rights reserved.