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Special to OWM: Alliance of Wound Care Stakeholders Fall Update
Earlier this year, the Alliance of Wound Care Stakeholders launched a quarterly e-newsletter to better keep its membership aware of ongoing activities. OWM is sharing excerpts from this newsletter to highlight the Alliance’s advocacy work in Q2 and over the summer thus far.
The Alliance collected comments from membership on the proposed Hospital Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule regulations issued in July, focusing attention on the proposal to consolidate and restructure the skin and debridement ambulatory payment classifications (APCs) into a single APC series and reviewing the calendar year 2016 high/low cost threshold for cellular- and/or tissue-based products (CTPs) which the Center for Medicare and Medicaid Services (CMS) has set at $25 per cm2 or a per daily cost threshold of $1,050.
The Alliance met with United States Food and Drug Administration (FDA) staff to share the Alliance’s topline recommendations for the Agency’s planned modernization of its 2006 Guidance for Industry — Chronic Cutaneous Ulcer and Burn Wounds Developing Products for Wounds. More than 15 FDA staffers, representatives from Alliance clinical associations that perform clinical research (among them, the Association for the Advancement of Wound Care), and members of the Coalition of Wound Care Manufacturers gathered at this first in a series of planned meetings with the FDA on this guidance update. The Alliance also attended the Medicare Evidence Development and Coverage Advisory Committee meeting, examining the scientific evidence of interventions for lower extremity peripheral artery disease (PAD) and addressing areas where evidence gaps exist. Before the meeting, the Alliance convened conference calls with its member groups involved with PAD in order to represent a unified expert voice on key wound- and vascular-relevant issues.
The Alliance sent a letter to Congress in support of the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act, which helps ensure Medicaid patients have access to podiatric care. Currently, access to care provided by a podiatrist is considered an optional benefit and not covered by all state plans. The bill will remedy this limitation to care. Comments also were submitted to Novitas Solutions, addressing its draft local coverage determination (LCD) on hyperbaric oxygen therapy and to Palmetto Government Benefits Administration addressing its draft LCD Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds.
Other actions of interest taken by the Alliance these past few months include seeking clarification from Novitas regarding its LCD for Application of Bioengineered Skin Substitutes (CTPs) to the Lower Extremity for Chronic Non-Healing Wounds. Clarification requests focused on the status of the 13 products that have HCPCS codes but are not listed in this policy and coverage of products to treat patients who have ulcers in other areas of the body. In related actions, the Alliance’s work with the international standards setting body ASTM to develop a new standard guide for CTPs continues.
The Alliance also submitted 2 letters regarding the January 2015 Durable Medical Equipment Medicare Administrative Contractors (DME MAC) Correct Coding Article for Surgical Dressings Containing Non-Covered Components and the subsequent decision by PDAC to no longer code surgical dressings containing medical grade honey as covered. In June, the 4 DME MACs issued policy adjustments, confirming coverage of multicomponent dressings that contain medicinal honey will be based on the underlying covered components. In addition, the Alliance submitted comments to First Coast Service Option’s draft LCD on Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities that addressed issues such as a problematic definition of a chronic nonhealing wound in the draft LCD, concern about allowable treatment timeframes, and discrepant guidance regarding the length of time for assessing a wound’s failure to respond to treatment. Subsequently, First Coast issued a final LCD that reflects several (but not all) of the Alliance’s inputs. The LCD will be implemented starting September 6. The Alliance asserts this policy needs to address all chronic nonhealing wounds, not just diabetic foot ulcers and venous ulcers.
The Alliance shared information about its successes at the European Wound Management Association (EWMA) meeting, shared insights about clinical effectiveness research and answered questions from Alliance membership with the Patient Centered Outcome Research Institute, and was represented at meetings of American Physical Therapy Association, Society for Vascular Medicine, Society for Vascular Surgery, and the American Podiatric Medical Association.
In August, the Alliance prepared comments to CMS’ DME MACs proposed revisions to its surgical dressings LCD. The Alliance also addressed the issue via oral testimony at a joint DME MAC public meeting on August 26.
For more information about Alliance mission, goals, and membership, please visit: www.woundcarestakeholders.org/.
The Alliance is an association of physician and clinical organizations focused on promoting quality care and access to procedures and technologies for patients with wounds through advocacy and educational outreach in the regulatory, legislative, and public arenas. This article was not subject to the Ostomy Wound Management peer-review process.
