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CCHIT has published their comments made on the Interim Final Rule (45 CFR Part 170, RIN 0991-AB58), published in the Federal Register of Jan 13, 2010, “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology.” Or as I like to call it, the EHR Certification criteria.

Here’s 3 paragraphs that kind of describe CCHIT’s broad feedback on the EHR Certification criteria:

Before offering detailed suggestions, the Commission wishes to highlight three overarching concerns with the IFR as written:

• Scope. While “Complete EHR”sounds like a desirable certification, the package of requirements in the IFR may not match the needs and expectations of doctors and hospitals, nor the realities of the marketplace, for EHRs. By including two functions of an administrative/billing system in the scope of EHR certification, ONC may exclude one third or more of the offerings in the current EHR marketplace, while suddenly forcing hundreds of billing products to undergo unnecessary certifications. In other areas, the scope falls short of being complete: for example, an EHR that does not offer competent electronic management of progress notes would be unusable and medico-legally unsound, and an EHR that fails to prominently display patient advance directives in an emergency could compromise patients’ rights at their time of greatest vulnerability.
• Interoperability. The Commission and its expert volunteer panels believe that certain criteria and standards in the IFR represent a step backwards in progress toward EHR interoperability. For example, well-defined standards for receiving electronic laboratory results in the doctor’s office and for exchanging clinical summaries had already been recognized by the Federal government and widely supported by industry – as evidenced by the certification of over 80 EHR products to those standards in 2008. Yet under the IFR, that standard for receiving laboratory results, and the specific implementation guidance for exchanging clinical data, have been dropped. Where one standard was previously recognized for clinical data exchange, the IFR offers two different, incompatible standards. Conversely, other interoperability criteria in the IFR, such as the requirement that EHRs be capable of transmitting biosurveillance data to public health authorities, could immediately increase EHR cost and complexity while benefits remain years away because public health authorities lack standards-compliant infrastructure and systems for receiving that data.
• Functionality. Some of the IFR criteria define required functionalities of an EHR too microscopically, adding unnecessary complexity and creating barriers to innovation. Other criteria are too vague to be reliably verified in a testing process, creating a risk that the expectations of providers, payers, and the public regarding the performance, safety, and benefits of Certified EHRs will not be met. A particular concern surrounds the reporting of quality measures, with the IFR calling for standards and measures that are yet to be defined or that require significant revision to make them computable from EHR-based data.

I’ll be interested to hear people’s comments about CCHIT’s feedback on the HHS EHR Certification Criteria.

I’ve written a number of times about Drummond Group becoming an EHR certification organization in order to obtain the EMR stimulus money. Well, the Drummond Group has created a blog to keep you informed about theri partcipation in EHR testing/certification.

Here’s the most important part of their first post on their blog:

It appears Booz Allen Hamilton (BAH) will be developing both the testing certification documents as well as the framework for authorizing certifying body for EHR certification.

Once that final piece of the puzzle is revealed, we can begin making more detailed plans for EHR certification. Until then, we believe attempting EHR certification is, at best, premature and, at worst, potentially a significant waste of time and money for ourselves, the certifying vendors and the adopting physicians and hospitals.

However, this waiting period does not mean we are idle. We will be making regular posts here on various EHR certification topics. Since many of you are not familiar with us, we will share a bit more about DGI and our qualifications to be an authorized HHS certifying body for EHR. We have a great deal of experience in system-to-system interoperability and are excited to bring that knowledge to the EHR community. Since we are getting so many emails from vendors interested in EHR certification, we will talk about some of the concerns we are hearing and thoughts on how to best address them.

This is exactly why you should want to be certified by Drummond Group and not CCHIT. I agree with them saying, “attempting EHR certification is, at best, premature and, at worst, potentially a significant waste of time and money for ourselves, the certifying vendors and the adopting physicians and hospitals.“

I just found this really nice interview by InformationWeek with David Blumenthal, Health IT Czar. Here are a few snippets of what David Blumenthal said with my own commentary in italics.

Congress set very ambitious goals for the HITECH legislation. The concept of meaningful use is novel, and a very powerful and important concept. The process of defining meaningful use has gone through many months, through many public hearings.

