Proposal for a national coverage determination for the treatment of varicose veins and venous disease due to disparate Centers for Medicare and Medicaid Services local coverage determination policies.

Varicose veins and chronic venous disease are common problems in the United States. Persons with these conditions often have an adversely affected quality of life. There are a number of proven interventions to treat varicose veins and to improve patients' life quality, but these interventions are often restricted by the Centers for Medicare and Medicaid Services and private third-party payers. The Centers for Medicare and Medicaid Services have private contractors that administer Medicare policies in 10 jurisdictions across the United States. There is no national policy or coverage for the treatment of varicose veins; rather, there are multiple, disparate regional policies written by the contractors that cover the same Medicare beneficiary population. These disparate policies are not evidence based and provide unfair coverage of the same disease to the Medicare population, depending on where they live. Our proposal is for a national coverage determination policy for the treatment of varicose veins.

Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS).

BACKGROUND: The Venous Clinical Severity Score (VCSS) was designed and validated as an objective measure of disease severity in patients with chronic venous disease (CVD). Recently, a revision of the VCSS (rVCSS) was performed to resolve ambiguity in the clinical descriptors and improve clarity and ease of use. This new revised VCSS requires validation to determine its repeatability and reproducibility in clinical evaluation of patients with varying levels of CVD. METHODS: A prospective multicenter protocol was designed to enroll patients undergoing evaluation for CVD at venous practices with experience using the original VCSS. At the time of initial evaluation, two clinicians independently assessed both lower extremities to determine the rVCSS and the CEAP clinical score. Between 1 and 6 weeks, patients returned and received repeat assessment of the rVCSS by the same two clinicians independently. Patients were excluded if any venous intervention occurred between the two separate evaluation visits. Scores were compared to determine inter- and intra-observer variability overall and within each CEAP clinical class. RESULTS: Seven centers enrolled a total of 136 limbs yielding 248 paired evaluations for interobserver variability and 258 paired evaluations for intraobserver variability. The mean interobserver rVCSS difference was 1.4 ± 1.7 and the mean intraobserver variability was 1.3 ± 1.6. Statistical assessment with weighted kappa yielded good repeatability (κ = 0.68; P < .0001) and good reproducibility (κ = 0.72; P < .000001) for the rVCSS. The rVCSS correlated well with the CEAP clinical class with significant differences between rVCSS in increasing classes. (P < .0001). CONCLUSIONS: In this multicenter evaluation, the rVCSS was demonstrated to be a reliable and reproducible instrument for documentation of the severity of symptoms in patients with lower extremity venous insufficiency.

Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group.

In response to the need for a disease severity measurement, the American Venous Forum committee on outcomes assessment developed the Venous Severity Scoring system in 2000. There are three components of this scoring system, the Venous Disability Score, the Venous Segmental Disease Score, and the Venous Clinical Severity Score (VCSS). The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. However, as a descriptive instrument, the CEAP classification responds poorly to change. The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment. Based on initial experiences with the VCSS, an international ad hoc working group of the American Venous Forum was charged with updating the instrument. This revision of the VCSS is focused on clarifying ambiguities, updating terminology, and simplifying application. The specific language of proven quality-of-life instruments was used to better address the issues of patients at the lower end of the venous disease spectrum. Periodic review and revision are necessary for generating more universal applicability and for comparing treatment outcomes in a meaningful way.

The importance of uniform venous terminology in reports on varicose veins.

There is a need for a standardized consistent language in vascular surgery that allows easy flow of information and comparison of results among clinicians. Beginning with current nomenclature, a common language serves as a framework for more detailed efforts. Understanding the outcomes assessment tools available provides the opportunity for universal outcomes reporting. Data collected at widespread points can then be fairly compared, and common goals of therapy can be determined. Common outcomes that have demonstrated verifiable trends and reproducibility should be subjected to the rigors of evidence-based questioning. The resultant standards of care and expectations of therapy are then confidently presented for everyday practice and ongoing research.