Many cardiovascular (CV) programs across the United States offer some level of electrophysiology (EP) services for a multitude of reasons.
In addition to fulfilling a community need, dedicated EP programs diversify and differentiate the CV service line, provide favorable hospital profits (when managed effectively), and enable hospitals to remain viable competitors within their markets.
- Level I EP Program – includes pacemaker and standard defibrillator procedures
- Level II EP Program – includes level I procedures as well as cardiac resynchronization therapy (CRT), diagnostic EP studies (mapping), and “simple” ablations
- Level III EP Program – includes all of the above procedures, and adds more “complex” and time-consuming ablations for atrial fibrillation and ventricular tachycardia, and can also include lead extraction.
It should be noted that Level II and Level III programs require the presence of an open heart surgical program on-site given the level of complexity, scientific advancement, and collaboration necessary among the electrophysiologists and cardiac/thoracic surgeons for more complex/hybrid procedures and lead extraction back-up.
The United States population is aging — the baby boomers are a prime example — and people are living longer, thus increasing healthcare costs and affirming the widely-accepted notion that behavior directly affects the risk of cardiovascular disease, diabetes, and cancer. According to the Global Burden of Disease Study1:
- In 1990, life expectancy was 62.8 for men and 68.1 for women.
- In 2010, life expectancy was 67.5 for men and 73.3 for women.
- During those 20 years, the gap between the years lived and the total number of years in which people had good health widened to 9.2 for males and 11.5 for females.
Additionally, the impact of the unknown — healthcare reform — is a topic that will remain top of mind for any healthcare provider. Throughout this discussion we will specifically address key matters for hospitals that are considering expansion into electrophysiology service offerings. There are four areas of focus that are imperative to implementing a solid, high-quality electrophysiology program. Each of these focus areas include quality as their fulcrum. They are:
- Service Line Leadership
- Operational Components
- Financial Impact
Service Line Leadership
What administrative issues should be top of mind when embarking on expansion of EP services at an organization?
Electrophysiology service expansion for today’s CV leaders is a daunting proposition. The addition of new services offers volume potential, revenue enhancement, and added convenience for patients and providers. However, EP services can quickly become a cost and regulatory nightmare if not managed effectively.
The role of the CV administrator becomes focused on creating support documentation and processes to ensure clinical appropriateness and financial viability of the program. Corazon believes that establishing a trusting relationship that includes frequent and open dialogue with the electrophysiologists on staff is crucial to the success of the program.
Understanding the equipment and supply needs of the physicians is equally as critical in order to develop competitive contracts with various vendors. It is also important to consider levels of vendor clinical/technical support provided to both referring cardiologists and electrophysiologists. Since most long-term device and arrhythmia follow-up will occur in the cardiologist’s office, established patterns for clinical and technical support must be evaluated to prevent disruptions in current practice.
Mandatory participation in the ACC-NCDR® ICD Registry™ adds a new dimension of complexity for the CV administrator. First, identifying knowledgeable staff to enter data is a top priority. Educating EP staff on the required elements for comprehensive and accurate documentation is critical. Data should be reviewed by the EP medical director and CV administrator prior to quarterly submissions in order to validate information and prevent non-compliance surprises when the data is published and available for public view. Benchmarked information from the ICD Registry™ Executive Summary should be reviewed as it becomes available, and should become a standard agenda item during service line meetings.
Successful programs utilize checklists for the ordering physicians that include all necessary elements of CMS’s National Coverage Determination (NCD) for Implantable Automatic Defibrillators (ICDs). Good collaboration with case managers and finance is also necessary to proactively address insurer or payment issues that may arise. Preauthorization and documentation requirements for procedures differ by payor, so it is essential to keep open lines of communication with office staff or hospital departments responsible for performing this function.
Finally, it is important to quantify the clinical efficacy of this important service line. For instance, longitudinal tracking of heart failure and atrial fibrillation (AF) patient outcomes should be a focus of the CV service line. Ideally, use of biventricular devices should decrease readmissions for heart failure, and ablations should reduce episodes of care for AF. Tracking 30-day readmissions for procedure patients is also an effective way to identify issues in this complex patient population. Understand, this is not an easy undertaking, and it requires follow-up phone calls with patients as a means to monitor frequency and effectiveness of follow-up care.
According to Dr. Jennifer Cummings from The University of Toledo, “A strong electrophysiology program cannot live in a vacuum. The strongest programs in both academic and private hospitals have been built around integration into the greater cardiovascular service line.” She goes on to say, “One example where this integration can help in improving quality, referral base, and billing is between device clinics and heart failure clinics. Remote checks, discharge medication review, nurse visits, and device optimization together in one visit can reduce readmissions and optimize service line efficiency.”