I think David Blumenthal realizes that meaningful use is going to be a major problem for many doctors offices. I think we’re going to hear him blaming Congress for the “ambitious” HITECH legislation which has his hands tied. It probably does, but it’s too bad he can’t just say it that way if it is the case.

The Office of National Coordinator is still committed to developing the Nationwide Health Information Network. Many of our federal colleagues and quite a number of larger healthcare organizations are on the verge of using NHIN as it was originally conceived and configured for their own purposes, and we’re continuing to invest in it.

At its last meeting the HIT Policy Committee adopted recommendations that they have not yet formally transmitted to me to encourage the development of a more flexible, adaptable, less complicated method of health information exchange than the Nationwide Health Information Network. And that’s something that we’ll be studying.

I think this is a good move. This national network in its current state just doesn’t seem like it’s going to have much affect on small doctors offices, which last I checked make up a large part of our healthcare system. I think in politics they call this move taking it to the people.

InformationWeek: Once you get clinicians using e-medical records, who pays to maintain the exchange infrastructure?

Blumenthal: It’s a short-term issue. Long term it’s going to become an expectation on the part of the clinician and patient that information is going to be exchanged. And I think it will become a cost of doing business in the healthcare sector just as physicians and nurses consider it a cost of doing business to buy stethoscopes and run an office.

Doctors will hate to hear this quote. Although, they shouldn’t be too upset. In reality, they’ll be passing this cost on to the consumers. Now how we get to the point Blumenthal talks about is beyond me. That’s a huge gap to cross.

InformationWeek: Will the Certification Commission for Heath IT–CCHIT– remain the organization doing these certifications, or will there be others?

Blumenthal: We’ll have to see what the regulation actually is and see where CCHIT fits in. CCHIT is clearly going to have the option to participate in certification going forward, but I can’t tell you what role exactly it will play.

Translation: I don’t care about CCHIT. If they want to participate great, but I’m playing no favorites here.

CCHIT’s Mark Leavitt has published his analysis of the $400,000 contract that NIST awared to Booz Allen Hamilton to develop a framework for electronic health record certification (see certified EHR).

Honestly, it seems that Mark’s as confused as everyone about this whole process. This is an interesting development since I would have thought that CCHIT would have had a close relationship with HHS, ONC, NIST, CMS, etc. The fact that CCHIT and Mark Leavitt are kind of left in the dark and full of lots of questions is not a good sign for CCHIT and fans of CCHIT. It is a good sign for those who don’t care for CCHIT.

I can’t help but repost something that HISTalk posted about one of the companies that’s now CCHIT preliminary ARRA certified and the meaning of said certification:

From Lester Bangs: “Re: ARRA certification. Companies like this one (and they aren’t alone) get checked off on SOME of the ARRA criteria (which are changing) and get labeled as Pre-ARRA Certified by CCHIT. Amazing. And we wonder how folks are confused.” I found CCHIT’s disclaimer more interesting (click the above screen shot to enlarge) since it clarifies that the certification is preliminary, possibly irrelevant depending on the standards that are eventually approved, and possibly worthless since CCHIT may not even be a recognized certification body by them.

I’ve always loved HISTalk, but I’m even happier to see that him and I agree about CCHIT certification. I’m sure Mark Leavitt is really glad he’s cutting out of CCHIT when he did.

Check out the following descriptions of the first four EHR vendors to become CCHIT 2011 and Preliminary ARRA EHR certified per Jim Tate’s guest blog post on Hitech Answers:

eHealth Made EASY, Version 3 by eHealth Made EASY, LLC, achieved Preliminary ARRA 2011 Certification for ‘CMS Quality Reporting” in both the Eligible Providers and Hospitals domains. They look to be on track to supply the ‘meaningful use’ reporting functionality across the entire range of platforms. I’m guessing they could become the reporting engine for quite a few hospital systems and EHRs.

KIS Track, Version 5.1, by Kaulkin Information Systems, achieved Preliminary ARRA 2011 Certification for ‘Patient Electronic Access to Health Information’ for Eligible Providers. Looks like they may be getting into the patient portal market.

