Alliance of Wound Care Stakeholders Advocacy Update

Leveraging Our Clinical Care Voice to Drive MAC Transparency and Accountability

"Comment season" is heating up. As summer temperatures rise, we at the Alliance are gearing up to address both recently issued policies that demand clinician perspectives and the summertime release of the FY2018 updates from the Centers for Medicare & Medicaid (CMS).

Taking action on surgical dressing future final LCD

Our immediate focus has been on the future final surgical dressing local coverage determination (L33831) and policy article (A54563) issued in mid-June by the Durable Medical Equipment Medicare Administrative Contractors (DMEMACs). The policy goes into effect on July 24, 2017.  As you will recall, the draft LCD was published in 2015 and the Alliance voiced our concerns at the DMEMAC public meetings and through our written comments.

However, the future final LCD reflects little of the comments submitted by stakeholders and is nearly identical to the original 2015 draft. Most concerning, the LCD does not conform to current clinical practice, and there is a lack of clarity and conflicting language in the policy which may lead to confusion in the clinical community. In many ways, the LCD in its current form is simply unworkable in many wound care clinical settings.

The Alliance has taken action. We've convened conference calls with our members to identify concerns. We've drafted and submitted letters to CMS and the DMEMACs requesting a delay in implementation of the policy due to clinical and procedural issues. We will keep working to protect patient and provider access to these important products, and we will keep you apprised as our advocacy efforts advance. 

Voicing need for transparency/accountability on Capitol Hill

In our mind, this surgical dressings policy - with a final LCD that is identical to the draft published two years ago and that takes little stakeholder input into consideration - is demonstrative of the ongoing and pervasive lack of transparency and accountability from CMS contractors. Congress addressed some of these issues in components of the 21st Century Cures Act, passed in 2016. More recently (March), legislation addressing this issue was introduced in the Senate (S.794 "Local Coverage Determination Clarification Act of 2017 "). Rest assured, we've been active in developing strategies to support this legislative initiative, as well as strengthen it . We will be advocating for the legislation to include "notice and comment" in reference to policy articles as well as LCDs.

Gearing up for comments to FY2018 PPS updates

Each summer, CMS issues rate updates for the fiscal year ahead to its prospective payment systems (PPS). CMS just recently published its draft CY2018 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (see CMS's press release and fact sheet), and its CY2018 revisions to the Physician Fee Schedule (see CMS' accompanying fact sheet). Others, such as the Home Health PPS, should be issuing shortly. As always, the Alliance will carefully review the proposed rules and share a summary of issues relevant to wound care practitioners. We will be reaching out for member input and organizing comments to submit. 

Having a voice representing a unified wound care perspective is of increasing importance as policies and regulations are drafted, debated and published. Our comments continue to put us "on the record" on key issues, even if they aren't immediately or ultimately addressed. Our ongoing advocacy plays an important role in educating, alerting, and opening doors for dialogue. Indeed, we have a busy summer ahead.

Submitted Comments: Ensuring Alliance's Clinical Expert Perspective is Heard

Alliance comments to regulatory agencies in Q2 included:

Comments to CMS: 

FY2018 Hospital Inpatient Prospective Payment System 

The Alliance focused our comments on four specific issues that impact wound care and specifically: (1) The proposal to remove the current pressure ulcer measure (NQF #0678) and replace it with a modified version of the measure entitled "Changes in Skin Integrity Post Acute Care: Pressure Ulcer: Injury"; (2) Clarification of "pressure ulcer/injury" terminology used throughout the proposed regulation; (3) patient safety and adverse events (Composite) NQF #5031; and (4) adoption of malnutrition eCQMs in the hospital.  

Comment Call-Outs:

"CMS is proposing to remove the current pressure ulcer measure (NQF #0678) and replace it with a modified version of the measure entitled 'Changes in Skin Integrity Post Acute Care: Pressure Ulcer: Injury.' The newly proposed measure is not NQF endorsed...The Alliance does not support moving forward 

with this measure until the measure has been vetted via the NQF endorsement process...The Alliance recommends that CMS delay implementation of this proposed measure modification until it can be vetted with the NQF."

Comments to MACs: 

WPS draft wound care LCD

The Alliance provided oral testimony and submitted written comments to Wisconsin Physician Services' (WPS) draft wound care LCD (DL37228) that addresses debridement, and biophysical agents including NPWT and MIST therapy. The Alliance noted its significant concerns that the policy has little foundation in medical evidence or clinical practice guidelines.

Comment Call-Outs:

"WPS not only did not gather all the evidence that exists when developing this draft LCD. It used data that is not clinically sound or comports to the standards of practice based on clinical practice guidelines. The Alliance believes that the changes that have been made in this draft LCD challenge the standard of practice and WPS does not provide the necessary evidence to support the multiple changes made including but not limited to the utilization parameters for debridement and NPWT. In fact, WPS does not adhere to Product Integrity Manual guidelines for making such changes."

* Remember, full-text of all Alliance comments and oral testimony are posted to the comments page of our website. 

Key Q2 Meetings & In-Person Advocacy

Alliance Q2 meetings with stakeholders included: 

• WPS public meeting: The Alliance provided oral testimony at the Wisconsin Physician Services (WPS) public meeting, outlining our comments to the draft wound care LCD (DL37228).  
• EWMA: Alliance executive director Marcia Nusgart was a keynote speaker at the European Wound Management Association's plenary session addressing "Change, opportunities and challenges - wound management in changing healthcare systems." Marcia joined a range of panelists from across Europe and spoke about the changing U.S. healthcare climate and what it can mean for wound care. In addition, the Alliance members Dr. Matthew Garafoulis and Dr. Jeffrey Lehman spoke at the meeting on various wound care topics. The Alliance is a EWMA International Partner.
• SAWC: Alliance In-Person Meeting- We hosted more than 60 members and guests at our April in-person meeting at SAWC. It was a productive meeting in which Alliance members shared their legislative and policy priorities for the year ahead, so that we could as a unified group identify where we had the most commonality and consensus need for action. We also had the chance celebrate the Alliance's 15th anniversary together, hear from Epstein Becker and Green health policy experts Lynn Snyder and Kim Tyrell-Knott on "Post Election Analysis of Health Care Legislative and Regulatory Trends" and gain insights from a "Political Update" talk from Dave McNitt of National Health Advisors.

Member conferences: Attended the Wound Ostomy Continence Nurses Association meeting in Salt Lake City and met with its leadership.Attended the Society for Vascular Medicine meeting in New Orleans and met with members of its leadership team as well as with American Venous Forum and American College of Phlebology leadership.

Q2 Publications & Policies Relevant to Alliance

• CMS released the draft CY 2018 Updates to MACRA's Quality Payment Program. The Alliance is preparing comments for submission by the Aug. 22 deadline.
• CMS issued the CMS just recently published its CY2018 Hospital Outpatient PPS and Physician Fee Schedule. (See above.)
• The DME MACs published the final surgical dressing LCD (L33831) and policy article. (See above.)
• CMS released in May its coverage decision for Supervised Exercise Therapy for PAD.

The Alliance of Wound Care Stakeholders 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. The Alliance unites leading wound care experts to advocate on public policy issues that may create barriers to patients' access to treatments or care, with a focus on reimbursement, wound care research and wound care quality measures. Follow on LinkedIn for updates.