Alliance Update: Wound Care Policy News and Comments for Q4 Protection Status
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In their quarterly Alliance Advocacy Update, the Alliance of Wound Care Stakeholders (Alliance) provides a review of 2017, and looks ahead to their plans and goals 2018.

2017 in Review:
Celebrating the Strength of our Collective, Collaborative Voice

We kick-off 2018 with a busy advocacy agenda ahead of us! Certainly, 2017 demonstrated that having a strong, united voice in today's hyper-partisan world remains essential. We celebrated our 15th anniversary in 2017. Fittingly, we celebrated with a party, a video, and a year spent collaboratively and productively providing a unified, balanced and rational wound care perspective to CMS, CMS contractors, FDA, Capitol Hill and other key policy stakeholders in the wound care space. We will continue our advocacy and build on our 15 years of successes throughout 2018. While a more detailed annual report will be circulated shortly, our "top 5" accomplishments in 2017 include:

1. Demonstrated the clinical and economic expenditure impact of chronic wounds to the Medicare program and illuminated the need for more wound-relevant quality measures, payment models and Federal research funding . Alliance-sponsored research culminated in a publication in the prestigious economic journal, ISPOR's Value in Health. Top-line findings of "An Economic Evaluation of the Impact, Cost and Medicare Policy Implications of Chronic Nonhealing Wounds" showed that chronic wounds impact nearly 15% of Medicare beneficiaries (8.2 million) at an annual cost to Medicare conservatively estimated at $28.1 to $31.7 billion. Upon publication of the study, the Alliance shared a topline news release and fact sheet to enable member organizations to share with their own memberships and constituents. We will continue to leverage this study to bolster our advocacy efforts.

2. Went on the record 15 times in 2017 with official comments, oral testimony and letters as we pursued accurate, clinically sound local coverage determinations and payment policies. This included:
5 comments to CMS on the CY2018Hospital Outpatient PPS, Hospital Inpatient PPS, Physician Fee Schedule, Physician Quality Payment Program, and the Request for Information regarding a new direction of the Center for Medicaid and Medicare Innovation (CMMI).

  • 7 oral and written comments to A/B MACs on Novitas, FirstCoast and WPS wound care LCDs that addressed a range of issues including NPWT, disposable NPWT (dNPWT), debridement, and more.
  • 2 letters to the DMEMACs raising concerns with the final surgical dressing LCD.
  • 1 letter to HHS and CMS, co-signed with the Alliance for HCPCS II Coding Reform.

3. Minimized the impact of Novitas' restrictive draft LCD on NPWT. The Alliance actively responded to a problematic Novitas wound care LCD issued in January. We testified at Novitas' public meetings and submitted written comments recording our concern about the overall lack of evidence to support their proposed changes, the elimination of coverage of disposable Negative Pressure Wound Therapy (dNPWT), and the arbitrary utilization parameters set for NPWT and debridement services. The final policy, published in September, resolved many of our comments. The LCD now includes more flexibility in performing debridement and NPWT, plus coverage for dNPWT.

4. Continued our advocacy to address clinical concerns with the DMEMAC final surgical dressing LCD, ultimately driving a "clarification letter" addressing several key issues. The final policy (published in June) was not consistent with how surgical dressing products are prescribed and utilized by wound care clinicians. The policy contained significant areas of concern including but not limited to: the removal of clinical judgment in the LCD language; imposing strict frequency limitations on all dressings; and new coverage and utilization criteria are ambiguous and inconsistent. We collaborated together with the Coalition of Wound Care Manufacturers to coordinate a synergistic advocacy strategy:

  • We developed a "request for delay" letter to senior CMS staff focused on clinical issues and ambiguity in the LCD. While CMS did not act on this delay request, our advocacy did achieve action and DMEMAC response.
  • In September, the Alliance requested clarification on issues regarding collagen dressings, staging systems and hydrogels - areas of the LCD that were causing confusion in clinical practice and impacting patient care/patient access to products and services.
  • In October, the DMEMAC medical directors responded with a clarification letter that addressed these issues.
  • Finally, when there was incorrect information on the surgical dressing LCD on a November Noridian webinar, the Alliance acted quickly to request that the DMEMACs correct this information in a public forum. (Noridian corrected this information in Feb. 2018 by sending emails to those who participated in the webinar.)

