§170.315(b)(4) Real-time prescription benefit
§ 170.315 (b)(4) Real-time prescription benefit
- Send and receive information. Enable a user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in § 170.205(c); at a minimum, a standard adopted in § 170.207(d)(1); and the standard in § 170.207(d)(2), as follows:
- Request patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the RTPBRequest transaction.
- Receive patient-specific prescription benefit information, estimated cost information, and alternative products in response to a request, in accordance with the RTPBResponse transaction.
- Display. Display to a user in human readable format patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with at least one of the versions of the standard adopted in § 170.205(c).
Paragraph (b)(4)(i)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
§ 170.207(d)(1)(i) RxNorm, July 5, 2022 Full Monthly Release
§ 170.207(d)(1)(ii) RxNorm, December 4, 2023 Full Monthly Release
§ 170.207(d)(1)(iii) RxNorm, September 8, 2015 Full Release Update
§ 170.207(d)(2) National Drug Codes (NDC)
Paragraph (b)(4)(ii)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ASTP/ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.
Deadline: December 31, 2027
Action to be taken: Developers maintaining adherence to the certification criteria outlined in the Base EHR definition must obtain certification to this criterion.
Dependent Criteria
Any developer that obtains certification for the “electronic prescribing” certification criterion in 45 CFR 170.315(b)(3) must also obtain certification for the “real-time prescription benefit” criterion in 45 CFR 170.315(b)(4).
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
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.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Initial publication |
10-01-2025
|
- Regulation Text
-
Regulation Text
§ 170.315 (b)(4) Real-time prescription benefit
- Send and receive information. Enable a user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in § 170.205(c); at a minimum, a standard adopted in § 170.207(d)(1); and the standard in § 170.207(d)(2), as follows:
- Request patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the RTPBRequest transaction.
- Receive patient-specific prescription benefit information, estimated cost information, and alternative products in response to a request, in accordance with the RTPBResponse transaction.
- Display. Display to a user in human readable format patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with at least one of the versions of the standard adopted in § 170.205(c).
- Send and receive information. Enable a user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in § 170.205(c); at a minimum, a standard adopted in § 170.207(d)(1); and the standard in § 170.207(d)(2), as follows:
- Standard(s) Referenced
-
Paragraph (b)(4)(i)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
§ 170.207(d)(1)(i) RxNorm, July 5, 2022 Full Monthly Release
§ 170.207(d)(1)(ii) RxNorm, December 4, 2023 Full Monthly Release
§ 170.207(d)(1)(iii) RxNorm, September 8, 2015 Full Release Update
§ 170.207(d)(2) National Drug Codes (NDC)
Paragraph (b)(4)(ii)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
- Required Update Deadlines
-
The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ASTP/ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.
Deadline: December 31, 2027
Action to be taken: Developers maintaining adherence to the certification criteria outlined in the Base EHR definition must obtain certification to this criterion.
- Certification Dependencies
-
Dependent Criteria
Any developer that obtains certification for the “electronic prescribing” certification criterion in 45 CFR 170.315(b)(3) must also obtain certification for the “real-time prescription benefit” criterion in 45 CFR 170.315(b)(4).
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
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.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
- Testing
-
Testing Tool
Electronic Prescribing (eRx)/Real-time prescription benefit (RTPB) Tool (link to be provided when tool is available)
- Revision History
-
Version # Description of Change Version Date 1.0 Initial publication
10-01-2025
This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ASTP/ONC Final Rule on the Certification Regulations page for a detailed description of the certification criterion with which these testing steps are associated. ASTP/ONC also encourages developers to consult the Certification Companion Guide in tandem with the test procedure as it provides clarifications that may be useful for product development and testing.
Note: The tests step order does not necessarily prescribe the order in which the tests should take place.
Testing components
Paragraphs (b)(4)(i) Send and receive information
- The health IT developer requests patient-specific prescription benefit information, estimated cost information, and alternative products (RTPBRequest) in accordance with (b)(4)(i)(A).
- The health IT developer receives patient-specific prescription benefit information, estimated cost information, and alternative products (RTPBResponse) in response to a request, in accordance with (b)(4)(i)(B).
- The tester verifies the Health IT Module sends and receives the following transactions and completes all required test tool interaction steps and verifies the validation report for the following required transactions:
- Send a request for patient-specific prescription benefit information, estimated cost information, and alternative products (RTPBRequest);
- Receive a response containing patient-specific prescription benefit information, estimated cost information, and alternative products in response to a request (RTPBResponse).
| System Under Test | Test Lab Verification |
|---|---|
|
|
Paragraph (b)(4)(ii) Display
- The health IT developer displays patient-specific prescription benefit information, estimated cost information, and alternative products to the user in human-readable format in accordance with (b)(4)(ii).
- The tester verifies through visual inspection of the System Under Test that the Health IT Module displays the patient-specific prescription benefit information, estimated cost information, and alternative products in a human-readable format.
| System Under Test | Test Lab Verification |
|---|---|
|
|
§ 170.315 (b)(4) Real-time prescription benefit
- Send and receive information. Enable a user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in § 170.205(c); at a minimum, a standard adopted in § 170.207(d)(1); and the standard in § 170.207(d)(2), as follows:
- Request patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the RTPBRequest transaction.
- Receive patient-specific prescription benefit information, estimated cost information, and alternative products in response to a request, in accordance with the RTPBResponse transaction.
- Display. Display to a user in human readable format patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with at least one of the versions of the standard adopted in § 170.205(c).
