The Department of Justice (DOJ) is conducting an ongoing multi-state, multi-provider investigation into hospitals billing Medicare for implantable cardioverter defibrillators (ICDs) for patients whose conditions did not satisfy the criteria outlined in a CMS National Coverage Determination. The primary area of interest is the timing of ICD procedures as CMS clearly states that it will not reimburse for procedures outside specific time periods. Specifically, Medicare does not cover implantation of ICDs within 40 days of an acute myocardial infarction (AMI) or within three months of a coronary artery bypass graft (CABG). This investigation could present a major challenge to hospitals as data shows many devices are implanted too soon after an AMI or CABG. More specifically, a recent retrospective analysis of the NCDR-ICD registry, which was published in the Journal of American Medical Association (JAMA), suggests that 22.5 percent of ICDs implanted did not meet evidence-based criteria for implantation. The cases deemed ineligible were largely due to timing issues around recent or late-stage heart failure diagnoses.
These findings may seem contrary to the conventional wisdom that ICDs are under-utilized (as demonstrated by several studies). However, both suspected over- and under-use are affected in part by the fact that many patients are treated by physicians who do not specialize in electrophysiology. Supporting this statement, data from the JAMA article showed that the rate of ICD implants for ineligible patients was significantly higher for non-electrophysiologists than electrophysiologists. Limited access to electrophysiologists can also explain under-utilization as medical cardiologists and PCPs may not routinely evaluate heart failure patients for possible ICD implantation. Given the concerns related to implanting devices shortly after a cardiac event and under-utilization of ICDs, hospitals should consider adopting a two-pronged approach to right-size utilization.
First, program leaders may invest in processes to improve adherence to evidence-based guidelines for patients receiving ICDs. Recognizing this imperative, John Hospital, a pseudonym, uses a one-page ICD Medicare Coverage Worksheet to assess appropriateness. The checklist is completed by the treating physician prior to scheduling the procedure. If the checklist indicates an ICD is appropriate, the procedure is scheduled and the completed form is included in the patient chart. In contrast, if the results indicate the procedure is inappropriate and the physician still wants to perform the procedure, the physician is expected to seek a second opinion from an electrophysiologist. If both physicians agree that the device would be beneficial, the procedure is scheduled. Hospital administrators give physicians leeway to perform procedures that deviate from the guidelines as they recognize that guidelines may not be appropriate for all patients. However, in the latter case the hospital does not submit the bill to Medicare. While withholding billing reduces revenues, this approach minimizes billing compliance concerns while providing physicians with the autonomy necessary to provide high quality care.
In addition to preventing inappropriate procedures from being performed, it is equally important to ensure all patients that could benefit from the device are offered the treatment. In hopes of capturing latent demand for electrophysiology procedures (while reducing readmissions), United Hospital and St. Paul's Heart Clinic developed a customized care plan for heart failure patients. During the patient's first appointment a cardiologist and nurse develop a customized 90-day care plan, which is discussed with the patient and faxed to the patient's PCP within 24 hours. At subsequent visits, the patient's progress is monitored, and the appropriateness of additional interventions is evaluated.
To conclude, given the increased scrutiny over appropriateness of ICD implantation, program leaders should hardwire processes to ensure patients meet coverage criteria to avoid compliance concerns. At the same time, hospitals can capture latent demand for appropriate ICD procedures by collaborating with non-hospital providers. For further guidance on ensuring patients receive appropriate tests and procedures, register for the New Economics of Quality, Part 2 webconference on June 23, 2011. (Husten, www.Cardiobrief.org, 02/16; Al-Khatib, Journal of the American Medical Association, 2011;305(1):43-49)