By Jenny Lower
Recently, the Centers for Medicare and Medicaid Services (CMS) considered relaxing its December 2011 directive that specifies the methods and frequency with which hospital equipment must be maintained in order to qualify for reimbursement. While some stakeholders viewed the prospect as a rational adjustment for efficiency, others saw it as an ill-advised compromise of patient safety. Now with its late-breaking December 2013 decision, CMS appears to have struck a middle course: Hospitals may introduce alternative equipment maintenance frequency or methods, but not in the case of imaging equipment. The latter must continue to adhere to manufacturer maintenance recommendations.
Sandy Katanick, CEO of the Intersocietal Accreditation Commission (IAC), expressed relief over the announcement. “It is everything we have been asking for with respect to imaging and radiation therapy preventative maintenance guidelines,” she said. “They should never be allowed to be less frequent than what the manufacturer recommends.”
Anxiety over the pending decision originally stemmed from the sweeping changes such a reform could bring. The original memorandum specified that hospitals must follow the manufacturers’ maintenance guidelines for any equipment CMS deemed “critical to health and safety.” That designation covered, but was not limited to, “life-support devices, key resuscitation devices, critical monitoring devices, equipment used for radiologic imaging, and other devices whose failure may result in serious injury to or death of patients or staff.” A change in regulation could have meant that hospitals would be free to set their own maintenance schedules for imaging equipment.
The response was swift and loud. Industry organizations put the pressure on CMS to maintain its original directive. The American Society of Neuroimaging (ASN), the American College of Radiology (ACR), the American Society of Radiologic Technologists (ASRT), the Society of Diagnostic Medical Sonography (SDMS), the Medical Imaging & Technology Alliance (MITA), and the IAC were among 30 signatories to a November 2013 letter sent to CMS challenging the projected changes. The missive cited poor performance, equipment downtime, and patient harm among the possible dangers resulting from irregular maintenance, and requested that the original December 2011 guidelines be reinstated.
For Katanick, the chief concerns were patient safety and radiation exposure. A former sonographer, she noted that imaging quality deteriorates over time. Without regular maintenance, “you could absolutely miss disease. The patient could be subjected to a succession of additional testing, which adds more cost to the system, or potentially improper treatment based on an incorrect diagnosis.”
Technologists also rely on regular maintenance to recalibrate machines and check dosage levels, particularly for MRI and CT. Improper upkeep could lead to excessive CT radiation dose and harm both the technician and the patient, Katanick said. In one high-profile case reported by the Los Angeles Times in 2009, 206 patients at Cedars-Sinai received eight times the normal radiation dose over an 18-month period after a CT scanner’s settings were reprogrammed.
Regular maintenance can be costly, Katanick acknowledged, and may place a burden on small hospitals, where taking equipment out of commission for servicing equals loss of income. Skeptics are quick to acknowledge the servicing fees some manufacturers earn. But what matters is not who does the maintenance, just that it be done, said Katanick. IAC’s current standards require hospitals seeking accreditation to service nuclear equipment according to manufacturer recommendations, or at least every 6 months. For CT and MRI equipment, an annual check is the minimum requirement.
“Our letter seems to have helped CMS make the right decision regarding the frequency of imaging and radiation therapy equipment preventative maintenance,” said Katanick. “I truly believe that the success we achieved by coming together on this issue will make a difference in the future safety and accuracy of imaging and radiation therapy for all patients.”
