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§170.315(g)(1) Automated numerator recording

Updated on 06-11-2024
Regulation Text
Regulation Text

§ 170.315 (g)(1) Automated numerator recording

For each Promoting Interoperability Programs percentage-based measure, technology must be able to create a report or file that enables a user to review the patients or actions that would make the patient or action eligible to be included in the measure's numerator. The information in the report or file created must be of sufficient detail such that it enables a user to match those patients or actions to meet the measure's denominator limitations when necessary to generate an accurate percentage.

Standard(s) Referenced

None

Certification Dependencies

Design and Performance: This certification criterion was adopted at § 170.315(g)(1). Quality management system (§ 170.315(g)(4)) and accessibility-centered design (§ 170.315(g)(5)) need to be certified as part of the overall scope of the certificate issued to the product.

  • 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.

Measure-Specific Guidance from CMS

Testing
Testing Tool

Testing Components

Criterion Subparagraph Test Data
Test Data Set 1 – EH/CAH
Test Data Set 2 – EP/EC
Revision History
Version # Description of Change Version Date
1.0

Initial publication

03-11-2024
1.1

Updated test steps under SUT to align with test data scenarios and current CMS requirements. 

06-11-2024

This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ONC Final Rule on the Certification Regulations page for a detailed description of the certification criterion with which these testing steps are associated. 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 test step order does not necessarily prescribe the order in which the tests should take place.

Testing components

Documentation Icon Visual Inspection Icon No Test Tool Icon ONC Supplied Test Data Icon No SVAP Icon

Organization

The tests are organized as follows:

  • Required Tests 1 through 15 are measure-specific sections that address required capabilities for each measure.

Health IT Modules that are ambulatory systems only must use the ambulatory test data. Health IT Modules that are inpatient systems only must use the eligible hospital test data and, if the inpatient system is used in the ambulatory setting, the ambulatory test data. Health IT Modules that are both ambulatory and inpatient systems must use the eligible hospital test data and the ambulatory test data. Health IT Modules that test for the ambulatory data must test for both the EC individual and EC Group calculation methods.

 

For Measure-Specific Sections

Within each of the measure-specific sections, the test procedure addresses the capability to record the numerator for § 170.315(g)(1) for each measure for Medicare Promoting Interoperability Program and the MIPS Promoting Interoperability performance category measures:

  • Record – evaluates the capability to electronically record the numerator for each objective with a percentage-based measure.
    • The health IT developer records all numerator measure elements for the method(s) by which the Health IT Module records the numerator for each measure.

ONC supplies Test Cases to be used during the test, and the health IT developer supplies information as directed in the test data. A single set of test patients has been created that occur across all required tests. The health IT developer is required to use all test patients in each scenario. The health IT developer must use the test patients that are in the test data and may not change their names, birthdays, or gender.

  • Report – evaluates the capability to create a report that includes the numerator associated with each percentage-based measure.
    • The health IT developer enters the test patients for Scenario 1 and the corresponding test data for each required test for which it is presenting for testing. Using the functions of the Health IT Module, the health IT developer creates a report that includes, as relevant, the numerator and resulting percentage for each measure based on the supplied test data from the test data scenario across all required tests. The report must also include the list of patients included in the numerator and denominator as relevant. Then the health IT developer marks the report for the associated scenario.
    • Scenario 1: baseline measurement report
    • Scenario 2: populate numerator
    • Scenario 3: populate numerator
    • Scenario 4: do not populate numerator
    • The health IT developer submits all four reports to the tester for review.
    • The tester verifies that the increments in the numerator produced in the delta report are accurate and complete and represent the expected increments in comparison to the baseline measure report, based on the ONC supplied test data. The tester uses the English Statements described in the Test Guide for each measure. The tester verifies that the correct patients are included in the numerator for each measure.

Each measure-specific Test Description provides a Measure Element list and English Statements for each measure. The Measure Element list deconstructs the English Statements to provide the discrete measure elements for recording the numerator.

