The US Government Accountability Office (GAO) published a report, “CMS Should Evaluate Providing Coverage for Disposable Medical Devices That Could Substitute for Durable Medical Equipment” at http://medgroup.biz/CMS-disp

GAO identified eight potential substitutes for covered durable medical equipment (DME) including infusion pumps, blood glucose monitors, sleep apnea devices, and nebulizers.

Health and Human Services (HHS) gave them a chicken-and-egg response.

“As only Congress has the authority to create new benefit categories and payment systems for these items… it is premature for HHS to conduct a formal study on all possible devices that could potential substitute for DME.”

My interpretation: What’s the point of the study if Congress hasn’t created new categories yet?

To which GAO replied (my words): Because Congress won’t act unless you present the case for it!

With whom do you side, GAO or HHS?

And to our discussion today, are you aware of innovations that go undeveloped because they might not get reimbursed?

What can we, as an industry, do about it?

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COMBINATION PRODUCT DESIGN
If you work in combination product design, you’ll find the ebook “Digital platforms for combination products” worthwhile at http://medgroup.biz/combo

It discusses why you need to digitalize your products, benefits healthcare apps can provide, and hurdles you’re likely to face.

Give it a look at http://medgroup.biz/combo

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TODAY’S WEBINAR
Leveraging Big Data to Mitigate Medical Device Risks at http://medgroup.biz/bigdata. I’ll send a link to slides and the replay to all who register.

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10x AGENDA COMING TOGETHER!
Take a look at http://medicaldeviceevents.com/#schedule and you can apply to speak at http://medgroup.biz/callforspeakers

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. I discovered the Hamilton soundtrack this week and am obsessed with it. Give a listen. http://medgroup.biz/Hamilton

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Hat tip to Kiran C Shetty for bringing the GAO report to my attention.

Julie Omohundro
Principal Consultant at Class Three, LLC
I don’t know about taking sides, but I think this is very true: “Because Congress won’t act unless you present the case for it!”

It seems to me that HHS was a little disingenuous in its reference to “all possible devices,” when the GAO listed only eight. Wouldn’t it be a reasonable compromise to do an initial study involving a limited number of devices, and see if the results warrant studying more?

Rumina Akther
Regional Marketeer at the Institute of Directors
Thanks for sharing on the digital revolution! Although the healthcare industry is still in the early stages of development it’s interesting to see how this trend can be used in combination product design.

Peg Graham
Improving the Caregiving Experience, Chair of the YANA Health Forum
The Durable/Home Medical Equipment sector provides a case study as to what companies/trade associations need to do. See this article from Seth Johnson of Pride Mobility re policy changes needed to provide seat elevation innovation in power wheelchairs as an example:
https://hme-business.com/Articles/2017/08/01/PASH.aspx

Peg Graham
Improving the Caregiving Experience, Chair of the YANA Health Forum
Further to my post about elevated seating, there is also the need to think about the stakeholders involved in the care continuum. Bring family caregiver perspective into your product innovation process – most care will be provided in the home and feedback loops/alerts should keep that in mind. Not ALWAYS clinical and requiring medical intervention. Sometimes, it will be a functional change that requires behavioral/environmental interventions, reducing/eliminating the need for acute care “rescue.”

Robert Weiss, MS
Independent Lymphedema Patient Advocate
It’s even worse than that! For 15 years I have been proposing that the compression bandages and garments used in the medical treatment of lymphedema already meet the coverage criteria for “prosthetic devices” and should not be denied. No new law needed–only the recognition that these items meet the definition of prosthetic devices in the Medicare Benefit Policy Manual CMS Pub. 100-02, Chapter 15, Section 120. No action. I have a revised Formal Request for a National Coverage Analysis in since September 2016 that has not been acted on. See http://www.lymphactivist.org/ncd_request.php for the text of the Request.

Martin Berka
IoT systems: putting it all together
Conflicted. It is hard to argue against having more cost-benefit information, but the GAO does thrive on making reports about everything. As for reimbursement – I am sure there would be more new products for dental, hearing, and vision aides, if Medicare was there to increase the market. The same goes for diseases and treatments of debatable necessity – we could have much more innovation in light therapy.

Agra Medical
Proprietor at Win Medical Services Agra
Thanks for sharing useful and knowledgeable facts