Medicare Program; Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; and Other Medicare Policies

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 424, 483, and 484</CFR> <DEPDOC>[CMS-1803-F]</DEPDOC> <RIN>RIN 0938-AV28</RIN> <SUBJECT>Medicare Program; Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; and Other Medicare Policies</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This final rule will set forth routine updates to the Medicare home health payment rates; the payment rate for the disposable negative pressure wound therapy (dNPWT) devices; and the intravenous immune globulin (IVIG) items and services payment rate for CY 2025 in accordance with existing statutory and regulatory requirements. In addition, it finalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements and provides an update on potential approaches for integrating health equity in the Expanded Health Value Based Purchasing (HHVBP) Model. It also finalizes a new standard for an acceptance-to-service policy in the HH conditions of participation (CoPs). Lastly, it updates provider and supplier enrollment requirements and changes to the long-term care reporting requirements for acute respiratory illnesses. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> These regulations are effective on January 1, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Brian Slater, (410) 786-5229, for home health and home IVIG payment inquiries. For general information about the Home Health Prospective Payment System (HH PPS), send your inquiry via email to <E T="03">HomeHealthPolicy@cms.hhs.gov.</E> For general information about the IVIG Items and Services Payment, send your inquiry via email to <E T="03">HIT_IVIGpolicy@cms.hhs.gov.</E> For information about the Home Health Quality Reporting Program (HH QRP), send your inquiry via email to <E T="03">HHQRPquestions@cms.hhs.gov.</E> For more information about the expanded Home Health Value-Based Purchasing Model, please visit the Expanded HHVBP Model web page at <E T="03">https://innovation.cms.gov/innovation-models/expanded-home-health-value-based-purchasing-model.</E> Frank Whelan, (410) 786-1302, for Medicare provider and supplier enrollment inquiries. Mary Rossi-Coajou at <E T="03">mary.rossi-coajou@cms.hhs.gov</E> or Molly Anderson at <E T="03">molly.anderson@cms.hhs.gov,</E> for more information about the home health conditions of participation (HH CoPs). Kim Roche at <E T="03">kim.roche1@cms.hhs.gov</E> or Diane Corning at <E T="03">diane.corning@cms.hhs.gov</E> for information about long term care facility acute respiratory illness reporting. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary and Issuance of the Final Rule</FP> <FP SOURCE="FP1-2">A. Executive Summary</FP> <FP SOURCE="FP1-2">B. Issuance of the Proposed Rule</FP> <FP SOURCE="FP-2">II. Home Health Prospective Payment System</FP> <FP SOURCE="FP1-2">A. Overview of the Home Health Prospective Payment System</FP> <FP SOURCE="FP1-2">B. Monitoring the Effects of the Implementation of PDGM</FP> <FP SOURCE="FP1-2">C. CY 2025 Final Rule Payment Adjustments Under the HH PPS</FP> <FP SOURCE="FP1-2">D. CY 2025 Home Health Low Utilization Payment Adjustment (LUPA) Thresholds, Functional Impairment Levels, Comorbidity Sub-Groups, Case-Mix Weights, and Reassignment of Specific ICD-10-CM Codes Under the PDGM</FP> <FP SOURCE="FP-2">III. Home Health Quality Reporting Program (HH QRP)</FP> <FP SOURCE="FP1-2">A. Background and Statutory Authority</FP> <FP SOURCE="FP1-2">B. Summary of the Provision of This Final Rule</FP> <FP SOURCE="FP1-2">C. Quality Measures Currently Adopted for the CY 2024 HH QRP</FP> <FP SOURCE="FP1-2">D. Proposal To Collect Four New Items as Standardized Patient Assessment Data Elements and Modify One Item Collected as a Standardized Patient Assessment Data Element Beginning With the CY 2027 HH QRP</FP> <FP SOURCE="FP1-2">E. Proposal To Update OASIS All-Payer Data Collection</FP> <FP SOURCE="FP1-2">F. Form, Manner, and Timing of Data Submission Under the HH QRP</FP> <FP SOURCE="FP1-2">G. HH QRP Quality Measure Concepts Under Consideration for Future Years—Request for Information (RFI)</FP> <FP SOURCE="FP-2">IV. The Expanded Home Health Value-Based Purchasing (HHVBP) Model</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Request for Information on Future Performance Measure Concepts for the Expanded HHVBP Model</FP> <FP SOURCE="FP1-2">C. Future Approaches to Health Equity in the Expanded HHVBP Model</FP> <FP SOURCE="FP1-2">D. Social Risk Factors</FP> <FP SOURCE="FP1-2">E. Approaches to a Potential Health Equity Adjustment for the Expanded HHVBP Model</FP> <FP SOURCE="FP1-2">F. Other Health Equity Measures</FP> <FP SOURCE="FP-2">V. Medicare