Pathways’ Pick of the Week: CMS Unswayed by Medtech Opioid Arguments


In this week’s top news pick from MedTech Strategist Market Pathways: CMS wrestled with the opioid abuse epidemic in its latest round of annual payment rules, but device firms’ efforts to better position spine devices, infusion pumps, and neurostimulators as alternatives to opioids for treating pain were largely unsuccessful.

[For a complete roundup of medtech policy happenings that should be on your radar this week and deeper analysis of the sector, check out Market Pathways.]

Evidence suggesting effectiveness as an opioid alternative didn’t carry weight with CMS for several medtech payment policies handed down by the agency in its final 2020 hospital outpatient payment regulation. And there were serious consequences for one particular technology—interspinous/interlaminar spine stabilization devices.

The device class, consisting of Boston Scientific’s Superion interspinous spacer and RTI Surgical’s coflex interlaminar stabilization device, was hit with a 22% pay cut in the 2020 Medicare hospital Outpatient Prospective Payment System proposed rule this summer, and CMS retained the large cut in the regulation finalized November 1. The agency stuck to its guns despite arguments from industry that the payment assignment was based on inaccurate charge data submitted by one large hospital that swayed the calculations. In multiple sets of comments and face-to-face meetings, industry made a big push to not only to underscore the inaccurate hospital data, but also to make the case that the spine stabilization devices can have a big impact on reducing opioid use in individuals with back pain.

In a last-ditch effort, Boston Scientific met with Trump administration officials on October 30 to spotlight a 2018 study finding that 85% of opioid users in the Superion IDE trial ceased use of the drugs after five years. But the effort didn’t have the desired impact. “It is generally not our policy to judge the accuracy of hospital coding and charging for purposes of rate setting,” the agency wrote in the final outpatient rule.

More broadly, companies and industry groups had lobbied the agency to provide distinct outpatient payments for certain device treatments, including continuous peripheral nerve blocks with infusion pumps and spinal cord stimulation, rather than continuing to include them in surgical supply payment “packages,” where one overall payment is provided to cover a procedure and all needed tools. Medtech firms argued that the packaging policies serve as a barrier to healthcare providers choosing pain management treatments based on effectiveness without being “unduly influenced by the costs of the available options,” as AdvaMed wrote.

But CMS was not convinced. “We have not found compelling evidence for other non-opioid pain management alternatives described above to warrant separate payment,” the agency concluded. It did, however, leave an opening and signaled that the conversation was not over. “We appreciate the various, insightful comments we received from stakeholders regarding barriers that may inhibit access to non-opioid alternatives for pain treatment and management in order to more effectively address the opioid epidemic. We plan to take these comments and suggestions into consideration for future rulemaking,” CMS noted.

Art courtesy Daniel Max/Flickr

Regulatory & Reimbursement

Pathways’ Picks February 19: Coronavirus Cancellations, EU Digital, NICE on Neurostim

The International Medical Device Regulators Forum cancelled its March meetings in Singapore due to the novel coronavirus, Europe issued a digital plan, and the UK’s closely watched health technology assessment body showed support for a neuromodulation therapy for overactive bladder. That and more in this week’s Pathways’ Picks, Market Pathways’ weekly roundup of the most important global medtech regulatory, reimbursement, and policy news.

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