How to Implement an Office-Based Vein Program

Abstract: Peripheral venous disease is a highly prevalent problem affecting over 25-30 million people in the United States. Office-based treatment of superficial veins for chronic venous insufficiency is a fast-growing area with a recent surge of interest by cardiologists in this field. We describe our own experience with establishing a vein clinic in a single-specialty, cardiology-based office, and provide tips and tricks on how you can start your own vein program. A program based on the mission of providing high-quality, appropriate care to patients and with knowledgeable providers and staff is of paramount importance for the reputation and growth of the clinic. Other important factors needed for success include diligent oversight by a director and/or supervisor, an efficient precertification process, prompt billing and coding, and establishing an internal database or participation in a national venous database to track outcomes and complications. Regular meetings of all clinic participants that discuss quality, outcomes, and operational issues are essential to help standardize care and meet the recently launched Intersocietal Accreditation Commission standards.

J INVASIVE CARDIOL 2014;26(9):493-496

Key words: chronic venous insufficiency, vein reflux, vein clinic, cardiology practice, superficial vein ablation

_______________________________________

Chronic venous insufficiency (CVI) is a highly prevalent problem affecting approximately 25-30 million people in the United States.¹ The complexity of venous disease and the impact CVI has on the population is often underappreciated by the medical community. This is particularly true of cardiologists, where the majority of education and training is focused on arterial disease. Office-based treatment of superficial veins for CVI is a fast-growing area, with a recent surge of interest by cardiologists in this field. Cardiovascular Medicine, PC (CVM) is an independent, single-specialty cardiology group consisting of 24 cardiologists and 16 nurse practitioners providing comprehensive cardiovascular services to eastern Iowa and Illinois. The treatment of peripheral venous disease has become an integral part of the corporation’s mission of providing compassionate, comprehensive cardiovascular patient care. We describe our experience in establishing a vein clinic and provide tips and tricks on how to start your own vein program.

Education/Training

Education of providers in the practice is of paramount importance when developing a vein program. The main referral base to the vein clinic will initially originate from within the practice. Providers should have knowledge of vein anatomy, physiology, and pathophysiology, and understand how to identify patients using a good history and physical examination. Providers need to understand the clinical, etiologic, anatomic and pathophysiologic (CEAP) classification. CEAP allows standardized reporting and treatment of the diverse manifestations of chronic venous disorders. CEAP must be documented on all patients referred for CVI. It is highly recommended that a more detailed quality of life questionnaire be used. The venous clinical severity score (VCSS) is useful and expands on the CEAP classification. It also allows the providers to document clinical improvement with various treatments. 

Educating patients and referring providers is also important when developing a vein program. Patients should understand venous disease, treatment options, and the treatment process. Medicare and most private payers require initial conservative treatment of CVI for a period of time, without an improvement in signs and symptoms, before authorizing endovenous thermal ablation (EVTA) procedures. Conservative treatment includes graded compression stockings, exercise, weight loss, and periodic leg elevation. Patients need to be started early on conservative treatment and be reevaluated in the clinic for continuous limiting symptoms. Establishing realistic patient expectations is important and should be documented in the medical record. Education of referring providers is needed to create awareness of the importance of the disease and available treatment options. It also helps build a referral base that will maintain the vein program. 

Providers who want to specialize in the treatment of venous disease will require additional didactic education and training. They need to have detailed knowledge of venous duplex scanning of both the superficial and deep venous systems. Hands-on venous duplex testing is an essential skill to be learned by these providers. There are several focused venous conferences available to help educate providers on the needed cognitive and hands-on experience. These providers are encouraged to pursue vascular board certification as means to demonstrate their commitment to education and training in vascular medicine and to enhance professional stature and credibility in the field of venous disease. Heterogeneity in practice patterns and provider desire to perform different venous procedures should be addressed by protocols and policies. It is important to ensure that patient safety and appropriateness of procedures are not compromised at any time. A quality assurance program should be in place where all complications, adverse events, or unsuccessful therapies are reviewed. A tracking database is important for procedural success and outcomes. This can be accomplished by participation in a national venous database, such as the American Venous Registry. 

Business Model

Cardiology practices currently face many challenges, including a significant rise in overhead to meet regulatory demands and a drop in procedural and ancillary service reimbursement. A vein program can be another source of revenue supporting the corporation’s strategy to remain a viable entity. CVM elected to develop a vein program based on the medically necessary treatment of venous disease in keeping with the corporation’s mission and vision. Some providers elect to perform cosmetic procedures and there is a growing market for these procedure types. 

