Medicare Compliance & Reimbursement

New databases make it possible to hold virtual clinical studies.

The Department of Health and Human Services' (HHS) campaign to usher the U.S. health care system into the digital age may carry unexpected bonuses.

Recent research supported by the Robert Wood Johnson Foundation's Pioneer Portfolio, Kaiser Permanente and the Agency for Healthcare Research and Quality indicates that the health histories contained in millions of electronic health records (EHRs) can help doctors estimate the efficacy of future treatments, according to a new Health Affairs report.

Because the databases of organizations such as the Veterans Health Administration, Kaiser and the Geisinger Health System record vital statistics for large numbers of patients with cancer, diabetes and other diseases, researchers can mine those records for data indicating how real patients react to various treatments. Ordinarily, pharmaceutical companies perform clinical studies using pre-screened patients who are typically much younger and healthier than the patients who will ultimately need treatment.
 
Data mining applications like Kaiser's KP HealthConnect permit researchers access to data on all the EHRs of patients with similar ailments, and simulations such as those available from Archimedes Inc. allow researchers to predict the drugs' effects more accurately. These rapid-learning tools and others like them promise to increase the rate of medical advances while promoting higher-quality health care.

"Rapid-learning systems, which offer the capacity for real-time learning from the experiences of millions of patients in actual clinical settings, can help physicians decide when to use which clinical tool, and for which individuals," said Lynn Etheredge, a consultant with the Health Insurance Reform Project at George Washington University.

These new technologies could potentially offer insight into cost analysis, prescription drugs' risks and minority health disparities. The information revealed by rapid-learning technologies will also allow patients and physicians to make more informed decisions concerning treatment options. Physicians would be able to search for individuals with personal profiles similar to their patients to determine what courses of treatment have been successful previously before making recommendations, Etheredge asserts.

Should EHR Technologies Receive Federal Funding?

As with any promising new technology, the rapid-learning gains promised by EHR database software require funding, and while the promise of fiscal gains may produce sufficient capital from private sources, some think it would be a mistake for the Centers for Medicare & Medicaid Services and other government agencies to remain out of the picture.

"The private sector can also contribute greatly on its own to rapid learning in health care; however, no private-sector entities have the size, visibility and resources potentially available to CMS and other federal health programs," says Sean Tunis, director of the Center for Medical Technology Policy in San Francisco and lead author of the study, "Federal Initiatives To Support Rapid Learning About New Technologies."

If HHS does decide to become involved, officials might find that their involvement now will save them effort later. By funding and regulating the growing field of EHR technology, Robert Kolodner, interim director for President Bush's Health IT Initiative (HITI), might find it easier to oversee the implementation of HITI interoperability standards.

Etheredge, for one, thinks that the government could assume that responsibility for a relatively low cost. "HHS investments could start at $50 million per year. Over the next five years, as research networks develop and research programs expand, new funding could rise to $300 million annually," Etheredge proposes.

The $50-million price tag might seem like a small penalty to pay for the performance boosts which EHR technology promises, especially in light of the National Institutes of Health's $28-billion annual budget. But Etheredge's search for funding comes at a bad time.

The Bush administration has expressed new resolve to balance the budget, and advocates for EHR technology might be forced to compete for funding with programs like the State Children's Health Insurance Program, whose funding plateaus in 2007. "Medicaid and SCHIP could be one of the highest-payoff areas for new EHR-based learning strategies and program management," Etheredge contends, but those programs might have to sacrifice funding dollars now to reap the promised rewards later.