CCHIT Certification

drbowen wrote on Friday, March 27, 2009:

By the way Dave.  Speaking of quality of consultants, I have emailed you and called your number and I am still waiting for you to call or to email.

Sam Bowen, MD
1-828-325-0950
drbowen@charter.net

donmcco wrote on Friday, March 27, 2009:

We are a non-profit 501(c) 3 organization in Houston, Texas that manages contracts for 540 physician offices. We started using OpenEMR in three of our clinics about a year ago.  Because it was open source we have been able to modifer it to fit our specific needs with very little expense. We have about five thousand records in the system now and we find that it is a better system than others that our doctors are paying as much as $40,000 to purchase.  Certification of this product does not matter to us as much as its being open source and usefull and not loaded with unneeded and unnecessary administrative fees.  If it must be certified because the government wants to protect the interests of those who have failed to do anything very well in this area in the past then it is time for government to change and for us to change it. 

The profit motive may be foremost in the minds some companies and their agents,but it has done little or nothing for physcians or patients. I am sure that we could raise the necessary funds to pay the fees to get CCHIT certificatrion or we could use that money to care for another 1000 patients in our non-profit clinics and the certification agencies recognized by the government could be more than one and better than the current offer, perhaps in the same spirit of volunterism as the open source community is already. 

If it would be helpful our organization will seek a grant to pay for the needed costs of either certification to assure that the software stays in the public domain continues to improve.  I do not understand why there has been such difficulty in getting 501(c)3 approval from the IRS, perhaps we can help in that regard for free.

Don McCormick


donmcco@gmail.com

drbowen wrote on Friday, March 27, 2009:

My wife has pointed out after the fact that I made some significant typos in the letter to my Congressman.  I will repost the letter after I correct these.

Patrick McHenry already knows abut me and our project.  His letter does not mention some of the background information.  So the second letter should be included as a supllementary background material.  I will combine these for you if you wish.

She also notes that President Obama is the one who is pushing Open Source and she suggests that we should  go to the source and send the same letter to President Obama.

I guess I need to listen to my wife a little more often.

Sam Bowen, MD

rpl121 wrote on Friday, March 27, 2009:

I personalized a letter about CCHIT and the Recovery Act, emphasizing the central city nature of my family medicine practice and faxed it to my two Pennsylvania senators and to my local representative.

Ronald Leemhuis MD

drbowen wrote on Friday, March 27, 2009:

This is the cleaned up version with the additional supplementary information.  Please modify this to meet your needs and send this to your Congressional Representative and both your Senators.  It may be helpful to also send a copy to President Obama.

Sam Bowen, MD

Open Source Medical Software
1470 Ninth Avenue Drive NE
Hickory, North Carolina, 28601
telephone 1-828-325-0950

March 26, 2009

Congressman Patrick McHenry
87 4th St. NW, Suite A
P.O. Box 1830
Hickory, NC 28603

Open Source Software Certification
Executive Summary

Honorable Congressman McHenry:

The new Economic Recovery and Stimulus Act of 2009 requires electronic health records to be certified.  As the developers of an electronic health record we agree in principle that the interoperablity standards of the Health Information Technology (HIT) division of Health and Human Services (HHS) will be good for Americans and help improve their health.  We could not help but notice that the plans for HIT to spend $19 Billion dollars to study Open Source Health Care Software primarily to support rural health care, free health clinics and primary health care in the United States to help protect the fundamental health care safety net in the United States.   The Act goes on to provide funds to reimburse medical practices up to 85% of the purchase price of a certified (emphasis added) electronic health record product.   At the same time the Center for Medicare & Medicaid Services (CMS) has proposed an initial 2% increase in reimbursement of fees for the adoption of ePrescribing by physicians with a 7% drop over the next 7 years for physicians that do not comply. 

