Development and Successful Operation of an Outpatient Vascular Center

Introduction

Endovascular procedures have traditionally been performed in the hospital where the patient was observed overnight following the procedure; this gradually transitioned to the patient being discharged on the same day. Once the safety and efficacy of these procedures was established in the hospital-based setting, studies were conducted by multiple investigators that documented the safety, cost efficiency, and clinical efficacy of conducting endovascular procedures in a dedicated office sertting. The Deficit Reduction Act of 2005 included the provision for the Center for Medicare and Medicaid Services (CMS) to reimburse endovascular procedures in the office setting. Same-day discharge of the patient after these procedures helps reduce the cost of the procedure. Other insurance companies followed CMS policy, and now provide the same coverage. Thus, endovascular procedures can now be performed in outpatient vascular centers. There are three types of outpatient centers that a patient may consider for endovascular procedures: a hospital-associated outpatient center, an ambulatory surgery center (ASC), or an office-based endovascular center (OEC). OEC is also referred to as office-based lab (OBL).

Outpatient vascular centers can be established by a hospital or by office-based practitioners. In hospital-developed outpatient centers, the hospital is paid under the outpatient prospective payment system, and each physician bills separately for professional services rendered. At a privately-owned ASC, the “facility fee” is paid to the ASC for the surgical procedure and the provider is paid the “facility rate” based on the surgical procedure performed. In an office setting, Medicare and other insurance companies pay at the “nonfacility” rate. This nonfacility fee is a combination of technical and professional fees. An office-based center or laboratory is defined as a procedural suite within an office and is an extension of the office where patients are seen and treated. The office-based center is not specialty specific and the elements described in this chapter can be applied to all specialties. ASC is governed by different rules and can be built in partnership with nonmedical organizations. There is some variation in the procedures that can be performed in the office as compared to the ASC. For example, coronary artery angioplasty can be performed in an ASC but not in an OEC. The payment for the same procedure done in OEC or ASC differs since different payment structures are used for reimbursement in different sites of service. This chapter will discuss the office-based endovascular center in detail.

Regulations

Office-based centers, in contrast to ASCs, do not have well-defined regulations guiding their operation. Instead, the centers are mostly regulated by state law ( Table 198.1 ), because there are currently no federal guidelines for an office-based center. These regulations mostly pertain to anesthesia, radiology, and the Occupation Safety and Health Administration (OSHA). Increasing number of states are passing laws to regulate these centers. Many of them require the lab to be certified. ASC is regulated by specific federal and state laws. To receive payment from CMS for procedures done in the ASC the facility must be certified by one of the deemed organizations.

TABLE 198.1

Comparison of Ambulatory Surgery Center and Office-Based Labs

	ASC	Office-Based Lab
Payment methods	Bill facility fee and professional fee	Global payment (nonfacility)
Procedures allowed	All ASC-approved procedures can be performed	Limited number of procedures
Physician usage	Other practitioners can use	Only practitioners seeing the patients in that office
Ownership	Multiple physicians can own it	Lab must typically be owned by physicians who are seeing patients and operating on them
Licensing	CMS and state license required	No license needed
Capital investment	Higher capital outlay for construction and equipment	Reasonable capital outlay
Size of facility	Bigger facility required	Depending on expected volume, smaller space can suffice
Regulations	Comply with federal and state laws	Comply with state laws
Services cost	Higher professional services cost at outset	Minimal cost
Staffing cost	Higher staffing cost; different staffing ratio	Office staff can be used in addition to added personnel
Monthly cost	Higher monthly cost	Lower cost
Accreditation requirements	Accreditation required	Not required except in certain states
Certification requirements	Certificate of Need required in many states	No Certificate of Need required
Transfer regulations	Need to provide hospitals documentation that includes information about their operation and their patient population.	Not needed, desirable if the practitioner is not a surgeon

ASC, Ambulatory Surgery Center; CMS , Center for Medicare and Medicaid Services.

