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Feature Article

Legislative Update: A Look at Upcoming Health Policy Through The Wound Care Lens

This article will discuss key legislative trends, advocacy opportunities, and challenges for the year ahead that are relevant to those in the wound care sector.

Editor’s Note: This article was written with the quick-moving and rapidly evolving activity ongoing on Capitol Hill. All information is considered completely accurate as of press time only. 

In politics and in life, the only constant is change. Rarely has this been more the case within the United States healthcare system than in today’s political climate. There is little we can safely predict, and the winds of change have been switching directions with alarming frequency. The recently foiled attempt to “repeal and replace” the Affordable Care Act (ACA) has dominated the recent news cycle, and may be picked up again moving forward. But regardless of which way the winds blow for the ACA, there are other health-policy trends and opportunities relevant to wound care that all clinicians should be paying attention to. This article will discuss key legislative trends, advocacy opportunities, and challenges for the year ahead that are relevant to those in the wound care sector.

1) New leadership means new opportunities for the wound care community.

With the confirmation of Tom Price, MD, as secretary of Health and Human Services (HHS) and Seema Verma, MPH, as administrator of the Centers for Medicare & Medicaid Services (CMS), and Scott Gottlieb, MD, expected to be the new head of the U.S. Food & Drug Administration (FDA), there’s renewed opportunity for dialogue and advocacy on key health and wound care issues. While many may have concerns about Price’s aggressive stance against the ACA, as a physician he has real-world knowledge of treating patients, billing, and the “business” of practicing medicine and managing patients. Although Price may not be familiar with the complexities of wound care, as a formerly practicing orthopedic surgeon he understands the concerns of medical specialties — which could be of benefit to the community of multidisciplinary clinicians who treat patients living with chronic wounds. Price has made it known that the door is wide open for regulatory relief, so there’s an opportunity for members of the wound care community to advocate for issues that are important to them, such as reform of the Healthcare Common Procedure Coding System coding process and competitive bidding.

2) Value-based care is here to stay.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) still shares wide bipartisan and bicameral support. Migrating away from volume-based payments toward quality- and outcome-based payments was an overriding goal of MACRA, so value-based care (VBC) and its payments against quality and resource incentives look to be here to stay in one form or another. 

CMS leadership could, however, slow MACRA implementation by halting some large “demonstration” projects that have guided MACRA implementation to date, or even potentially alter the new payment policies that have been proposed under MACRA. The wound care community and, certainly, all healthcare professionals (and organizations) who accept Medicare payments should continue with their own VBC transitions while monitoring for new developments from CMS. With reimbursement based on the reporting of quality measures under MACRA, wound care organizations such as the Alliance of Wound Care Stakeholders have been advocating for CMS to adopt wound-relevant quality measures. The VBC payment models being put in place today for clinicians, such as the Merit-Based Incentive Program and Alternative Payment Models (APMs), do not adequately take into consideration the specialists and subspecialists who practice wound care. Under the current system, the obligatory reporting of quality, resource-use, and clinical-performance measures does not capture a wound care clinician’s outcomes or resource use. 

This could negatively impact Medicare reimbursement. Organizations like the Alliance have been proactively advocating policymakers to add specific wound care quality measures within MACRA reporting requirements. Given Price’s history in medicine, he is likely to have an open ear to the unique challenges that medical specialties face under VBC reporting requirements. He is tuned into the administrative impacts of such regulations to healthcare practitioners and is likely to be both provider-friendly and specialist-friendly. So there are new doors open to advocacy on this front. 

3) Changes to Medicaid could also have significant impact on health coverage.

Verma led Medicaid waiver and Medicaid expansion initiatives for Indiana under current Vice President Mike Pence. Her work in Indiana implementing more stringent Medicaid requirements via a federal waiver process may serve as a preview for what she could do in Washington on a national scale. So, those who rely on Medicaid as an important payer to their practice or wound clinic should pay attention to initiatives that are making significant changes to state Medicaid programs and federal Medicaid funding, and take action on policy discussions by submitting comments. 

4) Remember, there is an active congressional health-policy agenda beyond ACA repeal.

