Office-Based Labs: An Evolving Healthcare Model

We first opened the Tyler Cardiac & Endovascular Center over 9 years ago. Located in Tyler, Texas, about an hour and a half east of Dallas, our single specialty practice consists of 11 cardiovascular specialists. As a convenience to our patients, we conduct office visits in numerous satellite offices throughout the region; however, the majority of our major procedures and interventions are performed in our Tyler facilities.  

Organizationally, we employ a ‘hybrid’ business model, combining an office-based lab (OBL) with an ambulatory surgery center (ASC). Four days a week we utilize the OBL model and one day a week we operate as an ASC. I prefer to use the term “office interventional suite (OIS)” as opposed to “OBL”, as it conveys the totality of cardiovascular, endovascular, venous, and non-vascular services performed in the office environment. Within our 40,000-square foot office, we have a freestanding cath lab where we conduct a wide array of cardiac procedures, including diagnostic coronary angiograms, coronary stenting, and electrophysiology work (diagnostic and ablations). We also perform a variety of device implants, including pacemakers, defibrillators, loop recorders, and biventricular pacers. 

On the peripheral side, in addition to diagnostic angiography, we perform lower extremity endovascular revascularizations, which include chronic total occlusion (CTO) and complex limb salvage procedures. We also perform renal and mesenteric revascularizations, as well as subclavian stenting. In our lab, we perform deep venous work, including venous angioplasty and stenting using intravascular ultrasound (IVUS) guidance for May-Thurner syndrome and iliocaval obstruction. Our office also includes a freestanding vein center where we do endovenous laser, radiofrequency, and chemoablations, among other procedures for total vein care, but these procedures are not performed in the office cath lab.

The Case for Outpatient Labs 

One of our early decisions was to partner with a management company that had a proven track record in setting up and managing OISs and ASCs. Equally important was their expertise in helping us with the licensing and accreditation processes. To demonstrate our commitment to a higher standard of patient safety and quality, we elected to obtain certification by the Joint Commission. The partnership with our management company has been mutually beneficial, as it enables the physicians and staff to focus on the clinical aspects of caregiving, allowing our partner to concentrate on the administrative and contracting side.  

Highly regarded service is another benefit our patients receive in our OIS. Patients consistently report overall satisfaction rates with their care and service at over 97%. We routinely conduct formal surveys asking for feedback on criteria such as friendliness, comfort, convenience, quality, and patient outcomes. Survey return rates are unusually high compared to the hospital and average grades exceed an overall 98% rating. This in turn, helps our practice grow, as these satisfied patients return for future procedures and enthusiastically recommend us to others. 

Physician operators are also very satisfied because of our streamlined services, the quality of our staff, and the alignment of goals. Not only is our staff comprised of the very best technologists and specialists, but all have a track record of quality patient care. Doctors really appreciate the smooth workflow, the lack of interruptions, and their input on product and device selections. We developed and track quality metrics for all procedures performed in the lab. This helps ensure the teams are focused on the patients’ as well as the organization’s needs. 

We began initially as an OIS, but nearly 3 years ago, we converted our existing lab to an ASC. We had to make many modifications to comply with the regulations to become ASC certified. Fortunately, we had the space to expand and incorporate the changes needed for the higher level of regulatory requirements. Incorporating emergency backup power, adding med-gas to wall couplings, adjusting wash sink placements, widening doorways and ensuring sufficient numbers of beds were just a few of the many facility upgrades necessary to certify our ASC.  

The primary benefit of the ASC for patients is that we are able to provide additional services and greater treatment options than in our OIS. In particular, Medicare patients benefit. Medicare patients can have pacemakers and other devices conveniently inserted in the ASC, since they are not covered in the OIS. However, there remains coverage discrepancy among the sites of service for cardiovascular services for Medicare beneficiaries. For example, we can perform a coronary angiogram on these patients in our OIS, but if stenting is indicated, it is not covered by CMS in that same OIS. Interestingly, commercial insurance allows us to perform both diagnostic and coronary stenting in the OIS. By doing the entire procedure in the ASC, everything can be completed in one setting and visit. 

The Evolving Outpatient Market 

Within the last 5 years, the proliferation of hybrid models has been the major outpatient improvement. The ASC allows for greater diversity in treatment options. Equally valuable is the ability to safely and appropriately perform more complex procedures, with safeguards, back up protocols, and procedures similar to, and in many cases, exceeding those in the hospital. I am seeing newer labs entering the market right out of the gate with this hybrid model. It is expensive to convert OISs to ASCs, so, finances permitting, it may make sense for many labs to make the upfront investment in the ASC for the added capabilities and diversity long-term. I think this trend is just beginning.  

