Time for PCORI’s Implementation

Now that the dust has settled and health care reform has been signed into law, many health care stakeholders are wondering what happens next. With more than 2,000 pages in the law, I wanted to focus on one aspect of it—comparative effectiveness research and the timelines associated with the implementation of the new private/public, non-profit entity, the Patient-Centered Outcomes Research Institute (PCORI). Building the Institute literally from the ground up will be a large task, given the number of details that must be worked out before it can begin its primary mission of spearheading and overseeing millions of dollars in new comparative effectiveness research.

The Institute and its activities would be governed by an independent, 19-member Board of Governors that includes the director of the Agency for Healthcare Research and Quality (AHRQ) and the director of the National Institutes of Health, with the remaining members appointed by the U.S. Comptroller General. Among these appointed stakeholders, there are three representing patients and health care consumers; five representing physicians and providers; three representing private payers; three members representing pharmaceutical, device, and diagnostic manufacturers or developers; one representing quality improvement or independent health service researchers; and two representing the federal government or the states. The members are to be appointed no later than six months after enactment of the law, or September 23, 2010.

PCORI also would have guidance from a standing methodology committee, permanent or ad-hoc expert panels, expert panels for clinical trials, and an expert advisory panel for rare diseases. Within the expert advisory panels, “the Institute may include a technical expert of each manufacturer or each medical technology that is included under the relevant topic, project, or category for which the panel is established.”

Eighteen months after PCORI is established, the methodology committee must issue methodology guidelines on how CER should be conducted. Embedded in the law is very specific language pertaining to transparency and the importance of opening the process for comment by patient groups, health care stakeholders, and the public. PCORI is required to have a public comment period of 45-60 days prior to the adoption of proposed methods, and PCORI also must have public comment periods prior to the adoption of national priorities and the research project agenda. The National Pharmaceutical Council will weigh in, when appropriate, during those comment periods.

Once PCORI is up and running, 90 days after receiving research findings, they must make these findings available to “clinicians, patients and the general public,” working through the Office of Communication and Knowledge Transfer at AHRQ. The public comment period for findings of various research will be 45-60 days from the release of these drafts.

PCORI also is required to submit several reports to Congress and the Administration, and to make these publicly available. One of these is an annual report. Another, required at least every five years, is a report on the “extent to which research findings are used by health care decision-makers, the effect of the dissemination of such findings on reducing practice variation and disparities in health care and the effect of the research conducted and disseminated on innovation and the health care economy of the United States.”

Other required reports would review the “dissemination and training activities and data networks” established by the law, as well as in 2018, a review the “adequacy and funding for the Institute and activities.”

Other clear timelines are set for PCORI’s funding, which kicks in this year. PCORI will be funded by the Patient-Centered Outcomes Research Trust Fund through 2019, which has been allocated $10 million for 2010, $50 million for 2011, and $150 million for 2012. In future years, the Trust Fund will comprise general revenues, an annual $2 fee per Medicare beneficiary transferred from the Medicare Trust Fund, and an annual $2 fee per-covered-life assessed on private health plans adjusted for health expenditure inflation. Taken together, total sustained annual funding for PCORI could be more than $650 million.

The next few months will be busy as the Board of Governors is appointed and the initial work to set up PCORI and coordinate activities begins. As with any new undertaking, it will take some time and thoughtful input from health care stakeholders to fully implement PCORI. We look forward to being part of that effort.

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