NCD, LCD, MACs, MMA, CMMI, VBC, OBC, BDD, EAP, MCI
Post# of 8387
(Total Views: 236)
Posted On: 10/17/2022 2:39:51 PM
NCD, LCD, MACs, MMA, CMMI, VBC, OBC, BDD, EAP, MCIT, TCET ... blah, blah, blah ... the banality of evil.
From the Conclusion: The lag between FDA Breakthrough Device Designation, FDA marketing authorization or approval, and the coverage of such devices by payers, including Medicare and private insurers, is not a new concern. It is largely driven by the amount of evidence required by a payer to justify a device’s use in a particular population, going beyond what is even required by the FDA in showing “safety and efficacy.”
Coverage delays and inadequate payment are disproportionately felt by new and emerging medical technologies that do not fit within any existing payment schema. Further, in many cases, CMS and private insurers make different decisions regarding coverage, making it difficult for innovators to see a path forward for the commercialization of new technologies.
Q: Is it possible that an innovator can make it through the FDA and then not get reimbursed?
A: Yes, and unfortunately it happens to many technologies. ... often referred to as the ‘Valley of Death.’
what to say, what to do ... I am out of words. How these slimy, gutless, worthless pieces of human detritus have the nerve to show themselves in public is beyond my understanding. To not do what any ordinary human being would do w/out a second thought, that is to relieve a patient's misery of chronic pain, is beyond the pale.
"In a time of universal deceit - telling the truth is a revolutionary act" - George Orwell
later, WB
From the Conclusion: The lag between FDA Breakthrough Device Designation, FDA marketing authorization or approval, and the coverage of such devices by payers, including Medicare and private insurers, is not a new concern. It is largely driven by the amount of evidence required by a payer to justify a device’s use in a particular population, going beyond what is even required by the FDA in showing “safety and efficacy.”
Coverage delays and inadequate payment are disproportionately felt by new and emerging medical technologies that do not fit within any existing payment schema. Further, in many cases, CMS and private insurers make different decisions regarding coverage, making it difficult for innovators to see a path forward for the commercialization of new technologies.
Q: Is it possible that an innovator can make it through the FDA and then not get reimbursed?
A: Yes, and unfortunately it happens to many technologies. ... often referred to as the ‘Valley of Death.’
what to say, what to do ... I am out of words. How these slimy, gutless, worthless pieces of human detritus have the nerve to show themselves in public is beyond my understanding. To not do what any ordinary human being would do w/out a second thought, that is to relieve a patient's misery of chronic pain, is beyond the pale.
"In a time of universal deceit - telling the truth is a revolutionary act" - George Orwell
later, WB
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