Hearing will be next Tuesday
A hearing on the bill is slated to occur seven days from filing — on May 2, 2017 at the House Energy and Commerce Committee, 2123 Rayburn House Office Building, Washington, D.C. That the hearing on such important and far reaching legislation would be scheduled within a week seems quite remarkable, as it had not been previously introduced in a prior legislative session.

Is this a possible amendment to MDUFA IV?
One congressional observer noted that it was likely the intention of the bill sponsors to add the servicer legislation to the Medical Device User Fee Amendments of 2017 (MDUFA IV). While at first blush this new bill seems unrelated to MDUFA IV, the user fee system requires medical device companies to pay fees to the FDA when they register their establishments and list their devices with the FDA.

If the servicer legislation is included in MDUFA IV, it would seem that ISOs might also be assessed fees, as the legislation (by its terms) requires all independent servicers both to register with the FDA and pay the associated fees and expenses of registration and the compliance management system imposed by FDA.

The FDA's recent examination of third-party service
On Tuesday, I called Peter Weems, MITA’s Policy Director, to inquire about the "Medical Device Servicing Safety and Accountability Act." While readily acknowledging that MITA was the catalyst for the Servicer Legislation, he declined to discuss further details and advised that MITA had a legislative director with whom he might check. Later Mr. Weems sent me a copy of the actual bill.

In October 2016, I met Mr. Weems when we both appeared at a two-day FDA workshop in Silver Spring, Maryland, to consider the possibility of further FDA regulation of servicers. Over 500 people attended in person and many more attended via web access. Over 40 speakers presented and 20 additional attendees voiced their opinions.


Mr. Weems, on behalf of MITA, showed pictures of rusty equipment attributed to nameless independents, and advocated for further regulation of independents. On behalf of IAMERS, I suggested that regulation by anecdote was not appropriate and advocated that further regulation of servicers could hamper competition and increase health care costs – a concern to all, but particularly a concern to rural hospitals.

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