Medios, Version 4.5, by IOS Health Systems, passed inspection on 27 of 27 objectives for Preliminary 2011 ARRA Certification for Eligible Providers. It appears they are interested in the Ambulatory EHR market.

ABELMed EHR-EMR/PM, Version 11, by ABEL Medical Software Inc., is the first EHR vendor to achieve the CCHIT 2011 Comprehensive Ambulatory Certification. Usability testing is now a part of the CCHIT Ambulatory Certification and in this area ABELMed scored 4 out of 5 stars.

My personal takeaways:

Takeaway #1: Four EHR vendors and I’ve only really heard of one of the four. Sifting through all the EHR vendors is just going to get more and more difficult.

Takeaway #2: How will these vendors and the users of these EMR vendors feel if HHS comes out with some drastically different or drastically simplified criteria for EHR certification?

There’s been a series of posts done on EMR and HIPAA that I think are worth highlighting on this site. They basically cover the status of where we’re at in understanding what will be defined as “certified EHR” in order to get the ARRA EHR stimulus money.

First, take a look a post talking about the HIT Policy committee meeting on EHR certification where they discussed and approved a number of items related to defining certified EHR.

After that initial meeting, CCHIT held a town hall meeting to present their new CCHIT Preliminary ARRA Certified EHR certification plan. Then, take a look at a bit of a comparison of the Preliminary ARRA Certified and CCHIT Certified that was presented at the same meeting.

Finally, no discussion of these EHR certifications is complete without taking a look at the costs for the new CCHIT EHR certifications. That link also discusses the new EHR certification bodies that are likely to be created and recognized by HHS to be able to certify EHR software in order to obtain the ARRA EHR stimulus money.

At EMR and EHR we welcome people to submit guest blog posts on our contact us page. We’re happy to post them with your name and a link to your website or anonymously. This week’s guest blog post comes from a doctor who wishes to remain anonymous but has some real questions about CCHIT’s involvement in the EMR world. Enjoy!

Companies are lobbying the Administration to keep product-testing and standard-setting within the sole jurisdiction of a nonprofit body called the Certification Commission for Healthcare Technology. Founded in 2004 with industry money and grants from nonprofits, CCHIT now receives $7.5 million a year under a contract with the federal government. The other half of CCHIT’s $15 million budget comes from fees paid by companies. Mark Leavitt, chairman of CCHIT, is a former tech vendor. He sold his electronic health records company to GE in 2002 and later became chief medical officer of the Healthcare Information & Management Systems Society (HIMSS), a trade group in Chicago. Seven of the CCHIT’s 19 voting members work for vendors or for-profit tech consulting firms. -– Chad Terhune, BusinessWeek, May 4, 2009, The Dubious Promise of Digital Medicine: Why huge spending on electronic records won’t produce quick improvements in efficiency or care.

$15 million dollars per year! To do what? Where is all the money going? I wonder how much Mark Leavitt makes per year? How much are the voting member paid per year? Boy, would I love this job! And what about the fact that almost half the voting members work for vendors or consulting firms! Is there a conflict of interest?

Does anyone have any additional information on CCHIT? This really makes me curious. Alarms are going off all over the place when I hear the basic information about CCHIT, how much they take in per year ($15 million) and what they actually do (certify a few EMR Systems).

Because of all the money being thrown at doctors and hospitals as part of the HITECH (Health Information Technology for Economic & Clinical Health) Act, a component of the ARRA (American Recovery and Reinvestment Act), it becomes important to use certified EMRs in a meaningful way.

It has always been important to use EMRs in a meaningful way, but now you can get paid ($44,000 per physician) if you jump through hoops created by organizations like CCHIT which is the Certification Commission for Healthcare Information Technology, who want to make money for their executives and suppress competition for their top clients. The government has put the wolves in charge of guarding the hen house. Diversity, choice and competition have taken a back seat to self-serving regulation based on big business payoff of our government at its highest level (the big EMR companies have bought Obama). This is truly breathtaking and incredible (see BusinessWeek May 4, 2009, page 31-37)! The best way to stunt the development of any system is to suppress diversity, choice and competition by putting the rich and powerful in charge. The people in charge want to make more money, they don’t want better EMRs and they don’t want what is best for our healthcare system.

