The Meaningful Use NPRM Public Comment Open
The Meaningful Use NPRM and the Initial Set of Standards and Certification Criteria IFR have now been published and are available for public comment.
To view/download the Meaningful Use NPRM: PDF [7.38 MB] | HTML
To view/download the Initial Set of Standards and Certification Criteria IFR: PDF [247 KB] | HTML
Please make your comments through regulations.gov.
Also, my recent article in the New England Journal of Medicine zooms out for a bird’s eye view of how these regulations fit within the larger context of the HITECH Act. Read the entire NEJM article here.
For those who find the search at regulations.gov a bit daunting:
To comment on the CMS NPRM – http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a74a4b
To comment on the ONC IFR – http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a7a225
This is very helpful. Trying to find the correct link on that web site is nearly impossible. Is that on purpose?
Thank you! I was almost lost. Why is it that hard searching on this site? I hope for a fix.
Thanks, this made it a lot better to find it. I made a comment, thanks for this.
Thanks for the direct links, but I am doubtful that those are the correct ones, since they say that the comments are due by January 13th, 2010! There’s a different link that looks like it goes to the NPRM, with a comment due date of March 15th. http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a7c4a8 for the CMS NPRM and http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a7c48a for the ONC IFR.
David
Thanks, David.
This is strange. Something must have changed. Both links have the same Docket ID, but only yours is active. I’ll pass them on….
Could, the ONC Blog guys remove my original post so we don’t mislead folks, please. Thank you!
556 pages on the CMS NPRM is not daunting?
Thanks for the NEMJ article. Very informative and helpful. I loved how you started it: “Information is the lifeblood of modern medicine. Health information technology (HIT) is destined to be its circulatory system.” I couldn’t agree more. Also, I think more personal trainers and fitness specialists should be doing more of their “homework.” I see too many guys giving advice that doctors and health professionals should be giving.
The NEMJ article was very informative. I also agree that accessing regulations can be a bit overwhelming.
Your article in the New England Journal of Medicine on these regulations is fantastic.
In the spirit of transparency and efficiency…
1. will public comments be available, and if so when,where will these be published?
2. CMS has indicated that FAQs will be published. Where will this be available? on the HIT site or on CMS.
3. Would suggest a new page on HIT site to specifically provide informational updates on the MU NPRM and the Cert front, as opposed to just following specific meetings. this is complicated and the ONC or FACs need to make information updates easier for all providers and vendors to get and absorb. (Researching any comments, status takes an incredible amount of time which equals ADMINISTRATIVE COST to healthcare entities to keep up)
4. When will the vendors speak? The major vendors will have the greatest impact to getting the software to satisfy MU and getting it certified, and advise customrs of best practices. We cannot get answers from our vendors due to current unknowns on cert and MU. They probably could name the top 5 items to make this faster and still meet dates for HITECH Act effective dates.
Why can’t any rule be under 25 pages long? Who has the time to read 168 pages and remember everything? You can’t be serious Dr. Blumenthal!
Thank you for the links, helped me out quite a bit!
Thank you for the PDF files!
I am deeply concerned about the absence of usability engineering and human computer interaction design reflected even thus far in the teams being assembled/assembled as well as the criteria being already developed regarding current federal health IT efforts. Putting aside the prevailing ignorance in most healthcare institutions regarding usability engineering, the federal government should not be simply duplicating mistakes and costly errors that have already been made by other industries which have failed to apply usability engineering in product development.
Take a lesson from the most successful IT efforts of private industry where sales as well as usability objectives have been established as a DIRECT result of a solid emphasis on usability engineering (i.e., Apple is at the top of that list) – if the federal government does not seek out and establish a very strong human computer interaction design standard for ANY health IT developed, the prevailing health IT effort will fail.
Having myself worked in Apple’s Human Interface Group as well as EDS, Medicus, and many of the major players over the years in health IT, I worry that claims of UI success by large private insurers such as Kaiser and BlueCross will be accepted and used as a standard (when we in the actual science of usability already know this is a false claim. I sat through 4 discussions with communities throughout the west Coast where Kaiser and other insurers participated. These insurers very aggressively promoted “their” IT UI systems as being “the best” and “successful because everybody at is using it”. Such criteria for success would not even garner a C in a UI design and development class in a community college.
We in the usability engineering field know that in order to get the target users (whether that be MDs, administrators, patients, government offices, or a specific combination of all 3) to make effective use of any IT product, usability engineering (including the research, testing, functional AND visual design, and development) MUST place MEASURABLE/QUANTIFIABLE USABILITY goals at the top of its requirements list. Cost containment is largely dependent upon usability …and is the reason for the success and popularity of Apple’s products.
