Proposed/Draft Local Coverage Determination (LCD): Treatment of Varicose Veins of the Lower Extremities (DL34924)

Transcription

1 March 9, 2017 Novitas Solutions, Medical Policy Department Union Trust Building, Suite Grant Street Pittsburgh, PA Re: Proposed/Draft Local Coverage Determination (LCD): Treatment of Varicose Veins of the Lower Extremities (DL34924) Dear Drs. Capehart and Patterson, On behalf of our seven specialty medical societies (American College of Phlebology, American Venous Forum, Society for Vascular Medicine, Society for Vascular Surgery, Society of Interventional Radiology, The Society for Cardiovascular Angiography and Interventions, and Vascular Interventional Advances), we respectfully submit the following comments in response to the proposed Local Coverage Determination (LCD) on Treatment of Varicose Veins of the Lower Extremities (DL34924). Our organizations have a combined membership of more than 16,000 physicians and are committed to ensuring access to safe and evidence-based treatments for patients with venous disease. We are writing as experts in the area of venous medicine to express our consensus medical opinion. We are concerned about several proposed policy changes for patients with Chronic Venous Disease (CVD). Many of these changes have no foundation in medical evidence, arbitrarily limit access to care for patients with clinically significant disease, and have the potential for serious patient health consequences. The changes in the LCD are a significant departure from prior Novitas policies, current LCDs from other Medicare contractors (MAC), as well as most commercial insurance carriers. Our reading of the LCD and the references on which it is based demonstrates that the authors of the LCD are aware of, and have referenced, the evidence-based guidelines that our Societies have developed. Some of our concerns relate to ambiguous language in the LCD, rendering the intended meaning unclear. Overall, the LCD utilizes the established guidelines selectively, and the LCD authors appear to have chosen to ignore important diagnosis and treatment recommendations made within those guidelines. We feel this renders the LCD flawed to the point where the issuance of a new proposed LCD is warranted. In the appendix that follows, we will point out our most important concerns. In each case we have provided evidence to support our concerns. We have also provided recommendations for alternatives requested, and the full text version of each supporting piece of evidence is attached to this correspondence. We are aligned with Novitas to provide the best evidence-based care available for Medicare beneficiaries and to respect the public trust placed in both the MAC and our professional community, while simultaneously recognizing and respecting the financial resources of the Medicare program. However, given these significant concerns, we ask that Novitas withdraw this proposed policy. We recognize that is a strong request, but we feel that we must make it as part of our obligation to advocate for patients with CVD for whom application of this policy will result in inappropriate restrictions to healthcare access and carry a significant potential for adverse patient consequences. Specialty Society Consortium Comment Letter: ACP AVF SVM SVS SIR SCAI VIVA 1

2 In our effort to support this obligation to patients with CVD, we would like to volunteer the services of experts in our organizations to engage with the Novitas coverage policy team to develop a coverage policy for CVD. This policy would be both in accord with recognized scientific evidence as well as being responsible and rational with regard to utilizing Medicare financial resources. We hope that our collaboration will result in a coverage policy that will also be recognized as the standard to which other MACs could look for guidance. We would be happy to provide Novitas with the names, curriculum vitaes, and contact information of potential volunteer physician members. As representatives of our societies, we understand the challenges encountered in developing coverage policies that provide fair access to scientifically reasonable care for Medicare beneficiaries, while ensuring that our Medicare financial resources are used appropriately and responsibly. We understand this is a national concern and are very interested in helping develop solutions to these challenges, both with Novitas and with the other MACs. We would like to work with Novitas to determine a pathway to ensure intellectual honesty is utilized by our peer physicians when making treatment recommendations to Medicare beneficiaries. We recognize the potential for misrepresentation of the condition of a patient and their disease state by physicians and their technical staff, and have specific recommendations to help alleviate this shared concern. In conclusion, we respectfully ask Novitas withdraw DL34924 and join in a partnership with experts in our organizations to develop a policy with which we all are comfortable and manage such issues on a continuous basis moving forward. We believe that together we can develop a coverage policy for CVD that can be recognized as the standard by which other MACs could look for guidance. Please consider Mr. Keith Darby (listed below) as the contact for our consortium of societies for your response to this correspondence. Regards, Neil Khilnani, MD, FSIR, FACPh President, American College of Phlebology Marc A. Passman, MD President, American Venous Forum John R. Bartholomew, MD, MSVM, FACC President, Society for Vascular Medicine Sean M. Roddy, MD, FACS Chair of the Policy and Advocacy Council, Society for Vascular Surgery Suresh Vedantham, MD, FSIR President, Society of Interventional Radiology Kenneth Rosenfield, MD, MHCDS, MSCAI President, The Society for Cardiovascular Angiography and Intervention John Kaufman, MD President, VIVA Physicians Contact information: Keith Darby, CAE, CMA, CFE Executive Director, American College of Phlebology kdarby@acpmail.org (510) Specialty Society Consortium Comment Letter: ACP AVF SVM SVS SIR SCAI VIVA 2

