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CMS Issues Final Rule on EHR Certification Flexibility, MU Stage 2 Extension, and MU Stage 3 Timeline

I can’t figure out what government process leads to final rules being regularly published at the end of the day on Friday. I know that Neil Versel from Meaningful Health IT News has hypothesized that they release it late on Friday when they want to bury the news. Maybe that’s the case, but the EHR certification flexibility doesn’t seem like something they’d want to bury. Regardless of the odd timing, CMS has just published the final rule that provides flexibility around EHR certification in the meaningful use program.

In their announcement, I’m not noticing any changes from what was in the proposed rule, but with some time we’ll know for sure if there’s any gotchas hidden in the final rule. No doubt many a meaningful use expert have just had their Labor Day weekend ruined by the announcement of this final rule.

Unfortunately, after the proposed rule was published most people loved the flexibility, but decided that it was too late for them to really benefit from the changes. I’ll be interested to see how many organizations will really benefit from these changes.

More importantly, the rule still includes the nebulous asterisk, “Only providers that could not fully implement 2014 Edition CEHRT for the EHR reporting period in 2014 due to delays in 2014 Edition CEHRT availability.” For EHR vendors that are already 2014 certified, this little asterisk feels like ONC is letting all the EHR vendors who didn’t perform well off the hook. It’s basically rewarding EHR vendors who can’t or have chosen not to keep up. Maybe that’s why the rule was published late on a Friday.

One could make the case that ONC was more worried about the doctors/hospitals whose EHR vendors failed to become 2014 certified, than the EHR vendors themselves. However, that part of the story is not likely to be told. Plus, it doesn’t take into account how a doctor/hospital whose EHR vendor is 2014 Certified will feel having to do the substantially harder MU stage 2 while their colleagues only have to do MU stage 1. (UPDATE: This EHR Certification Tool that CMS created seems to say that even if you’re on a 2014 Certified EHR and scheduled to do MU stage 2, that you can do Stage 1 or stage 2 objectives with 2014 CQMs. The chart linked at the bottom of this post says it as well. Seems like they’re being pretty open in their interpretation of “due to delays in 2014 Edition CEHRT availability”. Clear as mud?)

I’ve captured a chart showing the EHR Certification flexibility that this final rule provides:
EHR Certification Flexibility - 2014 Certified EHR

Plus, here’s the latest chart showing the meaningful use timelines:
Updated Meaningful Use Stage 3 Timeline

Other Resources and Responses:
CMS Official Press Release
CHIME’s Response
CMS’ EHR Certification Rule Tool
CMS HITECH 2014 CEHRT Flexibility Chart

We’ll keep adding other responses and commentary on the final rule as we find them.

August 29, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 15 blogs containing almost 6000 articles with John having written over 3000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 14 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John launched two new companies: InfluentialNetworks.com and Physia.com, and is an advisor to docBeat. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and Google Plus.

The Challenge of Clinical Quality Measures – ONC Dashboard

The incomparable Mandi Bishop just pointed out to me an amazing ONC dashboard that’s tracking issues with the clinical quality measures (CQM). I don’t know how I’d never seen this before, but it’s a treasure trove of amazing information. I’m proud of ONC for being this transparent in their efforts to make the clinical quality measures as effective as possible.

It’s also an amazing illustration of how hard it is to get these clinical quality measures correct. As Mandi pointed out to me, Beta-blockers, for example, can’t be tolerated by Asian-Americans, but that’s a required CQM: prescribe beta-blockers within 24 hours of surgery for cardiac patients. That’s scary to think that a clinical quality measure could actually do harm versus improving quality.

We’ve heard this from doctors for a really long time. Medicine is complicated and each patient is unique. This dashboard illustrates many of those challenges.

Personally I think that the clinical quality measures were a step too far in the EHR incentive program. Although, I’ve long wished that all the incentive money would have been focused on establishing a standard for EHR interoperability and then paying organizations that were interoperable. That would do more impact for good on healthcare than these clinical quality measures.

What are your thoughts and experiences with clinical quality measures?

April 22, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 15 blogs containing almost 6000 articles with John having written over 3000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 14 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John launched two new companies: InfluentialNetworks.com and Physia.com, and is an advisor to docBeat. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and Google Plus.