Today’s blog is going to be a little different. I am not going to comment on the present criteria used for CCHIT certification and I am not going to comment on the current state of the “meaningful use” definition. I KNOW what “meaningful use” is. I am a doctor, I have an EMR … I know “meaningful use” when I see it. Walks like a duck, quacks like a duck, looks like a duck. All doctors KNOW intuitively what “meaningful use” is.

I am not going to comment on the specifics of CCHIT Certification Criteria because I KNOW it is not optimal. Tear it all down and let’s start from scratch. It may have served a purpose in the past to move the industry forward, but it has now become a problem. It inhibits innovation, diversity and choice. It costs too much, it is too complex and many very good EMRs are not CCHIT certified. Company’s are wasting their time, money and effort to get certified rather than improving their EMR product! CCHIT’s primary purpose now seems to be self-preservation at any cost. Their executives want to preserve their six figure incomes at any cost.

Instead of commenting on what others have said about these two issues, I am just going to tell you what I think … I am going to keep it simple.

Any EMR that can be used in a meaningful manner should be certified. Period. End of the certification problem. My definition of meaningful use is so simple and so intuitive that certifying an EMR becomes very easy. So easy that you don’t need to pay much money and you don’t need an organization like CCHIT. You can hire a CPA or an Accountant to do the certifying.

Any EMR should be certified if it can do everything listed below. If it can do these tasks, it is being used in a meaningful manner and thus satisfies the “meaningful use” requirement.

What an EMR must do:
●Document a Progress Note
●Store, Index and Provide access to Lab Results, Test Results, Hospital Reports and Consultation Reports
●Store and Track Wellness information for Chronic Conditions like Diabetes (Fasting Blood Sugars, HgAICs, Eye Exams, Kidney Tests and Foot Exams) and Coronary Artery Disease (Blood Pressure, Cholesterol, EKGs, Stress Tests, Echocardiograms, Catheterizations, Cardiac Consultations).
●Store and Track Health Maintenance Information for Routine Care of Adults and Children (Flu Shots, Pneumonia Shots, Immunizations, Mammograms, Pap Tests, PSA, Colonoscopies, Bone Density Tests)
●Write Prescriptions
●Write Orders
●Help Select Diagnosis Codes (ICD-9 and CPT Codes)
●Help Select Level of Care Codes (Evaluation & Management (E&M) Codes)
●Perform Scheduling, Billing and Intra office Messaging OR Interface with a Practice Management System
●Collect and Report data for Quality Improvement Activities and Pay-for-Performance Activities
●Connect with Regional Health Information Exchange Platforms (HIE Platforms) AND be able to Import and Export Data in the Continuity of Care (CCR) or CCD Format

If an EMR can do the above tasks then it is being used in a meaningful manner and it should be certified. My background is Internal Medicine, so there may be adjustments that are need for certain specialties. Some may feel that I should include a patient portal and clinical decision support in the above criteria.

Let’s not overcomplicate this EMR thing. We want doctors using an EMR and we want companies coming up with better EMRs which help doctors provide better, more efficient care at a lower cost. The only way to achieve these goals is to let the market place select the best EMRs. In order to do this, you need innovation, variety and choice. You have to nurture and support small companies. We have to encourage people to get into the EMR business rather than create barriers to entry. Using CCHIT certification and possibly a complicated definition of “meaningful use” we risk inhibiting innovation by snuffing out new and small companies with regulations that are not practical, helpful or wise.

There’s been a lot of talk around the blogosphere about the new EHR certification pathways proposed by CCHIT. However, Neil Versel is reporting on his blog that there’s a rumor that ONC is planning a July meeting with several people that are considering starting up an EHR certification program.

Makes complete sense to me. David Blumenthal does seem open to the idea of not having CCHIT be the sole certification body. Certainly he’ll feel some big time pressure from the various big EHR vendors out there, but I’m hopeful that David Blumenthal will be able to do well and keep at least some competition in the EHR certification process.