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 ACP is taking an active role in formally objecting to the proposed policy to ensure that the changes do not limit patients’ access to care. To that end, the ACP provided expert testimony at the January 26, 2017 Novitas open public meeting, and we are currently participating with a coalition of several societies and organizations opposed to the draft policy. In addition to the official efforts undertaken by the ACP, we are asking 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.
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 email. In order to maintain a consistent message and cover all of our concerns, the ACP has put together 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.
Below are links to the full text of the draft policy and the link to submit comments. If you have any questions or concerns, please email us at firstname.lastname@example.org.
To access the full proposed/draft LCD, CLICK HERE.
For additional information regarding draft policy status and history, 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
US Mail addressed to:
Medical Policy Department
Union Trust Building
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
Thank you for your time and support of the ACP’s advocacy efforts.
|Neil M. Khilnani, MD, FACPh
|Keith A. Darby, CAE, CMA, CFE
Interim Executive Director