QCDR Self-Nomination Fact Sheet
2019 Finalized vs. 2020 Finalized
Burden Impact: The changes to this self-nomination fact sheet reflect proposals in the CY2020 proposed rule which result in an estimated increase in burden of 0.25 hours per QCDR seeking to self-nominate and 1.5 hours per QCDR measure submitted for approval.
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Final Rule 2019 |
Final Rule 2020 |
Reason for Change |
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Section Header: 2019 Qualified Clinical Data Registry (QCDR) Fact Sheet |
Section Header: 2020 Qualified Clinical Data Registry (QCDR) Fact Sheet |
Alignment with current year |
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Section Header - When is the self-nomination period?
September 1 – November 1 of the year prior to the applicable performance period |
Section Header - When is the self-nomination period?
July 1 – September 3 of the year prior to the applicable performance period. The Self-Nomination Period will promptly open at 8:00 pm ET on September 3rd. Self-Nominations submitted after the deadline will not be considered. |
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Section Header - Tips for Successful Self-Nomination:
The list of vendors that have been qualified to submit data to CMS as a QCDR for purposes of MIPS will be posted on the CMS Quality Payment Program website. |
Section Header - Tips for Successful Self-Nomination:
2. You must provide all required information at the time of self-nomination, and before the close of the self-nomination period via the CMS Quality Payment Program portal (https://qpp.cms.gov/login) for CMS consideration.
A simplified self-nomination form is available to reduce the burden of self-nomination for those existing QCDRs that have previously participated in MIPS and are in good standing (CMS did not take remedial action against or terminate the QCDR as a third party intermediaries).
The simplified form is available only for existing QCDRs in good standing.
The list of vendors that have been approved to submit data to CMS as a QCDR for the 2020 performance period of MIPS will be posted in the Resource Library of the CMS Quality Payment Program website. |
Edited for alignment with finalized requirements, edited for clarity |
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Section Header – What is a QCDR?
A QCDR is a CMS-approved vendor that collects clinical data on behalf of clinicians for data submission. Examples include, but are not limited to, regional collaboratives, specialty societies, or large healthcare systems. Please note that QCDRs cannot be owned or managed by an individual, locally-owned specialty group. Clinicians work directly with their chosen QCDR to submit data on the selected measures or specialty set of measures they have picked.
The QCDR reporting option is different from a Qualified Registry because QCDRs are not limited to reporting only MIPS Quality Measures within MIPS. A QCDR may submit a maximum of 30 QCDR developed measures (known as QCDR Measures, and previously as non-MIPS measures) for CMS review and approval for reporting.
Quality Measures submitted by a QCDR may include measures from one or more of the following categories:
• Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CAHPS), which must be reported via CAHPS certified vendor. Although the CAHPS for MIPS survey is included in the MIPS measure set, the changes needed for reporting by individual eligible clinicians are significant enough to treat it as a QCDR measure for the purposes of reporting via a QCDR. Please note that submitting a subset of CAHPS survey measures as a QCDR measure will not count for credit towards completing the CAHPS for MIPS Survey. • National Quality Forum (NQF) endorsed measures. • Current 2019 MIPS Quality Measures. • QCDR Measures developed by boards or specialty societies. • QCDR Measures developed by regional quality collaboratives. |
Section Header - What is a QCDR?
A QCDR is defined as an entity that demonstrates clinical expertise in medicine and quality measurement development that collect medical or clinical data on behalf of MIPS eligible clinicians to track patients and diseases and foster improvement in the quality of care provided to patients. A QCDR may include: • An entity with clinical expertise in medicine. Clinicians must be on staff with the organization and lend their clinical expertise in the work carried out by the organization as a QCDR. • An entity with stand-alone quality measurement development. • An entity that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. • An entity that uses an external organization for purposes of data collection, calculation, or transmission may meet the definition of a QCDR as long as the entity has a signed, written agreement that specifically details the relationship, roles and responsibilities of the entity with the external organization effective as of September 1 the year prior to the year for which the entity seeks to become a QCDR.
Entities without clinical expertise in medicine and quality measure development that want to become a QCDR, may collaborate with entities with such expertise.
As described in the CY 2018 Quality Payment Program final rule (82 FR 53809), changes to the QCDR’s organizational structure (for example, if a specialty society wishes to partner with a different data submission platform vendor) are considered substantive and would need to be updated at the time of self-nomination. The roles of each organization should be specifically detailed within the self-nomination form.
Alternatively, entities may seek to qualify as another type of third-party intermediary, such as a Qualified Registry. Becoming a Qualified Registry does not require the level of measure development expertise that is needed to be a QCDR that develops measures.
The QCDR reporting option is different from a Qualified Registry because QCDRs are not limited to reporting only MIPS Quality Measures. A QCDR may also submit a maximum of 30 QCDR measures for CMS consideration for the 2020 performance period of MIPS.
Measures submitted by a QCDR may be from one or more of the following categories:
• Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CAHPS), which must be reported via CAHPS certified vendor. Although the CAHPS for MIPS survey is included in the MIPS measure set, the changes needed for reporting by individual eligible clinicians are significant enough to treat it as a QCDR measure for the purposes of reporting via a QCDR. Please note that submitting a subset of CAHPS survey measures as a QCDR measure will not count for credit towards completing the CAHPS for MIPS Survey. • National Quality Forum (NQF) endorsed measures. • Current 2020 MIPS Clinical Quality Measures. • QCDR measures developed by boards or specialty societies with the appropriate documented permission to the QCDR measure. • QCDR measures developed by regional quality collaborative with the appropriate documented permission to the QCDR measure. |
Edited for alignment with finalized requirements, Edited for clarity |
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Section Header – What are the requirements to become a QCDR?
For the purposes of QCDR participation, we do not require that you provide a written report on Promoting Interoperability or Improvement Activities, as our primary focus is Quality. However, we encourage QCDRs to utilize auditing processes to ensure the accuracy of data submissions under the Promoting Interoperability and Improvement Activities performance categories as QCDRs would have certified at the time of submission, that all data submitted (across all performance categories) is true, accurate, and complete to the best of their knowledge.
A late submission of your Data Validation Execution Report from your QCDR will be seen as non-compliance with program requirements and may result in remedial action or termination of third party intermediaries in future program years.
Please note that CMS will provide a sample template for the Data Validation Execution Reports. The Data Validation Execution Report template will be posted on the CMS Quality Payment Program Resource Library.
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Section Header – What are the requirements to become a QCDR?
Your Data Validation Plan will be reviewed by CMS as a part of your self-nomination application and will need CMS approval prior to its implementation for the performance period.
We require QCDRs to utilize auditing processes to ensure the accuracy of all data submissions under all performance categories. QCDRs would have certified at the time of submission that the data submitted (for all performance categories) is true, accurate, and complete to the best of their knowledge.
Please note, a late submission of your Data Validation Execution Report from your QCDR will be seen as non-compliance with program requirements and may result in remedial action or termination of the QCDR in future program years.
Please note: CMS will provide a sample Data Validation Execution Report template, which will be posted on the CMS Quality Payment Program Resource Library.
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Section Header - What information is required to self-nominate?
You must provide the following when you self-nominate:
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Section Header - What information is required to self-nominate?
You must provide the following when you self-nominate:
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Section Header - What are the measure specification requirements?
You must provide specifications for each QCDR measure that you would like to nominate for CMS review and approval:
CMS proposes that beginning with the 2021 MIPS payment year, as a condition of a QCDR measure’s approval, the QCDR measure owner must agree to enter into a license agreement with CMS permitting any other QCDR to submit data on the specified QCDR measure (without modification). CMS also proposes that other QCDRs would be required to use the same CMS-assigned QCDR measure ID. If a QCDR refuses to enter into such an agreement, the QCDR measure may be rejected and another QCDR measure of similar clinical concept or topic may be approved in its place. Please note that this is included in the CY 2019 Quality Payment Program proposed rule. This information may be updated if it is modified or not included in the CY 2019 Quality Payment Program final rule.1 |
Section Header - What are the QCDR measure specification requirements?
