The Patient-Centered Outcomes Research Institute, established by the Affordable Care Act, has issued a draft of its initial priorities.
PCORI, as it is known, is not a government agency; it is independent and nonprofit and has a 21-member board of governors. But the organization has been, and continues to be, a primary focus of objections by Republican lawmakers who have alleged that it was established to find ways to ration care.
In its mission statement, PCORI says it "helps people make informed health care decisions and improves health care delivery and outcomes by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader health care community."
The board of governors has met eight times since November 2010. In late January, it issued a priority list that focused on five areas:
Assessment of Options for Prevention, Diagnosis, and Treatment.
Improving Health Care Systems.
Communication and Dissemination Research.
Addressing Disparities.
Accelerating Patient-Centered Outcomes Research and Methodological Research.
"We want to hear from patients, caregivers, providers, and the wider health care 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," PCORI Board Chair Eugene Washington, said in a statement.
Dr. Joe Selby, PCORI executive director, added, "This initial agenda does not limit which conditions or treatments will be studied. It is a starting point."
The organization did spell out in its draft where it thinks research should focus in each of the five broad areas. For instance, research comparing prevention, diagnosis, and treatment options should focus on "clinical options with emphasis on patient preferences and decision making."
To accelerate patient-centered research, proposals should hone in on "use of registries and clinical data networks to support research about patient-centered outcomes."
The draft is very likely to change. The organization is seeking public comment until March 15. It will hold a "national forum" in the District of Columbia on Feb. 27. PCORI said that once it gathers all the public feedback, it will publish a report summarizing the input and how it led to changes in the draft.
The research priorities then have to be approved by the PCORI board of governors. The organization said it will issue its first grants in May.
PCORI expects to have about $150 million in funding in 2012. Beginning in 2013, it will be funded by a tax on each insured American through private insurance or Medicare. It will receive an estimated $500 million a year.
Meanwhile, the consulting company Avalere Health is predicting where the Centers for Medicare and Medicaid Services will head with its comparative effectiveness research in 2012. The CMS conducts analyses of various technologies and therapies in making its National Coverage Decisions (NCDs).
In 2008, the CMS issued a list of 20 potential topics for public comment. So far, the agency has acted on 7 of those topics, Avalere noted in its report.
Avalere expects that in 2012, the CMS will focus heavily on oncology and molecular diagnostics, with a concentration on nonsmall-cell lung cancer therapies, localized prostate cancer treatments, pharmacogenomic testing for breast and colon cancers, and prostate and lung cancer screening.
The consulting company said that oncology is ripe for exploration by the CMS, in part because of an influx of costly new therapies and diagnostic tests, in particular, those that tailor a therapy to the patient. Forty-six percent of the 241 genetic tests that are approved and available for clinical use are for cancer, according to Avalere.
There have been no NCDs on molecular tests for oncology, but there have been decisions by local Medicare contractors, mostly negative.
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