New York Compounding Pharmacy Settles Fraudulent Billing and Kickback Allegations in Whistleblower Lawsuit

Upstate New York pharmaceutical companies FPR Specialty Pharmacy (now defunct) and Mead Square Pharmacy, along with their owners, agreed to pay $426,000 to settle fraudulent claims and kickback allegations brought forth by a whistleblower. According to the U.S. government, the pharmacies submitted fraudulent claims for reimbursement to federal healthcare programs for compounded prescription drugs in violation of the False Claims Act and the Anti-Kickback Statute. The pharmacies allegedly sold prescription drugs to federal healthcare program beneficiaries in states without a license, improperly induced patients to purchase expensive custom compounded medications by waiving all or part of the substantial co-payments required under the federal healthcare programs, and paid sales representatives per-prescription commissions to illegally induce writing more prescriptions.

“The rules governing federal healthcare programs require pharmacies dispensing prescriptions to their members to be licensed with the appropriate state authorities to request reimbursement for the cost of the medications.  The pharmacies violated the False Claims Act by dispensing and requesting reimbursement for hundreds of prescriptions of “Focused Pain Relief” cream dispensed to federal healthcare program beneficiaries located in states where the pharmacies were not licensed to operate by the appropriate state authorities, and by failing to disclose that they were not licensed.  The Pharmacies also violated the False Claims Act by billing federal healthcare programs for prescriptions dispensed in states where they had obtained their state licenses under false pretenses, including by failing to inform state authorities that they had previously dispensed drugs in the states without a license and by failing to disclose” one of the pharmacy owners’ “criminal history on pharmacy license applications.”

Additionally, the pharmacies violated the Anti-Kickback Statute by engaging in two separate illegal practices, according to the government.  First, the pharmacies regularly charged federal healthcare program beneficiaries co-payments substantially below program requirements (which often exceeded $100) to induce them to purchase its pain cream, “Focused Pain Relief,” for which the federal healthcare programs paid hundreds and sometimes thousands of dollars each.  Second, the Pharmacies often paid illegal kickbacks to their sales representatives by giving sales commissions for the number of prescriptions written by the physicians the sales reps marketed.

Manhattan U.S. Attorney Geoffrey S. Berman said:  “Pharmacies, like other participants in the healthcare industry, must follow the rules.  The defendants here brazenly flouted basic rules on licensing and kickbacks to line their pockets with dollars from federal healthcare programs.  That is a prescription for intervention by my office and our partners.”

Similar to this case, there have been many instances in which whistleblowers exposed company fraud against the Medicare system.


© 2020 by Tycko & Zavareei LLP

For more on pharmaceutical fraud, see the National Law Review Biotech, Food & Drug law section.

New York Compounding Pharmacy Settles Fraudulent Billing and Kickback Allegations in Whistleblower Lawsuit

Upstate New York pharmaceutical companies FPR Specialty Pharmacy (now defunct) and Mead Square Pharmacy, along with their owners, agreed to pay $426,000 to settle fraudulent claims and kickback allegations brought forth by a whistleblower. According to the U.S. government, the pharmacies submitted fraudulent claims for reimbursement to federal healthcare programs for compounded prescription drugs in violation of the False Claims Act and the Anti-Kickback Statute. The pharmacies allegedly sold prescription drugs to federal healthcare program beneficiaries in states without a license, improperly induced patients to purchase expensive custom compounded medications by waiving all or part of the substantial co-payments required under the federal healthcare programs, and paid sales representatives per-prescription commissions to illegally induce writing more prescriptions.

“The rules governing federal healthcare programs require pharmacies dispensing prescriptions to their members to be licensed with the appropriate state authorities to request reimbursement for the cost of the medications.  The pharmacies violated the False Claims Act by dispensing and requesting reimbursement for hundreds of prescriptions of “Focused Pain Relief” cream dispensed to federal healthcare program beneficiaries located in states where the pharmacies were not licensed to operate by the appropriate state authorities, and by failing to disclose that they were not licensed.  The Pharmacies also violated the False Claims Act by billing federal healthcare programs for prescriptions dispensed in states where they had obtained their state licenses under false pretenses, including by failing to inform state authorities that they had previously dispensed drugs in the states without a license and by failing to disclose” one of the pharmacy owners’ “criminal history on pharmacy license applications.”

Additionally, the pharmacies violated the Anti-Kickback Statute by engaging in two separate illegal practices, according to the government.  First, the pharmacies regularly charged federal healthcare program beneficiaries co-payments substantially below program requirements (which often exceeded $100) to induce them to purchase its pain cream, “Focused Pain Relief,” for which the federal healthcare programs paid hundreds and sometimes thousands of dollars each.  Second, the Pharmacies often paid illegal kickbacks to their sales representatives by giving sales commissions for the number of prescriptions written by the physicians the sales reps marketed.

