Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies

We proposed adding the claims-based MSPB-PAC measure to the HHVBP applicable measure set starting in CY 2026. This cross-setting 2-year measure was required by the Improving Post-Acute Care Transformation Act of 2014 (IMPACT Act) and was added to the Home Health Quality Reporting Program on January 1, 2017.

Public comments on the CY 2025 HH PPS proposed rule (89 FR 88354) in support of adding this measure to the expanded HHVBP Model suggested that the MSPB-PAC measure could help to identify the costs associated with the delivery of high-quality home health services, which could identify areas for improved efficiencies in resource usage.

The MSPB-PAC measure is intended to incentivize providers to redesign care systems to provide coordinated, high-quality, and cost- efficient care. It holds HHAs accountable for Medicare payments for an episode of care that includes the period during which a patient is directly under HHA care, as well as a defined period after the end of HHA treatment, which may be reflective of and influenced by the services provided by the HHA. Evaluating Medicare payments during an episode creates a continuum of accountability between providers and has the potential to improve post-treatment care planning and coordination. In conjunction with the other performance measures used in the expanded HHVBP Model, explicit measurement of costs of care will allow recognition of HHAs that provide high quality care at a lower cost.

We noted that we anticipate adding the MSPB-PAC measure would create incentives for greater care coordination to deliver high-quality care at a lower cost to Medicare and incentivize providers to find efficient ways to address patients' care needs. Incentivizing efficient resource utilization aligns with the pay-for-performance approach used in the expanded HHVBP Model. The MSPB-PAC measure would ensure that HHVBP payment adjustments consider not only patient outcomes but also HHA's ability to produce those outcomes at a lower cost.

The MSPB-PAC measure is a claims-based measure that includes price- standardized payments for Part A and Part B services. It measures Medicare spending during an episode of care relative to the Medicare spending for other HHAs. The Medicare spending measure is payment- standardized and risk-adjusted. The MSPB-PAC measure captures Medicare spending for most Part A and B services during the episode of care, excluding services that are clinically unrelated to post-acute care treatment or services over which HHAs may have limited to no influence (for example, routine management of certain preexisting chronic conditions). The episode of care window consists of a treatment period and an associated services period (from the admission to the home health services up to 30 days after the end of the home health treatment period). The episode includes the period a patient is directly under HHA care, as well as a defined period after the end of the HHA's treatment which may be reflective of and influenced by the services rendered by the HHA.\35\

\35\ See https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assesment-Instruments/NursingHomeQualityInits/Downloads/2016_07_20_mspb_pac_Itch_irf_snf_measure_specs.pdf for more details on the specifications for the MSPB-PAC measure.

We noted that we anticipate reporting preliminary benchmarks, achievement thresholds, and improvement thresholds for the MSPB-PAC measure in the October 2025 Interim Performance Reports (IPR). The MSPB-PAC measure would use 2 years of data covering CY 2022 and CY 2023 as baseline data. Because the MSPB-PAC measure is a 2-year measure, CY 2026 performance for the measure would be calculated based on 2 years of performance data (CY 2025/2026). The MSPB-PAC measure was designed as a 2-year measure to optimize reliability. In addition, each performance year would consist of 1 year of data that does not overlap with data from the prior performance year, which provides sufficient opportunity to capture quality improvement over time.

Adding the MSPB-PAC and function measures described below would increase the number of HHAs that have sufficient data for at least five measures, the minimum required to have a payment adjustment for the expanded HHVBP Model. Increasing the number of HHAs that receive payment adjustments would allow the Model to better incentivize high- quality home health care across the country.

We invited public comments on this proposal. The following is a summary of the comments we received and our responses:

Comment: Several commenters supported the addition of the MSPB-PAC measure, encouraging CMS to adopt MSPB-PAC to align with administrative priorities and focus on spending efficiency. They acknowledged that adding MSPB-PAC to HHVBP supported CMS's shift towards more comprehensive accountability by combining cost metrics with functional and patient-reported outcomes. They agreed the MSPB-PAC measure would advance HHVBP's emphasis on cost-effectiveness, which is a key indicator of value in home health care. A commenter stated that agencies that can deliver necessary care in fewer episodes should be recognized and rewarded. They also expressed appreciation that MSPB-PAC includes price-standardized payments for Part A and Part B services, and is risk-adjusted to reflect patient complexity, thereby making it an appropriate tool for assessing efficiency.

Response: CMS appreciates commenters' understanding of the value of the MSPB-PAC measure and the supportive feedback.

Comment: A few commenters encouraged CMS to ensure the new measure was validated and properly risk-adjusted to avoid unfairly penalizing agencies serving complex, high-need patients.

Response: CMS appreciates commenters' concerns. CMS is committed to ensuring fairness, accuracy, and feasibility for all quality measures used in the expanded HHVBP Model. CMS also reminds commenters that the MSPB-PAC measure is risk adjusted to account for variations in patient populations and resource utilization across PAC providers.

Comment: Multiple commenters stated that MSPB-PAC is not a measure of care quality, only of expenditures. A commenter noted that the introduction of the Patient-Driven Groupings Model (PDGM) for Medicare payment aligned payment with payment complexity and removed incentives to increase the volume of therapy visits, making the MSPB-PAC measure unnecessary. Another commenter noted that, within the PDGM, payment is determined by defined patient characteristics: admission source, clinical grouping, functional impairment level, and comorbidity adjustment. This commenter expressed concern that patients referred from acute settings or presenting with higher-acuity conditions such as wounds, neurological rehabilitation needs, or musculoskeletal impairments generate higher episodic payments due to increased resource requirements.

