ACA Rollout Raises Ante for Patient Access and Assistance

Amid the looming March 31 deadline for remaining uninsured and underinsured Americans to purchase health insurance mandated by the Affordable Care Act (6 million newly Medicaid-eligible individuals are expected to enroll), pharmaceutical manufacturers and other key players in this space are emphasizing the importance of enhancing access to medications for the now rapidly expanding patient base.

“We’re having a realignment through healthcare reform of how the money flows and who assumes risk,” said a company participant, speaking at the 15th Annual Patient Assistance & Access Programs (PAP) conference late last week in Baltimore. “We see hospitals and providers now assuming risk, and that will make changes in which products get selected and how patients get access to their medications.”

Converging to discuss the reshaped PAP environment – where demand, drugmakers say, is outpacing available support – were senior biopharma representatives in managed care, reimbursement, patient access, and financial assistance. They were joined in Baltimore by leaders from patient advocacy groups, non-profit foundations, the federal government, state healthcare agencies, public policy companies, law firms, and clinical and commercial service providers.

Much of the discussion focused on what the different stakeholders expect as the ACA is implemented in 2014, and the reality that quick fixes will likely be hard to come by for at least the next two enrollment periods, as health insurance marketplaces, or exchanges, mature. A major theme echoed throughout was the prevailing need to educate patients and close the gap that exists in healthcare literacy. There is very little awareness of even basic coverage provisions among those patients in need of health insurance and medical therapies the most, the speakers noted. Tracy Foster, president of Lash Group, a patient support services company, cited a recent poll that found that 47% of currently uninsured patients view the ACA as unfavorable and only 24% were aware of the March 31 registration deadline.

Greg Gierer, VP of policy at America’s Health Insurance Plans (AHIP), believes that the number of people who ultimately enroll in qualified health plans (QHPs) is of less importance than what the enrollment mix will look like, particularly for the long-term success of exchanges and the stability of the marketplace. He said that broad participation is critical, especially among younger and healthier people, because their fees help subsidize the costs for older and sicker individuals.

To that end, 25 states and Washington D.C. have indicated that they will expand Medicaid coverage to low-income adults in 2014. About 85% of Americans currently have minimal essential coverage. However, though not necessarily surprising, there remains a significant difference in the percentage of enrollees in Medicaid-expansion states that either qualify for Medicaid or subsidies versus those in non-expansion states (71% compared to 58%). Janet Miller, who works in the partners relations group at the Centers for Medicare & Medicaid Services (CMS), acknowledged that assessing the implementation of the ACA so far is a subjective exercise. She noted CMS has seen particular issues, specific to QHPs, arise in areas such as mental health and substance abuse disorders, formularies and prescription drug coverage, and rehabilitative services. Miller did point out that in 2013, the healthcare law saved senior members $8.9 billion on prescription drugs, and said as the doughnut hole closes in Medicare Part D coverage, the federal government believes future healthcare savings can be substantial.

Of course, such hopes won’t erase the continued concerns over insurance exchanges and their potential impact on PAPs. Under the ACA, health exchanges are required to be self-sustaining by Jan. 1, 2015. Craig Holden, president and chief operating officer at the law firm Ober Kaler, told attendees in Baltimore that there still is uncertainty surrounding which drugs will be covered and, if so, what level of coverage. This may leave more people in need of copay assistance and alternate funding services. There are also worries, Holden mentioned, around whether a QHP that pays all or part of a patient’s premium via subsidy is in violation of the federal anti-kickback law. If going by HHS’s statement last November that exchanges are not “federal healthcare programs,” then that shouldn’t be the case. However, HHS has expressed concern that third parties may buy policies for patients that could impact risk pools if they’re done to pay or subsidize premiums to enable use of certain drugs. The concern centers on the potential of insurance plans going under and falling out of exchanges as a result of pushing high-cost, chronically ill patients into particular plans. For now, the varying interpretations seem to cloud the legal picture some for PAPs.

For manufacturer-run PAPs, which some contend provide financial advantage to the company’s drug over competing treatments and steer enrollees to particular drugs, legal speakers suggested a few keys for compliance. Those included providing assistance entirely outside of the Medicare Part D program; limiting programs to drugs that are not eligible for coverage under Medicare Part B, but which may be eligible for Part D; and determining patient financial need in a reasonable and uniform manner. The sentiment from those in the audience representing manufacturers was that their objective is not to drive business with PAPs, but to remove barriers to appropriate patient care.

Speakers from a few biopharmas talked about PAP approaches in areas such as donation, education, and technology. Many provide call centers to assist patients in navigating the changes in the healthcare marketplace. Manufacturers acknowledge, however, that several challenges still exist. For example, some patients who would qualify for manufacturer-sponsored copay card programs aren’t taking advantage of those programs and instead are unnecessarily drawing from the pool of foundation funds. This is particularly an issue in specialty pharmacy, where patients are often referred to foundations more so than manufacturer copay card programs.

“The question is how do we help the industry do more for patients who need access to our products?” said one speaker.

Genentech announced that it will host a manufacturer-only PAP summit in October to gather hopeful answers to that question.