System Under Test Test Lab Verification

Required Attestation

Health IT developers with Health IT Modules certified to (g)(1) are required to attest that they have provided to other health IT developers and end-users documentation, including the following as applicable:

  • Identify and acknowledge specific situations where the Health IT Module certified to (g)(1) does not have access to information that allows the module to determine if a numerator should be incremented or decremented for a measure. 
  • Identify and acknowledge that the Health IT Module does not record TIN/NPIs and that the health IT developer or end-user is responsible for calculating performance at the TIN/NPI or group TIN for Promoting Interoperability measures. 

Required Attestation

Tester verifies that the attestation includes all required elements.


System Under Test Test Lab Verification

The health IT developer records and creates four reports, one for each ONC Test Data Scenario(s). Note that the health IT developer may create each report for a single required test or it may create one report for all of the required tests for which it is seeking certification. Any prescriptions written by the eligible clinician (EC), or discharge medication orders in an inpatient setting, will populate the numerator once per prescription transmitted electronically for a patient who was seen/admitted during the reporting/performance period.

EH/CAH Measure Description

Medicare Promoting Interoperability Program Measure:

  • EH/CAH: At least one hospital discharge medication order for permissible prescriptions (for new and changed prescriptions) is transmitted electronically using certified electronic health record technology (CEHRT).

Medicare Promoting Interoperability Program Measure English Statements:

  • Numerator: The number of prescriptions in the denominator generated and transmitted electronically.

Medicare Promoting Interoperability Program Measure Elements:

  • Numerator: Prescription generated and transmitted electronically.

EC Measure Description

Merit-based Incentive Payment System (MIPS) Promoting Interoperability Performance Category Measure:

  • EC: At least one permissible prescription written by the MIPS eligible clinician is transmitted electronically using certified electronic health record technology (CEHRT).

MIPS Promoting Interoperability Performance Category English Statements:

  • Numerator: The number of prescriptions in the denominator generated and transmitted electronically using CEHRT.

Merit-based Incentive Payment System (MIPS) Promoting Interoperability Performance Category Measure Elements:

  • Numerator: Prescription generated and transmitted electronically.

The tester verifies that each report, including the numerator, is created correctly and without omission and includes sufficient detail to match the patients or actions in the numerator report to the measure’s denominator limitations. The tester ensures that the correct patients are included in the numerator. The tester will use the information provided in required Test 1 and use ONC Test Data Scenario(s) 1, 2, 3, and 4.


System Under Test Test Lab Verification

The health IT developer records and creates four reports, one for each ONC Test Data Scenario(s). Note that the health IT developer may create each report for a single required test or it may create one report for all of the required tests for which it is seeking certification. The act of giving a patient timely online access to his or her health information will populate the numerator if:

Medicare Promoting Interoperability Program: Patient health information must be made available to the patient within 36 hours of its availability to the eligible hospital or CAH.

Promoting Interoperability performance category: Patient health information is made available to the patient within four business days of its availability to the EC.

Test Data

  • Health IT Modules that are certified to § 170.315 (e)(1), (g)(9) or (g)(10) must use test data in tab RT 2a Provider Patient Exchange (EH/CAH and EC).
  • Health IT Modules that are certified to § 170.315 (e)(1) only must use test data in tab RT 2b Provider Patient Exchange (EH/CAH and EC).
  • Health IT Modules that are certified to § 170.315 (g)(9) or (g)(10) must use test data in tab RT 2c Provider Patient Exchange (EH/CAH and EC) and will only be tested for the Medicare Promoting Interoperability Programs and Promoting Interoperability performance Category measures.

EC/EH Measure Description

Medicare Promoting Interoperability Program Measure:

  • Medicare EH/CAH: For at least one unique patient discharged from the EH or CAH inpatient or emergency department (POS 21 or 23): (1) The patient (or the patient-authorized representative) is provided timely access to view online, download, and transmit his or her health information; and (2) The eligible hospital or CAH ensures the patient’s health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the API in the eligible hospital or CAH's CEHRT.

Medicare Promoting Interoperability Program English Statements:

  • Numerator: The number of patients in the denominator (or patient-authorized representatives) who are provided timely access to health information to view online, download, and transmit to a third party and to access using an application of their choice that is configured meet the technical specifications of the API in the hospital's or CAH's CEHRT.

Medicare Promoting Interoperability Program Measure Elements:

  • Numerator:
    • Date and time information made available online to the patient;
    • Date and time of discharge;
    • Date and time information made available to an API.