The success of electrophysiology services in an organization is absolutely a group effort, and requires due diligence by all players to remain solvent. Keeping up-to-date on practice, regulatory, payment, and vendor technology changes will ensure the program thrives.
What are the physician qualifications that an organization planning for EP services should consider?
Unless qualified physicians are in place, an EP program may not exist at all. Implementation and success of an EP program at any organization is built around the availability of a well-qualified EP physician (or physicians). Corazon advocates that programs have this physician resource identified and committed prior to moving forward with other strategic or business planning for the services. The EP physician will be key in not only performing the procedures and the patient follow-up, but also in developing important program aspects from the ground up, when input is most valuable. The EP physician will be most helpful in collaborating with service line leadership to:
- Define procedural order sets
- Assist in educating and training staff members
- Provide oversight to policy and procedure development
- Identify quality metrics for monitoring
- Provide major equipment and supply preferences
- And more…
Unfortunately, however, obtaining the commitment of a board-certified EP specialist is not an easy task, as this specialty is in both short supply and high demand. If an EP specialist is not currently on staff at the facility, recruiting an EP physician leader can prove challenging in terms of time and money. The organization must dedicate the time and resources to recruit this individual so as to have ample time to get them on board early in the program planning process.
For a new program, it is important to have a board-certified electrophysiologist, or at a minimum, a board-eligible electrophysiologist. If the individual is board-eligible, a requirement should be made for successful completion of the board certification within two years of onboarding. Training and qualifications from the American Board of Internal Medicine (ABIM) board certification in the subspecialty of electrophysiology requires that the individual already be board-certified in cardiovascular disease, as well as have completed the formal training requirements before being eligible for the EP certification examination. The training pathway for EP includes:
- Successful completion of a cardiovascular disease fellowship training (including 24 months of clinical training) and a program accredited by the Accreditation Council for Graduate Medical Education (ACGME)
- One (1) year of additional clinical training in clinical cardiac electrophysiology
- For every year after completion of training, a commitment of a minimum of 50% of professional time to cardiac electrophysiology
The requirement for fellowship training through an ACGME-accredited program was instituted in July 1998; therefore, any physician who completed cardiac fellowship training prior to July 1, 1998 must meet some slightly different qualifications in the absence of a dedicated fellowship. Additional certifications in EP are available through the International Board of Heart Rhythm Examiners (IBHRE) as either a Certified Cardiac Device Specialist (CCDS) or Certified Electrophysiology Specialist (CEPS).
Organizations providing EP services must also ensure ongoing clinical competence of the procedural physicians. Incorporating volume and outcome thresholds in the credentialing and re-credentialing process is a common way to integrate this into the program. Should a program provide only Level I services (permanent pacemakers and implantable cardioverter defibrillators), attention must be given to the development of standardized credentialing and re-credentialing criteria that apply to all physicians who implant these devices. Historically, some invasive cardiologists, as well as surgeons, have performed these implantations, and we advise that all be held to the same credentialing requirements.
What operational components should be addressed in order to assure a programmatic approach for the EP program?
Given the considerations explained above and understanding the importance of a CV service line leader and qualified EP physician, operational issues are the next component of a solid, high-quality EP program. Regardless of the level of EP services the organization is considering, a solid methodical approach is necessary in making certain all of the following important operational components are addressed:
- Patient’s continuum of care
- Staff education needs
- Recruitment of EP staff with the knowledge base/expertise and related EP credentials
- Capital equipment needs
Corazon recommends this be facilitated through the creation of subcommittees for each area, with their goals clearly defined prior to the implementation of services.
When considering patient flow and the patient’s continuum of care, it is first important to consider what currently occurs for an existing cardiovascular patient, and then applying current flow to new EP services. (Of course, now would also be the time to make necessary improvements in this respect, as applicable!)
Understanding the basic patient flow algorithm is essential as part of the expansion of EP services. So, we recommend considering an individual patient example as a start. The patient is seen by either a primary care physician (PCP) or cardiologist who provides the name of an EP specialist, and from there the patient is on their own. Where to go for any pre-procedural testing, such as lab work or ECG testing, who is responsible for insurance verification and authorization of procedure, and the process to follow on the day of the EP procedure are all ultimately unknown. Ultimately, all of these and many other factors will impact throughput at any point of the continuum.
