Accredo: The Refill Score That Ignored Why Patients Stopped

In the Accredo Exjade settlement case, Accredo Health Group agreed to pay $60 million to resolve allegations that it accepted patient referrals from Novartis in return for promoting Exjade refills. Accredo admitted that it knew the refill score counted patients who stopped because of side effects or their physician’s instructions. For someone working with referral allocations, adherence reports or nursing scripts, the case reaches the decisions behind those records: what earned the pharmacy more patients, and what its nurses were told to say.

A whistleblower brought the allegations to federal law enforcement, and the government joined the case. The U.S. Attorney’s Office for the Southern District of New York handled the civil case, with investigative work by the Department of Health and Human Services’ Office of Inspector General and the Medicaid Fraud Control Units for New York, Washington, California and Ohio.

How the Exjade Referral Scorecards Worked

Novartis controlled a valuable source of business: prescriptions that its Exjade network could assign to a pharmacy. Accredo was one of three specialty pharmacies in that network, called Exjade Patient Assistance and Support Services, or EPASS.

Exjade treats iron overload caused by blood transfusions. The pharmacy’s work included more than dispensing it. In its November 2015 settlement admissions, Novartis described selecting the pharmacies for services including refill reminders, drug administration instructions and insurance reimbursement assistance. Nearly all Exjade prescriptions dispensed through the network went by mail. Pharmacies called patients or caregivers for consent before sending refills.

That phone call connected patient support to the next shipment. The manufacturer could influence who received the next patient as well.

Doctors sent prescriptions and registration forms to LASH Group, the vendor administering EPASS for Novartis. Some prescriptions went to a particular pharmacy because of insurance requirements or physician preference. Novartis directed where the remaining, undesignated prescriptions went. Initially, it divided that business evenly among the pharmacies.

Accredo admitted that Novartis began issuing monthly Exjade Scorecards in June 2007. The adherence measure tracked how long patients continued ordering refills. In late 2007 and early 2008, Novartis told Accredo that its performance was disappointing and asked for an improvement plan involving additional nurse intervention. Accredo also heard that it could lose undesignated referrals if it kept lagging behind the other pharmacies.

The October 2008 plan made the incentive explicit: the pharmacy with the highest adherence score would receive 60% of undesignated referrals, and each of the other pharmacies would receive 20%.

Novartis’s later admissions explain why that allocation mattered commercially. More referrals meant more dispensing fees, typically more rebates, and higher sales revenue for the pharmacies. The next patient had a price.

The Score Kept Counting Patients Whose Doctors Said Stop

Novartis’s own settlement admissions show whose stopped refills no longer counted against the pharmacy:

The pharmacies were already collecting reasons patients stopped refilling and regularly sending that information to LASH. Novartis admitted that, by 2007, the data showed physician decisions and side effects were common reasons patients stopped ordering.

We see a refill contest that counted a doctor’s decision to stop treatment against the pharmacy. Following that decision could hurt its chance of winning more business. The information explaining the stop existed. The score did not remove it.

For an insider, the definition behind an adherence report matters as much as the result printed at the top.

The Nurse Protocols Emphasized Staying on Exjade

Accredo’s admitted call protocols emphasized continued treatment while omitting specified serious risks. The omissions persisted after the drug received a stronger warning.

In July 2008, after renewed complaints from Novartis about performance, Accredo hired a nurse and assigned a sequence of calls to each Exjade patient. The pharmacy’s protocol told the nurse to stress compliance and describe the consequences of untreated iron overload. It listed common adverse reactions, including diarrhea and rash, but omitted the less common, more severe risks of 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.

In January 2010, the Food and Drug Administration required a black box warning addressing kidney failure, liver failure and gastrointestinal bleeding, including reactions that had been fatal in some reported cases. According to Accredo’s admissions in the Justice Department’s account of the settlement, no Novartis representative then asked or suggested that Accredo revise its protocols to require discussion of those serious risks.

Accredo revised its protocols in February 2010. The revised version still directed nurses to discuss common reactions while omitting severe risks such as kidney or liver failure. It continued emphasizing the consequences of untreated iron overload, now including stroke or death.

The difference was in the conversation the pharmacy designed. Its instructions emphasized what could happen without treatment while leaving specified serious treatment risks out of the required discussion. That is a concrete gap a nurse, clinical manager or protocol reviewer could recognize.

Novartis’s later admissions add another detail: its clinical team advised and trained the specialty pharmacies on the new warning, but Novartis did not ask them to revise their call scripts to require nurses to discuss the serious risks.

The Contract Left Out the Referral Formula

The written EPASS agreements did not explain how Novartis determined the volume of undesignated patients each pharmacy would receive. Novartis admitted that omission covered both the original agreements and subsequent amendments through March 2012.

The scorecards and allocation communications supplied the business terms missing from that contract language. Accredo admitted that, after it obtained the top adherence score in the fourth quarter of 2009, Novartis notified it that it would receive additional undesignated patients. The pharmacy understood that it had earned the larger allocation for later quarters.

The arrangement also had a clear ending. In March 2012, Novartis told the pharmacies that, starting in April, referral allocations would no longer depend on their scorecard rankings. Accredo stopped assigning nurses to the Exjade calls in April 2012.

The scorecards, allocation messages and staffing decisions showed how the relationship operated.

What Accredo Admitted and What the Government Alleged

Accredo admitted the facts about its scorecards, referral arrangement and nursing protocols. The government alleged that Novartis provided patient referrals and related benefits in exchange for Accredo’s refill recommendations, and that the resulting Exjade shipments generated Medicare and Medicaid reimbursements.

The government alleged that Novartis violated the Anti-Kickback Statute and the False Claims Act by offering the referral incentives and causing false Medicare and Medicaid claims. Its allegations concerned both patient care and the health care programs paying for prescriptions. Accredo also agreed to cooperate with the government’s claims against Novartis.

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

What a Pharmacy Insider Would Compare

The strongest account connects the referral promise to what happened inside the pharmacy and what the government paid for. We look at how the parts fit together with the person who understands the work.

Different staff members see different decisions. A nurse may understand what the protocol omitted. A referral manager may know why the next group of patients arrived. Someone working on the account may know what Novartis expected in return. Those perspectives help explain a business arrangement that the contract itself left incomplete.

How the Pattern Reached Other Pharmacies

BioScrip was another Exjade pharmacy whose refill performance Novartis used to shape the network. In its own settlement admissions, Novartis described telling BioScrip that it could lose business unless performance improved. BioScrip presented an improvement plan that included encouraging patients who had stopped ordering Exjade to resume refills.

Novartis later attributed BioScrip’s stronger score to its use of nurses and pushed Accredo and U.S. Bioservices toward similar programs. The manufacturer was comparing pharmacies, allocating business and encouraging the practices it associated with higher refill rates. Accredo’s experience sat inside that wider commercial arrangement.

A separate long-term-care pharmacy kickback case shows another use of scorecards and clinical staff. The Aranesp whistleblower complaint alleged that PharMerica staffed a call center with nurses and other healthcare personnel to encourage physicians to switch patients from Procrit to Aranesp. It also alleged:

That complaint tied the score to employee bonuses. Accredo’s admissions tied the score to future patients for the pharmacy. In each account, the internal performance measure helps explain the financial incentive behind a clinical conversation.

You Know What the Scorecard Rewarded

If you saw referral promises shape nurse scripts or refill targets, speak with our whistleblower experts about how the referrals were earned. We work with you to build your strongest pharmacy fraud whistleblower case around the decisions you understand, bring in pharmacy fraud whistleblower lawyers who know manufacturer referral arrangements, and stay beside you as the case moves forward.