Public Comment: New Status for Measure Deferrals Beyond 6 Years

Thank you for the request for feedback. 

I believe it is a reasonable approach to the unexpected challenge Battelle has to manage.  My only concern is the open-ended nature for the length in the phrase "not to exceed 8 years."  My suggestion is to set a specific length of years so that there will be consistency across all steward requests.  

Thank you.

I strongly support the new status for endorsed by extension. Given many of these stewards are healthcare organizations in a period of significant inflation of costs, I completely believe that they have had unprecedented financial struggles. Thus as long as measures meet the criteria showing benefits that a longer extension is a financially acceptable option to continue to keep measures that provide benefits to patients.

After reading, the brief and knowing so many people/organizations are being asked to do more with less staff.  I think an endorsement status - endorsed by extension - would be ok 

The proposed endorsement status changes seem needed and appropriate.  The lack of resources to provide the necessary data for maintenance appears to be a growing and concerning problem. I too have been more aware of statements by measure developers over the past year indicating their willingness but inability to have measures prepared for future E & M reviews. Given the short duration of the deferral, the scope, criteria, safeguards and oversight are reasonable and not burdensome. The attestation requirements cover essential information.  It will be important to provide guidelines for the attestation form related to relevance, adverse events and alignment with standards.  PQM also should consider including a description of planned tracking of deferrals in the proposal, including monitoring of patterns in deferral requests related to content, types of measures, and use and usability. Trends in delayed maintenance review related to specific areas of public reporting or quality reporting programs need to be monitored closely and reported to relevant organizations. 

It is not clear from the description of "Endorsed by Extension" whether the 8-year period starts when the original 5-year period expires (meaning a total of 13 years without the measure going through maintenance review) or whether the original 5-year period is included in the 8-year period. I would support the "Endorsed by Extension" if the original 5-year period is included. I would not support it if it meant that there would be a total of 13 years before a maintenance review was completed. (I suspect you do not intend a 13-year period; rewording for clarity is recommended.)

We appreciate PQM’s acknowledgement and awareness of the resource investment required to obtain and maintain endorsement. Mathematica supports Endorsed by Extension status for measures endorsed prior to October 2023. However, Mathematica seeks clarification on how changes in the measure specifications impact eligibility and status during the extension period. Mathematica also seeks clarification on the process for requesting this status.

PQM states, “Endorsed by Extension is a temporary, time-limited continuation of endorsement granted when a measure steward attests the measure remains safe and effective (with no materials changes) but cannot complete the maintenance review within 6 years.” Does this mean that a measure cannot have any “material changes” since initial endorsement to qualify for the Endorsed by Extension status? Measures are annually reviewed to align with guidelines, which may require changing the age requirement or other aspect of a measure. If a measure cannot have a “material change” as it is currently defined by PQM then the usefulness of the Endorsed by Extension may be limited as many measures may not be eligible.

PQM states, “The measure steward must complete an attestation form confirming … No material changes during the Endorsed by Extension period…” PQM states if a material change is needed, the steward may need to resubmit the measure for review prior to the end of the extension period. While this requirement aligns with PQM’s current early maintenance review process, this policy may result in a tension between changes needed for use and the endorsement status. Mathematica notes that measures are reviewed annually for alignment with guidelines and refinements based on feedback from measured entities to improve feasibility, reliability, and usability. In this scenario, the measure steward will likely still have the resource constraints originally present and accepted by the Endorsement by Extension and be unable to bring the measure back for early maintenance review. 

Lastly, Mathematica seeks clarification on the process. PQM states the steward should submit the request at least 1 month prior to the scheduled maintenance cycle. Is this the original maintenance cycle, the once deferred cycle, or the twice deferred cycle? For example, if a measure is due for Spring 2025, would the measure steward first email and request a deferment to Spring 2026? And then, a month before the start of the Spring 2026 cycle, would the measure steward email to request Endorsement by Extension? 

Mathematica applauds PQM’s recognition of the situation and supports this initiative, especially once additional information regarding material change is provided. 

I am against this “Endorsed by Extension” status due to the following concerns/confusions:

1. How is the term “resource constraints” defined? Why is it assumed that some measure developers (MD) have resource constraints, but others do not? Rather, it is best to assume that every developer has resource constraints; just because some developers deliver on time does not mean that they didn’t have constraints. When a measure developer takes up a contract to support and maintain a measure, it is their responsibility to assign/reserve sufficient resources and to develop contingency plans. 

