Alliance Update: Second Quarter 2017 Policy News and Comments Protection Status
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By The Alliance of Wound Care Stakeholders

In their quarterly Alliance Advocacy Update, the Alliance of Wound Care Stakeholders' (Alliance) provides an update on their ongoing advocacy initiatives on behalf of their clinical association members to ensure access, coverage and payment to wound care procedures and technologies for patients and providers.

"Comment season" is heating up. As summer temperatures rise, the Alliance is 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
The 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 their 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, convening conference calls with members to identify concerns. They have drafted and submitted letters to CMS and the DMEMACs requesting a delay in implementation of the policy due to clinical and procedural issues. They will keep working to protect patient and provider access to these important products, and will keep everyone apprised as their advocacy efforts advance.

Voicing need for transparency/accountability on Capitol Hill
In the Alliance's 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 "). The Alliance has been active in developing strategies to support this legislative initiative, as well as strengthen it. They 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. They 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. The Alliance's comments continue to put them "on the record" on key issues, even if the comments aren't immediately or ultimately addressed. The Alliance's ongoing advocacy plays an important role in educating, alerting, and opening doors for dialogue.

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 their 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.

Comments 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 the Alliance's 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 their 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 - The Alliance hosted more than 60 members and guests at their 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 they could as a unified group identify where they had the most commonality and consensus need for action. They 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.

About the Alliance of Wound Care Stakeholders
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.

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