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

2020 Qualified Registry Fact Sheet

Overview

To become a Qualified Registry for the Merit-based Incentive Payment System (MIPS) under the Quality Payment Program, you must self-nominate and successfully complete a qualification process.

When is the self-nomination period?

You can self-nominate from:

July 1 – September 3 of the year prior to the applicable performance period. The Self-Nomination Period will promptly open at 10:00 am ET on July 1^st and close at 8:00 pm ET on September 3^rd. Self-Nominations submitted after the deadline will not be considered.

Tips for Successful Self-Nomination:

1. To become qualified for a given performance period, the vendor must have at least 25 participants by January 1 of the year prior to the applicable performance period. These participants do not need to use the Qualified Registry to report MIPS data to us; rather, they need to submit data to the Qualified Registry for purposes of quality improvement.

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.

3. Self-nomination is an annual process. If you want to qualify as a Qualified Registry for a given performance period, you will need to self-nominate for that performance period. Qualification and participation in a prior program year does not automatically qualify a vendor 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 (CMS did not take remedial action against or terminate the registry as a third party intermediary).

The simplified form is available only for existing Qualified Registries in good standing.

The list of vendors that have been approved to submit data to CMS as a Qualified Registry for the 2020 performance period of MIPS will be posted in the Resource Library of the CMS Quality Payment Program website.

What is a Qualified Registry?

A Qualified Registry is a vendor that collects clinical data from an individual MIPS eligible clinician, group or virtual group and submits it to CMS on their behalf. Clinicians work directly with their chosen Qualified Registry to submit data on the selected measures or specialty set of measures they have picked.

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, 2019). 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. Please note that your system must be implemented and able to accept data from a clinician, group, or virtual group should they wish to submit data on MIPS Quality Measures starting on January 1, 2020.

2. Certification Statement: During the data submission period, you must certify that data submissions are true, accurate, and complete to the best of your knowledge. This certification includes the acceptance of data exports directly from an EHR or other data sources. If you become aware that any submitted information is not true, accurate, and complete, you will correct such issues promptly prior to submission, and understand that the knowing omission, misrepresentation, or falsification of any submitted information may be punished by criminal, civil, or administrative penalties, including fines, civil damages, and/or imprisonment.

3. Data Submission: You must submit data via a CMS-specified secure method for data submission, such as a defined Quality Payment Program data format. 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.

4. Data Validation Plan: During self-nomination, you must thoroughly explain your process for validation of data submitted on behalf of individual MIPS eligible clinicians, groups, and virtual groups through the development of a Data Validation Plan. You are required to provide the following as a part of your Data Validation Plan:

• Name of Qualified Registry

• Process of verifying Quality Payment Program eligibility of MIPS eligible clinicians, groups, and virtual groups.

• Process of verifying accuracy of TIN/NPIs.

• Process of calculating reporting and performance rates.

• Process of verifying that your system will only accept data (for purposes of MIPS) on 2020 MIPS Clinical Quality Measures and/or electronic Clinical Quality Measures during submission.

• Process used for completion of randomized audit.

• Process used for completion of detailed audit.

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.

5. Data Validation Execution Report: You must execute your 2020 Data Validation Plan and provide us with the results (i.e., Results of the randomized/detailed audits? Were there any calculation issues? If so, why did they occur and what was done to remediate?). Execution of your Data Validation Plan must be completed prior to the 2020 performance period data submission period, so errors can be corrected prior to data submission.

• The 2020 Data Validation Execution Report that includes the results of your audit, must be submitted to CMS by May 31, 2021.

• The following items should be addressed in the 2020 Data Validation Execution Report:

• Name of Qualified Registry

• Results of verifying MIPS eligibility of clinicians, groups, and virtual groups (i.e. were any issues identified when determining if clinicians, groups, and virtual groups meet the MIPS eligibility requirements? If so, please provide details and examples regarding the identified issues and how they were resolved.)

• Results of verifying the accuracy of Taxpayer Identification Number (TIN)/National Provider Identifier (NPI) (i.e. were any issues identified when verifying TINs/NPIs? If so, please provide details and examples regarding the identified issues and how they were resolved).

• Results of verifying that 2020 MIPS Quality Measure specifications are utilized for submission (i.e. were any issues identified when verifying that only 2020 MIPS Quality Measures were submitted? If so, please provide details and examples regarding the identified issues and how they were resolved).

• Results of calculating data completeness and performance rates (i.e. were any issues identified with how the MIPS quality measure specifications were implemented in the system? If so, please provide details and examples regarding the identified issues and how they were resolved).

• Results of the randomized audit (i.e. were there any data issues identified? If so, please provide details and examples regarding the identified issues).

• Results of the detailed audit (i.e., provide details and examples regarding how the identified data issues were resolved (Note: The detailed audit is required if errors are found through the randomized audit).

