Policy Tracker

Below is a listing of recently issued draft and final regulations, guidance documents and local coverage determinations, as well as legislation and other policies relevant to wound care. Visit the Coalition's comments page to review the comments we have submitted related to many of these policy publications. 

LOCAL COVERAGE DECISIONS (LCD) 

• April 2024: Re-issued LCDs/LCAs  on Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers from 
• Aug. 2023: Final LCD from Novitas, FCSO and CGS on Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer [WITHDRAWN - see news release]
• July 2023: Revision to Noridian/CGS LCD on pneumatic compression (L33829) removing the requirement of serial four week trials of conservative therapy for lymphedema.
• Sept. 2022: CGS proposed LCD and LCA on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36690 / DA56696)
• April 2022: FCSO proposed LCDs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377) and accompanying Billing & Coding article (DA57680)
• April 2022: Novitas proposed LCDs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041) and accompanying Billing & Coding article (DA54117)
• April 2022: CGS updated its local coverage article on “Billing and Coding: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities” to add Q4253 to Group 2 codes (A56696)
• Oct. 2021: Noridian final LCD on Wound and Ulcer Care  (L38904) 
• Oct. 2021: Noridian final policy article on Billing and Coding: Wound and Ulcer Care (A58567)
• Sept. 2021: Noridian and CGS Proposed LCD on Pneumatic Compression Devices (DL33829). 
• Jan. 2021: Noridian Proposed LCD on Wound Care (DL38902) 
• Jan. 2021: Noridian DRAFT Local Coverage Article - Billing and Coding: Wound Care (DA58565)
• Jan. 2021: WPS revisions to Wound Care LCD (L37228)
• June 2020: Noridian and CGS LCD: Oxygen and Oxygen Equipment (L33797)
• Dec. 2019: WPS Wound Care LCD
• Nov. 2019: First Coast Service Option final LCD on wound care (L37166) 
• Nov. 2018: Noridian Local Coverage Article: Use of Amniotic Membrane-Derived Skin Substitutes (A56156)
• April 2018: WPS Local Coverage Determination - Wound Care (L37228) and Wound Care Coding Companion for Wound Care (A55909) 
• Sept. 2017: Novitas policy on Wound Care (L35125) - Final
• June 2017: DMEMAC Surgical Dressing final LCD  (L33831)  and policy article 
• May 2017: DMEMACs final LCD on Negative Pressure Wound Therapy Pumps (L33821)l
• March 2017: DMEMACs coverage update with a revised NPWT policy that includes new NPUAP staging terminology – LCD & policy article

NATIONAL COVERAGE DECISIONS (NCD)

• April 2021 Final Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4) clarifying coverage for autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds.
• Jan. 2021: Proposed Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4)
• April 2017: CMS Decision Memo for Hyperbaric Oxygen (HBO) Therapy 

CMS REGULATIONS

Prospective Payment System (PPS) Regulations - proposed and final

• Nov. 2023: Final Rule - CY 2024 Physician Fee Schedule 
• Nov. 2023 Final Rule - CY 2024 Hospital Outpatient Prospective Payment System 
• Nov. 2023 Final Rule - CY 2024 Home Health Prospective Payment System Rate
• July 2023: Proposed Rule - CY 2024 Physician Fee Schedule 
• July 2023: Proposed Rule - CY 2024 Hospital Outpatient Prospective Payment System 
• July 2023: Proposed Rule - CY 2024 Home Health Prospective Payment System 
• April 2023: Proposed Rule - CY 2024 Hospital Inpatient Prospective Payment System. 

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

Miscellaneous - CMS

• Oct. 2023: 21st Century Cures Act - HHS Proposed Rule on Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (see HHS press release)
• June 2023: CMS notice outlining pathways for Transitional Coverage for Emerging Technologies 
• Feb. 2023: CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency that is set to expire in May.
• Dec. 2022: Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule 
• Nov. 2021: CMS repeal of Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary"
• June 2020: CMS creates Office of Burden Reduction and Health Informatics - an outgrowth of the agency’s Patients over Paperwork Initiative
• May 2019: CMS strategy to foster innovation for transformative medical technologies (includes allowing medical device manufacturers to submit HCPCS code applications twice a year rather than once a year)
• Oct. 2018: Changes to the Medicare Program Integrity Manual - Local Coverage Determinations (see accompanying MedLearn Matters)