When deciding to implement a vein program, a business proforma should be developed. The proforma needs to include all expenses and projected revenue of the program. Expenses include equipment, personnel (vascular sonographers, nursing staff, and medical assistants), office space, consumable supplies, precertification, billing and coding support, administrative costs, medical director time, and miscellaneous expenses. Revenue projections should be based on a conservative estimate of patient volume both from within the practice and outside referrals, and reimbursement amounts from governmental and private payers. 

It is realistic to expect a vein program to be up and running with the first patient treated with an EVTA procedure in 4-6 months after beginning the process. For this to happen, however, screening and a conservative treatment of patients with CVI needs to start as soon as a decision is made to implement a program. It is important to realize that clinic growth is inevitable as more patients are referred for treatment and providers become more interested in treating CVI. Planning for growth is important in terms of physical space, personnel, equipment, and consumable supplies. The management of the clinic becomes more complex in terms of scheduling and patient flow. Keeping track of growth is important, as it helps in resource utilization allocation (Figure 1).

Equipment, Personnel, and Facility Requirements

Identifying the modality of EVTA treatment in your practice is a personal preference. Both radiofrequency (RF) and laser therapy are effective, with likely equivalent long-term outcomes. Early identification of the thermal ablation system to be used is important since cognitive and live training of providers and staff is often facilitated by the vendors. It is not unusual for vendors to provide clinical specialist support at the start of the program. Vendor support should be taken into consideration when choosing a treatment modality in the clinic. At CVM, we elected to utilize the Venefit procedure using the Covidien ClosureFast Endovenous Radiofrequency Ablation (RFA) catheter (Covidien). The Recovery trial supported that RFA had less patient discomfort and bruising than the 980 nm laser.² A more recent study confirmed the same findings with the newer 1470 nm laser.³

It is important to have knowledgeable, well-trained staff when starting a vein program. Providers need to have the didactic education and training detailed above. Providers performing EVTA procedures for the first time typically start by performing greater saphenous vein (GSV) ablation with the instruction and support of experienced clinical specialists. As the provider gains experience, more complicated procedures such as small saphenous vein (SSV), accessory vein, and perforator vein procedures can be performed. Some providers add sclerotherapy and stab phlebectomy to their modalities of choice as they perform cases that are more complicated. The vein program will require the support of ancillary personnel. These personnel include vascular sonographers, registered nurses, and medical assistants. Highly trained vascular sonographers are crucial to the success of the program. They perform the venous duplex exams to diagnoses CVI. The sonographers must have the knowledge and skill to scan both the deep and superficial venous system. A comprehensive venous duplex exam is typically more time consuming than a standard venous duplex study. It is important that the laboratory has the resources in place to accommodate these additional studies. The sonographers also assist in the performance of the EVTA procedures. Nurses and or medical assistants usually assist with EVTA as well. They typically help with patient preparation, recovery, and procedure room preparation.  

Endovenous thermal ablation procedures are minimally invasive and can easily be performed in an outpatient office setting. The procedure room needs to be of adequate size, with good lighting and areas for storage of supplies and equipment. Plumbing and good environmental control are important for sterile preparation and patient and staff comfort during procedures. An ultrasound machine is an essential piece of equipment since EVTA procedures are typically ultrasound guided. A procedure bed that allows for trendelenburg and reverse trendelenburg patient positioning during the procedure is recommended. As procedure volumes increase, a separate area for patient preparation and recovery adjacent to the procedure room helps facilitate patient flow. 

Vein Program Accreditation

As of November 4, 2013, the Intersocietal Accreditation Commission (IAC) started accepting applications for vein center accreditation.⁴ Vein accreditation is a voluntary program designed to accredit centers that perform evaluation and management of venous disorders. While performing the accreditation process, facilities often identify and correct potential problems, revise protocols, and validate quality improvement programs. Accreditation is a testimony that the clinic has met quality benchmarks based on “resources, training, and outcomes.” A summary of the vein accreditation standards are detailed below:

1. The clinic should have the ability to perform two of the four services: (1) Sclerotherapy; (2) Phlebectomy; (3) Saphenous vein ablation; (4) Non-operative management of CVI with ulceration, such as compression therapy.
2. Appointing a medical director with the following experience: (1) a minimum of 200 cases over 3 years in at least 2 of the 4 categories above; (2) a minimum of 100 cases of focused, limited, or complete diagnostic venous duplex ultrasound examination; (3) ACLS certification; and (4) 30 category I CME credit hours related to vein therapy over the past 3 years. The director has to ensure compliance with policies and procedures, maintain quality control and quality/appropriateness of care, ensure patient safety, conduct regular quality assessment/improvement meetings, review case studies, and conduct personnel interviews. 
3. Medical staff need to participate in outcome documentation and have the following qualifications: (1) board certification and experience with a minimum of 100 cases over the previous 3 years in 1 of the 4 categories above; (2) experience with 30 cases of focused, limited, or complete diagnostic venous duplex ultrasound over the prior 3 years; ACLS certification; and completion of 30 category I CME credit hours over the past 3 years. 
4. Ultrasound technologists must be registered Vascular Technologists, Vascular Specialists, Phlebology Sonographers, or Technologist Vascular Sonographers. Sonographers need to have experience with 100 peripheral venous duplex (half as complete examination for reflux) in the prior 3 years. Also, 15 CME credit hours are needed over 3 years that are relevant to venous disease.
5. Nursing staff needs to have BLS or ACLS certification. Duties include review and recording of pertinent patient history and relevant supporting clinical data, obtaining and recording the CEAP class, and participation in vein center safety practices. They must be knowledgeable about sterile technique, medication administration, wound care, application of compression stockings, patient education. Nurses also provide postprocedure education and phone triage, and assist providers with sclerotherapy, phlebectomy, EVTA, or other invasive procedures. A total of 30 CE-approved contact hours are needed relevant to venous disease every 3 years. 
6. The clinic needs to be ready for easily accessible emergency equipment and medications, as well as an automatic external defibrillator. If conscious sedation is utilized, the American Society of Anesthesiologists (ASA) guidelines are recommended.
7. Protocols have to be available for each procedure that is performed in the clinic. Full history and physical exam should be on the chart and accepted nomenclature for anatomy should be used. Photographs before and after the treatment should be done. Both CEAP and VCSS need to be documented preprocedure and at completion of treatment. Treatment or referral plan for acute deep vein thrombosis or other complications should be in place. 
8. A database needs to be completed to measure outcome and record complications. Participation in a national venous database is highly recommended. A procedure to track patient outcomes is required. 
9. The clinic needs to maintain at least 75 superficial venous procedures per year in at least 2 of the 4 categories above, with a minimum of 25 cases per category in at least 2 categories. 
10. Participation in at least 2 quality improvement (QI) programs per year. Medical, technical, and ancillary staff are also required to attend QI meetings. Appropriate indication for the procedures must be assessed. Both technical and administrative quality assessments are to be conducted. 

Summary

1. Establishing an office-based vein program can be accomplished in a relatively short period of time. Some tips and tricks for starting a program include:
2. Education of providers is of paramount importance. 
3. Start conservative treatment of patients with CVI early in the process. The treatment needs to be well documented in the medical record.
4. Identify an EVTA vendor early in the process, as they can facilitate cognitive and hands-on provider and staff training. 
5. Knowledgeable and well-trained sonographers and ancillary staff are crucial to the success of the program.
6. Make sure you have the resources (space, equipment, and staff) in place to accommodate growth in the program.  

It is important that the clinic is committed to comprehensive, high-quality service. Clinic oversight by a medical director is important to ensure compliance with policies and procedures, as well as education of staff and other providers. A quality assurance program should be in place where all complications, adverse events, or unsuccessful therapies are reviewed. Vein program accreditation should be considered as a way to assess every aspect of daily operation and its impact on the quality of health care provided to patients.

References

1. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(5 Suppl):2S-48S. 
2. Almeida JI, Kaufman J, Göckeritz O, et al. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009;20(6):752-759 (Epub 2009 Apr 22).
3. Rasmussen LH, Lawaetz M, Vennits B, et al. Randomized clinical trial comparing endovenous laser ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011;98(8):1079-1087.
4. Intersocietal Accreditation Commission vein standards. Accessed at https://intersocietal.org/onlineaccreditation/news5.htm
5. https://www.intersocietal.org/vein/

_______________________________________

From the Midwest Cardiovascular Research Foundation and Cardiovascular Medicine, PC, Davenport, Iowa.

Funding: Supported in part by the Nicolas and Gail Shammas research fund at the Midwest Cardiovascular Research Foundation. 

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Shammas reports receipt of educational and research grants from Covidien to the Midwest Cardiovascular Research Foundation. He is also a trainer for the Venefit procedure. Mr Hauber reports no conflicts of interest.

Manuscript submitted February 6, 2014, provisional acceptance given March 17, 2014, final version accepted April 15, 2014.

Address for correspondence: Nicolas W. Shammas, MD, EJD, MS, FACC, FSCAI, Research Director, Midwest Cardiovascular Research Foundation, Medical Director, Vein Clinic, Cardiovascular Medicine, PC, 1236 E Rusholme, Suite 300, Davenport, IA 52803. Email: Shammas@mchsi.com