2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.
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The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.
2019 US Regulatory Review: Risk Management, EtO, Quality, Medicare, QSR/ISO 13485 Harmonization Hot-Button Topics For Industry
The US medtech regulatory landscape in 2019 was capped at both ends by news of an ambitious rewrite of risk management standard ISO 14971, which was finalized in December. The international standard – used by most manufacturers that make and distribute medical devices within the United States – instructs device makers on how to best put together a risk management program. Other news of interest to readers last year included a rewrite of the US FDA’s Quality System Regulation (QSR) to harmonize it with ISO 13485, expanded Medicare coverage, troubles with ethylene oxide (EtO) used to sterilize devices – and much more. Here are 2019’s 10 most popular US regulation and policy stories from Medtech Insight.
A bill meant to stop out-of-network "surprise billing" may have stalled but is likely to make a reappearance when Congress reconvenes next year according to lawmakers and experts. Despite support in key Senate and House committees, the bill hit a wall when lawmakers introduced an alternative version in the House Ways and Means Committee late in the legislative session.