Accredo: The Refill Score Ignored Why Patients Stopped

In the Accredo Exjade kickback settlement, Accredo Health Group agreed to pay $60 million over alleged specialty pharmacy kickbacks from Novartis in exchange for promoting refills. Accredo admitted that the score used to compete for new patients did not exclude patients whose physicians had directed them to stop therapy. For someone working with refill reports, referral allocations or patient calls, that is the revealing detail: following the doctor’s instruction could count against the pharmacy’s commercial performance.

What Accredo Settled

The Justice Department announced Accredo’s civil healthcare fraud settlement on May 1, 2015. Accredo admitted facts about its relationship with Novartis and agreed to cooperate in the government’s case against the manufacturer.

A whistleblower brought the pharmaceutical fraud case, and the government joined it. The government alleged that Novartis provided referrals and other benefits in return for Accredo’s refill recommendations, while patients received advice that understated serious risks. The government alleged that Medicare and Medicaid paid for the resulting Exjade shipments.

BioScrip, Novartis and US Bioservices settled separately. Accredo’s admissions describe what happened inside Accredo’s part of that network.

Accredo Exjade Monthly Refill Scorecards and Referrals

Accredo’s Exjade monthly refill scorecards tied referrals to how long patients kept ordering the drug. Novartis began issuing the scorecards in June 2007, and Accredo admitted knowing what the adherence score measured. Patients who stopped because of side effects stayed in the calculation. So did patients whose physicians told them to stop therapy.

Exjade is an iron-chelation drug approved for patients with iron overload resulting from blood transfusions. Accredo was one of three specialty pharmacies in Novartis’s Exjade Patient Assistance and Support Services network, known as EPASS. Novartis controlled how prescriptions received through that network were distributed among the pharmacies.

The Exjade arrangement gave Novartis a commercially valuable decision about where the patient went. The government’s complaint described undesignated patients as those whose insurers and doctors had not specified a pharmacy. Their prescriptions gave the manufacturer business it could allocate.

The whistleblower’s complaint reported that Florida Medicaid’s average reimbursement per claim for Exjade 500 mg was $5,378 in the first quarter of 2011. A new patient meant access to that repeat business. The complaint also alleged that Novartis paid specialty pharmacies performance rebates or discounts tied to sales benchmarks, and described Exjade rebates tied to refill performance.

In October 2008, Accredo agreed to a plan under which the pharmacy with the highest adherence score would receive 60% of undesignated patient referrals. Each of the other pharmacies would receive 20%. That is how specialty pharmacy refill rates determined referral allocation: the score decided who received most of the new business available for distribution.

Accredo later finished the fourth quarter of 2009 with the highest score. Based on its communications with Novartis, Accredo understood that this entitled it to additional referrals through 2011.

The commercial measure made no allowance for the clinical reasons Accredo knew could end treatment. A patient following a physician’s instruction to stop still left the pharmacy with fewer refills. The score rewarded continued orders, including in circumstances where the prescriber wanted them to end.

The Nurse Calls Followed the Sales Pressure

Accredo’s nurse counseling program developed under pressure to improve its refill score. In late 2007 and early 2008, Novartis expressed dissatisfaction with Accredo’s performance, asked for an improvement plan involving additional nurse intervention and warned that Accredo could lose undesignated referrals.

The manufacturer also made its own objective explicit. Between April and June 2008, Novartis managers told Accredo that its scorecard performance affected Novartis’s ability to meet Exjade sales targets. After further complaints from Novartis in July, Accredo hired a nurse and assigned a sequence of calls to each Exjade patient.

Accredo admitted that its call protocols told the nurse to emphasize the importance of complying with treatment and describe the consequences of untreated iron overload. The protocols covered common reactions such as diarrhea, abdominal pain, fever and rash. They left out less common but more severe reactions, including kidney or liver impairment.

In February 2009, a Novartis Exjade executive visited Accredo and met with its Exjade nurse, who described how she handled patient calls.

The whistleblower’s complaint quoted Novartis management describing how the Exjade scorecards were developed:

The complaint places the scorecards inside the manufacturer’s sales effort. Accredo’s admissions show how the resulting pressure reached a nurse’s assignment and the instructions for patient calls.

The government alleged the same referral pressure at BioScrip. Its amended complaint alleged that Novartis threatened to cut off undesignated referrals or remove BioScrip from EPASS unless it met performance requirements that included higher refill levels. Different pharmacies faced the same commercial demand to keep orders coming.

The Warning Changed, and the Protocol Still Omitted Severe Risks

Accredo updated its Exjade call protocols after the Food and Drug Administration required a black box warning, but the updated instructions still omitted severe kidney and liver risks.

In January 2010, the FDA required Novartis to add a warning highlighting kidney impairment and failure, liver impairment and failure, and gastrointestinal bleeding. The warning said some reported reactions had been fatal.

Accredo admitted that no Novartis representative asked or suggested that it revise its call protocols to require discussion of those serious risks. Accredo then updated the protocols in February. They continued to direct nurses to discuss common reactions, including diarrhea and rash, while leaving out severe reactions such as kidney or liver failure.

The revised script also told nurses to emphasize that compliance could prevent complications from untreated iron overload, with stroke and death among the consequences listed. Patients were to hear about the danger of leaving the condition untreated. The same instructions left out potentially fatal risks of the drug the pharmacy wanted them to keep ordering.

The Referral Incentive and Nurse Calls Ended Together

The additional-referral arrangement and Accredo’s nurse calls ended in April 2012. In late March, Novartis notified Accredo that it would stop allocating extra referrals to the pharmacy with the highest score the following month. In April, Accredo stopped assigning nurses to call Exjade patients about their therapy.

That ending belongs beside the program’s beginning. Accredo added a nurse after pressure over refill performance, maintained protocols emphasizing continued treatment, and ended the nursing assignments when the extra-referral arrangement ended. The company’s admissions connect the commercial program to the patient-facing work at both ends.

What Evidence Is Needed to Prove Fraud?

For a case involving refill incentives, we connect the manufacturer’s offer of business to the pharmacy’s response, the patient calls and the prescriptions billed to government health care programs. Accredo’s admissions identify concrete parts of that connection: monthly scorecards, communications about referral shares, nurse assignments and successive versions of call protocols.

For pharmacy insiders, the useful knowledge may be why a script changed, who reviewed the refill results or how a commercial target became a nursing assignment. Our whistleblower experts work with you to connect that knowledge to the business arrangement and the government’s payments.

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

You Know What the Refill Target Changed

If your scorecards or call scripts show how a manufacturer’s referral promise changed patient calls, talk with our whistleblower experts about the arrangement. We build your strongest pharmacy whistleblower case with you, bring in pharmaceutical fraud whistleblower lawyers who understand specialty-pharmacy incentives, and stay beside you as the case moves forward.