Response: Incentivizing care coordination and efficient resource allocation is consistent with the expanded HHVBP Model's goal of improving the quality and efficiency of Medicare home health care, leading to

better outcomes for beneficiaries and reduced costs for the Medicare program. CMS believes that the addition of MSPB-PAC will further the goal of improving the efficiency of home health care, creating incentives for coordination of care and incentivizing providers to find efficient ways to deliver high quality care. CMS acknowledges that higher-acuity patients often require more resource-intensive treatments. CMS notes that the MSPB-PAC measure is risk-adjusted to account for differences in patient acuity. In addition, clinically complex patients receive a higher payment rate under the PDGM, limiting the financial incentive to avoid these high acuity patients.

Comment: Some commenters questioned whether HHAs that spend more than the national average of MSPB-PAC will receive a lower score on the measure. They also questioned whether HHAs that spend more than the average for their cohort will receive a lower score on the measure.

Response: We appreciate the commenters' concerns. MSPB-PAC is a metric of cost-effectiveness and efficiency, and as such, lower spending results in a higher score on the measure. As with all expanded HHVBP Model measures, HHAs will receive TPS scores based on their measure performance relative to their cohort. Full measure specifications for MSPB-PAC are available at the following link: https://www.cms.gov/files/document/home-health-outcome-measures-table-oasis-e2025.pdf.

Comment: Some commenters stated that the incentive to reduce costs of care which would result from adding the MSPB-PAC measure would not necessarily lead to higher quality care for patients and would run contrary to the goals CMS has for promoting patient-centered care. Some commenters particularly noted the potential for unintended consequences associated with the introduction of the MSPB-PAC measure, stating that adding the measure would create disincentives for HHAs to admit clinically complex patients, undermining access to care for high-need patients.

Response: We appreciate these comments. As part of our ongoing monitoring of the expanded HHVBP Model, we will monitor for changes in patient characteristics that may suggest unintended consequences associated with adding the MSPB-PAC measure. We note that the MSPB-PAC measure is risk-adjusted to account for differences in patient acuity. In addition, clinically complex patients receive a higher payment rate under PDGM, limiting the potential for unintended consequences.

Comment: A commenter stated that the MSPB-PAC and DTC-PAC measures measure very similar outcomes and that only one should be added to the expanded HHVBP Model.

Response: We believe that the MSPB-PAC and DTC-PAC measures measure different dimensions of quality and efficiency. DTC-PAC is a measure of patient outcomes while MSPB-PAC is a measure of resource use and cost efficiency. The DTC-PAC measure uses inpatient hospital claims to identify episodes with an associated unplanned hospitalization and administrative data to identify patients who die within 31 days of discharge, both of which result in an episode being classified as not having a successful community discharge. The MSPB-PAC measure uses Medicare Part A and B claims to measure the average Medicare spending per patient during and after the home health stay. The goal of the DTC- PAC measure is to encourage the provision of comprehensive care that facilitates successful long-term recovery at home. The goal of the MSPB-PAC measure is to incentivize providers to improve care efficiency and coordinate services across the episode of care, ultimately reducing total Medicare spending. Analyses conducted as part of the endorsement process for the MSPB-PAC measure found a small but significant negative association between the MSPB-PAC measure scores and the DTC measure scores. These results show that MSPB-PAC and DTC-PAC measure separate dimensions of quality.\36\

\36\ National Quality Forum (NQF) (2021) Cost and Efficiency, Spring 2020 Cycle: CDP Report. Available from: https://digitalassets.jointcommission.org/api/public/content/926365c68be1441791340150005aacd6?v=39e48ce7.

Comment: Several commenters opposed adding any additional measures to the HHVBP applicable measure set, noting that HHAs have made substantial investments in quality improvement strategies tied to the current Model's framework. Some commenters expressed concern about the burden of adding additional measures, given the proposed reductions to home health payments. Another commenter encouraged CMS to maintain a stable and predictable measure environment, requesting that CMS maintain the current measure set and weight distribution in the near term, while engaging stakeholders in a phased, transparent process for any future expanded HHVBP Model refinements.

Response: We appreciate these comments but note that one of the goals of the expanded HHVBP Model is to study new potential quality and efficiency measures for appropriateness in the home health setting. Adding the MSPB-PAC measure to the HHVBP applicable measure set is consistent with this goal. We have and will continue to engage stakeholders in the measure development and implementation processes.

Comment: Some commenters expressed concern that, as a claims-based measure, MSPB-PAC lacks real-time transparency, limiting HHAs' ability to implement timely performance improvements.

Response: We recognize commenters' concerns regarding the timeliness of public reporting data. We remain committed to ensuring providers have access to the most timely data available to support quality improvement efforts. The MSPB-PAC measure is intended to provide actionable, transparent information to providers. By evaluating a given HHA's risk-adjusted Medicare spending in a defined timeframe as compared to that of the national median HHA, the MSPB-PAC measure recognizes HHAs that deliver high quality care at lower cost to Medicare, when used in conjunction with the other quality measures in the expanded HHVBP Model. The MSPB-PAC measure will have a six-month data lag, similar to the other claims-based measures already included in the HHVBP Model applicable measure set. Additionally, as discussed in the CY 2018 HH PPS final rule (82 FR 51676), improvements in performance in the MSPB-PAC measure over a one-year period will also be included in the two years of measure data, so providers' improvement efforts can still be reflected in their two-year measure scores.\37\

\37\ https://www.govinfo.gov/content/pkg/FR-2017-11-07/pdf/2017-23935.pdf.

