Health Care Policy Update: Comments from the Alliance of Wound Care Stakeholders Protection Status
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By the WoundSource Editors

Recently proposed legislation introduced in Congress with bipartisan support provides hope that many of the issues the Alliance of Wound Care Stakeholders (the Alliance) and its members have faced with the Medicare Administrative Contractors (MACs) local coverage determinations (LCDs) may have a legislative fix moving forward. The proposed legislation,"Local Coverage Determination Clarification Act of 2017" (S.794), would improve transparency and accountability when Medicare contractors set LCD policies for physician services provided to Medicare beneficiaries.

The Medicare Administrative Contractors (A/B MACS and DME-MACs) across the U.S. are responsible for local coverage decisions that impact millions of Medicare beneficiaries, determining which technologies, procedures and services are available to them. The Alliance has long emphasized in comments that the LCD process is flawed, lacks transparency, does not seem based on sound medical evidence and does not provide meaningful opportunity for stakeholder input or appeals. The result of this has been that wound care providers' ability to treat patients with the technologies and services they need has been compromised. This has been particularly evident in the field of hyperbaric oxygen therapy (HBOT) and negative pressure wound therapy (NPWT), but is also pervasive across the wound care space and indeed, across the entire health care space—hence the action from Congress.

This legislation addresses some of these concerns by:
• Requiring open and public MAC meetings that are on the record
• Requiring disclosure by MACs of the rationale for an LCD and the evidence for that decision at the beginning of the LCD process
• Providing a meaningful reconsideration process for an LCD
• Prohibiting MACs from adopting an LCD from another jurisdiction without first conducting its own independent evaluation of the evidence

The Alliance supports each one of these provisions. The final item on the list above, prohibiting MACs from adopting each other's LCD language without independent assessment, is particularly relevant to us in the wound care space today.

As you will read below, in the past few months, both Novitas and First Coast Service Option issued nearly identical wound care LCDs with nearly identical restrictions and limitations. This has been a trend that has been increasingly expanding, the result of which is that a policy introduced by one MAC—then broadly adopted by others without sufficient review—by default starts becoming more of a National Coverage Decision in practical terms without having followed more rigorous requirements. This legislation would put a clear stop to that practice of LCDs mirroring each other region by region, with the same flaws and inaccuracies repeated again and again.

While there is a long road ahead for the bill to move from "proposed" to "passed" and implemented, this finally shows that our Alliance concerns are shared across the entire healthcare sector, and that the MAC issues are pervasive and concerning enough to merit the bipartisan attention of Congress. The bill in its proposed form would significantly address our requests for improved MAC transparency and accountability - and the very introduction of it, even without passage, sends a powerful signal to MACs.

The Alliance will be voicing our support to the bill's co-sponsors as well as urging other to sign-on and move the legislation forward. In the Senate, the legislation was introduced by Sens. Johnny Isakson (R-Ga.), Thomas Carper (D-Del.), Debbie Stabenow (D-Mich.) and John Boozman (R-Ark.). We will share our letters with membership. We encourage each of you to have a voice and, through your own individual organizations, submit your own letters of support to Congress. We will also await the House version of the bill and support this as well.

Alliance of Wound Care Stakeholder Comments to Regulatory Agencies

Comments to CMS Contractors:

Novitas & First Coast Option Solutions LCDs: Wound Care
With the January issuance of two nearly identical and equally problematic wound care draft LCDs from Novitas and First Coast Service Option Solutions (FCSO), the Alliance kicked into action. After convening multiple calls with members to gain insights and build consensus around items to flag, the Alliance provided oral testimony at both the Novitas and FCSO public meetings held to collect feedback on the LCDs. Then, the Alliance submitted comprehensive written comments (March) to both Novitas and FCSO emphasizing concerns across a range of issues across the two LCDs, including: an overall lack of evidence to support proposed changes, elimination of coverage of disposable Negative Pressure Wound Therapy (NPWT), and "arbitrary" utilization parameters for both NPWT and debridement services.

Comment Call-Outs:

"Changes in the draft LCD[s] seem to have no foundation in medical evidence or clinical practice guidelines. The Alliance has concerns regarding the basis for which utilization parameters were established in that they do not adhere to current clinical practice guidelines and appear to be arbitrary... The Alliance is concerned about the lack of coverage of dNPWT (considered 'not medically reasonable and necessary') and the lack of transparency by which the non-coverage decision was made. We request that the analysis and clinical evidence used as the basis for the decision be provided."

Novitas LCD: Treatment of Varicose Veins of the Lower Extremities
An additional draft LCD—equally as problematic as the draft wound care LCD—was issued by Novitas addressing the treatment of varicose veins. The Alliance submitted comment supporting the more extensive inputs provided separately by our more vascular-focused members: American College of Phlebology, American Venous Forum, Society for Vascular Medicine and the Society of Vascular Surgeons. Alliance comments also flagged concerns about the lack of supportive evidence for the proposed policy changes and the selective fashion in which guidelines from clinical organizations were applied.

Several of the LCD's proposed changes "are a significant departure from prior Novitas LCDs and other Medicare Administrative Contactors (MACs) as well as most commercial insurance carriers. They have no foundation in medical evidence and arbitrarily limit access to care for patients with clinically significant disease, with the potential for serious patient health consequences."

Full-text of all Alliance comments and oral testimony are posted to the Alliance of Wound Care Stakeholders website comments page.

Alliance Key Q1 Meetings & In-Person Advocacy

Alliance first quarter meetings with stakeholders included:

• Novitas and First Coast public meetings to hear feedback on draft LCDs: the Alliance provided testimony at both. See above.
• Alliance board meeting: Convened the board in Washington D.C. for a strategic planning session on Feb. 2.
• National Quality Forum: Alliance members and staff participated and/or listened in to the April NQF sessions to benefit from the focused discussion on quality and quality measures in today's ever-changing and documentation-dependent healthcare environment.
• In-person meeting at SAWC: Thanks to those of you who joined us April 7 for our in-person meeting at SAWC. It was a productive meeting in which each member 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 to hear from EBG health policy experts Lynn Snyder and Kim Tyrell-Knott on "Post Election Analysis of Health Care Legislative and Regulatory Trends" while Dave McNitt of National Health Advisors gave a "Political Update."
• Attended American Venous Forum annual meeting

Q1 Publications & Policies Relevant to Alliance
• CMS released its coverage decision regarding topical oxygen and removing it as being non-covered in a NCD and allowing its contractors to determine coverage: "After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors."
• The DMEMACs released their coverage updates that include a revised NPWT policy that included the new NPUAP staging terminology. See the LCD and the policy article.
• PDAC issued a correct coding bulletin on NPWT, clarifying billing practices for wound dressings and related dressing change items used with negative pressure wound therapy pumps.
• CMS' January 1, 2017 OPPS update transmittal includes changes to the high cost/low cost CTP assignments in light of updated data. (See Table 5, Attachment A)
• Alliance visibility: The March issue of Ostomy Wound Management
ran the article "Advocacy Update from the Alliance of Wound Care Stakeholders"
• Alliance visibility: the April issue of Today's Wound Clinic included the article "Legislative Update: a Look at Upcoming Health Policy Through a Wound Care Lens" contributed by Marcia Nusgart on behalf of the Alliance.

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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