Advocacy in Action

In This Issue: Q2 2020 View online Leading Wound Care Advocacy in Response to COVID-19 Emergency Alliance Urges CMS Policy Modifications That Address Front-Line Wound Care Practitioners’ Challenges Q2 Comments & Meetings COVID-19 Advocacy: Comments to Public Health Emergency Interim Final Rules, Stakeholder Calls & Educational Webinars Q2 Advocacy Leadership (General): Surgical Dressing LCD Reconsideration Request, Letter to MACs, Noridian CAC Recent Policy Updates CY 2021 OPPS & Physician Fee Schedule Proposed Rules; Creation of CMS Office of Burden Reduction; AHRQ Technology Assessment on Platelet-Rich Plasma for Wound Care; New CTP HCPCS codes

Dear Alliance members, Without precedent, 2020 has been the most challenging year for American healthcare. Even before the coronavirus landed on American shores, it would have been a year of significant change due in part to the 21st Century Cures Act and other regulatory changes already underway. But COVID-19 created a seismic shift in health care delivery, and in the coverage and reimbursement policies for vital wound care services and products. (The pandemic also forced us to postpone our inaugural “Wound Care Evidence Summit,” rescheduled for 2021.) While our original 2020 work plan never envisioned a worldwide public health emergency, your flexible and responsive Alliance quickly focused advocacy to enable wound care clinicians to treat patients efficiently and effectively – and with appropriate reimbursement – amid the pandemic, while continuing the rest of our work. Below is an update on our activities this past quarter. Together as a collective voice, we are ensuring access and facilitating care. Never has our work been more important to patients and providers alike. We thank all of you who are on the front lines taking care of patients. Please keep healthy—all of us need you!

Caroline E. Fife MD, Matthew G. Garoufalis DPM; Co-chairs Marcia Nusgart, RPh; Executive Director Alliance of Wound Care Stakeholders

Alliance Urges CMS to Address Front-Line Wound Care Practitioners’ Challenges in Policy Modifications & Clarifications

Early in the pandemic, the Alliance’s rapid response team developed a position statement calling for the protection of wound care as an essential service. That March statement was just the first step of our proactive advocacy! Since that time, we’ve issued to HHS and CMS a series of letters and emails and participated in many calls to protect wound care. In our April letter to HHS/CMS, we detailed specific policies that, with regulatory relief, could remove barriers to treat wound care patients efficiently and effectively during the pandemic. While many of our recommendations were incorporated, many key ones were not – and we’ve been persistent in requesting and refining them in May recommendations and July requests to CMS's interim final rules to ensure that the Agency updates provisions impacting wound care based on our members’ front-line experience. In direct response to issues reported by members, we’ve made a series of specific recommendation to CMS in comments, calls and conversations. These include:

Expand of reimbursement for wound care-related telehealth visits Waive standard written order provisions in select LCDs Allow dNPWT telehealth billing Permit total contact casting to be provided on the same date of service as other procedures Increase access and reimbursement for alternative methods of debridement

Modify documentation requirements for continued need and refill of surgical dressings and other supplies Delay moving forward with the competitive bidding program during the public health emergency Enable patients to be treated at all appropriate sites of care outside traditional office and hospitals settings

The coronavirus has drastically changed how and where wound care providers treat their patients. CMS’s rules, waivers and policies must evolve to reflect this new world. We will continue to actively advocate for appropriate coverage and payment flexibilities to ensure that policies enable quality patient care – with appropriate reimbursement - while protecting patient/provider safety. Remember, this is all ON TOP of our ongoing work! Please join the many other wound care business entities, innovators, researchers and clinical associations who are supporting the Alliance of Wound Care Stakeholders’ Emergency COVID-19 Fund to ensure that we have the resources needed to continue this battle.

COVID-19 ADVOCACY LEADERSHIP Q2 Comments & Meeting:

Pursuing Regulatory Relief Waivers for Wound Care: CMS Letter The Alliance was proactive in sending a letter to HHS/CMS requesting temporary regulatory waivers to remove barriers and give flexibility to wound care clinicians amid the evolving realities of the pandemic. The Alliance identified specific provisions related to site of service, reimbursement, documentation, DME access and other relevant issues. (April) Read Alliance Letter

Removing Barriers to Care: Comments to PHE 1st Interim Final Rule In comments to CMS's Public Health Emergency (PHE) Interim Final Rule, the Alliance supported the Agency’s implementation of many policy modifications we’d requested in our April letter and pursued action on issues we’d flagged that had not been addressed, including: surgical dressing and negative pressure wound therapy billing, CTP co-pays, reimbursement for alternative methods of debridement, documentation requirements and more. (May) Read Alliance Comments

Addressing Clinical Challenges: Comments to PHE 2nd Interim Final Rule To ensure that policy updates reflected the realities of challenges faced by front-line wound care clinicians, the Alliance called on CMS to expand reimbursement for wound-care related telehealth visits; provide flexibility in documentation requirements for refill of surgical dressings and other supplies; and permit medically necessary procedures to take place on the same date of service. Comments also addressed competitive bidding, appropriate use criteria, temporary relocation sites, and LCD/DME issues. (July) Read Alliance Comments

Representing Wound Care on CMS Stakeholder Calls Alliance staff have regularly participated on CMS’s weekly “Office Hours” calls so that we can determine whether our issues are being addressed, plan our next advocacy actions and communicate the most up-to-date information to membership. The Alliance has flagged relevant calls and reported to members when relevant issues were raised or updated. In April, Alliance staff and representatives from clinical and business entity members participated in a call with CMS Centers for Medicare Management to address issues in the surgical dressing LCD.

