MITA has announced a further Canvass member teleconference to be held on January 12, 2018 to resolve the comments received before MITA circulates and re-ballots the standard.

Activity on Capitol Hill
During a recent visit to Capitol Hill, IAMERS learned that some of the senior staff of the two congressional committees charged with considering health care legislation, the U.S. Senate H.E.L.P. Committee and the U.S. House of Representatives Energy and Commerce Committee had also received the MITA draft standard. It was not clear that the staff had the benefit of also receiving the Canvass Group vote results or the comments associated with the negative votes. It was also not clear in what context this information was disseminated and for what purpose. While Congress will likely be deliberating on the FDA report on servicing, due in May 2017 pursuant to Section 710 of the FDA Reauthorization Act of 2017, P.L. 115-52, (“MDUFA Reauthorization Act”), there is no pending legislation in the U.S. Senate. H.R. 2118 which sought to register and regulate independent servicers, is still before the House Energy and Commerce Committee to be considered.



It is interesting to observe that the NEMA Lobbying Report (which includes some activities of MITA) filed with the Office of the Clerk for the U.S. House of Representatives and Senate, pursuant to the Lobbying Disclosure Act of 1995, disclosed expenses relating to lobbying activities for the 3rd quarter 2017 in the amount of $520,000. Among the activities listed was the MDUFA Reauthorization and H.R. 2118. The report does not specifically disclose what portion of the expenses pertained to lobbying with respect to independent servicing issues.

IAMERS has suggested in its comment responding to the draft MITA standard that it would be most appropriate to disclose to the MITA Canvass Group that they should consider the possibility of the proposed MITA standard not merely being used as a voluntary standard, but that it may well be incorporated as proposed legislation. In 2014, NEMA XR-29 standard on CT equipment relating to dose optimization and management (known as the MITA Smart Dose) was incorporated into PL 113-93.

Of course, all of this begs the question as to whether the resources being expended by MITA and other stakeholders are in fact for a QMS standard or rather for further legislation/regulation. ECRI noted that servicing has been a contributing factor in less than 0.0005% of medical equipment-related adverse events, suggesting that, at least based on history, a QMS standard or regulation would have made little or no significant impact on patient safety.

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