EC Measure Description

MIPS Promoting Interoperability Performance Category Measure:

  • For at least one unique patient seen by the MIPS eligible clinician: (1) The patient (or the patient-authorized representative) is provided timely access to view online, download, and transmit his or her health information; and (2) The MIPS eligible clinician ensures the patient's health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the Application Programming Interface (API) in the MIPS EC CEHRT.

MIPS Promoting Interoperability Performance Category English Statements:

  • Numerator: The number of patients in the denominator (or patient authorized representatives) who are provided timely access to health information to view online, download, and transmit to a third party and to access using an application of their choice that is configured to meet the technical specifications of the API in the MIPS EC’s CEHRT.

MIPS Promoting Interoperability Performance Category Measure Elements:

  • Numerator:
    • Date and time information available to the EC;
    • Date and time information made available online to the patient;
    • Date and time information made available to an API.

The tester verifies that each report, including the numerator, is created correctly and without omission and includes sufficient detail to match the patients or actions in the numerator report to the measure’s denominator limitations. The tester ensures that the correct patients are included in the numerator. The tester will use the information provided in required Test 2a, 2b, or 2c and use ONC Test Data Scenario(s) 1, 2, 3, and 4. The tester verifies that all of the required information below is made available to patients.

  1. USCDI (which should be in their English representation)
  2. Provider’s name and office contact information (ambulatory setting only)
  3. Admission and discharge dates and locations; discharge instructions; and reason(s) for hospitalization (inpatient setting only)
  4. Laboratory test report(s)
  5. Diagnostic image report(s)

System Under Test Test Lab Verification

The health IT developer records and creates four reports, one for each ONC Test Data Scenario(s). Note that the health IT developer may create each report for a single required test or it may create one report for all of the required tests for which it is seeking certification. The Health IT Module will populate the numerator when a provider creates and transmits/exchanges a summary of care record and confirms receipt of the transmitted/exchanged summary of care record. Actions taken before or after the reporting/performance period will not increment in the numerator.

Beginning with the 2024 Medicare Promoting Interoperability Program and MIPS Promoting Interoperability reporting period, the Health IT Module will populate the numerator when a provider creates and transmits/exchanges a summary of care record, and confirms receipt of the transmitted/exchanged summary of care record, no earlier than the first day of the calendar year of the reporting/performance period (for a 180-day reporting/performance period), during the reporting/performance period (for a 180-day and full calendar year reporting/performance period), or no later than the end of the calendar year (for a 180-day reporting/performance period).

EH/CAH Measure Description

Medicare Promoting Interoperability Program Measure:

  • Medicare EH/CAH: For at least one transition of care or referral the EH or CAH that transitions or refers its patient to another setting of care or provider of care (1) creates a summary of care record using CEHRT; and (2) electronically exchanges the summary of care record.

Medicare Promoting Interoperability Program Measure English Statements:

  • Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using CEHRT and exchanged electronically.

Medicare Promoting Interoperability Program Measure Elements:

  • Numerator:
    • Summary of care record created and exchanged;
    • Summary of care record receipt confirmed.

EC Measure Description

MIPS Promoting Interoperability Performance Category Measure:

  • For at least one transition of care or referral, the MIPS EC that transitions or refers his or her patient to another setting of care or health care provider (1) creates a summary of care record using CEHRT; and (2) electronically exchanges the summary of care record.

MIPS Promoting Interoperability Performance Category English Statements:

  • Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using CEHRT and exchanged electronically.

MIPS Promoting Interoperability Performance Category Measure Elements:

  • Numerator:
    • Summary of care record created and exchanged;
    • Summary of care record receipt confirmed.

The tester verifies that each report, including the numerator, are created correctly and without omission and include sufficient detail to match the patients or actions in the numerator report to the measure’s denominator limitations. The tester ensures that the correct patients are included in the numerator. The tester will use the information provided in required Test 7 and use ONC Test Data Scenario(s) 1, 2, 3, and 4.

