Tag Archives: reimbursement

Reimbursement Report

What Manufacturers Should Know About Reimbursement and Case Management Hotlines for Providers

By Kristofer C. Munroe
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While support services are important, manufacturers must be aware of both state and Federal regulations, as there can be conflicts and differences in interpretations.

While support services are important, manufacturers must be aware of both state and Federal regulations, as there can be conflicts and differences in interpretations.

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Reimbursement Report

Living with a Legacy – Reimbursement Barriers Based on Technologies that Came Before

By Elizabeth Brown, MD
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Prior “aggressive” tactics of manufacturers launching new technology can poison the reimbursement environment for a related, but distinct technology occupying the same space. This discussion traces the history of two of the most challenging reimbursement environments: wound healing and spine technologies.

Prior “aggressive” tactics of manufacturers launching new technology can poison the reimbursement environment for a related, but distinct technology occupying the same space. This discussion traces the history of two of the most challenging reimbursement environments: wound healing and spine technologies.

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Reimbursement Report

Humanitarian Use Devices and Third-Party Reimbursement

By Elizabeth Brown, MD
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Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?

Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?

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Reimbursement Report

HCT/P Regulation and Third-Party Reimbursement

By Elizabeth Brown, MD
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Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.

Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.

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