2022 >> Self-nomination: QCDR and Qualified Registry (see SS-A Tables 3 and 4)

2022 Qualified Registry Fact Sheet
What is a Qualified Registry?

A Qualified Registry is a data intermediary that collects Merit-based Incentive Payment System
(MIPS) data from MIPS eligible clinicians and submits it to the Centers for Medicare & Medicaid
Services (CMS) on their behalf. 1 Clinicians work directly with their chosen Qualified Registry to
submit data on the selected measures or activities they have selected.

What are the requirements to become a Qualified Registry?

1. Participants: You must have at least 25 participants by January 1 of the year prior to the
applicable performance period (January 1, 2021 for consideration for the 2022 MIPS
performance period). 2 These participants are not required to use the Qualified Registry to
report MIPS data to CMS, but they must submit data to the Qualified Registry for quality
improvement. 3 Please note CMS expects Qualified Registries would be up and running
by January 1 of the performance period to accept and retain data, to allow clinicians to
begin their data collection on January 1 of the performance period. 4 A system that is not
“live”, beginning with the start of the performance period, is considered non-compliant with this
requirement.
2. Certification Statement: You must certify that all data submissions to CMS on behalf of
MIPS eligible clinicians, groups, and virtual groups are true, accurate, and complete to the
best of your knowledge. This certification applies to data submissions based on the
acceptance of data exports directly from an electronic health record (EHR) or other data
sources. If you become aware that any submitted information is not true, accurate, and
complete, corrected information may be submitted until the end of the data submission period.
If false, inaccurate, or incomplete data are identified after the data submission period, you
should immediately notify CMS.
3. Data Submission: You should submit data via a CMS-specified secure method for data
submission, such as a defined Quality Payment Program data format. 5 Additional information
regarding data submission methodologies can be found in the Developer Tools section of the
Resource Section of the Quality Payment Program website: https://qpp.cms.gov/developers.
[Data submission is discussed in more detail below]

§414.1305
§414.1400(c)(2)
3 81 FR 77383
4 83 FR 59761
5 81 FR 77384 through 77385
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Except as provided in the Final Rule, 6 Quality Clinical Data Registries (QCDRs), qualified
registries, and health information technology (IT) vendors must be able to submit data for all
of the following MIPS performance categories:
● Quality, except:
o The CAHPS for MIPS survey; and
o For qualified registries and health IT vendors, QCDR measures;
● improvement activities; and
● Promoting Interoperability, if the eligible clinician, group, or virtual group is using Certified
Electronic Health Record Technology (CEHRT); however, a third party intermediary may be
excepted from this requirement if its MIPS eligible clinicians, groups or virtual groups fall
under the reweighting policies. 7
4. Data Validation and Targeted Audits: You must conduct Data Validation for the 2022
performance year prior to any data submission for the 2022 performance period. 8 Your
data validation must include all performance categories for which you will submit data
and each submitter type for which you will submit data, regardless of whether the clinician
or group are MIPS eligible, voluntary, or are opting in. 9 You must use clinical documentation
(provided by the clinicians they are submitting data for) to validate that the action or outcome
measured actually occurred or was performed. 10 In addition, each data validation audit must
include the following:
 Verification of the eligibility status of each eligible clinician, group, virtual group, opt-in
participant, and voluntary participant.
 Verification of the accuracy of tax identification numbers (TINs) and National Provider
Identifiers (NPIs)
 Calculation of reporting and performance rates.
 Verification that only MIPS quality measures that are relevant for the reporting periods will
be used for MIPS submission. For the 2022 performance year, this means:
o 2022 MIPS Clinical Quality Measures (CQMs) and/or electronic CQMs (eCQMs)
for the quality performance category.
o 2022 Promoting Interoperability measures and objectives for the Promoting
Interoperability performance category.
o 2022 improvement activities for the improvement activities performance category.

§414.1400(a)(2)(ii)
§414.1380(c)(2)(i)(A)(4) or (5) or §414.1380(c)(2)(i)(C)(1) through (7) or
§414.1380(c)(2)(i)(C)(9)
8 §414.1400(b)(2)(iv)(A)
9 §414.1400(b)(2)(iv)(B) & (C)
10 §414.1400(b)(2)(iv)(D)
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Each data validation audit (formerly known as “randomized audit”) must use a sampling
methodology that meets the following requirements for all performance categories for which
you will submit data:
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Sample size of at least 3% of the TIN-NPIs submitted to CMS, except that the sample
size must have a minimum of 10 TIN-NPIs and the sample size does not need to
include more than 50 TIN-NPIs.
Sample that includes at least 25% of the patients of each TIN-NPI in the sample,
except that the sample size must have a minimum of 5 patients and does not need to
include more than 50 patients.