3 Appendix: Most significant concerns with the LCD 1. Draft language: The Covered Indications. Concerns: It is unclear from reading these sections if patients with QOL affecting symptomatic C2 (varicose veins), C3 (venous edema), C4a and C4b (pigmentation, active venous eczema as well as atrophie blanche and lipodermatosclerosis) and C5 (healed venous leg ulcer) patients are eligible for coverage for therapy. If they are excluded, this would be in conflict with published evidence and clinical practice guideline recommendations in the US and UK. (1,2,3) The peer-reviewed literature shows that venous insufficiency, including selected patients with C2 disease, have a QOL impact similar to that of other chronic diseases such as CAD or DM. (4,5) Treatment has been unambiguously demonstrated to result in significant quality of life improvement from C2-C6 CVD. (6) Patients with healed (C5) and open (C6) venous ulcers have been clearly demonstrated to have reduced ulcer recurrence after elimination of superficial venous reflux with saphenous ablation. (9) Recommendation: We recommend that Novitas consider including patients with quality of life affecting symptomatic C2 disease, as well patients with documented swelling from CVD caused by venous reflux (C3) as well as patients with post inflammatory skin injury from venous hypertension (C4a, C4b) as well as patients with healed ulceration (C5), and suggest Novitas require providers to archive and on demand provide photographic documentation of the severity of the patients disease. 2. Draft Language: The limitations section. Concern: We are not sure what the 9.6 mm diameter criteria are referring to. Is this referring to a varicosity size or the diameter of a saphenous vein as a minimal threshold to provide coverage for ablation? Peer-reviewed evidence exists that saphenous vein diameter is not a useful metric in predicting patients who have symptoms and who will respond with symptomatic improvement following saphenous ablation. (7) Recommendation: We would recommend against the use of the 9.6 mm diameter, as it has no foundation in science. If such evidence exists, we would request that the author of the document provide a reference in the coverage policy for documentation and our review. 3. Draft language: Ambulatory or Stab Phlebectomy (CPT codes and 37766) is considered medically necessary for treatment of persons who meet medical necessity criteria for treatment of medium-sized varicose veins greater than 6mm in diameter or in whom symptoms and functional impairment are attributable only to the secondary venous clusters and in whom sclerotherapy or endovenous occlusion techniques are not feasible. Ambulatory or stab phlebectomy is considered not reasonable and necessary when performed on the same day as laser or radiofrequency ablation for the same vein. Concern: Microphlebectomy is used to treat refluxing varicose tributaries of the saphenous veins (GSV, SSV), not to treat the GSV or SSV. In fact, the use of microphlebectomy at the same time as GSV or SSV ablation has been demonstrated to prolong QOL benefit to patients. (8,24,25) Recommendation: We recommend modifying the language of this policy statement to ensure that microphlebectomy of tributary varicosities could be a covered benefit when done alone or at the same time as saphenous ablation. 4. Draft language: Treatment of Varicose Veins is covered as medically necessary when one or more of the following conditions exist regardless of the length of any applicable conservative treatment: Pain emanating from a specific varicosity severe enough to impair mobility. Concern: Impaired mobility is not a commonly used term to describe functional impairments in patients with CVD and therefore its definition as used in the proposed policy for coverage is vague. Specialty Society Consortium Comment Letter: ACP AVF SVM SVS SIR SCAI VIVA 3