The tester shall verify that at a minimum, the following fields (listed below) in the summary of care record contain all of the information (or an indication of none) prior to numerator population. If a summary of care record does not contain all of the information (or an indication of none), the numerator should not be populated for both ambulatory and inpatient settings:

  1. Current problem list;
  2. Current medication list;
  3. Current medication allergy list.

System Under Test Test Lab Verification

The health IT developer records and creates four reports, one for each ONC Test Data Scenario(s). Note that the health IT developer may create each report for a single required test or it may create one report for all of the required tests for which it is seeking certification.

EH/CAH Measure Description

Medicare Promoting Interoperability Program Measure (starting in 2019):

  • EH/CAH: For at least one electronic summary of care record received for patient encounters during the EHR reporting period for which an EH or CAH was the receiving party of a transition of care or referral, or for patient encounters during the EHR reporting period in which the EH or CAH has never before encountered the patient, the EH or CAH conducts clinical information reconciliation for medication, mediation allergy, and current problem list.

Medicare Promoting Interoperability Program Measure English Statements (starting in 2019):

  • Numerator: The number of electronic summary of care records in the denominator for which clinical information reconciliation is completed using CEHRT for the following three clinical information sets: (1) Medication – Review of the patient's medication, including the name, dosage, frequency, and route of each medication; (2) Medication allergy – Review of the patient's known medication allergies; and (3) Current Problem List – Review of the patient’s current and active diagnoses.

Medicare Promoting Interoperability Program Measure Elements (starting in 2019):

  • Numerator: The number of electronic summary of care records with an indication that clinical reconciliation of medications, medications allergy, and current problem list occurred.

EC Measure Description

MIPS Promoting Interoperability Performance Category Measures (starting in 2019):

  • For at least one electronic summary of care record received for patient encounters during the performance period for which a MIPS EC was the receiving party of a transition of care or referral, or for patient encounters during the performance period in which the MIPS EC has never before encountered the patient, the MIPS EC conducts clinical information reconciliation for medication, medication allergy, and current problem list.

MIPS Promoting Interoperability Performance Category Measures English Statement (starting in 2019):

  • Numerator: The number of electronic summary of care records in the denominator for which clinical information reconciliation is completed using CEHRT for the following three clinical information sets: (1) Medication – Review of the patient's medication, including the name, dosage, frequency, and route of each medication; (2) Medication allergy – Review of the patient's known medication allergies; and (3) Current Problem List – Review of the patient’s current and active diagnoses.

MIPS Promoting Interoperability Performance Category Measure Elements (Starting in 2019):

  • Numerator:
    • The number of electronic summary of care records with an indication that clinical reconciliation of medications, medications allergy, and current problem list occurred.

The tester verifies that each report, including the numerator, are created correctly and without omission and include sufficient detail to match the patients or actions in the numerator report to the measure’s denominator limitations. The tester ensures that the correct patients are included in the numerator. The tester will use the information provided in required Test 15 and use ONC Test Data Scenario(s) 1, 2, 3, and 4.

 


Updated on 03-11-2024
Regulation Text
Regulation Text

§ 170.315 (g)(1) Automated numerator recording

For each Promoting Interoperability Programs percentage-based measure, technology must be able to create a report or file that enables a user to review the patients or actions that would make the patient or action eligible to be included in the measure's numerator. The information in the report or file created must be of sufficient detail such that it enables a user to match those patients or actions to meet the measure's denominator limitations when necessary to generate an accurate percentage.

Standard(s) Referenced

None

Certification Dependencies

Design and Performance: This certification criterion was adopted at § 170.315(g)(1). Quality management system (§ 170.315(g)(4)) and accessibility-centered design (§ 170.315(g)(5)) need to be certified as part of the overall scope of the certificate issued to the product.

  • 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.

Measure-Specific Guidance from CMS

Revision History
Version # Description of Change Version Date
1.0

Initial publication

03-11-2024
Testing
Testing Tool

Testing Components

Criterion Subparagraph Test Data
Test Data Set 1 – EH/CAH
Test Data Set 2 – EP/EC

Certification Companion Guide: Automated numerator recording

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 ONC final rules. It extracts key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the Certification Regulations page for links to all ONC 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.

