Posts Tagged ‘Pharmaceutical Company’

What is Off-Label Marketing?

In 2013, False Claims Act recoveries reached record levels, drawing in more than $3.8 billion in settlements and judgments.  A staggering amount of that recovery – more than $2 billion – came from a little known aspect of healthcare fraud called “off-label marketing.”  The massive settlements related to off-label marketing make one thing clear: familiarity with the concepts of this scheme can enable pharmaceutical company insiders to bring successful False Claims Act cases and return significant funds to the government.

What Does Off-Label Marketing Really Mean?

All pharmaceutical drugs sold in the United States must be approved by the United States Food and Drug Administration prior to being marketed for public consumption.  In seeking approval, a pharmaceutical company must identify a selected “indication,” which is the ailment that the drug is intended to treat, relieve, or cure.  When the FDA approves a drug, the approval is limited to that identified indication.  When a patient is prescribed the drug for its approved use, the prescription is referred to as “on-label.”  However, when a patient is prescribed the drug for any other purpose, it is referred to as “off-label.”

It is important to remember that prescribing or using a pharmaceutical drug off-label is not illegal.  A physician has the ultimate discretion to prescribe a drug that he or she determines to be medically appropriate.  Studies have found that up to 20% of drugs are prescribed off-label, and the percentage increases significantly for certain types of medication.[1]  Certain ailments are also more likely to be treated with an off-label prescription.  For example, even in the early 1990’s, more than half of cancer patients received at least one off-label drug as part of their treatment regimen.[2]

However, even though off-label usage is not illegal or uncommon, it simply cannot be guaranteed to be safe or effective.  Off-label use of a drug essentially amounts to experimentation – usage without the benefit of proven outcomes or known side-effects.  For some physicians and patients, the potential reward is worth the risk, particularly if other drugs have not been able to help a patient.  So while the FDA does not interfere with a physician and patient’s discretion to choose a course of medical treatment, it does retain the discretion to regulate the promotion of a drug for off-label uses.

Pharmaceutical marketing is typically guided by the Food, Drug, and Cosmetic Act (“FDCA”).  Under the FDCA, drug companies are prohibited from marketing or promoting drugs for anything other than the approved uses.  Specifically, a drug is considered “misbranded” if its labeling includes information about an indication that has not been approved by the FDA.   Labeling does not mean just the information on the product’s packaging – it also covers any promotional material associated with the product.  The FDCA provides criminal liability for companies that violate the promotional rules.

The Center for Medicare and Medicaid Services (“CMS”) also regulates off-label use of prescription medications by prohibiting payment for drugs for a non-approved indication.  Both Medicare and Medicaid cover prescription drugs to varying extents, but both include limitations that require the medication be used for a medically-necessary indication.  The statutory language varies a bit between the two programs, but essentially, both programs require that the medication be used for an on-label purpose or be listed in certain approved compendia to qualify for reimbursement.

The governing regulations related to both the FDCA and CMS are very complex.  Any suspicions about a company’s marketing conduct, or whether government payments are proper, should be discussed with an experienced False Claims Act attorney.

Does the Government Really Care about Off-Label Marketing?

In short – absolutely.

In the past ten years, the United States government has shown an unparalleled interest in prosecuting and recovering funds for off-label promotion and marketing of pharmaceutical drugs.  Off-label marketing cases make up some of the largest healthcare fraud settlements in the history of the United States, including:

Of course, these cases are notable because of their very high settlement values.  Not every off-label case is expected to bring in billion-dollar settlements, and you should not be deterred from bringing a case just because it may have a smaller damage calculation.

If you believe you have information regarding the off-label promotion and marketing of a pharmaceutical drug and are considering bringing a False Claims Act case, please contact James Hoyer for an evaluation of your claims.  Click here for more information about the firm and to submit your information electronically, or you may contact our office at 813-397-2300.

[1] David Radley, Stan Finkelstein, Randall Stafford, “Off-label Prescribing Among Office-Based Physicians,” Archives of Internal Medicine, 2006.


[2] “Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies,” General Accounting Office, Report to the Chairman, Committee on Labor and Human Resources, U.S. Senate, September 1991.


