Alliance Update: Wound Care Policy News and Comments for Q3 Protection Status
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By The Alliance of Wound Care Stakeholders

In their quarterly Alliance Advocacy Update, the Alliance of Wound Care Stakeholders (Alliance) provides an update on their ongoing advocacy initiatives on behalf of their clinical association members to ensure access, coverage and payment to wound care procedures and technologies for patients and providers.

Alliance Study Documents Cost of Chronic Wounds

Policy Imperative for Quality Measures and Reimbursement Models Appropriate to Wound Care

With quality measure-based payment models now driving Medicare reimbursement under MACRA, wound care providers have been left with few quality measures to report that are relevant to the care they provide. The Alliance recently funded research to calculate the total cost to Medicare of chronic, nonhealing wounds, as part of advocacy efforts to bring improved data to CMS as the agency evolves MACRA quality measures and reimbursement models.

The study, "An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds," was recently published online in the International Society for Pharmacoeconomics and Outcomes Research's journal, Value in Health. Key findings:

  • Chronic wounds impact nearly 15% of Medicare beneficiaries (8.2 million).
  • A conservative estimate of the annual cost is $28 billion when the wound is the primary diagnosis on the claim. When the analysis includes wounds as a secondary diagnosis, the cost is conservatively estimated at $31.7 billion.
    • In regard to site of service, hospital outpatient settings drove the greatest proportion of costs ($9.9 to $11.4B), demonstrating a major shift in costs from hospital inpatient to outpatient settings.
    • Including cost of infections, surgical wounds ($11.7 to $13B) and diabetic foot ulcers ($6.2 to $6.9B) drove the highest total costs.
    • On an individual wound basis, mean Medicare spending per wound per beneficiary was $3415 to $3859. The most expensive wounds were arterial ulcers ($9105 to $9418), followed by pressure ulcers ($3696 to $4436).
    • Surgical infections were the largest prevalence category (4.0%), followed by diabetic wound infections (3.4%).

Why These Findings Matter: Policy Implications and Call to Action

The true burden of wound care to Medicare has previously been relatively hidden. The study's uniquely comprehensive analysis of the economic costs can have important implications for federal research and CMS policies. The documentation of the specific, significant burden of chronic wounds in the Medicare population illustrates the need for CMS and health policy makers to include wound-relevant quality measures in all care settings, as well as develop episode of care measures, chronic care models, and reimbursement models to drive better health outcomes and smarter spending in the wound care space.

See the full study online and/or share Alliance's summary and fact sheet within your organization via newsletters, blogs, and websites so that your membership can benefit from this new, comprehensive understanding of the economics driving wound care and the work that the Alliance are doing together to advocate for reimbursement models to follow.

Advocacy Success: Novitas Wound Care LCD

Novitas released its wound care final LCD (L35125) in September, and the updates made in the final version show that the Medicare Administrative Contractor (MAC) listened to and acted on stakeholder comments.

The Alliance had many concerns with the draft policy. The Alliance testified at the January 2017 public meetings and submitted written comments in March 2017 recording the Alliance’s concern about the overall lack of evidence and cited data to support proposed changes, the elimination of coverage of disposable negative pressure wound therapy (NPWT), and the "arbitrary" utilization parameters for Negative Pressure Wound Therapy and debridement services. Before the final LCD was released, Alliance co-chair Dr. Caroline Fife and executive director Marcia Nusgart communicated with the Novitas medical directors Dr. Debra Patterson and Dr. Sunil Lalla to request that the Alliance serve as a resource to Novitas as it finalized its policy.

The Alliance is pleased to inform you that Novitas made many changes to the final policy that reflect the Alliance’s comments. In the final LCD there are now:

  • More flexibility in performing debridements and NPWT
  • Coverage for dNPWT and palliative care
  • Corrections to some of clinically inaccurate information that was in the draft

Additionally, Novitas eliminated the language in which wound volume or surface dimensions needed to decrease by 10% per month or 1 mm per week. While there are still a few areas that the Alliance will need to address, this is a big "win" for the united Alliance advocacy.

