Submitted Comments

The Alliance submitted comments to CMS's COVID-19 Public Health Emergency Second Interim Final Rule that provided additional policy and regulatory revisions to provide flexibility during the pandemic. The Alliance  providing specific comments and recommendations addressing:

• The codes that should be utilized by Provider Based Departments (PBD) when billing for wound care services via telehealth that has been temporarily relocated to a patient’s home
• Competitive bidding program concerns
• Temporary relocation sites
• The Appropriate Use Criteria (AUC) program
• Merit-based Incentive Payment System (MIPS) Program Relief
• LCD/DME issues

Read Alliance press release
See Alliance Comment

The Alliance submitted a letter to three Medicare Administrative Contractors (MACs) addressing payment policies for services provided in the home (POS 12), assisted living facilities (POS 13), and nursing facilities (POS 32). In comment to Palmetto, National Government Services (NGS) and Wisconsin Physician Services (WPS), the Alliance suggested that for practitioners providing wound care  in these sites, application of cellular and/or tissue products for skin wounds (CTPs) and disposable negative pressure wound therapy services be paid at the applicable Medicare physician non-facility rate. "We submit that Policy Manual provisions along with the waivers that have been issued support our request…We are concerned that [MACs] have not been covering these services in these settings, even though there is a dire need to provide care to these patients.  Enabling payment of these proven wound care therapies (already covered by Medicare) would allow access to care while reducing the risk of COVID transmission for vulnerable wound care beneficiaries," the Alliance wrote. 
Letter to Palmetto
Letter to NGS
Letter to WPS

• CMS
• CTPs/(skin substitutes)
• Medicare
• Medicare Administrative Contractors (MACs)
• Negative Pressure Wound Therapy (NPWT)
• COVID-19

The Alliance has continued our proactive wound care advocacy with CMS surrounding the waivers and flexibilities implemented in policies addressing medical care amid the COVID-19 crisis. In comments to CMS's Interim Final Rule, the Alliance supported the Agency’s implementation of many policies while also pursuing clarification on several specific provisions that we'd flagged in our April 6th letter to the Agency that still have not been addressed. These included advocacy on issues related to surgical dressing benefits, negative pressure wound therapy billing, CTP co-pays, reimbursement and increased access for alternative methods of debridement, documentation requirements,  and more. The Alliance provided specific policy recommendations and requested that CMS add to its series of upcoming "Office Hours" teleconferences a call specific to wound care as well as one for DME suppliers/providers and manufacturers of medical equipment.
Read Alliance comments

• CMS
• CTPs/(skin substitutes)
• LCDs
• Negative Pressure Wound Therapy (NPWT)
• Surgical Dressings
• COVID-19

In response to the COVID-19 crisis, the Alliance has continued our proactive wound care advocacy by sending our letter to Secretary Alex Azar, Administrator Seema Verma and their staff requesting temporary regulatory waivers to give flexibility to wound care clinicians to provide necessary procedures and products to treat their patients amid the evolving realities of the pandemic. The  Alliance identified specific regulatory provisions related to site of service, reimbursement, documentation, DME access and other issues that, with regulatory relief, could remove barriers to treat wound care patients efficiently and effectively during this pandemic while at the same time keeping them as safe as possible while they receive the necessary care.
READ ALLIANCE LETTER

• COVID-19

• CMS
• CTPs/(skin substitutes)
• Prospective Payment System (PPS)

As hospitals and health systems are directed to halt all elective and “non essential” services as part of COVID-19 response, a concerning number have categorized wound care services and procedures as “non essential” – leaving a fragile cohort of chronic wound patients at risk. The Alliance developed a position statement to help health systems and providers avoid unintended consequences for wound patients amid the realities of the COVID-19 pandemic: “Wound Care is an Essential, Not Elective, Service that Prevents Hospital Admissions and ED Visits Among a Fragile Cohort of Patients at High-Risk of Mortality from COVID-19.”
See Alliance COVID-19 Resources for Wound Care
READ FULL STATEMENT 

• COVID-19
• position statement

The Alliance submitted comments to the DME MACs' preliminary determination to not cover Topical Oxygen Therapy (TOT) for would healing. The Alliance outlined why the current analysis of evidence on which the LCD was based is "incomplete" and urged the DME MACs to consider the available evidence on a per wound-type basis (i.e., for diabetic food ulcers) and make wound type-specific coverage determinations. 
Read Alliance Comments

• Diabetic Foot Ulcer (DFU)
• DMEMACs
• LCDs
• Medicare Administrative Contractors (MACs)

• CTPs/(skin substitutes)
• Debridement
• Negative Pressure Wound Therapy (NPWT)
• Prior Authorization
• Surgical Dressings
• medicaid

In response to Rep. Diana DeGette's (D-CO) and Rep. Fred Upton's (R-MI) request for stakeholder input on how to modernize how new cures and medical products are covered by health insurance, including Medicare and Medicaid, the Alliance submitted a letter offering our recommendations on how reform of Medicare coding, coverage and payment could better support patients’ access to innovative therapies. The letter focused on three main topics: (1) contractor coverage issues that need revising from 21st Century Cures, (2) transparency issues in coverage and coding processes, and (3) the importance of real-world evidence and the need for reporting of more wound-relevant quality measures.
Read Alliance letter

• Capitol Hill
• DMEMACs
• HCPCS
• LCDs
• real-world evidence

As part of comments submitted to Wisconsin Physicians Service Insurance Corporation’s Draft Local Coverage Determination for Wound Care, the Alliance flagged eight key concerns and flaws within the policy that negatively impact patient care. Comments focused on WPS’ limiting coverage of debridement while not providing adequate scientific evidence to support its coverage policy. The Alliance questioned the policy’s elimination of a significant number of CPT codes related to debridement and the inclusion of only a limited number of conditions which must be present in order to provide a debridement. The Alliance also flagged many areas where the policy conflicted with other existing DMEMAC policies or violated processes in CMS’s Program Integrity Manual. These comments follow similar comments submitted to WPS in 2017, 2018 and early-2019 raising the same issues. A series of recommendations from the Alliance, addressing each of the eight key concerns, were submitted for WPS consideration as part of comments.
Read Alliance Comments

• CMS
• Debridement
• DMEMACs
• Negative Pressure Wound Therapy (NPWT)