Archive for the ‘EHR’ Category

The Office of the National Coordinator (ONC) for Health IT announced two organizations as an Authorized Testing and Certification Body (ONC-ATCB). The two organizations are the:

1. Certification Commission for Health IT (CCHIT). Read the CCHIT press announcement.
   
2. Drummond Group (DGI). Read the DGI press announcement.

According to David Blumenthal, M.D., national coordinator for Health Information Technology:

“Less than two months following the issuance of final meaningful use rules, we have approved our initial ONC-ATCB certifiers.  EHR vendors can begin immediately to get their products certified. This is a crucial step because it ensures that certified EHR products will be available to support the achievement of the required meaningful use objectives, that these products will be aligned with one another on key standards, and that doctors and hospitals can invest with confidence in these certified systems.”

Additional information on the ONC certification programs is available on the HHS Health IT site.

This is another step forward in putting the parameters and processes in place which are being driven by HITECH and the standard of Meaningful Use. HITECH is driving the adoption of EHR systems, offering physicians up to $44,000 in Medicare incentives and almost $64,000 in incentives through Medicaid. Hospitals are eligible to receive millions of dollars as well. In addition to implementing certified EHR systems, providers must meet staged Meaningful Use benchmarks to gain the full incentive amount.

On Tuesday, the New England Journal of Medicine published a testimony by the Surgeon General of the U.S. Public Health Service, Regina Benjamin, M.D., M.B.A., advocating for the use of electronic health records (EMRs) reflecting on the recently released meaningful use criteria.

In addition to the article’s applicability to the HITECH news in the healthcare industry, the article was particularly profound given the events that the southern Louisiana area has experienced in the last decade.

Take a minute to read through our Surgeon General’s experience with EHRs and healthcare integration.

Finding My Way to Electronic Health Records

In a recent poll, we asked if PHRs and HIEs, in addition to EHRs, should be included in the proposed health IT certification program. The results clearly demonstrated a preference on behalf of respondents for both PHRs and HIEs to be included as a part of the proposed certification program.

Question: In addition to EHRs, should PHRs and HIEs be included in the proposed health IT certification program?

• Include both PHRs and HIEs – 64%
• Include neither – 27%
• Include PHRs only  – 9%
• Include HIEs only – 0%

If you are interested in more information or would like to provide feedback for policy makers on the proposed health IT certification program,  you can visit the Department of Health and Human Services’ website or submit a formal comment at www.regulations.gov during designated comment periods.

If there is a poll topic you think would be appropriate or interesting, please send it to info@HL7Standards.com.

In March 2010, HHS released the health IT certification program NPRM or Notice of Proposed Rule Making. Visit the HHS site to learn more about the NPRM for certification. The certification program is a result of HITECH and Meaningful Use. As part of the NPRM process, several organizations have released comments about the proposed rules for certifying health IT. Three to take note of include:

1. Health Level Seven (HL7) International – PDF statement
2. American Health Information Management Association (AHIMA) – PDF statement
3. Markle Connecting for Health - PDF statement

Each statement offers interesting perspectives. One of the differences between these three is on what to certify. While AHIMA and HL7 urge incorporating more into the certification program, primarily Personal Health Records (PHR) and Health Information Exchanges (HIE), Markle is hesitant to put it all under a certification program. Their perspective:

“Regardless of the technology in question, the approach to certification should be limited to the minimum needed to enable providers to meet the Meaningful Use objectives, interoperability and existing privacy and security requirements. The cost of expanding the certification program should be carefully weighed against the benefits. However, HHS should allow PHRs or HIEs that wish to be qualified as EHR modules for purposes of helping providers and hospitals achieve Meaningful Use. We consider PHRs and HIEs separately below.”

From my perspective, two key points from their statement:

• Keep certification focused on what is needed for providers to meet Meaningful Use and associated requirements
• There is a cost to expanding the program – be careful

Good advice. There is enough to be done, so stay focused on what is necessary to meet Meaningful Use. There are many programs being launched already as part of HITECH, so be careful to not over-extend and over-program (see point 1).

Connecting for Health does a good job with their comments on the proposed certification program. It is worth reading in detail their recommendations on four key areas of the proposed health IT certification program:

1. HHS should create clear, standard language about the purpose and goals of its certification program, and its limitations in addressing important public policy questions raised by the adoption and use of health IT.
2. HHS should clarify the rules by which EHR modules may be exempt from testing against all privacy and security certification criteria.
3. Except for the specific circumstances in which such services are being used to help health care providers and hospitals qualify for Meaningful Use incentives under ARRA, HHS should limit the scope of extending the current certification program to other forms of health IT such as electronic personal health records (PHRs) or health information exchanges (HIEs).
4. HHS should clarify the type and scope of modifications that would require a 65 product to be recertified.

If you have the time to review only one of the three organization’s comments, read Markle’s Connecting for Health’s statement. It is more meaningful and insightful.

There are two interesting articles worth a quick read on the subjects of health care reform and health IT reform. As a refresher, health care reform passed earlier this year after intense debates and interesting legislative tactics. Health IT Reform passed as part of the Stimulus bill over a year ago and is known as HITECH.

