Are you ready for a headache? Then continue reading. Don't want a headache? Then read on. As a part of our discussion of what is new in healthcare, it is important, whether a healthcare provider or a healthcare consumer to be aware of some of the changes which are being mandated. The use of the word "mandate" is not pejorative, i.e., it is not to imply a negative response to the changes coming to healthcare. The intent of the changes is to improve the quality and safety of the care we all receive. Whether the changes in the law will result in the intended progress, or not is yet to be seen but it may.

Here is the summary. If you know all of this, you don't need to read any further; if you don't, you stop reading at your own peril. In meeting the HITECH requirements, as defined in the ARRA, and published by the ONC through the ACTIB with final standards to be announced from the NIST, which are not yet available (got a headache yet? Read on), you may use the CCHIT or maybe not, and what you must report to HHS through CMS cannot yet be done, and in order to do this you must have a certified EHR and at present none exist and all of this must be done in 2011.

What Does this All Mean?

Your first response may be, "I don't care and I don't want to know," but you must remember that contrary to popular wisdom, the only thing which can hurt you is what you don't know.

On February 17, 2009, President Obama signed the American Recovery and Reinvestment Act (ARRA0 of 2009. The HITECH (Health Information Technology for Economic and Clinical Health) Act is part of this legislation and is designed to encourage physicians and other healthcare organizations to adopt and use (in a meaningful way) Electronic Health Records (EHR).

The HITECH Act will be administered by the Office of the National Coordinator for Health Information Technology (ONC) and appropriates $19.2 Billion dollars, most of which will be used as incentive money for hospitals and physicians who adopt EHRs.. The incentive payments are structured in a way to reward early adopters and ultimately penalize those physicians who have not implemented an EHR by reducing their Medicare payments beginning in 2015.

The Final Rule including the final HHS certification criteria and standards were published on July 13, 2010 and becomes effective on September 28, 2010. However all final test procedures are not yet available from the National Institute of Standards and Technology (NIST), nor has Certification Commission for Health Information Technology (CCHIT) been accredited yet by ONC as an Authorized Certification and Testing Body (ONC-ACTB). When those events occur, CCHIT will replace the Preliminary ARRA program with a final, ONC-accredited ARRA certification program.

Obviously, the framers of this law had heard of the "carrot and stick" method of motivation. In the short run there will be "carrots" for using a certified EHR in a meaningful way, but in the long run (2015), if you are not doing so, your payments will be cut.

A Certified EHR -- History

The first step in the HITECH Act is to insure that health care providers are using "certified EHRs." The twelve-year history of SETMA's use of EHR is well documented. The term "early adapter" has been applied to organizations like SETMA, and now it appears that we were prescient in migrating to EHR in 1998. When SETMA purchased NextGen's EHR, the electronic record market was volatile to say the least. When we purchased NextGen in March, 1998, it had been only four months since we had reviewed dozens of products at the MGMA meeting in Washington, D.C. Fifty percent of the products we reviewed in October, 1997, were no longer available in March, 1998.

CCHIT (Certification Commission for Health Information Technology)

It has long been believed that widespread adoption of health information technology (Health IT) can bring improvements in quality, safety, efficiency and access to healthcare delivery. It also is aapparent that the number and varying quality of EHRs required the adoption of a standardized measure so that healthcare providers could effectively compare products and so that insurance companies could begin planning for adjusting payments to providers on the basis of their using a high quality EHR. Thus a new industry was birthed: Certification of EHRs.

The first organization to be recognized by the Federal Government as an EHR certifier was the CCHIT®, a nonprofit, 501(c)3 organization with the public mission of accelerating the adoption of health IT.  CCHIT was founded in 2004, and began certifying electronic health records (EHRs) in 2006. The Commission established the first comprehensive, practical definition of what capabilities were needed in these systems.  The certification criteria were developed through a voluntary, consensus-based process engaging diverse stakeholders, and the Certification Commission was officially recognized by the federal government as a certifying body.

NextGen, SETMA's vendor, was among the first EHRs to be certified. CCHIT's website indicates that 200 EHRs have been certified. Currently, there are over 400 EHR vendors in North American alone. There are a number of "open source," or free; EHRs none of those are, or ever will be certified due to the cost of the process.

HIECH Act an EHR Certification

It would have seen logical, in that the Federal Government endorsed CCHIT, that CCHIT would be accepted as the certifier of EHRS for "meaningful use" (more about this later) and that those who had achieved CCHIT certification would thereby be certified for "meaningful use." Not so.

The Final Rule for Meaningful Use, including the final Heath and Human Services (HHS) certification criteria and standards were published on July 13, 2010 and become effective on September 28, 2010. However all final test procedures are not yet available from the National Institute of Standards and Technology (NIST). The Office of National Coordinator (OINC) certification process is and will be separate from CCHIT.  CCHIT may become one of the certifying bodies used by the ONC, but this has not yet been established.   All EMR vendors must reapply for certification with the ONC. 

The organization that will do the certifying has not yet been confirmed, but they will be known as the Office of National Coordinator Authorized Testing and Certifying Body (ONC- ATCB).  EHRs are not able to use previous certifications to prove they have been certified by the ONC.  The ONC will be listing ATCB organization on their website when they become qualified.  They expect to have some qualified organizations later this summer. 

The HITECH Act specifically states that the following conditions for meaningful use must be met.

1. The EHR must use certified technology;
2. The EHR must include ePrescribing;
3. The EHR must allow for the "electronic exchange of health information to improve the quality of health care".
4. The EHR must be able to submit clinical quality measures to HHS.

The Process

In healthcare, the Federal process is tortuous, which means that it has twists and turns which sometimes cause pain. First, the law is passed; then, to know what the law means for the healthcare provider, we have to await the "final rule." which is a detailed explanation about what compliance with the requirements of the law means. Then there are technical specifications which have to be published, interpreted and fulfilled.

The facts are:

1. Healthcare providers can elect not to participate in the incentive program which begins next year, but in 2015, those providers will experience targeted reductions in their reimbursement, thus the carrot and the stick.
2. To participate in the incentive program, a provider must use a certified EHR. At present, there are no certified EHRs as no agency or organization as been selected by the government to do the certification.
3. Once the Federal government designates a certification agency, all vendors will rush to become certified. If the EHR vendor for a particular healthcare provider or medical group does not apply for certification or fails certification, then those healthcare providers will not be able to participate in the program.
4. One of the key elements of a certified EHR is the ability electronically to report quality metrics data to the Federal government. However, the Federal government has already announced that it will not be able t receive that quality data, yet.
5. There are still only a very small percentage of physicians using an EHR or system which will potentially meet certification standards. The National Ambulatory Medical Care Survey (NAMCS) which was conducted by the National Center for Health Statistics (NCHS) for 2009 reported that only 4.4 percent of physicians reported using an EHR which was described as being a "fully functional system"

Now you can understand the summary statement given above. For those within the healthcare system who determined to transform themselves, like SETMA, this process, while not easy, is done; for those who are only responding to the pressure of reform, this process is going to be painful and perhaps impossible within the time frame given.

Next week, we'll talk about "meaningful use," that's when the cluster headache which you now have becomes a migraine.