2. The criteria that Battelle/PQM would apply in assessing and approving "endorsed by extension" status are unclear. What would be classified as a true resource constraint versus just deprioritizing the endorsement task, relative to other tasks that require similar resources? It seems quite likely that once any eligible measure developer receives such an extension, all the rest will request it (and will be entitled to it, based on fairness principles). 

3. Generally, federal measure maintenance contracts are in 5 year-cycles, and maintenance of endorsement should align with this term. Otherwise, contracted measure developers will be incentivized to dump E&M work on a different (subsequent) contractor, and some developers will maintain a measure less carefully knowing that they will not need to publicly defend how they maintained it.  

4. Data will change dramatically between endorsement cycles and cause huge burdens on measure developers who must get a measure through endorsement after a long time period with limited maintenance.

5. Given that measure developers must affirm that the measure remains relevant to an existing or ongoing health care gap/priority, with no reported adverse health outcomes and full alignment with current professional standards, it is unclear why they cannot take it to the finish line and have it re-endorsed? The proposed affirmation also requires significant effort by the measure developer.

The proposed new status of "Endorsed by Extension" will potentially apply to any and all measures that were endorsed prior to the Fall 2023 cycle (i.e., the start of the Battelle E&M process) and exhaust the allotted two consecutive cycle deferral. It is unclear how Battelle/PQM will distinguish between real "resource constraints" beyond the control of the developer and other scenarios such as poor planning, incorrect prioritization, underbudgeting, staff turnover, etc. Absent specific criteria for "extraordinary resource constraints," decisions are likely to be made in an arbitrary and non-reproducible manner. Battelle/PQM will have difficulty denying any properly documented request for endorsement by extension, which will end up shifting the entire timeline for these measures to 2028 (or later).

To avoid these issues, and to keep pressure on measure developers to work aggressively toward maintenance of endorsement at the earliest opportunity, it would be preferable to SUSPEND endorsement pending resubmission to the E&M process. SUSPENDED endorsement would make it clear that PQM is anticipating resubmission within 1-2 years and is not (yet) recommending removal of the measure from federal programs, while reinforcing that the measure has not been maintained in a timely and thorough manner. Suspension of endorsement would NOT be equivalent to removal of endorsement, but this status would be limited to 1-2 years.

Finally, I note an implied criticism of the previous CBE in this paragraph: "Measure endorsed after October 2023, are not eligible for an extension beyond 6 years, as they have received very specific feedback on their measures and are notified annually of when their measure is up for a maintenance review. This practice allows developers and stewards ample time to assign resources as needed for this process." In fact, the previous CBE also notified developers when their measures were up for maintenance review, and also offered web-based tools (e.g., QPS) to help developers anticipate the next endorsement cycle. Developers whose measures were last endorsed before October 2023 may have hoped for delays due to the CBE contract change, but they cannot argue that they were unaware of the endorsement end date. Such implied criticism of the previous CBE's communication activities may not be appropriate here.

Thank you for your consideration of these comments and suggestions.

I am against this “Endorsed by Extension” status due to the following concerns/confusions:

1. How is the term “resource constraints” being defined and why is it being assumed that some/all measure developers (MD) do not have resource constraints? Rather, it is best to assume that every MD has resource constraints for new and maintenance measures. Just because some MDs deliver on time does not mean that they didn’t have constraints. I think that when you take up these contracts, it is your responsibility to fulfil them and therefore, assign/reserve enough resources and have contingency plans. I do not understand the rationale of taking a project and then saying that you do not have time for it.
2. Who reviews/approves that it was a true resource constraint? What would be considered as true vs. the MD not thinking it “important enough to waste time on it, hence, take away resources from the measure”? Why should other MDs be motivated if some MDs get away with such excuses and get Endorsed by Extension status?
3. The phrase “not to exceed 8 years” is still confusing.
4. If MD have proven that they have resource constraints now, what proof do they have that would make you believe that they wouldn’t have the same constraints by the time the measure is up for endorsement review? If they couldn’t accurately predict/forecast for the current cycle, why the trust on future predictions?
5. Generally, the CMS contracts are in 5 year-cycles, and I prefer the measure to align with this term. Else, a lot of maintenance measures will be dumped on a different contractor. Not to mention, that since the current contractor will not be bound of the expectations of having it endorsed (such as by having strong reliability, etc.) , it may do things that break the measure.
6. In fact, every MD would be tempted to just do new measure development and endorsement because the measure might get endorsed with a some leniency as it was the first cycle. Then if MDs do not update it given that the 1st round was still not totally acceptable, then they can play the resource constraints card. Then all the recommendations for improvement in the 1st cycle would never be taken seriously by the MD.
7. Data will change dramatically between endorsement cycles and cause huge burdens on contractors who must get it through endorsement after a long time period.
8. Given that MDs must prove that measure remains safe, which means that they should study/test it on the data to prove it, then why can’t they take it to the finish line and have it endorsed? I am confused how one part of this can be done but rest of it is a “resource constraints” issue.

Thank you for your consideration.
 

We appreciate Battelle’s new “Endorsed by Extension” proposal to address resource challenges that developers have been experiencing.  We offer the following feedback on the proposal:

• No material changes: To qualify under the new Endorsed by Extension status, measures would not be permitted to have had “material” changes.  We note, however, that measure developers are at the same time trying to be responsive to CBE Advisory/Recommendation Group feedback, and addressing this feedback with measure changes may make measures ineligible for the new status.  We understand the reasons for this criterion however it conflicts with the goals of the measurement lifecycle. The text in the body of the proposal document could stand as is (it makes no mention of material changes):  “A maintenance measure may receive this status contingent upon a formal attestation that the measure remains relevant, has not been associated with reported unintended consequences or adverse outcomes for patients, and continues to align with current professional standards.”  We feel that these criteria in the cited text are adequate for the “Endorsed by Extension” policy and encourage Battelle to drop the requirement for lack of “material” changes but add a requirement for a description of changes and how the changes have impacted the measure.

   

• Measures must be endorsed prior to October 2023:   According to Battelle’s proposal, measures must have been endorsed prior to October 2023 to qualify for the new status.  Battelle states that “as they have received very specific feedback on their measures and are notified annually of when their measure is up for a maintenance review. This practice allows developers and stewards ample time to assign resources as needed for this process.”  We note that there are likely many reasons underlying developers’ challenges in meeting re-endorsement deadlines. In some cases, the challenges are purely the lack of available funding to support measures going through the resource-intensive endorsement process rather than a matter of having “ample time.”  We encourage Battelle to drop the requirement for the measure to have been endorsed prior to October 2023.

Finally, while we appreciate Battelle’s efforts to address developer challenges, we request that Battelle continue to be flexible with developers in scheduling measures for endorsement maintenance.  As noted above, developers may have different (and multiple) challenges that may not be addressed by this new endorsement status. In addition, Battelle itself has come under its own resource constraints and has asked developers to move measures to later dates, which can have downstream impacts on developers’ work and budgets. We would appreciate the continued flexibility by Battelle in working with developers individually to address scheduling and resource issues as they come to light and request that developers not be restricted to the proposed Endorsed by Extension option.

Thank you for your consideration of these comments and suggestions.

Upon review, I am in full formal support of this proposal's intent and agree that it appropriately acknowledges resource constraints increasingly faced by both measure developers and stewards. This includes backed measures prior to October 2023. By allowing a limited, time bound continuation of endorsement it prevents unnecessary disruption in measure use, administrative weight of resubmitting "new" measures and supports continuity for stakeholders that rely on formal, high-quality measures. Supported elements of the proposal include constricting eligibility to endorsed measures prior to October 2023 because it exemplifies process expectation differences and notice provided to stewards. Requirement of formal attestation that measures remain safe and concurrent with professional standards. Then establishment of a clear maximum duration, no more than eight years since last maintenance review. This would help maintain endorsement credibility and efficacy. In order to better strengthen this proposal I offer the considerations including extension period oversight, measure user transparency compliance, clear clarification of transition expectations, and approval criteria clarity and consistency in accordance with extension request demand. Overall, I believe the proposed Endorsed by Extension status is reasonable and balanced to the described challenges and has potential to maintain continuity and confidence in the endorsement process.