You can understand my chagrin after speaking to Dr. David Hughes of HIT at 11:00 AM on January 19th, 2009, that my not-for-profit free open source software company can not apply for assistance or compete for this project in any way because we are not certified.  They will provide no assistance for us to get certified.  He explicitly stated that we had to be CCHIT certified.   Currently the Certification Commission for Health Information Technology requires a $29,000 initial fee and requires at the same time a $6,000 annual software maintenance fee.  If we want to add child health this requires an additional $6,500 and $1,500 software maintenance fee.  This a total of $43,000 for a EHR that wants ambulatory care certification with a pediatric indication.  The actual reported cost to gt certified by certified by the companies that have been able to manage this is $200,000.  The difference being made up in the additional development necessary to achieve certification.

So what is the problem with this?  There are over 400 companies in the United States that offer ambulatory Electronic Healthcare Record software.  At this time only 21 one have managed to become certified in 2008 and in 2007 only 47 companies.  The roll call of these companies reads like a roll call of the whose who of the Rich-N-Famous of American software companies.  The smaller companies simply cannot afford this cost of this certification.  In comparison, Open Source Medical Software, is a not-for-profit free open source software company.  We give our software away for free.  We do not have an income stream.  Our past, present and future profit is intentionally zero.  If the for profit companies struggle with the cost of CCHIT certification,  how can we do this with an intentional profit of zero.  In fact this type of operation is typical of many open source software companies.

Now I want to reiterate something.  I am giving away for free $54 million dollars of software a month to anyone and everyone I can convince for free.  I am trying to give to the United States government this fully functional software for free.  The US government is refusing my free software because I don’t have the $200,000 to get certified.  Now the US government in the Economic Recovery and Stimulus Act is planning to spend $19 BILLION dollars between now and 2010 to investigate how to provide what I am giving away for free.  In addition the US Government has officially made law an offer to spend many more tens of Billions of dollars reimbursing well-to-do medical practices what they would have to buy on their own anyway.  Congressman,  this is so outrageous that I think it makes the jokes about $50 ashtrays and $1,200 toilets seem like a grains of sand on the entire coast of California.  Am I the only one that gets the irony of this?

Congressman,  We need your help. 

1) Obviously we are not playing on a level field and the Laws being passed are forcing us into an untenable position.  We either need the CCHIT to lower their fees to include supporting an organization that has no income.  (They have shown no inclination to do this when asked by multiple companies.)  Or we need a second certification body created for those software companies that cannot afford these outrageous fees.

2) The Federal Government is obviously hopeless lost when it comes to free open source software projects.  The majority of these open source projects work as not-for-profits.  The Mitre Corporation performed a study of Open Source Systems used by the Department of Defense (DOD) in 2001.  115 Open Source Software Systems were identified being used in about 250 applications.  When the Mitre Corporation queried the DOD staff about the use of the software and whether it proposed a security risk to the DOD and the United States.  The department that objected most strenuously was the IT security department who felt a number, up to 13, of the Open Source Systems were “Mission Critical” in their jobs of protecting the DOD.  The Mitre study and “The Cathedral and the Bazaar,” by Eric Raymond,  O’Reilly Associates, 1999 will go a long way educating the strengths and values of Free Open Source Software. 

Sincerely,

Samuel T. Bowen, MD
President
Open Source Medical Software

*****  Additional Information  ******

As you may remember, I am the president of Open Source Medical Software  (OSMS), the North Carolina not-for-profit company that  develops and maintains a free open source electronic health record and practice management software system called OpenEMR.  The electronic health record portion has a fair market value of $25,000 dollars per copy and the practice management software has a fair market value of $10,000 per copy.  The total package has a fair market value of $35,000 per copy. 

OSMS is a not-for-profit corporation dedicated to improving free open source medical software and distributing this software to needy populations in our State of North Carolina, The United States of America and the rest of the world thereby improving patient outcomes and positively affecting health care world wide.  Since October of 2008 we have been donating a fair market value of $54 million dollars per month.  We have increased our volunteer contributions and donated software in kind from $400,000 to $815,000 per year.  We have increased the number of professional developers in the project from 4 to approximately 15.    We have taken on International Planned Parenthood Federation (IPPF) as a major client.  IPPF is currently operating in 150 different countries and has started successful OpenEMR pilot projects in Barbados, Indonesia and Nepal.   IPPF plans to distribute our software worldwide over the next 5-10 years.

