Good Days: The Disease Fund Followed the Donor’s Drug

In the Good Days Chronic Disease Fund settlement, the foundation agreed to pay $2 million to resolve allegations that it helped drugmakers pay kickbacks to Medicare patients through charitable assistance. The government alleged that the funds favored the donors’ own drugs and that reports let manufacturers see where their money went. If you worked on fund eligibility, assistance payments or donor communications, you may recognize the decisions behind those allegations.

Chronic Disease Fund, doing business as Good Days from CDF, was the foundation in this pharmaceutical fraud settlement. The Justice Department announced the agreement on October 25, 2019. The allegations against Good Days concerned conduct from 2010 through 2014. The government set the payment according to what the foundation could afford.

How Do Pharmaceutical Kickbacks Work?

In the alleged Good Days arrangements, manufacturers financed assistance for Medicare patients taking their own products, using the foundation as the payment channel. The copay charity kickback mechanism connected a charitable contribution to prescriptions that generated Medicare payments.

A Medicare Part B or Part D patient may owe a copayment, coinsurance or deductible for a covered drug. In either setting, paying the patient’s share can help a manufacturer sell a drug without lowering its price.

Cost sharing gives patients a reason to consider a drug’s price. The government alleged that these arrangements took price out of the decision while keeping donors’ money away from competing products. Taxpayers financed the Medicare prescriptions that followed. The Anti-Kickback Statute bars drugmakers from using copay coupons or indirect payments to induce Medicare patients to buy their drugs.

That is why the fund’s boundaries matter. A disease name may sound broad. The medicines eligible for assistance can tell a much narrower story.

How Good Days’ Funds Favored a Donor’s Drug

The government’s addendum describes manufacturers asking Good Days to establish funds whose coverage favored particular products. The alleged disease-specific copay fund kickbacks took different forms: a competing drug left out, a drug class selected, travel assistance directed toward an infused product, and flare-up funds that excluded other treatments.

The PNET Fund Covered Afinitor and Left Out Sutent

Novartis allegedly asked Good Days to open a fund for patients with progressive neuroendocrine tumors of pancreatic origin, known as PNET. Its drug Afinitor was approved for that disease. So was Pfizer’s Sutent, and the government said Good Days knew it.

At Novartis’ request, Good Days opened the fund in August 2012. Novartis financed it alone. According to the government, it paid Afinitor copays and did not pay Sutent copays.

The exclusion was the point. A patient taking the competing approved drug had the disease named on the fund but could not receive its help for that prescription. For a foundation employee, the coverage decision and the donor’s request would explain something the fund’s name did not.

The ARI Fund Selected Xtandi Through Its Drug Class

Astellas allegedly sought a fund restricted to androgen receptor inhibitors, the drug class that included Xtandi. Xtandi treated metastatic castration-resistant prostate cancer in patients who had failed chemotherapy. The government said none of the other major drugs for that cancer was an androgen receptor inhibitor.

Good Days already had a fund for the cancer. Astellas had supported it after Xtandi’s launch, then asked for the narrower ARI fund. Good Days opened that fund in July 2013 with Astellas as its sole donor. The government alleged that Good Days knew the request meant earmarking assistance for Xtandi patients and intended the result: those patients received nearly all the disbursements.

A drug-class restriction could do the work of naming the brand. The government’s account connects the donor’s request, the foundation’s understanding and the patients it actually paid.

The Travel Fund Followed Kyprolis to the Infusion Visit

Onyx, owned by Amgen by the time of the settlement, allegedly asked Good Days to establish a travel fund around the time Kyprolis received approval for multiple myeloma. The drug must be infused at a healthcare facility, making the trip part of getting treatment.

The fund ostensibly covered health care travel for patients taking any multiple myeloma drug. Onyx financed it alone. The government said Good Days sometimes called it the “Kyprolis Travel” fund internally and that it functioned primarily to pay travel expenses for Kyprolis patients.

The assistance reached beyond the prescription’s copay. Its practical value to Onyx lay in helping patients reach the facility where its drug was administered. The broad description and the internal name told different stories about whom the fund served.

Flare-Up Funds Left Other Treatments Outside

Questcor, the Acthar Gel maker owned by Mallinckrodt by the time of the settlement, allegedly requested separate funds for exacerbations of multiple sclerosis, lupus and rheumatoid arthritis. Exacerbations meant flare-ups. Good Days opened the funds, and Questcor financed them alone.