Manhattan U.S. Attorney Geoffrey S. Berman said:  “Pharmacies, like other participants in the healthcare industry, must follow the rules.  The defendants here brazenly flouted basic rules on licensing and kickbacks to line their pockets with dollars from federal healthcare programs.  That is a prescription for intervention by my office and our partners.”

Similar to this case, there have been many instances in which whistleblowers exposed company fraud against the Medicare system.


© 2020 by Tycko & Zavareei LLP

U.S. District Court Issues Temporary Restraining Order for Silver Products Fraudulently Promoted as a Treatment for COVID-19

On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment.  The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19.

DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My Doctor Suggests LLC and GP Silver LLC.  The complaint alleges that defendants began fraudulently promoting and selling various silver products in early 2020 with claims that the silver products would treat and prevent COVID-19.  Some of the alleged false and misleading claims made by defendants include that having silver particles in the bloodstream would block the virus from attaching to cells, that silver would “usher” the virus out of the body, and that silver would destroy all forms of viruses and protect against COVID-19.

The U.S. Food and Drug Administration (FDA) issued a statement on the Utah case that “FDA will continue to help ensure those who place profits above the public health during the COVID-19 pandemic are stopped” and that FDA is “fully committed to working with the Department of Justice to take appropriate action against those jeopardizing the health of Americans by offering and distributing products with unproven claims to prevent or treat COVID-19.”

The enforcement action will be prosecuted in a coordinated action by the U.S. Attorney’s Office for the District of Utah and the DOJ Civil Division Consumer Protection Branch, with the assistance of the FDA’s Office of Criminal Investigations and Office of the Chief Counsel.  In addition to the TRO, prosecutors obtained a separate court order temporarily freezing the defendants’ assets in order to preserve the court’s ability to grant effective final relief and to maintain the status quo.  A hearing on the DOJ’s request for a preliminary injunction is set for May 12, 2020.  If the case proceeds to trial, the government will need to prove its allegations to obtain a permanent injunction against the defendants.

In another case, DOJ announced on April 17, 2020, that the United States District Court for the Southern District of Florida issued a TRO to halt the sale of an unapproved and potentially dangerous industrial bleach product being marketed as a “miracle” treatment for COVID-19.  The FDA and the U.S. Federal Trade Commission (FTC) had issued a warning letter to the defendant, Genesis II Church of Health and Healing, on April 8, 2020.  According to the FDA, oral ingestion of the defendant’s product called the Miracle Mineral Solution can cause nausea, vomiting, diarrhea, and severe dehydration.  The FDA and the FTC have issued nearly 40 separate warning letters in 2020 to companies selling unapproved or misbranded products with claims to prevent or to treat COVID-19.

Commentary

Particulate elemental silver and silver salts can be effective antimicrobial agents, and numerous products containing these active ingredients are currently registered for various antimicrobial uses.  The U.S. Environmental Protection Agency, along with other federal agencies, are working to ensure that necessary reviews and approvals of legitimate products intended to address COVID 19 are as expeditious as possible.  Products that need these regulatory reviews and approval, but that are marketed without them, are and will likely continue to be a current enforcement focus.


©2020 Bergeson & Campbell, P.C.

For more in COVID-19 fraud prevention, see the National Law Review Coronavirus News section.

Physicians Face Regulatory Exposure for Prescribing COVID-19 Drugs Cited by President Trump

Physicians and medical professionals throughout the world are facing and attempting to treat one of the most serious and deadly viruses that has affected the world in our lifetime. Medical professionals are on the front lines and in a position, despite their best efforts to protect themselves, to contract the disease. Medical professionals do not only fear for their own lives but also for the lives of their family members if they unintentionally bring this disease home.

In light of safety concerns for their family members, over the past few weeks, there have been reports claiming physicians throughout Ohio have prescribed chloroquine and hydroxychloroquine, frequently cited by President Donald Trump, to family members and friends. In some reported instances, prescriptions were issued even when such individuals did not exhibit signs or symptoms of the coronavirus.

In order to preserve the stockpile of medications for patients, on March 22, 2020, the Ohio Board of Pharmacy issued an emergency rule (OAC 4729-5-30.2) that prohibits a pharmacist from filling prescriptions for chloroquine or hydroxychloroquine without a valid COVID-19 diagnosis and positive test result.

