The Alliance monitors and tracks recently issued draft and final regulations, guidance documents, coverage determinations, legislation and other policies relevant to wound care. We provide summaries to members, highlight provisions impacting wound care, and point to areas that may necessitate Alliance comment.

Included in our tracker (available to members only) are:

• CMS Regulations (Prospective Payment Systems, Physician Fee Schedule, Quality Payment Program, etc.)
• Local Coverage Determinations (LCDs)
• National Coverage Determinations (NCDs)
• FDA Guidance & Regulations
• AHRQ Technology Assessments
• Medicare Payment Advisory Commission (MEDPAC)
• Medicare Contractor for Pricing, Data Analysis and Coding of HCPCS Level II DMEPOS Codes (PDAC)
• Federal Legislation, and more...

CMS Regulations

Prospective Payment System (PPS) Regulations 

• July 2025: Proposed Rule - CY 2026 Medicare Physician Fee Schedule (see CMS fact sheet and Alliance summary of provisions)
• July 2025: Proposed Rule - CY 2025 Hospital Outpatient Prospective Payment System (See CMS fact sheet) 
• June 2025: Proposed Rule - CY 2026 Home Health Prospective Payment System (See CMS fact sheet and Alliance summary of provisions)
• Nov. 2024: Final Rule - CY 2025 Hospital Outpatient Prospective Payment System (See CMS press release, CMS fact sheet and and Alliance summary of provisions)
• Nov. 2024: Final Rule - CY 2025  Medicare Physician Fee Schedule (see CMS press release, CMS fact sheet and Alliance summary of provisions)
• Nov. 2024: Final Rule - CY 2025 Home Health Prospective Payment System (see CMS fact sheet and Alliance summary of provisions) 

Quality Payment Program and MACRA implementation regulations 

• Nov. 2017:  Quality Physician Payment Program
• Oct. 2016: Quality Payment Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
• May 2016: Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service 
• Nov. 2016: Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models

Evidence Review and Development

• Jan. 2025: Proposed Guidance Document: Study Protocols That Use Real-world Data
• Aug. 2024: Coverage with Evidence Development Guidance Document 
• Aug. 2024:  CMS National Coverage Analysis Evidence Review Guidance Document  

Miscellaneous - CMS

• Aug. 2024: CMS final notice outlining the Transitional Coverage for Emerging Technologies (TCET) Pathway for certain devices designated as “breakthrough” by the FDA (see CMS fact sheet and analysis from The National Law Review)
• Jan. 2024: Advancing Interoperability and Improving Prior Authorization Processes Final Rule 
• Nov. 2021: CMS repeal of Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary"

Read More