Patient Assistance Programs Offer Limited Help
Many patient assistance programs operated by pharmaceutical companies provide no or limited assistance to low-income Medicare beneficiaries enrolled in the prescription drug benefit, regardless of whether beneficiaries have reached the "doughnut hole" coverage gap, the New Orleans Times-Picayune reports. Under the doughnut hole, Medicare beneficiaries are responsible for 100% of annual prescription drug costs between $2,250 and $5,100 (Walsh, New Orleans Times-Picayune, 12/13).
Several pharmaceutical companies ended their PAPs after the Medicare prescription drug benefit began over concerns that the programs could violate federal antikickback laws. According to the document, PAPs could violate federal antikickback laws in the event that the programs provided no-cost or low-cost medications to low-income Medicare beneficiaries who have reached the doughnut hole and required beneficiaries to use treatments manufactured by their pharmaceutical company operators.
A new guidance document issued in April said pharmaceutical companies can legally operate PAPs, provided that the programs meet certain criteria (California Healthline, 5/12). The document said that pharmaceutical companies could provide their medications to charity organizations, which could distribute the treatments to low-income Medicare beneficiaries.
According to the Times-Picayune, "Few have followed that advice, preferring to keep control over their own drug distribution chains." Some PAPs provide limited assistance to low-income Medicare beneficiaries who meet certain criteria, but most of the programs provide no assistance to beneficiaries who have reached the doughnut hole, the Times-Picayune reports.
Ken Johnson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said, "All we wanted to do was provide help to people struggling to pay their bills, and instead we were confronted with legal hurdles."
Bristol-Myers Squibb spokesperson Laura Hortas said the PAP operated by the company in most cases does not provide assistance to low-income Medicare beneficiaries who have reached the doughnut hole but makes exceptions for beneficiaries who have "life-threatening conditions" and face "serious financial hardships."
In 2007, a PAP operated by GlaxoSmithKline will begin to provide no-cost medications to low-income Medicare beneficiaries who have reached the doughnut hole and have spent at least $600 out of pocket. A PAP operated by Eli Lilly provides 30-day supplies of three drugs -- Zyprexa, Forteo and Humatrope -- to low-income Medicare beneficiaries for $25, and a program operated by Schering-Plough requires beneficiaries to prove that their medication costs exceed 3% of their annual household incomes to participate.
Some advocates maintain that the limited assistance provided by PAPs to low-income Medicare beneficiaries who have reached the doughnut hole restricts their access to necessary medications.
Martha Zimmerman, a clinical social worker at Duke University Medical Center, said, "This is the first time we've had to say, 'No, we can't get your medicines anymore.'"
Linda Jones -- director of Senior Rx, an organization that helps low-income Medicare beneficiaries in New Orleans -- said, "It's sad to say, but there isn't that much support out there for people who fall into the doughnut hole." Jones added, "We are dealing with drug companies, we're in their hands. As far as there being something available, honestly there isn't much" (New Orleans Times-Picayune, 12/13).