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§170.315(a)(10) Drug-formulary and preferred drug list checks
| Version # | Description of Change | Version Date |
|---|---|---|
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1.0
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Final Test Procedure |
01-08-2016
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1.1
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As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only. |
09-21-2017
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§170.315 (a)(10) Drug-formulary and preferred drug list checks—
The requirements specified in one of the following paragraphs (that is, paragraphs (a)(10)(i) and (a)(10)(ii) of this section) must be met to satisfy this certification criterion:
- Drug formulary checks. Automatically check whether a drug formulary exists for a given patient and medication.
- Preferred drug list checks. Automatically check whether a preferred drug list exists for a given patient and medication.
None
- Revision History
-
Version # Description of Change Version Date 1.0Final Test Procedure
01-08-20161.1As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only.
09-21-2017 - Regulation Text
- Regulation Text
§170.315 (a)(10) Drug-formulary and preferred drug list checks—
The requirements specified in one of the following paragraphs (that is, paragraphs (a)(10)(i) and (a)(10)(ii) of this section) must be met to satisfy this certification criterion:
- Drug formulary checks. Automatically check whether a drug formulary exists for a given patient and medication.
- Preferred drug list checks. Automatically check whether a preferred drug list exists for a given patient and medication.
- Standard(s) Referenced
None
Testing components
Gap Eligible
Self-Declaration: As of September 21, 2017, the testing approach for this criterion is satisfied by self-declaration.
The archived version of the Test Procedure is attached below for reference.
|
System Under Test |
Test Lab Verification |
|---|---|
|
The health IT developer submits their self-declaration to the ONC-ATL. |
The Tester verifies the self-declaration document contains all of the required data elements. |
| Version # | Description of Change | Version Date |
|---|---|---|
|
1.0
|
Initial Publication |
10-22-2015
|
|
1.1
|
Added clarification regarding drug formulary files if the Health IT Module is using the NCPDP Formulary and Benefit Standard v3.0. |
12-18-2015
|
|
1.2
|
Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant. |
04-24-2017
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|
1.3
|
Removal of Amendments (§ 170.315(d)(4)) under Approach 1 in the Privacy and Security section of the table. |
05-08-2017
|
|
1.4
|
Updated 'CEHRT Definition' value from "No" to "Yes" to match regulation text. |
02-22-2018
|
§170.315 (a)(10) Drug-formulary and preferred drug list checks—
The requirements specified in one of the following paragraphs (that is, paragraphs (a)(10)(i) and (a)(10)(ii) of this section) must be met to satisfy this certification criterion:
- Drug formulary checks. Automatically check whether a drug formulary exists for a given patient and medication.
- Preferred drug list checks. Automatically check whether a preferred drug list exists for a given patient and medication.
None
- Revision History
-
Version # Description of Change Version Date 1.0Initial Publication
10-22-20151.1Added clarification regarding drug formulary files if the Health IT Module is using the NCPDP Formulary and Benefit Standard v3.0.
12-18-20151.2Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
04-24-20171.3Removal of Amendments (§ 170.315(d)(4)) under Approach 1 in the Privacy and Security section of the table.
05-08-20171.4Updated 'CEHRT Definition' value from "No" to "Yes" to match regulation text.
02-22-2018 - Regulation Text
- Regulation Text
§170.315 (a)(10) Drug-formulary and preferred drug list checks—
The requirements specified in one of the following paragraphs (that is, paragraphs (a)(10)(i) and (a)(10)(ii) of this section) must be met to satisfy this certification criterion:
- Drug formulary checks. Automatically check whether a drug formulary exists for a given patient and medication.
- Preferred drug list checks. Automatically check whether a preferred drug list exists for a given patient and medication.
- Standard(s) Referenced
None
Certification Companion Guide: Drug-formulary and preferred drug list checks
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
| Edition Comparision | Gap Certification Eligible | Base EHR Definition | In Scope for CEHRT Definition |
|---|---|---|---|
|
Unchanged
|
Yes | Not Included | Yes |
Privacy and Security: This certification criterion was adopted at § 170.315(a)(10). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(a) “paragraph (a)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (a) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “VDT” and (e)(2) “secure messaging,” which are explicitly stated.
- Health IT presented for certification to this criterion would not have to demonstrate the capabilities required by the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)), unless the health IT is presented for certification to another criterion that requires certification to the 2015 Edition “amendments” criterion under the privacy and security certification framework.
- If choosing Approach 1:
- If choosing Approach 2:
- For each applicable P&S certification criterion not certified for approach 1, the health IT developer may certify for the criterion using system documentation which provides a clear description of how the external services necessary to meet the P&S criteria would be deployed and used. Please see the 2015 Edition final rule correction notice at 80 FR 76870 for additional clarification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively the developer must state that no accessibility-centered design was used.
Privacy and Security: This certification criterion was adopted at § 170.315(a)(10). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(a) “paragraph (a)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (a) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “VDT” and (e)(2) “secure messaging,” which are explicitly stated.
- Health IT presented for certification to this criterion would not have to demonstrate the capabilities required by the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)), unless the health IT is presented for certification to another criterion that requires certification to the 2015 Edition “amendments” criterion under the privacy and security certification framework.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively the developer must state that no accessibility-centered design was used.
- If choosing Approach 1:
- If choosing Approach 2:
- For each applicable P&S certification criterion not certified for approach 1, the health IT developer may certify for the criterion using system documentation which provides a clear description of how the external services necessary to meet the P&S criteria would be deployed and used. Please see the 2015 Edition final rule correction notice at 80 FR 76870 for additional clarification.
Applies to entire criterion
Clarifications:
- There is no standard required for this certification criterion. We encourage the industry to accelerate its work on a real-time individual patient-level standard for drug-formulary checking, which we will consider proposing in future rulemaking. [see also 80 FR 62623]
- Health IT needs to demonstrate either the ability to automatically check whether 1) a drug formulary exists or 2) whether a preferred drug list exists, for a given patient and medication.
Applies to entire criterion
|
Clarifications:
|
Paragraph (a)(10)(i)
Technical outcome – The health IT automatically checks for a drug formulary for a given patient and medication.
Clarifications:
- No standard is required for drug formulary checks. However, NCPDP Formulary and Benefit Standard v3.0 is widely implemented today in support of Medicare Part D requirements. Note that drug formulary files should be downloaded and incorporated into the health IT system if using the NCPDP Formulary and Benefit Standard v3.0.
- Health IT will not satisfy this provision if it provides a hyperlink to a patient’s drug formulary that a user would have to manually open and navigate. The health IT must perform an automated check for a drug formulary for a specific patient and the medication to be prescribed. [see also 77 FR 54204]
- An internally managed drug formulary is acceptable for the automatic checking. [see also 77 FR 54204]
Paragraph (a)(10)(i)
|
Technical outcome – The health IT automatically checks for a drug formulary for a given patient and medication. Clarifications:
|
Paragraph (a)(10)(ii)
Technical outcome – The health IT automatically checks for a preferred drug list for a specific patient and medication to be prescribed.
Clarifications:
- No additional clarifications available.
Paragraph (a)(10)(ii)
|
Technical outcome – The health IT automatically checks for a preferred drug list for a specific patient and medication to be prescribed. Clarifications:
|