A quarterly newsletter from the Alliance of Wound Care Stakeholders  
In This Issue:

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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 our key areas of focus in Q1 2016, as well as a look at issues keeping us busy ahead.  Please share this update within your specialty society, association or organization. 
Diving into Medicare Payment Reforms at Alliance Meeting during SAWC

We look forward to catching up with colleagues, building new connections, and setting our collective course for advocacy over the year(s) ahead when we convene once again in tandem with the Spring Symposium on Advanced Wound Care (SAWC) next week. The meeting will be held from 8:00-10:30am in Room 203 in the B building of the Georgia World Congress Center.

Our meeting's discussions and guest speakers are focused on the seismic shifts over the years ahead and specifically: physician payment reform. With the Medicare Access and CHIP Reauthorization Act (MACRA) implementation and CMS migrating toward the more quality measure-based Alternative Payment Models (APMs) and Merit-based Incentive Payment (MIPs) programs, we will be devoting time at our April 15 meeting - and throughout the year ahead - to educate our members on this issue. Together, we will work to ensure that appropriate wound care quality measures are incorporated, the impact of evolving policies on wound care practice are understood, and the wound care providers' expert voice is heard and reflected.

At our April 15th meeting we will hear about "Physician Payment Reform, CMS Proposed Rule on Part B Drugs/Biologics and other Regulatory Issues Impacting Wound Care" from Dr. Paul Radensky, partner in the law firm of McDermott Will & Emery LLP and co-chair of the Firm's Health Services and Medical Products Government Strategies team.  National Health Advisors' Dave McNitt will focus our attention on "Legislative Initiatives Impacting Wound Care and What the Alliance Can Do About Them."

As you can see, our 2016 Work Plan will focus not only on regulatory guidance and local coverage determinations - which remain important areas - but also, increasingly, on Medicare payment reform initiatives and opportunities for Alliance input, advocacy and comment. Indeed, our work on this front has already started:  we recently submitted comments to CMS addressing (1) quality measures development for MIPs and APMs and (2) creation of episode groups under the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. (See "comments" section below.)

At our SAWC gathering we'll also have opportunity to gain perspective on more global issues in wound care via speakers from Dr. Marco Romanelli, President of the World Union of Wound Healing Societies (WUWHS) 2016 Congress and Bent von Eitzen representing the European Wound Management Association (EWMA). The Alliance is proud to be selected as a "Sister Society" of the WUWHS Congress and will be convening a session there. Marcia Nusgart will be speaking at the EWMA meeting. We'll see you Friday, April 15 at SAWC.

Welcome to our Newest Member
Please join us in welcoming a new Alliance clinical association member: American Diabetes Association® Foot Care Interest Group.  They will be represented on the Alliance by Jill Kadish (ADA's Associate Director of Professional Engagement) and podiatrist Dr. Katherine Raspovic (MedStar Health). We look forward to working together and learning from your unique perspective!

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

Alliance advocacy continued throughout Q1 via our submission of comments to key stakeholders to protect patient and provider access to wound care procedures and technologies:

Quality Measures Development
The Alliance submitted March comments in response to the CMS Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). The Alliance used the comments to educate CMS on the seriousness of wound care and its multidisciplinary practice. It advocated that wound care quality measures be represented in this plan and that physicians who treat patients with wounds be part of the Technical Expert Panel as CMS continues to develop this plan.

View full comments

Comment Call-Out:
"The U.S. Wound Registry currently has 20 wound related quality measures available for reporting, all of which have been developed as electronic clinical quality measures and thus may be used in any certified electronic health record. There are measures within this Qualified Clinical Data Registry that should be rolled into CMS's initial measure release for patients since clinicians who treat these patients are not part of a clinical specialty and therefore do not have appropriate measures to report under [Physician Quality Reporting System] that is representative of the patients they treat. The Alliance requests that since those physicians who treat patients with wounds use QCDRs, that these measures should be able to be reported under MIPS." 

MAC contracting
The Alliance submitted February comments to CMS regarding its request for feedback on Medicare Administrative Contractor (MAC) contract awarding. Comments focused on the importance of clear accountability and transparency, expressing concerns about contractors exceeding statutory authority, and encouraging the establishment of a range of metrics for MACs as well as Pricing, Data Analysis and Coding (PDAC) contractor.

View full comments .

Comment Call-Out:
"The Alliance has, over the years, tried to find information on the CMS website regarding the performance measures of its contractors and have not been able to find such information. Therefore, our first recommendation is that CMS be required to provide the metrics on how the contractors are being measured. This transparency will not only help our clinicians but other stakeholders who interact with the MACs...CMS needs to ensure that the MACs are actually doing their job in a transparent way and are not exceeding the scope of their authority, and not co-mingling coverage, coding or payment issues, which unfortunately occurs often and will only increase if there are financial incentives being provided to them." 