Comment: Some commenters expressed concern that MSPB-PAC reflects spending related to factors outside of HHAs' control, potentially including spending for care the patient receives after discharge that may not have been preventable.

Response: We recognize commenters' concerns. We believe providers will not be unfairly punished for spending outside of their control. The MSPB-PAC measure excludes certain services and costs that are considered clinically unrelated or beyond the provider's control. This is done so that providers are held accountable only for the costs they can reasonably manage. The episode of care definition that the MSPB-PAC measure uses includes the period a patient is directly under a provider's care, as well as a defined

period after the end of that provider's treatment which may be reflective of and influenced by the services rendered by the provider.

Final Decision: After consideration of the public comments received, we are finalizing the addition of MSPB-PAC measure to the expanded HHVBP Model's applicable measure set as proposed. 3. Addition of OASIS-Based Function Measures to the Expanded HHVBP Model Applicable Measure Set

We proposed adding three OASIS-based function measures to the HHVBP applicable measure set beginning with CY 2026:

Improvement in Bathing (based on OASIS item M1830)

Improvement in Upper Body Dressing (based on OASIS item M1810)

Improvement in Lower Body Dressing (based on OASIS item M1820)

These measures are intended to complement the Discharge (DC) Function Score measure added to the HHVBP applicable measure set starting with CY 2025 to provide a more holistic picture of patients' functional status. The DC Function Score measure uses a cross-setting function item set which does not include items related to bathing or dressing.

These three measures have already been tested, validated, and implemented for other purposes within CMS models and programs. Improvement in Bathing is used in the Home Health Quality Reporting Program, the Home Health Quality of Patient Care Star Rating system and reported on Care Compare. All three of the OASIS items underlying these measures were also used in the Total Normalized Change (TNC) in Self- Care measure that were part of the CY 2023 and CY 2024 expanded HHVBP Model applicable measure set. Additionally, the underlying OASIS M1800 items are used in the Home Health Patient-Driven Groupings Model that is used for Medicare home health payments. Therefore, adding these measures to the expanded HHVBP Model would align with existing quality measurement and payment practices. Adding these measures would not create additional burden to HHAs, as the data for these measures is already collected on OASIS assessments.

In the CY 2024 HH PPS final rule (88 FR 77676), CMS finalized the policy to add the DC Function Score measure to replace the previous OASIS-based TNC measures (TNC Self-Care and TNC Mobility). That change aligned the expanded HHVBP Model with PAC quality programs. The DC Function Score measure is an OASIS-based measure that is used in the HH QRP and the expanded HHVBP Model starting in CY 2025. This measure reports the percentage of patients who meet or exceed an expected discharge function score during the reporting period. The DC Function Score measure considers two dimensions of patient function--self-care and mobility activities--using 13 OASIS items.\38\

\38\ These OASIS items and activities include GG0130 Self-Care, GG0130A Eating, GG0130B Oral hygiene, GG0130C Toileting hygiene, GG0170 Mobility, GG0170A Roll left and right, GG0170C Lying to sitting on side of bed, GG0170D Sit to stand, GG0170E Bed-to-chair transfer, GG0170F Toilet transfer, GG0170I Walk 10 feet, GG0170J Walk 50 feet with two turns, GG0170R Wheel 50 feet with two turns.

The Model's Technical Expert Panel (TEP) has raised concerns that the DC Function Score measure does not consider bathing or dressing abilities, as these items are not available across all PAC settings covered by this cross-setting measure. TEP members identified the ability to bathe and dress as being critically important for home health patients. Many patients who receive home health care are recovering from an injury or illness and may have difficulty performing the tasks of bathing and dressing, requiring help from another person or special equipment to accomplish these activities. Improving patients' ability to bathe themselves contributes to patient comfort and quality of life and is often a rehabilitative goal for home health patients. These metrics also promote safer discharges from home care. Improvement in both upper and lower body dressing are important indicators of usefulness and improvement for patients, as well as indicators of being able to stay home, care for themselves, and be independent.

In 2024, TEP members supported CMS moving ahead as quickly as possible to add bathing and dressing function measures to the Model's applicable measure set to complement the DC Function measure. The TEP recommended using existing measures based on the OASIS M1800 items, which could be added sooner than future measures based on section GG items.\39\

\39\ The Section GG items were added to patient assessment tools for home health, skilled nursing facilities, inpatient rehabilitation facilities, and long-term care hospitals to support alignment of measurement of functional abilities and goals across post-acute care assessment instrument.

The baseline data for these three measures will cover CY 2023, which was specified as the Model baseline year in the CY 2024 HH PPS final rule. This baseline data will be used to calculate benchmarks and achievement thresholds for the proposed OASIS-based function measures. We anticipate providing HHAs with the benchmarks, achievement thresholds, and improvement thresholds for the OASIS-based function measures in the October 2025 IPRs.

Adding these three measures would increase the number of OASIS- based measures used in the Model, allowing for more robust measurement of HHA performance. The change will also allow more HHAs to have sufficient data for at least five measures, the minimum required to calculate a payment adjustment. We anticipate that HHAs that receive payment adjustments will have greater incentives to improve or maintain quality of care.

