Nurse Counseling as Drug Promotion: Who Controls the Refill Conversation?

Specialty pharmacy nurse counseling kickbacks can turn a patient call into a sales tool when a manufacturer rewards the pharmacy for keeping patients on its drug. In the Exjade cases, the government alleged that Novartis used patient referrals to push pharmacies to assign nurses to encourage refills while understating serious risks. The pharmacy’s score counted patients who stopped because of side effects or a doctor’s instructions. If you worked those calls or managed the staff making them, the question is familiar: whose decision was the conversation supposed to serve?

Exjade treats iron overload resulting from blood transfusions. The government described Novartis launching it through a closed network of three specialty pharmacies: BioScrip, Accredo and US Bioservices. The manufacturer controlled a source of new patients, and the pharmacies provided the clinical voice on the telephone. The government’s account of the Novartis arrangement connects those roles to the demand for more refills.

Patient Education With a Sales Target

Manufacturer control over referrals can give a pharmacy a financial reason to shape its counseling around continued product use. A referral brings dispensing business. In a limited network, the power to send that business elsewhere can reach right into the nursing schedule.

The industry’s physical and financial relationships run along different paths. Drugs move from manufacturers through wholesalers to dispensers, while manufacturer payments and incentives also shape those relationships. In Exjade, another valuable asset traveled through the arrangement: the next patient. The government’s account describes the Exjade Patient Assistance and Support Services network, known as EPASS, putting allocation of that business in Novartis’s hands.

The concern about education serving sales predates these cases. In its 2003 guidance for pharmaceutical manufacturers, the Department of Health and Human Services’ Office of Inspector General described how manufacturer influence over educational content or presenters could turn a program toward inappropriate marketing. It also identified funding conditioned on product purchases as a kickback concern even when the educational purpose was legitimate.

For a nurse or pharmacy manager, that puts the program’s purpose in concrete terms. Who determined which patients received calls? What did the nurse have to emphasize? What happened to the pharmacy’s business when patients stopped treatment? The Exjade admissions answer those questions with scorecards, protocols and a change in staffing when the referral incentive ended.

The Refill Scorecard Controlled the Referral Flow

Specialty pharmacy refill rates determined referral allocation under the Exjade plan Accredo admitted accepting. Novartis began issuing monthly Exjade Scorecards in June 2007. The adherence score measured how long patients continued ordering refills.

Accredo admitted knowing that Novartis did not exclude patients who stopped because of side effects or because their physicians directed them to stop therapy. A doctor’s decision to discontinue treatment could therefore count against the pharmacy’s performance. The score rewarded persistence without removing those clinical reasons for stopping.

In October 2008, Accredo agreed to a plan allocating 60% of undesignated patient referrals to the pharmacy with the highest adherence score and 20% to each of the other two pharmacies. These were referrals without a pharmacy specified. The Accredo settlement announcement records both the allocation formula and the company’s factual admissions.

That arrangement gave the same refill two commercial consequences. It extended the existing patient’s purchases and helped the pharmacy compete for the next patient’s business. The nurse’s conversation sat between a clinical decision and a manufacturer-controlled stream of referrals.

The government’s amended complaint described the pressure on BioScrip in equally direct terms. It alleged that Novartis threatened to cut off undesignated referrals or remove BioScrip from EPASS unless it met performance measures that included higher refill levels. The complaint also alleged that Novartis increased BioScrip’s per-shipment Exjade rebate from $13 to $20 in January 2008. Continued dispensing could bring both another rebate and a better chance of receiving new business.

When Nurse Counseling Scripts Downplay Side Effects Under Manufacturer Pressure

In the Exjade cases, manufacturer pressure reached patients through specialty-pharmacy nurses. The government alleged that Novartis encouraged pharmacies to promote Exjade as preventing organ damage even though the FDA had called that claim unsubstantiated. Patients heard reasons to keep taking the drug while hearing too little about the kidney and liver risks.

Accredo admitted that its 2008 protocols told nurses to emphasize the importance of staying on Exjade and describe the consequences of untreated iron overload. They directed nurses to discuss common adverse reactions, including diarrhea, abdominal pain, fever and rash. They left out less common but more severe reactions such as kidney or liver impairment.

