The $1.1 billion earmarked for comparative effectiveness research in the economic stimulus bill passed on February 13 could be a sound investment in improving health care’s efficiency, cutting costs, and improving patient outcomes. Or it could be more roadkill on the much-traveled highway to a cheaper and better health care system.
Comparative effectiveness research (CER) is the rigorous evaluation of the impact of different options available for treating a given medical condition for a particular set of patients. The Congressional Budget Office (CBO) posits that there are a variety of opportunities to constrain health care costs, in both public programs and the rest of the health system, without adverse health consequences. It cites factors such as substantial geographical differences in spending without corresponding improvement in outcomes, lack of evidence about which treatments work best for which patients, the private sector’s lack of incentives to do CER, patient disincentives because of limited cost sharing, and the dearth of electronic health records to facilitate data exchange as impediments to CER. That may change if the $1.1 billion allocated to compare drugs, medical devices, and common medical procedures’ effectiveness succeeds. Ronni Sandroff, Director/ Editor of Health and Family at Consumer Reports, explained, As we learn which treatments really work best for which types of patients, the knowledge can be used to set up unbiased treatment guidelines to help prevent mistreatment, overtreatment, and undertreatment.
The recent CER initiative is off to a good start with the selection of its two lead agencies: the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH). AHRQ’s mandate is to synthesize scientific evidence to improve quality and effectiveness in health care and to disseminate information via summary guides for consumers, clinicians and policymakers (visit www.ahrq.gov to view, for example, guidelines on allergic rhinitis and acute bacterial sinusitis). In 2005 it added the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network to conduct accelerated practical studies about the outcomes, comparative clinical effectiveness, safety, and appropriateness of health care items and services. The network consists of research-based health organizations using electronic health information databases, with the capacity to conduct and turn around research. Although NIH wasn’t built for CER, it has the clinical firepower to produce it.
The $300 million allocated to AHRQ and $400 million to NIH will fund a host of important activities, including synthesizing findings from existing studies, analyzing available medical claims data, conducting new head-to-head clinical trials, comparing treatment options (surgery vs drug therapy), and analyzing different approaches to the same basic treatment (different levels of follow-up after surgery). How the information comparing high value and low value drugs, medical devices, and treatments from CER will be handled by stakeholders in the United Stats’ $2 trillion health care system remains unclear. Its back-door rationing will put economic losers on the defensive. For example, National Pharmaceutical Council president Dan Leonard endorses CER, with the caveat that CER examines all aspects of health care, including drugs, devices, and other medical treatments. When CER researchers start issuing guidelines based on comparing drugs head-to-head on efficacy and cost, look out!
Here’s a likely scenario. Medicare currently covers any treatment that is reasonable and necessary for the diagnosis of illness or injury. It cannot legally factor in treatment costs when deciding whether or not to cover a particular item. That could change if CER identifies higher-value care and promotes certain drugs, devices, and procedures throughout the health system via financial incentives-the payment doctors receive and/or the cost sharing that patients face. Would legislators dare to incense elderly constituents by enacting laws eliminating payments for popular treatments endorsed by their physicians? Most Americans have never faced health care rationing, and politicians’ soothing bromides about CER will meet fierce resistance if payment for popular treatments is denied.
The British Template
Some US politicians eye Britain’s National Institute of Clinical Excellence (NICE), which issues guidance on procedures, drugs, and medical devices for a CER model. Its Web site (www.nice.org.uk ) says: In order to make sure our standards represent good value for money, we use the best evidence to weigh up benefits and costs. Following this series of steps-fielding a request from the Department of Health to investigate a topic, gathering evidence, committee considering evidence, drafting guidance on the Web site for comment, committee considering comments and amending guidance, and publishing final guidance-defines clinical practice (see Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis on NICE’s Web site). It does not perform CER, but instead issues guidance on treatment efficacy.
So far, so good. But NICE gets less nice when a separate unit calculates a treatment by quality-adjusted life years (QALYs), refusing to pay for any treatment costing more than $29,050 (£20,000) that doesn’t extend a patient’s life by at least one year. For example, on August 12, NICE’s preliminary guidance denied access to Sutent, Avastin, Nexavar, and Tarisil to patients with advanced metastatic kidney cancer, leaving those patients to die months earlier than those whose treatment is paid for privately in the UK or publicly in other European countries.
Lori-Ann Rickard, JD, a Michigan attorney specializing in health care, said that while the US Joint Conference Report specifically denies the intent to mandate coverage or reimbursement, it would not be surprising for Medicare policies to be revised based on the findings and for private insurers to follow. CER could be used to both eliminate coverage for certain items and add coverage for other items.
Jason Hwang, MD, MBA, co-author of The Innovator’s Prescription, argued that flooding the health care system with money to upgrade information technology (IT), as the stimulus package and CER will do, is throwing money at existing institutions that don’t want competition. Until we move data into the hands of patients and find new venues of care we’re only maintaining the status quo, he said. Dr. Hwang also pointed out that IT, whether in the form of electronic medical records or heftier databases, will not cut costs unless government entities such as the FDA and CMS have the political will to use cost-effectiveness data.
The widely held belief that more IT will automatically make health care more cost-effective demands a closer look. Proponents of beefed-up IT spending, whether for CER, EMR interoperability, or other bells and whistles, rest on a short 2005 RAND Corporation study that predicted $77 billion in annual savings and improved outcomes if doctors’ offices, hospitals, and other stakeholders used the same IT platform. The study estimated that implementation would cost $1.7 trillion over 15 years and that 90% of stakeholders would use it. Practical experience says otherwise. Britain’s NHS has been trying since 2002 to connect its 30,000 physicians and 300 hospitals with an interoperable EMR, at a price tag of £2.3 billion. Seven years later and £12.7 billion over budget, the system has not yet been implemented. Compare that with 633,000 US physicians and 5708 hospitals, and confidence wanes. Closer to home, federal attempts to upgrade and unify IT at the IRS, the FBI, and air traffic control have failed.
All in all, CER is like motherhood and apple pie. In theory, no one opposes any of them, but only time will tell if putting cost/benefit price tags on drugs, medical devices, and procedures will go down easily with physicians and patients.
Summary of Health Care Spending in the Stimulus Bill
The $787 billion spending bill passed on February 13 included about $140 billion for health care. IT and comparative effectiveness spending are as follows:
- Comparative effectiveness research (AHRQ*): $300 million to AHRQ; $400 million to NIH; $400 million at HHS director’s discretion. Total: $1.1 billion
- IT (Office of the National Coordinator for Health Information Technology*): $2 billion, of which $300 million is designated for regional health information exchanges and $20 million to Department of Commerce National Institute of Standards and Technology
- IT (HRSA): $1.5 billion for health IT systems for community health centers
- Health IT (CMS): $19 billion to develop interoperable standards by 2010 that provide for the nationwide exchange of health IT for the use of information to improve the quality and coordination of care *lead agency
Source: Health Provisions in the Conference Report in the American Recovery and Reinvestment Act, Holland+Knight, 2/17/09
Evidence-Based Practice Centers (EPCs)
Since 1997, AHRQ has promoted evidence-based medicine in everyday care through the establishment of 13 EPCs. These centers develop evidence reports and technology assessments on clinical, social, behavioral, economic, and health care organization and delivery issues. The EPCs are:
- Blue Cross/Blue Shield Technology Evaluation Center
- Duke University*
- ECRI Institute*
- Johns Hopkins University
- McMaster University
- Minnesota Evidence-based Practice Center
- Oregon Evidence-based Practice Center
- RTI International-University of North Carolina
- Tufts- New England Medical Center*
- University of Alberta*
- University of Connecticut
- University of Ottawa
- Vanderbilt University
*Specializes in technology assessments for CMS
Source: www.ahrq.gov , accessed 2/19/09
©2009 The Triological Society