Mt. Vesuvius, Inc.
Two things can be gleaned from the most recent lightning strike revealed by Srinsocal/Swordfish indicating we have a GUDID listing for a 5-pack and a 100-pack Actipatch product. The first is BIEL either has a signed contract with a large organisation demanding product in quantity (consistent and on time) or is very close to it. Who else would want a 100 pack ???
The other is the company has resolved the manufacturing issue of not providing stock in a timely manner as alluded to by CoB Staelin. Both of these items signal that we have turned the corner and we are, in the words of CEO K Whelan, a key player. Either that or the company waded thru all the bureaucratic muck & mire for shats & giggles; not likely.
The obvious choices for this partnership is CMS, VA, or a GPO (Gen'l Purch'g Org.; for hospitals, clinics, & surgical centers). There is also a possibility of a sports league or organisation. Whichever it is, we are talking serious volume generating serious revenue. When the announcement takes place is anybody's guess. Should this pr reveal coincide w/ private insurance reimbursement, all bets are off on the share price.
The wheels of change turn slowly within large bureaucratic organisations, public or private - basically the same. Below are some links to educate. As you will see, the FDA required UDIs on class II devices on 24 Sep '18. Whether or not there is a UDI box redesigned into the insurance claims forms (eg - CMS 1500 universal claim form) is altogether a different question.
Personally, I am hoping we have an agreement with both CMS and the VA, in the least. Both have been the target of vicious criticism, oftentimes justified. Medicare/aid are constantly in the line of fire for cost overruns and inefficiency. The VA dispenses opioids like its a kids quarter-slot candy machine. The veterans, badly in need of pain relief that doesn't dictate a life of drug dependcy, have so far been treated shabbily, to say the least. For both agencies, Actipatch would be a godsend.
https://www.healthcaremedicalpharmaceuticaldi.../GPOs.html (profile of the GPO market sector)
A case can be made (no argument from me!) for GPOs (hospitals, clinics, surgical centers, retirement communities), as well, with equal facility. We (BIEL) did make a big fuss over getting those sales reps up and running asap so maybe this GUDID listing is the first glimpse of their success. A contract with one of the large GPO would send shockwaves thru-out the industry. More would definitely follow.
https://findanyanswer.com/who-are-the-largest...anizations
Two of them are Premier w/ over 350,000 beds and Dept of Veteran Affairs w/ about 40,000 beds. A contract w/ either would be substantial.
https://www.fda.gov/medical-devices/unique-de...quirements
Class II Medical Devices // Compliance Dates // Requirements
September 24, 2018
A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
September 24, 2016
The labels and packages of class II medical devices must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
https://www.medicaldesignandoutsourcing.com/b...ims-forms/
Implementing UDIs in claims forms (as of 02 Feb 17)
Implementing UDIs in claims forms will not be a simple task. Issues will include figuring out how to capture or document UDI at the point of care. “This is critical to ensure that UDI can then be used in various applications. For example, documenting UDI in the EHR (electronic health record) will then enable UDI to be used in downstream application such as in claims or registries.”
Starting in 2018, the EHR certification criteria will include a field for the UDIs of implanted medical devices, so EHRs will have the capability to capture UDI data before the next version of the claim documents are implemented. Moscovitch says hospitals are also starting to use UDI information for supply-chain purposes.
https://csph.brighamandwomens.org/wp-content/...r-2017.pdf
Transmitting the UDI from the Point of Use to Insurance Claims: Changes in Workflows and Information Systems May 2017
from the Conclusion: "The FDA has mandated the use of UDIs by device manufacturers, but to take advantage of their substantial benefits, including the ability to perform surveillance and assure patient safety, most experts believe UDIs must be incorporated into insurance claims. The purpose of the UDI2Claims project is to demonstrate the feasibility of doing that."
" ... We are confident that the processes we have described above for capturing the DIs of implanted devices into the patient's EHR, and ultimately transmitting them to the insurance
claim and ultimately to the payer, will work."
" ... based on our experience to-date ... it should be relatively easy for all providers to transmit DIs to payers."
So, there you have it. Lots of info to digest. And let's not forget about the Olympics. KT Tape is going all-out in it's promotion of Recovery+ Wave; maybe a tv commercial? Q2 sales and revenue #'s will be forthcoming (a pre-announcement?, pretty please?) in mid-July, coinciding w/ the Olympics. Maybe the SAI coming out party? If/when the dust settles, we get insurance coverage as a bonus, the company is profitable and humming along nicely, is a buyout so farfetched?
