Recently, there have been several headlines I’ve seen but haven’t had enough comments about them individually for a dedicated Editor’s Letter. Instead, I took a page from my podcast co-host, Mike Drues, who has suggested the need for a rollup 510(k) submission to handle multiple Letters-to-File. This is my variation of that idea—a headlines comments rollup. 

In September, Congress moved forward with actions necessary to pass coverage legislation for Breakthrough Devices. A discussion draft was released by the U.S. House Energy and Commerce Health Subcommittee, which endorsed the need for such funding. According to the draft, the policy would cover those devices that received the designation for four years to help support them while they await a CMS decision on reimbursement. 

In addition, the U.S. House of Representatives Committee on Ways and Means overwhelmingly passed legislation (38-3) to establish Medicare coverage of devices gaining the breakthrough designation. It was noted by AdvaMed, however, that this version did not include diagnostic technologies as part of the coverage and the organization urged for it to be included. 

I’ve written several updates over the last few years on where funding for breakthrough medical device technology stood and the changes taking place. This is yet another round, so forgive me if I’m less than enthusiastic about its potential passage. I certainly want it to be put into place, but the back and forth has created significant uncertainty. This policy seems to have support from both sides of the aisle, so I’m not sure what’s taking so long. Politicians love to campaign about how citizens of this country should have access to the very best medical innovations, yet too many drag their feet when it comes time to pay for it. It’s frustrating for industry, patients, and medical professionals. Congress, get it done.

Meanwhile, Abbott will be a co-star in an upcoming Hallmark Channel movie. Several of its innovations will gain some screen time, at least. In the movie “The More the Merrier,” five children and teens from Abbott’s HeartMates community have cameos. HeartMates is an Abbott-founded community developed to help those impacted by cardiovascular conditions to gain access to support from others who have or are currently going through the experience. Given the viewing habits of my wife and mother-in-law, I’d likely have seen the movie anyway, but now I consider it a work-related assignment. 

While the involvement of Abbott makes this movie a somewhat unique circumstance, it drew my attention for another reason. The current administration has made it clear it is not in favor of pharma’s direct-to-consumer (DTC) ads involving its prescription products. While medtech doesn’t follow suit to the same degree as its sister industry, there are still segments that use DTC ads. Would legislation eliminate those as well? This all remains to be seen, but in the meantime, this movie poses an interesting alternative. Would such arrangements circumnavigate legislation that bans DTC pharma/medtech advertisements? Could they represent an alternate route to speak with patients directly?  

Finally, earlier this summer, Health and Human Services Secretary Robert F. Kennedy Jr. mentioned a campaign to promote the adoption of wearables to help people track their health and take more control of it. On its own, this isn’t a bad idea at all. Information, when it comes to one’s health, is generally a good thing.  

As we’ve learned over time (it’s not like wearables are a new invention), there are challenges. For one, people stop using them. While initial adoption rates could potentially be positive, the eventual drop-off rate over time would likely be substantial. In addition, just because you’re able to show a person what their heart rate is, or tell them how many steps they’ve taken on a given day, doesn’t necessarily mean they are going to use that information as motivation to get off the couch. If engaging in physical activity is one goal, work needs to be done on the motivating factor aspect that’s missing from most wearable technologies. Data and cybersecurity is another challenge. The more data collected, the more attractive such devices are to nefarious parties. 

There is still another challenge involving this campaign. The fact that “one side” is making this suggestion means there’s a significant portion of the population that will avoid wearables at any cost. Regardless of what evidence could potentially be shown to them regarding the benefits of such a device, they will refuse to use it out of hand simply because it was suggested by “that side.” This current reality was confirmed by MDMA’s Brendan Benner during his session at this year’s MPO Summit (sessions available on demand later this year; watch for ads). 

What headlines have you seen that stir something in you? As always, I’d love to hear about them from you.

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com