INSIDE VTE added to patient safety challenges 8 Senate bill would make MU program friendlier 17 ACP Congress educating providers for 30 years 18 AMA fails to end recertification 26
AUGUST/SEPTEMBER 2016 Vol. 9 No. 5 VEINTHERAPYNEWS.COM
An ACP recognized resource for news and information for and about the phlebology community
MEDCAC Panel covers lower extremity venous disease By Larry Storer On July 20, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met in Baltimore to hear and examine the scientific evidence regarding the benefit and risk of existing lower extremity chronic venous disease treatments that aim to improve health outcomes for seniors. Chartered under the auspices of the Centers for Medicare & Medicaid Services (CMS),
See related article, page 12 MEDCAC is trying to identify evidence gaps that exist related to lower extremity chronic venous disease in the Medicare population. MEDCAC supplements CMS internal expertise by allowing an unbiased and current deliberation of “state of the art” technology and science. MEDCAC panels do not make
coverage determinations, but CMS can benefit from their advice. Clinical outcomes of interest to the Medicare program included: reduction in pain; reduction in edema; improvement in functional capacity; improvement in quality of life; avoidance of acute and chronic venous thromboembolism; avoidance of chronic thromboembolic pulmonary hypertension; avoidance of initial venous skin ulceration and recurrent ulceration; improvement in wound healing; reduction in all-cause mortality; and
avoidance of repeat interventions and harms from the interventions. By voting on specific questions, and through discussions, MEDCAC panel members will advise CMS about the extent to which it may wish to use existing evidence as the basis for any future determinations about Medicare
MEDCAC continued on page 33
Varithena earns FDA approval for 30-day post-activation shelf life
Michelle Huie, CEO and founder of VIM & VIGR, shares her experiences building a successful business in the compression hosiery market, noting ways to help physicians grow their practice. See her story in The Practice section on page 24.
The U.S. Food and Drug Administration has approved an extension of the postactivation shelf life of Varithena (polidocanol injectable foam) 7 days to 30 days. “This approval provides physicians with greater flexibility,” said John Sylvester, corporate development officer for BTG, the specialist healthcare company that manufacturers the prescription medication Varithena. “It highlights our continued work to provide a non-thermal chemical ablation solution that best fits practices’ needs.” Brian Ferris, MD and chief of surgery at Overlake Hospital Medical Center, said Varithena has become an important part of his practice. “Varithena is important in particular for patients with tortuous or difficult to treat veins, or for patients who do not want to undergo thermal ablation,” Dr. Ferris said. “With the FDA’s approval of a longer shelf life – once I have activated the canister – I have more flexibility in scheduling patients. This will help ensure that more patients who can benefit from Varithena will get the treatment.” The update enhances the ease of scheduling for a comprehensive, above and below the knee solution for great saphenous vein system incompetence and for veins that other
procedures cannot reach effectively. Physicians can adapt the Varithena procedure to the unique demands of their practice both in terms of timing of procedures, and the wide range of vein sizes and shapes they can treat, including tortuous veins and visible varicosities. Varithena’s UDSS formulation with Uniform Density, Size and Stability results in a long dwell time and thorough cohesion with the vein wall. It addresses underlying venous incompetence, improves vein appearance and shows significant improvements with an established safety profile. Tumescent anesthesia is avoided, and a cohesive, lownitrogen microfoam allows for consistent performance.
ABOUT VARITHENA Varithena is a microfoam made from polidocanol that is used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg’s GSV system. Varithena helps improve the symptoms of heaviness, achiness, swelling, throbbing, itching (HASTI symptoms) related to or caused by varicose veins, and the appearance of varicose veins. VARITHENA continued on page 25
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