Outpatient interventional radiology procedures require little additional infrastructure and capital investment.

Photo courtesy of Philips Healthcare

Over the last 5-plus years, many imaging industry analysts have been studying and hypothesizing about the potential impact of the consistently turbulent health care changes, including their impact on radiology, especially outpatient radiology services (often referred to as “in-office”). In general, I have considered myself an optimist throughout most of the dismal analyst calls, even when Congress and the Senate failed to pass the Access to Medical Imaging Act (HR 5704, S 3795), which would have put the brakes on the 2005 Deficit Reduction Act (DRA). If not for a major shift in the House and Senate, many industry executives, including myself, believed that the 2-year moratoriums would pass and that less aggressive changes would occur. That optimism got me through the buying decisions and expansion of two new outpatient centers when many just simply stopped. However, the DRA, as well as additional cuts in private payor reimbursements last year, have swayed my optimism. As the industry continues with deploying cost saving measures, it is difficult to retain that same optimism in the wake of new Medicare cuts, Accountable Care Organizations (ACOs), and bundled payor programs.

Today, as the imaging community now knows, the Supreme Court may or may not rule the President’s Health Care Reform as unconstitutional but, regardless, that will not stem the tide of additional cuts via federal and commercial payors. In short, payments will continue to be cut, as ACOs’ adoption of clinical integration will make it difficult for outpatient centers if they are not properly aligned in a network. After working so hard to squeeze the “blood from a turnip,” many well-run centers are giving up.

One thing that the health care community has taught us is that it all happens in cycles. The cycle time is long and painful, but if you push through, you will come out a winner in the end. Aside from looking at best practices, increasing efficiencies, and consistently measuring dashboards, I ask myself: What other new ideas are growing and working so that we can all come out as winners? Every once in a while, dismal changes can cause a positive shift in the imaging industry. In the past, this has come in the form of CT slice wars and cardiac scanning, as well as the MRI 3T craze. Those expensive modalities brought changes in how many outpatient providers marketed themselves. In the end, reimbursement did not warrant these expensive devices, and so, many were operated as marketing tools and simply overutilized. Enter utilization intermediaries (Radiology Business Managers), and authorizations were denied, or reimbursements denied after authorization, leaving many with expensive machines that took better images for referring doctors and patients, and saved money for payors downstream.

Capitalizing on a Niche

Today, there are still opportunities to provide new devices and products that not only are safe, but also build the bottom line using little additional infrastructure and capital investment. One opportunity is the growth in outpatient interventional radiology (IR) procedures.

RADNET INC is one of many in the radiology community that has been quietly growing in the IR sector for the past 2 years. Norman Hames, executive vice president and COO of RADNET INC, explains their reasoning, “RADNET has been purchasing and deploying R&F rooms in many outpatient centers due to their prospective growth. This occurs in specific markets where we can work with our own radiologists and expand into specific treatments and areas that are familiar and safe.” Surprisingly, many hospitals are space-constrained and need an IR suite for difficult cases and for patients who require hospitalization and admittance. As a result, this creates an opportunity for more routine and well-established procedures to be performed in an outpatient setting.

At Central DuPage Hospital, Nilesh H. Patel, MD, FSIR, interventional radiologist from Cadence Physician Group, says, “The hospital and physicians group continue to work toward a similar goal, choosing the correct procedures to push to the outpatient environment while maintaining high safety standards. IR procedures that have been shown to be safe are going back into the outpatient IR rooms to relieve backups and unneeded hospital 1-day admissions.”

IR growth is not just about patient convenience or a one-stop shop. It is really about changes in delivery as far as offering a safe and effective option for patients within a comfortable outpatient setting. In addition, the acceptance of new CPT codes that offer higher reimbursements than the previously allowed CPT codes further supports the trend. The good part is that many facilities have the capability to dust off their C-arm tables and IR rooms that have been lying partially dormant and start using them again with minimal cost. Rooms are relatively inexpensive to set up as compared to modalities like CT and MRI. Moreover, many facilities tend to prefer the x-ray/fluoroscopy rooms because, as the primary access point, general x-rays are the catalyst into radiology’s lucrative revenue areas, such as MRI, CT, PET, and ultrasound.

A Low Risk, Profitable Procedure

IR rooms are becoming safer and profitable during a time in which radiology’s downward reimbursement continues. Understanding the opportunities in outpatient radiology means watching trends in the industry, which lead me to look into a routine procedure that is less commonly performed in the freestanding IR labs, vertebral augmentation (formerly kyphoplasty) for the treatment of vertebral compression fractures (VCFs). A VCF occurs when the bony block or vertebral bone collapses, most commonly due to osteoporosis or cancer, which can lead to severe pain, deformity, and loss of height. According to industry data, it is estimated that more than 900,000 people suffer from VCFs every year.1

Recent changes in reimbursement for vertebral augmentation have created a potential new opportunity for IR groups positioned to take advantage of it. In evaluating this opportunity, I took a closer look at the available technologies for vertebral augmentation. One approach that caught my eye, and I think is particularly well-suited to the freestanding IR suite, is a therapy known as Radio Frequency Targeted Vertebral Augmentation (RF-TVA™). DFINE Inc, a privately held medical device company, is the developer of RF-TVA—an advanced therapeutic option for treating VCFs. RF-TVA offers a predictable and reliable treatment option that presents a low-risk and significant benefit for the patient. Other larger companies such as Medtronic, Stryker, and Carefusion offer more conventional technologies, and have larger shares of the inpatient market. These companies are all reaching into the outpatient market with different slants to their products. The DFINE product, known as the StabiliT® Vertebral Augmentation System, seems to be gaining traction due to its innovative approach to providing the interventional radiologist with greater control and improved safety during these procedures. It appears that with the StabiliT System, physicians are able to navigate within the vertebral body to target the spinal fracture with greater precision and control, while also sparing the bone—two unique benefits of RF-TVA over older, conventional therapies such as balloon kyphoplasty. Not only does the system allow greater control, it also allows the interventional radiologist to stand outside of the radiation field during cement delivery, thus reducing overall exposure to the clinician.