You must provide specifications for each QCDR measure that you would like to nominate for CMS consideration:
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Section Header - What is considered a QCDR measure?
The following are QCDR Measures:
• A measure that is not contained in the annual list of MIPS Quality Measures for the applicable performance period. • A measure that may be in the annual list of MIPS Quality Measures but has substantive differences in the manner it is submitted by the QCDR. • The CAHPS for MIPS survey, which can only be submitted using a CMS-approved survey vendor. Although the CAHPS for MIPS survey is included in the MIPS measure set, the changes needed for reporting by individual eligible clinicians are significant enough to treat it as a QCDR measure for the purposes of reporting via a QCDR. CMS will not approve patient survey measures that only measure whether the survey was distributed and/or completed. In addition, QCDRs will not receive CAHPS for MIPS survey credit for CAHPS for MIPS survey measures submitted as QCDR Measures. |
Section Header - What is considered a QCDR measure?
QCDR Measures may include:
• A measure that is not contained in the annual list of MIPS Quality Measures for the applicable performance period. • A measure that may be in the annual list of MIPS Quality Measures but has substantive differences in the manner it is submitted by the QCDR. • The CAHPS for MIPS survey, which can only be submitted using a CMS-approved survey vendor. Although the CAHPS for MIPS survey is included in the MIPS measure set, the changes needed for reporting by individual eligible clinicians are significant enough to treat it as a QCDR measure for the purposes of reporting via a QCDR. CMS will not approve patient survey measures that only measure whether the survey was distributed and/or completed. In addition, QCDRs will not receive CAHPS for MIPS survey credit for CAHPS for MIPS survey measures submitted as QCDR measures. |
Edited for clarity |
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Section Header - What are the QCDR measure consideration criteria?
Prior to self-nomination of a QCDR measure, the following checklist should be reviewed to increase the likelihood of approval of the QCDR measure. CMS and the contractor team use a similar checklist during the review of QCDR Measures.
QCDR Measures should:
• Be clinically relevant and evidence based (summary of current clinical guidelines). • Include evidence of a performance gap and/or eligible clinician performance variation. • Include requests made by CMS during the previous program year (Provisionally Approved Measures) or documentation of why the request is not clinically appropriate. • Focus on a quality action instead of documentation. • Focus on an outcome rather than a clinical process. • Preferably fall within clinical workflows so data collection is not burdensome. • Address one or more meaningful measure areas and National Quality Strategy domains. • Be fully developed and not just in the concept development phase. • Include accurate measure classification (inverse, risk-adjusted, ratio, proportional, or continuous variable). • Include proper spelling and grammar throughout the specification. • If approved for previous performance period, identify changes to the specification. Measures that undergo substantive changes will have a new QCDR measure ID assigned. Substantive changes alter the intent of the QCDR measure and may impact the performance score. In this instance, QCDR measure data would not be comparable across performance periods.
QCDR Measures should not:
• Duplicate an existing or proposed MIPS Quality Measure. • Duplicate an existing QCDR measure (unless the new measure is a dramatic improvement over the existing measure). • Duplicate a retired PQRS measure. • Be topped out: have high, unvarying performance where there is little room for clinician improvement. • Split a single or related clinical process or outcome into several QCDR Measures. For example: The results of 3 different tests are required for a standard of care. Each test should not be a single measure, but all included in one measure. • Have the potential of unintended consequences. For example: the measure disqualifies a patient from receiving oxygen therapy or other comfort measures. • Focus on the elimination of serious, preventable, and costly medical errors - “Never Events”. For example: Surgery performed on the wrong patient. • Be a standard of care with the expectation it is performed consistently (low bar). • Be incidence measures • Be a rare occurrence • Lack a quality action • Have a quality action that is not attributed to the submitting eligible clinician. • Be documentation/check box measures.