We require Qualified Registries to utilize auditing processes to ensure the accuracy of all data submissions under all performance categories. Qualified Registries 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 Qualified Registry will be seen as non-compliance with program requirements, and may result in remedial action or termination of the Qualified Registry 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.

6. Performance Category Feedback Reports: Qualified Registries are required to provide performance categories feedback at least four times a year to all individual MIPS eligible clinicians, groups and virtual groups they are reporting for. Please note:

• CMS does not provide a template for the performance feedback reports.

• If a real-time feedback dashboard is available to clinicians, CMS asks that the Qualified Registry e-mail clinicians, groups and virtual groups, at least four times a year, to remind them the feedback is available.

What information is required to self-nominate?

You must provide the following when you self-nominate:

• What is your Qualified Registry’s Name?

• Are you a new or existing Qualified Registry (approved in a previous year of MIPS and/or Physician Quality Reporting System [PQRS])?

• Are you supporting MIPS Clinical Quality Measures? Please note that the MIPS clinical quality measure must be used as specified. Measure specification changes are not permitted.

• Are you supporting MIPS electronic Clinical Quality Measures (eCQMs)? Please note that the MIPS eCQM must be used as specified. Measure specification changes are not permitted.

• Which MIPS performance categories do you intend to support? Please note Qualified Registries are required to support the Quality performance category.

• Which Improvement Activities are you supporting?

• Are you supporting the Promoting Interoperability Objectives and Measures set?

• Which data collection method(s) do you intend to support?

• Data Validation Plan

• Confirm you will provide your 2020 performance period Data Validation Plan results by May 31, 2021 (the Data Validation Execution Report)

• Which reporting options do you intend to support (i.e., Individual MIPS eligible clinician, Group, Virtual Groups)?

• Specify the Cost (frequency (monthly, annual, per submission) and if the Cost is per provider/practice) and Services Included in Cost

What data submission functions must a Qualified Registry perform?

Following the self-nomination process, an approved Qualified Registry must 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 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 patients, as applicable.

• Results for at least six MIPS Quality Measures (claims, MIPS CQMs, eCQMs), including one outcome measure, as applicable.

• If an outcome measure is not available, use at least one other high-priority measure.

• Appropriate measure and activity 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.

• Risk-adjusted results for any risk-adjusted measures.

• The sampling methodology used for data validation.

3. Report on the number of:

• Eligible instances (the eligible patient population).

• Instances a quality service is performed (performance numerator).

• Instances the applicable quality action was not met (performance not met).

• Instances a performance exception/exclusion occurred (denominator exceptions/numerator exclusions).

4. Verify and maintain eligible clinician information:

• Signed verification of clinician names, contact information, costs charged to clinicians, services provided, MIPS Clinical Quality Measures or specialty-specific measure sets (if applicable).

• Business associate agreement(s) with clinicians, groups or virtual groups who provide patient-specific data.

• A practice administrator may give consent on behalf of a group or virtual group reporting as a group, but not for an individual MIPS eligible clinician reporting as an individual

• Business associate agreements must comply with HIPAA Privacy and Security Rules.

• Include disclosure of MIPS quality measure results and data on Medicare and non-Medicare beneficiaries.

• Signed NPI-holder 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.

• Requirement to participate in the mandatory Qualified Registry kick-off meeting and monthly support calls.

• Participation requirements (Data Validation Execution Report, performance feedback to eligible clinicians, registry must be up and running by January 1 of the given performance period, etc.).

• CMS-approved secure method for data submission.

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 Qualified Registry due to the low data quality rating.

• Will have 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 percent and that remedial action has been taken against the Qualified Registry.

Data inaccuracies affecting more than 5% of your total MIPS eligible clinicians may lead to termination of the Qualified Registry for future program years.

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, 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.

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 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.

What is the overall process to become a Qualified Registry?

The overall process includes these steps:

• The Qualified Registry completes and submits the self-nomination form, supported MIPS Quality 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, a Qualified Posting is developed for the Qualified Registry that includes 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), approved MIPS Quality Measures, 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 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 Qualified Registry from future years of MIPS.

Resources

• Qualified Registry Support Calls - CMS will hold mandatory support calls for Qualified Registries that are approved to participate in the 2020 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 2020 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 a vendor supporting multiple Qualified Registries, will NOT be counted as attendance for multiple Qualified Registries.

• 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.

• Quality Payment Program - If you have questions, the Quality Payment Program is here to help and will be able to direct you to the appropriate staff to best meet your needs. You can reach the Quality Payment Program at [email protected] or 1-866-288-8292 or 1-877-715-6222 (TTY) Monday – Friday, 8:00 AM – 8:00 PM Eastern Time.

• The Self-Nomination User Guide - This guide provides step-by-step instructions for vendors looking to become a Qualified Registry for the 2020 performance period of MIPS.

• QCDR/Registry Google Calendar - Will be used to track and highlight key milestones and activities for the annual self-nomination period.

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