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Alliance Co-Chairs Dr. John Steinberg and Dr. Caroline Fife at Spring 2014 meeting

Alliance Official Comments to Regulatory Agencies and Congress


2017

  • May 2017-Oral testimony at Wisconsin Physician Services (WPS) public meeting, providing comments to draft wound care LCD that addresses debridement, and biophysical agents including NPWT and MIST therapy.
  • March 2017-Alliance comments to First Coast Service Option (FCSO) draft LCD on wound care (DL37166)
  • March 2017-Alliance comments to Novitas Solutions draft LCD on wound care (DL35125)
  • March 2017-Alliance comments to Novitas Solutions draft LCD on treatment of varicose veins of the lower extremities (DL34924)
  • February 2017-Alliance oral testimony to FCSO at public meeting convened to collect comments on its draft wound care LCD
  • January 2017-Alliance oral testimony to Novitas at its open meeting to collect comments on its draft LCD on wound care

2016

  • December 2016-Alliance submits comments to CMS on MACRA final rule.
  • November 2016-Alliance comments to FDA’s General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee supporting classification of antimicrobial wound care products as Class II with special controls.
  • October 2016-Alliance comments to FDA draft guidance on “Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices"
  • September 2016-Alliance comments to FDA draft guidance “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products
  • September 2016-Alliance comments to FDA draft guidance “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products”
  • September 2016-Alliance oral comments at FDA’s Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
  • September 2016-Alliance submits comments to FDA’s General and Plastic Surgery Panel of the Medical Devices Advisory Committee for its September 20-21 Meeting
  • September 2016-Alliance submits comments to CMS regarding the Hospital Outpatient Prospective Payment System
  • September 2016-Alliance submits comments to CMS regarding the Physician Fee Schedule
  • August 2016-Alliance submits comments to CMS on Medicare Program; Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures; Proposed Rule
  • August 2016-Alliance submits comments to CMS on CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
  • August 2016-Alliance comments to CMS on CMS Patient Relationship Categories and Codes
  • August 2016-Alliance comments to Noridian Local Coverage Determination (LCD) for Hyperbaric Oxygen (HBO) Therapy (DL 36686)
  • August 2016-Alliance commentsto Cigna Government Services Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds of Lower Extremities (DL36690)
  • August 2016-Alliance comments (as member of the Venous Care Partnership) to AHRQ regarding Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD)
  • May 2016-Alliance comments to CMS on Medicare Program; Part B Drug Payment Model
  • March 2016-Alliance comments to CMS on CMS Quality Measure Development Plan
  • March 2016-Alliance comments to CMS on MACRA Episode Groups
  • February 2016-Alliance comments to CMS regarding Medicare Administrative Contractors (MAC) contracting process
  • January 2016-Alliance comments to DMEMAC medical directors requesting that the LCDs for pneumatic compression devices (PCD) conform to the binding national coverage determination for PCDs.

2015

  • December 2015-Alliance comments to National Government Services on Debridement of Wounds (DL 33614)
  • November 2015-Alliance powerpoint for meeting with CMS leadership on concerns with 2015 pneumatic compression LCD
  • November 2015-Alliance letter to CMS leadership regarding concerns on 2015 pneumatic compression LCD
  • November 2015-Alliance letter to DMEMACs regarding concerns on 2015 pneumatic compression LCD
  • November 2015-Alliance comments to Novitas on LCD for Strapping (DL36423)
  • November 2015-Alliance comments to First Coast on LCD for Hyperbaric Oxygen Therapy (DL36504)
  • November 2015-Alliance comments to Palmetto GBA on Local Coverage Determination (LCD) for Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds (DL364166), Bibliography of CTPs
  • October 2015-Alliance presentation at Palmetto GBA public meeting on LCD for Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds (DL364166)
  • September 2015-Alliance comments to CMS on Physicians Fee Schedule
  • September 2015-Alliance comments to DMEMACs on draft surgical dressings LCD
  • August 2015-Alliance comments to CMS on CNS-1633-P Medicare Program: Hospital Outpatient Prospective Payment System proposed regulation
  • August 2015-Oral testimonies from Marcia Nusgart and Alliance member Kara Couch at the DMEMAC Surgical Dressing LCD Public Meeting
  • July 2015-Alliance comments to Palmetto draft Local Coverage Determination (LCD) for Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds (DL36123)
  • July 2015-Alliance letter to Senators Chuck Grassley (R-IA) and Charles Schumer (D-NY) and Representatives Renee Ellmers (R-NC) and Diana DeGette (D-CO) in support of the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act (HR 1221 / S 626)
  • July 2015-Alliance comments to Novitas Solutions Draft Local Coverage Determination (LCD) for Hyperbaric Oxygen (HBO) Therapy (DL35021)
  • May 2015-Alliance comments to First Coast Service Option regarding draft Local Coverage Determination (LCD) for Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities (DL36013)
  • May 2015-Alliance response to DMEMAC and PDAC letter on non-covered surgical dressing article
  • April 2015-Alliance letter to Novitas to clarify issues in final skin substitute policy
  • April 2015-Alliance second letter to DMEMAC and PDAC on non-covered surgical dressing article
  • February 2015-Alliance Letter to DMEMACs PDAC non-covered surgical dressing article
  • February 2015-Alliance Comments to FDA Minimal Manipulation of Human Cell, Tissues, and Cellular, and Tissue-Based Products guidance document
  • February 2015-Alliance Letter to Energy and Commerce Committee in support of disposable medical technology in the 21st Century Cures discussion draft bill

2014

  • December 2014- Alliance comments to CMS on CMS-1612-FC: CY 2015 Physician Fee Schedule Final Rule
  • December 2014- Alliance comments to CMS on CMS-1613-FC: CY 2015 Hospital Outpatient Prospective Payment System Final Rule
  • November 2014-Alliance comments to Novitas on draft skin substitute policy
  • October 2014- Alliance letter to DMEMACs on clinical issue concerns related to pneumatic compression LCD
  • October 2014- October 2014 Alliance letter to CMS regarding concerns on pneumatic compression LCD
  • September 2014- Alliancecomments to CMS on CMS-1612-P: CY 2015 Physician Fee Schedule
  • September 2014- Alliance comments to CMS on CMS-1613-P: CY 2015 Hospital Outpatient Prospective Payment System
  • September 2014- Alliance comments to Cahaba Government Benefit Administrators®, LLC draft LCD regarding Ultrasound Therapy for Wounds (DL 35300)
  • August 2014- Alliance comments to CMS on CY 2015- Update to Home Health Agency PPS- Face to Face Requirement (CMS- 1611-P)
  • August 2014- Alliance comments to Palmetto draft LCD on Debridement of Wounds (DL 35415)
  • July 2014 Alliance comments to AHRQ on Negative Pressure Wound Therapy Technologies for Chronic Wound Care in the Home Setting
  • July 2014 -Alliance comments to First Coast Service Options on draft LCD-DL35384 - Application of Bioengineered Skin Substitutes for the Treatment of Diabetic and Venous Stasis Ulcers of the Lower Extremities
  • July 2014- Alliance comments to the DME MACs regarding Request for Information: Medical Grade Honey as a Surgical Dressing Component
  • July 2014- Alliance comments to CMS on Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items
  • May 2014 Alliance comments summary at May 20 2014 HCPCS Public meeting
  • March 2014 Alliance comments to Novitas Solutions for Local Coverage Determination on Hyperbaric Oxygen Therapy
  • February 2014 Alliance letter for CMS’ Hospital Outpatient Panel meeting
  • January 2014 Alliance comments to CMS on Hospital Outpatient Prospective Payment System Final Rule
  • January 2014 Alliance letter to Cochrane Collaboration Regarding Recent Wound Care Review

2013

  • December 2013 Alliance Response to Milliman Care Guidelines Email and Letter Including Attachments - Exhibit A, Exhibit B, Exhibit C
  • November 2013 Alliance comments to Novitas Solutions on Wound Care and Bioengineered Skin Substitutes
  • September 2013 Alliance comments to CMS on Hospital Outpatient Prospective Payment System [Attachment A, Attachment B]
  • July 2013 Alliance sends letter of concern to Milliman Care Guidelines (MCG) on inaccuracy of its guidelines on intermittent pneumatic compression
  • July 2013 Alliance comments to Novitas Solutions on Wound Care and Bioengineered Skin Substitutes
  • June 2013 Alliance comments to CMS on Inpatient Prospective Payment System
  • April, 2013 Alliance comments Cigna Government Services on CTPs
  • March 2013 Alliance comments to First Coast on Cellular and/or Tissue Derived Products for Wounds (CTPs)
  • January 27, 2013 Alliance comments to CMS on coverage with evidence development

2012

  • December 2012 Alliance comments to CMS regarding G codes as part of the Physician’s Fee Schedule
  • September 2012 Alliance comments to CMS on the Physician’s Fee Schedule
  • August 10 2012 Alliance Letter to Congress to support Equity and Access for Podiatric Physicians Under Medicaid Act (S. 1309 / H.R. 3364)
  • July 12, 2012 Alliance comments to Noridian on draft LCD on skin substitutes
  • June 29, 2012 Alliance thank you letter to AHRQ for meeting about draft technology assessment on skin substitutes
  • May 2012 Alliance comments to CMS on Inpatient Hospital Prospective Payment System
  • January 17, 2012 Comments to AHRQ on skin substitute technology assessment.
  • February 1, 2012 Letter to Acting Administrator Tavenner thanking her for meeting on NPWT supplier accreditation checklist.

2011

  • November 1, 2011 Letter to National Correct Coding Initiative requesting changes in current billing edits to ensure appropriate wound care delivery.
  • November 1, 2011 Comments to AHRQ on venous stasis ulcer comparative effectiveness review
  • October 3, 2011 Letter to Congressional Committees of Jurisdiction regarding the need for CMS to use NPWT quality standards for suppliers in competitive bidding
  • October-Submitted the following wound care quality measures to CMS:
    • Support surface or offloading of patients with stage III/IV pressure ulcers - Form, Spec, Letter
    • Offloading status for patients with DFU - Form, Spec, Letter
    • Vascular testing of patients with leg ulcers - Form, Spec, Letter
    • Venous compression each visit of patients with venous stasis ulcers - Form, Spec, Letter
  • September 23, 2011 Comments to DMEMAC medical directors medical directors on suction pump draft LCD
  • Septemer 23, 2001 Comments to DMEMAC medical directors on pneumatic compression draft LCD
  • August 30, 2011 Presented powerpoint at DMEMAC public meeting regarding Pneumatic compression draft LCD
  • August 30, 2011 Comments to CMS on Physicians fee schedule
  • July 21, 2011 Comments to AHRQ on “Methods Guide for Effectiveness and Comparative Effectiveness Review: Avoiding Bias in Selecting Studies”
  • July 1, 2011 Comments to AHRQ on “Engage Stakeholders to Identify and Prioritize Future Research Needs
  • June 6, 2011 Comments to CMS on proposed rule on Accountable Care Organizations
  • March 31, 2011 Letter Submitted to CMS “Draft Negative Pressure Wound Therapy Quality Standards for Suppliers” to be used in the second round of competitive bidding

2010

  • December 17, 2010 Comments to Cahaba on the Draft LCD for Bioengineered Skin Substitutes (DL31428)
  • October 15, 2010 Recommendations to the National Health Care Quality Forum Strategy & Plan
  • October 15, 2010 Comments to Pinnacle on the Draft LCD for Skin Substitute Use in Lower Extremities Chronic Ulcers (DL31385)
  • August 31, 2010 Comments to CMS on Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2011 Payment Rules (CMS-1504-P)
  • August 24, 2010 Comments to CMS on the Proposed Payment Policies Under the Physician Fee Schedule CY 2011 (CMS-1503-P)
  • April 12, 2010 Comments to Trailblazer on Draft LCD for Bioengineered Skin Substitutes 4S-162AB
  • April 7, 2010 Comments to NHIC, Corp. on Draft LCD for Biologic Products for Wound Treatment and Surgical Interventions DL29867
  • February 24, 2010 Comments to National Government Services on LCD for Debridement Services DL27373

2009


2008

  • December 3, 2008 Comments on Wisconsin Physician Services Draft LCD on Wound Care
  • September 28, 2008 Comments to CMS on Potential Topics for Future National Coverage Determinations
  • September 2, 2008 Comments on Proposed Changes to HOPPS
  • August 29, 2008 Comments on Physician Fee Schedules
  • June 13, 2008 Comments on Proposed IPPS Changes
 

Alliance of Wound Care Stakeholders © 2013