The Dental Quality Alliance (DQA) appreciates the opportunity to comment on Battelle’s proposal to establish an “Endorsed by Extension” status within the Endorsement and Maintenance (E&M) process.

The DQA strongly supports this proposal. As a measure developer and steward of multiple nationally endorsed oral healthcare quality measures, the DQA has direct experience with the resource demands associated with maintaining endorsement. These demands include evidence review, testing, documentation, stakeholder engagement, and coordination across multiple partners and data sources. While these activities are essential to maintaining measure integrity, they are also resource intensive and often compete with new measure development, measure implementation support, and emerging national priorities.

We recognize that the current 5-year maintenance period, even with the option for two deferral cycles, does not always reflect the operational realities faced by measure stewards. In particular, measures that remain clinically relevant, widely-implemented, and aligned with current professional standards may nonetheless be at risk of losing endorsement due solely to temporary resource limitations rather than any issue with measure performance, safety, or validity.

The proposed “Endorsed by Extension” status appropriately addresses this gap. The requirement for formal attestation that the measure remains relevant, has not resulted in adverse outcomes, aligns with professional standards, and has not undergone material change provides important safeguards to preserve the integrity of the endorsement process while preventing unnecessary disruption in measure use.

From the DQA perspective, loss of endorsement for measures that remain actively used in Medicaid, CHIP, and other quality reporting programs can create unintended consequences. These include confusion among implementers, additional administrative burden to resubmit measures as “new,” and potential disruption to longitudinal measurement efforts at the state and national levels.

We believe the proposed eligibility criteria, time limitation, and oversight mechanisms strike an appropriate balance between flexibility for stewards and accountability to the endorsement process.

For these reasons, the DQA supports the implementation of the “Endorsed by Extension” designation as outlined in the proposal and believes it will help preserve continuity for high-quality measures during periods of documented resource constraints while maintaining the credibility of the endorsement program.

Thank you for the opportunity to provide comment on this important proposal.

Dear Partnership for Quality Measure (PQM) Staff, 

On behalf of the more than 37,000,000 Americans living with kidney diseases and the nearly 22,000 nephrologists, scientists, and other kidney health care professionals who are members of the American Society of Nephrology (ASN), we take seriously the opportunity to provide comments in response to Batelle’s “New Status for Measure Deferrals Beyond 6 Years” public comment period. 

ASN expresses deep concern regarding the Partnership for Quality Measurement (PQM)’s proposed “Endorsed by Extension” status. This temporary designation would bypass the current system and allow currently endorsed measures that cannot undergo scheduled maintenance review due to presumed resource constraints to retain endorsement for up to eight years from their most recent review. ASN strongly believes that this proposal threatens the validity of the measure endorsement process because it delays stakeholder input and public comment for an additional two years. This puts patients at risk.

ASN Opposes the Partnership for Quality Measurement’s “New Status for Measure Deferrals Beyond 6 Years” Proposal 

ASN believes that Battelle’s proposal contradicts the intent of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, Public Law 110-275). MIPPA requires Consensus-Based Entities (CBEs) to “establish and implement a process to ensure that measures are endorsed are updated (or retired if obsolete) as new evidence is developed.”[i] By extending the endorsement period and postponing scheduled review, Battelle’s proposal directly conflicts with this statutory mandate.

Given the rapid pace of medical innovation and the frequent evolution of clinical standards, stakeholders must review and update quality measures on a regular basis. Independent third-party review remains essential to minimize conflicts of interest and preserve the objectivity, credibility, and trustworthiness of the endorsement process. Battelle’s proposed deferral policy weakens these safeguards by allowing measures to retain endorsement status for up to eight years without undergoing the standard review and public comment processes. This delay would slow the identification and removal of outdated or obsolete measures, place patients and clinicians at risk, and undermine the integrity of the endorsement framework.

ASN Underscores the Importance of Robust and Transparent Quality Measurement in Kidney Care

Currently, more than 800,000 Americans have kidney failure, including more than 550,000 receiving chronic dialysis and more than 200,000 living with a kidney transplant. Individuals with ESRD have substantial and permanent loss of kidney function and require either a regular course of dialysis or a kidney transplant to survive. In 1972, Congress enacted legislation allowing qualified individuals with ESRD under the age of 65 to enroll in the Medicare program. It is estimated that Medicare now covers 80% of patients with dialysis. 

