2021 Qualified Clinical Data Registry (QCDR) and Qualified Registry Participation Requirements - June 18, 2020 - AWS
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Quality Payment Program
2021 Qualified Clinical
Data Registry (QCDR)
and Qualified Registry
Participation
Requirements
June 18, 2020
Disclaimer
This presentation was prepared as a tool to assist providers and is not intended
to grant rights or impose obligations. Althoughevery reasonable effort has been
made to assure the accuracy of the information within these pages, the
ultimate responsibility for the correct submission of claims and response to
any remittance advice lies with the provider of services.
This publication is a general summary that explains certain aspects of the
Medicare Program, but is not a legal document. The official Medicare
Program provisions are contained in the relevant laws, regulations, and
rulings. Medicare policy changes frequently, and linksto the source documents
have been provided within the document for yourreference.
The Centers for Medicare & Medicaid Services (CMS) employees,agents, and
staff make no representation, warranty, or guarantee that this compilation of
Medicare information is error-free and will bear no responsibility or liability for
the results or consequences of the use of this presentation.
2
Agenda
• Self-Nomination Information
• Self-Nomination Demonstration
• QCDR Measure Submission Template Information
• QCDR Measure Submission Template Demonstration
• Resources & Who to Call for Help
• Questions & Answer Session
3
SELF-NOMINATION
INFORMATION
Hector Cariello, MIPS QCDR/Registry
Support Team
(PIMMS Team)
4
Qualified Clinical Data Registry (QCDR)
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 clinicians to track patients and diseases
and foster improvement in the quality of care provided to patients.
‒ 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 clinician for the purpose of patient
and disease tracking to foster improvement in the
quality of care provided to patients.
• Clinicians work directly with their chosen registry to submit data on
the 2021 MIPS Quality measures or specialty set of measures they
have picked.
• QCDRs may also support up to 30 QCDR measures. 5
Qualified Clinical Data Registry (QCDR)
What is 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.
‒ 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.
6
Qualified Registry
What is a Qualified Registry?
• A Qualified Registry is an entity
that collects clinical data from
an individual clinician, group or
virtual group and submits it to
CMS for them. Clinicians work
directly with their chosen
registry to submit data on the
2021 MIPS Quality measures or
specialty set of measures they
have picked.
• Qualified Registries may NOT
support QCDR measures.
7
QCDR & Qualified Registry
Participation Requirements
• When self-nominating to act as a QCDR or Qualified Registry,
organizations attest to meeting all requirements set forth by the CY
2020 Physician Fee Schedule (PFS) Final Rule for the Quality Payment
Program, which finalized the vendor requirements for the 2021 MIPS
performance period.
• All CMS-approved QCDRs and Qualified Registries for the 2021 MIPS
performance period are requiredto provideservicesfor the entire
performanceyear and applicable submissionperiod.
‒ In the event a QCDR or Qualified Registry must discontinueservices, they must
notify CMS and support thetransitiontoan alternate submission methodor third-
partyintermediary.
• All CMS-approved QCDRs and Qualified Registries for the 2021 MIPS
performance period are required to support the performance
categories, measures, activities and services listed on the CMS
published Qualified Posting as a condition of their participation in the
MIPS performance period.
8
QCDR & Qualified Registry
Participants, System Implementation and Performance Categories
• Participants: QCDRs or Qualified Registries must have at least 25
participants actively participating within the QCDR or Qualified
Registry by January 1, 2020. The participants are not required to use
the QCDR or Qualified Registry to report data to CMS, but they must
be submitting data to the QCDR or Qualified Registry for quality
improvement purposes.
• System Implementation: QCDRs and Qualified Registries must
implement and be able to accept data from a clinician, group or virtual
group should they wish to submit data on MIPS Quality Measures
and/or QCDR measures (QCDRs only) starting on January 1, 2021.
• Performance Categories: QCDRs and QualifiedRegistriesare requiredto
support the reporting of measuresand activities in the:
‒ Quality;
‒ Improvement Activities;and
‒ Promoting Interoperabilityperformancecategories.
9
QCDR & Qualified Registry
All Payer Data, Data Submission and Feedback Reports
• All Payer Data: QCDRs and Qualified Registries must include quality measure
results and data on Medicare and non-Medicare beneficiaries, as applicable.
• Data Submission: QCDRs and Qualified Registries 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.
• Feedback Reports: QCDRs and Qualified Registries must provide performance
category feedback at least four times a year to all supported clinicians, groups
and virtual groups. If unable to submit feedback 4 times a year, the QCDR or
Qualified Registry must notify CMS immediately.
‒ Performance feedback must include informationon howparticipantscompare to
other clinicians within the Qualified Registry or QCDR cohort who have submitted
dataon a given measure (MIPS quality measure and/or QCDR measure).