HIMSS: The FDA Should Tread Carefully With Health IT Oversight

Of late, the FDA has been looking at into how it will regulate health IT generally, and EMRs especially, under the authority of the Food and Drug Administration Safety Innovation Act of 2012.  This, of course, has the vendor community very nervous, as they’re not eager to have an agency as powerful as the FDA breathing down their neck.

In an effort to soften the blow somewhat, the chairman  and CEO of HIMSS  have written a letter to HHS outlining why health IT products, especially EMRs, have unique functions and requirements.

In the letter, they argue that any regulatory efforts that are made should have the following characteristics:

• Holistic Approach: Any regulatory or oversight framework should recognize that health IT is part of a complex patient care ecosystem involving providers, product developers, vendors, a  wide array of use cases, and consumers as patients and caregivers.
• Shared Responsibility: The safety and efficacy of health IT as it fits within the patient care
system can be enhanced through non-punitive surveillance and reporting systems based on mutual trust and shared responsibility by all participants.
• Clear Oversight Direction: Clear and consistent guidance regarding proposed regulatory and/or  oversight activity is essential to ensure that health IT can continue to provide the innovation and tools necessary to achieve the patient safety and quality improvement goals, and cost efficiencies sought by all stakeholders.
• Role of Intended Use/Functionality: Regulation and oversight actions should be based on the  intended purpose and intended user of a particular product or service.

Cutting a nice wide path for EMRs and related clinical data systems, HIMSS argues that health IT products largely used for transmission, storage and management of data should not be considered medical devices. The execs also argue that there’s a big difference between products which are “integral to the functioning of a medical device,” and those that communicate with such devices. (While there’s definitely a move on to integrate EMRs and medical devices, progress has been scant to date.)

We’ll see how successful HIMSS was at shaping the FDA’s expectations next year, when the agency releases a joint report outlining its strategy in cooperation with the FCC and ONC.

In the mean time, the three agencies have formed a workgroup under the ONC’s HIT  Policy Committee which will provide recommendations to the Health IT Policy Committee.  If you’re as worried as HIMSS is, and there’s no reason not to be, the workgroup may offer a chance to make your voice heard. Getting involved, or at least commenting on draft report docs, is probably a good idea.

November 12, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies.

Honoring Government Furloughs

With so many government employees on furlough today, I thought I’d honor them by doing the same on this blog. At ONC, only 4 people were not furloughed. That’s amazing. Should we feel bad for those 4 that are still at work?

Next week I’ll be at CHIME most of the week. So, this cartoon about the government sequestration (which caused similar issues to the furloughs) seemed appropriate. If you’ll be at CHIME 2013, I hope you’ll say Hi.
Government Furlough Cartoon

October 4, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 15 blogs containing almost 6000 articles with John having written over 3000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 14 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John launched two new companies: InfluentialNetworks.com and Physia.com, and is an advisor to docBeat. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and Google Plus.

Critical Access, Small Hospitals Lagging In Meaningful Use

Many critical access hospitals and other smaller hospitals are falling behind on Meaningful Use and may be at risk for being slapped with Medicare reimbursement penalties in 2015, according to a study reported in Health Data Management.

The study, which appeared in the journal Health Affairs, was conducted by Mathematica Policy Research and the American Hospital Association.  Its bottom line conclusion was that smaller and rural hospitals were less likely than other hospitals to have met Stage 1 criteria, and that very few had all of the IT systems in place needed to reach Stage 2, HDM reports.

The researchers noted that between 2011 and 2012, the percentage of hospitals with at least 200 beds getting Meaningful Use almost doubled, but that those with less than 100 beds had a lower rate of Meaningful Use compliance. Meanwhile, the proportion of critical access hospitals that received a Meaningful Use payment in 2012 fell slightly from the previous year.

The study also concluded that teaching hospitals had a higher rate of Meaningful Use compliance than non-teaching hospitals, and that a small percentage of government-owned and non-profit hospitals received MU incentive payments compared with for-profit facilities.

According to Health Data Management, the study isolated three challenges faced by critical access and smaller hospitals:

* Low patient volume complicates long-range planning and limits ability to maintain adequate cash flow,

* The hospitals may not be able to offer competitive salaries for skilled information technology professionals, and

* Smaller hospitals may have difficulty finding a suitable I.T. vendor.

