Alliance Advocacy Update: Newsletter

A quarterly newsletter from the Alliance of Wound Care Stakeholders

In This Issue:

New legislation on Capitol Hill aims to improve MAC LCD transparency & accountability

Q1 Comments Submitted to Regulators & Stakeholders

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

Below is an update on some of our key areas of focus this past quarter (Q1: Jan.-March). Please share this update within your specialty society, association or company.

Newly introduced legislation aims improve MAC LCD transparency, accountability

New proposed legislation introduced in Congress with bipartisan support provides hope that many of the issues the Alliance and our 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 local coverage determination (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 comprised. This has been particularly evident in the field of HBOT and 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.

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

Alliance comments to regulatory agencies in Q1 included:

Comments to CMS Contractors: Novitas & FCSO 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, 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."
* Remember, full-text of all Alliance comments and oral testimony are posted to the comments page of our website.

Key Q1 Meetings & In-Person Advocacy

Alliance Q1 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.

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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.