Alliance Update: Third Quarter Policy News and Comments
by The Alliance of Wound Care Stakeholders
The Alliance of Wound Care Stakeholders' (Alliance) quarterly update provides an overview of ongoing advocacy initiatives to ensure access, coverage and payment to wound care procedures and technologies for patients. This update includes current action items, updates on key areas of focus from the past quarter (Q3: July – September 2015), and future issues the Alliance is tracking that are of importance to the wound care community, including clinicians who may be impacted by policy changes.
LCDs addressing CTPs, Pneumatic Compression
This fall the Alliance has been tackling issues on two fronts: cellular and/or tissue based products for wounds (CTPs) and pneumatic compression devices. Both issues are highlighted via new draft Medicare local coverage determinations (LCDs) that merit collective concern, attention and comment from the wound care community.
CTP LCD: Engaging CMS via Comments, Proactive Education
In September, Medicare Administrative Contractor Palmetto GBA issued a new draft Local Coverage Determination (LCD) on the Application of Skin Substitutes – a draft policy that is very different from the previous draft policy that the Alliance had reviewed and commented on back in July. This new draft is a restrictive prescriptive policy that covers only 11 CTP products, eliminates access to CTPs for clinicians to use on their Medicare patients, and contains a rather limited outdated bibliography. The LCD also mistakenly classifies most CTP products as wound dressings, entirely missing the distinction and unique benefits of CTPs.
Marcia Nusgart and Karen Ravitz of the Alliance spoke at two out of the four open public meetings focused on this LCD and alerted Alliance members to attend and speak at the meetings held in Virginia, West Virginia, North Carolina and South Carolina. The Alliance is now in the process of submitting formal written comments and encourages organizations within the wound care community to develop and submit their own set of comments on this issue. The deadline for comments submission is Nov. 27.
The Alliance is working on the following initiatives to ensure that the wound care community’s voice is heard:
- Drafting of a "model" CTP LCD to submit to Palmetto: Together with the Coalition of Wound Care Manufacturers (Coalition), the Alliance will develop a "model" CTP LCD to submit to Palmetto for consideration. The medical director has expressed openness to receiving and reviewing a model document from both the clinical and manufacturer communities.
- Educational in-service: The Alliance has offered to assemble a team of clinical experts to convene an educational session for the Palmetto medical team in order to help them gain a better understanding of clinical decision-making surrounding the application of CTPs.
- Published study submission/bibliography: After the Alliance expressed concern over the incomplete bibliography that accompanied the LCD, Palmetto medical staff invited the Alliance and Coalition to submit a comprehensive list of studies for their review and potential inclusion. The Alliance will collaborate in the development of a more robust bibliography of supportive studies.
Pneumatic Compression Devices LCD
Last year, the Alliance was successful in leading efforts to have the Durable Medical Equipment Medicare Administrative Contractors (DMEMACs) delay the implementation of a problematic pneumatic compression LCD issued last year. Unfortunately, the DMEMACs released recently a new LCD on pneumatic compression devices which is equally as problematic on a legal, procedural and clinical basis. While there are some updates the Alliances has advocated for - such as enabling podiatrists to prescribe - the final policy is still restrictive and merits the clinical community’s attention in terms of follow-up comments, letters and meetings.
This LCD goes into effect on Dec. 1st unless action is taken, and the Alliance encourages wound care community members to leverage communication channels with CMS and DMEMACs.
Regulatory News to Note
- CMS has recently issued its final 2016 Medicare Physician Fee Schedule and final 2016 Medicare Hospital Outpatient/ Ambulatory Surgical Center Payment Systems rules. A more detailed sum of the implications of these rules to wound care will be forthcoming.
- National Government Services issued a draft LCD addressing debridement services in October. The comment period extends until Dec. 12. Review the draft policy here.
- On Oct. 29, the FDA issued a draft guidance "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products." The agency will be convening a public meeting on this and related draft guidance on April 13, 2016. The comment period extends through April 29, 2016.
Alliance of Wound Care Stakeholder Official Comments
Alliance advocacy continued throughout Q3 via submission of comments to key stakeholders, protecting patient and provider access to wound care procedures and technologies:
Comments regarding surgical dressing policies:
The Alliance submitted comments to DME-MACs in September on the draft surgical dressings local coverage determination (LCD).
Comprehensive comments focused on five key concerns: (a) The removal of clinical judgment in the LCD language; (2) New coverage criteria for dressings inappropriately focused on materials not recognized as effective and multi-component dressings; (3) New coverage and utilization criteria that is ambiguous and inconsistent; (4) a lack of clarity on key issues; (5) the lack of a complete bibliography.
Comments to Centers for Medicare & Medicaid Services (CMS):
The Alliance submitted August comments to CMS on its CY 2016 Hospital Outpatient Prospective Payment System (HOPPS), touching on a broad range of issues in the proposed regulation, including the restructuring of the skin and debridement Ambulatory Payment Classifications (APCs), problematic new codes for total contact casting, payment rates for disposable negative pressure wound therapy (NPWT), and status indicators assignment of ancillary services to traditional NPWT and low-frequency ultrasound therapy. HOPPS has important implications to wound care, as the proposed regulations set reimbursement for services and procedures.
Comments to A/B Medicare Administrative Contractors (MACs):
The Alliance submitted comments in July to Palmetto's draft LCD for Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds (DL36123).
The Alliance also submitted comments to Novitas Solutions in July regarding its draft LCD for Hyperbaric Oxygen (HBO) Therapy (DL35021).
Comments to Capitol Hill:
The Alliance submitted a letter in July 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).
To view the Alliance's official comments to regulatory agencies and Congress, click here.
About the Author
The Alliance of Wound Care Stakeholders: The Alliance is a nonprofit multidisciplinary trade association of health care professional and patient organizations whose mission is to promote quality care and access to products and services for people with wounds through effective advocacy and educational outreach in the regulatory, legislative, and public arenas.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.