5. Elevated the need for HCPCS coding reform to help improve patient access to medically necessary products and simplify the process for bringing new products to the wound marketplace. In collaboration with the Alliance for HCPCS II Coding Reform, the Alliance co-signed a letter to (then) HHS Secretary Tom Price and CMS Administrator Seema Verma expressing concerns with the current coding process and asking CMS to (1) Increase transparency of coding decisions; (2) Separate criteria used to establish a new HCPCS code from criteria used to establish a coverage policy for the product; (3) Establish an appeals process to provide independent review/reconsideration of coding decisions and (4) Improve the PDAC coding verification and code revision processes. Senior HHS/CMS staff followed-up the letter by meeting with the Alliance leadership and members twice - in November and December. Another meeting was scheduled for January 2018 to continue the dialogue addressing many of the concerns raised.

The breadth and depth of our comments puts us "on the record," builds credibility and opens doors for ongoing advocacy and dialogue - entrenching the Alliance as a "go-to" resource for government agencies and policy makers. Looking forward, we have much work ahead of us in 2018 and look forward to continued collaboration and success.

Q4 Submitted Comments:
Ensuring Alliance's Clinical Expert Perspective is Heard

Comments to CMS:

In November, the Alliance submitted comments to CMS' request for information on new directions for the CMMI after convening many conference calls with members to determine issues of importance. Comments focused on opportunities within specialty physician models, program integrity, and benefit design/price transparency. The Alliance also focused on the growing importance of real world evidence and patient registry data. The Alliance emphasized once again the importance of developing quality measures that are more relevant to wound care, and pointed again to the relevance of HCPCS coding reform to the CMMI's focus on improved payment models - given the correlation of coding and payment in practice.

DMEMAC Surgical Dressing LCD
In October, the DMEMACS sent the Alliance a "clarification letter" in response to our September letter requesting clarity on issues regarding to collagen dressings, staging systems and hydrogels - areas of the LCD that would cause confusion in clinical practice. The letter provided clarity on many of the issues the Alliance had raised. (See summary in "accomplishments" article above.)

Comment Call-Outs:

"Historically, CMS has focused on care provided by specialty physicians and created the Quality Physician Payment regulations. However, if CMMI is interested in innovation, then the Alliance believes that it should be taking a more multidisciplinary approach to care and promote care coordination and create more incentives to encourage the creation of these multidisciplinary models in order to reduce costs to the Medicare program...We request that the Agency advance patient care by collaborating with us on this joint journey to establish a care pathway for wound care clinicians and the patients they serve."

"You specifically cite the LCD sentence 'A collagen-based dressing or wound filler is covered for full thickness wounds (e.g. stage III or IV ulcers), wounds with light to moderate exudate, or wounds that have stalled or have not progressed toward a healing goal.' You ask if this means that the following wound types are included: (1) full-thickness wounds; (2) wounds with light to moderate exudate; and (3) wounds that have stalled or not progressed toward a healing goal. We understand your point to be an inquiry attempting to discern whether only wounds with all three characteristics are covered versus whether each is an independent criterion that justifies coverage. The latter interpretation is correct. Each of the specified wound types are independent criteria that can justify coverage."

