Interesting, to say the least.. Introduction
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Posted On: 10/17/2022 12:39:20 PM
Interesting, to say the least..
Introduction
Bringing any new medical product or service to market is quite difficult. Bringing a new or emerging healthcare technology to market is that much more complicated, with an end-to-end commercialization process that includes robust research and development, clinical trials, data collection and analysis, the regulatory pathway and reimbursement.
It is predominantly believed that navigating this circuitous and challenging road for innovative medical technologies and receiving FDA approval are the biggest drivers of commercial success. Yet, this is not the case. FDA approval does not guarantee commercial success, primarily because it does not guarantee that payers will cover the technology nor at the desired amount of reimbursement.
Government payers, like Medicare, and commercial payers, like United Healthcare or Aetna, establish their own rules for reimbursement for every given service or technology. The coverage determination has direct bearing on its reimbursement, meaning that the technology must provide both a clear medical benefit and more value (“reasonable and necessary”) vs. the current standard of care.
With both a strategic view and hands-on experience, our blog’s featured guest, Brian Carey, Co-Chair of the Life Sciences Coverage & Payment Group at law firm, Foley Hoag, provides a mini primer on reimbursement, a perspective on what innovators face, and an interesting lens from which to view policies to date.
Brian advises a wide range of life sciences companies and health care providers on federal legal, regulatory and legislative policy matters impacting the commercialization of novel technologies. He brings deep experience with biopharma and medical technology companies on Medicare coverage and payment and FDA approval challenges for innovative technologies.
Mr. Carey also regularly advocates on behalf of technology developers and medical trade associations before the U.S. Congress, U.S. Department of Health and Human Services, and federal agencies.
Getting FDA approval, a base hit.
Getting reimbursement, that’s the ball game. - Renalytix
https://renalytix.com/getting-fda-approval-a-...ball-game/
"The hope: Congress will pass legislation to expedite novel technologies to market. Payers will be ready to pay for them.”
– Mr. Carey
Introduction
Bringing any new medical product or service to market is quite difficult. Bringing a new or emerging healthcare technology to market is that much more complicated, with an end-to-end commercialization process that includes robust research and development, clinical trials, data collection and analysis, the regulatory pathway and reimbursement.
It is predominantly believed that navigating this circuitous and challenging road for innovative medical technologies and receiving FDA approval are the biggest drivers of commercial success. Yet, this is not the case. FDA approval does not guarantee commercial success, primarily because it does not guarantee that payers will cover the technology nor at the desired amount of reimbursement.
Government payers, like Medicare, and commercial payers, like United Healthcare or Aetna, establish their own rules for reimbursement for every given service or technology. The coverage determination has direct bearing on its reimbursement, meaning that the technology must provide both a clear medical benefit and more value (“reasonable and necessary”) vs. the current standard of care.
With both a strategic view and hands-on experience, our blog’s featured guest, Brian Carey, Co-Chair of the Life Sciences Coverage & Payment Group at law firm, Foley Hoag, provides a mini primer on reimbursement, a perspective on what innovators face, and an interesting lens from which to view policies to date.
Brian advises a wide range of life sciences companies and health care providers on federal legal, regulatory and legislative policy matters impacting the commercialization of novel technologies. He brings deep experience with biopharma and medical technology companies on Medicare coverage and payment and FDA approval challenges for innovative technologies.
Mr. Carey also regularly advocates on behalf of technology developers and medical trade associations before the U.S. Congress, U.S. Department of Health and Human Services, and federal agencies.
Getting FDA approval, a base hit.
Getting reimbursement, that’s the ball game. - Renalytix
https://renalytix.com/getting-fda-approval-a-...ball-game/
"The hope: Congress will pass legislation to expedite novel technologies to market. Payers will be ready to pay for them.”
– Mr. Carey
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