I am URGING all who have any power or say whatsoever in the federal health IT development process to attend to this current omission IMMEDIATELY in order to assure this effort is successful.
It will crash.
Let it.
Agreed—but lose the handle.
If “Regulations” are valid, they will stand on their own accord, regardless of government codification. If regulations have true utility, then that utility will prevail—regardless of government intervention. Therefore, the problem is not with valid regulations—it is with invalid regulations.
Problems with Ease of Access to regulations merely demonstrates that regulations exist that are invalid—otherwise people would not need to “access” them—they would just proceed with their work, and do what is right.
Therefore, deregulation is the true solution—not better access to those regulations because some of them might be invalid.
Remember—your taxes pay for these absurd pedantics.
Agree,:)
I appreciate the significant dialogue occurring on the blog related to the NPRM and IFR; it assures me that you are all doing your part to provide feedback. One of the most important aspects of the regulatory process is that everyone’s voice is heard. Therefore, we want to make it as easy as possible for you to share your thoughts. There has been conversation about the difficulty of locating the IFR and NPRM on regulatioins.gov, so I want to provide you the direct links and instructions on how to provide comments:
Step 1: Select one of the links below:
IFR: Health Information Technology: Initial Set of Standards, Implementation
NPRM: Medicare and Medicaid Programs; Electronic Health Record Incentive Program
Step 2: (Optional) Enter your identification information (Name/Organization).
Step 3: Type your comments in the field box or upload your comment from a file.
Step 4: Select the “Submit” button
Your comment will be assigned a “comment tracking number” once it is received in the system.
Thank you again for your insights, and please do not forget to submit your comments before March 15th, as they are a critical step in the process.
We are a CORE and EHNAC accredited clearinghouse and provide electronic eligibility (270/271) to our hospital and physician clients. Our eligibility software currently interacts with the hospitals or physicians HIS/PMS allowing the user to execute the eligibility request from the HIS/PMS software and we deposit the associated response back into the requesting system. Or plan is to do the same with the EHR systems.
We are hearing from our hospital based clients that they are under the impression that in order for them to achieve meaningful use, our eligibility software has to become certified under CCHIT or one of the future certifying bodies.
Are hospitals required to use a certified eligibility vendor or clearinghouse to perform the eligibility inquiry and response in order to achieve meaningful use?
If so can you direct me to the citation in the proposed rule that details this. I have reviewed all of the proposed rules and I can find nothing on certification of eligibility vendors/clearinghouses.
I appreciate any assistance you can offer me. Thank you
glad to here that:)
At last I found them… Had some problems searching for them =)
Thanks so much for the links! I’m a personal fitness trainer as well as a nutritionist so this will really help me out as I just got certified!
As a Family Nurse Practitioner providing primary care in a rural family practice office, I a concerned about a provision in the American Recovery and Reinvestment Act of 2009 that excludes Nurse Practitioners and other advanced practice nurses from receiving incentives for information technology (IT) use. According to the proposed rules, eligible professionals (EP) are defined as “a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor who is legally authorized to practice under state law. A qualifying EP is one who demonstrates meaningful use for the HER reporting period” (CMS, 2010). The proposed rule does allow NP’s to access the program for incentive payments that are meaningful users of certified Electronic Health Records (EHR) only in the Medicaid portion of the rules. The programs are mutually exclusive in that providers may only choose one program for participation and reimbursement. However, the proposed rules also state that if the Medicaid program is chosen, over 30% of the patient population served must have this type of coverage. NP’s are currently recognized providers of Medicare recipients, but are not recognized as elibible professionals for this portion of the program.
See http://www.cms.hhs.gov/apps/media/press/factsheet.asp?Counter=3563.
I urge all to comment on the HITECH rules before March 15 and advocate for inclusion of all current Medicare providers in receiving incentives for meaningful use of electronic records.
Sincerely,
Dianne Conrad, FNP-BC
Reference: Centers for Medicare & Medicaid Services, (2010). Details for: CMS proposes requirements for the electornic health records (EHR) Medicare incentive Program. Retrieved from: http://www.cms.hhs.gov/apps/media/press/factsheet.asp?Counter=3563
If a hospital is eligible to receive EHR payments under Medicare and Medicaid, but then their Medicaid patient volume drops below the alotted threshold, what happens? If the provider’s patient volume increases the following year, will they start in a later payment year or continue where they left off?
As long as it is searchable then surely this is feasable
This is an interesting topic – and seems to be a good thing if it is workable.
I hope so.
Hi nice site! Thank you for nice information.
Meaningful Use NPRM is warranted….worth a download and read
many thanks for the information! in each country, the same problems and discussions
Qualification requirements are in dollars and not RVU’s. Where does this leave the careful planning practitioner when the medicare fee schedule gets cut 22%?
The big sellers will surely have the big role to getting the software to satisfy MU and getting it certified.
NPRM is a tricky read but there are some good points listed here. I think keeping sensitive information private and protected is a major concern. This goes double for the digital age we are living in.
From a UK perspective, a vast network of data stores carries many risks: how do you keep the information secure? Commercial interests will see huge potential value in obtaining access to it. In addition to sophisticated raiding of information there are the simple mistakes, which have happened many times here – laptops left in cars or on trains, data sticks which go missing. Keeping the system tight is a huge responsibility.
I am going to have to chime in on this one… Keeping systems secure and stable is and will always be something that has to be contended with as new protocols and systems are developed. As technology moves forward (and it will) we should be concerned with serving the end user and making systems more efficient.
Everyone in the Medical Industry can, and does at some point, feel absolutely drowned in paperwork and slow to react due to current accessibility to records.
Wouldn’t it be great to shift all of that energy towards proper health care instead of filing and retrieval?
It’s interesting debate – the technology needs to be secure, but medical records need to be easily accessible. I see a future where medical records can be easily transferred and shared by those with legitimate reason to access them, but kept safe from those who don’t. I’m not sure how you juggle the two. It will interesting to see if these regulations help or hinder that process.
After reading through this document – took a little bit to get through it…
I agree with “singlepayer” in his earlier post. For some reason usability is the last item that is addressed if at all in most government healthcare projects and as a result a “not so usable” system is designed because they were focused to much on the details and not the input or adoption of the entire system. This single problem often costs the tax payers millions every year and they never hear about the failed systems – just the news on the replacement or “system upgrades”.
Take a lesson from the most successful IT efforts of private industry where sales as well as usability objectives have been established as a DIRECT result of a solid emphasis on usability engineering (i.e., Apple is at the top of that list) – if the federal government does not seek out and establish a very strong human computer interaction design standard for ANY health IT developed, the prevailing health IT effort will fail.
All that we need in today’s economy is another failing system!
When working as a local government CIO I saw many applications fail and larger less inferior systems that cost twice as much to build and maintain get purchased due to their “unlimited flexibility” which just translates to tens or hundreds of thousands of dollars in design changes and fixes on a single project.
This is a large void and should be addressed!
Your article in the New England Journal of Medicine on these regulations is very informative,thanks for the great information and your insights. Glad that found this site and this great information.
I think most providers are in favor of electronic records. After all, what good is electronic billing if you then have to submit supporting documentation by mail in order to get paid? But it seems that CMS is once again creating a mountain of regulations that nobody understands (including the front-line people at CMS) to implement a system that should really be pretty simple. While hospitals have teams of lawyers on staff to interpret all of this stuff, small health care offices are left in confusion, and worried about what the penalties are if they make an honest mistake and break one of the rules. All of this comes on top of the reimbursement cuts. In the current economy, we all have to do more with less, but there is a limit!
As a former software developer I know that it’s virtually impossible to create a 100% foolproof and secure system. Whenever budgets are addressed for these initiatives they should include a heavy dose of cyber security funding as well as rules and regulations that address how to deal with breaches and exposure of information. It is almost certain that information will be exposed at one time or another and the most likely time is during the process of of transcription and converting to the new systems.
This is a critical point. We know no matter how hard we try there will be cracks in any system and particularly of concern when the data is medical records and confidential information. My concern as a health professional would be what kind of “back up”, safety net or contingency plan is going to be in place when the teething problems and glitches occur?
Most providers have both electronic billing and manual , most dont want to shift over since there primary business is been manual for so long. I feel we better be careful as a society with our medical records being so exposed via unprotected databases.
The idea has a lot of merrit. I am sure there may be some teething issues but if these ideas can be shaped and are feasible this could be a win win for all involved. Thanks for an interesting post.
Some things regarding health & technology are better kept private and I believe this is one of them.
The reality is that technology (IT) that is used by employees versus patients versus MD’s can be dramitically
different regarding user-friendly, security etc.
Regards
Jaris
I think that the benefits of having records electronic is great.. I personally have had many times where I have to have an exam or x-rays done at one place and then a doctor exam them at another, even things such as the fact that now x-rays are done electronic and show up on a screen instead of having to print them out saves time and money. Its great for dentistry as well if you want to have cosmetic surgery, your cosmetic dentist could call your regular dentist for all your files and they could be emailed. I personally hate to bring my own files with me and run around dropping them off like a mail carrier. Ive read a couple articles at Http://www.bestcosmeticdentistincherryhillnj.com that talk about dentists in particular.
