Perpetually Perplexed by Regulatory Interpretations? Separate the Fact from Fiction
June 10, 2011, 2:45 pm /Posted by Steven Posnack, Director Federal Policy Division, ONC, on ONC’s Health IT Buzz blog and republished by e-Healthcare Marketing here.
If enough people believe something, it has to be true, right? In my travels, I’ve found that regulatory interpretations range from being largely factual to wildly fictitious. The latter often results from misinterpretations of regulatory language, improper combinations of regulatory language from different rules, or accurate interpretations getting lost in translation as they are passed from person-to-person. These inaccurate interpretations, intentional or not, often unsurprisingly lead to confusion. Accordingly, I thought it would be helpful to clear up a few things I’ve heard related to certification.
- Statement 1: If an eligible professional or eligible hospital combines multiple certified electronic health record (EHR) Modules together (or a certified EHR Module[s] with a certified Complete EHR), that combination also needs to be separately certified in order for it to meet the definition of Certified EHR Technology – *FICTION*
- Part 2 of the definition of Certified EHR Technology acknowledges that a combination of certified EHR Modules can be used to meet the definition of Certified EHR Technology. At 75 FR 2023, we clarified that as long as each EHR Module which makes up the combination has been certified, the definition could be met. See also FAQ 17.
- Combining certified EHR Modules or certified EHR Modules with a certified Complete EHR (or even two certified Complete EHRs) will not invalidate the certification assigned to the EHR technologies. Each EHR technology retains the certification assigned to it. Our FAQs (such as #7, #14, and #21) identify cases where combining certified Complete EHRs with other certified EHR Modules could occur without any negative effects.
- Note, generating the “CMS EHR Certification ID” on ONC’s Certified HIT Products List (CHPL) for meaningful use attestation purposes is different. Using the CHPL, an eligible professional (EP) or eligible hospital (EH) generates a CMS EHR Certification ID (a unique alpha-numeric string) to report to CMS as part of its attestation. The CMS EHR Certification ID represents the combination of certified EHR Modules or other combination of certified EHR technologies that meet the definition of Certified EHR Technology and were used during the meaningful use reporting period.
- Statement 2: The ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) operate under contract with and receive funding from ONC – *FICTION*
- ONC-ATCBs do not receive funding from ONC to perform their ONC-ATCB duties. ONC-ATCBs support their operations through testing and certification fees charged to Complete EHR and EHR Module developers.
- The Temporary Certification Program Final Rule established certain responsibilities and rules for ONC-ATCBs. ONC-ATCBs must fulfill these requirements and adhere to the rules in order to maintain good standing under the program. For example, ISO/IEC Guide 65 requires ONC-ATCBs to make their services accessible to all applicants (e.g., EHR developers) whose activities fall within its declared field of operation (e.g., the temporary certification program), including not having any undue financial or other conditions.
- Statement 3: Testing and certification under the Temporary Certification Program does not examine whether two randomly combined EHR Modules will be compatible or work together – *FACT*
- ONC-ATCBs are not required to examine the compatibility of two or more EHR Modules with each other. EHR Module developers, however, are free, and highly encouraged, to work together to ensure that EHR Modules are compatible.
- Statement 4: The ONC-ATCBs favor big EHR technology developers – *FICTION*
- The ONC-ATCBs do not favor large developers, and such favoritism is precluded by the international standards to which ONC-ATCBs must adhere.
- As of June 3, 2011, 438 EHR technology developers were represented on the CHPL. Of those, approximately 60 percent are small companies (<51 employees) and approximately 12 percent are large companies (>200 employees).
- Statement 5: Certification doesn’t require that an EHR technology designed by one EHR developer make its data accessible or “portable” to another EHR technology designed by a different developer – *FACT*
- We are very interested in exploring future certification requirements to improve data portability.
- If you have any insights on how to improve data portability between EHR technologies, please feel free to leave a comment below.
- Statement 6: As an EP or EH, you need to demonstrate meaningful use in the exact way that EHR technology was tested and certified – *FICTION* (mostly)
- Statement 7: Certifications “expire” every two years – *FICTION*
- A certification represents a “snapshot.” It indicates that EHR technology has met specific certification criteria at a fixed point in time. In other words, an EHR technology would not “lose its certification” after a given time period. If, however, certification requirements change (e.g., new and/or revised certification criteria are adopted), the snapshot the certification represents would no longer accurately reflect that the EHR technology meets the changed requirements.
- In our certification program rules, we indicated that we anticipated adopting new and/or revised certification criteria every two years to coincide with changes to the meaningful use objectives and measures under the Medicare and Medicaid EHR Incentive Programs. We did not, however, set a specific expiration for certifications. Rather, we explained that once the Secretary adopts new and/or revised certification criteria, EHR technology may need to be tested and certified again. In other words, the previously taken snapshot would no longer accurately represent what is required to meet the adopted certification criteria and, thus, would no longer be sufficient to support an EP or EH’s ability to achieve updated meaningful use requirements.
- For more information about the validity of a certification, please refer to the Temporary Certification Program final rule (75 FR 36188) and the Permanent Certification Program final rule (76 FR 1301).
As someone who has played a roll in drafting all of ONC’s regulations, I take pride in making our rules readily understandable and as easy to read as possible. Sometimes, though, no matter how hard we try to convey a regulation’s intent, there is always another believable interpretation. Hopefully, this blog helps clear up a few points and furthers your personal understanding of our rules.
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