Targeted Audits. If a data validation audit identifies one or more deficiency or data error, you
must also conduct a targeted audit (formerly known as a “detailed audit”) into the impact and
root cause of each such deficiency or data error for that MIPS payment year. 11 Any required
targeted audits for the 2022 performance year and correction of any deficiencies or data errors
identified through such audit must be completed prior to the submission of data for the 2022
performance year. 12) The sample used for auditing in the targeted audit must be based on a
sampling methodology that meets the requirements for data validation audits and must not
include data from the sample used for the data validation audit in which the deficiency or data
error was identified. 13 (Note: The targeted audit is required if any errors or deficiencies are
found through the data validation audit).
5. Data Validation Execution Report (DVER) and Targeted Audits: You must execute your
2022 Data Validation and any required targeted audits prior to the submission of data for
the 2022 MIPS performance period.
 The 2022 Data Validation Execution Report that includes the results of your data
validation audit, must be submitted to CMS by May 31, 2023. 14
 The 2022 Data Validation Execution Report must include:
o Name of Qualified Registry
o Was data submitted for any of the performance categories for the 2022 MIPS
performance period?
o Overall Data Deficiency and Data Error Rate - (Number of Clinicians with a Data
Issue / Total Number of Clinicians Supported)
 The overall data error rate includes only data errors that were not
corrected before submission to CMS.
§414.1400(b)(2)(v)(A)
§414.1400(b)(2)(v)(B)
13 §414.1400(b)(2)(v)(C)
14 §414.1400(b)(2)(iv)(G)
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For each type of deficiencies or data errors discovered you must provide (1)
description and examples of the deficiency/error; (2) the percentage of clinicians
impacted by the deficiency/error and (3) when and how each deficiency/error was
corrected. Types of deficiencies or data errors include, but are not limited to, the
following:
 Errors or deficiencies related to verifying MIPS eligibility of clinicians,
groups, and virtual groups.
 Errors or deficiencies related to verifying the accuracy of TINs and NPIs.
 Errors or deficiencies related to use of 2022 MIPS measures and activities
were utilized for submission, namely
• 2022 MIPS CQMs and/or eCQMs for the quality performance
category.
• 2022 Promoting Interoperability measures and objectives for the
Promoting Interoperability performance category.
• 2022 improvement activities for the improvement activities
performance category.
 Errors or deficiencies in calculating data completeness and performance
rates (i.e., were any issues identified with how the MIPS quality measure
specifications (as applicable) were implemented in the system?)
If you are required to conduct any targeted audits for performance year 2022, the
corresponding 2022 Targeted Audit results should also be submitted to CMS by
May 31, 2023.
Your report with the results of each targeted audit must include:
 the overall deficiency or data error rate;
 the types of deficiencies or data errors discovered;
 how and when the error or deficiency was corrected; and
 the percentage of your total clinicians impacted by the data error.

Please note, late, incomplete, and/or absent submission of your Data Validation Execution
Report or the results for a required targeted audit constitutes non-compliance with program
requirements and may result in remedial action or termination of the Qualified Registry for the
current and possibly future program years of the MIPS program.
Please note: CMS will provide a sample Data Validation Execution Report template for Data
Validation and Targeted Audit results, which will be posted on the CMS Quality Payment
Program Resource Library.
6. Performance Category Feedback Reports: Qualified Registries are required to provide
performance category feedback at least four times a year, and provide specific feedback to all
clinicians, groups, virtual groups, and Alternative Payment Model (APM) Entities on how they
compare to other clinicians, groups, virtual groups, and APM Entities who have submitted data
on a given measure.
• CMS does not provide a template for the performance feedback reports.

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If a real-time feedback dashboard is available to clinicians, CMS asks that the
Qualified Registry e-mail clinicians, groups, virtual groups, and APM Entities at least
four times a year, to remind them the feedback is available.
Exceptions to this requirement may occur if the Qualified Registry does not receive the
data from their clinician until the end of the performance period, as discussed in the
Final Rule. 15

7. Attest that you understand the Qualified Registry qualification criteria and program
requirements and will meet all program requirements.

