COVERAGE ALERT: VENOUS PROCEDURES
Comments Due by March 9th
Attention: SIR members in Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania and Texas.
Novitas, Inc., a Medicare Administrative Contractor (MAC), recently proposed a draft Local Coverage Determination (LCD) regarding Treatment of Varicose Veins of the Lower Extremities (DL34924). This LCD would affect the twelve states within Centers for Medicare and Medicaid Services (CMS) jurisdiction J-H, which includes: Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania and Texas.
The SIR has been partnering with other specialties, and has concerns about this draft. Access to care will be constrained if this policy is implemented.
SIR is inviting that our members in the impacted jurisdictions to submit their own written comments directly to Novitas. The public comment period ends on March 9, 2017, so time is of the essence. SIR is also commenting as specialty, but letters from practicing MDs are often more impactful.
Links to the full text of the draft policy, supplementary reading materials, options to submit comments, and recommended references can be found at the end of this memo.
In order to maintain a consistent message and cover all of our concerns, here is a list of specific objections that can be included in your comments. Novitas will reject public comments that look like a form letter, so please draft your comments into your own voice as much as possible.
· Paragraph 1 indicates that only patients with advanced post inflammatory skin injury (C4b) or active ulcer (C6) will be eligible for coverage for ablation of the saphenous vein (if present), eliminating patients with symptomatic C2 (varicose veins), C3 (venous edema), C4a (pigmentation and active venous eczema) and C5 (healed venous leg ulcer) patients.
· Paragraph 1 suggests that the minimum acceptable GSV diameter to qualify for coverage of GSV ablation is 9.6mm; no medical literature exists to support this diameter and seems arbitrary.
A statement, “(CVD) are very common and do not cause symptoms or medical problems in most people”, which is inaccurate.
· Paragraph 2 lists “impaired mobility” as a criterion for treatment. Impaired mobility is not a commonly used phrase to describe functional impairments in patients with CVD and therefore its definition as used in the proposed policy for coverage is vague.
We are also concerned about a restriction to allow coverage for saphenous ablation in patients with GSV and SSV reflux in patients with open venous leg ulcers (C6 disease) only after a several week trial of elastic compression stocking use.
Mechanicochemical Ablation is listed as an investigational therapy. There is significant clinical data to demonstrate that this procedure is safe and as effective in relieving clinical symptoms as thermal ablation, with durability demonstrated to at least two years. This procedure has good evidence of short and mid-term efficacy, should be considered a viable care option and should be covered.
The limits of 6 sessions of thermal saphenous ablation per lifetime of the patient and 3 sessions of sclerotherapy per leg per year are scientifically arbitrary.
It is important that coverage policies are made based on clinical evidence and established science, not claims data. If you live in the Novitas jurisdiction, please make your voice heard. If adopted, policies such as this will have far-reaching consequences for patient care, not just in the states specified, but for the whole country.
To access the full proposed/draft LCD, CLICK HERE.
Comments can be submitted via one of the four (4) methods listed below (all methods are given equal consideration). If you are referencing literature for the Novitas Contractor Medical Directors to consider with your comments, the full text article(s) (PDF) must be submitted via the postal service or e-mail.
Electronically at: SUBMIT COMMENTS ONLINE
Email:
US Mail addressed to:
Novitas Solutions
Medical Policy Department
Union Trust Building
Suite 600
501 Grant Street
Pittsburgh, PA 15219
Fax: (717) 728-8767
Recommended References for Citation in Public Comments:
Andreozzi GM, Cordova R, Scomparin MA, et al. “Quality of Life in Chronic Venous Insufficiency” Int Angiol 2005; 24:272-277 Carradice D, Mazari FAK, Samuel N et al. “Modelling the Effect of Venous Disease on Quality of Life” Br J Surg 2011; 98:1089-1098 Gibson K, Meissner M, Wright D. “Great Saphenous Vein Diameter Does Not Correlate with Worsening Quality of Life Scores in Patients with Great Saphenous Vein Incompetence” J Vasc Surg 2012; 56:1634-1641 King T, Coulomb G, Goldman A, et al. “Experience with Concomitant Ultrasound-guided Foam Sclerotherapy and Endovenous Laser Treatment in Chronic Venous Disorder and Its Influence on Health Related Quality of Life: Interim Analysis of More Than 1000 Consecutive Procedures” Intl Angiol 2009; 28:289-297 Labropoulos N, Leon L, Kwon S, et al. “Study of Venous Reflux Progression” J Vasc Surg 2005; 41:291-295 Lee AJ, Robertson LA, Boghossian SM, et al. “Progression of Varicose Veins and Chronic Venous Insufficiency in the General Population in the Edinburgh vein Study” J Vasc Surg: Venous and Lym Dis 2015; 3:18-26 Raju A, Mallick R, Campbelle C, et al. “Real-World Assessment of Interventional Treatment Timing and Outcomes for Varicose Veins: A Retrospective Claims Analysis” J Vasc Interv Radiol 2016; 27:58-67 Sam RC, MacKenzie RK, Paisley AM, et al. “The Effect of Superficial Venous Surgery on Generic Health-related Quality of Life” Eur J Vasc Endovasc Surg 2004; 28:253-256