By the WoundSource Editors
With the ongoing shifts in the U.S. health care landscape under a new Presidential administration, the unpredictable future of the Affordable Care Act, and the implementation of Medicare payment reform, having a voice in draft policies and regulations to represent the wound care perspective is of paramount importance.
The Alliance of Wound Care Stakeholders' (the Alliance) 2016 work focused not only on the regulatory guidances and local coverage determinations that Alliance always focused on; but also on the value-based care payment initiatives that the Alliance dramatically changing the U.S. health care delivery. Over the past year, the Alliance identified and took advantage of multiple opportunities for input, advocacy and comment, and worked tirelessly to ensure that regulatory agencies are aware of the issues and impacts to wound care as policies are crafted and considered.
Several of the Alliance's top accomplishments in 2016 include:
- Elevating visibility of wound care issues to CMS as it refined regulations guiding implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), ensuring that the agency and its policy-makers heard and considered of the impacts of the evolving value-based care/payment reform policies to wound care. The Alliance submitted comments to MACRA's quality physician payment proposed rule as well as on the "quality measures development plan," "patient relationships categories and codes," and "episode groups" draft policies. Our comments put specific wound care issues "on the record" and set the stage for future advocacy activities. We will continue to advocate for inclusion of specific wound care quality measures for wound care clinicians to be able to utilize and submit moving forward.
- Demonstrating to CMS the clinical and economic expenditure impact of chronic wounds to the Medicare program by commissioning health consultants Dobson DaVanzo & Associates to perform an analysis of Medicare claims and payments. The data illustrated that expenditures for treating Medicare wound care patients are larger than recognized, result in a severe clinical burden, impair quality of life for Medicare beneficiaries and are most likely underreported. The Alliance submitted findings directly to CMS via our MACRA comments, and we are now seeking publication of the data in a respected medical journal.
- Playing a key role in effectively educating the FDA and its advisory panel on real-world use and value of antimicrobial wound care dressings, resulting in the panel's recommendation to the FDA that antimicrobial wound dressings should be classified as a Class II with special controls. The Alliance educated its members on the concerning impact to access/availability/price that a change in classification could mean, and implemented a four pronged approach that included (1) submission of comments in advance of the meeting to provide relevant background information on wound care complexities, (2) submission of post-meeting follow-up comment, (3) mobilization of a team of expert speakers to testify at the open public hearing portion of the meeting and (4) provided Alliance testimony during the panel meeting.
- Ensuring that wound care concerns were articulated and flagged to CMS as it set payment rates and policies via its CY 2017 prospective payment systems (PPS) regulations by submitting written comments on the provisions that impacted wound care within the Hospital Outpatient Services PPS and Home Health PPS, as well as submitted comments to the CY2017 physician fee schedule.
- Pursuing accurate and clinically sound local coverage determinations with its persistent advocacy with A/B MAC and DMEMAC medical directors for fair and equitable LCDs and coverage processes. Advocacy in 2016 focused on LCDs addressing hyperbaric oxygen therapy and cellular and tissue-based products (CTPs) for wounds.
Overall, we built the Alliance's reputation as a proactive, professional voice on wound care policy through the submission of a total of 21 sets of written and oral comments to regulatory agencies and contractors on diverse topics in 2016, including:
- 6 to FDA,
- 11 to CMS,
- 3 to CMS contractors, and
- 1 to ARHQ
The breadth and depth of these comments builds the Alliance's reputation as the wound care association that responds quickly and addresses wide range of wound care issues.
For a more detailed look at the Alliance's collective accomplishments, click here.
Submitted Comments: Ensuring Alliance's Clinical Expert Perspective is Heard
Alliance comments to regulatory agencies in Q4 included:
Comments to CMS: MACRA Final Rule
The Alliance responded to CMS's Final Rule on Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) with comments highlighting the Alliances' two most pressing and important concerns: that it fails to encourage the use of qualified clinical data registries (QCDRs) as part of quality measurement and reporting. Also focusing on the rule's quality performance categories.
The Alliance advocated that quality development should be "patient centric," or at the very least, problem centric rather than setting-based. "In other words, the measures should follow the patient and not the site of care if patient-centered care is going to exist," we advocated.
Comments to FDA: "Real-World Evidence" Draft Guidance
The Alliance submitted comments to FDA draft guidance on "Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices" and voiced its support for the use of data from registries, claims, and electronic health records to support the evaluation of medical devices. Comments noted to FDA the limitations of randomized clinical trials to evaluate the effectiveness of a wound care product or intervention and provided specific examples of how registry data could be used in assessing the safety of a wound care medical device.
Comments to FDA: Classification of Antimicrobial Wound Care Products
The Alliance continued its leadership role in educating the FDA on the role and real-world value of antimicrobial wound dressings. Following FDA's Sept. 20-21 advisory committee meeting, we led the charge in asking for an extension to the comment period so that stakeholders could have sufficient time to respond to the specific issues raised at the meeting. At the request of Alliance members and others, the comment period was extended from October to November. At that time, the Alliance, and many of our members, submitted comments supporting the FDA panel's recommendation that antimicrobial wound dressings should be classified as a Class II with special controls. We focused on issues discussed at the meeting that either needed to be emphasized due to their importance, or that needed some additional clarity and context.
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.