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Nolan Auerbach is or has actively investigated the following situations involving:

  • kickbacks provided to physicians and other healthcare providers to induce them to prescribe certain medical devices. The kickbacks essentially involve phony clinical trials and clinical registries designed to provide a legitimate reason to make payments to physicians for prescribing the devices to their patients.
  • hundreds of non-FDA approved drugs that have been paid for by multiple Government Healthcare Programs. Large as well as small pharmaceutical companies, distributors and labelers have engaged in this conduct. These include DESI drugs found to be ineffective, drugs which were never submitted to the DESI panel for review and approval, copies of OTC monograph drugs in prescription strength, approved component drugs in unapproved combinations and unapproved components added to approved combinations. The investigation revealed that the companies have taken no steps to dispel the widely held public and medical belief that their respective drugs are FDA-approved; instead, they have fostered such belief. A review of marketing materials distributed by random manufacturers, including information furnished to the Physicians’ Desk Reference (PDR), reveals that the overwhelming majority of these manufacturers simulate descriptions and nomenclature of FDA-approved drugs, including the use of the words “indicated for.” Had the truth been known, and made public, Government Healthcare Programs would not have paid for them, and patients would not have been able to consume same to their detriment.
  • a hospital chain’s practices of inducing doctors to make patient referrals in violation of the Federal Stark and/or Anti-kickback Act. The practices at issue include but are not limited to the provision of office space, renovations, equipment, furniture, housekeeping services, office supplies, copy and fax machines, telephone, utility and transcription services to referring physicians for free or less than fair market value. They also include the provision of medical directorships, interest free loans/forgiveness of debts, illegal recruitment arrangements and improper discounts which represented additional financial windfalls to physicians, locking in hospital referrals to the hospital. The hospital also inflated and falsely claimed statements of expenses in its filed cost reports including but not limited to the following: falsely claimed depreciation costs to cost-based units, such as for capital equipment used physician offices which were not related to hospital patient care; falsely claimed medical director fees which were not necessary or reasonable; shifted costs to hospital-based units that have largely been cost-reimbursed, all in violation of the Stark and/or Anti-kickback Act.
  • false claims submitted to Medicare and other Government Healthcare Programs for manufacturing compounded drugs that were not FDA-approved, although identical commercially available FDA-approved drugs were on the market.
  • a marketing and sales promotion which caused physicians to prescribe a prescription drug for off-label use resulting in the majority of its sales. The pharmaceutical company engaged in this marketing program despite the fact that there were no adequate and well-controlled studies demonstrating the efficacy of the drug for such use. The end result is that the majority of prescriptions for the drug were not covered and should not have been paid for by Medicare, Medicaid, and other federally-funded healthcare programs. The claims should not have been paid, because, for instance, such uses were not supported as medically acceptable in any major compendia; and such uses were not capable of being medically accepted by any Medicare contractor based on supportive clinical evidence in peer-reviewed medical literature.
  • the making of and submitting of false statements in connection with a drug manufacturer’s New Drug Application (NDA). The manufacturer made these false statements and records to the United States Food and Drug Administration. Subsequent similar false statements and claims have been included in the manufacturer’s marketing materials that were promoted to the medical community, all causing submission of hundreds of millions of dollars worth of claims to Government Healthcare Programs in addition to potentially serious safety issues.
  • the Medicare impact of the contractual arrangement between two Group Purchasing Organizations (GPO) and their hospital members, including how the hospitals reported vendor fees on Medicare cost reports.
  • improper coding in an acute care hospital.
  • claims for interrupted stays as well as outlier payments made to inpatient rehabilitation facilities, under the Prospective Payment System (PPS).
  • the medical necessity of admissions to a PPS exempt psychiatric unit of a general hospital, as to medical necessity and coverage issues.
  • a provider that attempted to circumvent the Prospective Payment System by coordinating patient stay at acute and post acute care hospitals through subsequent stays at different hospitals and/or units.
  • whether rebates paid to hospitals are properly identified by the hospitals as purchase credits in a separate line item in their Medicare cost reports.
  • the relationship between physicians who furnished pathology services in their offices and outside pathology companies with whom they have agreements with, to determine whether there were violations of the Stark law or Anti-kickback law.
  • whether wound care services were medically necessary, were delivered pursuant to a physician order, and so on.
  • whether air ambulance services were provided in accordance with Medicare guidelines, including whether ground ambulance transportation services would have sufficed.
  • whether false claims were submitted by a hospital billing for emergency room services furnished to undocumented aliens where the undocumented aliens did not have emergency situations.
  • improper claims made for outpatient alcoholism services because treatment was not rendered, patients were obtained through unlawful inducements, etc.
  • a systematic and very successful course of action to cause physicians to prescribe an anti-epileptic drug for off-label uses for which there were no adequate and controlled studies to support such use as to effectiveness. The situation included a well-oiled and implemented marketing plan where programs were put in place so that physicians could be induced and/or rewarded with kickbacks in order to enhance the drug manufacturer’s efforts to cause physicians to prescribe its drug for off-label uses.
  • Form 3038, a requisite of payment for emergency services for uninsured illegal aliens. Form 3038 is the form that state Medicaid agencies use to establish that the patient was in need of, and received, emergency services, during a specified time period. Claims cannot be paid without a Form 3038 signed by the practitioner who actually saw the patient, or a practitioner with first-hand knowledge of the patient and services required. In this investigation the Form 3038 was neither completed at the time the patient was seen or admitted, nor was it signed by someone with first-hand knowledge of the patient or the services furnished. Forms were also prepared for patients seeking non-emergency (i.e., observational) care.
  • claims for medical services that a hospital system represented were personally and identifiably provided by attending physicians when in fact, they were not.
  • kickbacks provided to physicians and other healthcare providers to induce them to prescribe certain pharmaceutical products. The practices, part of a highly organized and orchestrated campaign, include: Offering kickbacks to physicians and healthcare providers in the form of samples; Offering kickbacks to physicians in the form of “overfilled” vials; Offering kickbacks to physicians and healthcare providers in the form of clinical drug trials; Actively marketing and facilitating a “spread,” as a kickback to physicians; Providing lavish entertainment, etc.; Providing physicians and healthcare providers with phony speaker fees a/k/a “honorariums”; Providing physicians and healthcare providers with phony grants; Providing physicians with phony preceptorships; Using “investigator meetings”as inducements; Using “advisory board meetings” as inducements; Creating phony paperwork programs as a means to provide kickbacks to physicians.

the false Average Sales Price (ASP) reported by a drug manufacturer to Medicare under Medicare Part B.