Introduction to CMS’s CY 2024 OPPS/ASC Proposed Rule & THA/TKA PRO-PM

July 13, 2023, CMS released the Calendar Year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule. As part of the OPPS/ASC proposed rule, CMS is proposing several changes to the Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgical Center Quality Reporting (ASCQR) programs, including a new measure that impacts elective primary Total Hip and/or Total Knee Arthroplasty. The final rule will be issued in early November 2023. This blog gives a background on the OPPS/ASC Payment System, the OQR/ASCQR Programs, an overview of the Risk-Standardized Patient-Reported Outcomes Following Elective Primary Total Hip and/or Total Knee Arthroplasty performance measure (THA/TKA PRO-PM), and specific information for organizations impacted by the measure.

Background of the OPPS/ASC Payment System

CMS makes Medicare payments for HOPD and ASC services through the Hospital Outpatient Prospective Payment System (OPPS). The OPPS went into effect on August 1, 2000, and it is updated on an annual basis by CMS. Within the OPPS are the Hospital OQR Program and the ASCQR Program, which are pay-for-reporting quality programs that require hospital outpatient departments (HOPDs) and ASCs to meet certain quality reporting requirements or receive a reduction in their annual payment update (APU) if the requirements are not met. Both quality programs were authorized by the Tax Relief and Healthcare Act of 2006 to promote higher quality, more efficient health care for Medicare beneficiaries.

Background of the THA/TKA PRO-PM

Elective primary THA and TKA are very common, effective procedures for those suffering from degenerative joint disease or osteoarthritis. These procedures can alleviate pain, improve function, and improve quality of life; however, patients’ outcomes can vary. Until recently, THA and TKA could only be performed as inpatient until CMS made the decision to remove TKA from Medicare’s Inpatient-Only List (IPO) effective January 2018, followed by the removal of THA procedures from the IPO list effective January 2020.

One of the earlier attempts to collect large scale PRO data from patients undergoing these procedures was when CMS first created the Comprehensive Care for Joint Replacement (CJR) model in 2015. This program incentivized hospitals to voluntarily collect and submit PRO data for elective primary THA/TKA procedures. The THA/TKA PRO-PM was then developed using data from CJR participants.

In the FY 2023 IPPS/LTCH PPS final rule, CMS adopted the THA/TKA PRO–PM in the Hospital Inpatient Quality Reporting (IQR) Program. The measure reports the risk-standardized improvement rate (RSIR) in PROs following elective primary THA/TKA for Medicare FFS beneficiaries aged 65 years and older. There are two voluntary reporting periods available, followed by a mandatory reporting period which goes into effect for procedures performed in 2024. CMS is proposing using the same specifications as finalized for the hospital-level measure THA/TKA PRO–PM for the OQR/ASCQR Program for procedures performed in the HOPD and ASC setting.

This measure comes at a pivotal time in healthcare when an increasing majority of procedures, THA and TKA in particular, are now being done on an outpatient basis. The proposal of the PRO-PM for HOPDs and ASCs demonstrates the need to ensure that quality data accompanies this shift in procedure settings. The following has further information about the PRO-PM such as the inclusion/exclusion criteria, data sources, reporting window, success criteria, and more.

Impacted HOPDs/ASCs

The OPPS/ASC proposed rule affects approximately 3,500 hospitals and 6,000 ASCs. All HOPDs and ASCs that perform elective primary THA and TKAs will be impacted by the PRO-PM. However, the following are excluded:

• Critical access hospitals (CAHs)
• Hospitals located in Maryland and paid under Maryland’s All-Payer or Total Cost of Care Model
• Hospitals located outside of the 50 States, the District of Columbia, and Puerto Rico
• Indian Health Service (IHS) hospitals

Patient Inclusion/Exclusion

The THA/TKA PRO-PM includes only elective primary THA/TKA procedures (fractures and revisions are not included) performed in an HOPD or ASC and includes patients who are:

• Enrolled in Medicare FFS Part A and Part B for the 12 months prior to the date of the index admission and enrolled in Part A during the index admission
• Aged 65 or older

Data Sources

The THA/TKA PRO-PM uses four (4) data sources for calculation of the measure:

• PRO data
• Claims data
• Medicare enrollment and beneficiary data
• U.S. Census Bureau survey data

PRO Data includes:

• PROMIS Global (mental health subscale items) or VR–12 (mental health subscale items)
• HOOS, JR (for THA patients) or KOOS, JR (for TKA patients)
• Single-Item Health Literacy Screening (SILS2) questionnaire
• Total painful joint count (patient reported in non-operative lower extremity joint)
• Quantified spinal pain (patient-reported back pain, Oswestry index question)

Collection Intervals:

PRO data is collected both before and after THA/TKA at the following collection intervals:

• Pre-operatively (90 to 0 days before surgery) and
• Post-operatively (300 to 425 days after surgery)

Reporting Periods:

For the first voluntary reporting period for CY 2025:

• The pre-operative PRO data collection window will be from October 3, 2024 through December 31, 2025 (90 to 0 days before the procedures) with a submission due date of May 15, 2026
• The performance period is for eligible elective THA/TKA procedures performed from January 1, 2025, through December 31, 2025
• The post-operative PRO data collection window will be from October 28, 2025 through March 1, 2027 (300 to 425 days after the procedure) with a submission due date of May 15, 2027.

For the second voluntary reporting period for CY 2026:

• The pre-operative PRO data collection window will be from October 3, 2025 through December 31, 2026 (90 to 0 days before the procedures) with a submission due date of May 15, 2027
• The performance period is for eligible elective THA/TKA procedures performed from January 1, 2026, through December 31, 2026
• The post-operative PRO data collection window will be from October 28, 2026 through February 29, 2028 (300 to 425 days after the procedure) with a submission due date of May 15, 2028

For the mandatory reporting period for CY 2027:

• The pre-operative PRO data collection window will be from October 3, 2026 through December 31, 2027 (90 to 0 days before the procedures) with a submission due date of May 15, 2028
• The performance period is for eligible elective THA/TKA procedures performed from January 1, 2027, through December 31, 2027
• The post-operative PRO data collection window will be from October 28, 2027 through February 28, 2029 (300 to 425 days after the procedure) with a submission due date of May 15, 2029

Data Submission

HOPDs and ASCs will submit the data sources collected pre- and post-operatively for each eligible patient. The calculated measure will be presented as a RSIR. Similar to the IQR program, HOPDs and ASCs can either choose to submit their own data to CMS directly or utilize an external entity, such as a vendor or registry.

Success Criteria

The measure outcome is the RSIR proportion of patients who underwent elective primary THA/TKA and met or exceeded a substantial clinical improvement threshold between pre-operative and post-operative using the joint-specific PRO survey. Improvement is defined as a binary outcome (“Yes”/“No”) of meeting or exceeding the following pre-defined improvement thresholds:

• For THA patients, this means meeting or exceeding the threshold of 22 points of the HOOS, JR. between pre-op and post-op
• For TKA patients, this means meeting or exceeding the threshold of 20 points on the KOOS, JR. between pre-op and post-op

During mandatory reporting in the Hospital OQR and ASCQR Program, HOPDs will be required to submit pre-op and post-op data for at least 50 percent of eligible procedures and ASCs will be required to submit pre-op and post-op data for at least 45 percent of eligible procedures.

Summary

The CY 2024 OPPS/ASC proposed rule serves as one of the latest examples highlighting the growing importance of patient-reported outcomes as a measure for evaluating patient care. As healthcare continues to evolve towards value-based care in an outpatient setting, patient experiences take center stage in evaluating the effectiveness of medical interventions like THA/TKA procedures. It is crucial for hospitals to have reliable systems and processes in place for collecting and monitoring data to ensure success.

Sources | CY 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule | Fact Sheet: CY 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule | CY 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule | CY 2020 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule | FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule