(Total Views: 753)
Posted On: 09/01/2020 9:41:10 AM
Post# of 8473
credit to Hawk05 on Ihub - post #234351 - ref: CMS
It scares me just a little bit to ponder what this could mean. Coverage by Medicaid and Medicare? One of the requirements is for the device to be covered by commercial insurers. How does one go about this? I will presume Dr. Staelin has contacts in the FDA and the insurance industry. The most recent letter to shareholders, including, and especially, not having a safe harbor statement was a 'thing of beauty'. I am desperately hoping that BIEL, via Dr. Staelin, is working on this. Should we become a MCIT-covered device, how far would that go to make us, our technology, the Actipatch, Standard of Care?
https://www.massdevice.com/cms-agrees-to-cove...l-devices/
MCIT-covered devices would also have to fit Medicare statutory definitions of “Reasonable and Necessary” for treating patients. To that end, the proposed rule would refine the definitions of “reasonable and necessary.” Among the requirements, devices would need to be considered:
• Safe and effective.
(good to go; head to toe)
• Not experimental or investigational.
(FDA cleared for full body treatment)
• Appropriate for Medicare patients, including the duration and
frequency that is considered appropriate and whether it is
covered by commercial insurers.
It scares me just a little bit to ponder what this could mean. Coverage by Medicaid and Medicare? One of the requirements is for the device to be covered by commercial insurers. How does one go about this? I will presume Dr. Staelin has contacts in the FDA and the insurance industry. The most recent letter to shareholders, including, and especially, not having a safe harbor statement was a 'thing of beauty'. I am desperately hoping that BIEL, via Dr. Staelin, is working on this. Should we become a MCIT-covered device, how far would that go to make us, our technology, the Actipatch, Standard of Care?
https://www.massdevice.com/cms-agrees-to-cove...l-devices/
MCIT-covered devices would also have to fit Medicare statutory definitions of “Reasonable and Necessary” for treating patients. To that end, the proposed rule would refine the definitions of “reasonable and necessary.” Among the requirements, devices would need to be considered:
• Safe and effective.
(good to go; head to toe)
• Not experimental or investigational.
(FDA cleared for full body treatment)
• Appropriate for Medicare patients, including the duration and
frequency that is considered appropriate and whether it is
covered by commercial insurers.
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