HCPCS CODING

• HCPCS main page
• PDAC main page

FDA

• Real-World Evidence & Clinical Trials
  • Dec. 2023: Draft guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  • Oct. 2023: Draft guidance - Diabetic Foot Infections: Developing Drugs for Treatment
  • May 2023: Draft guidance - Decentralized Clinical Trials for Drugs, Biological Products, and Devices
  • May 2022: Food and Drug Administration perspective: Advancing product development for non-healing chronic wounds as published in Wound Repair & Regeneration
  • Nov. 2021: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
  • Oct. 2021: Data Standards for Drug and Biological Product Submissions Containing Real-World Data - Draft Guidance for Industry
  • Sept. 2021: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products – Draft Guidance for Industry
  • Dec. 2018: Framework for FDA’s Real-World Evidence Program
  • Aug. 2017:  Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices – Guidance for industry and FDA staff

• Other FDA Guidances
  
  • Nov. 2023: Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Creams, or Ointment, and Liquid Wound Washes 
  • Nov. 2023: Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials
  • June 2023: Human Cells, Tissues, and Cellular and Tissue-Based Product Establishments That Are Improperly Registered in the Electronic Human Cell and Tissue Establishment Registration System Due to Lack of Annual Registration Update - Update on inactivation 
  • July 2020: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use - Guidance for Industry
  • Nov. 2017: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff

TECHNOLOGY ASSESSMENTS

• February 2020: AHRQ final technology brief: Skin Substitutes for Treating Chronic Wounds
• June 2019: AHRQ re-opening of and update to Skin Substitutes technology brief: "Disposition of Submissions of Supplemental Evidence and Data for Systematic Reviews”  
• January 2018: AHRQ draft technology brief Skin Substitutes for Treating Chronic Wounds
• April 2017: AHRQ technology assessment report Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD)

MEDICARE PAYMENT ADVISORY COMMISSION (MEDPAC)

• MedPAC reports to Congress
• MedPAC public meetings

HHS OFFICE OF INSPECTOR GENERAL 

• March 2023: ASP pricing for skin substitutes. "Some Skin Substitute Manufacturers Did Not Comply with New ASP Reporting Requirements" (OEI-BL-23-00010)
• Dec. 2022: CMS Should Bolster Its Oversight of Manufacturer-Submitted Average Sales Price Data To Ensure Accurate Part B Drug Payments (OEI-03-21-00390)
• Dec. 2022: Manufacturers May Need Additional Guidance To Ensure Consistent Calculations of Average Sales Prices (OEI-BL-21-00330)

GOVERNMENT ACCOUNTABILITY OFFICE (GAO)

• March 2021 “Medicare Part B: Payments and Use for Selected New, High-Cost Drugs”
• Jan. 2021 “Medicare Severe Wound Care: Spending Declines May Reflect Site of Care Changes” 

FEDERAL LEGISLATION IMPACTING WOUND CARE

• June 2023: Reintroduction of the Amputation Reduction and Compassion Act to reduce preventable amputations by requiring Medicare, Medicaid, and plans sold on the federal healthcare exchanges to fully cover screening tests for individuals at-risk of peripheral artery disease (PAD).
• June 2023: Reintroduction of the CONNECT for Health Act to expand Medicare coverage of telehealth services and make it easier for patients to connect with their doctors.
• May 2023: introduction of the “Providing Relief and Stability for Medicare Patients Act of 2023” (H.R. 3674) to increase the nonfacility practice expense relative value units and help mitigate cuts to office-based specialists.
• December 2022: The Lymphedema Treatment Act (LTA) was passed into law as part of the Consolidated Appropriation Act of 2023, creating a new Medicare benefit category and coverage for lymphedema compression supplies. (See text of the LTA provisions included here.)
• December 2022: The Better Wound Care at Home Act was passed into law as part of the Consolidated Appropriation Act of 2023, removing several CMS bureaucratic barriers and making it easier for home health agencies to provide disposable negative pressure wound therapy. (See provisions here)