If you are in the US and treat Medicare patients, then you appreciate how a morass of complex coverage and payment regulations dictate which products and services you can provide. How are these policies developed, and why are they so often out of sync with best practices? How can providers be effective advocates on policy issues that create barriers to care?
For 20 years, the Alliance of Wound Care Stakeholders has focused on these questions. Representing more than 20 clinical associations and specialty societies, the Alliance has led advocacy initiatives since 2002 to promote coding, coverage, and payment policies that support evidence-based quality care and access to products and services for people with chronic wounds and the providers who treat them. In fact, in 2021 alone, the Alliance went "on the record" more than 20 times, including the submission of 15 comments to the CMS and its contractors, two to the FDA, three letters to Congress, and two to the National Quality Forum.
How does this "coding, coverage, and payment" advocacy impact clinical practice in the real world? Below are a few examples.
COVERAGE
Decisions about which wound care products and services are (or are not) covered under Medicare are made at the national level by the CMS or regionally by Medicare contractors that each make local coverage determinations (LCDs) for the parts of the country they cover. The impact of these policies is significant. If something is not covered by Medicare, you cannot be reimbursed for it. As a result, many clinical treatment decisions are guided by Medicare coverage decisions rather than best clinical practices. A core focus of the Alliance is to address clinical inaccuracies in policies and ensure that they support best practice.
As policies are developed and published, the Alliance provides guidance, recommendations, and comments to the CMS to ensure that they understand the intricacies of wound care clinical decisions and impacts of coverage policies on patient care. Provided here are a few examples of how our advocacy work impacts care.
Example of a Recent Coverage "Win"
When the CMS contractor Wisconsin Physicians Insurance Corporation (WPS) released an LCD that dangerously limited debridement coverage, the Alliance jumped into action. Stage 2 pressure injuries and diabetic foot ulcers were not initially included in the list of conditions that must be present to obtain a debridement. Through submitted comments, testimony at public meetings, calls with WPS leadership, and more, the Alliance spearheaded a multiyear advocacy campaign that ultimately resulted in the WPS significantly revising its LCD to one that is more clinically accurate and that now allows patients with these types of wounds to get the procedures they medically need.
Ongoing Advocacy
In 2021, the Alliance served as a resource to Medicare contractor Noridian as it was developing an updated local coverage policy on wound care. Through meetings, submitted comments, calls, and more, the Alliance has worked to educate Noridian so that its new policy accurately reflects the complexities of treating patients with wounds and covers procedures and treatments recommended in the most up-to-date clinical guidelines.
PAYMENT
Although coverage policies dictate whether a product or service can be provided to Medicare patients, CMS payment policies set the reimbursement that physicians and facilities receive for care provided.
Example of a Recent Payment "Win"
The Alliance saw years of advocacy work come to fruition when the CMS proposed a national fee schedule amount for disposable negative-pressure wound therapy (dNPWT) in the physician office in the CY 2020 Physician Fee Schedule. As the CMS was determining the reimbursement rate, the Alliance flagged concerns with the supply price CMS was referencing and instead urged them to rely on objective third-party data sources or actual invoices showing prices paid by physicians for dNPWT devices when providing office-based care. As a result of these efforts and a campaign urging our members to submit invoices, the CMS increased reimbursement from $100 to $208.
Ongoing Advocacy
A focus this past year has been on problematic Medicare reimbursement policies for cellular and/or tissue-based products for wounds (CTPs, also known as "skin substitutes") that have challenged clinicians and created barriers for Medicare patients to access the care they need. For example, although larger wounds require more square centimeters of CTPs than smaller wounds, "add-on codes" to cover additional CTP are not covered under current outpatient payment policies. As a result, many outpatient clinics cannot provide CTPs to Medicare patients with larger wounds as it is cost prohibitive without reimbursement for the extra product needed.
The Alliance has urged the CMS to amend its 2022 Hospital Outpatient Prospective Payment System to allow payment of CTP application add-on codes so that clinics no longer have to absorb the cost and could provide CTPs more broadly for patients with large wounds rather than referring them for inpatient care. Although the Alliance's recommendation was endorsed by the CMS's Advisory Panel on Hospital Outpatient Payment, it was not incorporated in the final rule.
Advocacy, however, is a long game. It can take years of going on the record and multiple comment submissions for changes to be considered, accepted, and implemented. Reforming the payments for CTPs will continue to be a key advocacy focus area of the Alliance over the year ahead, especially because the CMS has indicated that it plans to overhaul its overall payment methodology for CTPs in the future as it considers Episodic Payment, Single Ambulatory Payment Classification, and Comprehensive APC options. The Alliance has already weighed in with recommendations and will continue to be in dialogue with the CMS as it moves toward a policy proposal.
CODING
For many years, the Alliance has advocated for reform of the Healthcare Common Procedure Coding System (HCPCS) level II coding process. Regulations and processes surrounding coding may seem quite removed from day-to-day clinical practice, but in fact, this coding policy underlies the entire public and private reimbursement system. Establishing an HCPCS code for a procedure, service, or product is essential for health insurance claims processing by Medicare and other insurers.
The Alliance has led advocacy to make the HCPCS coding process more transparent, understandable, and predictable. Reforming the HCPCS process is ultimately good for patients and the clinical community: an improved process can increase the speed of code assignments so that patients have access to the latest products, devices, and technologies more quickly.
Example of a Recent Coding "Win"
The Alliance's persistent advocacy helped mobilize the CMS to allow medical device manufacturers to submit HCPCS code applications twice a year rather than once a year, and drug and biologic applications four times a year. This will speed the entry of new technologies to market.
Ongoing Advocacy
Over the past year, the CMS has hindered the entry of new CTP products to market by deferring HCPCS coding requests for CTPs "because the scope of the request necessitates that additional consideration be given before CMS reaches a final decision." The Alliance has been seeking clarity from the CMS to address its specific considerations and avoid further delays in patient/provider access to new CTPs.
CAPITOL HILL
The Alliance's advocacy extends to the halls of Congress. In 2021, the Alliance submitted letters of support for the Lymphedema Treatment Act, legislation that would amend Medicare statutes to allow for coverage of compression supplies for patients with lymphedema. The Alliance also went on the record to Congressional leadership supporting the Better Wound Care at Home Act, legislation that would update home health payment policies to make dNPWT more accessible. We will continue to support these pieces of legislation as they move through Congress.
SOLUTION-BUILDING WITH POLICYMAKERS AND PAYERS
Because many of today's coverage restrictions stem from a lack of shared clarity about what and how much clinical evidence payers need to cover wound care products and procedures, the Alliance will be convening payers, policymakers, researchers, clinicians, and manufacturers in May 2022 at its inaugural Wound Care Evidence Summit (http://www.woundcarestakeholders.org/meetings/wound-care-evidence-summit). The meeting will provide a unique platform for this broad range of stakeholders to explore how practice guidelines, real-world evidence, and clinical research findings can be used in the development of coverage policies. The time is right for a multidisciplinary conference that looks at both state-of-the-art research and the reimbursement landscape, as both directly affect patient outcomes. Interactive panel discussions will focus on collaboratively establishing greater clarity around what clinical evidence payers need to cover wound care products and procedures.
As the Alliance enters its 20th anniversary year, it will continue to serve as a vocal, visible, and effective advocate on wound care issues. Keep up with Alliance advocacy, track relevant policies, review our submitted comments, and learn more about the Summit at http://www.woundcarestakeholders.org.