Secondly, consider whether the necessary talent to begin to offer EP services is in place. Recruitment and retention of clinicians who possess the appropriate skillset and expertise must not be understated. Additionally, many programs are challenged with the following question: whether to share or train current cardiac cath lab staff to provide EP services, or recruit and employ a “dedicated EP” staffing model? These are not easy questions to answer, and there is no one “right” answer or model that works for every program. And, remember, the staffing model will be dependent upon the level of EP services planned. In Corazon’s experience, Level II or Level III providers usually employ the “dedicated” staffing model in many cases because of the complexity of the intended procedures, and because these organizations are often larger or have more tertiary centers. Conversely, many Level I programs will utilize a “cross-trained” approach since the expansion offering includes only device implants.
Once the necessary talent is recruited, guaranteeing their commitment to the program is critical. Ways to accomplish this include educational support or enrichment to pursue IBHRE certification, a clinical ladder, or perhaps even a supervisory or charge role. Retention of this talent is just as important as the recruitment.
The level of EP services offered will directly impact how to address and select capital equipment. Fixed imaging, regardless of the level of EP service, is essential and important to the EP specialists performing the procedures. Often, and again, depending upon the level of EP services offered, a bi-plane unit may be required for the more complex ablations and/or hybrid procedures that may be facilitated through the collaboration of the EP specialist and cardiothoracic surgeon. It is vital to engage the EP specialist during this selection process because, after all, they are the end user. Likewise, other capital equipment decisions will require their support, especially for selection of the recording system, radiofrequency generator, program stimulator, and intracardiac echocardiography (ICE) probe, just to name a few.
There are additional key operational areas of consideration, such as program marketing, patient education, information technology, and any additional documentation needs necessary to implement a solid, high-quality EP program. Moving forward with an expansion will require attention to these areas as well, as they all impact the overall operations of the program, the patient experience, and ultimately, the bottom line.
What financial considerations need to be addressed and what actions need to take place when planning implementation of an EP program?
Assessing the financial impact of an EP expansion is a fundamental aspect in preparing for a successful program. Not only does expanding a CV program to include EP service offerings allow for the opportunity to fulfill a community need, this strategy can also potentially deliver financial gains to the hospital. Successful implementation of an EP program requires a number of critical steps and careful analyses prior to initiating the service, including the development and approval of a detailed financial pro forma depicting the feasibility and monetary appropriateness of building such a program.
Corazon advises hospitals to gather key players into an EP Program Financial Committee at the onset of the program planning process, in collaboration with the other implementation committees (i.e., operations, quality, CVIS, etc.). The financial committee should be comprised of representatives from patient access, billing, coding, medical records, implementation project leaders, and the CFO of the organization. The primary function of this committee is to ensure that the framework is in place for financial success of the program.
Once hospital leadership approves the program, service line leaders, with assistance from the financial committee, can use the feasibility pro forma as a starting point for EP program and departmental budget development. The budget development process should also include a review of the organization’s current costing systems and enactment of a plan to incorporate the needs of the CV service line, because critical to the success of the CV service line is the ability to accurately track costs. Further, controlling device costs is imperative for EP program profitability, since these comprise the largest portion of total EP procedure costs. Initial and ongoing vendor negotiations, along with choosing the right mix of device types and appropriate inventory management are central to taking advantage of cost savings opportunities. There are also substantial variations in payor reimbursement. Thus, Corazon encourages organizations to determine estimated program costs and potential reimbursement before entering into individual payor negotiations for new procedures and/or renegotiation of existing procedures.
Organizations implementing an EP program should plan for significant start-up investment costs, mainly for facility renovations and equipment procurement. Some programs have quoted an initial investment in the range of $2.5–3.5 million. However, initially investing too much too quickly in constructing the infrastructure of an EP lab can yield low (or no!) profitability in the short run, and can even put the entire CV program into debt. If this occurs, focus should be placed on increasing volumes of the more profitable EP procedures, such as device implants and radiofrequency ablations.
It is also possible that initial acquisition of some EP program equipment can be delayed for a period of time while the EP program “borrows” equipment already owned and used in the cath lab. This technique can prove beneficial if the EP program also uses the cath lab staff who is already familiar with the maintenance and operation of the transferred equipment. Purchasing EP-specific equipment from a single vendor is also a viable strategy to reduce costs and perhaps achieve price discounts.
Favorable EP program profitability is contingent upon strong and increasing volumes and steady referrals. Sometimes the on-boarded EP specialist brings enough clout and a strong enough referral base that only maintaining and improving the volume is necessary. More often, however, programs will need to develop and solidify referral relationships through a clear and detailed outreach effort. Corazon strongly recommends developing solid relationships with local cardiologists and primary care physicians to build a referral base. Offering educational outreach sessions for these clinicians is another way to create strong ties to the hospital and new EP service.
The Overall Importance of Quality
What are the major considerations for a new EP program in regards to quality oversight and regulatory compliance?
Program quality should be the cornerstone of any clinical service. While sometimes understated when discussing program planning and implementation, quality must be, and remain, the crux of any hospital program. A CV service line leader must give strong attention to the following considerations, and never lose sight that this, indeed, may be the most critical element of EP services.
With any new program, having a process in place to monitor outcomes from not only an operational and budgetary perspective, but most importantly, from a clinical outcomes perspective, is key. Implementing EP services requires the development of a quality dashboard with well-defined metrics and targets for monitoring. Proactive planning for quality assurance should include data submission to the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR)® for ICDs. ICD Registry™ submission will act as a repository for collected data, and will provide data reports that allow for benchmarking with not only similar size/volume organizations, but with national benchmarks as well. Quality metrics for EP programs should include case volume by type and physician, costs per case, device type and use, clinical outcomes, and complications (such as infections, hematomas, etc.), to name just a few.
Implantation of ICDs and CRT devices has recently been under much scrutiny due to published reports of high incidences of inappropriate use. This has prompted several actions of a regulatory nature, including the August 2012 U.S. Department of Justice investigation of device use and the development of a model for hospital self-reporting and claims resolution of potential inappropriate implants. CMS has also made these devices a focus of Recovery Audit Contractors (RAC). For those reasons alone, a new program must provide meticulous program oversight.
Increasingly, diagnostic and procedural areas within cardiovascular services are subject to Appropriate Use Criteria (AUC) as a means to validate their use in patient care. With the regulatory compliance concerns regarding ICD and CRT implants, it is not surprising that AUC criteria specific to CRT and ICDs was recently released (in February 2013). Organizations that perform these procedures must be prepared to address these criteria in their documentation and reporting, which will be no small feat as the criteria include 369 clinical scenarios covering six domains, including:
- ICD implantation for secondary prevention
- ICD implantation for primary prevention
- CRT device implantation
- Generator replacement
- Dual vs. single-chamber ICDs
The criteria score the procedure as either “appropriate,” “may be appropriate,” or “rarely appropriate.” If the organization has cases performed that fall into the “may be appropriate” or the “rarely appropriate” categories, they must be prepared to justify performing the implantation with supportive documentation. The previously mentioned ACC-NCDR® CathPCI Registry™ currently provides feedback for participating organizations on the appropriateness of cath and PCI cases performed. It is natural to suspect that with the release of the ICD/CRT Appropriate Use Criteria, their ICD Registry™ will soon follow suit, providing this valuable information for organizations to use in program oversight.
When considering AUC, Dr. Kinder asserts, “It is imperative for the EP physician leader to help educate the staff regarding the difference between medically appropriate versus reimbursable…There may be situations where the AUC deems the implant appropriate, but the case will not be reimbursed according to the 2005 CMS NCD for ICDs, and therefore must not be billed to CMS.” This is just one example showcasing the complexity and clinical/financial nuances that exist when considering AUC and quality overall. A strong and dedicated Quality Oversight Committee is one way to assure a solid and methodical approach has been taken, especially as increased scrutiny regarding AUC continues to impact any program offering device implants.
While the development of an EP program involves many people and necessitates a great deal of effort and investment, the rewards can be substantial — clinically for the patients in the community and financially for the hospital. Ensuring EP program implementation success requires partnership with dedicated EP staff and physicians, stable operational structures and processes, intense focus on quality outcomes and patient safety, regular community and physician outreach, smart payor negotiations based on research, and solid relationships with vendors. These are just some of the many areas requiring focus when considering the addition of EP services, in any capacity. If your team can successfully deploy each of these critical steps, the EP implementation at your organization won’t miss a beat!
Corazon, Inc. is a national leader in strategic program development for the heart, vascular, neuro, and orthopedics specialties, offering consulting, recruitment, interim management, and physician practice & alignment services to clients across the country and in Canada. To learn more, visit www.corazoninc.com or call 412-364-8200. To reach the authors, email email@example.com, firstname.lastname@example.org, email@example.com, or firstname.lastname@example.org.
Disclosure: The authors have no conflicts of interest to report.
- Global Burden of Disease Study 2010. The Lancet. Published Dec 13, 2012. Available online at http://www.thelancet.com/themed/global-burden-of-disease. Accessed April 11, 2013.