What data submission functions must a Qualified Registry perform?
Following the self-nomination process, an approved Qualified Registry should be able to
perform the following data submission functions:

1. Indicate:
 Whether the Qualified Registry is using CEHRT data source
 End-to-end electronic reporting, if applicable.
 Performance period start and end dates.
 Report data on quality measures, Promoting Interoperability objectives and measures or
improvement activities, as applicable, to the standards and requirements of the respective
performance categories.
2. Submit:
 The data and results for all supported MIPS performance categories.
 The data must include all-payer data, and not just Medicare Part B claims patients
 Results for at least six quality measures (MIPS CQMs and eCQMs), including one
outcome measure, as applicable.
 If an outcome measure is not available, use at least one other high priority measure.
 Give entire distribution of measure results by decile, if available.
 Appropriate measure and activity identifiers (IDs) for quality measures, Promoting
Interoperability measures and objectives, and improvement activities.
 Measure-level data completeness rates by TIN-NPI and/or TIN.
 Measure-level performance rates by TIN-NPI and/or TIN.
 The sampling methodology used for data validation.
 Risk-adjusted results for any risk-adjusted measures.
3. Report on the number of:
 Eligible instances (eligible patient population).
 Instances a quality action is performed (performance met).
 Instances the applicable quality action was not met (performance not met).
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§414.1400(c)(2)(ii)

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 Instances a performance exception/exclusion occurred (denominator
exceptions/numerator exclusions).
4. Verify and maintain clinician information:
 Signed verification of clinician names, contact information, services provided, costs
charged to clinicians, quality measures, or specialty-specific measure sets (if applicable).
 Business associate agreements must comply with Health Insurance Portability and
Accountability Act (HIPAA) Privacy and Security Rules (82 FR 53812).
 Business associate agreement(s) with clinicians, groups, virtual groups, or APM Entities
who provide patient-specific data.
 Obtain and keep on file signed documentation that each holder of an NPI whose data are
submitted to the Qualified Registry, has authorized the Qualified Registry to submit quality
measure results, improvement activities measure and activity results, promoting
interoperability results and numerator and denominator data or patient-specific data on
Medicare and non-Medicare beneficiaries to CMS for the purpose of MIPS participation.
This documentation should be obtained at the time the clinician or group signs up with the
Qualified Registry to submit MIPS data to the Qualified Registry and must meet the
requirements of any applicable laws, regulations, and contractual business associate
agreements. Groups participating in MIPS via a Qualified Registry may have their group’s
duly authorized representative grant permission to the Qualified Registry to submit their
data to us. If submitting as a group, each individual clinician does not need to grant their
individual permission to the Qualified Registry to submit their data to us.
 A practice administrator may give consent on behalf of a group or virtual group reporting
as a group, but not for an individual clinician reporting as an individual. If you are
submitting the individual clinician data as an individual, you must have a business
associate agreement and consent in place for each individual clinician.
 Include disclosure of MIPS quality measure results and data on Medicare and nonMedicare beneficiaries.
 Clinician consent with signed authorization to submit results and data to CMS for MIPS.
 Certification statement that all data and results submitted to CMS are true, accurate, and
complete to the best of your knowledge.
5. Comply with:
 Any CMS request to review your submitted data. For the purposes of auditing, CMS may
request any records or data retained for the purposes of MIPS for up to 6 years from the
end of the MIPS performance period.
 Requirement to attend and complete training and support sessions.
 Participation requirements (for example, and not limited to conducting data validation and
submitting required reports, performance feedback to clinicians, Qualified Registry would
be up and running by January 1 of the given performance period, etc.).
 CMS-approved secure method for data submission.

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What is the threshold for posting a Qualified Registries’ rate of data
inaccuracies? What are considered data inaccuracies?
Data inaccuracies may result in:
• Remedial action, up to and including termination.
• The Qualified Registry Posting updated for the performance period of MIPS to indicate the
Qualified Registry’s data error rate on the CMS website until the data error rate falls below
3% and to indicate that remedial action or termination has been taken against the
Qualified Registry.
CMS will further evaluate the Qualified Registry to determine if any additional inaccurate,
unusable, or otherwise compromised data has been submitted. Data inaccuracies may lead to
remedial action/termination of the Qualified Registry for future program year(s) based on CMS
discretion.
CMS will evaluate data submitted for quality measures for data completeness and accuracy.
The Qualified Registry will also certify that all the data submitted (including quality measures,
improvement activities, and Promoting Interoperability objectives and measures) are true,
accurate, and complete to the best of their knowledge.
CMS will determine error rates calculated on data submitted to CMS for clinicians, groups,
virtual groups, and APM Entities.
CMS will evaluate data inaccuracies including, but not limited to:

• TIN/NPI Issues – Incorrect TINs, Incorrect 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, Qualified Registries should correct all identified errors prior to submitting the
data to CMS. Qualified Registry acknowledgement of data discrepancies found post
submission from clinician feedback reports will be taken into consideration by CMS.

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What is the overall process to become a CMS-approved Qualified
Registry?