Manhattan U.S. Attorney Files Healthcare Fraud Claims against Novartis Pharma & Settles Suit against BioScrip

U.S. Attorney’s Office Southern District of New York – News Release:

Suit Alleges Novartis Orchestrated a Kickback Scheme with Bioscrip, Inc., by Referring New Patients and Giving Rebates to BioScrip in Return for Bioscrip Increasing Refills of Exjade Prescriptions Through Biased Recommendations to Patients, Which Emphasized the Benefits of Refills While Understating Exjade’s Serious, Potentially Life-Threatening Side Effects

BioScrip Agrees to Pay $15 Million and Makes Extensive Factual Admissions to Resolve Claims

Preet Bharara, the United States Attorney for the Southern District of New York, and Ronald T. Hosko, the Assistant Director of the Federal Bureau of Investigation, Criminal Investigative Division (“FBI”), announced today that the United States has filed additional civil healthcare fraud claims in Manhattan federal court against NOVARTIS PHARMACEUTICALS CORP. (“NOVARTIS”) and BIOSCRIP, INC. (“BIOSCRIP”). The Government’s Amended Complaint seeks treble damages and civil penalties under the False Claims Act against NOVARTIS and BIOSCRIP for NOVARTIS providing kickbacks, in the form of patient referrals and in the guise of rebates, to BIOSCRIP in exchange for BIOSCRIP recommending refills to Exjade patients. The lawsuit alleges that, as a result of this kickback scheme, Medicare and Medicaid have paid tens of millions of dollars in reimbursements based on false, kickback-tainted claims for Exjade shipped by BIOSCRIP.

Simultaneous with the filing of the Amended Complaint, U.S. District Judge Colleen McMahon approved a settlement to resolve the United States’ claims against BIOSCRIP. Under that settlement, which takes into account BIOSCRIP’s limited financial resources, BIOSCRIP (i) agrees to pay $11,685,705.43 to the United States; (ii) admits numerous facts concerning its relationship with NOVARTIS; and (iii) agrees to cooperate with the United States in the prosecution of the claims against NOVARTIS. BIOSCRIP has also agreed in principle to pay $3.31 million to a group of States to settle the States’ claims based on the same alleged conduct.

Manhattan U.S. Attorney Preet Bharara said: “As alleged, Novartis is caught having orchestrated yet another scheme whereby it used the lure of kickbacks to co-opt a healthcare providers’ independence and, in this case, turned pharmacy employees at BioScrip into salespeople for Exjade. By allegedly having BioScrip promote refills under the guise of purported ‘counseling’ and ‘education,’ Novartis caused patients to receive one-sided advice that did not discuss Exjade’s serious, potentially life-threatening, side effects. Further, by hiding this illegal quid pro quo from federal healthcare programs, Novartis caused the public to pay tens of millions of dollars for kickback-tainted drugs.”

FBI Assistant Director Ronald T. Hosko said: “Investigations such as these are a high priority for the FBI and we will aggressively pursue providers that boost their profits at the expense of Medicare and other government programs. Due to the potential impact to the nation’s health care system and to the public from these types of multifaceted schemes, we have created a centralized team to provide nationwide support to our field offices called the Major Provider Response Team. The FBI is committed to working with our partners in these types of investigations and appreciates the public’s involvement in the process.”

According to the allegations contained in the Amended Complaint filed today in Manhattan federal court:

NOVARTIS markets and manufactures Exjade, an iron chelation drug approved for use by patients who have iron overload resulting from blood transfusions. Between February 2007 and May 2012, NOVARTIS orchestrated a scheme whereby it offered kickbacks, in the form of patient referrals and under the guise of rebates, to BIOSCRIP, a specialty pharmacy, in exchange for BIOSCRIP increasing its Exjade refills through biased recommendations to patients.

BIOSCRIP was part of a Novartis-created exclusive distribution network for Exjade, and through this network, Novartis was able to refer Exjade patients to particular pharmacies within the network. In order to obtain greater numbers of patient referrals and rebates, BIOSCRIP, in coordination with NOVARTIS, implemented a program of calling patients to recommend Exjade refills or to get patients who stopped ordering Exjade refills to resume ordering them.

NOVARTIS and BIOSCRIP promoted these calls as part of an effort to offer clinical “counseling” or “education” to Exjade patients. In fact, however, the real purpose behind this call program was to obtain more refill orders so that Novartis could increase its Exjade sales and meet its national Exjade sales target and BIOSCRIP, in turn, could get more patient referrals and higher rebates. Thus, the BIOSCRIP employees making those calls to Exjade patients emphasized the importance of getting refills, but ignored Exjade’s serious, potentially life-threatening side effects, such as kidney failure and gastrointestinal hemorrhage. Indeed, according to a former BIOSCRIP supervisor, the incentives offered by NOVARTIS caused BIOSCRIP to focus exclusively on getting Exjade patients to order refills, rather than caring for these patients. This Exjade scheme violated the federal anti-kickback statute, which prohibits the offer or payment of remuneration to induce the purchase or recommendation of any drug or service covered by Medicare, Medicaid, or another federal healthcare program.

By orchestrating this scheme, NOVARTIS and BIOSCRIP further caused pharmacies to submit tens of thousands of claims to Medicare and Medicaid, resulting in those programs paying out tens of millions of dollars in reimbursements based on false claims tainted by kickbacks.

