Bioelectronics Corp (BIEL)

[GetSeriousOK]

Do you see how that journal article you're citing does NOT satisfy the requirement of demonstrating a reduction in opioid use?

https://onlinelibrary.wiley.com/doi/10.1155/2019/3154194

That journal article doesn't demonstrate ANYTHING about opioid use other than the fact that the survey participants said they used opioids BEFORE using the ActiPatch. That is Table 3.

Then, in the Discussion, they merely say this:

Unsurprisingly, pain reduction was accompanied with functional improvements in sleep quality, physical activity, patient global impressions of life changes, and a reduction in medication use.... This decrease in analgesic medication use over the 6-month period is a significant outcome

Then, in the Conclusion, they state this:

They also decreased consumption of pain medication, including prescription and opioid-based pain medications.

They can only make these all-encompassing statements about analgesics because that's what they asked participants in the follow-up survey. They didn't ask specifically about OPIOID reduction; they asked about ANALGESIC reduction.

I want to see a clinical study that demonstrates a reduction in opioid use. The CMS wants to see proof that the device reduces opioid use; they don't want to see generic assumptions or unsubstantiated claims about a reduction in opioid use from BIEL employees Rawe, Staelin, and Koneru. I gave a specific example of what the CMS wants to see in post #330764 -- perhaps you should read, and respond to, THAT post.

And contact the CMS yourself if you want to talk to the CMS. That's what I did, but I'm not sharing anyone's contact information in a public forum. That would be unprofessional, inconsiderate, and rude.