Our intention is to improve health care by reducing barriers to care, including economic barriers, cultural barriers and language barriers to improve health outcomes in traditionally disadvantaged populations.  OpenEMR is multi-language capable and has fully functional in English and Dutch.  Spanish and Chinese translations are  being developed.  We hope to add French, German and Russian within a year.  The program keeps track of family incomes and such factors as primary language spoken and whether or not the client is homeless.

OpenEMR is a free open source software that is already being used both locally in the United States and world wide to positively impact patient health care.   We have taken on International Planned Parenthood Federation (IPPF) as a major client.  IPPF is currently operating in 150 different countries and has started successful OpenEMR pilot projects in Barbados, Indonesia and Nepal.   IPPF plans to distribute our software worldwide over the next 5-10 years.  OpenEMR is currently being used in Australia, Sweden, Holland, India, Nepal, and Kenya.    Expatriate physicians in China are working on a Chinese version.

OpenEMR allows physicians and practitioners to maintain health records for their patients in an electronic (i.e., non-paper) format.  This software has the additional capabilities of faxing and emailing prescriptions, generating medical billing, and maintaining accounts receivables, as well as keeping all patient medical records.  In addition to increasing medical practice efficiency and reducing practice costs, another, substantial benefit of this software is that it insures compliance by the physician or practice with the privacy requirements for patient medical records imposed by federal law.  This is a particularly important feature of electronic medical records software like OpenEMR since it is nearly impossible to comply with federal requirements using a paper format.  That is because paper can be easily stolen or read by an intruder, cannot effectively be “backed up” (a back up copy that can survive and be accessible to the user in the event the original is destroyed by fire or other casualty), and must be shredded in order to be destroyed.

A large number of physicians, practitioners and medical practices are still using paper records in spite of the difficulty in maintaining compliance with the HIPPA law.   These physicians, practitioners,  and practices fear the high cost of electronic medical record software and implementation.  Many Electronic Medical Record software installations fail because of poor installation and implementation.  The practice go on using paper records.  These paper records are cumbersome at best.  It does not allow efficient communication between various practitioners and makes portability of medical records difficult. More often than not, these medical records are not available to consultants when they are needed. There is duplication of x-rays and laboratory results decreasing overall system efficiency.

Electronic health records (EHRs) allow fewer people to do more with less. This is especially true for organizations operating on limited budgets. Instead of hiring another staffer to file papers, the clinic might be able to provide free blood pressure medicines or hire a nurse who can do blood pressures checks for less compliant patients. Electronic health records allow cross-checking of drugs for known interactions. Electronic faxing or e-mailing prescriptions improves legibility and decreases communication errors between the physician and the pharmacist. Less storage space is needed for EHRs, decreasing the need for a larger building, resulting in decreased rent or building costs.

EHRs allow the introduction of computer assisted diagnostics. Improved diagnoses translates into fewer "blind alleys," reduced empiric medications trials and fewer opportunities for treatment errors. All of these effects will reduce physician anxiety over lawsuits and encourages physician participation in clinics that provide care to indigent or underprivileged patient populations.  EHRs help improve patient care in many ways and reduce costs at the same time. This ultimately lowers the barriers to high quality patient care.

The Institute of Medicine reported in 1999 that between 44,000 and 98,000 deaths occur annually from medical errors. In a year where the CDC reported 2.4 million deaths, Barbara Starfield reported in JAMA (Volume 284, No. 4, 2000) placing the estimates even higher, citing a total of 225,000 deaths due to iatrogenic causes (injuries caused by medical treatment), which would place health-caused deaths as the 3rd leading cause of death in the USA. Medication errors, misdiagnosis and "blind alleys" are a big problem in the United States and in the world.

OpenEMR was originally developed as an experimental project by Synitech, a for profit corporation in Massachusetts, from 1999 to June, 2001 and subsequently released as open source under the GNU General Public License. Additional development was funded by PennFirm in San Diego, California. The benefit to cost (B/C) analysis for Synitech and PennFirm in the short term was prohibitive. The project was dropped by PennFirm March 8th of 2005. OSMS took over management of that project at that time.

