The Advent of Voluntary and Mandatory Patient-Reported Outcome (PRO) Collection for Total Hip and Knee Arthroplasty (THA/TKA).
Centers for Medicare & Medicaid Services (CMS) continues to seek out means of reducing variation in clinical practice and outcomes across hospitals to improve and standardize procedural outcomes and reduce cost burdens stemming from clinical practice variation, complications, and readmissions, among other criteria. In its FY2023 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule, CMS made updates to its Hospital Inpatient Quality Reporting (IQR) Program, through which hospitals are incentivized to collect and report specific data, that will have a direct and substantial impact on pre-, peri-, and post-operative orthopedic care practice for years to come.
In particular, CMS has adopted 2 new quality measures revolving specifically around THA and TKA:
- Hospital-Level, Risk Standardized Patient-Reported Outcomes Performance Measure (PRO-PM) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA)
- Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary THA/TKA
Below, we discuss the significance of each of these new measures for orthopedic providers, explaining the timelines, data specifications, inclusion/exclusion criteria, and implications for orthopedic providers, as well as the various advantages afforded by participating in voluntary PRO collection and reporting.
1. PRO-PMs Following THA/TKA
Why is this being implemented?
CMS is implementing this measure—which was developed through a voluntary PRO data collection program in the Comprehensive Care for Joint Reconstruction (CJR) model—to address disparities in outcomes and clinical practice across US hospitals, namely readmission and complication rates, by encouraging an emphasis on care coordination throughout the entire episode of care for THA and TKA. Because the primary motivations for THA and TKA procedures are to lower pain and improve joint function, CMS contends that PROs represent an important measure of outcomes.
How will this be measured?
Clinical improvement will be measured based on the difference in patient score on joint-specific PRO instruments between preop PRO assessment and postop PRO assessment; more specifically, the outcome measure depends on the proportion of patients who meet or exceed a threshold of 22 points on Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) for THA and 20 points on Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) for TKA.CMS will utilize PROs (further detailed below), as well as claims data, Medicare enrollment and beneficiary data, and US Census Bureau survey data for measure calculation, to conduct data matching and risk adjustment analyses, and to account for non-response bias. This will result in a hospital-level risk-standardized improvement rate (RSIR), representing a quality of care metric that accounts for patient mix, patient-level risk, and non-response bias.
What data do I have to submit? How can I submit them?
Providers will be able to submit data themselves or via a vendor or registry through the existing CMS infrastructure, namely a HCQIS Access Roles and Profile (HARP) account, which provides access to the Hospital Quality Reporting (HQR) website. Below is a list of all assessment variables that will be required for data submissions:
Specific technical data specifications demonstrating all data elements and response options or ranges are not yet available, but will be made available for providers and vendors through CMS’ QualityNet at a later time. However, given that this measure was developed under the CJR model, technical data specifications from that model—available in the THA/TKA PRO-PM Development Methodology Report and the Measure Methodology for Hip and Knee Arthroplasty Patient-Reported Outcomes—can help provide clarity for stakeholders until CMS makes specifications under the IQR program available through QualityNet.
Which patients do I have to collect data from?
THA/TKA patients must meet the following criteria to be eligible for PRO collection:
- 65 years or older undergoing elective primary THA or TKA, excluding revisions, fractures, and staged procedures
- Enrolled in Medicare FFS Part A and B for 12 months prior to the date of the index admission and enrolled in Part A during index admission
- Discharged alive (patients that leave hospitals against medical advice are excluded)
When will this be required?
This measure will be implemented through a phased approach, with two voluntary reporting periods followed by the first period of mandatory reporting; the specific timelines for performance periods, data collection windows, and submission deadlines are shown in the table below:
The first window for pre-op data collection has already started, and orthopedic providers participating in voluntary reporting can now begin collection of pre-op data for procedures scheduled for the first 6 months of 2023. Importantly, providers and vendors will have the ability to adjust data submissions only during the collection windows but will not be able to make any adjustments once submission deadlines have passed.
There are no penalties for hospitals that choose to not participate in voluntary reporting, but hospitals that do not meet the requirements of mandatory quality reporting will see a negative impact—specifically a one-quarter reduction of the applicable percentage increase—on their annual payment update (APU) for FY 2028.
To be clear, the IQR program is exclusively a pay-for-reporting program, and any payments arising from this program are not affected by patient outcomes, but rather only by a lack of reporting compliance; therefore, hospitals that do not meet the minimum requirement of submitting timely data on more than 50% of their eligible patients will be penalized as noted above, regardless of quality of patient outcomes.
Why should I participate in voluntary reporting?
- Ensure PRO collection flows with clinical workflows efficiently:
- For hospitals not already collecting PROs, beginning to do so requires careful consideration of how such a process may impact internal workflows and what time and cost burdens a hospital may have to adapt to.
- For hospitals not submitting data directly, the voluntary reporting periods provide time to partner with a vendor or establish a submission process through a registry.
- Test and refine data submissions through the HQR website before mandatory reporting begins.
- Receive confidential feedback reports including details on response rates and results, as well as RSIRs, which would provide insight on how your hospital is performing relative to other participants in voluntary reporting:
- Hospitals participating in the first voluntary reporting period will receive their feedback reports in 2025, while those participating in the second period will receive them in 2026.
- This information can be helpful for hospitals wanting to ensure all processes for effective clinical practice are established prior to mandatory reporting.
Will any of these results be reported publicly?
During the first voluntary reporting CMS will make public the list of hospitals that chose to participate and/or the proportion of pre-op data they submitted; in the second period, the proportion of patients for which complete pre- and post-op can be matched (out of all eligible patients) will be reported.During mandatory reporting, hospitals will receive feedback reports before results are made available publicly, after which results and response rates will be posted on the Department of Health and Human Services’ Compare tool.
2. RSCR Following THA/TKA
A less refined version of this measure was previously included in the IQR program but was removed in FY 2018, though it remains in the Hospital Value-Based Payment (VBP) program. This updated measure has been expanded to include 26 mechanical complication ICD-10 codes, and following one year of reporting in the IQR program, CMS intends to introduce it into the VBP program, replacing the less comprehensive version of the measure.
This measure will be calculated by CMS through claims data, so no additional data reporting will be required by providers, but it is important for providers to be aware that the updated measure will have an impact on FY 2024 payment determination.
To learn about key considerations you should make when selecting a partner for effective PRO collection and submission, see here.
We know that these updates may create challenges for your current clinical workflows. We're here to help. Our team of clinical experts is prepared to support your organization and patients as you navigate any challenges surrounding PRO collection and submission, and we are happy to answer any questions you may have. Reach out to us here.