4 Suggestion: We suggest that another term should be used and defined in a reasonable manner to include symptoms that interfere with patient s ability to complete activities of daily living, including work tasks, child care, or routine household chores. Specific documentation of these limitations could be required. 5. Draft language: Treatment will be considered reasonable and necessary only for symptomatic varicose veins that have failed a 12 week trial of conservative therapy as outlined under the pathophysiology section of the policy and meet one of the following criteria: Recurrent superficial phlebitis in dilated incompetent veins or clusters. Stasis dermatitis associated with a specific varicosity and incompetent venous valve Non-healing ulceration adjacent to an identified incompetent varicosity of truncal or perforator vein. Concern: A restriction to delay coverage for saphenous ablation in patients with GSV and SSV reflux in patients with open venous leg ulcers (C6 disease) and recurrent superficial phlebitis only after a several week trial of elastic compression stocking use. Delaying treatment of patients with open ulcers and recurrent phlebitis places these patients at risk for clinical deterioration, and therefore this restriction should be eliminated. Even if the ulcer were to heal with compression in this interval, elimination of the saphenous reflux is essential to reduce the risk of ulcer recurrence. (9) Recommendation: Eliminate the 12 week requirement for conservative care for these issues. 6. Draft language: The following are currently considered experimental, investigational, or unproven as substantial equivalent therapy for varicose vein ablation (this list may not be all-inclusive): Endomechanical ablative approach (e.g., Clarivein Catheter), (CPT codes 36473, 36474) Endovascular embolization with cyanoacrylate adhesive (e.g., VenaSeal Closure System) Concern: Mechanochemical and Cyanoacrylate Ablation are listed as unproven treatments. These FDA approved catheter-based therapies to ablate saphenous veins have clinical data, including randomized trials to demonstrate equivalence in elimination of clinical symptoms and improving QOL as thermal ablation with durability of this clinical impact for 2 years and equivalent safety. (10,11,12,13,14,15) Use of these modalities would be a replacement for thermal ablation and not an addition. Mechanochemical ablation has a CPT code although cyanoacrylate ablation does not. A third ablation tool Varithena polidocanol microfoam has also been demonstrated in data including a RCT to result in QOL benefit over compression, (16) but is not discussed in this policy draft. Cyanoacrylate ablation (VenaSeal) and Varithena just received a CPT and RVU, and are scheduled for publication in the CPT directory in January Suggestion: We would advocate elimination of listing the procedures as investigational and giving them similar coverage as for thermal ablation. 7. 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. However, we would find them as an acceptable compromise, used as a tool for rationing of the financial resources of our shared Medicare trust. An exception to this would be the limitations for patients who have had or have a venous leg ulcer (C5 and C6 disease). These patients will require further procedures over time at a much higher rate than patients presenting with lower CEAP scores as their disease progresses as a rule and venous ulceration is likely to recur. (17,18) We therefore recommend removing the C5 and C6 patients form this limitation. 8. Draft language: (Varicose veins) are very common and do not cause symptoms or medical problems in most people. Symptoms that have been associated with varicose veins may include aching, leg heaviness, swelling, itching, pain, or fatigue of the affected lower extremity. However, limited evidence exists to support that these subjective symptoms respond to techniques designed to destroy the visible varicose vein and underlying trunks. Specialty Society Consortium Comment Letter: ACP AVF SVM SVS SIR SCAI VIVA 4

5 Concern: There is substantial evidence to substantiate varicose veins results in symptoms in a large fraction of affected patients (19-21) and that ablative treatments significantly improve vein related symptoms as evidenced by improvements in meaningful patient centered metrics such as VCSS and QOL instruments in patients older than 65yo. (22) Recommendation: Eliminate the last sentence in this paragraph. 9. Draft language: Provider qualifications: All procedures to treat symptomatic varicose veins as outlined in this LCD must be: Performed by a qualified physician, or performed under the general supervision of a qualified physician by a licensed non-physician practitioner (NPP) certified by a qualified vascular credentialing organization. Concern: We are very concerned about the definitions of the terms general supervision and nonphysician practitioner and do not feel that general supervision as defined in the Novitas policy of any of the listed professionals is in the best interest of patient safety. We strongly believe that direct supervision (using the definition used by the ACGME, which can be understood as supervision in the procedure room and at the elbow of the person being supervised) is required for supervision of a licensed Physician trainee, Nurse Practitioner or Physician Assistant for the procedures being discussed in the draft policy. However, we would not condone as safe situations where the qualified physician is not present in the room (not just in the facility), even with these providers. The Societies believe that it would be inappropriate, not in the best interest of the patient, against established standards, and would create an increased potential for harm, if non-physician RVTs, RPhs or RVSs were allowed to perform venous procedures under any kind of supervision. The LCD states that Novitas recognizes the IAC- Vein Center Board as one of the nationally recognized guidelines and accreditation bodies. The LCD s allowance for an expanded list of NPPs who would be permitted to perform procedures includes personnel who are not permissible practitioners under IAC Vein Center Standards. (23) We also are concerned about the statement regarding qualified physicians as, Physician properly enrolled in Medicare; with training and expertise acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or that reflects equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States could exclude physicians who completed accredited residency and fellowship programs but who have acquired clinical skills and experience after the completion of that training. Recommendation: We recommend that any procedures performed by personnel other than qualified physicians should be performed under direct supervision of a qualified physician and should be limited only to physician trainees, NPs and PAs. We also suggest modifying the definition of qualified physician substituting it with Physician properly enrolled in Medicare; with training and expertise acquired within the framework of an accredited residency and/or fellowship program in an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States. Specialty Society Consortium Comment Letter: ACP AVF SVM SVS SIR SCAI VIVA 5