To become a Qualified Registry for the MIPS program under the Quality Payment Program, you
must self-nominate and successfully complete a qualification process.
The overall process includes these steps:
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The Qualified Registry completes and submits the self-nomination form and supported
measures the Quality Payment Program website for CMS consideration (82 FR 53817).
If the self-nomination form and MIPS Quality Measures are approved, a Qualified Posting
is developed for the approved Qualified Registry and include organization type, specialty,
previous participation in MIPS [(if applicable), program status (remedial action taken
against the Qualified Registry or terminated as a third party intermediary (if applicable)],
contact information, last date to accept new clients, virtual groups specialty parameters (if
applicable), the approved quality measures, reporting options supported, performance
categories supported, services offered, and costs incurred by clients. All approved
Qualified Registries are included in the Qualified Posting that is posted on the CMS
Quality Payment Program Resource Library.
Approved Qualified Registries are required to support the performance categories,
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 Qualified
Registry from future program years of MIPS. Prior to discontinuing services to any
clinician, group, virtual group, or APM Entity during a performance period, the third-party
intermediary must support the transition of such clinician, group, virtual group, or APM
Entity to an alternate third party intermediary, submitter type, or, for any measure on which
data has been collected, collection type according to a CMS approved transition plan.

The list of CMS-approved Qualified Registries that have been approved to submit data to CMS
as a Qualified Registry for the 2022 MIPS performance period will be posted in the 2022
Qualified Registry Qualified Posting on the Resource Library of the CMS Quality Payment
Program website.

When is the self-nomination period?
You can self-nominate from:

July 1 – September 1 of the year prior to the applicable performance period. For the 2022
performance period, the self-nomination period will promptly open at 10 a.m. (Eastern Time) ET
on July 1st and close at 8 p.m. ET on September 1, 2021. Self-Nominations submitted after the
deadline were not considered.

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Tips for successful self-nomination:

1. 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 website
(https://qpp.cms.gov/login) for CMS consideration.
2. Self-nomination is an annual process. If you want to qualify as a Qualified Registry for a given
MIPS performance period, you will need to self-nominate for that MIPS performance period.
Qualification and participation in a prior program year does not automatically qualify an entity
for subsequent MIPS performance periods.
A simplified self-nomination form is available to reduce the burden of self-nomination for those
existing Qualified Registries that have previously participated in MIPS and are in good
standing (i.e., CMS did not take remedial action against or terminate the Qualified Registry as
a third party intermediaries). Please note that the simplified self-nomination form must
be successfully submitted during the self-nomination period to be considered for the
given MIPS performance period.
A simplified self-nomination form is available only to existing Qualified Registries who are in
good standing. Existing Qualified Registries in good standing should contact the MIPS
QCDR/Registry Support Team (PIMMS Team) at [email protected] if
they cannot find or access the simplified self-nomination form instead of submitting a
new self-nomination form.

What information is needed to self-nominate?

You must provide the following when you self-nominate:
 Your Qualified Registry’s entity name.
 Whether you are a new applicant or previously approved Qualified Registry (approved in a
previous year of MIPS and/or Physician Quality Reporting System [PQRS]).
 MIPS performance categories you will support. Please note Qualified Registries are
required to support the quality, Promoting Interoperability, and improvement activity
performance categories. Third party intermediaries could be excepted from this
requirement if ALL of its supported clinicians, groups, virtual groups or APM Entities fall
under the reweighting policies.
 Are you supporting MIPS CQMs? Please note that the reporting of MIPS CQMs must
utilize the current measure specification for the performance period in which they will be
used and must be used as specified. Third party intermediaries are not permitted to alter
or modify measure specifications.
 Are you supporting MIPS eCQMs? Please note that the reporting of MIPS eCQM must
utilize the current measure specification for the performance period in which they will be

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used and must be used as specified. Third party intermediaries are not permitted to alter
or modify measure specifications.
Which 2022 improvement activities are you supporting?
Which 2022 Promoting Interoperability objectives and measures are you supporting?
An entity seeking to become a Qualified Registry must submit specifications for each
measure, activity, and objective that the entity intends to submit for MIPS (including the
information described in paragraphs §414.1400 (b)(3)(ii)(A) and (B) of this section) at the
time of self-nomination.
Please identify your vendor type (i.e., Collaborative, Health Information
Exchange/Regional Health Information Organization, Health IT vendor, Regional Health
Collaborative, Specialty Society, Other).
Which data collection method(s) do you utilize (i.e., claims, EHR, practice management
system, web-based tool, etc.)?
Confirm you will conduct your 2022 data validation audits and any required targeted audits
and correct any deficiencies or data errors identified through such audits prior to the
submission of data for the MIPS payment year.
Confirm you will submit reports with the results of each 2022 performance period Data
Validation audit and targeted audit by the deadline of May 31, 2023.
Which reporting options do you intend to support (i.e., clinician, group, virtual group, APM
Entity)?
Specify the Cost [(frequency (monthly, annual, per submission)] and if the Cost is per
provider/practice) and Services Included in Cost.