The difficulty with providing financial incentives for the adoption of these measures is that you will have respondents who jump through the hoops to get the incentive without fully committing to the spirit of the measures. It is a problem seen whenever a political agenda is backed by financial incentives. Ultimately, it produces individuals who benefit personally and financially whilst giving the minimum required to meet the payment criteria.
In short it is the easy way out and doesn’t change the thinking process required for wide adoption of the policy.
An individual or organisation which acts in order to get the financial incentive has no interest in the ultimate success or failure of the policy. Indeed, they are likely to have a greater commitment to its failure as it requires less effort on their part.
A longer-term but higher response is achieved by committing to a program of persuasion and education.
Additionally, widely publicised ‘public’ accountability for the actions being promoted should be an integral part of any such incentive scheme.
I fully agree on public accountability and committing to a program of persuasion and education. Nevertheless, I think it should also be possible to put in place a short term and effective financial incentive system. The key is to establish not only individual incentives for an individual, but to have common goals to all individuals such as a measurements on the wide adoption of the policy and many others. And even the weight of the common incentives could be higher than the individual ones. The benefits of this addition are clear focus and short term results.
Very interesting debate. I´t thinking on Google Health – same thing. Should medical records be easily accessable? Should they be “owned” by some companys? I don´t know where this kind of technology is taking us.
Look Guys this can only be for the better, think about how much money and time this will save us. You go to one hospital have an xray these records will always be easy to access nothing will go missing like paper work normally does. God to think how many times hospitals have lost my records to have this on a central system where doctors can access you records throughout the county, I think is great.
have a great day and don’t let the debate die
Shifting everything to a “Big Brother” database is the direction all of this is leaning. And I agree with it. More efficient. More economical. Those that need the info quickly may access it to make those critical, time-sensitive decisions. Yes, the IT folks will have their hands full establishing tight security. But it’s worth it.
This sounds like a more efficient workaround, less red tape and delays in getting what you need. But like what William says, IT security might be a big issue. Unless they can come to a trade-off, this might just be good in theory.
Electronic records would be convenient but at what cost? What assurance do we have that some kind of massive system failure wouldn’t result in years of lost files? The cost in reclaiming these lost files would be enormous, if they could be reclaimed at all. And what of the cost to the patient who’s records contain some kind of glitch resulting in a misdiagnosis or medication error. I just think we have a long way to go yet before any kind of system like this would be truly functional and another long testing period before it could be considered viable. There would have to be an incredible amount of redundancy built in before I would ever feel safe using it.
I am personally all for going full steam ahead with electronic records and all of the benefits they will provide. Although no software can be 100% secure I believe the benefits this will provide to many patients and doctors alike vastly outweigh the certain few problems that will come with hacked security and privacy issues.
If a hospital is eligible to receive EHR payments under Medicare and Medicaid, but then their Medicaid patient volume drops below the alotted threshold, what happens? If the provider’s patient volume increases the following year, will they start in a later payment year or continue where they left off?
I can’t imagine what it would do to my business if all of my patient’s private records were somehow hacked and leaked to the public. That kind of thing could ruin a practice. The relationship between a chiropractor and patient is based on trust. If I can’t keep his records safe how can he trust me with his health? No thanks…I think I’ll stick with the old fashioned method of keeping records. If it ain’t broke, don’t fix it.
It all sounds a great idea but as with most IT systems they will keep stuffing more requirements into it. It will get so big (and expensive) that it will keep having to be re-spec’d and therefore never finished. They need to think like the military and finalise the specification and build it to that, but at the same time have upgrades decided on. This will allow a usable system that can be grown. It will also allow staff to learn it without worrying that it will all suddenly change and they will have to relearn, with the corresponding delays and training costs
Thanks for the NEMJ article. Very informative and helpful. I loved how you started it: “Information is the lifeblood of modern medicine. Health information technology (HIT) is destined to be its circulatory system.” I couldn’t agree more. Also, I think more personal trainers and fitness specialists should be doing more of their “homework.” I see too many guys giving advice that doctors and health professionals should be giving.
Regarding a previous comment of providing health care in rural areas. Most specialists tend to stay closer to bigger cities due to easier access to hospitals and obiviously more patients. However, I’m starting to see more physicians branching-out to rural areas due to innovation and due to the growth and demand within (closer) those rural areas.
Overall it’s a good idea to have more physicians in or closer to these rural areas.
Regards,
Jaris
Specialists tend to stay closer to big cities because that is where the demand is. There is no hospital that will pay a specialist what they should get payed unless they see a large volume of patients.