Submitted Comments

Items Related to LCDs

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.
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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.
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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.
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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).
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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.
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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.
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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.
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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. 
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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. 
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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
January 7, 2016

Letter to DMEMAC medical directors requesting that the LCDs for pneumatic compression devices conform to the binding national coverage determination

The Alliance submitted a letter to DMEMAC Medical Directors on the LCDs for pneumatic compression devices (PCD). The letter reiterated past comments submitted addressing the LCD for Pneumatic Compression Devices (PCDs) that took effect on December 1, 2015. The Alliance again emphasized its opinion that the scope of coverage under the LCDs is far more restrictive than the NCD for pneumatic compression devices. We again assert that the new LCD does not merely “clarify” existing requirements as stated by the DMDs, but rather adds a number of new substantive binding criteria that are more restrictive than the NCD; the practical effect of these changes eliminates beneficiary access to PCDs that has long been afforded by the NCD. There is no doubt that if a beneficiary had access to a PCD on November 30, 2015 based on existing criteria, but that same patient no longer qualified for PCD coverage on December 1, 2015 based on new LCD criteria, then those new criteria are more restrictive – and that is the case for a large number of beneficiaries.
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