Further, as part of its settlement with the United States, BIOSCRIP made extensive factual admissions, including, among other things, that:

  • BIOSCRIP was one of three specialty pharmacies permitted to dispense Exjade as part of “EPASS,” NOVARTIS’s distribution network for Exjade.
  • NOVARTIS controlled how approximately half of the patient prescriptions received by EPASS were distributed among BIOSCRIP and the other two EPASS pharmacies.
  • In 2007, NOVARTIS informed BIOSCRIP that the level of refill orders among BioScrip’s Exjade patients was below the refill levels achieved by the other two EPASS pharmacies. NOVARTIS demanded that BIOSCRIP implement a Performance Improvement Plan (“PIP”) due to its low refill levels relative to the other EPASS pharmacies. NOVARTIS informed BIOSCRIP that it had to increase its refill levels or NOVARTIS would cut off the flow of certain patient referrals to BIOSCRIP and, potentially, remove BIOSCRIP from EPASS.
  • In response, and to avoid losing access to patient referrals, BIOSCRIP launched an intensive effort to (i) increase overall patient orders for Exjade refills, and (ii) “restart” many patients who had stopped ordering Exjade. To achieve that goal, BIOSCRIP hired a group of staff to work exclusively on Exjade (the “Exjade Team”). BIOSCRIP directed the Exjade Team to call many patients to encourage them to order refills and to encourage many patients who had stopped ordering refills to “restart” Exjade.
  • The efforts of the Exjade Team resulted in significant increases in Exjade refill levels at BIOSCRIP – by September 2007, the refill levels at BIOSCRIP were higher than at the other two EPASS pharmacies. Recognizing the improvement in refill levels at BIOSCRIP, NOVARTIS continued to direct patient referrals to BIOSCRIP.
  • BIOSCRIP developed a protocol, named ScripCare, for the Exjade Team to call patients to encourage many patients to order refills and to encourage many patients who had stopped ordering refills to restart Exjade. In developing ScripCare, BIOSCRIP shared key elements with NOVARTIS.
  • The Exjade marketing team at NOVARTIS provided input on aspects of the ScripCare protocol, including how to discuss potential side effects with Exjade patients.
  • In 2007, NOVARTIS began issuing monthly “Exjade Scorecards” to BIOSCRIP and the other two EPASS pharmacies that measured, among other things, “adherence” scores. Based on discussions with NOVARTIS, BIOSCRIP knew that the “adherence” scores in the Exjade Scorecards were designed to show how long Exjade patients continued to order refills. Later that year, NOVARTIS began discussions with BIOSCRIP about a plan to allocate more patient referrals to BIOSCRIP if, according to the adherence scores in the Exjade Scorecards, it remained the highest performer in terms of obtaining refill orders.
  • In 2008, BIOSCRIP agreed to a new patient allocation plan proposed by NOVARTIS, which linked the percentage of patient referrals for BIOSCRIP to its refill rates as measured by the Exjade Scorecard.
  • In 2011, BIOSCRIP was placed under a “corrective action” plan by NOVARTIS due to its low refill rates relative to the other EPASS pharmacies and other issues, and stopped receiving certain patient referrals. In response, BIOSCRIP launched an intensive effort to “restart” many patients and to encourage many patients to order refills. By late 2011, BIOSCRIP’s refill rates had increased significantly; and, starting in January 2012, NOVARTIS increased its allocation of patient referrals to BIOSCRIP based on its higher refill rates relative to the other EPASS pharmacies in late 2011.

* * *

The additional claims in the Amended Complaint seek treble damages and penalties under the False Claims Act for the tens of millions of dollars in reimbursements that Medicare and Medicaid paid for Exjade shipments that resulted from the kickback scheme involving NOVARTIS and BIOSCRIP. In addition, the Government seeks compensatory damages under the common law for the tens of millions of dollars for the profits that NOVARTIS and BIOSCRIP obtained as the result of Medicare and Medicaid reimbursements for Exjade.

The allegations of fraud stated in the Complaint were first brought to the attention of federal law enforcement by a whistle-blower who filed a lawsuit under the False Claims Act. The False Claims Act permits the Government to recover up to three times the amount of damages incurred by the United States, plus civil penalties ranging from $5,500 to $11,000 per violation. Private parties who have knowledge of fraud committed against the Government may file suit on behalf of the Government and share in any recovery. The United States may then intervene and file its own lawsuit for treble damages and penalties, as it did in this case.

Mr. Bharara praised the investigative work of the FBI’s Major Provider Response Team, HHS-OIG, and the Medicaid Fraud Control Units for New York, Washington, and Ohio. He also thanked the Commercial Litigation Branch of the U.S. Department of Justice’s Civil Division in Washington D.C., for its extraordinary assistance in this case.

The case is being handled by the Office’s Civil Frauds Unit. Mr. Bharara established the Civil Frauds Unit in March 2010 to bring renewed focus and additional resources to combating healthcare and other types of frauds. Assistant U.S. Attorneys Li Yu, Rebecca C. Martin, and Ellen M. London are in charge of the case.