“If this was a pill that you could prescribe to patients at hospital discharge, people would jump on it. But CardioMEMS is not as simple as prescribing a pill. There are a lot of logistical issues that make it very difficult,” said Stony Brook’s Dr. Butler in an interview.
This sentiment was shared not only by other cardiologists but also by St. Jude itself, as a company spokesman itemized several challenges the company encountered once it began trying to sell CardioMEMS commercially. “Developing the market for CardioMEMS will continue to take time,” said the St. Jude staffer during a July webcast on the company’s second-quarter 2015 performance. CardioMEMS’ sales were affected by the need to educate multiple constituencies, satisfy new-technology review committees, address reimbursement, access capital budgets, and create consensus among disparate stakeholders, the webcast said. In addition, the early St. Jude experience selling CardioMEMS showed that once a new customer signs a contract, “we find that customers tend to introduce CardioMEMS ... [on] a pilot basis to gain experience with the technology and the reimbursement process.”
First is the challenge of selling a hospital’s administrative leadership on making an upfront capital investment in CardioMEMS equipment, giving the green light to performing procedures that just about break even relative to reimbursement, and then waiting to recoup the initial expenditure and perhaps make some money in the long term by avoiding readmissions and cutting lengths of stay. According to an analysis run by Dr. Parks of MGH, based on the CHAMPION results, for every 10 patients managed using CardioMEMS for 6 months, a center could expect to prevent nearly 15 patient-days in the hospital.
“Our administration is in support, but skeptical; I think that’s why it’s been slow to start,” said Dr. Parks. “The biggest limitation is the upfront cost of the device, and it’s not clear that the reimbursement will allow you to break even” when putting in devices, she said in an interview. “You could justify this by saying you’ll reduce hospitalizations, but the first impression from our administrators was that we were already doing a pretty good job limiting rehospitalizations so why do we need to add this?” The MGH leadership and clinicians eventually agreed on a plan to start the program with 10 implants and then analyze the results to decide if it makes sense to continue. Dr. Parks said she and her colleagues hope to have their first 10 patients implanted with a CardioMEMS before the end of this year.
Another hurdle at MGH was setting up the infrastructure so that a nurse could monitor patients and set in motion the alerts and treatment changes designed to normalize PAP normalized when it falls out of the target range. “It’s a lot of work to put the system in place to manage the devices,” Dr. Parks noted.
Dr. Butler echoed both these challenges. “You need to convince the hospital administrators and make a case based on the cost savings [later on during ongoing management] rather than positive revenue when you do the procedure. If you can expect future cost savings it’s a viable case to make, but a more difficult case to make,” he said. “You also take on the liability of monitoring patients” long term. “If you can follow several hundred patients there may be enough [follow-up] interventions to pay the salaries of staff ” who monitor the patients, but it is very difficult if you have a nurse who is monitoring five patients,” he said. Another issue complicating the economics is that the physicians who supervise monitoring are mostly not the same ones who performed the CardioMEMS placement procedure and received the procedure’s reimbursement. “These are the system barriers that are out there,” Dr. Butler said.
Dr. Altman in Colorado faced a different challenge. “We had good buy-in from our administration. Everyone is interested in reducing rehospitalizations so the administrators were very supportive. The major roadblock has been insurers. Medicare covers it, but so far Colorado Medicaid and several private insurers do not,” Dr. Altman said in an interview. The inconsistent pattern of insurance coverage has already meant that some heart failure patients in her program who were good clinical candidates for CardioMEMS could not receive the device. “I’ve had at least six or seven good candidates, but only three received the device because of insurance reimbursement issues,” she said.
But Dr. Altman expressed optimism that the coverage situation would improve as more programs start using CarioMEMS and insurers grow more familiar with daily PAP monitoring of heart failure patients. She noted that a new CardioMEMS program will soon start at a second Denver-based medical center, and she expressed confidence that ongoing pressure from physicians and administrators at both institutions will change the mind of officials at Colorado’s Medicaid program to provide reimbursement, and once that happens she expects the private insurers will change their policies as well.