Key Q4 Meetings & In-Person Advocacy

Alliance Q4 meetings with stakeholders included:

  • HCPCS Coding Reform - November meeting: Marcia Nusgart, together with other representatives collaborating with the Alliance of HCPCS Coding Reform, met with CMS to share HCPCS coding reform recommendations. Senior CMS staff at that meeting included Demetrios Kouzoukas - Principal Deputy Administrator for Medicare; Liz Richter - Deputy Director, Center for Medicare; Jeanette Kranacs - Deputy Director Division of Chronic Care Management; Joel Kaiser, Director, Division of DMEPOS Policy; Cynthia Hake, Deputy Director, Division of DMEPOS Policy; Kimberly Combs Miller- HCPCS. We are pleased to report that CMS staff were engaged, asked questions, willing to consider reforms, and requested further details. In fact, Demetrios Kouzoukas asked that Liz Richter and her staff meet with us, and he asked for us to give them examples and more details supporting our concerns and recommendations. This led to a follow-up December meeting.
  • HCPCS Coding Reform - December Meeting: To forward our conversation and recommendations, we and other representatives with the Alliance of HCPCS Coding Reform held a follow-up meeting with CMS staff in Baltimore. We shared examples of how the declining number of new codes, the opaque standards for obtaining a new code, the grouping of more and more dissimilar products all have adverse impacts on patients, providers, innovators, and other stakeholders. An additional meeting took place with CMS staff in January 2018.
  • MEDPAC: Marcia Nusgart attended the November MEDPAC meeting, which included a discussion of the possibility of adding more DMEPOS to competitive bidding. We took advantage of an opportunity to speak at that meeting to advise the Panel that if the MEDPAC staff decides to add new products to competitive bidding that it should recommend that CMS reform the HCPCS coding process since coding is aligned with payment. As follow-up to her remarks, the Alliance reached out to MEDPAC staff and set up a meeting in Jan. 2018.
  • ASTM:Dr. Chuck Drueck flagged to the Alliance the Nov. 16 ASTM call that would be addressing the now-outdated skin substitute ASTM standard, which has the possibility of replacing the new CTP standard that the Alliance had helped to establish. Coalition staff encouraged Coalition members to become ASTM members and those who are also in ASTM to participate in the ASTM ballot vote being discussed on its November call: "F2311-08 Should be Sunsetted and not be Reinstated
  • SAWC: Our annual in-person meeting was held at the Fall SAWC and commemorated our 15th anniversary with a celebratory video and toasts. Also at SAWC, the Alliance spoke at the AAWC board meeting & convened a Cellular and/or Tissue based products for wounds (CTP) work group meeting
  • HCPLAN: Alliance staff and members attended the October Health Care Payment Learning & Action Network (HCPLAN) workshop in Arlington VA which provided the opportunity to meet with CMS and CMMI senior staff. The conference featured talks from CMS head Seema Verma and many CMS senior staff, as well as panelists from BCBG, Anthem, Aetna and other payers. Alliance is a "committed partner" to the HCPLAN. See the topics covered here.
  • Member conferences: Alliance staff attended the Society for Vascular Surgery's VEITH Symposium, Nov. 14-17 in NYC.

Recent Publications & Policies Relevant to Alliance

  • Value in Health: The Alliance-sponsored article "An Economic Evaluation of the Impact, Cost and Medicare Policy Implications of Chronic Nonhealing Wounds" published online in October in the International Society For Pharmacoeconomics and Outcomes Research's Value in Health journal. The Alliance had prepared fact sheets, newsletter articles and news releases to help members share the findings with your constituents and stakeholders.
  • Media coverage: Gained coverage of the Value in Health study in a range of wound publications including: Ostomy Wound Management, Wound Source, Today's Wound Clinic, SmartTRAK, American College of Hyperbaric Medicine's newsletter, APTA's "PT in Motion" newsletter, Diabetic Food Online blog, APWCA blog, and more.
  • CMS final rules issued in in November for the CY 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System, the Physician Fee Schedule and Qualified Physician Payment (QPP). The Alliance circulated summaries of these final rules to membership.
  • HCT/Ps: In November FDA released a guidance document on regulatory considerations on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - minimal manipulation and homologous use. The Alliance commented on this in Sept 2016 in the public meetings and via written comments.
  • MEDCAC: The Medicare Evidence Development & Coverage Advisory Committee published a Request for Nominations for Members which we sent to Alliance members for their consideration.

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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