CMS recommends that QCDRs utilize the following when developing and self-nominating QCDR Measures:
• Measure Development Plan • QCDR Measure Guide Handbook • CMS Blueprint |
Section Header - What are the QCDR measure consideration criteria?
Prior to self-nomination of a QCDR measure, the following checklist should be reviewed to increase the likelihood of approval of the QCDR measure. CMS and the contractor team use a similar checklist during the review of QCDR measures.
QCDR measures should:
• Be developed using the measure development processes as defined in the CMS Blueprint. • Be clinically relevant and evidence based (align with current clinical guidelines). • Include evidence of a performance gap either by providing performance data or the most recent study citation supporting a performance gap. • Address requested revisions made by CMS during the previous performance period of MIPS (Provisionally Approved measures) or provide rationale of why the CMS request is not clinically appropriate. • Focus on a quality action instead of documentation. • Focus on an outcome rather than a clinical process. • Have opportunity for adequate patient population and measure adoption for the QCDR measure to have a more significant impact on quality improvement. • Clearly define the quality action and population in the description for eligible clinician ease of understanding. • Address one or more Meaningful Measure Areas and National Quality Strategy domains. • Be fully developed and not just in the concept development phase. End to end testing or process validation should be performed to ensure data can be collected or extracted, received and calculations can occur. • Indicate accurate measure analytics (inverse, risk-adjusted, ratio, proportional, or continuous variable) • Be thoroughly proofread by the QCDR to ensure proper spelling and grammar throughout the QCDR measure specification. • Identify whether there are changes to the QCDR measure specification for the upcoming performance period of MIPS, if approved from a previous performance period of MIPS. Please note, substantive changes that alter the intent of the QCDR measure, and may impact the performance score and benchmarking may result in a new measure ID being assigned.
QCDR measures should not:
• Duplicate an existing or proposed MIPS clinical quality measure (CQM/eCQM). • Duplicate an existing QCDR measure (unless the new measure is a substantial improvement over the existing measure). O To reduce the number of duplicative QCDR measures in MIPS, CMS encourages QCDRs to share and/or harmonize QCDR measures that are similar in topic and/or concept. • Duplicate a retired Physician Quality Reporting System (PQRS) or quality measure. • Include measures that are considered topped out with performance rates. Topped out non-process measures means a measure where the Truncated Coefficient of Variation is less than 0.10 and the 75th and 90th percentiles are within 2 standard errors. Topped out process measures mean a measure with a median performance rate of 95 percent or higher. • Split a single or related clinical process or outcome into several QCDR measures. For example: the results of three different tests are required for a standard of care. Each test should not be a single measure but all three should be combined into one comprehensive measure. • Have the potential of unintended consequences. For example, a measure that discourages an oncology patient from receiving oxygen therapy or other comfort measures. • Focus on the elimination of serious, preventable, and costly medical errors that are highly unlikely to occur, so-called “Never Events”. For example: Surgery performed on the wrong patient or a fire in the operating room. • Be overly burdensome to the MIPS eligible clinician. • Be a standard of care with the expectation it is performed consistently (low bar). • Be incidence measures - measures that count the occurrence of new or newly diagnosed cases of a specified disease, illness, or injury within the indicated timeframe. • Have a quality action that is not attributable to the submitting eligible clinician. • Be documentation/check box measures.
CMS recommends that QCDRs utilize the following when developing and self-nominating QCDR measures:
• Measure Development Plan • QCDR Measure Development Handbook • CMS Blueprint |
Edited for alignment with finalized requirements, Edited for clarity |
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Section Header - What data submission functions must an approved QCDR perform?
