Submitted Comments

Items Related to LCDs

July 3, 2020

Comments to CMS COVID-19 Public Health Emergency Second Interim Final Rule

The Alliance submitted comments to CMS's COVID-19 Public Health Emergency Second Interim Final Rule that provided additional policy and regulatory revisions to provide flexibility during the pandemic. The Alliance  providing specific comments and recommendations addressing:
  • The codes that should be utilized by Provider Based Departments (PBD) when billing for wound care services via telehealth that has been temporarily relocated to a patient’s home
  • Competitive bidding program concerns
  • Temporary relocation sites
  • The Appropriate Use Criteria (AUC) program
  • Merit-based Incentive Payment System (MIPS) Program Relief
  • LCD/DME issues

Read Alliance press release
See Alliance Comment
May 29, 2020

Comments to CMS COVID-19 Public Health Emergency Interim Final Rule

The Alliance has continued our proactive wound care advocacy with CMS surrounding the waivers and flexibilities implemented in policies addressing medical care amid the COVID-19 crisis. In comments to CMS's Interim Final Rule, the Alliance supported the Agency’s implementation of many policies while also pursuing clarification on several specific provisions that we'd flagged in our April 6th letterto the Agency that still have not been addressed. These included advocacy on issues related to surgical dressing benefits, negative pressure wound therapy billing, CTP co-pays, reimbursement and increased access for alternative methods of debridement, documentation requirements,  and more. The Alliance provided specific policy recommendations and requested that CMS add to its series of upcoming "Office Hours" teleconferences a call specific to wound care as well as one for DME suppliers/providers and manufacturers of medical equipment.
Read Alliance comments
February 10, 2020

Alliance Comments to Draft LCD on Topical Oxygen Therapy for Wound Healing

The Alliance submitted comments to the DME MACs' preliminary determination to not cover Topical Oxygen Therapy (TOT) for would healing. The Alliance outlined why the current analysis of evidence on which the LCD was based is "incomplete" and urged the DME MACs to consider the available evidence on a per wound-type basis (i.e., for diabetic food ulcers) and make wound type-specific coverage determinations. 
Read Alliance Comments

December 17, 2019

Letter to Congress on "Cures 2.0" updates to 21st Century Cures Act

In response to Rep. Diana DeGette's (D-CO) and Rep. Fred Upton's (R-MI) request for stakeholder input on how to modernize how new cures and medical products are covered by health insurance, including Medicare and Medicaid, the Alliance submitted a letter offering our recommendations on how reform of Medicare coding, coverage and payment could better support patients’ access to innovative therapies. The letter focused on three main topics: (1) contractor coverage issues that need revising from 21st Century Cures, (2) transparency issues in coverage and coding processes, and (3) the importance of real-world evidence and the need for reporting of more wound-relevant quality measures.
Read Alliance letter

August 12, 2019

Comments to CMS Patients Over Paperwork

The Alliance submitted comments to CMS in response to its Request for Information regarding Patients Over Paperwork related to reporting and documentation requirements, coding and documentation requirements for Medicare or Medicaid payments, and prior authorization procedures. Our comments focused on several key issues, including:

  • NCCI edits
  • HCPCS coding reform
  • Local coverage decisions (LCDs) versus coverage articles (LCAs)
  • Prior authorization
  • Billing for disposable negative pressure wound therapy in home health care setting
  • Implementation timing of rules issued by CMS

Read Alliance Comment
February 17, 2019

Letter to Noridian Requesting Withdrawal of Local Coverage Articles on Medicare Coverage of "Amniotic Membrane-Derived Skin Substitutes” 

Following initial comments (Dec. 2018) addressing Noridian’s local coverage articles A56155 and A56156 on "Amniotic Membrane-Derived Skin Substitutes” and an initial response from Noridian, the Alliance sent a follow-on letter in February 2019. The letter requests withdrawal of the policy and outlines why ithe Alliance believes that Noridian followed improper procedure. “The Coverage Articles made substantive changes to reduce Medicare coverage but did not follow CMS’s rules for changing coverage and are not a substitute for an LCD. They improperly attempt to achieve the same goal as an LCD because they state comprehensively that the use of amniotic membrane derived skin substitutes for treatment of any condition other than a DSU or VSU is 'not reasonable and necessary and non-covered.' These Coverage Articles also are not a clarification of an existing policy or CMS regulation already in effect, as is the case with other Coverage Articles. Rather, the Coverage Articles created a new substantive standard for Medicare coverage."

The Alliance will be meeting with Noridian in March to further discuss this issue.

Read Alliance Letter

December 14, 2018

Comments to Noridian coverage article “Use of Amniotic Membrane Derived Skin Substitutes”

The Alliance submitted a letter to Noridian in response to its coverage article published on November 8, 2018 entitled “Use of Amniotic Membrane-Derived Skin Substitutes” (A56155) and (A56156). The article stated that Noridian had determined that the clinical use of amniotic membrane-derived skin substitutes outside of the care of DFU and VSU as not reasonable and necessary and non-covered. The Alliance noted concerns that Noridian’s actions disrupt the care being provided to many Medicare beneficiaries, and questioned whether Noridian had authority to create Medicare coverage restrictions under the guise of an "article" that is not subject to public notice and comment.

Read Comments
Read Noridian'S  e-mail response
October 4, 2018

Comments to WPS Wound Care Coding Companion for Wound Care L37228

Via email, the Alliance requested clarification from WPS regarding its new A55909: Wound Care Coding Companion for Wound Care L37228. The Alliance requested the literature that WPS reviewed to eliminate coverage of specific codes related to debridement, noting that  the 21st Century Cures Act requires MACs to provide the evidence utilized in making coverage decisions or eliminating coverage. 

Read Alliance emaiL

 

January 4, 2018

DMEMAC response to Alliance request for an advisory article addressing surgical dressing webinar

The DMEMACs responded to the Alliance’s December 2017 letter flagging inconsistencies between the guidance the DMEMACs provided to the Alliance in an October 2017 “clarification letter” and the instructions that Noridian gave in a November educational webinar on the surgical dressing LCD.
View Alliance Comment
December 18, 2017

Letter to DMEMACs requesting clarification of misinformation shared on surgical dressing educational webinar

The Alliance alerted the DMEMACs that the information being given out on the Nov. 30, 2017 Noridian surgical dressing educational webinar about the new surgical dressing LCD differed from the information provided to the Alliance in the Oct. 20, 2017 “clarification letter.” The DMEMAC medical directors had developed the clarification letter for the Alliance in response to its detailed questions. The Alliance suggested that a more formal DMEMAC Advisory would be appropriate so that other stakeholders could benefit from the clarity provided to the Alliance regarding the surgical dressing policy.
View Alliance Comment 
October 11, 2017

Durable Medical Equipment Medicare Administrative Contractor (DMEMAC) response to Alliance September 2017 letter to clarify issues in the Surgical Dressing LCD

The DMEMACS sent the Alliance a “clarification letter” in October 2017, responding to our September letter requesting clarity on issues that the Alliance had raised with regard to collagen dressings, staging systems and hydrogels - areas of the LCD that would cause confusion in clinical practice and impact patient care/patient access to products and services.
View Alliance Comment
September 11, 2017

Letter to the DMEMACs requesting clarifications on surgical dressing LCD (L33831)

The Alliance submitted a letter to the DMEMAC Medical Directors regarding the application of New Provisions of Surgical Dressing LCD (L33831). The letter reported to the DMEMACs that there was significant disagreement and confusion over how certain LCD provisions should be applied. The Alliance requested clarification on the coverage criteria for collagen dressings and for clarity on confusing wound staging criteria and pressure injury terminology included in the policy.
View Alliance Comment
May 1, 2017

Testimony at Wisconsin Physician Services (WPS) public meeting convened to collect comments on draft wound care LCD

The Alliance provided oral testimony at the Wisconsin Physician Services (WPS) public meeting on its draft wound care LCD (DL37228). The Alliance voiced concern that WPS has created arbitrary parameters without clinical or scientific basis. In its submitted comments, the Alliance requested that WPS provide the evidence for the utilization parameters identified with respect to debridement as well as Negative Pressure Wound Therapy (NPWT).
View Alliance Comment
March 9, 2017

Comments to First Coast Service Option draft LCD on wound care (DL37166)

The Alliance submitted comments to FCSO’s wound care draft LCD (DL37166). Comments noted that the LCD lacked a foundation in medical evidence and clinical practice guidelines in regards to utilization parameters for both debridement and NPWT. Furthermore, the Alliance noted that the LCD lacks sufficient evidence for the change in coverage for disposable negative pressure (dNPWT) products.  The Alliance expressed concerned that FCSO may be using problematic proprietary claims data as a rationale in crafting this policy. The comments also pointed to inaccurate information and confusing/conflicting language found throughout the policy.
View Alliance Comment
March 9, 2017

Comments to Novitas Solutions draft LCD on wound care (DL35125)

The Alliance submitted comments to Novitas Solutions on wound care draft LCD (DL35125). Comments noted that the LCD lacks compelling medical evidence and clinical practice guidelines support for the utilization parameters proposed for debridement and negative pressure wound therapy (NPWT). The Alliance also expressed concern about the changes in coverage for disposable NPWT (dNPWT). The comments point out that FCSO may be relying on problematic proprietary claims data as a main source in crafting the draft regulation. The comments also note inaccurate information and confusing/conflicting language found throughout the policy.
View Alliance Comment 
March 9, 2017

Comments to Novitas Solutions draft LCD on treatment of varicose veins of the lower extremities (DL34924)

The Alliance submitted comments to Novitas Solutions on draft LCD (DL34924) regarding the treatment of varicose veins of the lower extremities. Alliance comments support those submitted by the American College of Phlebology and the American Venous Forum and Society of Vascular Surgeons.  Each of these groups expressed concern that the proposed regulation arbitrarily limits access to care for patients with clinically significant disease and selectively applies certain clinical practice guidelines while ignoring others. The Alliance expressed concerns that the draft LCD goes against prior LCDs from other Medicare administrative contractors (MACs) as well as most commercial carriers.
View Alliance Comment 
February 16, 2017

Testimony at FCSO public meeting on draft wound care LCD

The Alliance provided oral testimony at the FCSO public meeting on wound care LCD (DL37166). Testimony focused on: the lack of coverage for disposal negative pressure wound therapy (dNPWT); utilization parameters proposed for NPWT; utilization guidelines that limited debridement; and concerns with policies surrounding the application of Unna Boots or a multi-layer compression system. 
View Alliance Comment
January 26, 2017

Testimony at public meeting on draft Novitas LCD on wound care

The Alliance provided oral testimony at the Novitas Solutions public meeting convened to collect feedback on its wound care LCD (DL35125). Alliance testimony focused on several key issues: the lack of coverage for disposal negative pressure wound therapy (dNPWT); utilization parameters proposed for NPWT that are not based on evidence or clinical practice; utilization guidelines that limited debridement; and concerns with policies surrounding the application of Unna Boots or a multi-layer compression system. 
View Alliance Comment 
August 8, 2016

Comments to Cigna Government Services Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds of Lower Extremities (DL36690)

The Alliance submitted comments to Cigna Government Services (CGS) on Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds of Lower Extremities (DL36690). The Alliance reminded CGS that the term “skin substitutes” is clinically inaccurate and should be replaced with more inclusive descriptor “Cellular and/or tissue based products for wounds (CTPs).” The comments addressed issues in the draft policy related to the classification of products, utilization instructions, coverage limitations and confusing language in the guidance regarding its distinction when providing coverage for diabetic foot ulcer (DFU) vs. venous leg ulcer (VLU). Comments also highlighted the need for CGS to recognize podiatrists as providers who can and do treat patients with wounds, and the indications for use (IFUs) for products affected by the LCD. 
View Alliance Comment
August 5, 2016

Comments to Noridian Local Coverage Determination (LCD) for Hyperbaric Oxygen (HBO) Therapy (DL 36686)

The Alliance submitted comments to Noridian on Local Coverage Determination (LCD) for Hyperbaric Oxygen (HBO) Therapy (DL 36686). The Alliance recommended that Noridian revise the policy to recognize the implicit coverage of skin grafts and flaps and expressed concern about the policy’s wording around adjunctive treatment of the diabetic foot ulcer (DFU). Comments also flagged several areas in the draft policy in which Noridian provided specific dose and frequency parameters that are contrary to current standards of practice. In addition, the Alliance noted that some of the evidence that Noridian has used to substantiate the provisions in this policy is outdated. 
View Alliance Comment
logo
Follow us on:
linkedin