Legislative Update: Taking Action to Improve Transparency & Accountability of LCDs for CTPs, Hyperbarics, and Negative Pressure

Medicare coverage policies have significant impact on the products and services that wound care practitioners can provide to patients. The denial of products, technologies, or services under Medicare denies patients access to those services, thus taking away the ability of providers to use those products and services. There have been increasing Medicare policies challenging use of disposable and traditional negative pressure wound therapy (NPWT), hyperbaric oxygen therapy (HBOT), and cellular and/or tissue-based products (CTPs) for wounds, among others, throughout the wound care space. Some Medicare draft local coverage determinations (LCDs) are limiting the number of debridements a clinician can perform. The list of barriers and restrictions to practice put in place by regional LCDs goes on. The wound care community should be aware of the national and local policy changes that impact the ability to practice wound care. Additionally, the wound care community has the opportunity today to band together and elevate its voice to oppose egregious policies. This article will discuss national and local policy as it pertains to wound care and empower those working within the industry to contribute on a legislative level.

The Regional LCD Process

Medicare is a complex system with covered treatments and services guided by a web of national coverage determinations (NCDs) and LCDs. LCDs are set by Medicare Administrative Contractors (MACs) — private healthcare insurers that have been awarded a contract to process Medicare Part A and Part B (A/B) medical claims or durable medical equipment (DME) claims for Medicare’s fee-for-service (FFS) beneficiaries in specific geographic jurisdictions. Each MAC has the discretion to establish which services are “reasonable and necessary,” and therefore covered as a Medicare benefit. Each final LCD is implemented across a distinct geographical coverage area. There are 12 A/B MACs and four DME MACs that, according to the Centers for Medicare & Medicaid Services (CMS), process more than 1.2 billion Medicare FFS claims annually and pay $367 billion in Medicare benefits. So, the LCDs from MACs have a broad, far-reaching impact in the wound care clinic, in the hospital room, in the exam room, in the home setting, and beyond. Wound care practitioners should be aware that MACs have increasingly been issuing policies that are attempting to restrict coverage for wound care products and services. In order to achieve these restrictive changes, the MACs have issued LCDs through processes that some believe lack appropriate transparency, cite evidence that is outdated, provide policy that is not based on current standards of clinical practice, and have contained alarming inaccuracies with regard to real-world wound care practice.^1-8 Furthermore, some LCDs are issued with accompanying “policy articles” that are not subject to notice and comment. MACs are mandated to obtain public comments on the LCDs, but not the accompanying policy articles that clarify the LCD, coding descriptors, and coding guidelines. This can be problematic, as some policy articles have made substantive policy changes beyond the language of the LCD itself and can have the effect of changing existing coverage policy outside of the more transparent notice-and-comment process. 

LCDs Impacting Wound Care Practice

As an example of the emerging LCDs impacting the wound care industry, let’s consider those issued by Novitas Solutions Inc. and First Coast Services Options Inc.^® (FCSO) in January that raise concerns for this author. These MACs issued nearly identical LCDs with nearly identical restrictions and limitations — eliminating coverage of disposable NPWT and changing utilization parameters for both debridement and NPWT, among many other items addressed. This “mirroring” of LCDs (when one MAC adopts another’s policies without due vetting and independent analysis) has been an increasing trend, the result of which is a policy that starts becoming more of an NCD in practical terms without having followed more rigorous requirements. When multiple MACs copy each other’s (often faulty) language and adopt the same LCD text, local policies quickly become national concerns. More recently, Wisconsin Physicians Service Insurance Corp. (WPS) issued a draft policy on wound care that doesn’t exactly mirror Novitas and FCSO, but does have similar restrictions on the utilization of NPWT. If this sounds familiar, that’s because this LCD mirroring has been recurring for years in the wound care space. Today, in a time when clinicians are responsible for justifying wound care services and technologies used to treat their patients via significant documentation requirements, it’s more incumbent than ever for these clinicians to pay attention and be active in the policy process by taking advantage of channels for stakeholder input and comment.