The following is a summary of the comments we received and our responses:

Comment: Most of the commenters supported CMS' proposed addition of the measures of bathing and dressing to complement the DC Function measure. However, many of the supportive commenters encouraged CMS to work toward replacing these measures with GG-based counterparts.

Response: We appreciate commenters' support of these measures. CMS agrees with commenters about the desirability of section GG-based versions of these measures. Once section GG-based versions of these measures are available, we may consider proposing changing to the GG- based measures through future rulemaking.

Comment: Some commenters opposed adding any measures based on the OASIS M1800 items, even in the short-term. These commenters stated that the functional areas addressed by these measures would be better served by developing new quality measures based on the OASIS GG items. One commenter expressed concern that using the M1800-based measures could delay development and implementation of the GG-based measures.

Response: We agree with commenters about the desirability of Section GG-based versions of these measures but note that each of the M1800 item-based measures were used in the TNC in Self-Care measure that was used in the expanded HHVBP Model prior to 2025. The addition of the M1800-based measures will not delay development or implementation of the GG-based measures, as CMS will continue to work toward development of the GG-based measures, even while the M1800-based measures are publicly reported. Both the M1800 items and GG items will continue to be collected during this development period. Once section GG-

based versions of these measures are available, we may consider proposing changing to the GG-based measures through future rulemaking.

Comment: A few commenters encouraged CMS to replace the DC Function measure with individual OASIS-based function measures.

Response: We finalized the proposal to add the DC Function measure to the HHVBP applicable measure set in the CY 2024 HH PPS final rule (88 FR 77676). Public comments on this change were generally supportive. CMS will not remove the DC Function measure at this time. The DC Function measure contributes valuable insights about the quality of care provided to patients. For many patients, the overall goals of HHA care may include optimizing functional improvement, returning to a previous level of independence, maintaining functional abilities, or avoiding institutionalization Unlike the individual OASIS-based function measures, the DC Function measure does not solely reflect improvement of patients at discharge, as it estimates the percentage of patients who meet, as well as exceed, an expected discharge function score. The measure gives credit for patients who, based on their own demographic and clinical characteristics, are expected to maintain, as opposed to improve in, function. We will continue to monitor performance trends of the DC Function measure.

Comment: Some commenters opposed adding any additional measures to the HHVBP applicable measure set. A few commenters cited concerns with the administrative burden of adding new measures, while another noted the investments that providers have made in quality improvement strategies based on the current measure set.

Response: We appreciate commenters' concerns about changes to the HHVBP applicable measure set. We note that these measures were used in the TNC in Self-Care measure that was part of the HHVBP applicable measure set prior to 2025, when it was replaced by the DC Function measure. As a result, CMS believe that HHAs should be able to adjust to this change in the measure set without unreasonable burden.

Comment: A commenter requested that CMS not obscure the role of the nurse in providing patient-centered care.

Response: We appreciate the comment and remain committed to supporting the contributions made by all members of an interdisciplinary patient-centered care team.

Comment: A few commenters expressed concerns about the fairness, accuracy, and feasibility of new measures. A commenter encouraged CMS to validate all proposed new measures before tying the measures to payment. Another encouraged CMS to ensure that functional measures are appropriately risk-adjusted to account for the complexity of patient populations. Another commenter encouraged CMS to adopt a perspective oriented around comprehensive care. Another commenter recommended CMS either delay the proposed changes or make at least some of the changes voluntary for the first performance year before payments are impacted.

Response: We appreciate commenters' concerns about quality measure accuracy and fairness. We remain committed to ensuring that all HHVBP applicable measures account for providers' patient populations and notes that all three of the proposed function measures are risk- adjusted. Additional information about the specifications of these function measures is available at the following link: https://www.cms.gov/files/document/home-health-outcome-measures-table-oasis-e2025.pdf. While CMS recognizes commenters' concerns about the timing of adding these measures, we do not believe the addition of these measures needs to be delayed particularly given that the three measures are included in the TNC in Self-Care measure previously used in the expanded HHVBP Model. The function measures have been thoroughly vetted and two of the measures have been utilized in HH QRP for multiple years. These function measures would add valuable information about quality of care to the expanded HHVBP Model, which we believe will be beneficial to incorporate into the Model sooner rather than later. After implementation, we will monitor performance trends for these function measures to verify that the measures are meaningfully identifying HHAs' quality of care. Therefore, CMS has decided not to delay implementation of these measure changes.

In addition, we do not believe making the new measures voluntary would be viable or beneficial to the expanded HHVBP Model or providers. The expanded HHVBP Model is designed to incentivize HHAs to provide high-quality home health care across the country.

Given the intent of the expanded HHVBP Model to improve the quality of care furnished to Medicare beneficiaries and study what incentives are sufficiently significant to encourage HHAs to provide high quality, CMS believes that it is important that none of the measures used in the Model be voluntary. Permitting HHAs to voluntarily decide whether to use the newly finalized measures would result in some HHAs receiving performance scores that are based on less complete and less representative data, reducing the impact of the Model on quality. In addition, the addition of the three finalized OASIS-based function measures to the Model increases the number of HHAs that have sufficient data available to receive a payment adjustment, which also increases the impact of the Model on quality.