“We believe RF-TVA, using the StabiliT System, is ideally suited to the outpatient IR environment because the system was designed to offer a greater level of control and safety versus conventional augmentation technologies. We are very excited about the growth we are seeing in this new site of service,” said Kevin Mosher, president and CEO of DFINE. Vendors such as Philips and GE tell of a similar story, indicating C-arms sales have doubled in some markets. Mosher agrees but also says DFINE is careful not to push overutilization, an issue in imaging from the days of open MRI scanners and cardiac and whole body CT scanners. According to Mosher, “At DFINE, we emphasize safety, education, and appropriate patient selection, as well as synergies between patients, doctors, and hospitals alike. Our hope is that as more IR labs begin performing these procedures, it will open new pathways for patients to be treated for this debilitating condition. There are still many patients with VCFs that are not treated with this advanced therapy.”

Juan Rodriquez, MD, FSIR, from Radiology Medical of Santa Cruz Group, welcomes these new procedures, stating that DFINE’s RF-TVA and StabiliT Vertebral Augmentation System are not only safe for the patient, but for the radiologist in the rooms as well. They can be operated from 10 feet away from the C-arm or fluoro-head, limiting radiation exposure to the radiologist. The other advantage, says Rodriguez, is the fact that no balloon is used to break apart the vertebral body (unlike conventional balloon kyphoplasty), which means he can enter from only one side of the vertebral body and use the articulating tip on the end of the instrument to navigate across the midline. This allows him to spare the remaining intact cancellous bone and incorporate it into the cement, creating a more stable and stronger fracture construct. “It is just like using the bone as rebar and filling the cracks to create an ultra-tight bone. Using more of the patient’s bone and the articulating instrument makes the procedure safer,” said Rodriguez.

Steven R. Renard, CEO and President, Diagnostic Radiology & Oncology Services (DRS)

He also believes that these procedures will be accretive to the other modalities in the radiology clinics. Rodriguez remains excited about the new devices that continue to enter the IR market, allowing hospital physicians to relieve the busy IR suites and perform these types of procedures in a friendly, comfortable, outpatient environment. Furthermore, bone densitometers, PET/CT, MRI, and ultrasound can all see incremental increases from new IR procedures in the outpatient centers.

Beneficial to All

The business case for outpatient vertebral augmentation is attractive to all parties. The average hospital stay is 1 to 8 days, costing hundreds of millions in revenue to Medicare that the hospitals are now being paid. Hospitals average approximately $6,000 per procedure and will be capped and penalized by performance. Moreover, this year Medicare approved new outpatient codes using CPT 22253 (Thoracic), which reimburses globally at $7,665, and CPT 22254 (Lumbar) at $7,604. I believe this will be the year when many choose to start looking to incorporate IR into their outpatient centers. If vertebroplasty and vertebral augmentation are being done today with new codes that warrant little financial risk, then we should continue to see new and exciting products being introduced that are safer for outpatient procedures. Skeptics, no doubt, remain worried about just how many procedures should be chased out of the hospital environment. They will choose to test the waters in an attempt to determine safety, outcomes, and business feasibility of new purchases. Just as vendors have been so helpful in fighting to save Medicare reimbursement, they must also assist radiology in educating local and commercial payors not to blindly follow Medicare. Providing statistics reflecting how new applications in imaging benefit not only the patients, but also the payors, could prove extremely valuable in the months to come.

The Future of Outpatient IR

In conclusion, the growth of interventional procedures occurring in outpatient radiology will almost certainly continue provided its constituents, such as hospitals, payors, patients, and referring physicians, all find common ground. The latest advancement in VCF therapy known as RF-TVA is a safe, proven, and effective procedure that presents low risk and a significant benefit for the patient. It is an exciting development in outpatient interventional radiology and may open new pathways for patients to be treated for this debilitating condition, and is just one example of more to come to the outpatient world. However, some IR procedures may not be readily adopted due to control of referring patterns or just the progressive nature of breaking old treatment habits.

Safety, not economics, still must remain in the forefront when determining outpatient IR utilization. The radiology industry can realize significant setbacks by putting financial gains in front of proper safety. Radiology must not be lured into procedures that are simply paying extra dollars if safety—and therefore ethics—is an issue. Radiology is slowly climbing out of the reimbursement gutter after years of double-digit growth and huge profits, which forced a spotlight on the industry. As radiology and IR move out of inpatient environments, payors and device companies are watching closely this time for signs of overutilization driven by newly adopted technologies.


Steven R. Renard is the founder, CEO, and President of Diagnostic Radiology & Oncology Services (DRS), a development, consulting, and management company serving radiology groups nationwide and major ventures with Trident Health, Rely Radiology, and Frazier Healthcare.

References
  1. Medtronic Inc updated estimate from 700,000 spinal fractures estimated in 1985-89 study published by Riggs BL, Melton LJ 3rd. The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995;17(5 suppl):505S-511S, for demographics and incidence rate per
  2. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007;22:465-475.