‒ If a dashboard is available to clinicians with real-time feedback, CMS asks that the
QCDR or Qualified Registry email the clinicians at least four times per year to
advise that feedback is available.
10QCDR & Qualified Registry
Data Requests and Certification Statements
• Data Requests: QCDRs and Qualified Registries must comply with any
CMS request to review your submitted data:
‒ QCDRs and Qualified Registries must have the ability to randomly request and
receive documentation from clinicians to verify accuracy of data.
‒ QCDRs and Qualified Registries must provide CMS access to review the Medicare
beneficiary data on which 2021 MIPS submissions are based or provide to CMS a
copy of the actual data (if requested for validation purposes).
• Certification Statement: QCDRs and Qualified Registries must certify
that data submissions are true, accurate, and complete to the best of
their 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, or
refrain from submitting it, 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.
11QCDR & Qualified Registry
Business Associate Agreements and Clinician Consent
• Business Associate Agreement (BAA): QCDRs and Qualified Registries must enter
into and maintain with all clients an appropriate business agreement or contract
that dictates the services offered to the client by the QCDR or Qualified Registry.
The agreement must comply with HIPAA Privacy and Security Rules.
‒ Electronic or written agreements are acceptable to CMS providing that electronic
signatures/authorization are legal in your jurisdiction.
• Clinician Consent: QCDRs and Qualified Registries must obtain signed
documentation to indicate each client has authorized the QCDR or Qualified
Registry to submit their quality measure data to CMS for the purpose of MIPS
participation.
‒ Signed verification of clinician names, contact information, costs charged to clinicians,
services provided, and quality measures (MIPS quality measures and/or QCDR measures)
or specialty-specific measure sets (if applicable) should also be included.
‒ 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.
‒ This process needs to comply with the requirements of the BAA to ensure that it provides
for your receipt of patient specific data from an individual clinician, group or virtual group,
as well as the QCDR’s or Qualified Registry’s disclosure of quality measure results and
numerator and denominator data and/or patient-specific data on Medicare and non-
Medicare beneficiaries on behalf of clinicians, groups or virtual groups.
12QCDR & Qualified Registry
Access to CMS Systems
• CMS policy prohibits non-U.S. citizens from accessing CMS IT systems, and also
requires all CMS program data to be retained in accordance with U.S. Federal
policy, specifically National Institute of Standards and Technology (NIST)
Special Publication (SP) 800–63, which outlines enrollment and identity
proofing requirements (levels of assurance) for federal IT system access.
Access to the Quality Payment Program would necessitate passing a remote or
in-person Federated Identity Proofing process (that is, Equifax or equivalent). A
non-U.S. based third party intermediary’s potential lack of a SSN, TIN, U.S.
based address, and other elements required for identity proofing and identity
verification would impact their ability to pass the necessary background
checks.
• An inability to pass identity proofing may limit or fully deny access to the
Quality Payment Program if the intent is to interact with the Quality Payment
Program outside of the U.S. for the purposes of reporting and storing data.
The CY 2019 PFS Final Rule for the Quality Payment Program amended this
requirement to indicate that a third-party intermediary’s principle place of
business and retention of associated CMS data must be within the U.S.
13QCDR & Qualified Registry
Data Validation Plan
• During Self-Nomination, QCDRs and Qualified Registries are
required to submit a Data Validation Plan (DVP) that thoroughly
explains the process for validation of the data that will be
submitted on behalf of individual MIPS clinicians, groups and
virtual groups. The DVP must have included:
‒ Process of verifying Quality Payment Program eligibility of clinicians,
groups, and virtual groups as QCDRs and Qualified Registries are required
to identify their clinicians as eligible reporters, opt-in reporters or
voluntary reporters.
‒ Process of verifying accuracy of Tax Identification Numbers (TINs) /
National Provider Identifier (NPIs).
‒ Process of calculating reporting and performance rates.
14QCDR & Qualified Registry
Data Validation Plan
• Process of verifying that your system will only accept data (for purposes of
MIPS) on 2021 measures and activities during submission.
̶ 2021 MIPS Clinical Quality Measures (CQMs), electronic Clinical Quality Measures
(eCQMs) and/or QCDR measures for the Quality performance categories.
̶ 2021 Promoting Interoperability measures and objectives for the Promoting
Interoperability performance categories.
̶ 2021 Improvement Activities for the Improvement Activities performance
categories
• Process used for completion of randomized audit for the Quality, Promoting
Interoperability, and/or Improvement Activities performance categories. At
a minimum must meet the following sampling methodology to meet
participation requirements: Sample 3% of the TIN/NPIs submitted to CMS,
with a minimum of 10 TIN/NPIs or a maximum sample of 50 TIN/NPIs. At
least 25% of the TIN/NPI’s patients (with a minimum sample of 5 patients
or a maximum sample of 50 patients) should be reviewed for all measures
applicable to the patient).
