Final Meaningful Use and Certification Standards for Electronic Health Record Systems

July 13 was a big day for electronic health record vendors and users. The federal government released its long awaited final rules on standards for certification and on “meaningful use” incentives. The healthcare IT blogosphere exploded with excitement. In the automobile racing world, the parallel announcement would have been, “Gentlemen, start your engines!”

Why all the excitement? Because thanks to the HITECH portion of the American Recovery and Reinvestment Act of 2009 (ARRA), the federal government has plunged right into the middle of the design and implementation of medical record systems. The Office of the National Coordinator of Health Information Technology (ONC) released standards for how a certified electronic health record system (EHR) must function. Meanwhile, the Centers for Medicare & Medicaid Services (CMS) announced its final rules for providing financial incentives to physicians if they “meaningfully use” a certified EHR.

For those with an appetite for detail, the new rules are posted on the Federal Register website. The 288 page “Initial Set of Standards……for Electronic Health Records Technology” is posted at http://www.ofr.gov/OFRUpload/OFRData/2010-17210_PI.pdf . The 864 page “Electronic Health Record Incentive Program” is posted at http://www.ofr.gov/OFRUpload/OFRData/2010-17207_PI.pdf .

Meaningful Use

Here are some key points about how eligible physicians and hospitals must meaningfully use a certified EHR if they want to receive incentive payments and avoid future financial penalties. First, and most importantly, they must use a certified EHR or a set of certified EHR modules. Then they have to meet certain criteria that phase in over time, starting in 2011 and gradually tightening in three “Stages.” Stage 1 will apply in years 2011 through 2013. Stage 2 will apply in years 2013 through 2014 and possibly beyond. Stage 3 has not yet been determined. The incentive payments will be significant. CMS estimates that Medicare and Medicaid will pay out between $9.7 billion and $27.4 billion in incentive payments from 2011 through 2019.

The final Meaningful Use rules for Stage 1 are broken into a 15 core requirements for physicians and 14 for hospitals. There are an additional 10 menu items from which 5 (not any 5, there are some restrictions) must be selected and met. The expectation is that the menu items will become required in later stages, but that has not yet been defined.

Examples of the core requirements are CPOE (computerized provider order entry) such as drug and drug-allergy interaction checks, electronic prescribing, patient demographics recordings, lists of current medications and height and weight and blood pressure information. The summary table is shown on pages 221 through 224 of the final rule.

An example of a menu items is, “Performed at least one test of certified EHR technology's capacity to provide electronic syndromic surveillance data to public health agencies and follow-up submission

if the test is successful… “Another example is “More than 10 percent of all unique patients seen by the EP [eligible provider] are provided timely (available to the patient within four business days of being updated in the certified EHR technology) electronic access to their health information…”

A summary table can be found on pages 224 through 226 of the final rule.

In Jan. 2011, physicians begin a 90-day process of using a certified EHR according to the Meaningful Use requirements. They must “attest” to this use beginning in April 2011 and incentive payments will begin in min-May 2011. Medicaid payments (Medicaid is a state program) will be rolled out on a state-by-state basis but the dates are subject to approval of the state-specific Medicaid HIT plan (which is a whole story unto itself).

Certification

The new Standards for Certification of EHRs include many details regarding not only technical standards but also their implementation. First of all, who does the certification testing? On July 1st ONC began accepting applications from entities that want to become an “Authorized Testing and Certification Body.” As of the beginning of July, ONC reported that 14 entities had requested applications. The testing entities will be selected and ONC expects that EHRs will be tested and available by the fall of this year, a very aggressive schedule. Vendors, however, have still been selling their systems to hospitals and physicians making the promise in one way or another that they will become certified. And for most this is a reasonable expectation.

Specific requirements for certification include content exchange standards (170.205) which include technical standards for patient care summaries (which are used to exchange data among EHRs, PHRs and HIEs), public health reporting, syndromic surveillance and immunizations, electronic prescribing and other areas.

Another section covers vocabulary standards (170.207) including how to code lab test results, immunizations, procedures and diagnoses. Section 170.210 details privacy and security standards including acceptable encryption and decryption methods. Section 170.302 defines detailed certification criteria for “Complete EHRs” or “EHR Modules.” This includes functions like drug-formulary checks, and smoking status and patient-specific education.

While the list of standards seems overbearing, in fact choices are given throughout by allowing developers to select from among a set of already accepted standards. Where there are no standards, ONC has left some room for innovation and flexibility.

Dr. John Halamka has an excellent blog outlining his thoughts on both regulations at http://geekdoctor.blogspot.com/2010/07/meaningful-use-and-standards-are.html .

Commentary

Why aren’t more people complaining about this massive government intervention? I think there are two main reasons. First, Republicans and Democrats alike believe that tremendous efficiencies can be gained from the automation of health records. Virtually no one is against it. Second, everyone agrees that healthcare automation in the USA hasn’t been happening fast enough. Blame it on our convoluted healthcare financing system or blame it on inadequate entrepreneurialism, it was just happening too slowly and something had to be done. The decision to spend billions of dollars to stimulate the economy was just a convenient opportunity to administer a big shock the healthcare technology industry in an attempt to get things moving. Time will tell, but this announcement has vendors ramping up and physicians and hospitals finally seem to be moving more rapidly towards automation. As someone said to me recently, “something is just plain wrong when the taxi cab that takes you to the doctor’s office is more computerized than the doctor’s office itself.” That is about to change.