Certification Regulations Complicate Meaningful Use Program

by Protima Advani


Of the three tenets of meaningful use -- adopt certified electronic health record technology, demonstrate core and menu set requirements, and report on clinical quality measures -- the piece about adopting certified EHRs is more complicated than most health care providers anticipated. For starters, the Office of the National Coordinator of Health IT clarified in December 2010 that health care providers must possess all of the meaningful use capabilities, not just those that they intend to report on.

This means that even though CMS has afforded health care providers the flexibility in reporting on any five of the 10 menu requirements in addition to all the core requirements, ONC requires those providers to possess all the core set and the 10 menu set capabilities. In essence, health care providers are being forced to possess capabilities that they do not intend to use and report on in Stage 1.

To further complicate matters, a recent clarification from ONC stated that "stand-alone, separate components of a certified Complete EHR do not derive their own separate certified status based solely on the fact that they were included as part of the Complete EHR when it was tested and certified." As a result, health care providers who do not possess the certified Complete EHR from a single vendor need to secure their EHR certification status in one of three ways detailed below:

  1. Acquire all the capabilities of the certified Complete EHR from their primary EHR vendor. Under this scenario, providers would have to abandon use of stand-alone modules from other vendors and migrate over to similar capabilities offered by their primary EHR vendor. In addition to capital costs associated with acquiring new modules to possess the certified Complete EHR, there also is the lost benefits/opportunity cost of not using a potentially better stand-alone product in the name of certification. Health care providers also face the political and change management costs associated with migrating users from a familiar system to a new system, all on a short timeline to maximize meaningful use incentives.
  2. Possess redundant capabilities from the primary EHR vendor. This option also requires health care providers to possess all the capabilities of the certified Complete EHR from their primary EHR vendor, but it would allow them to continue using certified versions of stand-alone modules from other vendors. In essence, health care providers would possess (defined by ONC as having the license to access and use) redundant capabilities from their primary EHR vendor to secure the vendor's Complete EHR certification status even though they have no intention of using them. It is worth noting that ONC clarified that health care providers need only to possess all the capabilities as certified -- not use them -- to secure the certification status of the Complete EHR.
  3. Seek self-certification for the collection of modules implemented for meaningful use. The last option enables health care providers to seek self-certification for the combination of modules they intend to use to demonstrate meaningful use. In this scenario, the health care provider can directly approach one of the Authorized Testing and Certification Bodies to certify any combination of modules that collectively comprise all the meaningful use capabilities. The Certification Commission for Health IT's self-certification for hospitals costs $33,250 for the full suite of meaningful use capabilities, while the Drummond Group's self-certification for hospitals is priced at $19,500. In selecting this option, health care providers should not only account for self-certification costs but also the time and expertise required to successfully complete the testing and certification process for meaningful use.   

Needless to say, meeting the certification requirements is an added hurdle to demonstrating meaningful use and securing incentives. Here are some considerations in selecting the appropriate certification route for your organization and next steps for meeting the certification requirements for meaningful use:

  • Visit ONC's Certified Health IT Product List to check your vendor's certification status. If your EHR vendor is certified as a Complete EHR and you do not possess all the meaningful use capabilities from the same vendor, start evaluating the above three options to meet the certification requirement. Vendor certification status can be found on ONC's website: http://onc-chpl.force.com/ehrcert.  
  • Approach your primary EHR vendor to seek modular certification. The certification rule will drive many hospitals to pay for redundant capabilities unless they can convince their vendors to seek modular certification for non-core components such as interfaces for exchange, reporting modules, etc.
  • Alternatively, contract with your vendor to "possess" the remaining certified capabilities for a small fee. Vendors should be pressured into providing "possession" rights for a nominal, one-time fee instead of paying full price for redundant capabilities that the hospital has no plans to implement. Hopefully, health care providers can secure "possession" rights at a lower price and with less work than is required to successfully undergo self-certification.
  • Weigh the short- and long-term ramifications of supporting certified best-of-suite versus a single vendor product: ONC certification rules as currently written might unintentionally be pushing the market away from a best-of-suite to a single vendor environment. A well-integrated, single vendor EHR might be favorable for the long haul -- especially to meet future meaningful use requirements and support cross-continuum care coordination under accountable care. However, for organizations whose priorities demand more sophisticated capabilities offered only by niche vendors, they must weigh the costs of purchasing stand-alone certified products and subsequently seeking self-certification for their unique bundle of modules or alternatively purchasing redundant capabilities from their primary EHR vendor to secure the certification status. Remember, purchasing redundant capabilities or seeking self-certification today (options 2 and 3 above) will only overcome the certification barriers to Stage 1 and leave health care providers dealing with the same certification options for capabilities required in future stages.
  • Consider the effect of each option on overall meaningful use plans. Every option must also be considered in light of its impact on the organization's meaningful use plans. Delays in securing certification, whether dependent on the primary EHR vendor to seek modular certification or on internal IT staff for self-certification, could jeopardize the organization's ability to maximize meaningful use incentives.
  • Put pressure on ONC to change its requirements for EHR vendor certification. Self-certification was intended for highly customized environments. However, the scope of meaningful use has expanded traditional EHR vendor offerings to include capabilities such as patient portals, etc. -- not necessarily their core competency. Without changes to the certification rule, health care providers will be forced to either purchase redundant capabilities to leverage the vendor's certification or self-certify to incorporate niche stand-alone modules.
  • Finally, get your unique certification number prior to meaningful use attestation. Irrespective of the certification route chosen, every health care provider must visit ONC's Certified Health IT Product List site to secure a unique CMS Certification ID number for attestation. Different from self-certification, this is a formality that assigns each provider a certification number based on the certified Complete EHR or certified modules adopted for meaningful use. Providers will need to include this unique certification number during attestation.
Frank Poggio
Yes, the ONCHIT program is voluntary...sort of. No regulatory or legal reason to go thru it. But if you do not get certified as a full EHR or as a EHR Module, the likelyhood of selling another system, or keeping your client base in not good. As a vendor if you do not it will be a long but sure death. More at : kelzongroup.com /To Certify or Not? Frank Poggio The Kelzon Group
Bobby Lee
All legitimate points but the overall impact should be minimal. First of all, EHR Incentive Program is a voluntary program. Second, the more complicated situations described above will likely be with larger organizations who’s potential incentive amounts will be many folds above the certification fee and they can assess their ROI and will proceed accordingly. Third, with the clarification provided by ONC, most will be able to construct an agreement with vendors such that you do not paid for the features that you don’t need. This was very important and reasonable clarification ONC provided. Lastly, I would also argue that if someone is in a situation of multiple vendors with overlapping features then that situation itself is probably bigger issue to solve than whether and how you get the certification number. Certification is mostly vendor activity whereas providers and hospitals, as buyers, must still make good purchasing and switching decisions.
Bobby Gladd
Relatedly -- but also separately -- what about the Clinical Quality Measures (CQM)? Many of the "complete EHR" vendors are only certifying to 9 rather than the full 44. Does that mean that end-users cannot choose from among the optional CQM regarding which their vendors have not explicitly "certified," as reflected on CHPL? I'm getting conflicting views on that issue.

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