On July 13, 2010, the Department of Health and Human Services released a pair of final regulations (one from CMS, one from the Office of National Coordinator for HIT ) detailing the “meaningful use” criteria which will determine whether users of electronic health records will qualify for the government subsidies under the HITECH Act during the first two years of the program (2011-2012). The final rule modified the agency’s January 16, 2010 proposed rule and addressed issues raised in the over 2000 comments that proposal drew. The HITECH Act provides EHR funding over 5 years of up to $44,000 (through Medicare) and $63,750 (through Medicaid) per qualifying physician or other clinician, as well as additional funding for qualifying hospitals.

The agency responded to the numerous complaints that its earlier, all-or-nothing approach mandating 25 objectives (23 for hospitals) was unrealistic. Instead, the final proposal requires 15 “core” objectives and a menu of additional objectives EHR users can choose from to qualify for the financial help.

The New England Journal Of Medicine published a summary article by HHS insiders David Blumenthal, M.D., M.P.P., national coordinator for HIT, and Marilyn Tavenner, R.N., M.H.A., principal deputy administrator of CMS. They noted:

“In the original proposal, we identified a broad set of objectives, all of which would need to be met. This included 23 objectives for hospitals and 25 for clinicians. The DHHS received many comments that this approach was too demanding and inflexible, an all-or-nothing test that too few providers would be likely to pass.  In the final regulation, we have divided these elements into two groups: a set of core objectives that constitute an essential starting point for meaningful use of EHRs and a separate menu of additional important activities from which providers will choose several to implement in the first 2 years.

. . .

Core objectives comprise basic functions that enable EHRs to support improved health care. As a start, these include the tasks essential to creating any medical record, including the entry of basic data: patients’ vital signs and demographics, active medications and allergies, up-to-date problem lists of current and active diagnoses, and smoking status.

Other core objectives include using several software applications that begin to realize the true potential of EHRs to improve the safety, quality, and efficiency of care. These features help clinicians to make better clinical decisions — and avoid preventable errors. To qualify for incentive payments, clinicians must start employing such clinical decision support tools. They must also start using the capability that undergirds much of the value of EHRs: using records to enter clinical orders and, in particular, medication prescriptions. Only when providers enter orders electronically can the computer help improve decisions by applying clinical logic to those choices in light of all the recorded patient data. And to begin extending the benefits of EHRs to patients themselves, the meaningful use requirements will include providing patients with electronic versions of their health information.

In addition to the core elements, the rule creates a second group: a menu of 10 additional tasks, from which providers can choose any 5 to implement in 2011–2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.

For example, the menu includes capacities to perform drug-formulary checks, incorporate clinical laboratory results into EHRs, provide reminders to patients for needed care, identify and provide patient-specific health education resources, and employ EHRs to support the patient’s transitions between care settings or personnel.”

The AMA issued a press release which stated the association’s intent to carefully review the final rule to see if the requirements have been reduced to allow more flexibility than the proposed rule, as AMA urged. Noting that the looming cuts under the physician fee schedule have not yet been permanently fixed, the AMA said:

“Physicians recognize the potential for health IT and want to adopt new technologies, but costly EHR systems are out of reach for many physicians because of low Medicare payments and the prospect of steep cuts in December. Congress needs to repeal the flawed Medicare physician payment formula to help eliminate one major obstacle to physician adoption of new technologies.”

It may be an uphill battle to drag the healthcare industry into the 21^st century. The New York Times quoted HHS Secretary Kathleen Sebelius’ concern that "only 20 percent of doctors and 10 percent of hospitals use even basic electronic health records.”

The rule will be published in the Federal Register in the near future. An advance copy is available at http://www.ofr.gov/OFRUpload/OFRData/2010-17207_PI.pdf  and http://www.ofr.gov/OFRUpload/OFRData/2010-17210_PI.pdf 

HHS Fact Sheets are here: Electronic Health Records At A Glance; and CMS and ONC Final Regulations Define Meaningful Use And Set Standards For Electronic Health Record Incentive Program. The HHS press release is here. A technical fact sheet on ONC’s standards and certification criteria final rule is available at http://healthit.hhs.gov/standardsandcertification