Following AbbVie Lawsuit, Government Scrutinizes Industry-Provided Drug Educational Support Services
A federal investigation is underway into whether or not the nursing and other medical services provided by some pharmaceutical companies to doctor’s offices actually violate the law due to serving an illegal commercial service.
This morning the Wall Street Journal raised the question as several companies are under investigation over the notion of the services being part of a kickback scheme. This week California’s Insurance Commissioner filed a lawsuit against Illinois-based AbbVie over allegations of a kickback scheme to support sales of blockbuster rheumatoid arthritis treatment Humira in the state. Part of the charges leveled by the insurance commissioner argues that the nurses employed by AbbVie to new Humira patients are not there to benefit the patients or doctors, but to benefit AbbVie. The commissioner said that AbbVie will only provide the nurses if the doctors continue to prescribe Humira to patients.
The Journal reported that other companies such as Amgen, Biogen, Bayer, Eli Lilly, Gilead Sciences and Sanofi, all offer these kinds of services and more. The companies say the assistance they field benefits patients be helping defray copay costs and by providing disease education. However, in its report, the Journal said critics and federal prosecutors are concerned that the employees being fielded by drug companies are there to encourage the use of drugs prescribed by the companies that pay for the assistance, rather than alternative treatments. The Journal added that critics also argue the use of these extension-employees actually contributes to the high costs of healthcare because they are “pushing higher-priced drugs on people.”
There are laws on the books against this. A federal anti-kickback law “prohibits payments to induce drug prescriptions or other medical care that is reimbursed by government health programs.” The Journal reported.
AbbVie said it has complied with all state and federal laws regarding its Ambassador program. However, other programs run by different pharma companies have shut down, the Journal said. Following a probe by the U.S. Attorney’s office in New York, Sanofi shut down its certified diabetes educator program. The certified nurses in that program assisted patients with questions related to diabetes, as well as trained them on how to use Sanofi’s diabetes treatments. The Journal reported that Sanofi is cooperating with the latest investigation.
Gilead Sciences has been probed over assistance it provided to patients who were prescribed with hepatitis C drugs Sovaldi and Harvoni. Federal authorities have probed Biogen for “educational assistance” it provided for multiple sclerosis patients, the Journal added.
The nursing and medical assistance programs aren’t the only types of issues some investigators have had with the industry. Companies have also been investigated over charitable donations to 501(c)(3) organizations that provide financial assistance to Medicare patients. Pharma companies are allowed to provide philanthropic support to charities that provide patient assistance. However, companies are not allowed to use their financial influence to urge the charitable organizations to give preference to their own medications. The companies are further prohibited from providing financial assistance to people who receive their medications through government assistance programs such as Medicaid or Medicare.
Despite those rules, some companies have come under investigation for supporting those organizations. In 2016 BioSpace highlighted allegations made in court that Celgene had donated millions of dollars to charities to help patients afford high-priced cancer drugs the company manufactures and markets. The government said it was a scheme to turn a profit of billions of dollars. In August 2017 Celgene agreed to pay $280 million to settle the allegations of fraud.