In the May release of its 21st Century Cures Act Final Rule, the Office of the National Coordinator (ONC) made several revisions to the 2015 Edition Health IT Certification Program. One significant change was made to the e-Prescribing protocol certification requirement as outlined in 170.315(b)(3) Cures Update criterion.
Prior to the release of the 2015 Edition Cures Update Final Rule, electronic healthcare records (EHRs) were required to use NCPDP Script 10.6 to interface with electronic prescription systems. The new requirement is to use NCPDP Script 2017071 for e-Prescribing messaging to align with the 2020 CMS Medicare Part D requirements. As of June 30, health IT technology can certify to the revised (b)(3) ERX criterion.
The Centers for Medicare & Medicaid Services (CMS) required the health IT technology to adopt NCPDP SCRIPT 2017071 messaging since Jan. 1, 2020. In order to comply with this CMS mandate, ONC announced in 2019 that developers certified to the 170.315(b)(3) criterion would be allowed to modify their e-Rx implementations to support SCRIPT 2017071. ONC’s announcement instructed developers of certified e-Rx implementation to notify their ONC-Authorized Certification Body (ONC-ACB) prior to Dec. 31, 2019, if their product adopted and deployed modifications to align with the CMS SCRIPT 2017071 requirement.
However, this attestation notification in 2019’s fourth quarter – that a Certified EHR Technology (CEHRT) developer had modified its e-Rx implementation to support SCRIPT 2017071 – does not constitute a certification to ONC’s 170.315(b)(3) Cures Update criterion. As of July 1, 2020, there are a couple of ways developers may test and certify to this revised 170.315(b)(3) e-Prescribing criterion.
For products already certified to 170.315(b)(3)
- ONC permits the developer to self-test using the NCPDP ERX Test Tool, capture the test tool reports for each test scenario, and submit with a signed attestation statement to the ONC-ACB as proof of compliance to the revised 170.315(b)(3) requirements. Self-testing results would need to cover all required tests and any optional tests. For additional guidance, a Drummond Account Manager/Test Proctor may provide details on how to self-test the revised 170.315(b)(3) criterion.
For products that have never been certified to 170.315(b)(3)
- A test may be scheduled with an ONC-Accredited Test Lab (ONC-ATL). This live test will be conducted using the NCPDP test tool. For additional guidance, Drummond provides proctor sheets that relate to the test procedure and can be found on the Drummond Customer Portal.
To date, Surescripts has yet to be authorized by ONC to provide an alternative test method for the revised 170.315(b)(3) criterion. There is no estimated timeline for this approval, and until authorization by ONC, ONC-ACBs cannot accept Surescripts certifications as proof of compliance to the revised (b)(3) criterion. Currently, the only way to achieve (b)(3) Cures Update certification is one of the applicable two methods discussed above.
The test procedure and certification requirements of the revised (b)(3) Cures Update criterion is similar to the original 2015 Edition (b)(3) criterion, but some new requirements have been added. In addition to the update from SCRIPT v10.6 to SCRIPT 2017071 messages, certified products must now support “Verify and Error” messages. Verify messages are part of the NCPDP Test Tool’s Cancel scenarios, and Error messages must be visually inspected. Also, several new optional tests are available, including Prior Authorization, Risk Evaluation and Management Strategy, Transferring between Pharmacies, Long-term post-acute care, New Rx request, and Rx Fill Indicator. These are optional test scenarios, but proof of compliance of support for these messages can be certified by the developer and listed on the products’ ONC CHPL listing.
Test date availability in the fourth quarter is expected to fill quickly. If your plans include testing in 2020, register here and schedule soon to get your preferred test date.