• Process used for completion of detailed audit for the Quality, Promoting
Interoperability, and/or Improvement Activities performance categories.
(Note: The detailed audit is required if any errors are found through the
randomized audit). 15QCDR & Qualified Registry
Data Validation Execution Report
• The QCDRs and Qualified Registries approved for the 2021 MIPS performance period
must execute their 2021 DVP and provide the results to CMS by 5:00 PM ET on May
31, 2022 within a Data Validation Execution Report (DVER).
• As described in the PFS Final Rule for the Quality Payment Program, QCDRs and
Qualified Registries must conduct the execution of their DVP prior to submitting the
data to CMS for all performance categories supported to ensure that any identified
issues or data errors can be corrected prior to data submission to CMS.
‒ Overall data error rate based on all the identified data errors found during validation that
were not corrected prior to data submission to CMS
‒ Number of clinicians, groups and/or virtual groups supported
‒ Results of verifying accuracy of TIN/NPIs
‒ Results of verifying MIPS eligibility of MIPS clinicians, groups, and virtual groups
‒ Results of verifying the calculation of the reporting and performance rates
‒ Results of verifying 2021 MIPS Clinical Quality Measures, electronic Clinical Quality
Measures and/or QCDR measures (as applicable) for the performance period
‒ Results of randomized audit
‒ Results of detailed audit, if applicable
• Additional information related to the DVER will be conveyed to the QCDRs and
Qualified Registries approved for the 2021 MIPS performance period. 16QCDR & Qualified Registry
Data Inaccuracies
• CMS will evaluate the data submitted by QCDRs and Qualified Registries for completeness and
accuracy, in addition to the information submitted within the 2021 DVER. If inaccurate,
incomplete or false data is found, CMS may also require remedial action, up to and including
termination, from a QCDR or Qualified Registry for the current performance year and/or the
subsequent performance year, as applicable.
- CMS will further evaluate the QCDRs and Qualified Registries if any inaccurate, unusable or otherwise
compromised data affects clinicians, groups or virtual groups for which the data was submitted by the
third-party intermediary.
• CMS may 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 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, Not updating and resubmitting 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.
17QCDR & Qualified Registry
Remedial Action and Termination
• The CY 2020 PFS Final Rule for Quality Payment Program provides CMS the ability to
enforce remedial action or termination based on its determination that a third-party
intermediary was non-compliant with any applicable criteria or if the third-party
intermediary submitted data that are inaccurate, unusable or otherwise compromised.
‒ Non-compliance with the timeline and/or late, incomplete, or absent deliverables may lead
to remedial action, up to and including termination, as a third-party intermediary for the
current and/or future performance periods.
• QCDRs and Qualified Registries requiring remedial action will be required to submit a
corrective action plan to address any deficiencies and detail any steps taken to prevent
them from reoccurring. The corrective action must include the following:
‒ The issues that contributed to the non-compliance.
‒ The impact to the individual clinicians, groups and virtual groups.
‒ The corrective action implemented by the vendor to ensure that the non-compliance issues
have been resolved and will not be repeated in the future.
‒ The timeline from the issue identification to resolution.
‒ The resolution follow-up plan to communicate the final resolution and plan to monitor for
future issues.
18QCDR & Qualified Registry
Remedial Action and Termination
• The Qualified Posting will be updated to reflect when remedial action is
required, or a vendor has been terminated. The table below shows an example
of an updated Qualified Posting following remedial action and termination.
QCDR Name Remedial Action/Terminated Contact Website Cost
as Third-Party Intermediary Information
ABC QCDR **CMS has taken ABC QCDR ABC QCDR Annual
Remedial Action Contact Website subscription of
against this QCDR for Information up to $500 per
2021** clinician
XYZ QCDR **Terminated: No XYZ QCDR XYZ QCDR Annual
longer a 2021 QCDR Contact Website subscription of
Vendor** Information up to $500 per
clinician
• Failure to comply with the remedial action process may lead to the
termination for the current and/or subsequent performance periods.
19QCDR & Qualified Registry
Support Call Attendance
• As communicated in the CY 2020 PFS Final
Rule for the Quality Payment Program and
2021 QCDR and Qualified Registry Fact
Sheet, Support Call attendance is mandatory.
Failure to attend mandatory calls will result
in remedial action, up to and including
termination, being taken against the QCDR
or Qualified Registry.
‒ Remedial action and/or termination as a
third-party intermediary may carry over to
future MIPS performance periods.
