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ONC Regulation FAQs

#01 Question [09-10-001-2]

What certification criteria will ONC-ATCBs and ONC-ACBs use to certify EHR technology for purposes of the “deeming” provision of the Physician Self-Referral Prohibition and Anti-Kickback Electronic Health Record (EHR) Exception and Safe Harbor Final Rules?


Both the Physician Self-Referral Prohibition EHR Exception and the Anti-kickback EHR Safe Harbor regulations, at 42 CFR 411.357(w) and 42 CFR 1001.952(y), respectively, provide that software “is deemed to be interoperable if a certifying body recognized by the Secretary has certified the software within no more than 12 months prior to the date it is provided to the recipient.” The “recognition” of certification bodies process referred to in these regulations, as discussed in the Temporary Certification Program Final Rule (the Final Rule) (75 FR 36185) has been superseded or folded into the ONC-ATCB and ONC-ACB “authorization” processes. Consequently, the ONC-ATCB and ONC-ACB “authorization” processes will constitute the Secretary’s “recognition” of a certification body. With that said, as further explained in the Final Rule, ONC-ATCBs and ONC-ACBs are required to test and certify EHR technology to all applicable certification criteria adopted by the Secretary at 45 CFR part 170, subpart C. We believe that the certification criteria adopted by the Secretary specify essential interoperability requirements and build the foundation for more advanced interoperability in the future. Any questions regarding compliance with the exception or safe harbor should be directed to the Centers for Medicare & Medicaid Services (CMS) and the HHS Office of Inspector General (OIG), respectively.


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