On March 30, 2020, the Ohio Attorney General’s Office issued the following statement, which highlighted the Pharmacy Board’s new emergency rule and advised physicians to self-report to the State Medical Board of Ohio if they prescribed these medications improperly:

It has come to my attention that physicians may be abusing their privilege to prescribe medications by writing prescriptions for chloroquine and hydroxychloroquine for themselves, their friends and their families without any legitimate medical need for the medication. As Attorney General, I am very concerned with these reports and will work vigorously with Ohio’s regulatory boards and agencies to address any illegal or prohibited conduct. I encourage anyone who has written a prescription of this type improperly to self-report to their respective regulatory authority.”

The State Medical Board of Ohio is also on record stating that it takes allegations of inappropriate prescribing very seriously, and that it will be actively investigating complaints as they come in and working with the Ohio Attorney General on any necessary enforcement actions for bad prescribing.[i]

In addition to state regulators, the U.S. Attorney’s Office for the Northern and Southern Districts of Ohio have set up a COVID-19 Task Force. One of its responsibilities is to investigate and criminally prosecute physicians who have egregiously prescribed chloroquine and hydroxychloroquine to themselves, family members, or friends without a legitimate medical purpose. The Task Force is comprised of representatives of the United States Attorney’s Office, Ohio Attorney General’s Office, State Medical Board, and the Pharmacy Board.[ii]

Physicians who recently prescribed chloroquine and hydroxychloroquine and who are considering whether they should self-report to the Medical Board should first contact experienced legal counsel to determine the implications of a possible self-report, including the potentiality of license discipline and/or criminal charges.


[i] See:  https://clt945532.bmeurl.co/A27E486

[ii] Seehttps://www.dispatch.com/news/20200324/feds-yost-will-prosecute-doctors-who-abuse-power-with-personal-coronavirus-prescriptions


© 2020 Dinsmore & Shohl LLP. All rights reserved.

For more COVID-19 developments, see the dedicated National Law Review Coronavirus News page.

Tennessee-Based Health Services Company Settles FCA Case Alleging Medicaid Fraud For $9.5 Million

The Department of Justice (“DOJ”) announced another False Claims Act (“FCA”) settlement centered around a health services company’s practice of providing unnecessary therapy services to patients in order to receive the maximum amount of reimbursement under Medicare.  The $9.5 million settlement is with Diversicare Health Services Inc, a Tennessee-based company that provides nursing and rehabilitation services at 74 locations throughout the country.  Diversicare’s alleged violations are similar to those in a medicaid fraud case settled by the DOJ for $15.4 million two weeks earlier concerning fraudulent Medicare reimbursements for unnecessary rehabilitation services.

The settlement resolves two separate qui tam FCA lawsuits filed by whistleblowers Mary Haggard and Bryant Fitzmorris, both former Diversicare employees.  Ms. Haggard will receive a whistleblower award of roughly $1.4 million, and Mr. Fitzmorris will receive $145,350.  The FCA allows private citizens who possess inside information of fraudulently billing against the United States Government to initiate a lawsuit on the Government’s behalf to recover those funds.  The citizens, known as qui tam relators, are then entitled to receive a share of any damages that the Government ultimately recovers from the litigation.

The settlement concerned Diversicare corporate policies, in use from the beginning of 2010 through the end of 2015, that specifically instructed its employees to provide patients rehabilitation treatments to receive the highest level of Medicare reimbursement, regardless of the need for, the efficacy of, or risks associated with such treatment.  Specific allegations include “instances of improper co-treatment in order to achieve minute thresholds, repetitive and unskilled exercises that did not match plan of care goals to obtain additional minutes, engaging patients in activities contraindicated by underlying medical conditions, [and] extending patient lengths of stay beyond what was medically indicated.”  In addition to the allegations of improper therapy, it was alleged that Diversicare billed Medicare for therapy services that were never in fact provided.

Additional allegations highlight the fraudulent attempts to maximize Medicare revenue, claiming that Diversicare threatened to undertake, and in some instances took, adverse employment actions against employees who failed to meet set budgetary goals and quotas. Finally, the settlement also resolves allegations of FCA violations regarding Diversicare’s Medicaid billing practices, including its submission of “forged, photocopied, or pre-signed physician signatures” on certifications necessary for Medicaid reimbursement.

Federal regulations governing the disbursement of taxpayer dollars for Medicare and Medicaid exist to both protect the patients receiving treatment, as well as the taxpayers whose dollars fund the programs.  When companies intentionally circumnavigate these regulations in search of higher revenue, they not only rip off the taxpayers but also put vulnerable populations of patients at risk with unnecessary and often dangerous treatments.  In the fiscal year 2019, the United States Government reported that using the FCA, it recovered $2.6 billion of taxpayer dollars fraudulently paid out under health care programs, including for violations such as those alleged against Diversicare.  FCA relators and the Government should continue to utilize this powerful tool to protect Medicare and Medicaid patients, as well as every United States taxpayer.