It’s not lost on the ONC that these hospitals face significant disadvantages in getting their Meaningful Use program rolling. About a year ago, the agency rolled out a campaign intended to get 1,000 critical access and small rural hospitals meaningfully using certified EMR technology by the end of 2014. To get things rolling, ONC is spending up to $30 million for Regional Extension Centers targeting these facilities.

But as I see it, funding more REC activity is far from enough. The plain fact is that mounting a Meaningful Use program is time consuming and expensive, so much so that some smaller hospitals simply make it happen without help. Maybe the time has come for the feds to offer grants outright to hospitals struggling with these challenges.

August 14, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies.

Feds Plan EMR Certification For Specialty Facilities

Federal HIT leaders are planning to set up a voluntary program for testing and certification of EMRs used by behavioral health, long-term care and post-acute care, according to a story in Modern Healthcare. 

As things currently stand, they’re off the hook, as ARRA doesn’t require long-term or behavioral health facilities to buy certified EMRs.

These plans came to light last week at a webinar held by outgoing ONC head Farzad Mostashari, who said that his office is working on what the scope of such a program should be, MH reports. The webinar was held to discuss government officials’ reaction to public comments on how to improve interoperability.

In its original request for input, federal regulators noted that 4 in 10 hospitals were sending lab and radiology information to outside providers, though only one in four were  exchanging medication lists and clinical summaries, Modern Healthcare said.

Meanwhile, only 6 percent of long-term acute-care hospitals, 4 percent of rehab hospitals and 2 percent of psychiatric hospitals had even a basic EMR, the feds reported.

Launching these specialty-focused options seems like a logical next step for the certification program, and a long-delayed one at that. EMR certification has been a fact of life for several years, since then-ONC chief David Brailer kicked off the formation of the CCHIT.

Over the long haul, however, such new certification options may not be worth much unless they’re better matched to provider needs. My colleague John, for one, thinks the certification will have to change to actually offer value to doctors and healthcare organizations.

What do you think, readers?  Do you think certification programs for EMRs are a waste of time, or do you see them doing anything meaningful to improve care?

August 13, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies.

ONC, FCC, FDA Seek Comment On Pending Health IT Regulations

This is big stuff, folks.  The FCC, FDA and the ONC are asking the public for comments they can use in developing a regulatory framework for health IT, according to iHealthBeat.  While the agency alphabet soup doesn’t sound very exciting on the surface, I’d argue that this is a turning point for health IT as a whole, as such a framework is likely to change the way the HIT market does business.

So why go ahead with such a request  now?  iHealthBeat reports that the request for comments cites “a growing need for the federal government to develop a coordinated approach to its oversight of health IT that promotes innovation, protects patient safety and avoids regulatory duplication.”

The report is being executed by a 32-member workgroup, housed under the ONC’s Health IT Policy Committee. It’s being tasked under the authority of the 2012 FDA Safety and Innovation Act, which requires the group to submit a report by January 2014.  One portion of the report will be dedicated to mobile health applications.

According to iHealthBeat, the request for comments covers three key areas:

  • Taxonomy, including what types of health IT the agencies should address in the report;
  • Risk and innovation, including what types of risks health IT poses to patient safety; and
  • Regulation, including what regulatory areas are overseen by more than one of the agencies and what can be done to minimize such overlap.

Commenters are encouraged to offer their in put no later than June 30, but the comment period will remain officially open until August 31.

June 4, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies.

EMRs Have Certifications Yanked

A California EMR developer has become the first to have its certification for Meaningful Use taken away by the ONC.

EHRMagic-Ambulatory and EHRMagic-Inpatient, both of which were developed by Santa Fe Springs, Calif.-based EMRMagic, failed to meet certification requirements, reports EMR Thoughts.

The de-certification process began when ONC and ONC-authorized certification body InfoGard Laboratories were notified that the EHRMagic products didn’t meet Meaningful Use certification requirements.

InfoGard Laboratories analyzed the information sent along with the notification and contacted the vendor. It then began the process of ONC-ACB required surveillance activities, according to HIN. At that point, InfoGard decided to test the two products for compliance with certain requirements.  EHRMagic’s products were then retested, and failed to meet criteria for Meaningful Use certification.

