Read this editorial and you’d get the impression that the Feds are using health care as a Trojan horse to strip us of our freedoms. Listen to this guy and you may want to don your war paint and dump some tea into Boston’s Harbor. No… wait! It’s the other side that’s evil. They’re vicious, ignorant fear mongers who should just sit down and shut up. Because, this is Good and Righteous. It's Very Good.
And so it begins.
What’s got everyone so riled up? ‘Comparative effectiveness research’ and the ‘health council.’ Confused, the DMCB went to the original language of the stimulus bill (p. 63 of this 407 page behemoth) and found language that states $1.1 billion will go to the National Institutes of Health (NIH) and the Secretary of Health and Human Services for ‘comparative effectiveness research’ that measures ‘clinical outcomes, effectiveness and appropriateness’ of ‘items, services and procedures that are used to prevent, diagnose or treat.’ The money can also be directed to encourage the use of registries, clinical data networks and electronic health data that can be used for outcomes data. The money can be granted to ‘appropriate public and private entities.’ $1.5 million is allocated to the Institute of Medicine to decide on priorities for the research.
There will also be a ‘Federal Coordinating Council for Comparative Effectiveness Research’ (FCCCER) (page 73) which will be made up of 15 individuals who ‘foster’ coordination of the research as well as advise, assist and report. This Council will not be allowed to mandate coverage, reimbursement, or other policies for any public or private payers such as clinical guidelines for payment, coverage or treatment.
Like factcheck.org, the DMCB is not worried. But it’s not all that impressed either. Here’s why:
In its days as a managed care medical director, we were constantly scouring the peer-reviewed medical literature to help us divine insurance coverage decisions. We found no matter how carefully crafted, even the best studies leave unanswered questions and are riddled with exceptions. Recent case in point? The rigorously performed SYNTAX trial, which found open surgery bypass had better outcomes compared to the use of stents among persons with severe coronary artery disease. You’d think case closed until you read how these two experts differed in their interpretation of the findings. What they agreed most strongly on was the need for more research. More research begets more research.
In addition, the DMCB isn’t sure that the current insular medical-industrial complex is prepared to conduct the kind of comparative research we need today. We need speed, we need community-based studies, we need to simultaneously implement promising interventions and we need to ask not only ‘if’ it worked but ‘how’ and ‘why’ and for who and under what special circumstances. It’s not just the DMCB that feels that way.
What’s more, clinical effectiveness research won’t answer many important questions – even if money isn’t an issue and even if everyone in Washington DC would like to ethically advance cost effectiveness. Should hundreds of thousands of dollars be spent to prolong the life of an elderly man with advanced brain cancer? What should ICU physicians do in the face of overwhelming but not absolute odds of dying? Is State by State variation due to physicians and is it necessarily bad? Even if we know something doesn’t work, would we still pay for it?
And how about FCCCER? Assuming ‘advise’ and ‘assist’ and ‘report’ are really action verbs, does it have any hope of navigating through the hugely bloated DC bureaucracy? Note that many of its members will be from AHRQ, CMS, NIH, FDA and the VA. Think members of Congress won’t be calling them on behalf of their constituencies? Think again.
Last but not least, FCCCER is an unfortunate acronym. Quite.
Summary: It’ll take years before results appear from traditionally conducted effectiveness research. It won’t answer the important questions. Medical directors will still need to use clinical judgment in deciding coverage issues. It’s not a Trojan Horse and it’s not a panacea. Hopefully, if it has any negative impact, my medical colleagues won't use their own FCCCER-like action verbs to describe its performance.