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 (LCDs) 

• Jan. 2021: Noridian Proposed LCD on Wound Care (DL38902)
• Jan. 2021: Noridian DRAFT Local Coverage Article - Billing and Coding: Wound Care (DA58565)
• June 2020: Future Effective Oxygen and Oxygen Equipment LCD (DL33797)
• Dec. 2019: WPS Wound Care LCD
• Nov. 2018: Noridian policy article "Use of Amniotic Membrane Derived Skin Substitutes”
• April 2018: WPS Wound Care Coding Companion for Wound Care L37228 (A55909) 
• April 2018: WPS  Future Local Coverage Determination - Wound Care (L37228) 
• Sept. 2017: Novitas policy on Wound Care (L35125) - Final
• June 2017: DMEMAC Surgical Dressing LCD  (L33831)  and policy article – Final
• May 2017: DMEMACs LCD on Negative Pressure Wound Therapy Pumps (L33821) – Final
• March 2017: DMEMACs coverage updates with a revised NPWT policy that included the new NPUAP staging terminology. See LCD and policy article
• March 2017: Wisconsin Physicians Service Insurance Corporation (WPS) draft LCD on wound care (DL37228)
• Feb. 2017: Novitas Solutions draft LCD on treatment of varicose veins of the lower extremities (DL34924)
• Jan. 2017: First Coast Service Option draft LCD on wound care (DL37166)
• Jan. 2017: Novitas Solutions draft LCD on wound care  (DL35125)

National Coverage Decisions (NCDs)

• May 2017: CMS Decision Memo Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) 
• April 2017: CMS Decision Memo for Hyperbaric Oxygen (HBO) Therapy 

CMS Regulations

Prospective Payment System (PPS) Regulations - proposed and final 

• July 2021: Proposed Rule - CY 2022 Physician Fee Schedule (see CMS press release, and fact sheet on specific changes to the Quality Payment Program
• June 2021: Proposed Rule - CY 2022 Home Health PPS (see CMS fact sheet)
• April 2021: Proposed Rule - CY 2022 Hospital Inpatient PPS (see CMS fact sheet)
• December 2020: Final Rule - CY 2021 Hospital Outpatient PPS (see CMS press release)
• December 2020: Final Rule - CY 2021 Physician Fee Schedule (see CMS fact sheet and press release)
• August 2020: Proposed Rule - CY 201 Hospital Outpatient PPS (see CMS fact sheet)
• August 2020: Proposed Rule - CY 2021 Physician Fee Schedule
• May 2020: Proposed Rule - CY 2021 Hospital Inpatient PPS for Acute Care and Long-Term Care Hospitals
• April 2020:  Proposed Rule - CY 2021 PPS for Skilled Nursing Facilities
• November 2019: Final Rule - CY 2020 End-Stage Renal Disease/Durable Medical Equipment
• November 2019: Final Rule - CY 2020 Hospital Outpatient Prospective Payment System
• November 2019: Final Rule - CY 2020 Physician Fee Schedule
• October 2019: Final Rule - CY 2020 Home Health Prospective Payment System
• August 2019: Final Rule - CY 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) 

Quality Payment Program and MACRA implementation regulations - proposed and final

• Nov. 2017:  Quality Physician Payment Program
• June 2017: CMS CY 2018 Updates to MACRA’s Quality Payment Program and fact sheet
• 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
• Dec. 2016: CMS updates to Patient Relationship Categories and Codes
• May 2016: CMS proposed Patient Relationship Categories and Codes
• May 2016: Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service (CMS-5517-P) 
• 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

• 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)
• May 2018: Pre-Claim Review Demonstration for Home Health Services
• Sept. 2017: CMS Request for Information regarding the direction of the Center for Medicare and Medicaid  Innovation Center (CMMI)
• July 2017: CMS Withdrawal of Part B Drug Payment Model Proposal

PDAC, MEDCAC, HCPCS Workgroups

• Nov. 2018: Changes to the HCPCS Coding Process for 2019
• Nov. 2018: CMS Level II HCPCS Coding Decisions for the 2018-2019 Coding Cycle
• Nov. 2017: CMS release of the 2018 Healthcare Common Procedure Coding System (HCPCS) code set

FDA

• 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
• Aug. 2017:  Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices – Guidance for industry and FDA staff
• Aug. 2016 - FDA’s General & Plastic Surgery Devices Panel public meeting notice regarding the classification of antimicrobial wound care products as Class II with special controls
• Dec. 2015: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and FDA Staff
• Dec. 2015: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and FDA Staff

AHRQ

• February 2020: AHRQ final technology brief: Skin Substitutes for Treating Chronic Wounds
• June 2019: AHRQ re-opening of and update to Skin Substitutes technical brief: "Disposition of Submissions of Supplemental Evidence and Data for Systematic Reviews”  
• January 2018: AHRQ draft technical 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

Legislation

• Oct. 2017: H.R. 2445 DMEPOS Access & Transparency Act of 2017 
• Aug. 2017: H.R. 3635 Local Coverage Determination Clarification Act of 2018
• March 2017: S.794 Local Coverage Determination Clarification Act of 2018
• March 2017: H.R.1542 - HELLPP Act