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

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 Q2 2016, as well as a look at issues keeping us busy ahead.  Please share this update within your specialty society, association or organization. 
"Quality Reporting Measures in Proposed Rule Not Meaningful to Wound Care," Alliance Tells CMS in Comments Addressing Proposed 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 of Wound Care Stakeholders advised 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 FDA addressing:

- FDA's guidance documents on minimal manipulation and homologous use of human cells, tissues and cellular and tissue-based products (CTPs)

- Local Coverage Determinations (LCDs) on Hyperbaric Oxygen Therapy and CTPs

- CMS proposed rules on the CY2017  Home Health Prospective Payment System (PPS), Hospital Outpatient PPS, Physician Fee Schedule, End-Stage Renal Disease PPS, and the Medicare appeals process.

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

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 DMEPOS where preliminary coding and payment 

Local Coverage Determinations (LCDs)
The Alliance continues to work on Palmetto's Cellular and/or Tissue Based Products (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. 

Clinical Association Meetings:
  • Marcia Nusgart spoke at the European Wound Management Association meeting's "Global Outlook and Insider Perspective on the Future Wound Care Market" forum.
  • The Alliance led a panel discussion " Harnessing Big Data for Wound Healing Research: Which is More Relevant in the Quest for Evidence - Patient Centered Outcomes or Randomized Trials?" at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) meeting. Panelists included Marcia Nusgart (moderator), Dr. Caroline Fife, Dr. Marissa Carter and AHRQ's Dr. Elise Berliner.
  • The Alliance convened our in-person membership meeting at the Spring SAWC meeting in Atlanta and featured guest speakers Dr. Paul Radensky and Dave McNitt to update members on physician payment reform, Part B Drugs proposed rules and legislative issues. Dr. Gerald Lazarus of the Johns Hopkins School of Medicine gave an update on his paper regarding "Upgrading Clinical Research in Venous Ulcers."
  • Alliance staff attended the Society for Vascular Surgeons annual meeting and Marcia Nusgart updated the American Diabetes Association Foot Interest Group about Alliance activities at its annual meeting.  

The Alliance "In The News"
  • In June, the Alliance was featured in ACFAS Update in an article titled "The Alliance of Wound Care Stakeholders is in Your Corner."
  • In August, the Alliance will have an article in Today's Wound Clinic on Legislation Through a Wound Care Lens, written together with Dave McNitt.
R ecent Publications & Policies Relevant to Alliance
  • In April, Palmetto issued its final LCD policy for CTPs effective for dates of service on or after May 17, 2016.  The Alliance had testified at public meetings and submitted written comments on the draft policy. While Palmetto did not adopt all of our recommendations, they did incorporate several of our suggestions into the final policy including permitting the clinician to choose the product they would like to utilize and not have restricted coverage to just a few products. Palmetto will place the onus on clinicians to choose the most appropriate product and justify their choice through documentation.  Furthermore, while Palmetto did not utilize the CTP terminology in the title of the LCD, they do refer to these products throughout the final policy as CTPs. 
  • In May, CMS has released its final Quality Measure Development Plan, the framework for clinician quality measurement development to support the new Merit-based Incentive Payment System (MIPS) and advanced alternative payment models (APMs). The Alliance had submitted comments to the draft plan, and we will be closely reviewing this final publication and updating our membership.
Upcoming Compliance Webinar & Other Meetings of Interest
  • Invite your membership to participate on Aug. 17: Together with Lynn Snyder of Epstein Becker & Green, the Alliance will host a free educational webinar addressing risk management tools for the wound care industry related to federal/state health care fraud enforcement and what to do when facing a government inquiry. The webinar will take place on Wed., Aug. 17 at 12noon ET. It will be recorded and also posted to the Alliance website for future reference. Registration information will be circulated in the weeks ahead, as well as a more detailed description/invitation to circulate within your organizations. Please help us promote the webinar to your membership.
  • CMS will hold a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting on July 20 to examine the scientific evidence underpinning the benefit and risk of existing lower extremity chronic venous disease treatments that aim to improve health outcomes in the Medicare population. This meeting will also identify evidence gaps that exist related to lower extremity chronic venous disease. The Alliance is coordinating with members to create a unified voice to weighing in to the MEDCAC. 
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.