Final Decision: After consideration of the public comments received, CMS is finalizing the addition of the three OASIS-based function measures to the HHVBP applicable measure set as proposed. 4. Updates to Individual Measure Weights and Category Weights

Along with the proposed revisions to the current HHVBP applicable measure set, we proposed revising the weights of the individual measures starting with the CY 2026 performance year as well as revising the measure category weights. Table D-22 has current and proposed individual measure weights and category weights.

Changes to the measure weights are necessary given the proposed changes to the expanded HHVBP Model applicable measure set. Reflecting the reduction in the number of HHCAHPS Survey-based measures, the proposed weights include a lower total weight for the HHCAHPS Survey- based measures and a higher weight for the OASIS-based and claims-based measures. In addition, some of the weight for the current claims-based measures is shifted to the MSPB-PAC measure and some weight for the OASIS-based measures is shifted to the additional function measures. As with the current measure weights, higher weight is given to claims- based measures because they may have a greater impact on reducing Medicare expenditures. For example, HHAs with better performance scores on the claims-based PPH measure have lower rates of potentially preventable hospitalizations for their patients, reducing Medicare expenditures.

Currently, the OASIS-based, claims-based, and HHCAHPS Survey-based measures contribute 35 percent, 35 percent, and 30 percent, respectively, to the Total Performance Score (TPS) for HHAs in the larger-volume cohort. We proposed adjusting the measure category weights for the larger-volume cohort such that the OASIS-based and claims-based measure categories each contribute 40 percent, and the HHCAHPS Survey-based measure

category contributes 20 percent to the TPS due to the reduction in the number of individual HHCAHPS Survey-based measures. For HHAs in the smaller-volume cohort, the OASIS-based and claims-based measures both contribute 50 percent to the TPS. We did not propose changing the measure category weights for the smaller-volume cohort as the HHCAHPS measures are not used for the smaller-volume cohort.

As proposed, changes to the applicable measure set would increase the number of OASIS-based measures from three measures to six and increase the number of claims-based measures from two to three. The number of individual measures for the HHCAHPS Survey-based measures would decrease from five to two. Note that we have changed weights for measures and measure categories in the past due to changes to the applicable measure set (for example, replacing the two TNC measures with the DC Function Score measure). [GRAPHIC] [TIFF OMITTED] TR02DE25.048

Comment: A few commenters supported all of the proposed changes to HHVBP Model's measure weights. Another commenter only supported modifications caused by the proposed changes to HHCAHPS Survey-based measures, as they opposed the other proposed changes to the HHVBP applicable measure set.

Response: We appreciate the comments supporting the proposed changes to HHVBP measure weights. We note that all proposed changes to measure weights are necessary given the changes to the expanded HHVBP Model's applicable measure set that are being finalized in this rule.

Comment: Several commenters disagreed with CMS's proposed measure weight changes. A commenter expressed concern about the increased weight for the OASIS-based measures. A different commenter expressed concern about the increased weight each individual HHCAHPS Survey-based measure would receive under the proposed measure category weights. Another commenter requested that measure weight changes be introduced gradually. A different commenter expressed concerns about the differential impact the revised measure weights might have on providers in Puerto Rico. A few commenters opposed any measure set or measure weight changes at this time.

Response: We appreciate the comments received on the proposed changes to the expanded HHVBP Model individual measure and category weights. We note that changes to measure weights are necessary given the changes to the expanded HHVBP Model applicable measure set that are being finalized as part of this rule. The increase in the number of total measures in the expanded model, the increase in the number of measures in the OASIS-based and claims-based categories, and the decrease in the number of measures in the HHCAHPS Survey-based category, necessitate adjusting the weight assigned to some or all of the measures in the HHVBP Model applicable measure set.

As measures are removed and added to the expanded HHVBP Model, CMS works to balance measure weights across both measure categories and across individual measures. For example, the removal of three HHCAHPS Survey-based measures is required to align with the finalized changes to the HHCAHPS Survey, reducing the total number of HHCAHPS Survey- based measures in the HHVBP Model to two. As outlined in the proposed rule and below in section IV.C.5, CMS evaluated options which could preserve the HHCAHPS Survey-based measure category weight (30 percent) or preserve the individual HHCAHPS Survey-based measure weights (6 percent) but could not preserve both. CMS determined that these alternatives would be inconsistent

with previous decisions about applying differential weights to measures, and therefore these alternatives were not proposed.

At this time, CMS has not identified any disproportionate impacts the revised measure weights would have on providers in Puerto Rico. We will continue to monitor trends in measure performance that may indicate unintended consequences from participating in the expanded HHVBP Model.

Final Decision: After consideration of the public comments received, we are finalizing the changes to the expanded HHVBP Model's individual measure weights and category weights as proposed. 5. Alternatives Considered

We considered two alternative options for revising the HHVBP measure weights prior to choosing the previously discussed proposals. Table D-23 describes these alternative options for HHAs in the larger- volume cohort, including maintaining measure category weights consistent with current measure set weights and adjusting within- category measure weights (Option 1), reducing the HHCAHPS-based measure category weight to 20 percent (Option 2), and maintaining HHCAHPS-based measure weights consistent with current measure set weights, adjusting measure category weights accordingly (Option 3). We also considered these options for the smaller-volume cohort and came to the same conclusions. Therefore, we only provided a table with measure weighting alternatives for the larger-volume cohort. [GRAPHIC] [TIFF OMITTED] TR02DE25.049

We determined that these alternatives would be less consistent with previous decisions about applying differential weights to measures, and therefore these alternatives were not proposed.