What may cause remedial action to be taken or termination of third
party intermediaries from the program?

CMS has the authority to impose remedial action or termination based on its determination that
a third party intermediary is non-compliant with one or more applicable criteria for approval, has
submitted a false certification or has submitted data that is inaccurate, unusable, or otherwise
compromised. 16
Qualified Registries that have remedial action taken against them will be required to submit a
corrective action plan (CAP) to address any deficiencies and detail any steps taken to prevent
the deficiencies from reoccurring within a specified time period. The third party intermediary is
required to submit a CAP by a date specified by CMS. The CAP must address the following
issues unless different or additional information is specified by CMS:
• The issues that contributed to the non-compliance.
• The impact to individual clinicians, groups, or virtual groups, regardless of whether they
are participating in the program because they are MIPS eligible, voluntary participating, or
opting in to participating in the MIPS program.

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§414.1400(f)

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• The corrective actions implemented by the third party intermediary to ensure that the noncompliance issues have been resolved and will not recur in the future.
• The detailed timeline for achieving compliance with the applicable requirements.
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 Qualified Registry Qualified Posting will be updated to reflect when remedial action has
been taken and/or termination of third party intermediaries participating as a Qualified Registry.

Resources
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CY 2021 Payment Policies under the Physician Fee Schedule - CMS provides an
overview of the major policies we finalized for the 2021 performance period in the 2021
QPP Final Rule Resources zip file, which includes a table comparing the previous policy
to the newly finalized policy and the Electronic Code of Federal Regulations.
Qualified Registry Support Calls - CMS will hold mandatory joint support calls for
Qualified Registries and QCDRs that are approved to participate in the 2022 performance
period. These support calls will be held approximately once a month, with the kick-off
meeting (in-person or virtually) being the first of the monthly calls. The support calls
address reporting requirements, steps for successful submission, and allow for a question
and answer session. The monthly support calls are limited to only approved 2022
performance period Qualified Registries. Each Qualified Registry must attend both the
webinar and audio portion via computer or phone to receive credit for attending the
support call. One representative, from an entity supporting multiple Qualified Registries,
will NOT be counted as attendance for multiple Qualified Registries.
Virtual Office Hours (VOHs) - CMS will host joint VOHs to offer QCDRs and Qualified
Registries an opportunity to ask CMS subject matter experts questions related to the
assigned topics for those calls. Please note that only topic specific questions will be
addressed during each call. All other questions will be referred to the Quality Payment
Program. Participation in the VOHs is not required but is strongly encouraged.
Quality Payment Program ListServ - The Quality Payment Program ListServ will provide
news and updates on new resources, website updates, upcoming milestones, deadlines,
CMS trainings, and webinars. To subscribe, visit the Quality Payment Program
website and select “Subscribe to Updates” at the bottom of the page or in the footer.
Quality Payment Program Website - Educational documents for Qualified Registry
participation will be available on the website to help support you in your submission
process. In addition, lists with the criteria used to audit and validate data submitted in each
of the MIPS performance categories will be available on the website.
Quality Payment Program - For additional questions related to the Quality performance
category, please contact the Quality Payment Program Service Center at
[email protected] or 1-866-288-8292 (Monday – Friday, 8 a.m. – 8 p.m. ET). To receive

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assistance more quickly, please consider calling during non-peak hours—before 10 a.m.
and after 2 p.m. ET. Customers who are hearing impaired can dial 711 to be connected to
a TRS Communications Assistant.
The Self-Nomination User Guide - This guide provides step-by-step instructions for
entities looking to become an approved Qualified Registry for the 2022 performance
period of MIPS.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of
information unless it displays a valid OMB control number. The valid OMB control number for this information
collection is 0938-1314 (Expiration date: 01/31/2022). The time required to complete this information collection
is estimated to average 2 hours per response, including the time to review instructions, search existing data
resources, gather the data needed, and complete and review the information collection. If you have comments
concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS,
7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland
21244-1850. ****CMS Disclosure**** Please do not send applications, claims, payments, medical records or
any documents containing sensitive information to the PRA Reports Clearance Office. Please note that any
correspondence not pertaining to the information collection burden approved under the associated OMB control
number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns
regarding where to submit your documents, please contact QPP at [email protected]

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