Paragraph (b)(4)(i)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
§ 170.207(d)(1)(i) RxNorm, July 5, 2022 Full Monthly Release
§ 170.207(d)(1)(ii) RxNorm, December 4, 2023 Full Monthly Release
§ 170.207(d)(1)(iii) RxNorm, September 8, 2015 Full Release Update
§ 170.207(d)(2) National Drug Codes (NDC)
Paragraph (b)(4)(ii)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ASTP/ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.
Deadline: December 31, 2027
Action to be taken: Developers maintaining adherence to the certification criteria outlined in the Base EHR definition must obtain certification to this criterion.
Dependent Criteria
Any developer that obtains certification for the “electronic prescribing” certification criterion in 45 CFR 170.315(b)(3) must also obtain certification for the “real-time prescription benefit” criterion in 45 CFR 170.315(b)(4).
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
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.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Initial publication |
10-01-2025
|
- Regulation Text
-
Regulation Text
§ 170.315 (b)(4) Real-time prescription benefit
- Send and receive information. Enable a user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in § 170.205(c); at a minimum, a standard adopted in § 170.207(d)(1); and the standard in § 170.207(d)(2), as follows:
- Request patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the RTPBRequest transaction.
- Receive patient-specific prescription benefit information, estimated cost information, and alternative products in response to a request, in accordance with the RTPBResponse transaction.
- Display. Display to a user in human readable format patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with at least one of the versions of the standard adopted in § 170.205(c).
- Send and receive information. Enable a user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in § 170.205(c); at a minimum, a standard adopted in § 170.207(d)(1); and the standard in § 170.207(d)(2), as follows:
- Standard(s) Referenced
-
Paragraph (b)(4)(i)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
§ 170.207(d)(1)(i) RxNorm, July 5, 2022 Full Monthly Release
§ 170.207(d)(1)(ii) RxNorm, December 4, 2023 Full Monthly Release
§ 170.207(d)(1)(iii) RxNorm, September 8, 2015 Full Release Update
§ 170.207(d)(2) National Drug Codes (NDC)
Paragraph (b)(4)(ii)
§ 170.205(c)(1) NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13
- Required Update Deadlines
-
The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ASTP/ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.
Deadline: December 31, 2027
Action to be taken: Developers maintaining adherence to the certification criteria outlined in the Base EHR definition must obtain certification to this criterion.
- Certification Dependencies
-
Dependent Criteria
Any developer that obtains certification for the “electronic prescribing” certification criterion in 45 CFR 170.315(b)(3) must also obtain certification for the “real-time prescription benefit” criterion in 45 CFR 170.315(b)(4).
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
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.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
- Revision History
-
Version # Description of Change Version Date 1.0 Initial Publication
09-30-2025 - Testing
-
Testing Tool
Electronic Prescribing (eRx)/Real-time prescription benefit (RTPB) Tool (link to be provided when tool is available)
Certification Companion Guide: Real-time prescription benefit
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements outlined in regulation and related ASTP/ONC final rules. It extracts key portions of ASTP/ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the Certification Program Regulations page for links to all final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.
The below table outlines whether this criterion has additional Maintenance of Certification dependencies, update requirements and/or eligibility for standards updates via SVAP. Review the Certification Dependencies and Required Update Deadline drop-downs above if this table indicates “yes” for any field.
| Base EHR Definition | Real World Testing | Insights Condition | SVAP | Requires Updates |
|---|---|---|---|---|
| Included | Yes | No | No | No |
Applies to entire criterion
- The estimated cost information included in the RTPBRequest and RTPBResponse transactions only pertains to patient out-of-pocket costs. Prescribers using Real-Time Benefit Tools (RTBTs) that implement the NCPDP RTPB standard, version 13, have the capability to request and receive information on overall costs. This includes fields such as “estimated net plan cost” and “estimated combined plan and patient savings” but only when allowed and provided by the plan. [see also 90 FR 37154]
- There are no restrictions to the scope of products included in this criterion, allowing coverage of any pharmacy benefit products (e.g., medications, vaccines, supplies, devices). [see also 90 FR 37157]
- Developers must support transactions with at least one version of RxNorm.
|
Paragraph (b)(4)(i) Send and receive information
Technical outcome – Enable a user to perform real-time prescription benefit (RTPB) requests and receive RTPB information using the XML format in accordance with the NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13, RxNorm and NDC.
Clarifications:
- A Health IT Module must enable a user to use conduct transactions in accordance with one of the versions of RxNorm “at a minimum” to ensure alignment with the existing minimum standards code set policy in the Certification Program in 45 CFR 170.555. [see also 90 FR 37158]
- RTPBError transactions are not a requirement under this criterion as error handling is built into the RTPBResponse transaction. [see also 90 FR 37154]
|
Technical outcome – Enable a user to perform real-time prescription benefit (RTPB) requests and receive RTPB information using the XML format in accordance with the NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13, RxNorm and NDC. Clarifications:
|
Paragraph (b)(4)(ii) Display
Technical outcome – Display to a user in human readable format patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13.
Clarifications:
- ASTP/ONC previously referred to “alternative products” as “therapeutic alternatives” in earlier proposed rules. However, to be consistent with NCPDP terminology, regulation was finalized to reference “alternative products.” [see also 90 FR 37154]
- Developers have flexibility in determining how to present information to users.
|
Technical outcome – Display to a user in human readable format patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13. Clarifications:
|