Alliance Update: Second Quarter 2016 Policy News and Comments Protection Status
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by The Alliance of Wound Care Stakeholders

The Alliance of Wound Care Stakeholders' (Alliance) quarterly update provides an overview of ongoing advocacy initiatives to ensure access, coverage and payment to wound care procedures and technologies for patients. This update includes current action items, updates on key areas of focus from the past quarter, and future issues for the second half of 2016 that the Alliance is tracking that are of importance to the wound care community, including clinicians who may be impacted by policy changes.

"Quality Reporting Measures in Proposed Rule Not Meaningful to Wound Care," Alliance Tells CMS in Comments Addressing Proposed Medicare Access and CHIP Reauthorization Act (MACRA) Rule on Merit-Based Incentive Payment System (MIPS)

"CMS must take chronic wound care seriously as its expenditures for treating Medicare wound care patients are larger than recognized, results in a severe clinical burden and impaired quality of life for Medicare beneficiaries and most likely underreported as the Agency develops its final MACRA rule," the Alliance advised the Centers for Medicare & Medicaid Services (CMS) in comments addressing the Proposed Rule on the Merit Based Incentive Program System (MIPS) and Alternative Payment Model (APM) programs being implemented under the physician fee schedule. To validate this, the Alliance submitted to CMS initial findings from an analysis of Medicare costs of ulcers and wounds, to give the Agency context to the clinical and economic expenditure impact of wound care. A more detailed analysis of the data and report on findings will be forthcoming from the Alliance moving forward.

"The Merit Based Incentive Program System developed for general physicians and certain specialties (i.e. cardiology, oncology) do not take into consideration the physician specialists and subspecialists who practice wound care," the Alliance wrote, noting that the obligatory reporting of quality, resource use and clinical performance measures may not truly be indicative of the wound care work nor of the resources that would care practitioners use to treat patients. In addition, existing wound care quality measures are not currently included in the proposed rule.

The Alliance made the following recommendations to CMS:

  1. Quality measures: Allow wound care practitioners to utilize the U.S. Wound Registry Qualified Clinical Data Registry (QCDR) measures to satisfy the Quality Reporting requirements under MIPS.
  2. Implementation schedule: Postpone implementation for 6 months to one year to give clinicians and vendors adequate time to implement the changes proposed
  3. Cost measures and episode groups: Convene a work group to address inpatient/outpatient costs issues and establish episode-based measures for wound care, as CMS has not included any wound care related diagnoses on the list of 41 episode based measures in its draft regulation.
  4. Advancing Care information requirements: Delete the requirement for immunization registry reporting for physicians who do not provide immunizations and request that a customized clinical data registry be allowed to substitute for the immunization registry for specialty physicians.
  5. Multi-disciplinary inclusion: Include physical therapists should be included in the MIPS program beginning in 2017; Convene a Technical Expert Panel comprised of individuals representing these "other professionals" (e.g., registered dietician nutritionists) to inform adaptation of the Quality Payment Program to meet their needs before these professionals become eligible clinicians under this program.

"Of the 300+ Physician Quality Reporting System (PQRS) measures that are reportable under MACRA, there are none specific to wound care," the Alliance wrote, emphasizing that "there are 20 quality measures specific to the practice of wound care, fully programmed as electronic clinical quality measures (eCQMs) available within the U.S. Wound Registry Qualified Clinical Data Registry (QCDR), available for reporting under CMS's Physician Quality Reporting System (PQRS). However, at current time, these same quality measures are not eligible for MIPS reporting under the current rules. This means that while wound care clinicians can use these measures, they will not count for their composite score under MIPS...and hence unduly and negatively impacting the reimbursements they will be eligible for under the quality incentive payment program."

"The Alliance clinical associations and specialty societies do not want MIPS to be a step backward from the vital advancements in wound care which have been promoted by engagement of all stakeholders and resulting in the QCDR. We request that CMS allow wound care practitioners to utilize QCDR measures to satisfy the quality measure requirements under MIPS," wrote the Alliance.

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. In addition to our comments on the MIPS/APM rule, we submitted the following comments:

CMS Part B Drug Payment Model
The Alliance submitted comments to CMS in May on its proposed new Part B drug payment methodology, noting an over-riding lack of transparency provided by the Agency in establishing this new model.

Comment Call-Out:
"CMS has continued to disregard transparency by issuing a regulation without providing data or evidence which:

  • Shows how the proposed methodology will save costs and improve quality of care and how CMS plans to assess access and quality during the "test" period
  • Explains how CMS determined that ASP +2.5% plus the flat fee will address saving costs and improve quality as opposed to ASP+5% or any other variable
  • Provides specific details on the design, evaluation or implementation of this program other than to say that it will be done in a sub-regulatory fashion...

"We urge you to withdraw this proposed rule, engage patient and professional societies, to develop a program which is substantiated in data and evidence and is more limited in scope (such as a pilot program) in order to achieve a proposal that is best for patient care in a cost-sensitive environment."

Comments in Progress
The Alliance is currently busy this summer developing a series comments to submit to CMS and the Food and Drug Administration (FDA) addressing:

Comment Call-Out:
Draft comments will be sent for Alliance input over the weeks ahead for submission in August and September. Help them shape these comments by weighing in on the drafts by visiting

Key Q2 Meetings & In-Person Advocacy

Alliance meetings with stakeholders this quarter addressed the following issues:

MACRA Implementation:
Alliance staff attended the Health Care Payment Learning and Action Network (HCP-LAN) summit which provided strategies for payers, providers, patients and manufacturers to work together to adopt and use alternative payment models nationally. The Alliance met with commercial payer medical directors and CMS staff to discuss wound care issues. The Alliance is now signed on as a "committed partner" to this valuable LAN network. There will be another HCP-LAN meeting this fall; we will share details when available.

HCPCS Coding:
The Alliance attended CMS's Healthcare Common Procedure Coding System (HCPCS) Public Meeting on May 19 on biologicals and the June 1-2 meetings on Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) where preliminary coding and payment were discussed.

Local Coverage Determinations:
The Alliance continues to work on Palmetto's CTP LCD issues. When Palmetto released the final CTP policy, it did not include the C codes for the low cost CTPs. The Alliance is in conversation with Palmetto to ensure these are added into the policy.

Legislative Issues:
The Alliance spoke with both the Alliance for Regenerative Medicine and American Association of Tissue Banks to learn more about REGROW Act - which would grant five-year conditional approval to cellular therapeutic products that have been either minimally manipulated for a non-homologous use or more than minimally manipulated for a homologous or non-homologous use but haven't been genetically engineered and have been shown to be safe and probably effective without initiating Phase III trials. The bill additionally allows for reimbursement of a product with a conditional approval. The Alliance is monitoring progress of the bill but has not weighed in with comment.

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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