by Glenda Motta RN, MPH
Coverage and payment for new wound care technology is never automatic, and demands skillful assessment of what various payers require to accept a new treatment modality. Reimbursement is complex and involves coding, coverage, and payment. Too many companies erroneously believe that “getting a code” guarantees payment. Nothing could be further from the truth!
If a new technology is more expensive than the currently approved alternative, or does not fit into an existing coverage policy, payers require an evaluation of clinical effectiveness and appropriateness. This usually means that an evidence-based assessment, along with a pharmaco-economic analysis is expected. Ultimately, it is the payers that assess whether devices improve health outcomes (length of life, quality of life, and functional ability) and are worth the cost. A payer’s comprehensive assessment includes:
- Identifying the potential clinical indications and uses of the technology
- Identifying any alternative treatment modalities with which the technology should be compared
- Identifying the most important health outcomes that might be affected by the technology
- Reviewing clinical evidence such as peer-reviewed, published, and unpublished sources, as well as specialty society meeting abstracts and standards of care
- Examining the credibility and strength of available scientific evidence
Specifically, the scientific evidence that payers require includes the following:
- Well-designed, well-conducted, randomized, and controlled clinical trials with consistent results
- A pharmaco-economic analysis demonstrating that the desired outcomes focus on saving the payer or reducing utilization of other services
- Findings published in peer-reviewed journals as evidence of acceptance by the medical community - to avoid labeling the device or technology as “investigational” or “experimental”
- Evidence demonstrating that the technology can measure or alter the physiological changes related to a disease, injury, illness, or condition, and that such alteration affects health outcomes
- Evidence that the beneficial effects outweigh any harmful effects on health outcomes
- Evidence that the technology improves the net health outcome as much as - or more than - established alternatives
- Evidence that the proposed technology is cost-effective
- Adoption of the device or technology by designated specialty professional associations (as evidenced by inclusion in clinical practice guidelines and standards of care)
Only after a proposed device or technology has been thoroughly evaluated can the payers justify adopting it into practice. Medical technology manufacturers and distributors, regardless of product, simply have to be subjected to these types of evaluations to ensure the best possible health outcomes for patients, and the best possible environment for healthcare professionals.
About The Author
Glenda Motta RN, MPH is a reimbursement consultant and wound care expert, publishing over 125 articles and books, serving as the President of the WOCN (1987-1989), and founding GM Associates, Inc., a healthcare marketing and reimbursement firm.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.