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

Alliance comments to regulatory agencies in Q3 included:

Comments to CMS:

FY2018 Hospital Outpatient Prospective Payment System

The Alliance submitted comments to the proposed CY 2018 Hospital Outpatient Prospective Payment System updates. The Alliance’s comments focused on the methodology of packaging policies for cellular and/or tissue-based products for skin wounds (CTPs), policies that the Alliance believes may be hampering patient access.

Comment Call-Outs:

"The packaging of CTPs has resulted in unintended consequences. Instead of controlling costs, packaging has forced hospital outpatient departments to significantly reduce or cease using CTPs for the sickest of patients that require product in excess of the calculated amount within the application codes. If CMS is determined to continue with packaging, the Agency needs to look to the true cost of the products, establish multiple levels of packaging and ensure that no package provides a larger payment incentive than the other."

Physician Fee Schedule

The Alliance submitted comments to the Proposed CY18 Physician Fee Schedule updates addressing a range of issues including evaluation and management services (E/M codes), hyperbaric oxygen therapy (HBOT), CPT® codes for NPWT, and quality measures.

Comment Call-Outs:

"The Alliance applauds CMS decision to update the equipment items and the amount of oxygen for HBOT so that the amount of oxygen conforms to the RUC recommended value...The Alliance recommends that CMS finalize these provisions in the final rule."

Quality Payment Program

The Alliance's comments to the CY 2018 Quality Payment Program (QPP) emphasized the continued need for development of quality measures more relevant to wound care, as well as focused on value and challenges of Qualified Clinical Data Registries (QCDR) in reporting under the MACRA programs.

Comment Call-Outs:

"The Alliance recommends that while there were 14 measures created and currently accessible for reporting under the QPP, that additional wound care measures are necessary to ensure that wound care practitioners are and continue to provide quality care."

HCPCS Coding Reform

In collaboration with the Alliance for HCPCS II Coding Reform, the Alliance—together with 30+ organizations—signed on to a letter to request a meeting with (then) HHS Secretary Tom Price and CMS Administrator Seema Verma regarding concerns with the current coding process and asking CMS to 1) increase transparency/due process; 2) separate criteria used to establish a new HCPCS code from criteria used to establish a coverage policy; 3) establish an appeals process to provide independent review and reconsideration, and 4) improve PDAC coding verification and code revision processes.

The Alliance is pleased to report that it has set a meeting this month with senior CMS staff to discuss issues and recommendations.

Comment Call-Outs:

"The need to make these improvements stems from a longstanding history of concerns with the HCPCS Level II coding process. The process restricts patient access to certain devices, products, and technologies, stifles innovation, and fails to keep current with important technological developments...We believe our recommendations will ultimately help improve patient access to medically necessary products."

Comments to DMEMACs:

Surgical Dressings

In response to the concerning final LCD issued earlier this summer, the Alliance jumped into action and mobilized stakeholders to join us in submitting July letters to DMEMAC medical directors and CMS staff outlining procedural and clinical concerns and requesting delay or withdrawal of the policy. When that request was declined, the Alliance pursued a strategy seeking clarity on areas of the LCD causing the greatest confusion in clinical practice. The Alliance’s September follow-up letter to the DMEMACs requested clarifying language addressing collagen dressings and wound staging. The Alliance is currently reviewing a recent response from the DMEMAC medical directors and will be sharing updates with Alliance membership.

Comment Call-Outs:

"We continue to confront important requests for clarifications that are critical to treating physicians, patients, and suppliers. Despite our best efforts to interpret the new [collagen dressings and wound staging] language of the LCD, there continues to be significant disagreement and confusion over how the LCD provisions apply. Unfortunately, inconsistent interpretations have led to direct impacts on patient care."

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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