Practice Fusion Blog

Check That! Feds to Fund Cost Studies After All

Just 10 days after AHRQ chief Carolyn Clancy announced there was no way federally-funded comparative effectiveness research funds would be used to study the cost implications of medical innovation, her agency and the NIH released a joint statement saying they’d do just that.

The gratifying about-face came in the form of a report to Congress that was bound to inflame conservative lawmakers who worry such initiatives might eventually support efforts to limit access to health care.

Before the report, it looked like the entire $1.1 billion designated by the Obama Administration through ARRA for comparative effectiveness research would focus solely on outcomes and efficacy studies, not cost-effectiveness.

Of the $1.1 billion, roughly $300 million had been set aside for the Agency for Health Care Research and Quality, with disbursements set to begin this October. AHRQ had previously announced that all the funding would be released in one year, and would be targeted at arthritis, cancer and 12 other common medical conditions.

"This is unprecedented investment in helping clinicians and patients identify what's the best for them in treatment," Clancy told the Wall Street Journal.

For its part, the NIH is set to receive and then release $400 million over a 2-year period for comparative effectiveness research.  According to Richard Hodes, director of the NIH's National Institute on Aging, the famed agency has already received 1,800 applications for the hand-out.

Hodes said the NIH will begin releasing the money later this month.

Neither agency has a mandate to establish federal spending policies, but Medicare officials regularly rely on the results of studies funded by them in deciding which treatments to cover.

That said, Nicholas Papas, a spokesperson for HHS—the agency that oversees both AHRQ and NIH—told the Journal that the fine print in ARRA prohibits Medicare from using these research findings to deny coverage to patients.

That’s a loophole bound to cause trouble down the road.

Glenn Laffel, MD, PhD, Sr. VP Clinical Affairs

NHS Study: P4P Doesn't Improve Care

Early trials of systems that award bonus payments to physicians who adopt quality-enhancing, health-improving practices have shown promise, and the possibility of including such systems in health reform legislation has been there since it began snowing last winter.

But to the chagrin of many, a study published in last week’s New England Journal of Medicine suggests that P4P doesn’t always work.

Stephen Campbell and colleagues at the University of Manchester conducted a time-series analysis of the quality of care at 42 family practices in England.

Focusing on the management of asthma, diabetes and coronary heart disease, they assessed care practices twice before a pay for performance scheme went into effect (1998 and 2003) and twice more after it was implemented (2005 and 2007).

With respect to the behaviors specifically addressed by the P4P program, the scientists found that between 2003 and 2005, the rate of improvement in the quality of care increased for asthma and diabetes but not for coronary disease. By 2007, the rate of improvement had plateaued for all 3 conditions.

The scientists also found that some behaviors not covered by the P4P program actually worsened during the trial period. In particular, a measure of the continuity of care declined shortly after the P4P scheme began, and remained at the lower level for the rest of the trial period.

"This could be an unintended and perverse effect of the scheme and is a concern, since continuity is an aspect of family practice that patients value," they wrote.

They attributed the decline to practices devoting excessive resources towards a particular incentive that rewarded practices in which patients were seen by a physician within 48 hours of their initial request.

The researchers hypothesized that the declining rates with which quality improved during the P4P program might have been caused by the failure of the program to reward gains beyond a certain level, or that "family practitioners had sufficient income and had little personal motivation to improve performance and income further.”

Glenn Laffel, MD, PhD, Sr. VP, Clinical Affairs

Comparative Effectiveness Roadmap

Just weeks after the IOM released its“Top 100” list of agenda items it hopes will drive the Feds’ $1.1 billion comparative effectiveness program, Stanford scientists have weighed in on the matter as well.

In a JAMA editorial, Randall Stafford and colleagues suggest that if comparative effectiveness research is to realize its potential to improve the quality and cost-effectiveness of care, it must focus not just on drugs and devices, but on health-delivery processes and lifestyle practices as well.

Examples of the latter are various diets and exercise programs, as well as alternative therapies that have become popular in the US, according to Stafford’s group.

The group also recommended that comparative effectiveness studies be undertaken earlier on in the life of new drugs and devices. Had such analyses been done regarding the ill-fated pain-killer Vioxx, millions would not have been exposed to its cardiotoxic effects, they say.
 
In addition, the group said more work needs to be done on translating the results of comparative effectiveness studies to the bedside. “Unfortunately, we still want to believe that information alone will change physician practice,” Stafford told BurrillReport. “There are more potent influences on physicians, including their local culture of practice.”
 
The scientists also recommend that early-stage drug and device trials feature head-to-head comparisons against already-approved drugs in the same category rather than placebo-controlled trials. This strategy would assure a flow of improved products to the marketplace while driving innovation among drug and device makers.

Lastly, the Stanford group suggests a greater focus on the cost-effectiveness of new therapies, despite methodological problems associated with such evaluations. “What good is comparative effectiveness if it cannot be used to discern anything about value to clinicians, insurers, patients, and society?” they ask.

Glenn Laffel MD, PhD, Sr. VP Clinical Affairs