Pneumatic Compression Devices 
The Alliance continued to make its case to CMS and Durable Medical Equipment Medicare Administrative Contractors (DMEMACs) that the 2015 local coverage determinations on pneumatic compression devices are improperly and substantively more restrictive than the corresponding national coverage determinations (NCD) - which is a violation of the Medicare Program Integrity Manual. In a January letter to DMEMAC medical directors, the Alliance wrote:

View full letter .

Comment Call-Out:
"We again assert that the new LCD does not merely 'clarify' existing requirements...but rather adds a number of new substantive binding criteria that are more restrictive than the NCD; the practical effect of these changes eliminates beneficiary access to PCDs that has long been afforded by the NCD. There is no doubt that if a beneficiary had access to a PCD on Nov. 30, 2015 based on existing criteria, but that same patient no longer qualified for PCD coverage on Dec. 1, 2015 based on new LCD criteria, then those new criteria are more restrictive - and that is the case for a large number of beneficiaries." 

Episode Groups under MACRA
The Alliance submitted comments in response to CMS' request for comments on the methodology the agency is using to create Episode Groups under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). 

Comment Call-Out:
CMS should "create episodes of care around high resource use conditions including (1) diabetic foot ulcers, (2) venous stasis ulcers and (3) stage 3 and 4 pressure ulcers.
-When CMS develops its episodes of care regarding wound care, we request that the Agency includes clinicians who treat patients with wounds within the workgroup.
-We urge CMS to investigate whether it is possible to use patient groups identified through QCDRs as the basis for resource use calculations. QCDRs seem to be an excellent opportunity to evaluate novel approaches to resource use methodology, since clinicians with unique practices must develop risk stratification methods specific to their unique patient populations."

Key Q1 Meetings & In-Person Advocacy

Alliance meetings with stakeholders this quarter addressed the following issues: 
Pneumatic Compression Devices:
The Alliance convened two meetings with senior CMS staff (Jan 15 and March 4) on pneumatic compression to continue the dialogue about the restrictive LCD that was put into place and to review the denied claims data we had submitted showing the restrictive impact of the LCD. Dr. Fedor Lurie (AVF) represented the Alliance clinical associations, and was joined in person and over the phone by Alliance clinical organizations including APMA, APTA, and ACFAS. Despite a productive and data-filled meeting, CMS officials indicated that they believed the MACs were within their authority to issue the LCD and they did not deem the LCD to be more restrictive than the National policy. The Alliance will continue to seek opportunities to address the overly restrictive LCD moving forward.
Hyperbaric oxygen therapy (HBOT)
Led by APMA's Dr. Mark Block and AAWCM's Jule Crider, the Alliance has been in conversation with First Coast and Novitas regarding their LCDs on HBOT. Dr. Block indicated that the overly restrictive language regarding podiatrists was resolved and that the First Coast Policy should mirror the Novitas policy when released in final.
Clinical Association Meetings:
Alliance's Executive Director Marcia Nusgart presented on "Regulatory and Legislative issues Impacting Wound Care Including Physician Payment Reform" at the American Professional Wound Care Association national meeting and attended the American Venous Forum's and Diabetic Limb Salvage annual conferences.
R ecent Publications & Policies Relevant to Alliance
  • This month, Palmetto issued its final CTP policy on the use of Skin Substitutes or Cellular and/or Tissue Based Products (CTPs) for treatment of Lower Extremity Non-Healing Wounds - which will go in to effect in May. Some - but not all - of the comments that the Alliance submitted were accepted, but there are still several issues with the policy as it was released that the Alliance will be discussing and addressing in the weeks ahead.
  • In March, CMS issued a Proposed Rule to create a new payment model for Part B drugs. There would be two phases to this proposal: replace the ASP +6% payment methodology to 2.5% plus a $16.80 flat fee add-on which would be updated annually and then introduce a value based purchasing model for part B drugs. This issue will be discussed in detail at the Alliance's April 15 meeting.
  • In February, FDA announced a decision to postpone its April hearing regarding the Draft Guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps") in order to accommodate the significant interest and response to be heard on this matter. FDA intends to extend the comment period for the draft guidance documents as well. A new date has not yet been announced. The agency will schedule a scientific workshop to gather information from manufacturers, researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics. The Alliance is currently developing our comments on these guidance documents.
Upcoming Meetings of Interest
  • HCPCS Public Meetings will be convened by CMS to discuss pending applications for new and revised HCPCS codes: May 17-19 Drugs/Biologicals, Radiopharmaceutical/Radiologic Imaging Agents; June 1-2 Durable Medical Equipment, Orthotics and Prosthetics; Supplies and Other.
  • Health Care Payment Learning and Action Network will hold its "Accelerating to Value" Spring summit April 25-26 in Tysons Corner, Va. focused on alternative payment models 

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.