Think outside the box - WBeacham
Two things can be gleaned from the most recent lightning strike revealed by Srinsocal/Swordfish indicating we have a GUDID listing for a 5-pack and a 100-pack Actipatch product. The first is BIEL either has a signed contract with a large organisation demanding product in quantity (consistent and on time) or is very close to it. Who else would want a 100 pack ???
The other is the company has resolved the manufacturing issue of not providing stock in a timely manner as alluded to by CoB Staelin. Both of these items signal that we have turned the corner and we are, in the words of CEO K Whelan, a key player. Either that or the company waded thru all the bureaucratic muck & mire for shats & giggles; not likely.
The obvious choices for this partnership is CMS, VA, or a GPO (Gen'l Purch'g Org.; for hospitals, clinics, & surgical centers). There is also a possibility of a sports league or organisation. Whichever it is, we are talking serious volume generating serious revenue. When the announcement takes place is anybody's guess. Should this pr reveal coincide w/ private insurance reimbursement, all bets are off on the share price.
The wheels of change turn slowly within large bureaucratic organisations, public or private - basically the same. Below are some links to educate. As you will see, the FDA required UDIs on class II devices on 24 Sep '18. Whether or not there is a UDI box redesigned into the insurance claims forms (eg - CMS 1500 universal claim form) is altogether a different question.
Personally, I am hoping we have an agreement with both CMS and the VA, in the least. Both have been the target of vicious criticism, oftentimes justified. Medicare/aid are constantly in the line of fire for cost overruns and inefficiency. The VA dispenses opioids like its a kids quarter-slot candy machine. The veterans, badly in need of pain relief that doesn't dictate a life of drug dependcy, have so far been treated shabbily, to say the least. For both agencies, Actipatch would be a godsend.
https://www.healthcaremedicalpharmaceuticaldi.../GPOs.html (profile of the GPO market sector)
A case can be made (no argument from me!) for GPOs (hospitals, clinics, surgical centers, retirement communities), as well, with equal facility. We (BIEL) did make a big fuss over getting those sales reps up and running asap so maybe this GUDID listing is the first glimpse of their success. A contract with one of the large GPO would send shockwaves thru-out the industry. More would definitely follow.
https://findanyanswer.com/who-are-the-largest...anizations
Two of them are Premier w/ over 350,000 beds and Dept of Veteran Affairs w/ about 40,000 beds. A contract w/ either would be substantial.
https://www.fda.gov/medical-devices/unique-de...quirements
Class II Medical Devices // Compliance Dates // Requirements
September 24, 2018
A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
September 24, 2016
The labels and packages of class II medical devices must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
https://www.medicaldesignandoutsourcing.com/b...ims-forms/
Implementing UDIs in claims forms (as of 02 Feb 17)
Implementing UDIs in claims forms will not be a simple task. Issues will include figuring out how to capture or document UDI at the point of care. “This is critical to ensure that UDI can then be used in various applications. For example, documenting UDI in the EHR (electronic health record) will then enable UDI to be used in downstream application such as in claims or registries.”
Starting in 2018, the EHR certification criteria will include a field for the UDIs of implanted medical devices, so EHRs will have the capability to capture UDI data before the next version of the claim documents are implemented. Moscovitch says hospitals are also starting to use UDI information for supply-chain purposes.
https://csph.brighamandwomens.org/wp-content/...r-2017.pdf
Transmitting the UDI from the Point of Use to Insurance Claims: Changes in Workflows and Information Systems May 2017
from the Conclusion: "The FDA has mandated the use of UDIs by device manufacturers, but to take advantage of their substantial benefits, including the ability to perform surveillance and assure patient safety, most experts believe UDIs must be incorporated into insurance claims. The purpose of the UDI2Claims project is to demonstrate the feasibility of doing that."
" ... We are confident that the processes we have described above for capturing the DIs of implanted devices into the patient's EHR, and ultimately transmitting them to the insurance
claim and ultimately to the payer, will work."
" ... based on our experience to-date ... it should be relatively easy for all providers to transmit DIs to payers."
So, there you have it. Lots of info to digest. And let's not forget about the Olympics. KT Tape is going all-out in it's promotion of Recovery+ Wave; maybe a tv commercial? Q2 sales and revenue #'s will be forthcoming (a pre-announcement?, pretty please?) in mid-July, coinciding w/ the Olympics. Maybe the SAI coming out party? If/when the dust settles, we get insurance coverage as a bonus, the company is profitable and humming along nicely, is a buyout so farfetched?
Think outside the box - WBeacham
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