$1.1 Billion For Comparative Effectiveness Research Meant to Improve Quality, Save Money

The $1.1 billion in comparative effectiveness research funding that is included in the recently enacted economic recovery legislation should lead to more studies to help public and private payers identify and adopt the most cost-effective and beneficial health care treatment regimens, said one FP expert recently interviewed by AAFP News Now.

The $1.1 billion will be split among the Agency for Healthcare Research and Quality, NIH, and HHS, enabling each of the agencies to conduct head-to-head studies to determine the best drugs, devices and procedures based on cost and overall effectiveness.

"The idea here is to try to save the health care system money and to improve quality," said Doug Campos-Outcalt, M.D., M.P.A., associate head of the department of family and community medicine and assistant dean for outreach and multicultural affairs at the University of Arizona College of Medicine, Phoenix. "It is being driven by the fact that the federal government pays for so much of health care through Medicare and Medicaid."

With the additional funds, the agencies should be able to conduct more studies that provide "clear-cut decisions on treatments where controversy exists," said Campos-Outcalt.

"The medical literature is vast, it is confusing, and it is hard to sort out," he said. "A busy practitioner, on a daily basis, has conflicting claims being made about the effectiveness of different therapies, and (those claims) are usually not from unbiased sources. An unbiased source of an analysis on very important clinical topics will be a very big help to … clinicians."

A literature review used in formulating a clinical guideline recently released by the American College of Physicians, for example, found no significant difference between the effectiveness of second-generation antidepressants versus first-generation antidepressants for the treatment of major depressive disorders.

"Knowing they are all equally effective is useful because now we (FPs) can switch a patient from one to another, and we can look for the right medication based on adverse effects without worrying about the (overall) effectiveness," said Campos-Outcalt. "I think there will be other conditions where the result will be more clear-cut than that."

Not everyone is a fan of the stimulus package's effectiveness research provisions, however. Sen. Tom Coburn, M.D., R-Okla., who is also a family physician, said during a recent Senate committee hearing that comparative effectiveness "ignores the art of medicine."

Coburn said he tries to prescribe generic medications for patients, but in some instances, the side effects from those medications are significant and nongeneric medications are a better choice. These types of situations may not be reflected in comparative effectiveness research, said Coburn.

Campos-Outcalt acknowledged that the recent legislation has the potential to create "unintended consequences." Private and public health plans could establish treatment guidelines that do not allow for any exemptions, he said.

"Not every patient is going to respond to therapy that is more effective," he said. "So we are always going to need to make sure there are some contingencies for patient-specific exceptions."

The provisions in the economic recovery legislation also call for the creation of a Federal Coordinating Council for Comparative Effectiveness to oversee research efforts and encourage coordinated and complementary uses of resources while making recommendations to the president and Congress on the infrastructure needed to support the research. The legislation says that the council has to be composed of as many as15 representatives of federal agencies, and half must be physicians or other experts with clinical expertise.

Campos-Outcalt said primary care physicians should fill some of the slots on the council to give it a primary care perspective. Family physicians and other primary care health professionals are more likely than subspecialists to care for the "whole" patient and to treat patients with multiple chronic conditions, rather than provide partial care by focusing on one ailment or a defined set of ailments, Campos-Outcalt said.

"If you have a patient with five chronic illnesses and you are trying to find the best combination (of medications), it is a little different question than if you only see a patient with arthritis, and you are not paying attention to the hyperlipidemia, the heart disease and the hypertension," he said.

The legislation, meanwhile, requires the HHS secretary to contract with the Institute of Medicine to produce and submit a report to Congress by the end of June that includes recommendations on the national priorities for comparative effectiveness research and to consider recommendations made by the Federal Coordinating Council for Comparative Effectiveness. The measure also requires HHS to publish information on grants and contracts and to disseminate research findings from the grants and contracts to clinicians and the general public.

The comparative effectiveness provisions in the recently enacted legislation have a lot of potential to save money and improve quality, Campos-Outcalt said. However, "we need to follow the process to make sure the family medicine viewpoint is there."