The ESRD Quality Incentive Program (QIP) was the first mandatory federal pay for performance program. Launched on January 1, 2012, the QIP links 2% of the payment that a dialysis facility receives for Medicare patients on dialysis to the facility’s performance on quality of care measures. Quality measures are evaluated annually for inclusion on the basis of importance, validity, and performance gap. Critically, these quality measures drive care delivery and resource allocation, and therefore are highly impactful for patients

The Social Security Act requires QIP measures to be endorsed, unless the Secretary determines that no feasible and practical endorsed measure exists for a specified area or medical topic, in which case the Secretary may specify an alternative measure after considering measures endorsed or adopted by a recognized consensus organization. MIPPA strengthened this requirement by expecting the consensus-based entity responsible for measure maintenance to uphold its role and to maintain an ongoing process for updating measures. Section 1881(h) of the Social Security Act explicitly requires the Secretary to establish a process for updating measures in consultation with interested parties, reinforcing the need for continuous review and public engagement[ii].

Under the new proposal, two ESRD QIP measures would be eligible for the proposed endorsement status: the Standard Readmission Ratio (SRR) and the Percentage of Prevalent Patients Waitlisted (PPPW). We are concerned that this approach would prevent nephrologists and other clinical experts from reviewing and providing ongoing input on these measures. Given anticipated shifts in payer mix, the expansion of mandatory and voluntary value-based care models, and changes to provider reimbursement nationwide over the next several years, ongoing review of measure specifications is essential. Without continued oversight, there is a risk of unintended consequences related to readmissions and transplant waitlisting that could negatively affect patient care.

Conclusion

ASN urges Battelle and PQM to maintain the existing review and public comment process. Extending the endorsement period would reduce transparency, weaken stakeholder participation, and risk allowing outdated measures to influence patient care and reimbursement. To discuss this letter further, please contact Lauren Ahearn, ASN Policy and Government and Affairs Coordinator, at [email protected]. 

Thank you, 

Tod Ibrahim

ASN Chief Executive Officer and Executive Vice President
 

[i] https://www.govinfo.gov/content/pkg/PLAW-110publ275/pdf/PLAW-110publ275…

[ii] https://www.ssa.gov/OP_Home/ssact/title18/1881.htm

NCQA supports the new Endorsed by Extension status and requests the following clarifications:

1. Battelle states an attestation form confirming several criteria for this status will be required. What evidence is expected of the developer to meet the six criteria listed under Attestation. Will an organization’s self report suffice?  
2. NCQA typically adjusts or modifies measures for various program or user intent. The proposed criteria for "no material changes" would not create the flexibility for measure developers to delay re-endorsement. Typically, the minor measure changes for a program are not as resource intensive as the re-endorsement process.
3. Battelle states that the status would last up to but not exceed 8 years. What is the criteria for determining the length of time? It is not clear how Battelle plans to systematically approach the length of the extension granted to ensure that is fair and in a reproducible manner.

Thank you for soliciting comments on the suggested “Endorsed by Extension” status. We appreciate PQM’s awareness of the resource constraints and the acknowledgement of the investment needed for the endorsement process. 

HSRI supports the addition of the new status. 

HSRI offers the following suggestions:

1. HSRI recommends PQM provide more specificity regarding what constitutes a “material change,” e.g., an updated risk adjustment model, revised survey item wording, modifications to the eligible population or exclusion criteria, etc., to ensure consistent interpretation across attestations.
2. HSRI suggests PQM consider the dates of the data used for testing in the previous endorsement/maintenance cycle when determining which measures are appropriate for “endorsed by extension” status. Data recency is a potentially important consideration in the continuing reliability and validity of a measure. Data recency could also inform the duration of the extension. 
3. HSRI recommends making this new status available to all measures regardless of resource constraints. Defining and enforcing a “resource constraints” threshold could be challenging and burdensome for both stewards and PQM. It is also not necessary, if the implication of the proposed “Endorsed by Extension” status is that the endorsement can be postponed without negative outcomes. 

Again, thank you for considering this new status and for soliciting public feedback.