BioScrip: The Refill Score That Decided Who Got the Next Patient

The BioScrip Exjade settlement called for $15 million to resolve allegations that manufacturer referrals and rebates bought Exjade refill recommendations. BioScrip admitted that its access to new patients depended on how long existing patients kept ordering the drug. For the staff making those calls, the instruction to keep patients on treatment came from a business whose next referrals depended on the answer.

What BioScrip Agreed to Pay

BioScrip agreed to pay $11,685,705 to the United States and agreed in principle to pay $3.31 million to participating states. The Justice Department announced the settlement on January 8, 2014. The government alleged that Medicare and Medicaid had paid tens of millions of dollars for Exjade shipments generated by the arrangement.

This pharmaceutical fraud settlement also required cooperation with the government’s case against Novartis. BioScrip made extensive factual admissions about referral pressure, patient calls, refill scorecards and the manufacturer’s involvement in its counseling protocol.

The government alleged that the kickback arrangement ran from February 2007 through May 2012. Novartis supplied the incentives, BioScrip encouraged refills, and Medicare and Medicaid paid for prescriptions the government said resulted from that arrangement. In the government’s account, patients received advice about continuing treatment from a pharmacy with a financial stake in keeping the orders coming.

Accredo and Novartis reached separate settlements later.

The Exjade Referral Business

Exjade treats iron overload resulting from blood transfusions. The complaint describes patients with underlying conditions including beta-thalassemia, sickle cell disease and myelodysplastic syndrome. Novartis created an exclusive distribution network called Exjade Patient Assistance and Support Services, known as EPASS. BioScrip admitted that it was one of only three specialty pharmacies permitted to dispense the drug through that network. Novartis controlled the allocation of approximately half the patient prescriptions EPASS received.

Under the original arrangement described in the complaint, BioScrip shipped Exjade, contacted patients about refills and confirmed delivery. It needed the patient’s consent before sending a refill even when a doctor’s prescription authorized one. It also sent Novartis therapy information, including dosage, refill orders and whether a physician had discontinued treatment. The patient call was the pharmacy’s opportunity to secure the next order, while the manufacturer received information about physicians discontinuing therapy.

Control over referrals gave the manufacturer something valuable to offer a pharmacy beyond a rebate. A new patient brought dispensing business, and higher refill scores improved the pharmacy’s chances of receiving more patients. In this specialty pharmacy kickback arrangement, the government alleged that referrals and rebates worked together to purchase recommendations.

The pharmacy also occupied the point where the commercial arrangement reached the patient. BioScrip developed ScripCare, a protocol for its Exjade Team to call patients, encourage refills and encourage people who had stopped ordering to restart. BioScrip admitted sharing key elements with Novartis. The manufacturer’s Exjade marketing team provided input on how staff should discuss potential side effects.

The government alleged that this marketing influence reached into calls presented as nurse counseling and patient education.

How Refills Became the Performance Metric

BioScrip admitted that Novartis judged its performance by refill orders and used access to referrals to demand improvement. In 2007, Novartis told BioScrip that its refill levels lagged behind those of the other EPASS pharmacies. It required a performance improvement plan and threatened to cut off certain patient referrals or remove BioScrip from the network.

BioScrip responded by hiring staff dedicated to Exjade and directing them to encourage refills and restarts. By September that year, its refill levels exceeded those of the other network pharmacies. Novartis continued sending patients.

The monthly Exjade Scorecards made that pressure measurable. BioScrip admitted knowing that the score labeled “adherence” measured how long patients continued ordering refills. In 2008, it agreed to a patient allocation plan linking its share of referrals to that score.

The government’s amended complaint describes the flaw in that measure. A patient’s decision to follow a doctor’s instruction to stop treatment could lower BioScrip’s adherence score. The pharmacy could lose ground for a patient doing exactly what the doctor ordered.

Rebates reinforced the referral incentive. The complaint alleged that Novartis increased BioScrip’s per-shipment Exjade rebate from $13 to $20 in January 2008 to reward its refill performance and keep the calls going. The complaint also described higher rebates for shipments during a patient’s fourth through ninth months of therapy, when the manufacturer particularly wanted to keep patients ordering.