Educating members about the intricacies of policy changes: Launched the COVID-19 Action Center on the Alliance website to serve as a go-to resource page for all wound care related COVID-19 updates. (March) Collaborated in two webinars: “Understanding HIPAA During COVID-19” with AAWC and “Wound Care Challenges and Solutions During the COVID-19 Pandemic: A Roundtable Discussion with Frontline Experts” with Wound Source. (May) Co-authored “Wound Center Without Walls: The New Model of Providing Care During the COVID-19 Pandemic” published in WOUNDS and spearheaded by Alliance member Dr. Lee Rogers. (June)

GENERAL (NON-COVID) ADVOCACY LEADERSHIP Q2 Comments & Meeting:

Expanding CTP/dNPWT Payment Policies: Letter to MACs The Alliance submitted a June letter to three Medicare Administrative Contractors (MACs) – Palmetto, National Government Services (NGS) and Wisconsin Physician Services (WPS) – requesting payment for the application of cellular and/or tissue products for skin wounds (CTPs) and disposable negative pressure wound therapy (dNPWT) services – when taking in place in the home, assisted-living facilities and nursing facilities. UPDATE: In response to our advocacy, Palmetto stated it will pay for disposable negative pressure therapy in nursing facilities at the applicable Medicare physician non-facility rate. This is an important advocacy win, though an incremental one. We continue to seek payment for services provided in the home and assisted living facilities, as well as pursue similar updates from the other two MACs. Read Alliance Letters

Requested Reconsideration of Surgical Dressing LCD The Alliance submitted a formal reconsideration request for the Surgical Dressing LCD (L33831) to the DMEMAC medical directors. The Alliance is seeking an update in the category “Alginate and/or other Fiber Gelling Dressings” to allow these to be used as both primary and secondary dressings. Currently they can only be billed as primary dressings.

Serving as a Go-To Resource for the GAO on Wound Care & CTPs The Government Accountability Office specifically reached out to the Alliance earlier this year (Feb.) for insights when it was tasked to develop two reports: “How Medicare Provides its Beneficiaries Treatment for Severe Wounds” and “The Impact of Medicare’s Policy for Packaging High-cost Drugs and Biologicals.” We provided additional expertise to the GAO in June when it reached out for insights as it analyzed Medicare’s claims data to learn more about the high cost of drugs, including CTPs.

Representing Wound Care Concerns to Noridian’s CAC The Alliance served as a resource to Noridian and participated in its April Contractor Advisory Committee (CAC) call on both wound care and CTPs. We expressed concern that the MAC’s call did not focus on a discussion of evidence, which is generally agreed to be the purpose of a CAC meeting. The Alliance will follow up with Noridian as the MAC develops its draft LCDs later in 2020.

Be Up To Speed: Recent Policy Updates Relevant to Wound Care

JUST RELEASED: Hospital Outpatient PPS and Physician Fee Schedule: The CY2021 Medicare Outpatient Prospective Payment System (OPPS) Proposed Rule and the CY2021 Medicare Physician Fee Schedule Proposed Rule recently published. The Alliance circulated a summary to membership and will be convening calls to discuss issues to be addressed in submitted comments. (August) CMS will be convening a virtual meeting of its Advisory Panel on Hospital Outpatient Payment on Aug. 31. AHRQ: The Agency for Healthcare Research and Quality's Technology Assessment Program posted a draft systematic review for comment: "Platelet-Rich Plasma for Wound Care in the Medicare Population." (June) CMS Office of Burden Reduction: CMS announced the creation of the Office of Burden Reduction & Health Informatics to unify the agency’s efforts to reduce regulatory and administrative burden and to further the goal of putting patients first. The new office is an outgrowth of the agency’s Patients over Paperwork Initiative. (June) HCPCS Codes: CMS released 13 new CTP HCPCS codes in MLN Matters MM11814, which became effective on July 1 2020. There was one code of particular interest: C1849- skin substitute, synthetic which was designated in the high cost bucket where the rest are in the low bucket. COVID-19 Action & Resource Center: Check the page for policy updates such as the: new COVID-19 FAQ on Medicare Fee-for-Service Billing expansion of the Hospital Without Walls initiative new MLN Matters Medicare Fee-For-Service (FFS) Response to the Public Health Emergency recordings/transcripts of CMS COVID-19 stakeholder calls.

Keep Up With Clinical Association Colleagues:

Curious what your clinical association colleagues are up to? Keep up with your clinical association colleagues during these crazy times. Check out a few of our member clinical associations’ recent newsletters and blogs: AAWC Blog ACFAS Update APTA Magazine APWCA Advocacy Update SVS Pulse Pressure (Undersea & Hyperbaric Medical Society) Vein Specialist (American Venous Forum) WOCN Blog WHS Newsletter Want us to share your association’s newsletter or other updates relevant to Alliance membership? Email updates to share to [email protected] and [email protected].