6 References 1. Writing committee. Management of chronic venous disease: Clinical practice guidelines of the European society for vascular surgery (ESVS). European journal of vascular and endovascular surgery. (June 2015) Vol 49 issue 6 pgs Gloviczki, et al. The care of patients with varicose veins and associated chromic venous disease: Clinical practice guidelines of the society for vascular surgery and the American venous forum. JVS (May 2011). Vol 53 issue 5 supplement pgs 2S-48S 3. Marsden, et al. Diagnosis and management of varicose veins in the legs: summary of NICE guidance BMJ (July Andreozzi GM, Cordova R, Scomparin MA, et al. Quality of Life in Chronic Venous Insufficiency. Int Angiol 2005; 24: Carradice D, Mazari FAK, Samuel N, et al. Modelling the Effect of Venous Disease on Quality of Life. Br J Surg 2011; 98: Sam RC, MacKenzie RK, Paisley AM, et al. The Effect of Superficial Venous Surgery on Generic Healthrelated Quality of Life. Eur J Vasc Endovasc Surg 2004; 28: 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: Hager, et al. Evidence summary of combined of saphenous ablation and treatment of varicosities versus staged phlebectomy. JVS venous lympat disorders (2017) Jan 5 (1): Gohel, et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomized controlled trial. BMJ 2007 Jul 14: 335 (7610): Leung, et al. Endovenous laser ablation versus mechanochemical ablation with Clarivein in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomized controlled trial. Trials 2016 Aug 24 : 17 (1) Lane, et al. A multi-centre randomized controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins. Final results of the Venefit versus Clarivein for varicose veins trial. Phlebology 2017 Mar. 32 (2) Tang, et al. Clarivein- early results from a large single-centre series of mechanochemical endovenous ablation of varicose veins. Phlebology 2017 Feb 32(1) Gibson, et al. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post procedure compression: Initial outcomes of a post market evaluation of the VenaSeal system (the waves study.) Vascular 2016 May 20. pii: [Epub ahead of print] 14. Chan, et al. Cyanoacrylate glue used to treat great saphenous reflux: measures of outcome. Phlebology 2017 Mar 32 (2) Morrison, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). JVS 2016 April 61 (4) Gibson, et al. A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetients. Phlebology 2016 Mar 24 pii: [Epub ahead of print] 17. Marston WA. Efficacy of endovenous ablation of the saphenous veins for prevention and healing of venous ulcers. JVS venous lymphat disord 2015 Jan 3 (1) Carradice, et al. Endovenous thermal ablation for healing venous ulcers and preventing recurrence. Cochrane Database syst rev oce 4 (10) 19. Wrona M, Jockel KH, Pannier F, Bock E, Hoffmann B, Rabe E. Association of Venous Disorders with Leg Symptoms: Results from the Bonn Vein Study 1. Eur J Vasc Endovasc Surg. 2015;50(3): Carpentier PH, Maricq HR, Biro C, Poncot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg. 2004;40(4): Specialty Society Consortium Comment Letter: ACP AVF SVM SVS SIR SCAI VIVA 6

7 21. 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: Sutzko DC, Andraska E, Obi A, Sadek M, Kabnick L, Wakefield T, Osborne N. Age is not a barrier to good outcomes for varicose vein interventions. JVS: Venous and Lymphatic Disorders Jan 5 (1) Lane TRA, Kelleher D, Shepherd AC, et al. Ambulatory varicosity avulsion later or synchronized (AVULS): a randomized clinical trial. Ann Surg 2015; 261: Carradice D, Mekako AI, Hatfield J, et al. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. BJS 2009; 96: Specialty Society Consortium Comment Letter: ACP AVF SVM SVS SIR SCAI VIVA 7