'Pathways Picks' June 26: The News this Week

‘Pathways Picks’ June 26: The News this Week

By David Filmore, Executive Editor, MedTech Strategist Market Pathways

Welcome to the June 26 edition of ‘Pathways Picks’, our MTS Market Pathways’ weekly roundup of the most important global medtech regulatory, reimbursement, and policy news.

Top Pick

Source: Edwards Lifesciences; TAVR procedure with Edwards  Sapien 3  valve

Source: Edwards Lifesciences; TAVR procedure with Edwards Sapien 3 valve

CMS eyes TAVR outcome metrics. Up to 200 more hospitals may be able to start new transcatheter aortic valve replacement programs under a June 21-finalized national Medicare coverage policy update that reduces the procedure-volume threshold to qualify for TAVR coverage. But of even more potential significance is the Centers for Medicare and Medicaid Services’ suggestion that it is considering implementing outcome measures to replace volume requirements. “CMS may reconsider this NCD [National Coverage Determination] to review replacing procedural volume criteria with an outcome metric, however it is too premature to predict any timing around a future reconsideration,” the agency writes. To help address the issue, CMS is adding a new question to be included in the TVT Registry that is linked to the coverage policy; it will explore “the relationship between procedure-related factors and patient health outcomes.” In parallel, the coverage policy update notes that the CMS Innovation Center is exploring application of a composite outcome measure to support a bundled payment program for TAVR.

More from Medicare


MedPAC pans breakthrough proposal. CMS’ proposal to temporarily waive the “substantial clinical improvement” requirement for FDA-designated Breakthrough Devices to receive a new-technology add-on payment (NTAP) for hospital inpatient procedures is misguided, writes the Medicare Payment Advisory Commission, an independent agency tasked to advise Congress. MedPAC was responding to CMS’ FY 2020 hospital inpatient payment system proposal from April, which included a plan to give devices that gain approval through FDA’s Breakthrough program a more automatic path to elevated payment while more data is collected. But, MedPAC argues, “the Medicare program, not the FDA, should adjudicate spending determinations based on the specific needs of the Medicare population.” MedPAC, meanwhile, doesn’t have a problem with the agency’s plan to increase the maximum dollar amount of NTAPs. A final inpatient rule is expected in August to take effect October 1.

MITA advocates. On June 20-21, the US Department of Health and Human Services held a hearing in Washington, DC on accelerating clinical innovation. It included testimony from the Medical Imaging & Technology Alliance in support of a streamlined provisional coverage pathway for new technology that would require data collection to support long-term coverage. CMS has signaled plans to issue such a proposal, potentially sometime next month.


Source: Boston Scientific; Eluvia™ Drug-Eluting Vascular Stent System

Source: Boston Scientific; Eluvia™ Drug-Eluting Vascular Stent System

Paclitaxel puzzlement. Members of an FDA advisory panel agreed that a statistical signal of elevated late mortality in peripheral artery disease patients treated with paclitaxel-coated devices exists, but what it means clinically and what to do about it remained unclear after two days of deliberations by the Circulatory System Devices Panel last week in Maryland. The signal comes from a meta-analysis of manufacturers’ randomized, pivotal trials, but panelists were flummoxed by the massive amounts of missing data from the trials, divergent outcomes from large observational studies, and no clear biological mechanism to explain the data. What's clear is more data collection requirements are coming, but whether that will involve a continuation of pivotal studies, registry requirements, new randomized trials, or some combination, remains to be seen. Also, look out for new label warnings. Companies want FDA to soften a March 15 safety warning that has significantly curbed use of the devices based on updated data presented at the meeting, but the agency gave no signals of its next moves.

Safety data dump. FDA posted 20 years’ worth of (mostly) previously unpublished adverse event reports June 21 in conjunction with formally ending of the Alternative Summary Reporting (ASR) program. The ASR program had allowed companies to submit qualifying adverse events, which were deemed linked to well-known risks, in quarterly summaries rather than as individual reports. Until 2017, the summary report data did not make it into FDA’s public MAUDE database. ASR data from 1999 to 2019 is now online in the form of 21 compressed zip files, though not searchable in MAUDE. Meanwhile, the  Voluntary Malfunction Summary Reporting Program launched in 2018 to allow summary reports for certain device malfunctions, but those reports will go to the public database and will not included deaths or serious injuries, FDA says. FDA also says it will make the MAUDE database more user friendly in the next few years.

Prostate ablation guidance. FDA posted a draft guidance document June 25 to map out clinical expectations to support 510(k) clearance for high intensity ultrasound devices and new technologies to ablate prostate tissue. Public comments are due Aug. 26. Look out for a feature on regulatory and reimbursement dynamics for HIFU device firm EDAP TMS in the July issue of MTS Market Pathways.

European Updates

Upcoming EU MDR nominations. The European Commission says it is getting ready to start the nomination process for the clinical specialty-specific “expert panels” required for the oncoming Medical Device and IVD Regulations. Expert panels will be tasked with conducting extra assessments for certain high-risk devices that will need an additional sign-off beyond the standard notified body process to enter the market under the new regulations.


Notified body retreat continues. The Swiss-based QS Zurich AG is the latest organization to fold its cards in the face of the new EU Regulations. The group is closing down its medical device department and is not going to pursue designation under the EU MDR, according to reports. The organization, which is designated as a notified body under the current Medical Device Directive, told the Regulatory Affairs Professional Society’s Regulatory Focus that costs were too high to continue under the MDR. But it will maintain support for the ISO 13485 medical device quality standard.

Dates To Remember


June 27: Public comments are due on FDA’s draft guidance document updating its processes and standards for device establishment inspections, based on the 2017 FDA Reauthorization Act.


July 10-12: The Medical Devices ASEAN 2019 conference will take place in Bangkok, Thailand.

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Further Reading in MedTech Strategist Market Pathways:

  • “Positive Signs Out of CMS, But Many in Medtech Need to See More,” by David Filmore

  • “EUMDR: Welcome to the New Reality,” by Stephen Levin


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