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Meanwhile, federal enforcement actions over improper patient assistance continue to arise
Healthwell Foundation, one of the leading 505(c)3 charities that manage patient assistance programs (PAPs) for the pharma industry, has opened a contact center in Frederick, MD, to manage queries and patient support. The facility will have 75 dedicated case managers; the organization says that peak demand can rise to 26,000 calls per month from patients seeking financial support for prescriptions. In 2018, Healthwell Foundation disbursed over $512 million to over 117,500 underinsured Americans who have high out-of-pocket costs; these occur through 50 distinct disease-specific programs that the organization manages.
All that being said, PAPs continue to be a friction point between manufacturers and the federal government. In March, the Senate Finance Committee issued a request to HHS to review recent settlements over violations of the False Claims Act involving PAPs.
In April, The Dept. of Justice announced settlements with three companies—Jazz Pharmaceuticals, Lundbeck and Alexion Pharmaceuticals, totaling $122.6 million, for alleged violations of the False Claims Act. Later that month, two more companies--Astellas Pharma US and Amgen--agreed to pay a total of $124.75 million for similar allegations. (None of these settlements involved accepting a plea deal.) The basic problem, which has been batted back and forth by HHS and DoJ for years, is how copay or other assistance can be handled for Medicare or Medicaid patients; additionally, there needs to be a clear separation between the financial aid pharma companies provide, and the patients who qualify for assistance. (A good review of this controversy was published by Baker Donelson Bearman Caldwell & Berkowitz, P.C., and the American Bar Assn.)
In June, Mallinckrodt settled on some alleged violations over its Acthar drug, but said it would contest anti-kickback allegations.