Fortunately for the company’s customers, no providers had yet attempted Meaningful Use attestation using these products. One can only imagine the frustration they would have faced if they attempted to attest in good faith and found out that the EMR product they were using wasn’t capable of supporting MU certification.

I’m left wondering whether providers would have grounds for a lawsuit against the offending vendor if they attempted certification with a product that didn’t support Meaningful Use, particularly if the vendor had any idea that this might be the case.

Realistically, it seems likely at some point in the future, some provider will be left high and dry by a certified product that shouldn’t have gotten the go-ahead.  My guess is that things will get nasty pretty quickly!

April 29, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies.

ONC Proposes New EMR Vendor Fee

It looks like federal budget balancing fervor could soon have an impact on EMR vendors (See also this post on EHR Incentive and Sequestration). As part of President Obama’s current budget proposal, the ONC is suggesting that health IT vendors pay about $1 million in fees to help pay for its certification and standards work, reports Modern Healthcare. Collection of the fee, which would probably begin late in the fiscal year, would be collected by ONC-Authorized Certification Bodies.

The proposal is part of the ONC’s section of the overall budget proposal released this week by the Obama Administration. The president’s budget is already causing a stir in healthcare circles outside of IT, as it calls for $5.6 billion in Medicare payment cuts for fiscal 2014.

So what has caused the ONC to look for fresh revenue?  One key reason is that ONC’s $2 billion appropriation from ARRA is scheduled to expire at the end of fiscal 2013, and the agency needs new funds to stay on its feet.

By its logic, the improved testing and certification programs will help vendors save time and money, which justifies their kicking in some money to support the process, Modern Healthcare says.

Not only would the funds gear up the certification program, it would also help maintain ONC’s Certified Health IT product list, as well as its development work around standards for interoperability and policy docs related to HIT certification, the magazine reports.

Without a doubt, the proposed fees will make vendors unhappy, but as I see it they’re just not large enough to justify a major uprising by the health IT community.  The only real issue I see is whether the fees are going to be proportionate to the size of the vendor; if I were a small ambulatory player I’d be quite upset if I paid the same fee as Epic or Cerner.

Otherwise, this fee seems like a relatively small issue, particularly if ONC does a good job of using the funds to improve the certification program. Let’s hope it works out that way.

April 12, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies.

Best Of Breed Systems Lead In Battle For Meaningful Use Dollars

This week, Modern Healthcare published a very interesting analysis of ONC and CMS data on which vendors were used for Meaningful Use attestation.  The results suggest that the battle for market dominance may be closer than it looks when it comes to producing results that count. Perhaps more importantly, the data suggests that best-of-breed systems may have a stronger foothold than unified systems (see more below).

According to Modern Healthcare, four vendors stood out as leader in the complete inpatient EMR market:

* Epic Systems, with 370 hospitals customers, or 17.9 percent of 2,071 hospitals which have attested using one of the four

* Meditech, with 323 hospitals, or 15.6 percent

* CPSI, with 313 hospitals, or 15.1 percent

* Cerner Corp., with 208 hospitals, or 10  percent

All told, these top four players have sold 1,214 hospitals a complete inpatient EMR system. That’s represents 58.6 percent of all systems sold to hospitals that have gotten a Medicare incentive check using a complete inpatient EMR. The top 10 vendors swelling such systems, meanwhile, have sold them to 1,902 hospitals, owning almost 92 percent of this niche, Modern Healthcare notes.

It’s important to note, however, that best-of-breed implementations have won even more Meaningful Use dollars, the analysis suggests.  In fact, 2,438 hospitals using modular inpatient EMRs have achieved Meaningful Use. According to Modern Healthcare research, three developers lead the modular inpatient EMRs hospitals have used for this purpose:

* Meditech, with 637 hospitals, or 26.1 percent

* Cerner, with 530 hospitals, or 21.7 percent

* HCA Information & Technology Services, with 274 hospitals, or 11.2 percent

Collectively these vendors account for 59.1 percent of modular inpatient EMR market, the analysis shows.

I thought it was quite noteworthy that a larger share of hospitals are using best-of-breed inpatient systems to achieve Meaningful Use than complete inpatient systems. It would be interesting to find out if interoperability was one of the reasons hospitals are making this choice — since we know that the big vendors are shaky on the concept at best.

April 1, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies.