Submitted Comments
August 8, 2016
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.
August 5, 2016
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the Alliance noted that some of the evidence that Noridian has used to substantiate the provisions in this policy is outdated.
August 3, 2016
As member of the Venous Care Partnership, the Alliance submitted comments to the Agency for HealthCare Research and Quality (AHRQ) on the June 28, 2016 Technology Assessment (TA), “Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD).” The comments expressed concern about that the assessment relied solely on research published after the year 2000, as the diagnosis and treatment of venous diseases has a long history and much of the evidence supporting the diagnosis and treatment of venous disease was established before the limited time period covered by this review.
May 9, 2016
The Alliance submitted comments to CMS on the Medicare Program; Part B Drug Payment Model stating that it “disagrees with a broad sweeping change to the payment methodology for drugs and biologics…since there is no evidence to support the change.” The Alliance noted that it believes that the proposed rule focuses solely on costs rather than on the complexities of patient care. The Alliance urged CMS to go through a formal rulemaking process for Phase 2 instead of a sub-regulatory process – which is insufficient due to the complexity of the models being developed.
March 1, 2016
The Alliance submitted comments to CMS on MACRA Episode Groups. In its comments, the Alliance reported that chronic wounds and ulcers are reaching epidemic proportions in the United States. Despite their prevalence, this problem remains off the CMS radar screen even though Medicare will devote at least $30 billion dollars to their treatment this year (and by some estimates, twice that amount). The Alliance urged CMS to create episodes of care around the following high resource use conditions:
- Diabetic foot ulcers
- Venous stasis ulcers
- Stage 3 and 4 pressure ulcers
March 1, 2016
The Alliance submitted comments to CMS on its Quality Measure Development Plan. The Alliance emphasized chronic wound care’s significant economic burden to Medicare and other health care payers. The Alliance encouraged CMS to also adopt measures used in Qualified Clinical Data Registries (QCDR) while also utilizing those under PQRS.
February 19, 2016
The Alliance submitted comments to CMS on the Medicare Administrative Contractors (MAC) contracting process. Comments noted that CMS failed to describe what “exceptional MAC performance” means and how that will be measured. The Alliance recommended that CMS be required to provide the metrics on how the contractors are being measured, as transparency would help clinicians and other stakeholders who interact with the Medicare Administrative Contractors (MACs).
January 7, 2016
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.
December 10, 2015