For OSMS the B/C ratio is much higher because of low project overhead. The absence of the profit motive reduces the amount of donations and grants to allow the project to progress. The development servers operate for free as part of the SourceForge Project. SourceForge is an organization that specifically supplies server space and forums for free open source software projects. SourceForge currently has 150,000 registered free open source projects and 1.6 million registered users.

All of the hard costs of the project such as telephone, secretarial assistance, general office expenses, and Internet service are donated by myself, Sam Bowen, MD.  The OSMS web servers have been  obtained through a grant made by Hickory Springs Corporation in Hickory, North Carolina.

There have been substantial ongoing donations of volunteer time and software donations in kind that have sustained the OpenEMR project. The volunteer donations in time and software donations in kind typically run $815,000 per annum. These donations in kind are contributed by approximately 15 main developers and 6-12 part-time developers. OSMS has invested $50,000 in start up costs, establishing the not-for-profit status.   United States Internal Revenue Service tax exempt (501 (c)(3)) status has been applied for and is pending.  Since our last communication from IRS Agent Laurie Thrasher we have been waiting for 18 months for some news on our tax exempt status.  As previously stated, OSMS is already a tax exempt organization in the State of North Carolina.  OpenEMR is being used successfully in multiple locations in multiple states in the United States and Puerto Rico.  Its popularity and ease of use have been growing rapidly. 

OpenEMR provides excellent legibility. Typed prescriptions are faxed or e-mailed to the pharmacist decreasing the risk of misread prescriptions. There is drug interaction checking available through on-line databases through OpenEMR decreasing the likelihood of a medical injury occurring because of an interaction between two or more drugs (drug-drug interaction).   OpenEMR has fax handling capabilities, scanned document handling, prescribing by printed prescription, fax, email or ePrescribing.  Easy transfer of medical records by paper, email or PDF.

The impact of OpenEMR over its relatively short existence has clearly exceeded the imagination of its creators by a wide margin.  It is an all volunteer organization that works almost exclusively off of volunteer time and donated software.   The new push by the Obama administration is essentially forcing all electronic health records in the United States to become certified.  The new CMS rules and the Economic Recovery and Stimulus Act of 2009 introduce a number of changes that are going to force this.  CMS reimbursement for physician fees are scheduled to be be reduced over a period of 7 years if the physicians do not use a Certified Electronic Health Record.  The Economic Recovery and Stimulus Act of 2009 has a provision specifically requiring HIT to provide plans to provide an open source electronic health record for rural health clinics and other primary care providers by 2010.

CMS is setting up five “Recovery Centers” to aggressively audit reimbursement for charges submitted to CMS.  The intent is to discover “fraudulent” behavior and recover these fees. 

Unfortunately, physicians who are still using paper records  have a hard time documenting their charges sufficiently.  The current average “recovery” from a medium to large practice is $200,000 per audit.  The dropping reimbursement from CMS over the next 7 years and the aggressive behavior of CMS to “recover” what amounts to poorly documented physician office visits will be to force all physicians to start using a “certified” electronic health record over the next 7 years.  This of course will also apply to any agency that files for reimbursement from CMS for any health related interaction.   This will potentially negatively affect rural health clinics, public health departments, free health clinics and free mental health clinics.

By “certified” the Health and Human Services Heath Information Technology means certified by the Commission on Certification of Health Information Technology (CCHIT).  I have spoken with Dr. David Hughes of HIT by telephone on January 19th, 2009.  Dr, Hughes may it very clear that there will be no assistance from HIT, financial or otherwise, for any EHR that is not certified by CCHIT.  Even though OpenEMR is a free open source Electronic Health Record as specified in the Act.  As an all volunteer organization that functions entirely off of volunteer time and donated software, OSMS is being left out in the cold.  CCHIT is well known among the Open Source community for two things 1) CCHIT is very unfriendly to open source projects, 2) CCHIT certification is enormously expensive.  Only 2.5% of the existing Electronic Health Record in the United States are certified.   The initial certification fee is $38,000.    Those EHR companies that are certified report an average cost of $200,000 to actually achieve certification.  

What Open Source Medical Software is seeking is a means to pay the initial certification fee and assistance with developing the small number of modules that OpenEMR still lacks to achieve certification.  These include an interoperability module, a laboratory communication module, and some improvements in the underlying database connections to improve security at an estimated cost of $110,000.

