In order to successfully commercialize a wound care product in the United States, a manufacturer needs to secure an appropriate Healthcare Common Procedure Coding System (HCPCS) number or billing code. The Centers for Medicare and Medicaid Services (CMS) has issued very few new HCPCS codes for durable medical equipment, orthotics, prosthetics, and supplies (DMEPOS). For years, manufacturers of wound care DMEPOS products have been challenged by a coding process that was not transparent, understandable, or predictable. This situation has not only had a chilling effect on innovation, but it also has resulted in driving research and development investments away from DMEPOS. Ultimately, this compromises access to quality care for millions of Medicare beneficiaries and other individuals.
Organizations such as the Alliance of Wound Care Stakeholders and Alliance for HCPCS II Coding Reform have been fierce advocates for changes in the HCPCS coding process. The Alliance for HCPCS II Coding Reform is comprised of key law firms, lobbying firms, associations, coalitions, medical device companies, and reimbursement consulting companies who recognized the need to take action to reform the HCPCS coding system. The Alliance of Wound Care Stakeholders, representing 20+ medical societies and clinical associations and serving as a unified voice for wound care providers, is one of the associations supporting this effort. These groups have been busily advocating for HCPCS coding reform and provided specific reform recommendations to the CMS and to Congress via comments, letters, calls, public hearings, and private meetings.
In late November, the CMS finally took action and announced a first wave of updates to its HCPCS coding application process. CMS’s promising, newly announced changes to the HCPCS coding and application processes are geared to help foster greater transparency in the coding process. The changes the CMS is making to the process can be found on its website. These specific updates include:
- Clarifying and updating website guidance associated with the application process;
- Advancing a new electronic application process and initiating the first public beta test of this process with a limited number of stakeholders for the 2019 cycle;
- Eliminating the 3% (of market) volume criteria as a coding criteria for nondrug items. The CMS will continue to collect marketing data on the application to support the establishment of a new code;
- Providing more detailed responses to applications in order to provide for greater transparency and to assist the public in understanding CMS’ decision making;
- Providing for greater transparency and public input by providing for remote participation in HCPCS Public Meetings; and
- Increasing transparency by including an archive of past years’ files/decisions on the CMS.gov HCPCS website (instead of their current process of replacing the past year when a new one is available). This will provide a research archive for potential applicants and stakeholders.
Both the Alliance for HCPCS Coding Reform and Alliance for Wound Care Stakeholders will continue to dialogue with the CMS on this issue; they regard these changes as a first step in what they hope will be an ongoing series of reforms. The ultimate goal is a transparent and speedier process that will enable more DMEPOS manufacturers to gain HCPCS billing codes to submit claims for their products, hence bringing more innovative products to the wound care space.