First, the health care reform related article is entitled Cash for Doctors. The article highlights Dr. Brian Forrest’s practice in North Carolina, Access Healthcare. What is unique about his approach is that he accepts no insurance, and he has a published price list for the services he offers. Patients can see exactly what the service or test will cost. Dr. Forrest has negotiated lab test costs directly with labs, which are lower than what the insurance company has in place. All is paid by the patients immediately, no waiting for insurance processing, etc.

Consideration point: Health care reform has turned into a complex maze which will be costly and still has an enormous amount of unknowns. Dr. Forrest’s approach is simple, straightforward, with no hidden costs or agendas. Maybe there should have been more time during the legislative process to explore ways to simplify health care.

Second, in a Dallas Morning News article entitled Hospitals Criticized over Offers to Earn or Save Money by Sharing Electronic Patient Data, it highlights the concern over patient data privacy. Although there are significant penalties and other restrictions now in place, there are concerns on whether too much patient information would be transferred to various physicians and clinicians. Additionally, unidentified patient data is being sold to drug companies as another way for health care providers to make money. This raises concerns as well. This article outlines some of the practices and unease as we enter a highly electronic patient information era.

Consideration point: Maybe the model is somewhat backwards. All patient information should be sent electronically to a Personal Health Record, and the individual decides who gets what information. Additionally, if they want to sell their data to drug companies, let the individuals make that decision. This places more responsibility on the patient in the flow and privacy of their own data.

Two interesting articles on health care reform and health IT reform… It is worth spending a few minutes reading both to consider impacts and unique ways to accomplish improved healthcare delivery objectives.

Health Level Seven (HL7) International sent a letter to the Office of the National Coordinator (ONC) for Health Information Technology regarding the proposed rule on the certification programs for health information technology. The two primary comments are as follows:

• HL7 has produced the Electronic Health Record  System Functional Model (EHR-S FM), which was done at the urging of CMS and HHS and has been used by CCHIT in past certification criteria. “HL7 strongly recommends that ONC continue to include functional requirements as part of the certification program.”
• HL7 recommends that other systems other than EHRs be certified. HL7 has developed the PHR System Functional Model (PHR-S FM) which can be used as part of the certification process, just as the EHR-S FM is. HL7 goes on to recommend that EHR systems across the spectrum of care be certified as well, and HL7 has profiles for “…Emergency Department, Long Term and Post Acute Care, Behavioral Health, and Child Health…”

Read the complete HL7 Letter on the proposed certification programs (PDF).

A few other comments on the proposed certification programs have been submitted. American Health Information Management Association (AHIMA ) and the Medical Group Management Association (MGMA) have submitted letters to the ONC. iHealthBeat has an article – Groups Comment on Proposed Certification Rule for EHR Systems - which highlights the key points of their comments. Both of these organizations comment on already certified EHRs:  “allow CCHIT-certified products to remain certified until temporary certification entities are operational and able to re-certify the products” (AHIMA position) and “recognize EHR products certified by CCHIT in 2008 or later as meeting the requirements of stage 1 of the EHR incentive program” (MGMA position).

So, a quick summary of comments emerging on the proposed EHR certification programs – one coming from a healthcare standards organization and the others coming from healthcare trade associations. There is a definite difference in comment approach between the two types of organizations, and there will likely be more comments coming from others.

One thing is certain about HITECH / Meaningful Use today – it has created opportunity for many, many organizations to comment on its various components.

What did not happen in health care reform is happening in healthcare IT reform – Bi-Partisan Support. One letter contained Senatorial signatures ranging from Al Franken to John Thune (I never thought I would be using these two names in a healthcare IT blog post!). Although they are from neighboring states, they are on different ends of the political spectrum.

So, what is uniting this diverse group of 27 US Senators on Meaningful Use? In a letter to Charlene Frizzera, Acting Administrator at the Centers for Medicare and Medicaid Services (CMS), they offered comments and clarifying HITECH/ARRA points on the proposed rules driving Meaningful Use. The highlights from the esteemed colleagues from both sides of the aisle include:

• The definition of Meaningful Use is deemed too restrictive, resulting in many hospitals, especially rural and safety-net providers, not being able to participate in the incentives.
• Give hospitals more time to comply, extending the transition time so that the 23 separate EHR objectives and requirements can be met.
• Provide “flexibility” in the early years so that hospitals and physicians have time to gain access to the full incentive benefits.
• Critical Access Hospitals should not be excluded from the Medicaid incentive program.
• Delay electronic reporting of quality measures through EHRs – wait until EHRs can deliver on these requirements.
• Re-define a hospital-based physician (don’t exclude physicians practicing in outpatient centers and clinics which may be owned by the hospital system).
• Modify the scope of services it considers to be outpatient hospital services — don’t physicians practicing in hospital ambulatory sites.
• The Medicare provider number should not be used to determine hospitals for EHR incentives, especially since one number may include multiple hospitals. In other words, each hospital within a system should be eligible for EHR incentive payments.
• Provide direction to states on how to make the incentive payments — keep the funds focused on health IT implementation; don’t let the states stray from that goal.