Sincerely,

Samuel T. Bowen, MD
President
Open Source Medical Software

drbowen wrote on Friday, March 27, 2009:

I hand delivered my copy of this letter to Congressman Patrick McHenry’s office today.

Sam Bowen, MD

tmccormi wrote on Wednesday, April 01, 2009:

This was posted by Dr I.Valdez on the OpenHealth forum this morning:

Alesha Adamson wrote in with:

CCHIT is making it’s general call for volunteers.

application here http://www.cchit.org/participate/volunteer/

There is a tremendous amount of concern and discussion around the role
of CCHIT as it pertains to OS and federal dollars. Fundamentally, I
believe that the way to shape the body is from within. Here we are.

Be a contributor!

tmccormi wrote on Wednesday, April 01, 2009:

This from the CCHIT Interoperability Working Group main page may be of interest…
-
Project LAIKA is a collaborative, *open-source project* between CCHIT and MITRE designed to develop an interoperability testing environment for EHR. Learn more about Project LAIKA.
-

Anybody heard if it?

–Tony

aperezcrespo wrote on Friday, April 10, 2009:

Hi

I just got an email today from the CCHIT with the subject of :

CCHIT eNews: Interoperability and Open Source, Redline documents, Volunteer.

Here is a link they provide to the original text.
http://www.cchit.org/about/news/enews/20090409.asp

http://ehrdecisions.com/2009/04/07/cchit-roundtables-at-himss-09-interoperability-roadmap-and-open-source-forum/

Thanks

drbowen wrote on Tuesday, April 14, 2009:

I have received $1,250 in cash donations towards certificatioon.

$600 dollars in additional pledges.

$2,000 in a request to the parent organization for donation.

I am meeting with the Cleveland County (North Carolina) Health Department (CCHD) to for a grant request of:

$29,000  CCHIT    certification fee
  $6,000  CCHIT maintenance fee
$15,000  Interoperability module   
$30,000  Laboratory communication module
$30,000  Security Enhancements (for HIPPA compliance)
$50,000  Contingency  (software development is hard to estimate)
   
$160,000  total request

This will be a many month project if successful.

The Cleveland County (North Carolina) Health Department is interested in setting up a Public:Private partnership to get them a certified EHR and is interested in using OpenEMR.   They understand the need of certification.

I do believe long term we need an alternative to the CCHIT certification authority.  There are lot of barriers to an Open Source project and CCHIT is simply been set up to serve the proprietary community.  This is a longer term project and is the subject of the FOSS Healthcare meeting in  Houston on July 31st, 2009.

Sam Bowen, MD
President
Open Source Medical Software

dlee5400 wrote on Monday, December 07, 2009:

Has there been any other updates to the CCHIT status?

bradymiller wrote on Monday, December 07, 2009:

hey,

Currently there is a large ongoing effort. This wiki page is best place to assess the current status of the CCHIT project:

-brady

  : http://www.openmedsoftware.org/wiki/OpenEMR_Certification

gutiersa wrote on Wednesday, December 09, 2009:

I feel it is unfortunate that the system cannot accommodate for different types of programs and small doctor offices.

The government should require CCHIT certification if it could offer it for free or low cost, sort of like your auto inspection. Especially for those providers who may be handy and want to manage their own software. Really, some of us wanna do it ourselves to save some money but then need to get certified?

Well, what if we (I’d like to help too) met the requirements, and just called ourselves “CCHIT certification elligible”?

drpwayne wrote on Wednesday, December 09, 2009:

I believe that CCHIT is only one of the pathways to federal certification. I don’t yet know what the other methods will be, but HHS is clearly going to allow open source and self-developed systems to become certified based on “meaningful use” as opposed to the 400+ criteria of CCHIT. This was made apparent in the summer meeting of the HIT advisory committee on standards.
Some of the comments made at the meeting include:

Non-vendor systems  (Self-developed and Open Source)
Organizations with self-developed systems, view certification as an aid to purchasers.    Since they already have an operational system that is not intended for use outside of their organization(s), they don’t understand why they need to go through the expense of detailed certification processes and potentially developing unneeded functionality for the sole purpose of meeting certification criteria.      
Some vendors and customers of vendors believe in an egalitarian approach in which everybody is treated the same way.    
The Open Source community is similarly impacted.
Significant concern around curtailing research and development associated with open source and self developed applications if resources must be diverted for certification processes.
Timeframe and costs for certification and re-certification are a concern.