According to the government, the funds excluded other drugs treating the underlying diseases. The multiple sclerosis fund did not cover other multiple sclerosis treatments, and the same exclusion operated in the lupus and rheumatoid arthritis funds.

The narrowing happened in the definition of the condition being funded. Calling assistance a flare-up fund gave it a medical description while leaving Acthar as the supported treatment. Someone who handled the coverage rules would see which prescriptions the wording admitted and which it kept out.

What Good Days Told Its Donors

Good Days allegedly supplied information that let manufacturers connect their contributions to assistance for their own drugs. Some reports described past payments. Others showed what the foundation expected to spend next. That distinction matters to someone who prepared a donor report or reviewed a funding request.

Dendreon Could Compare Its Patients With Competitors’ Patients

Dendreon allegedly asked Good Days to create a metastatic castration-resistant prostate cancer fund and initially financed it alone. The government alleged that Good Days repeatedly provided counts of patients receiving assistance for Dendreon’s Provenge and for the competing therapy Taxotere, together with the average assistance amounts for each group. Taxotere was a less costly injectable treatment.

After Zytiga’s approval, Good Days also supplied counts of patients receiving assistance for that drug. The government said these reports let Dendreon confirm that its money primarily covered Provenge copays even with competing treatments on the market.

The report’s categories carried the commercial information. A total for the disease fund would describe its overall work. Counts and average payments broken out by drug showed the donor how its product fared against the others.

Onyx Learned What Kyprolis Patients Would Need Next

Good Days also operated a multiple myeloma copay fund covering Kyprolis and other medicines, with support from several manufacturers. This was separate from the travel fund. The government alleged that Good Days gave Onyx both actual and anticipated spending on Kyprolis copays.

According to the addendum, Onyx then paid enough to cover the anticipated Kyprolis spending. The fund served multiple drugs, but the report let a donor size its contribution around its own product.

For staff inside the foundation, the forecast and the request sent to Onyx would show one side of the transaction. Inside the manufacturer, the decision about how much to contribute would show the other.

Questcor Learned the Cost of Its Referrals

The government alleged that Good Days’ reports told Questcor how much the foundation had spent on Acthar patients and how much more it needed for patients Questcor referred. The fund definitions and the reports worked together: the definitions limited the treatments covered, while the reports described the funding needed for the donor’s patients.

The report, its drug categories and the money that followed show how the government connected donations to sales.

What the Good Days Settlement Required

Good Days entered a three-year Integrity Agreement with the Department of Health and Human Services’ Office of Inspector General. The Justice Department said it required measures designed to ensure independent operations and lawful arrangements and interactions with manufacturer donors.

The agreement also required compliance certifications from the board of directors and detailed reviews by independent review organizations.

The Same Pattern in Patient Transfers and Pharmacy Data

Other cases connect foundation assistance to drug revenue through patient transfers and pharmacy reporting. A whistleblower’s complaint against Incyte alleged that the company moved some Medicare patients from free Jakafi to foundation assistance so their prescriptions would produce Medicare claims:

Incyte later agreed to a separate $12.6 million settlement over alleged foundation payments of Jakafi copays. The economic connection is plain: supplying free medicine and financing a copay lead to different revenue for the manufacturer.

A specialty pharmacy could handle another part of that connection. In a separate resolution, Advanced Care Scripts acknowledged relaying foundation data to Teva so Teva could match contributions to spending on Copaxone patients. The pharmacy also acknowledged sending application files consisting almost entirely of Copaxone patients when funds reopened. Those batch-file and application-timing arrangements show why the foundation, donor and pharmacy may each hold part of the same account.

What Proof Do You Need as a Whistleblower?

For a case involving fund design and donor information, the useful evidence connects the coverage decision, the assistance paid and what the manufacturer requested or learned. In the Good Days allegations, that meant drug exclusions, patient counts, spending forecasts and reports that informed contributions. We work with you to connect the part you know to the government-paid prescriptions it supported.

A foundation employee may understand why a fund’s rules changed or why a report separated patients by drug. A manufacturer employee may know what the same report meant to a donation decision. A pharmaceutical whistleblower can bring that knowledge of the business to a case even when the payment trail crosses organizations.

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

You Know Why the Fund Was Drawn That Way

If you handled drug eligibility rules, donor reports or the funding decisions behind patient assistance, speak to one of our whistleblower experts about how the fund was drawn. We build the case with you and bring in pharmaceutical kickback whistleblower lawyers who understand the connection between charitable assistance and Medicare prescriptions. We stay with you through the whole process, using your knowledge of the fund and its donors to build your strongest pharmaceutical whistleblower case.