Advanced Care Scripts: The Batch Files Behind Copay Funding

In the Advanced Care Scripts Copaxone settlement, the specialty pharmacy agreed to pay $3.5 million to resolve allegations that it helped Teva pay Medicare patients’ copays through charitable foundations. Advanced Care Scripts acknowledged relaying foundation spending data, reporting patients waiting for assistance and sending batches of applications when funding became available. For a pharmacy or patient-support employee, the revealing part is the work between those events: who knew which patients were waiting, who knew money was coming, and whose applications arrived when the fund reopened.

The Pharmacy Behind the Copaxone Funding

Advanced Care Scripts provided benefits investigation services to certain patients prescribed Copaxone, Teva’s drug for multiple sclerosis. The Justice Department’s announcement also described ACS dispensing Copaxone. From approximately October 2006 through January 2015, it worked as a contracted vendor for Teva. That put the pharmacy inside the patient-assistance process, with information about patients’ prescriptions, eligibility for foundation support and whether they were still waiting for help.

This pharmaceutical fraud case reached the pharmacy’s role in coordinating assistance. Teva later agreed to its own $425 million Copaxone copay settlement, announced October 10, 2024.

Advanced Care Scripts Copaxone Batch File Applications

Advanced Care Scripts sent batches of applications to foundations promptly after learning that their copay funds had reopened. The batches consisted almost entirely of Copaxone patients. The sequence ACS acknowledged begins earlier, with the information it passed to Teva while patients were waiting.

Foundation Spending Reached the Manufacturer

ACS relayed data from the Chronic Disease Fund and The Assistance Fund to Teva. The data allowed Teva to correlate its payments to the foundations with the money those foundations spent on Copaxone patients.

That connection matters in copay charity kickback cases. A donation and a prescription may sit in different organizations’ records. Here, the pharmacy supplied information that connected the donor’s payments with the product receiving support.

The Waiting List Could Shape the Next Payment

When the foundations lacked money and stopped accepting new applications, ACS regularly told Teva how many of its Medicare Part D patients were waiting. These patients had Copaxone prescriptions and met the criteria for foundation copay coverage.

ACS acknowledged that at least one employee understood Teva would use that waiting-patient count to help determine its next payment to a foundation.

Teva sometimes gave ACS advance notice of its foundation payments. That placed information about the pending money at the same pharmacy that knew which patients needed it.

The Fund Reopened and the Batch Arrived

Once ACS learned that a foundation had reopened its copay fund, it promptly sent the batch file. ACS often then received notice that most or all of the submitted applications had been approved. As each Copaxone patient gained coverage, ACS removed that patient from its reports to Teva of people still waiting.

Someone reading only the donation ledger would miss the waiting reports, the advance notice and the applications that followed the reopening.

How Do Pharmaceutical Kickbacks Work?

In the Advanced Care Scripts case, the government alleged that manufacturer money traveled through charitable foundations to pay patients’ Medicare copays and encourage purchases of the manufacturer’s drug. The pharmacy’s acknowledged data sharing and application timing explain how the parties could coordinate that route.

The economics start with the patient’s share of the bill. A Medicare prescription can leave the patient owing a copayment, coinsurance or a deductible. The Justice Department explained that Congress included cost sharing partly to make patients sensitive to price and put a check on healthcare costs, including what manufacturers could charge. The Anti-Kickback Statute prohibits a manufacturer from paying patients, directly or indirectly, to induce purchases of its Medicare-covered drugs.

Patient-support staff work near an important divide in the business. Manufacturer copay coupons reduce patients’ immediate out-of-pocket costs, but those coupons typically exclude people covered by federal health care programs. In its copayment-coupon guidance, the HHS Office of Inspector General pointed manufacturers wishing to help federal-program patients toward independent charities. That makes the independence of the foundation central to the arrangement.

The Inspector General’s foundation guidance called for assistance independent of donor control, awarded without regard to the donor’s product and based on a consistent measure of financial need. It also addressed the information flowing back: manufacturers should not receive data that lets them correlate donations with subsidized prescriptions for their own products.

The government alleged that Teva increased Copaxone’s price while directing foundation funding to its patients. The patient received help with the copay. Taxpayers financed the Medicare payment behind the prescription.

The foundations also settled. In late 2019, the Chronic Disease Fund paid $2 million and The Assistance Fund paid $4 million to resolve allegations that they helped drugmakers pay kickbacks to Medicare patients.

The Separate Biogen Settlement

Advanced Care Scripts agreed to a separate $1.4 million settlement involving Biogen’s multiple sclerosis drugs Avonex and Tysabri. The Justice Department announced that resolution on December 17, 2020, alongside Biogen’s own $22 million settlement. The alleged arrangement again involved the Chronic Disease Fund, The Assistance Fund and batches of patient applications.

Here, the government’s account shows a further commercial purpose: moving people who were receiving free drugs into a system that generated Medicare revenue for the manufacturer.

For Avonex, the government alleged that Biogen identified Medicare-eligible patients in its free-drug program in 2011 and arranged for ACS to transfer them to foundation assistance. Biogen paid the Chronic Disease Fund, ACS promptly sent batches of applications, and the foundation approved most of them. The patients’ purchases could then generate Medicare revenue for Biogen while the foundation covered their copays.

For Tysabri, the government alleged that Biogen arranged similar transfers to The Assistance Fund in 2012. Biogen made payments, and ACS followed each with batch files for Medicare-eligible patients receiving free drugs. The foundation paid most or all of those patients’ copays.

Under the alleged arrangement, a patient already receiving medicine for free became a patient whose prescription brought Medicare reimbursement to the manufacturer. Funding the copay helped open the way to the larger payment. The pharmacy’s application work connected those business decisions to individual patients.

What Evidence Is Needed to Prove Fraud?

For this kind of specialty pharmacy kickback arrangement, the useful evidence connects patient-assistance records with manufacturer funding and the prescriptions Medicare paid for. ACS’s acknowledged practices make that connection concrete: foundation spending data, waiting-patient reports, payment notices, application batches and approval results.

Different employees may know different parts of the sequence. Someone handling applications may understand why a particular batch was ready to send. Someone maintaining the waiting report may know which patients disappeared after approvals. Someone communicating with the manufacturer may know why the count was requested. That knowledge gives the documents their meaning, and it is what our whistleblower experts explore with you.

Free Drugs, Foundation Funding and Medicare Revenue

A whistleblower’s complaint against Incyte described a similar alleged financial shift for Jakafi: moving patients from free drugs to foundation copay coverage so their prescriptions would generate Medicare claims. The complaint also described information returning to the manufacturer:

The parallel joins the two features visible in the ACS matters: an alleged move from free medicine to reimbursed prescriptions, and information showing the manufacturer where its foundation money went. Across those accounts, patient support also served the manufacturer’s interest in getting its own prescriptions paid.

The Whistleblower’s Share of the Recovery

The Biogen and ACS settlements resolved allegations originally brought in whistleblower lawsuits under the False Claims Act. In that announcement, the Justice Department reported an expected whistleblower’s share of approximately $3.96 million from the recovery associated with the announced settlements.

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

You Know Why the Batch Went Out

If you know who requested the waiting list or why a batch went out as a fund reopened, talk with our whistleblower experts about the coordination you saw. We build your case around the pharmacy work, the manufacturer’s decisions and the Medicare payments, and bring in pharmaceutical kickback whistleblower lawyers who understand patient-assistance arrangements. You have us beside you throughout the case, connecting what you know inside the business to the strongest case you can bring.