Home Intravenous Immune Globulin (IVIG) Items and Services</FP> <FP SOURCE="FP1-2">A. General Background</FP> <FP SOURCE="FP1-2">B. Scope of Expanded IVIG Benefit</FP> <FP SOURCE="FP1-2">C. Home IVIG Administration Items and Services Payment</FP> <FP SOURCE="FP1-2">D. Home IVIG Items and Services Payment Rate</FP> <FP SOURCE="FP-2">VI. Home Health Agency Condition of Participation (CoP) Changes and Long Term Care (LTC) Facility Requirements for Acute Respiratory Illness Reporting</FP> <FP SOURCE="FP1-2">A. Home Health Agency CoP Changes</FP> <FP SOURCE="FP1-2">B. Long-Term Care (LTC) Requirements for Acute Respiratory Illness Reporting</FP> <FP SOURCE="FP-2">VII. Provider Enrollment—Provisional Period of Enhanced Oversight</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Provisional Period of Enhanced Oversight (PPEO)</FP> <FP SOURCE="FP-2">VIII. Collection of Information Requirements</FP> <FP SOURCE="FP1-2">A. Statutory Requirement for the Solicitation of Comments</FP> <FP SOURCE="FP1-2">B. Information Collection Requirements (ICRs)</FP> <FP SOURCE="FP-2">IX. Regulatory Impact Analysis</FP> <FP SOURCE="FP1-2">A. Statement of Need</FP> <FP SOURCE="FP1-2">B. Overall Impact</FP> <FP SOURCE="FP1-2">C. Detailed Economic Analysis</FP> <FP SOURCE="FP1-2">D. Regulatory Review Cost Estimation</FP> <FP SOURCE="FP1-2">E. Alternatives Considered</FP> <FP SOURCE="FP1-2">F. Accounting Statements and Tables</FP> <FP SOURCE="FP1-2">G. Regulatory Flexibility Act (RFA)</FP> <FP SOURCE="FP1-2">H. Unfunded Mandates Reform Act (UMRA)</FP> <FP SOURCE="FP1-2">I. Federalism</FP> <FP SOURCE="FP1-2">J. Conclusion</FP> <FP SOURCE="FP1-2">K. Waiver Fiscal Responsibility Act Requirements</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary and Issuance of the Final Rule</HD> <HD SOURCE="HD2">A. Executive Summary</HD> <HD SOURCE="HD3">1. Purpose and Legal Authority</HD> <HD SOURCE="HD3">a. Home Health Prospective Payment System (HH PPS)</HD> As required under section 1895(b) of the Social Security Act (the Act), this final rule updates the CY 2025 payment rates for home health agencies (HHAs) and the CY 2025 payment rate for disposable negative pressure wound therapy (dNPWT) devices. This rule finalizes a crosswalk for mapping the Outcome and Assessment Information Set-D (OASIS-D) data elements to the equivalent OASIS-E data elements for use in the methodology to analyze the difference between assumed versus actual behavior change on estimated aggregate expenditures and finalizes a permanent adjustment to the CY 2025 home health base payment rate. In addition, this rule finalizes the recalibrated PDGM case-mix weights and updates the low-utilization payment adjustment (LUPA) thresholds, functional impairment levels, and comorbidity adjustment subgroups under section 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for 30-day periods of care in CY 2025; finalizes the proposal to adopt the most recent Office of Management and Budget (OMB) Core-Based Statistical Area (CBSA) delineations for the home health wage index; and finalizes an occupational therapy (OT) LUPA add-on factor and updates the physical therapy (PT), speech-language pathology (SLP), and skilled nursing (SN) LUPA add-on factors. Additionally, this rule updates the CY 2025 fixed-dollar loss ratio (FDL) for outlier payments (so that outlier payments as a percentage of estimated total payments are projected not to exceed 2.5 percent, as required by section 1895(b)(5)(A) of the Act). <HD SOURCE="HD3">b. Home Health (HH) Quality Reporting Program (QRP)</HD> In accordance with the statutory authority at section 1895(b)(3)(B)(v) of the Act, we are finalizing updated policies. We are finalizing a proposal to add four new assessment items and modify one assessment item on the OASIS, update the removal of the suspension of OASIS all payer data collection and summarize public feedback on future HH QRP quality measure (QM) concepts. <HD SOURCE="HD3">c. Expanded Home Health Value-Based Purchasing (HHVBP) Model</HD> In accordance with the statutory authority at section 1115A of the Act, we are doing the following for the expanded HHVBP Model: (1) providing an update on potential approaches for integrating health equity that are being considered; and (2) summarizing comments we received on a request for information (RFI) related to potential future performance measure concepts. <HD SOURCE="HD3">d. Home Intravenous Immune Globulin (IVIG) Items and Services</HD> In section V.D.1. of this rule, we finalize the rate for the CY 2025 IVIG items and services payment under the home intravenous immune gl ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 612k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━