• Each QCDR and Qualified Registry must have at least one representative in
attendance on every Support Call. One attendee may count for one QCDR
and one Qualified Registry if an organization operates under each vendor
type. One attendee will NOT count for multiple QCDRs or multiple Qualified
Registries.
20QCDR & Qualified Registry
Virtual Office Hours
• CMS will host Virtual Office Hours
(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 Virtual Office Hour
sessions is not required but is strongly
encouraged.
21SELF-NOMINATION
DEMONSTRATION
Anastasia Robben, MIPS QCDR/Registry
Support Team
(PIMMS Team)
22QCDR MEASURE
SUBMISSION TEMPLATE
INFORMATION
Marla Throckmorton, MIPS
QCDR/Registry Support Team
(PIMMS Team)
23QCDR Only
QCDR Measure Submission Template
QCDRs submitting QCDR measures will need to
submit their QCDR measures for consideration using
the 2021 QCDR Measure Submission Template.
The following suggestions should be considered prior
to submitting your QCDR measure submission template.
• Documentation of permission to use another active QCDR’s measure must be
obtained prior to submission of your QCDR measure submission template containing
the QCDR measure or if included without permission, the QCDR measure status must
show to be a “work in progress” and not “Ready for PIMMS review” until
documentation of permission is obtained.
• Only limited information is required in the template for a “borrowed” QCDR
measure. (See QCDR measure submission template instructions.) The final QCDR
measure owner specifications will be inserted by the QCDR/Registry Support Team
(PIMMS Team).
• Previously approved QCDR measures can be withdrawn from consideration by
updating the QCDR measure status to “Withdrawn”.
24QCDR Only
QCDR Measure Submission Template
• Pre-populated templates will contain blanks for columns new to the 2021
template
• Opportunity to fix any errors, encourage internal Quality Assurance as you
review your QCDR measures
• Verify that standardized language (drop-down selections) were used in the
appropriate columns
• If a QCDR measure has a change that does not impact the intent of the
measure, it is still important to note that change to aid in review
• Verify that the meaningful measure area selected meets the intent of that
area as applied to your QCDR measure
• Verify that measure analytics can be correctly applied to the QCDR measure
• “QCDR Notes” column to be used to communicate any pertinent information
you feel did not have another place to document. (e.g. notes about
harmonization efforts)
• Perform spelling and grammar checks and correct identified items
252021 QCDR MEASURE
SUBMISSION TEMPLATE
DEMONSTRATION
Marla Throckmorton, MIPS
QCDR/Registry Support Team
(PIMMS Team)
26RESOURCES & WHO TO CALL
FOR HELP
Hector Cariello, MIPS QCDR/Registry
Support Team
(PIMMS Team)
27Resources
Key Websites
• Quality Payment Program Website
• QPP Participation Status Look-up Tool
• MIPS Explore Measures Tool
• QPP Resource Library
• QPP Webinar Library
• QPP Help and Support Page
• QPP Listserv – available on the Quality
Payment Program website
28Resources
Who to Call for Help?
• For Quality Payment Program support, contact the Quality Payment
Program at QPP@cms.hhs.gov or 1-866-288-8292 (Monday-Friday
8AM-8PM ET). TTY users can call 1-877-715-6222.
‒ Emails must be sent directly, not forwarded or
Cc’ed, and must utilize the Quality Payment
Program e-mail address (qpp@cms.hhs.gov) in
the “To” line. Inquiries forwarded to
qpp@cms.hhs.gov or sent via e-mail with
qpp@cms.hhs.gov in the “Cc” line will not
trigger the creation of a case number for your
inquiry.
‒ To ensure that inquiries are routed to the
appropriate subject matter experts, all inquiries
must be submitted through the Quality Payment
Program and NOT the QCDR or Qualified
Registry Vendor Support mailbox.
29Technical Assistance
Available Resources
Learn more about technical assistance: https://qpp.cms.gov/about/help-and-support#technical-assistance
30Help us improve the
Quality Payment Program experience!
We’re looking for participants to collaborate with us and provide feedback related to
qpp.cms.gov, including the following topics:
• Educational Materials • Reporting
• Website Content • Eligibility
• Website Design • Performance Feedback
The QPP Research Teams invite you to participate in our
Human-Centered Design efforts.
Our research sessions range from 30-60 minutes and you can join by phone or
webinar.
Interested in participating?
Email your name, title, topic of interest, and organization to:
QPPUserResearch@cms.hhs.gov
31Q&A
32Q&A
To ask a question, raise your hand and we will unmute
your line, or submit via the Questions box.
For those dialed in via phone, you must have your audio pin entered. If you’re
listening through your computer speakers and want to ask a question, you
must have a working microphone.
Speakers will discuss as many as time allows.
3334
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