Copyright Kohn, Kohn & Colapinto, LLP 2020. All Rights Reserved.

For more Medicaid False Claims Act settlements, see the National Law Review Health Law & Managed Care section.

Pharmaceutical Company Agrees To $54 Million To Settle False Claims Kickback Allegations

Teva Pharmaceuticals has agreed to pay $54 Million to settle false claims kickback allegations brought by two whistleblowers, Charles Arnstein and Hossam Senousy. In their 2013 complaint, the whistleblowers asserted that Teva Pharmaceuticals (“Teva”) violated the False Claims Act when the company knowingly induced physicians to prescribe two of the company’s drugs in exchange for “speaker fees.”

Physicians hosted Teva’s speaker events, which were attended by the speakers, their families, Teva employees, and various repeat attendees. In her memorandum decision and order denying Teva’s motion for summary judgment, Chief Judge Colleen McMahon pointed to the suspect audience in attendance as well as the event locations, and the amount of alcohol served as further evidence of the questionable nature of the events.

Physician speakers earned speaker fees for their event appearances. These same physicians subsequently prescribed the drugs Copaxone and Azilect, both manufactured by Teva. The physicians in question also encouraged other doctors to prescribe the medications that treated multiple sclerosis and Parkinson’s disease, respectively. Pharmacies across the United States filled the prescriptions and submitted reimbursement claims to government-funded healthcare programs. Reimbursement funds to the pharmacies are taxpayers’ dollars.

The whistleblowers allege that the reimbursement payments from the various Federal health care programs were a result of fraud, namely the questionable “speaker fees” paid to the physicians in exchange for their prescribing Copaxone and Azilect. Furthermore, the Anti-Kickback Statute of the False Claims Act makes it illegal to knowingly pay or offer to pay kickbacks, bribes, or rebates to encourage someone to recommend the purchase of a pharmaceutical covered by a Federal health care program.

The False Claims Act has been a vital tool in the fight against government programs fraud since its inception; however, the success of the act depends on private citizens like Charles Arnstein and Hossam Senousy who are willing and able to speak out against the wrong that they encounter and work closely with the help of an experienced False Claims Act attorney to get results for everyone. The settlement of this case is not only beneficial to the government from a monetary perspective, but it is also a win for the taxpayers – those who ultimately pay when companies like Teva Pharmaceuticals choose to defraud the government.


© 2020 by Tycko & Zavareei LLP

For more false claims act settlements, see the National Law Review Litigation & Trial Practice section.

Medicaid Billing Upcharges Prompts Oklahoma Nurse to Blow the Whistle on Hospital

Oklahoma Heart Hospital (OHH) has agreed to pay $2.8 Million to settle U.S. and Oklahoma government claims that the hospital committed Medicaid Fraud. Jennifferr Baird, a retired registered nurse, filed the complaint, which reported that her former employer, OHH was consistently billing  Oklahoma’s Medicaid insurance program inpatient rates for outpatient procedures – regardless of whether a doctor ordered inpatient care or not.

Ms. Baird’s 2015 complaint, filed under the False Claims Act (FCA) and a similar Oklahoma law because Oklahoma administers its Medicaid program with federal funds. The practice of billing inpatient rates for outpatient service is more commonly known as “upcoding” and is a form of fraud. Specifically, in question was the hospital’s tendency to bill stent procedures at higher inpatient rates, which, according to Ms. Baird, are typically performed on an outpatient basis. According to the prosecutors who investigated the claim, the fraud lasted at least seven years.

Private citizens, like Ms. Baird, play a crucial role in holding healthcare providers accountable for their fraud by acting as whistleblowers on behalf of the government.  These whistleblowers do not go without reward for their assistance. Successful whistleblowers receive up to 25 percent of the settlement amount of the case. “Under the False Claims Act, private citizens, also known as relators, can bring a suit on behalf of the United States and share in any recovery. … [These] relators are awarded 15 to 25 percent of the settlement amount depending on the extent to which the relator substantially contributed to the recovery.”

“Jennifferr did her best to resist the administrators who pushed this fraudulent billing scheme,” said R. Scott Oswald, managing principal of The Employment Law Group. “And she urged everyone she managed to do the same. But when she realized she was fighting a losing battle—and that the true victims were U.S. taxpayers—she appealed to a higher power: The U.S. legal system, which welcomes whistleblowers like her. I am pleased that it delivered.”