We invited comments on these alternatives considered. The following is a summary of the comments we received and our responses:

Comment: A commenter recommended that CMS adopt Option 3, retaining the 6.00 percent individual measure weight for the remaining two HHCAHPS Survey-based measures.

Response: We appreciate the commenter's suggestion. However, as stated previously, we determined that the alternative measure weight options would be less consistent with previous decisions about applying differential weights to measures.

Final Decision: After consideration of the public comments received, we are finalizing the changes to the expanded HHVBP Model's individual measure weights and category weights as proposed.

The expanded HHVBP Model provides an opportunity to examine a broad array of quality measures that address critical gaps in care. A comprehensive review of the Value-Based Purchasing (VBP) experience, conducted by the Office of the Assistant Secretary for Planning and Evaluation (ASPE), identified several objectives for HHVBP measures.\40\ The recommended objectives emphasize measuring patient outcomes and functional status; appropriateness of care; and incentives for providers to build infrastructure to facilitate measurement within the quality framework. The study identified the following seven objectives which served as guiding principles for the development of performance measures used in the original Model:

\40\ U.S. Department of Health and Human Services. Office of the Assistant Secretary for Planning and Evaluation (ASPE) (2014). Measuring Success in Health Care Value-Based Purchasing Programs. Cheryl L. Damberg et al. on behalf of RAND Health.

Use a broad measure set that captures the complexity of the HHA service provided.

Incorporate the flexibility to include Improving Medicare Post-Acute

Care Transformation (IMPACT) Act of 2014 measures that are cross- cutting amongst post-acute care settings.

Develop second-generation measures of patient outcomes, health and functional status, shared decision making, and patient activation.

Include a balance of process, outcome, and patient experience measures.

Advance the ability to measure cost and value.

Add measures for appropriateness or overuse.

Promote infrastructure investments.

A central driver of the process used to select measures for the original Model was incorporating innovative thinking from the field while simultaneously drawing on evidence-based literature and documented best practices. Broadly, measures were selected based on their impact on care delivery and to support the goal of improving health outcomes, quality, safety, efficiency, and experience of care for patients.

As we continue to leverage our value-based purchasing initiatives to improve the quality of care furnished across healthcare settings, we are interested in considering new performance measures for inclusion in the expanded HHVBP Model. We requested public comments on one specific performance measure as well as general comments on other potential future model concepts that may be considered for inclusion in the expanded HHVBP Model. 1. Falls With Major Injury Measure (OASIS-Based and Claims-Based)

Within the home health population, approximately one third of individuals over the age of 65 experience one or more falls each year.41 42 Since 2022, CMS has reported rates for the Falls with Major Injury (FMI) measure on Care Compare. This measure is based on OASIS data.

\41\ Avin KG, Hanke TA, Kirk-Sanchez N, McDonough CM, Shubert TE, Hardage J, Hartley G; Academy of Geriatric Physical Therapy of the American Physical Therapy Association. Management of falls in community-dwelling older adults: clinical guidance statement from the Academy of Geriatric Physical Therapy of the American Physical Therapy Association. Phys Ther. 2015 Jun;95(6):815-34. doi: 10.2522/ ptj.20140415. Epub 2015 Jan 8. PMID: 25573760; PMCID: PMC4757637.

\42\ Carande-Kulis V, Stevens JA, Florence CS, Beattie BL, Arias I. A cost-benefit analysis of three older adult fall prevention interventions. J Safety Res. 2015 Feb;52:65-70. doi: 10.1016/ j.jsr.2014.12.007. Epub 2015 Jan 6. PMID: 25662884; PMCID: PMC6604798.

A recent study \43\ found that more than half of falls with a major injury (identified using Medicare claims data) were not reported on OASIS assessments. OIG observed that a low fall rate reported on Care Compare may reflect a provider's lack of falls reporting, rather than a low incidence of falls among its patients. OIG further observed that HHAs with low falls with major injury rates on Care Compare were more likely than other HHAs not to report falls among patients enrolled in Medicare. These findings raised concerns about the accuracy of this measure. In response to this OIG study, CMS is currently working on a respecified version of the FMI measure that uses fee-for-service claims, encounter data, and OASIS data. Using multiple data sources will produce a more robust and complete data set, allowing the respecified FMI measure to be more accurate and include more providers. Members of the Post-Acute Care (PAC) and Home Health Cross-Setting TEP also broadly agreed that data accuracy is vitally important for the measure's aim of making cross-provider comparisons.

\43\ https://oig.hhs.gov/reports/all/2023/home-health-agencies-failed-to-report-over-half-of-falls-with-major-injury-and-hospitalization-among-their-medicare-patients/.

In addition, the respecified FMI measure includes other injuries not explicitly covered in the OASIS-based FMI measure, which uses a specific measure of falls with major injury that includes only bone fractures, joint dislocations, closed head injuries with altered consciousness, and subdural hematomas.

We requested comments related to the potential addition of the respecified FMI measure to the measure set for the expanded HHVBP Model. The following is a summary of the comments we received and our responses:

Comment: Several commenters agreed that CMS should include the Falls with Major Injury (FMI) measure in HHVBP applicable measure set in the future. Supporters agreed that the measure would improve the robustness and completeness of the data set, and that falls are a relevant concern for patients that should be tracked. A commenter suggested that CMS consider adding questions to HHCAHPS survey instrument related to falls, to complement OASIS data and improve accuracy. However, other commenters cited concerns about accuracy of reporting, the unique circumstances of episodic home health care compared to 24/7 institutional care, the potential risk of penalizing providers for factors outside of their control, potential overlap with the MSPB-PAC measure, and the possibility that providers might be discouraged from admitting high-risk patients. A commenter welcomed an opportunity for CMS to validate agencies' existing fall reporting and prevention rather than add new elements to the current FMI quality measure.