 

Certification Requirements
Technical Explanations and Clarifications

Technical outcome – A user must be able to create a report or file to review patients or actions that would make the patient or action eligible to be included in a Promoting Interoperability Programs percentage-based measure’s numerator. The user must be able to use the information in the report or file to match those patients or actions to meet the measure’s denominator limitations.

Clarifications:

  • There is no standard required for this certification criterion.
  • ONC administers the ONC Health IT Certification Program; CMS administers the Medicare Promoting Interoperability Program and the Quality Payment Program's (QPP) Merit-based Incentive Payment System (MIPS) Promoting Interoperability Performance Category. 
  • Questions regarding program requirements for the Medicare Promoting Interoperability Program and QPP MIPS Promoting Interoperability performance category should be directed to CMS.
  • Please refer to CMS’ Promoting Interoperability Programs webpage and Quality Payment Program webpage for more resources on specific measures.
  • The test for (g)(1) does not require a live demonstration of recording data and generating reports. Developers may self-test their Health IT Modules(s) and submit the resulting reports to the ONC-ATL to verify compliance with the criterion. The test procedure specifies what reports must be submitted for each required test, as well as what the tester must verify within each report.
  • Developers should refer to the numerator and denominator statements in the measure specification sheets provided by CMS’ Promoting Interoperability Programs webpage to determine the reporting/performance period technology needs to support.
    • Starting in 2019, CMS has clarified that the numerator for the Medicare Stage 3 Eligible Hospital/CAH measures is constrained to the EHR reporting period. The numerator action therefore must take place during the reporting period. Actions occurring outside of the reporting period, including after the calendar year will not count in the numerator.
    • Starting in 2019, a MIPS Promoting Interoperability performance category measure numerator and denominator is constrained to the performance period chosen, with the exception of the "Security Risk Analysis" measure which may occur any time during the calendar year.
  • The test data used for this criterion is supplied by ONC and is organized into 4 Test Data scenarios, with a single set of 8 Test Cases. Health IT developers are required to use the ONC-supplied test data and may not modify the test case names.
  • The Medicare Promoting Interoperability Program's Provide Patients Electronic Access to Their Health Information measure requires that two conditions be met in order to increment/populate the numerator: patient data must be available to view, download, or transmit AND it must be available to an API within 36 hours (Eligible Hospital/CAH). The MIPS Promoting Interoperability performance category "Provide Patients Electronic Access to Their Health Information" measure requires that two conditions be met in order to increment/populate the numerator: patient data must be available to view, download, or transmit and it must be available to an API within 4 business days (Eligible Clinician). As such, Health IT Modules certified to only (e)(1) or certified to only (g)(9) or (g)(10) will be required to demonstrate that the product increments the denominator for the condition for which they are certified. For example, if the test case indicates that only view, download, or transmit was met, the numerator will increment for products certified to (e)(1) but will not increment for products certified to (g)(9), or (g)(10). Health IT Modules certified for (e)(1) AND (g)(9) or (g)(10) will be expected to increment the numerator as the measure specifies. Health IT Modules certified to only (e)(1) or certified to only (g)(9) or (g)(10) will be required to provide documentation during testing that demonstrates how the Health IT Module performs the calculation for its “portion” of the measure as a condition of passing testing. This documentation must also be made available with the health IT developer’s transparency statement regarding costs and limitations. Documentation should enable Eligible Professionals, Eligible Clinicians, Eligible Hospitals, and Critical Access Hospitals to determine how to correctly add together the numerator and denominator from systems providing each of the capabilities. 
  • The "Support Electronic Referral Loops by Sending Health Information" measure for the Medicare Promoting Interoperability Programs, and the MIPS Promoting Interoperability performance category require that the Eligible Professional/Eligible Clinician/Eligible Hospital/Critical Access Hospital confirm receipt of the summary of care by the referred to provider in order to increment the numerator. The test data tests this baseline requirement by requiring that a Health IT Module demonstrate confirmation of receipt before incrementing the numerator. ONC does not require a specific method Health IT Modules should use to confirm receipt. Health IT Modules could use a number of methods, including but not limited to, the Direct Message Disposition Notification, a check box, report verifications, etc.
  • The Medicaid Promoting Interoperability Program ended January 2022, the required tests that only supported the Medicaid Promoting Interoperability Program were removed.