WASHINGTON — Almost no one got everything they wanted out of the Monday deal to reopen the government — except perhaps medical device companies, who managed to fend off an industry-wide excise tax before the first payments were due. The stopgap spending deal that was signed by President Trump on Monday included a two-year delay of the 2.3 percent tax, which was originally included in the Affordable Care Act to help pay for the law’s health insurance subsidies.
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Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill.
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George Mills, Director of Engineering for the accrediting organization, The Joint Commission, announced yesterday at the American College of Clinical Engineers (ACCE) meeting a new element of performance expected which essentially requires healthcare organizations to have on hand service manuals and technical bulletins:
EP 3 provides “The organization has a library of information regarding inspection, testing, and maintenance of its equipment and systems. Note: This library includes manuals, procedures provided by manufacturers, technical bulletins and other information.”
In other news, our general counsel Robert Kerwin, also spoke to the ACCE on the amendment to the MDUFA IV legislation passed this week by the House Energy and Commerce Committee which requires the FDA, if enacted, to provide a report to Congress on its assessment of the need for further legislation/regulation of servicing by any person other than manufacturers. Mr Kerwin had previously testified before the Subcommittee on Health in opposition to Servicing Legislation and welcomed the House Committee’s compromise decision to await the FDA report. “Independent services are essential to the healthcare ecosystem and if it’s truly about patient safety, why should some manufacturers withhold manuals all the while claiming further regulation is necessary to address uneven levels of servicer performance.”