If you parse through this letter, there are several intriguing elements to it.

First, the summary comments are remarkably similar to the many healthcare trade associations who have commented on both the healthcare standards IFR and the Meaningful Use NPRM. (Read an overview of their Meaningful Use NPRM and Healthcare Standards IFR comments.) The various trade associations are doing their job in leveraging their relationships with various congressional leaders. This is not a bad thing; it’s part of our political and legislative process.

Second, these Senators want to ensure the rural and safety-net providers are not overlooked in the incentive payments, and they want the opportunity for hospitals within a system to maximize their EHR adoption plans and, accordingly, their incentive participation. The same applies to the number of physicians who are eligible to partake. Again, this is not a bad thing. If we really want to drive a more electronic, interoperable, efficient, high quality, and meaningful health care system, then the more hospitals and physicians making the change, the more likely the opportunity for success.

OK, so we had bi-partisan support on the letter to CMS, but no bi-partisan support on the letter to Health & Human Services Secretary, Kathleen Sebelius. I am not sure why, since the content is similar. I guess we are no longer in Kansas. The letter to CMS was more detailed than the letter to the HHS, so maybe that was the deciding factor.

That wait is on for the next step to our new, new HITECH world of health care and healthcare IT!

The Healthcare Blog has an interesting post entitled EHR Redux. The impacts of the proposed regulations will  have a ripple impact which may be somewhat unknown at this time. David Kibbe, in his post, highlights some of these potential changes in EHR technologies as the NPRM on Meaningful Use and IFR on healthcare standards near refinement and regulations.

The real changes being unleashed are causing hesitation on defining a clear direction for providers to take and calls for “relaxation” on the Meaningful Use requirements. To a certain degree, there seems to be a giant collective deep breath taking place in the healthcare IT market in trying to sort out the right course of action to take. Even when the public comment periods end soon for the NPRM and IFR, the direction may still be hazy.

Regardless, the wave of change that HITECH will have is quickly unfolding. Being prepared is a must, as well as being nimble. Get your project teams ready, and prepare your organization – and the patients they serve – for the changes coming.

Centers for Medicare & Medicaid Services (CMS) has a site in which you can read the public comments on the Interim Final Rule (IFR) for Meaningful Use. It is interesting and entertaining reading, ranging from clinics currently using EHRs to physicians just not buying into the whole approach. A few examples:

From a rural health clinic in Nebraska:  “I have only read the first 103 pages of this proposed ruling and have been focusing on what we will have to do to receive incentive payments as an early adopter in 2010.

I find myself discouraged that we will ever be able to comply with this meaningful use definition. I also reflect on the last eight years of using the EHR and wonder how a new user of an EHR would qualify as well.

Just installing and getting everyone using electronic records is a difficult task. So I believe that this version of meaningful use is too aggressive for the first year.”

From a provider in Pennsylvania:  “Acceptable Standards. Organizations should not have to rewrite existing fully functional interfaces to comply with MU criteria. This will add a great deal of unnecessary cost. For example we already submit lab results and surveillance data to public health agencies using an older version (HL7 2.2). The new criteria calls for a minimum of HL7 2.5.1 for lab submission and HL7 2.3.1 for public health submission. Redeveloping/retesting these interfaces, for no other reason than to bring it up to a current version, is a waste of resources. Please clarify this rule and change it so that existing working links can remain in place until there is a need to upgrade.”

From a physician in Illinois:  “This is a steaming pile of crap. If one could imagine what the worst possible outcome of the process of creating these rules could be, this is it. These are rules that only a bureaucrat could love and will not help increase the implementation of EHR. 556 pages?! You are out of your minds if you think this is helpful or necessary. What a waste of time and money…  This is so disappointing I almost cried.”

Take the time to read the comments being submitted on the proposed Meaningful Use rules, and also please take the time to submit your comments. It is a part of our democratic process.

Vendors race to certify their applications to ensure certification by 2011 and meet Meaningful Use requirements. Have doctor’s (i.e., potential customers of these EMR/EHR applications) shifted the requirements from new, innovative functionality for their practice and patients to a focus more on how to gain access to the Federal stimulus money?

One could argue that the government, along with the certification commission, have determined which pieces of the standards and requirements for interoperability and functionality every vendor must provide to a customer. This is now done in conjunction with “Meaningful Use” requirements to ensure stimulus money will be accessible by the doctors. The thought is that a certified EMR/EHR will lead to better patient care and lower costs, yet I wonder if this has stalled innovation somehow.

While speaking to people in the industry, this question comes up frequently, and vendors seem to have shifted their focus to make their software certifiable, although their customers may not find it “meaningful.” The result:  losing the focus on innovation which set vendors apart. There are many niche vendors with great innovative software who do not fit into the current certification program or simply do not have the funds to alter their software to meet the general requirements. Will doctor’s using software from those vendors sacrifice functionality that fits them to get the incentive money instead?

I am interested to start a discussion on this topic as I am sure many of you have great points on this topic.