Following the self-nomination and measure review and approval process, an approved QCDR must perform the following functions related to data submission:
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Section Header - What data submission functions must a QCDR perform?
Following the self-nomination process and QCDR measure review process, an approved QCDR must perform the following data submission functions:
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Section Header - What are the thresholds for data inaccuracies? What are considered data inaccuracies?
If any data inaccuracies affect more than 3% of your total MIPS eligible clinicians, you:
• Remedial action may be taken due to your low data quality rating. • Will have the QCDR Qualified Posting updated for the performance period to indicate remedial action has been taken. Data inaccuracies affecting more than 5% of your total MIPS eligible clinicians may lead to termination of third party intermediaries for the following year(s).
CMS will evaluate each Quality Measure for data completeness and accuracy. The vendor will also attest that the data (Quality Measures, Improvement Activities, and Promoting Interoperability measures and objectives, if applicable) and results submitted are true, accurate and complete.
CMS will determine error rates calculated on data submitted to CMS for MIPS eligible clinicians.
CMS will evaluate data inaccuracies including, but not limited to, TIN/NPI mismatches, formatting issues, calculation errors, and data audit discrepancies affecting in excess of three percent of the total number of MIPS eligible clinicians, groups or virtual groups submitted. Examples of such errors include:
• TIN/NPI Issues – Incorrect Tax Identification Numbers (TINs), Incorrect National Provider Identifiers (NPIs), Submission of Group NPIs. • Formatting Issues – Submitting files with incorrect file formats, Submitting files with incorrect element formats, Failure to update and resubmit rejected files. • Calculation Issues – Incorrect qualities for measure elements, Incorrect performance rates, Incorrect data completeness rates, Numerators larger than denominators. • Data Audit Discrepancies – Vendor acknowledgement of data discrepancies found during data validation but not corrected in submissions, Vendor/clinician acknowledgement of data discrepancies found post submission from clinician feedback reports and our Quality Use Resource Use (QURU) reports. |
Section Header - What are the thresholds for data inaccuracies? What are considered data inaccuracies?
Data inaccuracies that affect MIPS eligible clinicians, may result in:
• Remedial action may be taken against your QCDR due to the low data quality rating. • Will have the QCDR Qualified Posting updated for the performance period of MIPS to indicate the QCDR’s data error rate on the CMS website until the data error rate falls below 3 percent and that remedial action has been taken against the QCDR. Data inaccuracies affecting more than 5% of your total MIPS eligible clinicians may lead to termination of the QCDR for future program year(s).
CMS will evaluate each quality measure for data completeness and accuracy. The vendor will also attest that the data (quality measures, improvement activities, and promoting interoperability objectives and measures) results submitted are true, accurate, and complete to the best of their knowledge. CMS will determine error rates calculated on data submitted to CMS for MIPS eligible clinicians.
CMS will evaluate data inaccuracies including, but not limited to:
• TIN/NPI Issues – Incorrect Tax Identification Numbers (TINs), Incorrect National Provider Identifiers (NPIs), Submission of Group NPIs. • Formatting Issues – Submitting files with incorrect file formats, Submitting files with incorrect element formats, Failure to update and resubmit rejected files. • Calculation Issues – Incorrect qualities for measure elements, performance rates, and/or data completeness rates; Numerators larger than denominators. • Data Audit Discrepancies – Since data audits are required to occur prior to data submission, QCDRs should correct all identified errors prior to submitting the data to CMS. QCDR acknowledgement of data discrepancies found post submission from clinician feedback reports. |
Edited for clarity |
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Section Header - What may cause remedial action to be taken or termination of third party intermediaries from the program?
CMS may take remedial action for failing to meet certain standards and/or participation requirements. These requirements include, but are not limited to the following:
If remedial action is taken, CMS will require that the QCDR take remedial action by submitting a corrective action plan to address any deficiencies or issues and prevent them from recurring. The corrective action plan must be received by CMS within 14 calendar days from the date of the CMS remedial action notification for CMS review and approval. Failure to comply with the remedial action process may lead to termination of third party intermediaries for the current and/or subsequent performance year.