Response: CMS appreciates the public comments regarding the respecified FMI measure. CMS will consider this input while continuing to refine the expanded HHVBP Model in the future. 2. Potential Future Changes to HHCAHPS Scoring Rules and Applicable Measure Set

We sought public comments regarding two potential changes to the HHCAHPS Survey-based measures scoring rules and applicable measure set as they relate to the expanded HHVBP Model: a. Measuring HHA Performance on Forthcoming HHCAHPS Items Based Only on HHA Achievement

As discussed previously within the rule, CMS anticipated proposing new HHCAHPS Survey-based measures to replace the Care of Patients, Communication Between Providers and Patients, and Specific Care Issues measures through future rulemaking. These revised HHCAHPS Survey-based measures will be based on data collected from the revised HHCAHPS Survey instrument. Data for these revised measures will be required to establish benchmarks and achievement thresholds. CMS will require 1 year of data to establish appropriate benchmarks and achievement thresholds for measuring HHAs' level of performance. By contrast, CMS will require 2 years of data to measure improvement over time and establish improvement thresholds.

Therefore, CMS sought public comments on the possibility of initially measuring HHA performance on the future HHCAHPS Survey-based measures based solely on achievement, rather than both achievement and improvement. This would allow CMS to potentially begin using the revised HHCAHPS measures in the expanded HHVBP Model starting with the CY 2028 performance year. If CMS proposes adding the achievement-based HHCAHPS Survey-based measures to the expanded HHVBP Model starting with the 2028 performance year, then benchmarks and achievement thresholds would be published in 2027, using data from 2026.

After sufficient data are available to develop appropriate improvement thresholds, CMS anticipates measuring HHA performance on these HHCAHPS Survey-based measures based on both achievement and improvement. This change would be proposed through future rulemaking.

b. Adding to the Applicable Measure Set for the Expanded HHVBP Model the Three Remaining Items in the Specific Care Issues Measure as Single Item Measures

As discussed previously, CMS proposed and finalized the decision to modify the HHCAHPS Survey instrument. Among other changes, the proposal removed several items used in the multi-item Specific Care Issues measure. Three of the items used in the Specific Care Issues measure will remain in the HHCAHPS Survey instrument. The three items from the Specific Care Issues measure included in the revised HHCAHPS Survey instrument are as follows:

When you first started getting home health care from this agency, did someone from the agency talk about ways to help make your home safer? For example, they may have suggested adding grab bars in the shower or removing tripping hazards.

Has someone from the agency ever reviewed the prescribed and over-the-counter medicines you were taking? For example, they might have asked you to show them your medicines and talked with you about how and when to take each one.

In the last 2 months of care, did home health staff from this agency talk with you about any side effects of your medicines?

CMS sought public comments on the possibility of adding these three remaining HHCAHPS Survey items to the expanded HHVBP Model as single- item measures. We also sought public comments on the possibility of giving each of these single item measures a weight of one third the weight of the other HHCAHPS items, thus maintaining the same relative weight of the Specific Care Issues measure. The following is a summary of the comments we received and our responses:

Comment: Several commenters disagreed with CMS's potential future uses for HHCAHPS Survey-based measures. A few commenters recommended CMS not include the remaining individual items from the Specific Care Issues measure, and instead prioritize patient reported outcome measures. Several commenters discouraged CMS from reporting future HHCAHPS Survey-based measures using only achievement points. These commenters believed that incorporating achievement points and improvement points simultaneously would avoid additional disruptions, better inform agencies' decisions, and avoid disadvantaging agencies that are improving. They uniformly expressed that agencies should be given the full two-year period before the HHCAHPS Survey-based measures are reintroduced.

Response: We appreciate the public comments regarding the HHCAHPS Survey-based measures. We will consider this input while continuing to refine the expanded HHVBP Model in the future.

Comment: Several commenters offered suggestions other than those directly named in the RFI. A commenter suggested that CMS adopt comprehensive functional outcome measures that accurately capture a patient's full range of functional status, including communication, cognition, and swallowing. A few commenters opposed any additional data collection or measures.

Response: CMS appreciates the public comments submitted in response to this RFI. CMS will consider this input while continuing to refine the expanded HHVBP Model in the future.

Section 1891(d) of the Act, cross-referencing section 1891(c)(2)(C)(i)(I) of the Act (section 4022(a) of Pub. L. 100-203 (December 22, 1987)), required the Secretary to develop a comprehensive assessment for Medicare-participating HHAs. Section 1891(c)(2)(C)(i)(II) of the Act also requires a survey of the quality of care and services furnished by the agency as measured by indicators of medical, nursing, and rehabilitative care provided by the HHA. Subsequently, CMS developed an assessment instrument that identifies each patient's need for home care and the patient's medical, nursing, rehabilitative, social and discharge planning needs. Part of this assessment requires Medicare-certified HHAs to use a standard core assessment data set, the Outcome and Assessment Information Set (OASIS). Thus, OASIS became the designated assessment instrument for use by an HHA in complying with these reporting requirements.

