ACA Creates Outcomes Research Organization
In a politically charged environment where lawmakers from both sides of the aisle are searching for a solution to Medicare's financial woes, one agency created by the Affordable Care Act (ACA) and funded by Medicare has the luxury of turning a blind eye to concerns about the program's solvency.
Studies funded by the Patient-Centered Outcomes Research Institute (PCORI), the independent, non-profit organization established to seek and review comparative clinical effectiveness research on various prevention and treatment options, will examine medical treatments and services side-by-side to determine which are more clinically effective.
PCORI has reviewed more than 850 applications submitted in response to its first request for research proposals. In June 2012, the institute announced its approval of 50 research funding awards totaling $30 million over two years. As part of the PCORI Pilots Projects Program, these awards will be used to investigate how to engage patients in the health research and dissemination process. Details on the research institutions that received these awards are available on PCORI's website.
Funding for PCORI’s research comes largely from Medicare. Its budget through 2012 totals $210 million and is expected to swell to $500 million by 2014 as $2 fees for each Medicare beneficiary are transferred each year from the Medicare Trust Fund to PCORI’s. Additional funding is supplied by private insurers and self-insured plans through annual fees of $2 per covered-life, adjusted for health expenditure inflation.
Examining Outcomes, Ignoring Costs
After opening up its draft research agenda for public comment in late January, PCORI hosted a formal dialogue to obtain feedback from patients, caregivers, clinicians and others. The event was held Monday, February 27 at the National Press Club in Washington, DC, and included three-and-a-half hours of public comment and featured two moderated discussion panels of patient and caregiver advocates, clinicians and other stakeholders.
Although the PCORI-funded research won’t take into account costs, the findings could help the Independent Payment Advisory Board, another agency created by the health reform law to control Medicare spending, determine which medical treatments and services to recommend for Medicare coverage.
Without considering cost, “it is impossible to inform patients about the effects of the trade-off they are making. So what can be done?” wrote UCLA professor of medicine and health services Robert H. Brook, M.D., Sc.D., in the November 9, 2011 issue of the Journal of the American Medical Association. ”A scientific and political case could be made to amend health care legislation to require that cost be included in the studies that the PCORI funds.”
Despite excluding cost
considerations, “the research could help the Center for Medicare and
Medicaid Innovation and the Centers for Medicare and Medicaid Services
define appropriate service bundles or other bundled payment mechanisms
over time,” wrote Alexander K. Ommaya, ScD, MA of the US Department of
Veterans Affairs and Joel Kupersmith, MD of the Veterans Health
Administration in the August 17, 2011 issue of JAMA.
Encouraging Public 'Ownership'
Studies in the first round of proposals were according to PCORI’s research agenda, which was released for public comment on January 23, 2012. As PCORI’s Board of Governors sifted through proposals, it also looked for guidance from “patients, caregivers, providers and the wider healthcare community on whether our draft priorities and initial research agenda capture the broad areas where more evidence-based information is needed to make better decisions,” said Dr. Eugene Washington, chairman of PCORI's board, in a press release. The public comment period ended on March 15.
The draft of research priorities identified five focus areas: assessing options for treatments, diagnoses and prevention strategies; improving healthcare systems; communication and dissemination of research; addressing healthcare disparities; and accelerating outcomes research and methodological research. Even though Medicare, one of PCORI’s primary funding streams, accounts for 21 percent of the nation’s total health care spending and 15 percent of the federal budget, PCORI-funded research will not directly evaluate the cost effectiveness of comparable treatments or clinical practices.
Now that the first round of studies have been selected for funding, PCORI’s long-term challenge is ensuring that the findings actually make it to Medicare patients’ bedsides. Any indication that an experimental design is flawed or that a study’s findings are not generally applicable could jeopardize whether patients and caregivers participate in the research or adopt PCORI’s recommendations, wrote Ommaya and Kupersmith.
This is why caregivers, health care administrators, volunteer scientists and, most importantly, patients were an integral part of the proposal selection and review process, along with PCORI’s 21-member Board of Governors, hand picked by the Government Accountability Office.
“If patients across this country had a deeper understanding of research and more of a sense of ownership of it, I think we would be ahead of where we are today,” Joe Selby, MD, MPH, PCORI’s executive director, said in an interview for the December 2011 issue of Health Affairs. “And as a consequence, we might see greater participation in trials, which would enable us to do more trials.”
“If we really do succeed in engaging patients more thoroughly, and if patients really have a hand in considering a research question, prioritizing it, refining it, and advising on the study population that would make the most sense, will the research that gets done be different and more applicable to them?” Selby added. “I am very interested in finding out.”