BioScrip’s admissions show the pressure returning in 2011. Novartis placed the pharmacy under a corrective action plan because of low refill rates and other issues, and stopped sending certain referrals. BioScrip intensified its efforts to restart patients and obtain refills. After its rates improved, Novartis increased its allocation of patient referrals beginning in January 2012.

The reward for improving a refill score was more patients whose refill scores would then be measured. The manufacturer’s sales target traveled through a pharmacy performance system and arrived at a patient’s telephone.

What Patients Heard

The government alleged that BioScrip’s calls emphasized staying on Exjade while understating serious side effects. The complaint described a team that included a licensed practical nurse, medical assistants and customer service representatives. Its account of the newly hired nurse shows how the assignment began:

In that account, she had an instruction to keep patients on the drug before she had training on the drug. That is the practical meaning of the government’s allegation that counseling had become a sales channel.

The complaint alleged that Novartis approved talking points describing initial discomfort as something that usually resolved over time, and that BioScrip required staff to follow them when discussing therapy with new patients. Yet the drug’s warnings addressed serious gastrointestinal bleeding and potentially fatal kidney and liver impairment. The government alleged that the calls focused on less serious effects while ignoring the more severe ones.

Novartis’s later admissions describe BioScrip promising to urge patients to continue Exjade because untreated excess iron could damage organs and kill. The FDA had already told Novartis that promotional materials should not imply Exjade had been shown to prevent damage to multiple organs.

The missing information extended beyond training. According to the complaint, BioScrip’s patient information system did not track serum creatinine or current serum ferritin levels for most Exjade patients. Those measurements mattered to kidney function and whether the patient still needed treatment or had reached the therapeutic goal. Staff allegedly recommended continued therapy without the patient data needed to assess it.

The complaint also alleged that staff pushed refills even when a patient already had more than a month’s supply. It also alleged that BioScrip kept shipping to physicians’ offices where patients were not picking up the drug, leaving the offices overstocked.

The patient-facing materials also left out the incentives. The government alleged that neither the marketing materials nor the team’s talking points disclosed the bundle of rewards tied to shipment goals. In that account, patients heard about care while the pharmacy was being measured against a manufacturer’s sales expectations.

What Medicare and Medicaid Paid For

The government alleged that BioScrip’s Exjade shipments produced more than 37,900 reimbursed Medicare Part D claims during the scheme. New York Medicaid alone reimbursed more than 4,800 claims. The complaint connected those payments to the pharmacy’s undisclosed referral and rebate arrangement.

As the court described the government’s case, pharmacies told public healthcare programs that their claims complied with the rules against kickbacks while allegedly receiving those incentives for promoting the drugs. The government challenged the bills for prescriptions generated through that arrangement, including drugs actually dispensed to patients.

That connects the patient conversation to the public payment. The manufacturer allegedly bought refill recommendations through referrals and rebates, and the health care programs reimbursed the resulting shipments. That was how the government connected the commercial decision inside the pharmacy to the taxpayer’s bill.

What an Insider Would Recognize

The BioScrip complaint connects records from different parts of the business: referral decisions, rebate terms, scorecards, call instructions, training and prescription claims. It also alleges that the written rebate contracts omitted key terms of the relationship. Neither the original contract nor its replacement disclosed the understanding that continued referrals depended on refill performance, or the competition for additional referrals.

That gap matters to someone who saw the arrangement operate. The contract could describe rebates while a performance improvement plan or a referral email carried the pressure to increase orders. A scorecard showed the metric. ScripCare materials showed how staff were expected to move it. Patient information fields showed what the callers could know about the people they were encouraging to stay on treatment.

US Bioservices later supplied a useful comparison within the same network. In its separate August 2017 settlement, that pharmacy admitted training nurses to emphasize severe consequences of untreated iron overload and to say common side effects typically went away with time. Its nurses did not use written scripts. Training carried the message that a script carried at BioScrip.

For a pharmacy manager, nurse, account manager or reimbursement employee, the useful connection is between the business incentive, the patient contact and the bill. The BioScrip case began with a whistleblower, and the government joined it.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When You Know What Drove the Refill Calls

If you know how manufacturer referrals or rebates shaped the calls your pharmacy made, talk with our whistleblower experts about the instructions behind those refills. We build your strongest pharmacy whistleblower case with you around the decisions you saw, bring in pharmaceutical fraud whistleblower lawyers who understand specialty-pharmacy incentives, and stay at your side throughout the case.