Reimbursement Report

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

By Elizabeth Brown, MD
No Comments

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.

Continue reading

Reimbursement Report

Humanitarian Use Devices and Third-Party Reimbursement

By Elizabeth Brown, MD
No Comments

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?

Continue reading

Reimbursement Report

HCT/P Regulation and Third-Party Reimbursement

By Elizabeth Brown, MD
No Comments

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.

Continue reading

Reimbursement Report

PMA Approval and Third-Party Reimbursement

By Elizabeth Brown, MD
No Comments

The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?

The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?

Continue reading

Reimbursement Report

The Appeals Process

By Elizabeth Brown, MD
No Comments

Presenting clinical evidence to payers is the most efficient method of gaining coverage. But when this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology.

Presenting clinical evidence to payers is the most efficient method of gaining coverage. But when this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology.

Continue reading