In November 2023, the Centers for Medicare & Medicaid Services (CMS) took a monumental step in advancing patient reported outcome (PRO) collection in outpatient settings when it announced its CY2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center (ASC) Payment System Final Rule. In its proposal, CMS rolled out mandates for collecting patient reported outcome-based performance measures (PRO-PMs) before and following total hip and knee arthroplasty (TKA and THA, respectively) for organizations participating in either the Hospital Outpatient Quality Reporting (OQR) or ASC Quality Reporting (ASCQR) Programs.

Whether you’re preparing for these specific CMS mandates or planning to use PROs in other initiatives, it’s essential to understand exactly how these rules are being rolled out, the implications for your organization, and how to effectively and efficiently meet these new outpatient standards.

1. Why did CMS decide to establish new PRO standards for THA and TKA programs?

CMS’s ultimate goal with this regulatory rollout is to gather insights on addressing disparities in outcomes and clinical practice across the U.S. — such as readmission and complication rates — while reinforcing care coordination throughout care journeys among patients undergoing THA and TKA procedures.

CMS is specifically addressing hospital outpatient departments (HOPDs) and ambulatory surgery centers (ASCs) that perform THAs and TKAs, since these procedures aim to lower pain and improve joint function. Thus, PROs leveraged in these contexts present unique opportunities to gather concrete health outcomes information on multiple aspects of care delivery.

It’s also important to note that these recent mandates build on CMS’s inpatient rules finalized in late 2022 — which introduced similar requirements to THA and TKA providers participating in the Hospital Inpatient Quality Reporting (IQR) Program. 

2. What modes of patient data collection does CMS accept for this initiative?

CMS allows providers to collect PROs through multiple modes to meet its requirements. These include email, telephone, mail, smartphone or tablet, or paper forms with a provider present.

In recent years, providers across the country have started leveraging digital channels to glean electronic patient reported outcomes (ePROs) to streamline data collection, account for a diverse array of care settings, and improve overall response rates.

For the submission period, hospitals can send their information directly to CMS to calculate results or contract a third-party vendor to submit data on their behalf. Acceptable formats sent through the Hospital Quality reporting system include comma-separated value (CSV) files, extensible markup language (XML) files, or manually entered information.

Here’s how one medical center used Memora Health’s platform to reach a 75% ePRO response rate.

3. What should I consider when selecting a patient reported outcomes collection mode?

Just because CMS allows a wide range of options for collecting PROs doesn’t make them all equally effective. For example, relying only on follow-up appointments to gather data manually hinges on patients attending their scheduled visits — inherently affecting any provider’s ability to acquire predictable response volumes.

As a result, some providers might be tempted to glean required information via patient portals. However, findings from the American Medical Association suggest most patients don’t use them to begin with — meaning strategies depending on this digital technology might yield inconsistent results.

One of the most convenient and reliable modes for reaching patients to collect PROs is through SMS text messaging. Over 90% of text messages are read and responded to within three minutes of receipt. And almost 80% of patients want providers to offer text-based features — which don’t require internet or data plans to use. Innovative intelligent care enablement technologies leverage universal communication channels like text messaging to improve accessibility and encourage higher engagement rates.

4. What are the minimum requirements for mandatory reporting according to CMS’s new PRO mandates?

Participating HOPDs are required to collect and submit complete preoperative PRO data, risk variable information, and corresponding postoperative PRO data for at least 50% — and ASCs for at least 45% — of eligible THA and TKA patients within mandatory CMS-established reporting and submission periods. 

5. When do these PRO requirements take effect for THA and TKA programs?

CMS has outlined two distinct reporting periods for its outpatient THA and TKA PRO collection mandates. One is for three-year voluntary reporting that begins Jan. 1, 2025 and extends until Dec. 31, 2027. 

The other is for mandatory reporting that begins with preoperative PRO collection on Oct. 3, 2027 — 90 days before the Jan. 1, 2028 procedure collection start date — and extends until May 15, 2030, when post-procedure data submission is due. Notably, CMS has allowed a 300-425 day window for post-procedure data collection to accommodate varying survey methods.

