A physician who purchased Botox® from an unlicensed foreign wholesaler faces up to five years in prison after pleading guilty to felony charges. The doctor received faxes from a foreign drug wholesaler that offered low prices for prescription drugs, including “Botox (Turkish)” for $354.99 a vial. At the time, the FDA-approved version of Botox® was sold through licensed drug wholesalers in the United States for about $525 a vial. According to the government, the physician made at least 50 separate purchases of the counterfeit drugs from the foreign wholesaler, which he provided patients without informing them of the source. When special agents investigators from the U.S. Food and Drug Administration (FDA) questioned the physician, he told the agents he had only made three purchases from the unlicensed foreign wholesaler. This was a big mistake. Making a false statement to a federal agent is a felony that carries a penalty of up to five years in prison and fines up to $250,000. It also results in immediate exclusion from Medicaid, Medicare and other government programs. While it may have been difficult to for the government prove that the physician knew that the drugs were counterfeit or had actually used them to treat patients, the number of purchases could easily be proved with the physician’s own bank and credit card records. If government agents ask to speak with you, remember this. You have the right to remain silent and the right to legal counsel. Do not give up those rights. Tell the agents politely that you want to speak with your lawyer. Then call an experienced Medicare and Medicaid fraud defense attorney immediately. To arrange a free initial consultation, call John Howley, Esq. at (212) 601-2728. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules.
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The New York Attorney General's Office recovered more than $335 million last year from companies and individuals who engaged in Medicaid fraud and abuse. New York has one of the most aggressive Medicaid Fraud Control Units (MFCU), with a staff of more than 315 people across the state. They work closely with the Medicaid Inspector General in the NYS Health Department to detect and prevent Medicaid fraud. The most common forms of Medicaid fraud in New York last year included:
The largest Medicaid fraud recoveries came from pharmaceutical companies. Abbott Labs, Boehringer-Ingelheim, Dava Pharmaceuticals, GlaxoSmithKline, K-V Pharmaceutical, McKesson, Merck, and other pharmaceutical companies paid more than $250 million to settle allegations that they submitted false price reports to Medicaid and/or promoted their products for uses not approved by the federal Food and Drug Administration (off-label marketing). Other significant recoveries involved pharmacists, hospitals, and dental clinics. Pharmacy Fraud: Four pharmacists and a pharmacy owner agreed to pay $9.9 million in restitution after pleading guilty to billing Medicaid for drugs that they never dispensed to their patients. Stark Law Violations: Cayuga Medical Center paid $3.1 million to settle a whistleblower or qui tam lawsuit alleging that the hospital billed Medicaid and Medicare for patients referred by physicians who had financial relationships with the hospital. The Stark Act prohibits a physician from referring patients to a hospital if the physician has a financial relationship with the hospital, unless an exception applies. The whistleblower in this case, a physician at the hospital, received 18% of the settlement (approximately $560,000) as his whistleblower reward. Dental Fraud: Kaleida Health repaid $1.6 million to Medicaid after an internal audit revealed that it had billed Medicaid for patients who received teeth cleanings more often than once in six months, which violated Medicaid reimbursement rules. The audit also revealed that the dental clinic had billed Medicaid for multiple visits to complete exams, x-rays, and cleanings. Medicaid regulations require dental clinics to perform and bill these tasks in one office visit. If you are under investigation or have been charged with Medicaid fraud, then you should consult with an experienced Medicaid fraud attorney immediately, before you speak with government investigators. Anything you say to the investigators can and will be used against you. To arrange a free and confidential consultation, call John Howley, Esq. at (212) 601-2728 or click here to reach our office via email. You should also consult with an experienced Medicaid and Medicare fraud lawyer if you know that your employer is submitting false claims to the government. You may be entitled to a substantial whistleblower reward and legal protections if you help the government recover money paid on false and fraudulent claims. Call our office today to schedule a free and confidential consultation. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. Amgen Inc. has agreed to pay $612 million to settle ten whistleblower lawsuits alleging that the company illegally promoted a misbranded drug. Under the qui tam provisions of the False Claims Act, the whistleblowers are entitled to a reward of between 15% and 30% of the amount actually paid to the government as a result of their efforts. The lawsuits involved the drug Aranesp, which was approved by the FDA for treatment of anemia in patients with chronic renal failure. The FDA approval was specific to calibrated doses for particular patient populations. The lawsuits alleged that Amgen knowingly promoted the sale and use of Aranesp for dosing regimens and indications that were not approved by the FDA. The off-label marketing allegedly included promoting Aranesp for treatment of anemia caused by cancer, anemia caused by chronic disease, chronic anemia, and anemia caused by myelodysplastic syndrome. Under the Food, Drug and Cosmetic Act, it is illegal for a drug company to promote a drug for uses or at doses not approved by the FDA. This is known as “off-label” marketing and renders the drug “misbranded.” Promotion of a misbranded drug may also violate the False Claims Act because any resulting claims for reimbursement from Medicare or Medicaid are considered “false claims.” As the whistleblowers filed their lawsuits, the government conducted investigations and decided to intervene in the actions. The government alleged that Amgen engaged in three types of illegal conduct: Off-Label Marketing: The government alleged that Amgen promoted Aranesp and two other drugs that it manufactured, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not properly reimbursable by federal insurance programs. The government also alleged that Amgen used journal articles that were insufficient to support the safety and efficacy of the off-label uses at issue, and improperly obtained listings in medical compendia in an effort to establish that the off-label uses were medically accepted and thereby eligible for coverage by federal health care programs. Kickbacks: The government alleged that Amgen offered illegal kickbacks to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary. The Anti-Kickback Statute prohibits offering, paying, or accepting anything of value in return for recommending the use of a product or service that will be reimbursed by Medicare and certain other government healthcare programs. False Price Reports: The government alleged that Amgen engaged in false price reporting practices, including knowingly submitting false Average Sales Prices, Best Prices, and Average Manufacturer Prices for several drugs. Pricing reports from pharmaceutical companies are used by Medicare, Medicaid, and other government healthcare programs to set reimbursement rates. The qui tam or whistle-blower provisions of the False Claims Act allow private citizens to bring lawsuits on behalf of the United States and share in any recovery. The lawsuits are initially filed “under seal” (in secret) to give the government an opportunity to conduct an investigation. If the lawsuit is successful, the whistleblower is entitled to a reward of between 15% and 30% of the amount actually paid to the government. If you are aware of off-label marketing, kickbacks, false price reports, or other types of false or fraudulent marketing of pharmaceuticals, you may be eligible for a substantial reward and legal protection as a whistleblower. To arrange a free and confidential consultation with an experienced False Claims Act attorney, call John Howley, Esq. at (917) 652-6504 or click here to contact our office via email. No legal fees are charged unless the case is successful. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. Pfizer Inc. has agreed to pay $55 million plus interest to settle allegations that Wyeth LLC, a Pfizer subsidiary, promoted the prescription drug Protonix for off-label use. Protonix is a proton pump inhibitor (PPI) that was used by physicians to treat various forms of gastro-esophageal reflux disease (GERD). The Food and Drug Administration (FDA) approved Protonix for short-term treatment of erosive esophagitis, a condition associated with GERD that can only be diagnosed with an invasive endoscopy. The government alleged that Wyeth engaged in a “multifaceted” campaign to promote Protonix for all forms of GERD, including symptomatic GERD, which was far more common and could be diagnosed without an endoscopy. These other uses were not approved by the FDA. Under the Federal Food Drug and Cosmetic Act, manufacturers must obtain FDA approval for any indication for use for which a manufacturer intends to market a drug. A prescription drug that is intentionally marketed for unapproved off-label uses is considered “misbranded.” The government alleged that Wyeth intentionally engaged in the following conduct to promote Protonix for off-label use:
Pfizer denied the allegations, and the settlement resolves the case without a finding of guilt or innocence. While the Pfizer case was brought by the government directly, many off-label promotion cases are brought by whistleblowers. Under the qui tam provisions of the False Claims Act, whistleblowers are entitled to a reward of up to 30% of the amount of money the government recovers. In some cases, the rewards in pharmaceutical cases have reached millions of dollars. If you have information that a pharmaceutical company is promoting its drugs for off-label uses, then you should consult with an experienced False Claims Act attorney immediately. To schedule a free and confidential consultation by telephone or in person, call my office today at (917) 652-6504 or click here to communicate with me via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. A whistleblower lawsuit brought against Healthpoint Ltd. and DFB Pharmaceuticals was settled for $48 million. The suit was brought under the qui tam provision of the False Claims Act, which allows individuals to sue on behalf of the government and share in any recovery. Whistleblowers can be current or former employees, sales representatives, physicians, trainers, consultants, patients, customers, competitors, or anyone else with knowledge of Medicare or Medicaid fraud. Under the False Claims Act, a whistleblower who brings a qui tam suit is entitled to a reward of between 15% and 25% of the amount the government actually collects. The government and the whistleblower in this case are negotiating the amount of her reward. In this case, the settlement resolves allegations that Healthpoint caused false claims to be submitted to Medicare and Medicaid for an unapproved drug, Xenaderm, a prescription skin ointment for the treatment of nursing home patients’ bed sores. Prescription drugs that have not been approved by the Food and Drug Administration (FDA) are not eligible for reimbursement from Medicare or Medicaid. The government alleges that Healthpoint actively promoted Xenaderm as a prescription drug that, unlike non-prescription skin ointments such as Vaseline, was “Medicaid reimbursed” and therefore cost nursing homes nothing to administer to Medicaid patients. In fact, Xenaderm was not eligible for reimbursement and Healthpoint did not include Xenaderm on its quarterly list of reimbursable drugs that it submitted to the government. The government also alleges that Healthpoint did not complete any double-blind placebo-controlled clinical studies to establish the safety and effectiveness of Xenaderm. It points to an internal email written by a Healthpoint clinical researcher who admitted that the safety and efficacy data for Xenaderm was “cruelly insufficient” to meet FDA standards. The lawsuit was originally filed under seal (in secret) by the whistleblower, and the whistleblower’s evidence was provided only to the government. After reviewing the secret complaint and conducting an investigation, the government joined the lawsuit. The government and the whistleblower, have not yet agreed on the size of her award. Under the False Claims Act, she is entitled to a reward of 15% top 25% of the total amount recovered, or between $7.2 million and $12 million if the government collects the full amount of the settlement and determines that her lawsuit covered the claims that were settled. Two issues may be under negotiation. First, it is unclear whether the lawsuit filed by the whistleblower was as broad as the lawsuit the government ultimately pursued. If the whistleblower’s lawsuit had a more narrow scope, then her reward may be limited to the portion of the settlement attributable to her claims. Second, Healthpoint and DFB have agreed to pay $28 million now, plus another $20 million if there is a change in ownership of Healthpoint or DFB over the next three years. If there is no change in ownership and the settlement is limited to $28 million, then the whistleblower would be entitled only to a percentage of the amount actually paid. If you are aware of false claims being submitted to Medicare or Medicaid, then you should consult with an experienced False Claims Act attorney immediately. You may be entitled to a substantial reward and the legal protections afforded whistleblowers under state and federal laws. To arrange a free and confidential consultation, call John Howley, Esq. at (917) 652-6504 or click here to contact us via email. John Howley, Esq. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. I invite you to contact our law offices and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established. I practice law and offer legal services only in jurisdictions where I am properly authorized to do so. I do not seek to represent anyone in any jurisdiction where this web site does not comply with applicable laws and bar rules. |
John Howley, Esq.
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