The safety information then became more explicit. In January 2010, the FDA required a black box warning covering 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 after that warning. Accredo updated the protocols in February 2010, but they continued to direct nurses toward common reactions such as diarrhea and rash while leaving out the more severe risks, including kidney or liver failure. The label changed. The imbalance in the counseling instructions remained.

The government’s complaint supplies a different view of the same problem at BioScrip: the preparation of the person making the call.

The alleged assignment came before training on the drug or its side effects. The instruction to keep patients on treatment was already in place.

The Calls Stopped When the Referral Reward Ended

Accredo stopped assigning nurses to Exjade therapy calls after Novartis ended the reward of extra referrals for the highest score. Its admissions place the notice in late March 2012 and the end of the nurse assignments in April 2012, when the referral change took effect. The staffing decision followed the commercial incentive.

The pharmacy resolutions show different parts of the arrangement. In January 2014, the Justice Department announced BioScrip’s approximately $15 million federal and state resolution. The allegations concerned refill counseling influenced by referrals and rebates while understating risks. BioScrip made extensive factual admissions and agreed to cooperate.

The Justice Department’s May 2015 announcement described Accredo’s $60 million settlement. Accredo admitted facts about the scorecards, referral allocation and call protocols, and agreed to cooperate against Novartis. Those admissions connect the commercial arrangement to instructions given to nurses.

US Bioservices supplied an important variation. It admitted that, to improve its adherence score, it trained nurses to tell patients about severe consequences of untreated iron overload and that common Exjade side effects typically went away with time. Its nurses did not use written scripts. The Justice Department announced its $13.4 million settlement in August 2017. Training and expectations carried the message without a script for each call.

Novartis’s own $370 million civil False Claims Act settlement, announced in November 2015, covered the Exjade and Myfortic specialty-pharmacy arrangements. The government alleged that referrals and rebates bought recommendations, and reported extensive factual admissions by Novartis. Exjade put the pressure on continued refills.

What Are Red Flags for Pharmacists?

Refill targets tied to manufacturer referrals, counseling instructions that omit serious risks, and scores that count physician-directed stops against the pharmacy are the central warning signs in the Exjade accounts. For a specialty pharmacist, manufacturer referral scorecard evidence becomes more revealing when it is read alongside what staff were trained to say.

Network agreements, scorecards, call instructions and rebate records connect the pharmacy’s commercial incentives to its clinical work. We work through those connections with you, including how the scores treated patients whose doctors stopped therapy and how staff were trained when there was no written script.

The Employer Can Gain From the Clinical Decision

The financial beneficiary of a pharmacy decision can be the healthcare business employing the clinician. A 2020 University of Portsmouth thesis on pharmacists’ decision-making surveyed working pharmacists using hypothetical cases and moral statements.

The thesis makes a useful point about where the benefit goes:

In Exjade, the pharmacy’s opportunity to receive new patients depended on the refill performance of patients already in its care.

A separate whistleblower complaint against US WorldMeds alleged another way nursing services could carry financial value. It alleged that the company supplied paid nurses at no charge to doctors and patients for initial APOKYN administration and dose adjustment, while encouraging doctors to bill as though they had provided the service. The complaint also alleged bonuses for nurses who obtained paperwork allowing patients to continue their prescriptions. Those allegations concern free services and billing as well as continued drug use. They show why the work performed, the business receiving its value and the payment claim belong in the same inquiry.

Can a Pharmacy Kickback Case Pay a Whistleblower Reward?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. The Novartis case began with a whistleblower, and the government joined it, alleging violations of the Anti-Kickback Statute and the False Claims Act.

When Medicare or Medicaid pays for prescriptions resulting from kickbacks, taxpayers fund the sales incentive through their health care programs. A manufacturer can face a False Claims Act case for causing a pharmacy to submit those bills. The referral has value even when no cash changes hands between the manufacturer and the pharmacy.

When Your Patient Calls Carry a Sales Target

If you are a nurse, pharmacist or pharmacy manager who knows how referral targets shaped patient calls, speak to one of our whistleblower experts about the targets your staff were given. We tie those calls to the referral decisions and the government’s payments, and shape them into a case built around what you saw. We bring in pharmaceutical fraud whistleblower lawyers who understand specialty-pharmacy kickbacks and remain your partners throughout the case.