Anesthesia

Regulations pertaining to anesthesia depend on the degree of sedation administered to the patient. In most states there is no requirement for an anesthesiologist to be present for minimal to moderate sedation. Many states, including New York, require the presence of anesthesiology personnel if moderate to severe sedation is needed for the procedures being performed. Different accrediting bodies may also have specific requirements regarding anesthesia that must be followed for the center to be accredited.

Radiology

Each state has different regulations governing the radiology suite in the office. Not all states require lead lining of the lab if a C-arm is being used. Some states mandate that only a certified radiology technician can operate the C-arm. The lab should follow the state law related to C-arm inspection, lead lining, staffing, and training regulations. In addition, there may be regulations governing the integrity of lead aprons and dosimeters.

Occupation Safety and Health Administration

OSHA regulations need to be followed diligently. This requires compliance training, policies and procedures, employee handbooks, and forms for recording incidents (needlesticks, etc.). The complete set of regulations can be found at www.osha.gov .

Components For Success

Office for Patients

Office-based outpatient interventional centers are defined as locations where patients traditionally see physicians or surgeons to diagnose and discuss their clinical condition. The office must meet the basic requirements of space and personnel, such as examination rooms for patients to be seen, and nursing staff to provide patient care, among other requirements.

Noninvasive Vascular Lab

A noninvasive vascular lab is needed to support the office-based practice and the endovascular laboratory suite. An ultrasound machine that can reliably perform imaging of the venous system and peripheral arterial system including the aorta, carotid, and visceral arteries is required. The same machine can be used to access arteries and veins in the endovascular suite. A Doppler machine is necessary to obtain wave forms and measure ankle and toe pressures to assess circulation in the extremities. Additionally, the appropriate equipment is required to conduct photoplethysmography of digital vessels to check the digital circulation in patients with conditions such as Raynaud phenomenon, vascular steal in dialysis patients, and distal occlusive disease in diabetics. The lab should be certified by the Intersocietal Accreditation Commission or the American College of Radiology.

Endovascular Lab

Almost all percutaneous endovascular procedures currently performed in the hospital can be safely conducted in the office-based lab. ^, Because there are limited resources in the office as compared to a hospital, patient selection is crucial in optimizing results and diminishing potential complications. The absolute contraindications to treating a patient would be the need for general anesthesia, the need for hospital admission due to comorbidities, the expected need for prolonged observation post procedure, or severe allergy to dye. Relative contraindications for patients would include the weight of patient exceeding 400 pounds or a patient with decreased pain tolerance, if conscious sedation is not available. Endovascular repair of an aortic aneurysm and carotid stenting cannot be performed in an office-based lab and are not reimbursable in the office-based setting. In a pilot study (not published), endovascular repair of infrarenal aneurysms was safely done in the office-based lab in appropriately selected patients. However, until a larger study is conducted, this procedure should not be performed in the office-based setting.

Types of Procedures

Hemodialysis Access-Related Procedures

The outpatient management of the dialysis access patient population is discussed in Chapter 199 (Development and Operation of Outpatient Dialysis Access Centers), and only a brief overview of the spectrum of procedures is provided in this chapter (see Ch. 177 , Hemodialysis Access: Failing and Thrombosed). Insertion of catheters should be avoided as much as possible due to the inherent complications of infection and stenosis caused by the catheters. Patients needing urgent dialysis without a functioning access will need catheters, however, and these can be easily placed in the office setting. Midlevel operators can be trained to remove catheters.

Indications for performing a fistulogram in this setting include: (1) decreased blood flow; (2) increased venous pressure; (3) increased bleeding after removal of the needle; (4) ultrasound-proven hemodynamically significant stenosis; (5) inability to access the vein; (6) increased recirculation time; or (7) decreased urea clearance. There is no indication for doing a fistulogram on a predetermined schedule. Stenoses identified can be treated in the outpatient setting with either angioplasty and the selective placement of bare or covered stents, such as for elastic recoil. Laser atherectomy of stenoses at the dialysis access stent is currently not FDA approved, so it should not be performed. Coil embolization to occlude venous branches contributing to “steal” can be performed in the outpatient setting. Balloon-assisted maturation of a fistula may be performed but at this time there is no reimbursable code for this procedure. ^, Intravascular ultrasound (IVUS) may be helpful in determining the degree of stenosis and appropriate sizing of devices.

