Leaders from charitable organizations that provide the safety net so patients can meet their healthcare costs and access their required medical treatment have concerns with the widening gap between patient financial needs and available resources. They were speaking at the Cost-Sharing Roundtable in Washington, DC, co-hosted by the Patient Access Network Foundation and The American Journal of Managed Care®.
“The gap between patient financial needs and available resources is widening,” said Clorinda Walley, president, Good Days, during a panel titled "The Patient Access Safety Net: How Many Need Help? How Many are Helped?" Walley joined Dan Klein, president and CEO, the Patient Access Network (PAN) Foundation, and Michele McCourt, senior director, CancerCare Co-Payment Assistance Foundation, at the Cost-Sharing Roundtable, co-hosted by the PAN Foundation and The American Journal of Managed Care®, on February 23, 2018, at the Barbara Jordan Conference Center in Washington, DC.
Klein told the audience that PAN offers financial assistance to anywhere between 150,000 to 250,000 individuals on an annual basis. “We are 1 of 7 fairly large charities, and we provide financial support to about 50% of patients in need. However, the assistance we provide is for less than half of those who are in need,” Klein said.
“Of the 35 programs we had running, only 15 are currently active,” said Walley, agreeing with Klein’s assessment of charities falling short of the need. “A majority of our active programs are for oncology,” she said, adding that 51% of the programs that Good Days used to support are now closed due to lack of funding.
McCourt provided similar statistics, saying that CancerCare provided assistance to 25,000 individuals in 2017; less than 7% of the requests that the organization received were denied while 20% of those seeking aid were turned away due to lack of funding. “That points to the need that’s not been fulfilled,” she said.
Access to aid via specific programs may be determined by the timing and availability of funding, Klein explained. Changing demands have outstripped the availability of funding. “Across the 7 to 9 charities that we track, 125 different indication-specific programs are offered—about 50% to 60% are available at a given time,” Klein said, adding that the recent trend has been for funds to open and close, while a decade ago, there was more continuity and the programs stayed open, even if the funds were reduced.
The pharmaceutical industry has been on the edge since the Department of Justice (DOJ) started issuing subpoenas as part of its investigations into pharma donations to patient assistance charities. “This has had a big impact on what we receive from our donors,” Walley said.
“It is important that we parse this carefully,” said Klein. “There are differences between what [drug] manufacturers do with charitable assistance versus co-pay programs versus patient assistance programs. Co-pay assistance is being paid to charities in a different way.”
Additionally, the growing cost-sharing in people with diseases makes it harder to keep disease funds open all through the year. “So, donors are working more on a quarterly schedule, rather than donating money whenever our funds run dry.”
When asked to share their process for soliciting funds, Walley said that they can either submit grant requests or directly reach out to the advocacy and compliance teams within the pharmaceutical company.
“We speak more with lawyers nowadays,” McCourt admitted. “There are a lot of portals, processes, and it involves a lot of waiting.”
Charitable foundations have to follow certain rules and guidelines, developed by the Office of the Inspector General (OIG), that stemmed from the anti-kickback statute. “We have been working under it for the past 14 years,” Klein said, and the guidelines recommend serving patients on a first-come-first serve basis that cannot be “influenced” directly or indirectly by manufacturers. “We are comfortable operating within this regulatory framework, but the new territory is on the enforcement side, with the DOJ’s involvement,” he added.
Walley is concerned with defining the term “influence.” “There’s no black-and-white, and the directives are vague. The unclear ground rules make us very cautious.”
With a mission to help patients, which can only be fulfilled with donations, “these rules and scrutiny could get in the way of our mission,” said Walley.
When asked to define a significant policy change that can have the biggest impact in the next 2 years for patients seeking financial aid, McCourt hoped for changes that could close the Medicare coverage gap, so the donut hole would disappear.
“DOJ completed their investigation and OIG has clear guidelines for audits,” Walley wished.
For Klein, an out-of-pocket cost limit of $100 for specialty medications would go a long way.