While OHH did not admit to fault outright in the matter of overbilling, the hospital operator did agree to settle the case, paying $2.8 million to both U.S. and Oklahoma government coffers.  Additionally, the hospital operator has vowed to follow a new “Corporate Integrity Agreement” that will be enforced by the Inspector General of the U.S. Department of Health and Human Services.

“I’m hopeful that the culture at Oklahoma Heart Hospital now will change,” said Ms. Baird. “The frontline medical team has always been great, but I think some hospital officials cared more about dollar signs than vital signs.”

Unfortunately, Ms. Baird’s “dollar signs and vital signs” sentiment is laced with fact as, historically, there have been many instances where whistleblowers have exposed healthcare providers that were taking financial advantage of the Medicaid system.

 

© 2019 by Tycko & Zavareei LLP
For more on Medicaid-related cases see the National Law Review Health Law & Managed Care page.

The Department of Justice Continues to Bring the "Heat" in Pursuing Health Care Fraud

Barnes Burgandy Logo

The False Claims Act (31 U.S.C. §§ 3729 – 3733) (the FCA) penalizes individuals and companies (often government contractors) who defraud the government by either submitting a false request for payment or avoiding payment of an obligation to the government. In May 2009, the Department of Justice (DOJ) and Department of Health and Human Services jointly announced the formation of the Health Care Fraud Prevention and Enforcement Action Team, or the “HEAT” initiative, to specifically target fraud in the health care industry, and using the FCA as a primary tool.

 

According to the DOJ’s own estimates, the HEAT initiative has been successful. Indeed, the DOJ claims that in only five years, it has recovered more than $13.4 billion based on its pursuit of FCA and other claims against alleged perpetrators in the health care industry.

 

It is no shock based on those numbers that the DOJ remains as determined as ever to bring the “HEAT” against the health care industry. For example, on Feb. 25, 2014, the DOJ announced a $15.5 million settlement under the FCAagainst a chain of diagnostic testing facilities in New Jersey and New York. The DOJ alleged that the facilities falsely billed federal and state health care programs for tests that were not performed or not medically necessary and by paying kickbacks to physicians. Three whistleblowers received over $2.5 million in connection with the settlement.

 

On Feb. 10, 2014, the DOJ announced the settlement of FCA allegations against an addiction clinic, clinical lab, and two doctors in Kentucky for $15.75 million, approximately $12 million of which represent funds to be refunded to the federal government. The settlement arose out of allegations that the targets defrauded Medicare and Kentucky Medicaid by seeking reimbursement for unnecessary tests or tests that were more expensive than those performed.

 

These and other settlements demonstrate the DOJ’s ongoing commitment to aggressively pursuing allegations of fraud in the healthcare industry.

Article by:

Kathleen L. Matsoukas

Of:

Barnes & Thornburg LLP

 

Health Care Fraud 2013 – May 15-17, 2013

The National Law Review is pleased to bring you information about the upcoming ABA Health Care Fraud Conference:

Health Care Fraud May 15-17 2013

May 15 – 17, 2013

Where

  • Eden Roc Renaissance Miami Beach
  • 4525 Collins Ave
  • Miami Beach, FL 33140-3226
  • United States of America

The 23rd Annual National Institute on Health Care Fraud provides a rewarding educational experience for health care attorneys, regulators, prosecutors, criminal defense attorneys, and qui tam relators’ counsel. This National Institute draws panelists, facilitators, and participants from each of these significant groups and offers unique opportunities to meet and share experiences and concerns in a non-adversarial setting.  The program planning committee is committed to creating a program that advances education, communication, professionalism, and discussion of current legal and ethical issues that arise in the health care fraud practice. These issues are addressed in panel discussions and small workshop formats designed to maximize audience participation.

Health Care Fraud 2013 – May 15-17, 2013

The National Law Review is pleased to bring you information about the upcoming ABA Health Care Fraud Conference:

Health Care Fraud May 15-17 2013

May 15 – 17, 2013

Where

  • Eden Roc Renaissance Miami Beach
  • 4525 Collins Ave
  • Miami Beach, FL 33140-3226
  • United States of America

The 23rd Annual National Institute on Health Care Fraud provides a rewarding educational experience for health care attorneys, regulators, prosecutors, criminal defense attorneys, and qui tam relators’ counsel. This National Institute draws panelists, facilitators, and participants from each of these significant groups and offers unique opportunities to meet and share experiences and concerns in a non-adversarial setting.  The program planning committee is committed to creating a program that advances education, communication, professionalism, and discussion of current legal and ethical issues that arise in the health care fraud practice. These issues are addressed in panel discussions and small workshop formats designed to maximize audience participation.