Declotting of a fistula can be carried out using percutaneous, chemical, or mechanical thrombectomy, and underlying stenoses can then undergo angioplasty following recanalization.

Central venous stenoses due to previous catheters or the presence of a pacemaker/defibrillator on the ipsilateral side can be treated in the outpatient center, typically using bare metal or covered stents. ^, Likewise, arterial inflow stenoses can be corrected by angioplasty using a retrograde approach through the access or by using an antegrade approach via the femoral artery in the outpatient center.

Peripheral Arterial Procedures

Arteriography may be performed for carotid artery disease, renal artery stenosis, lower or upper extremity ischemia, aneurysmal disease or visceral ischemia. A diagnostic arteriogram can be performed and reimbursed for any vessel in the body except the coronary arteries. If this procedure is performed in an ASC, however, it is reimbursed. The procedure can be done via a femoral, brachial, radial, or tibial approach. Femoral artery access is the most common approach. Prior to the procedure, kidney function should be assessed and in cases where renal function is compromised, an appropriate hydration protocol should be used. In patients with moderate to severe renal impairment, CO ₂ angiography should be performed. In cases of morbid obesity or hostile groin, a brachial, radial or tibial approach can be used. The complication rate is higher with the brachial approach as compared to radial access. Closure devices are used based on physician preference. Although there is no significant decrease in post-procedure bleeding when these devices are used, the time to discharge is often diminished.

Visceral and renal angioplasty and stent placement can be performed for appropriate indications. ^, Angioplasty and stenting of iliac arteries results in satisfactory long-term results. Atherectomy at this anatomical location is not proven to be clinically beneficial and is not reimbursable. Likewise, carotid stenting is not reimbursable and aortic angioplasty is seldom indicated.

Interventions for superficial femoral, popliteal, and infrapopliteal arterial disease are the most common procedures performed in many labs. Documentation of prior medical management and noninvasive vascular lab studies is recommended to justify the intervention. Angioplasty, stenting, and atherectomy are all performed in these vessels in the outpatient setting. A recent paper from an office-based endovascular center demonstrated the efficacy of atherectomy in infrainguinal arteries. Drug-eluting balloons, new design stents, and drug-coated stents being increasingly utilized. A retrograde tibial approach is being used to cross lesions when an antegrade method fails, or in the case of a hostile groin. ^, Stenoses in the subclavian, axillary, brachial, radial, and ulnar arteries can be managed by angioplasty and stenting when indicated.

Venous Procedures

Venous stenosis in the iliac and femoral veins due to post-thrombotic obstruction or external compression, can be detected using venography and IVUS, and treated in the outpatient center. Neglén et al. have demonstrated long-term patency of venous stents and sustained clinical symptom relief, and Ganelin et al. demonstrated the safety of this procedure in an office-based setting. FDA-approved stents are now available for treating venous stenoses. The stents needed are usually large, ranging from 14 to 28 mm in diameter, which requires stocking larger balloons than usually kept in the lab. IVUS is proving to be more accurate than venography in diagnosing venous stenoses. Thrombolytic therapy of iliac vein thrombosis will likely soon be considered safe in the office setting. Finally, vena cava filters can be inserted and removed safely in the office-based lab. ^, It may be possible to improve retrieval rate of filters when the procedure is carried out in the OBL.

Port Insertions

Ports for chemotherapy, nutrition, or antibiotic therapy can be inserted in an office-based lab as long as the patient is not on Coumadin.

Venous Center

Use of an outpatient venous center to primarily manage superficial venous reflux has gained wide acceptance among physicians and patients, utilizing endovenous ablation, microphlebectomy, sclerotherapy, and evolving new techniques like foam and glue injections for truncal venous insufficiency. ^, The venous center can be developed with or without an accompanying endovascular center. A combined venous and endovascular center can be beneficial since some patients may also be candidates for interrogation of iliac and femoral veins through venography and intravenous ultrasound and subsequent treatment with angioplasty and stenting. Providing treatment for all types of vascular conditions at one location improves the safety and convenience for the patient.

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