While ACA “repeal and replace” was the proverbial talk of the town and dominated news headlines for the first few months of this new administration, there are a number of other important health priorities shared by both Democrats and Republicans in Congress. The wound care community should pay attention to the following policy initiatives being explored on Capitol Hill:

Shifting to site-neutral payments

Most likely, site-neutral reimbursement will increasingly be looked to as a source for healthcare saving — something to be watchful of in this Congress. Site-neutral payment reform seeks to equalize payment for services that are delivered in multiple settings under different fee schedules to patients with similar clinical profiles. This is not a new concept; the Medicare Payment Advisory Commission has called for site-neutral policy changes for years. The concept is, however, a major shift in reimbursement policy that affects providers in different ways depending on setting and whether or not they are participating primarily in fee-for-service Medicare or an APM (such as an accountable care organization). Legislation addressing site-neutral payments can, of course, impact wound care, which spans many different practice settings. This is an area for wound clinics and wound care clinicians to monitor and provide a collective voice to as draft policies are shaped and circulated for comment. 

Managing the cost of chronic conditions

The ever-growing cost of care for Medicare beneficiaries living with chronic diseases presents a health-policy concern that is taken seriously across both sides of the aisle. A bipartisan U.S. Senate Chronic Care Working Group (CCWG) was formed to discuss policy options and develop legislative solutions as part of the efforts to improve outcomes for vulnerable Medicare beneficiaries living with multiple chronic conditions. Since its formation in 2015, the CCWG has held a series of public hearings, reviewed hundreds of submitted comments, and issued a policy-options paper with proposals. The CCWG’s efforts to craft and pass a legislative package may shape up to be a 2017 exercise. As many patients living with chronic wounds frequently have comorbidities such as diabetes or obesity, wound care clinicians have the opportunity to insert themselves into CCWG conversations. Chronic wounds are conditions that should be relevant to CCWG deliberations. There is opportunity for the wound care community to meet with CCWG members, committee staff, and health-policy leaders to educate them on how and why wound care should be addressed in policy recommendations and legislation being developed. This is something to comment on in terms of opportunities to insert relevant wound care issues into the chronic care conversation. 

Encouraging coordinated care with Stark Law reform

Stark Law was enacted in the 1990s to address potential conflicts of interest and anticompetitive activities that could drive inappropriate utilization in a fee-for-service world. As new reimbursement models are shifting to VBC that incentivize improved quality/outcomes and reduced costs, these laws now have the unintended consequence of serving as obstacles to some of the care coordination and risk-sharing financial arrangements that are needed under the new VBC paradigm. There is growing attention from regulators and legislators to modernize Stark Law to address the significant False Claims Act exposure that Stark Law violations can currently pose for hospitals, clinics, and providers working to build new coordinated-care relationships under the APMs incentivized by MACRA. As wound patients tend to have so many comorbid conditions and receive care from a range of medical specialists across a range of settings, wound care clinics should be interested in care-coordination opportunities to reduce potential Stark Law exposure. Stark Law reform discussions and draft legislation will certainly be something for clinicians, wound clinics, and health systems to comment on. 

5) Legislative deadlines and reauthorization will also, as always, drive Congressional attention to health policy. 

On top of the aforementioned issues, the 115th Congress will face the reauthorization deadlines of several key pieces of high-impact health legislation, including:

  • Prescription Drug User Fee Act reauthorization, as the current legislation covered FDA funding for the fiscal years 2013-17.
  • Children’s Health Insurance Program, which was extended under MACRA through September 2017 and will require Congressional action to extend federal funding to states to enable health insurance coverage to uninsured children who are not eligible for Medicaid.


Across a range of different policy issues, wound clinic business leaders must be prepared to be nimble and develop strategies today to plan for the potential scenarios, challenges, and opportunities of tomorrow. Mahatma Gandhi was attributed as saying, “Be the change you wish to see in the world,” and we can apply that by having a voice in health-policy debates today by submitting comments, testifying at hearings, and meeting with legislative staff on key issues impacting practice. Clinician voices carry weight on health-policy issues, and trade associations provide opportunity to have a collective voice on key issues. 

Marcia Nusgart is the executive director of the Alliance of Wound Care Stakeholders. She may be reached for consultation at
Dave McNitt, partner at Oldaker Law Group LLP in Washington, DC, contributed to this article. 

Feature Article
Marcia Nusgart, RPh
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