Cooperative Care

An interesting phenomenon we are seeing within and among OISs around the U.S. is the collaboration and sharing of best practices with multispecialty operators such as vascular surgeons, radiologists, and cardiologists. In many labs, different specialists work toward common goals in the same facility where there is opportunity to learn from one another about improving efficiencies and care for same-day interventions (SDI) in an office. This provides unique opportunities for both patients and physicians.      

Increasingly Complex Procedures

Over the 9 years of operating our OIS, I have seen the complexities of lesions treated increase as we became more experienced in same-day interventions, and incorporated new and improved technologies into our practices. We are safely and effectively taking on more peripheral artery disease (PAD) patients with multiple comorbidities and challenging lesion subsets, including very long chronic total occlusions (CTOs) and calcified vessels. We have seen a shift to treating more resting and critical limb ischemic patients compared to claudicants. Here in Tyler and around the country, physicians working in OISs are doing increasingly complex peripheral interventions, with the aim toward alleviating pain and preventing major amputations.

Greater Transparency

Another aspect we focus on is continuous process improvement (CPI). We are dedicated to credentialing new operators, conducting regular and focused peer review, measuring outcomes, and implementing appropriate use criteria in our OIS. Since inception, we have done this voluntarily, but now through the Outpatient Endovascular and Interventional Society (OEIS), these efforts have been expanded into formal, nationwide initiatives. The OEIS is a medical society for office and outpatient models that promotes transparency for the types of services, safety, and outcomes patients experience in OISs, ASCs and hybrids.   

Migration of Procedures From the Hospital to the OIS

This is an area where OEIS and other groups are actively educating policymakers and advocating changes, including those related to equitable reimbursement. It includes efforts to authorize services currently only done in a hospital as a same-day intervention, to be conducted in office and ASC environments. New technologies and advances in pharmacology have been the great enablers for the migration of minimally invasive procedures to be done in hospital outpatient and freestanding settings. In 2008, Medicare changed the reimbursement for office and outpatient procedures to encourage the shift away from expensive inpatient services. As a result, we have seen a reduction in inpatient workload and services inside the hospital, and commensurate growth in outpatient procedures. For example, the number of lower extremity bypass surgery cases (inpatient) has significantly fallen, shifting to endovascular revascularizations (outpatient) in the hospital outpatient and office settings. However, there are coverage policies for new technologies in which the OIS has been disadvantaged from a reimbursement standpoint, compared to the hospital. Currently, there has been a transitional pass-through payment that was authorized in hospital settings for drug-coated balloons (DCBs). However, when DCBs are utilized in the office, there is no separate coding or payment mechanism to capture the additional DCB technology cost. This challenges office labs financially. We are working to educate Centers for Medicare & Medicaid Services (CMS) to create avenues to allow for coverage of DCBs in the office environment. 

Technological Advancements Facilitating Transition Out of the Hospital

Any technology that improves safety and efficacy for same-day intervention facilitates growth of procedures in freestanding facilities. A major advance in my practice has been CTO crossing. I find I am able to predictably, effectively, and efficiently cross lower extremity artery long CTOs. There are multiple different devices that can be used, depending on plaque composition and lesion characteristics. Preparatory devices such as specialty wires, crossing catheters, or atherectomy devices are usually successful in crossing. However, a reliable reentry device is critical when the other devices can’t cross, as they can be guided through the subintimal space, around the occlusion and back to the true lumen. The ability to offer multiple crossing options for the complex CTO environment requiring treatment is crucial to successful intervention. 

For cardiac work, radial access continues to grow in the office environment. Although sometimes more technically difficult than the groin access, radial access is safer for patients, results in quicker recovery, and represents the future as new products are under development for office-based interventional procedures for the heart and peripheral arteries.   

A third technology, and perhaps one likely to significantly improve outcomes in the outpatient environment, is ultrasound-guided access. As an interventional cardiologist, I used to believe that ultrasound guidance was not needed for access, but several years ago my radiology and vascular surgery colleagues convinced me of its value. Now I use it nearly 100% of the time for all access sites. It has improved both safety and outcomes for my patients because I can avoid accessing through unseen lesions or branch vessels. This has translated into documented, superior outcomes compared to access without ultrasound. Most cardiologists do not use it and yet almost all radiologists do. This is an example of the value in sharing best practices in an open fashion across specialties. 