I don’t know what alternative method has been established for federal certification but it the advisory committee recommended that HHS set up its own criteria and delegate certification to several agencies, of which CCHIT is only one.  It will not be necessary to be CCHIT certified in order to become eligible for federal certification.

tmccormi wrote on Saturday, December 12, 2009:

Just as a a reminder - we are tracking the project and it’s process on the wiki page at http://www.openmedsoftware.org/wiki/OpenEMR_Certification

This is where the specific implementation decisions and progress are starting to get posted.  Various discussions on the topic are scattered about the forum, mostly with CCHIT - in the subject.

drbowen wrote on Sunday, December 13, 2009:

In addition to Rod Roark, Brady Miller and Justin Doiel there are currently there are 7 professional development companies that are working full time on certification.  This include:

Medical Information Integrated: Tony McCormick with 4 additional developers<br>
ViSolve: Sena Palanasami with 8<br>
Garden State Health Systems: John Williams with 2, and 1 QA professional<br>
Misys Open Source Solutions: Tim Elwell is coming on board with additional developers<br>
Intesync: Thomas Wong with 3<br>
OpenEMR Support: 2 developers and 6 additional outsourced developers

This diverse development group is being coordinated by Tony McCormick.  Rod and Brady will be doing their best to get code incorporated into the SourceForge/openemr repository.  We are attempting to get Meaningful Use completed by the end of February.  Application to CCHIT will take about 3 months.  We hope to be finshed and cerified by the end of June, 2010.

I very much appreciate the effort of these professional teams of developers on our behalf.  Is does take money to support this effort and the non-profit Open Source Medical Software could use donations to support the effort.  If you believe in this effort please donate.

Sam Bowen, MD
President
Open Source Medical Software

mbrody wrote on Thursday, December 17, 2009:

We are moving very nicely towards certification and I think it is time for some serious discussion regarding how that will be ‘managed’ once accomplished.

It is anticipated that developers of ‘certified’ software will need to inform the federal government who is a user of the certified software.  That means we will need to track all users of the ‘Certified’ version of OpenEMR and we will be responsible for verifying to the Federal Govt that those people are eligible for the incentive payment.

This is no small responsibility.

It is complicated by the nature of ‘OpenSource Software’.

I propose the following:  In order to be registered as a user of the Certified Version of OpenEMR,  a user will be required to purchase an installation CD from the Open Source Foundation for a fee of $1000.00.  This will have NO impact on the ability of anybody to download the software, but we will only be able to certify that people who purchased the CD actually have the certified version.  That money could then be used for future development costs, future re-certification costs etc.

Basically they are purchasing registration, and we are giving the CD away to insure that they have a certified copy of the software.

Remember managing and reporting who has the certified software will cost us in terms of time and $.

Michael

sunsetsystems wrote on Thursday, December 17, 2009:

Michael, please explain in more detail what “developers of ‘certified’ software will need to inform the federal government who is a user of the certified software” means.

Does “developers” mean copyright holders of the software?  One of them?  All of them?  Most of them?  What is the nature of the obligation?  What are the consequences of not doing it?  What happens if the informing is done, and then the software is changed?  Or if the user purchases certification and then continues to use whatever they were using before, if anything?  Are the authors of this requirement aware of and interested in the unique aspects of open source EHRs?

Inquiring minds want to know.

Rod 
(http://www.sunsetsystems.com/)

sunsetsystems wrote on Friday, December 18, 2009:

Sam accidentally responded to my question in the (https://sourceforge.net/projects/openemr/forums/forum/202506/topic/3474159) (see #15).

Thanks Sam!  That’s very good information.

Rod 
(http://www.sunsetsystems.com/)

paanii13 wrote on Friday, April 02, 2010:

Sam

Currently the total donations for CCHIT certification is $1,850 (According to the wiki page). Is this figure correct?

Nii