The QCDR Qualified Posting will be updated to reflect when remedial action has been taken and/or termination of third party intermediaries participating as a qualified QCDR. |
Section Header - What may cause remedial action to be taken or termination of third party intermediaries from the program?
CMS may take remedial action for failing to meet applicable criteria for approval or submit data that is inaccurate, unusable, or otherwise compromised.
Failure to comply with the remedial action process may lead to termination of third party intermediaries for the current and/or subsequent performance year.
The QCDR Qualified Posting will be updated to reflect when remedial action has been taken and/or termination of third party intermediaries participating as a qualified QCDR. |
Edited for clarity |
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Section Header - What if I do not meet the criteria to become a QCDR on my own?
QCDRs are welcome to collaborate with another vendor to meet the requirements and become a QCDR. A vendor that uses an external vendor for data collection, calculation, or transmission may meet the definition of a QCDR if the vendor has a signed, written agreement that specifically details the relationship of the vendor with the external vendor. This agreement must be effective as of September 1 prior to the performance period. |
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Section Header - What is the overall process to become an approved QCDR?
The overall process includes these steps:
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Section Header - What is the overall process to become an approved QCDR?
The overall process includes these steps:
• The QCDR completes and submits the self-nomination form, supported measures (MIPS Quality Measures and/or QCDR Measures), and Data Validation Plan through the Quality Payment Program portal for CMS consideration. • If the self-nomination form, MIPS Quality Measures, and Data Validation Plan are approved, all submitted QCDR measures are reviewed (if applicable). CMS may approve, provisionally approve, or reject the QCDR measures. The QCDR measure statuses are defined as: O Approved – The QCDR measure is approved for the given performance period. O Provisionally Approved – The QCDR measure is approved for the given performance period however, CMS is requesting additional information or action if the QCDR measure is resubmitted for subsequent performance periods. CMS will provide a rationale for the provisional status. This may include performance data to assess performance gaps, revision or harmonization of the QCDR measure if it is to be submitted during the next self-nomination period. O Rejected – The QCDR measure is not approved for the given performance period. CMS will provide a rationale for the rejection. • The Qualified Posting is developed for the approved QCDRs and include organization type, specialty, previous participation in MIPS (if applicable), program status (remedial action taken against the QCDR or terminated as a third part intermediary (if applicable)), contact information, last date to accept new clients, virtual groups specialty parameters (if applicable), the approved measures, performance categories supported, services offered, and costs incurred by clients. All approved QCDRs are included in the Qualified Posting that is posted on the CMS Quality Payment Program Resource Library. • Approved QCDRs review and acknowledge the measure specifications for their approved QCDR measures. • Approved QCDRs are required to support the performance categories and measures and activities listed on their Qualified Posting and meet all applicable approval criteria for the applicable performance period as a condition of participation in MIPS. Failure to do so may lead to remedial action or possible termination of the QCDR from future years of MIPS. |
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Section Header – Resources
requirements, steps for successful submission, and a question and answer session. Attendance to all support calls is mandatory, and is a requirement of participation as an approved QCDR. Each QCDR must attend both the webinar and audio portion via computer or phone to receive credit for attending the support call. One representative, from a vendor supporting multiple QCDRs, will NOT be counted as attendance for multiple QCDRs.
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Section Header – Resources
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1 Disclaimer: The information noted is subject to change based upon what is finalized in the
CY 2019 Physician Fee Schedule Final Rule for the Quality Payment Program. If needed, this
document will be updated to what is finalized in the final rule and reposted accordingly.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Appendix L - JIRA Measures Under Consideration Data Template for Candidate Measures: 2018 Finalized vs. 2019 Finalized |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-01-15 |