Building an Outpatient Interventional Suite

Business Plan

The group planning to open an office-based lab in all likelihood already has an existing practice that performs endovascular procedures. Most of the outpatient procedures performed in the hospital could be done in the office. However, we do not recommend discharging patients from the hospital to have a procedure done in the office. A pro forma accounting statement describing “typical financial activities” needs to be created based on last year's outpatient procedures performed in the practice. Projections of growth need to be realistic. While creating the pro forma, one needs to calculate revenue, capital expense, cost of disposables, labor cost, cost of space, and loan expense. For example, the cost structure will change if the building is leased compared with being owned by the practice.

Agreement Among Physicians

Like any other business, all physician employees in the group need to be in agreement that starting an office-based lab is the right decision for the practice. All the cases that can be safely done in the office need to be done in the office. If one partner does not do a particular endovascular procedure, then that case should be transferred to another partner. The compensation formula for physicians may need to be adjusted depending on the practice dynamics. If everyone is not in agreement at the initiation of the outpatient laboratory, the practice should anticipate conflict in the future.

Regulations

The deficit reduction act of 2005 permitted Medicare to pay for endovascular procedures done in the office setting. This was expanded in 2008 to include intervention in peripheral arteries. To qualify for these payments, the procedures should be carried out in the office where the patients are normally seen for established visits. There are no other Medicare rules governing the conduct of these procedures in the office setting. Different states have different rules and laws that govern the conduct of these procedures. Ambulatory surgery centers have their own set of rules that do not apply to office-based endovascular labs. As a result, the procedures done in the office are paid in a global manner that includes both technical and professional components. After the Centers for Medicare and Medicaid Services (CMS) started paying for these services, other insurance companies adjusted their fee structure and also started to pay for these services.

Financing

Various arrangements can be made for financing the center. If the practice is mature, money could be borrowed to build out the center in an existing space or a new space and to buy capital equipment. Cash flow from the existing practice can be used to buy the disposables and pay the salaries of new employees needed for the center. In a less established practice the group could borrow money for the building, lease the equipment, and get disposables on a contingency basis. Another option is to create a separate leasing company to acquire the capital equipment and lease it back to the practice. Cash flow could start as early as 2 weeks after performing the first procedure.

Location

The lab needs to be established in the same physical location where the patients are seen, to qualify as an office-based lab. If the current space is not sufficient to build the center, a separate center can be created, as long as the space is also used for patient care. If building a brand-new space for the office and lab, geographic location should be carefully chosen. Because most labs provide care to a hemodialysis-dependent population, it is important to have the office in close proximity to outpatient dialysis units. Close proximity to a hospital where physicians have operating access and easy access for emergency vehicles is essential in case of an emergency, so a quick transfer can be made. Proximity to a blood analysis lab also helps in case blood needs to be urgently tested prior to procedures.

Building

In addition to the existing facility used for seeing patients, the new endovascular lab space should have an interventional suite, procedure room, preoperative/postoperative area, decontamination room, supply storage area, drug storage area, and office for the laboratory manger. The interventional suite should be lead lined. Although not currently mandated by all states, lead lining the room during the initial build will prevent future remodeling costs if state law changes. With increasing awareness of radiation injury, the laws are likely to change. In addition to the lead-lined interventional suite, a procedure room may be needed to manage patients with superficial venous insufficiency. The interventional suite should be larger than the procedure room. The larger suite should be able to accommodate a C-arm, radiolucent table, intravascular ultrasound (IVUS) machine, supplies, and other equipment needed during the procedure. A preoperative and postprocedure area are also required; however, the same space can be used for both. Depending upon patient volume, the center will need between three and eight bays for patients. This area should be clearly visible to the supervising nurse and other personnel in charge of patient care. The scheduling, coding, and billing is usually done by existing employees so new construction is often not required.

Equipment

The office-based lab is not the interventional suite one is used to in the hospital. It is neither a hybrid suite, a room in the catheterization lab, or interventional radiology lab; it is specifically designed to safely and effectively accomplish the procedures performed by the outpatient endovascular center. The equipment needed is specific to the procedures being conducted. The largest piece of equipment in the suite is the x-ray system. There is a debate between buying a fixed room x-ray system versus a portable C-arm x-ray system. A fixed system is obviously more powerful, could be helpful for obese patients, and have additional features not present in the portable C-arm. However, the fixed system is less versatile compared with a portable C-arm when doing dialysis cases. C-arms have become quite advanced and now provide almost equal-quality imaging when compared with the fixed system. In our outpatient endovascular center, we have not felt the need for a fixed system after performing successfully more than 10,000 cases with a portable C-arm. If one is contemplating coronary angiography or placement of pacemakers/defibrillators, then a fixed system has definite advantages. Fixed systems may also be helpful in renal, mesenteric, and carotid artery procedures. One disadvantage of portable C-arms is the greater radiation exposure risk; therefore appropriate precautions should be taken. In terms of cost, a fixed system is more expensive than a C-arm. Purchasing a new machine is recommended rather than buying a refurbished system because it is very expensive to have a system down for any period of time. The cost of lost business and inability to provide care in a timely manner can be very detrimental to the success of the lab.

The second biggest item in the suite is the radiolucent table. The table should be movable and operator controlled. Side tilt is almost never required in cases being done in the office. Weight limit of the table is important because you may be doing procedures on patients up to 400 lb. Even if the operator is not doing peripheral revascularization procedures in very obese patients, some of the patients on dialysis may fall in that category and the vascular procedures needed for their dialysis can be taken care of in the office.

An IVUS is a required piece of equipment if venous angioplasty and stenting are planned. It can also be beneficial for certain peripheral arterial cases. A power injector is also required for arterial cases. Use of the ultrasound machine for percutaneous access of arteries and veins helps to avoid many complications associated with catheterization. In addition, venous ablation procedures cannot be done without an ultrasound machine. Ultrasound guidance during arterial catheterization diminishes the entry site complications. If a tibial approach is used for arterial revascularization, based on our experience a hockey stick probe is recommended. Other equipment needed can be found in Box 67.1 .

Supplies and Medications

The biggest running cost to the center is the disposable supplies and medications, listed in Boxes 67.2 and 67.3 . The physicians in the group should collaborate and decide what supplies they need. To simplify purchasing and get the best prices, the majority of supplies should come from one vendor; however, some companies will have proprietary products, necessitating specific vendors. The center should provide at the very least the same care that the physicians provide at the hospital. If a patient needs a drug-eluting balloon or a drug-eluting stent, then one should use it despite the fact that they are more expensive and there is no additional reimbursement from insurance companies. There are various atherectomy devices, and the group should decide which devices they will use and stick to that decision unless the data indicate otherwise.