Advocacy for OISs and ASCs

Just 4 years ago, there was little governance or regulation to provide oversight and help manage the proliferation of OISs. In response to this unmet need, we formed the Outpatient Endovascular and Interventional Society (OEIS) in August 2013. Bringing together interventional cardiologists, vascular surgeons, interventional radiologists, and other specialists as an inclusive medical society, we now have a voice for OISs. To better support the office and outpatient value proposition, we set out to establish quality standards for care, safety, credentialing, accreditation, appropriateness, peer review, education, research and outcome measures. As the founding president of OEIS, I was privileged to help advocate for what I consider an extraordinary model of same-day interventions for the healthcare system at large. 

Alongside other groups, we are working to preserve and expand access to care for both office and ASC procedures. There have been disparities in reimbursement due to different Medicare coding systems for each of the sites of service. The goal is to have a more comprehensive, unified reimbursement system for appropriately selected patients. The OEIS has grown in membership and we continue to establish guidelines, quality standards, and outcomes measures. Our message is compelling, but we must continue to band together as one large and coordinated voice to make a difference for our patients.

OEIS Registry — A Path to MACRA Compliance

I serve as the medical director for the OEIS National Registry. This year we launched the peripheral vascular intervention (PVI) registry module for all same-day procedures. In just a few months, we have over 4,000 patients in the registry. We have also obtained CMS certification as a Qualified Clinical Data Registry (QCDR), which allows us to report quality data on behalf of physicians to CMS. This has been a major achievement for us. Part of the certification process was implementing 9 quality measures that are used for MIPS scoring and reporting to Medicare at the end of this year. This quality scoring is specified under the MACRA legislation.  

Participation in a registry is currently voluntary; however, moving forward, Medicare has mandated their value-based compensation system be platformed via registries. Accordingly, all outpatient labs will likely need to participate in a registry, through which compensation will be determined. Further, we designed the registry to meet not only MACRA requirements, but to serve as a database tool for individual labs to query and review their own utilization, trends, and outcomes data. The OEIS National Registry is also scalable as it grows and evolves. 

Cardiovascular Coalition — A Voice for PAD Patients

I have been privileged to serve as the physician lead and board member for the Cardiovascular Coalition (CVC), an advocacy organization whose mission is to advance patient access to care for peripheral arterial disease (PAD). Geographic and racial disparities in amputation prevention and PAD still remain. We are working hard to educate policymakers about this leading and preventable cause of death in the U.S. When we formed the CVC, there was a significant lack of knowledge by policymakers surrounding PAD. One of the main efforts of the CVC is to educate healthcare officials and policymakers, practitioners, and patients about this issue through community-based solutions, as well as other sites of service. 

Considerations for Launching an OIS

A goal for many busy interventional physicians in practice is to provide a better experience for patients, but also to gain control of one’s schedule. When I first considered making the leap to an OIS, the cath labs in the 2 hospitals where I worked were so busy that elective procedures were sometimes being started as late as 7-8 pm, with patients waiting all day long because of interruptions from other, more acute cases. This frustration, compounded by a diluted voice in product choices and a lack of alignment with hospital cath lab staff regarding patient care, were the impetus for my group and me to make the personal and professional decisions to launch an office interventional suite.  

My professional life today has markedly improved. In addition to providing high quality, cost efficient care to very satisfied patients, we are usually done by 5 pm. The workflow is much more predictable and there is rarely a disruption to the schedule. That was the strongest motivator for us to launch Tyler Cardiac & Endovascular Center. In addition, with sustained downward pressure on reimbursement for physicians, the OIS and ASC enable us to focus on what we are trained to do, but with more direct involvement and impact on the cost and revenue streams.

There are several key considerations before deciding to launch out on your own. My advice is to ask the following questions: 1) Do my colleagues and I have enough experience to consistently perform safe and effective same-day interventions — and with a sufficient patient base? 2) Should we partner with a management company or consultant, or do we have the expertise to launch and run the business on our own? 3) What is the right model and what specific services will we offer? 4) What are our main goals for opening a lab and what will be the impact on our practice? 

It’s a big decision and not without risk, so conduct some serious strategic assessments and planning. Educate yourself and reach out to colleagues that have done this before (joining the OEIS is a good starting point). Consider tapping into industry expertise as well.      

Once you make the decision to transition to a physician-businessperson role, there remains a host of other requirements to determine such as site selection, build out, financing, staffing, equipment, product selections, and licensing. The first few months will be challenging and you may have to remind yourself of all the great reasons you are doing it, but my prediction? You’ll never look back!  

For more information on the Outpatient Endovascular and Interventional Society, the OEIS National Registry and the CVC, check out: 

oeisweb.com
cardiovascularcoalition.com

Disclosure: Dr. Jeffrey Carr reports no conflicts of interest regarding the content herein.

Dr. Carr can be contacted at jeffcarr@me.com.