Section 704 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, December 8, 2003) suspended the legal authority of the Secretary to require HHAs to gather or report non-Medicare and non-Medicaid patient data to CMS until certain conditions \44\ were met. Subsequently, CMS conducted a study from 2004 to 2005 and submitted a report \45\ to Congress which recommended that the suspension of data collection on non-Medicare and non-Medicaid patients continue. In addition, the Improving Medicare Post-Acute Care Transformation Act (IMPACT Act) (Pub. L. 113-185, October 6, 2014) required CMS to create a uniform quality measurement system that allows CMS to compare outcomes across post-acute care (PAC) providers, which include HHAs.

\44\ Section 704(b) of the MMA suspended legal authority to require HHAs to report on non-Medicare and non-Medicaid patient data until at least two months after the Secretary published final regulations on CMS's collection and use of OASIS data for non- Medicare/Medicaid patients following the submission of a report to Congress on the study described under section 704(c) of the MMA.

\45\ The “OASIS Study: The Costs and Benefits Associated with the Collection of Outcome and Assessment Information Set (OASIS) Data on Private Pay Home Patients--Report to Congress” https://www.cms.gov/files/document/cms-oasis-study-all-payer-data-submission-2006.pdf.

In response to the IMPACT Act, the final rule titled, “Medicare Program; Calendar Year (CY) 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded Model Requirements; and Home Infusion Therapy Services Requirements” (87 FR 66790, November 4, 2022) finalized the requirement for HHAs to report OASIS data on all patients, regardless of payer, for the applicable 12-month performance period (for example, July 1, 2025-June 30, 2026) (87 FR 66862 through 66865). With the CY 2025 HH PPS final rule (89 FR 88354, November 7, 2024), CMS established that start of care (SOC) is the first assessment that can be submitted for a non-Medicare/non-Medicaid patient, either on or after January 1, 2025, for the phase-in (voluntary) period or on or after July 1, 2025, for the mandatory reporting period (89 FR 88439 through 88441). This ended the suspension of the OASIS data collection on non-Medicare and non-Medicaid HHA patients.

B. Updates to the Home Health Agency (CoPs) To Align With the OASIS All-Payer Submission Requirements (Sec. Sec. 484.45(a) and 484.55(d)(1)(i))

Section 484.45(a) of the HHA CoPs currently requires an HHA to encode and electronically transmit each completed OASIS assessment to the CMS system, “regarding each beneficiary” with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the “assessment of the beneficiary.” To

align with the transition to OASIS all-payer submission requirements we proposed at Sec. 484.45(a) to remove the term “beneficiary” and replace it with the term “patient.”

Additionally, under section 484.55 of the HHA CoPs, all patients must receive, and an HHA must provide, a comprehensive assessment no later than 5 calendar days after the start of care. The comprehensive assessment must incorporate the most current version of the OASIS data items. This includes clinical record items, patient history, supportive assistance, etc. Section 484.55(d)(1)(i) specifies a “beneficiary elected transfer” in reference to one scenario in which an OASIS assessment must be updated. To support the transition to OASIS all- payer submission requirements, we also proposed to remove the term “beneficiary” at Sec. 484.55(d)(1)(i).

Comment: A commenter requested additional clarification regarding the OASIS all-payer requirements. The commenter noted that the proposed policy shift would be a significant operations change for HHAs and the electronic medical record (EMR) systems they utilize. The commenter suggested CMS update the OASIS validation rules and engage EMR vendors in pilot testing.

Response: While the commenter noted the operational change that may be required, HHAs have had substantial time to prepare for the transition to the OASIS all-payer requirement as this policy was initially finalized in 2022 in the CY 2023 HH PPS final rule (87 FR 66862). With implementation of OASIS all-payer data submission, there is no required change to HHA electronic medical record systems. CMS is not introducing any new required OASIS items with the implementation of the all-payer proposal that would require a change to OASIS submission processes. With all-payer submission, HHAs will now be required to submit OASIS for patients receiving skilled care regardless of payor source using the same processes currently in place for Medicare and Medicaid patients. Lastly, all HHAs will continue to have access to technical support relative to submission of OASIS data via the QIES Technical Support Office website https://qtso.cms.gov/ and iQIES team at CMS.

After consideration of public comment, we are finalizing the technical changes to the CoPs as proposed. Thus, Sec. 484.45(a) will state that an HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, “regarding each patient” with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the “assessment of the patient” and Sec. 484.55(d)(1)(i) will state “Elected transfer.” These technical changes further clarify that the requirement for reporting OASIS information applies to all HHA patients receiving skilled services and align the language in the CoPs with the requirements finalized in the CY 2023 and CY 2025 HH PPS final rules. We emphasize that there is no change to existing policy regarding patient exemptions from OASIS, which are as follows: patients under the age of 18; patients receiving maternity services; and patients receiving only personal care, housekeeping, or chore services. Additionally, we remind readers that the OASIS submission requirements continue not to apply to patients receiving Part B outpatient therapy services provided by an HHA that elects to provide these outpatient services.\46\ Patients receiving Part B outpatient therapy services would not have an HHA plan of care nor would an OASIS assessment be completed on these patients.

\46\ In accordance with 484.105(g) an HHA that furnishes outpatient physical therapy or speech-language pathology services must meet all of the applicable conditions of Part 484 and the additional health and safety requirements set forth in Sec. Sec. 485.711, 485.713, 485.715, 485.719, 485.723, and 485.727 to implement section 1861(p) of the Act.