Potential Fix To The LCD Process

Recently, legislation was introduced in Congress (with bipartisan support) — S.794, Local Coverage Determination Clarification Act of 2017 — that could improve transparency and accountability when MACs set LCD policies by: 

• requiring open and public MAC meetings that are on record; 
• requiring disclosure by MACs of the rationale for an LCD and the evidence for that decision at the beginning of the LCD process; 
• providing a meaningful reconsideration process for an LCD; and
• prohibiting MACs from adopting an LCD from another jurisdiction without first conducting its own independent evaluation of the evidence.

While there is a long road ahead for the bill to move from “introduced” to “passed” and implementable, this congressional initiative shows that LCD concerns related to wound care are shared across the entire healthcare sector and that the issues are pervasive and concerning enough to merit the bipartisan attention of Congress. The bill in its proposed form would significantly address demands for improved MAC transparency and accountability. The very introduction of the bill on the Senate floor, even without passage, sends a powerful signal to MACs. In the Senate, the legislation was introduced by Sens. Johnny Isakson (R-GA), Thomas Carper (D-DE), Debbie Stabenow (D-MI), and John Boozman (R-AR). The House of Representatives has not yet introduced a companion bill, although one is expected to be introduced shortly. Clinicians and program directors should make their voices heard and submit letters of support to Congress for the LCD Clarification Act if they hope to see these types of changes follow through. Additionally, those in the wound care industry should take an active role in monitoring and following LCD policies in real time as they are issued in draft and final versions to help ensure that coding and billing are correct, to flag areas of concern, and, when appropriate, to request evidence-based changes to existing LCDs as clinical practice evolves and changes. Wound care professionals have the opportunity to submit comments to draft LCDs (each is issued with a minimum 45-day comment period) or to speak at open public meetings that MACs convene to collect feedback. Clinicians do not have to practice within a particular MAC’s local jurisdiction in order to present comments. As of press time, WPS had issued a draft LCD on wound care (DL37228) for which comments could be submitted until June 22. For a listing of recent LCDs that impact wound care, see the Table. 

Marcia Nusgart is executive director of the Alliance of Wound Care Stakeholders. 

References

1. RE: Draft LCD – Wound Care (DL35125). Alliance of Wound Care Stakeholders. 2017. Accessed online: www.woundcarestakeholders.org/images/documents/2017/March_9_2017_Alliance_comments_Novitas_Wound_Care_draft_LCD_final.pdf

2. RE: Draft LCD – Wound Care (DL37166). Alliance of Wound Care Stakeholders. 2017. Accessed online: www.woundcarestakeholders.org/images/documents/2017/March_9_2017_Alliance_comments_FCSO_Wound_Care_draft_LCD_final.pdf

3. Re: (CMS 1653-NC) Medicare Program; Request for Information Regarding the Awarding and the Administration of Medicare Administrative Contractor Contracts. Alliance of Wound Care Stakeholders. 2016. Accessed online: www.woundcarestakeholders.org/images/documents/2016/Feb_2016_ALLIANCE_comments_CMS_RFI_re_MAC_contracts.pdf

4. Senate Bill Would Improve Transparency, Accountability of Medicare LCD Process. AdvaMed. 2017. Accessed online: www.advamed.org/newsroom/press-releases/senate-bill-would-improve-transparency-accountability-medicare-lcd-process

5. Senators Introduce Bill to Make Medicare Local Coverage Decision Process More Transparent. GenomeWeb. 2017. Accessed online: www.genomeweb.com/reimbursement/senators-introduce-bill-make-medicare-local-coverage-decision-process-more-transparent

6. Senate Bill Proposes More Transparency, Accountability in Reforming Medicare's LCD Process. College of American Pathologists. 2017. Accessed online: www.prnewswire.com/news-releases/senate-bill-proposes-more-transparency-accountability-in-reforming-medicares-lcd-process-300432645.html

7. Friedberg R. Medicare’s Local Coverage Decision Process Needs Legislative Fix. MLO. 2016. Accessed online: www.mlo-online.com/medicare%E2%80%99s-local-coverage-decision-process-needs-legislative-fix

8. Friedberg R. Medicare’s coverage decisions need more input from physicians. The Hill. 2017. Accessed online: https://thehill.com/blogs/congress-blog/healthcare/329503-medicares-coverage-decisions-need-more-input-from-physicians