6. From whom must providers collect data to meet CMS’s PRO requirements?

Participating providers must collect required PRO data from THA and TKA patients who meet the following criteria:

• 65 years or older having elective primary THA or TKA

• Enrolled in Medicare FFS Part A and B for 12 months before admission and enrolled in Part A during admission

Patients undergoing procedures for the following reasons are excluded from CMS’s eligibility:

• Revisions/Removals/Mechanical Complications

• Partial/Hemi/Uni-compartmental 

• Musculoskeletal Malignancy 

• Fractures

• Staged procedures and discontinued procedures

CMS notably excludes all Medicare Advantage patients from eligibility. Patients undergoing inpatient procedures are also excluded.

7. What is the preoperative PRO collection timeline for THA and TKA providers?

CMS requires participating providers to collect PRO and risk variable data from eligible patients 0-90 days before elective or primary THA and TKA procedures. 

8. What is the postoperative PRO collection timeline for THA and TKA providers

CMS requires participating providers to collect PRO data 10-14 months (300-425 days) from eligible patients after elective or primary THA and TKA procedures. 

9. What patient reported outcome measures (PROMs) must providers collect from THA and TKA patients?

While CMS doesn’t require organizations to collect information with standardized administrative modes, it does require collecting and reporting specific data elements. The PROMs participating providers must gather depend on the type of procedures offered. THA patients are issued a Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.) survey that includes inquiries such as:

• What amount of hip pain have you experienced the last week during the following activities (on a scale of none to extreme)?
  • Going up or down stairs
  • Walking on an uneven surface
• What amount of knee pain have you experienced in the last week during the following activities (on a scale of none to extreme)?
  • Rising from sitting
  • Bending to floor/pick up an object
  • Lying in bed (turning over, maintaining hip position)
  • Sitting

TKA patients are issued a Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) survey that includes inquiries such as:

• How severe is your knee stiffness after first waking in the morning (on a scale of none to extreme)?
• What amount of knee pain have you experienced in the last week during the following activities (on a scale of none to extreme)?
  • Twisting/pivoting on your knee
  • Straightening knee fully
  • Going up or down stairs
  • Standing upright
•  For each of the following activities please indicate the degree of difficulty you have experienced in the last week due to your knee (on a scale of none to extreme).
  • Rising from sitting
  • Bending to floor/pick up an object

10. What are the reimbursement implications of these new CMS PRO policies?

CMS has indicated that HOPDs that fail to meet reporting requirements will be subject to a reduction of their Annual Payment Update (APU) in the CY 2030 payment determination, while ASCs that fail to meet reporting requirements will see a reduction in their annual fee schedule update in the CY 2030 payment determination. As both Hospital OQR and ASCQR programs are exclusively pay-for-reporting structures, participating organizations’ subsequent payments will remain unaffected by the PRO results themselves. Rather, reimbursements will only be adjusted based on a lack of reporting compliance. There is no reimbursement penalty during the voluntary reporting period.

11. Will results be publicly reported?

HOPDs that submit PRO data during the voluntary reporting period will receive confidential feedback reports that detail their performance results — none of which will be made public. However, CMS plans to publicly report which facilities choose to participate in voluntary reporting. It might also showcase the percent of pre-operative data submitted for the first voluntary reporting period along with the percent of pre- and post-operative matched PRO data submitted for subsequent voluntary reporting periods.

With the onset of the mandatory reporting period, CMS plans to publicly report the percentage of patients who achieve a substantial clinical benefit (SCB), which is assessed at a 22 point threshold for HOOS, JR. (THA patients) and at a 20 point threshold for KOOS, JR. (TKA patients). CMS will create a final risk-standardized improvement rate (RSIR) for each organization that takes into account PRO, claims, Medicare enrollment and beneficiary, and U.S. Census Bureau survey data.

Once reporting becomes mandatory and submissions conclude in 2030, results will be published on CMS’s Care Compare website for public review in 2031.

CMS’s recent announcements to begin mandatory PRO collection from THA and TKA patients in both inpatient and outpatient settings mark a significant commitment to expanding PRO use in the clinical context. As you prepare to meet these new standards, it’s important to sufficiently understand your requirements, deadlines, and the implications for compliance. Using a convenient, universal communication channel to issue ePROs can significantly improve your organization’s ability to rapidly and effectively meet mandatory reporting requirements.   

Want to see how Memora Health’s platform can help your organization improve PRO collection? Speak with one of our experts.