Bioelectronics Corp (BIEL)

[Probity]

‘“The survey only asked follow-up questions about all analgesics grouped together, INCLUDING opioids, not about opioids alone, which means the CMS won't accept it for the NOPAIN Act…The CMS won't accept that. Here is the published journal article for that survey -- this is the "evidence" that BIEL would have to submit to the CMS. There is nothing in this article about opioid reduction. -- nothing about "those taking opioids pain drugs alone."’


Please furnish us with your CMS contact so we can verify that the noted opioid reductions in the study is invalid because it references non-opioid analgesics reductions too.

“An interventional study has to be, by definition, a prospective study since the investigator determines the exposure for each study participant and then follows them to observe outcomes.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6176693/

The prospective study: A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy

What is the intervention? “ActiPatch”

…Ninety-five percent (95%) reported using at least one OTC or prescription analgesic and 43% indicated using at least one opioid or morphine medication…

…Ninety-one percent of the study sample reported being in severe pain prior to using the medical device (baseline), but only 3% continued to be in severe pain after the 7-day PSWT treatment period…

…Evaluating treatment durability is important for any medical intervention, since a vast body of clinical research indicates that many pharmacological treatments show a decline in effectiveness over time…

…The results indicate that pain relief was sustained for 6 months in over 85% of subjects…They also decreased consumption of pain medication, including prescription and opioid-based pain medications.”
https://onlinelibrary.wiley.com/doi/10.1155/2019/3154194

1. Any premise about this Clinical Study not showing (significant and sustained) opioid reduction is incorrect.
2. That this clinical study shows significant and sustained opioid reductions with a BIEL product, and should ANY OTHER Company’s clinical study and product now or in the future (other than the one already accepted) show likewise, that is no guarantee of CMS acceptance for insurance reimbursement. Why?…
3. Meeting the clinical requirements for CMS insurance reimbursement and an actual acceptance by CMS, are two very different processes.
4. There are no slam dunks. Do your own due diligence and assess your resources and risk flexibility. High risk and yet possible high reward here.

The only guarantee is the ever-increasing “efforts” as we inch towards 01 January 2025.

Once again, the fact is that neither you, nor I, nor anyone here, knows where this whole thing goes for BIEL via the NPA/CMS.

All imo