Legislators Push CMS to Drop Idea of Loosening Device Maintenance Standards

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Five Congressional representatives are asking the Centers for Medicare and Medicaid Services (CMS) to not implement a proposed rule change that would allow hospitals to deviate from manufacturer maintenance recommendations for medical imaging equipment.

Currently, hospitals that treat Medicare patients must service medical equipment such as CT and MRI scanners according to the U.S. Food and Drug Administration-approved equipment maintenance standards recommended by the manufacturer. The proposal, which has not been made public, would allow hospitals to deviate from the standards without risking their Medicare reimbursement.

The proposed change is opposed by medical imaging manufacturers. "Lowering patient safety standards by weakening the December 2011 CMS maintenance directive for medical imaging and radiation therapy equipment in hospitals jeopardizes public health. Medical imaging and radiation therapy equipment should be maintained according to the manufacturer’s recommended maintenance standard. Deviation from the manufacturer’s recommended maintenance standard poses unnecessary risk to patient and operator safety, while also compromising equipment performance and image quality," wrote the Medical Imaging & Technology Alliance (MITA) in a statement emailed to ImagingBiz.

Four of the five the U.S. House members who signed the letter to CMS were from Pennsylvania — a state that is home to 576 medical device companies and despite its small size is the fourth leading medical device producing state. They were Representatives Tim Murphy (R-Pa), Mike Kelly (R-Pa), Keith Rothfus (R-Pa) and Allyson Schwartz (D-Pa). The lone non-Pennsylvanian was Rep. Chris Gibson (R-NY).

The proposed loosening of equipment maintenance standards for hospitals is also opposed by the ACR. In May, Harvey L. Neiman, chief executive of the ACR, wrote to the CMS to express his strong support of the current standards.

“It is only reasonable and common sense that the manufacturer of imaging equipment would be the best judge as to the maintenance requirements for such equipment,” he wrote.

In the letter, the lawmakers asked CMS to not implement the change to its medical equipment maintenance rules without first going through the formal rule-making process that gives the public a chance to comment.

According to the Congressional newspaper The Hill, Rep. Murphy said on Friday, “We’re not dealing with an automobile or refrigerator here. The consequences [of loosening the standards] can be pretty deadly.”