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Latest From Sue Darcey
With most of the Nov. 6 election tally completed, it’s clear there will be many new faces for the device industry to engage with in the halls of Congress, but the sector still appears to have a significant group of supporters on Capitol Hill. Also, several medtech-relevant measures were on the ballot.
The clinical laboratory industry praised the US Centers for Medicare and Medicaid Services for making changes in its final Clinical Laboratory Fee Schedule rule to allow more data from hospital outreach labs to be considered in setting laboratory test pay rates. But lab advocates are still pursuing a lawsuit and pushing for legislative reforms.
Medtech firms are accustomed to rooting for House and Senate candidates they have backed in traditionally medtech-facility heavy regions of the US including Minnesota, Indiana and Massachusetts. As the sector grows in new regions, there are a broader set of important races for the industry, including in California, Texas, and New Jersey, this election season.
Remote patient monitoring costs can be reported by home health agencies as allowable Medicare costs starting in 2020 under a new regulation. And, in a separate rule, Medicare has established new reimbursement categories for "virtual" health care.
AdvaMed is asking for three new safe harbors from potential Anti-Kickback Statute (AKS) violations to shelter value-based pricing, warranty, and risk-sharing arrangements formed among hospitals, physicians and device manufacturers.
On this week's podcast, David Filmore talks to Sue Darcey about the US opioids bill enacted this week, including its expansion of "sunshine" payment reporting requirements for device-makers. And Elizabeth Orr discusses some recently launched 510(k)-process pilot programs and questions from industry.