ImpediMed (ASX: IPD) has received significant cheer from a decision by the state of North Carolina in the US on health plan coverage of the diagnosis, evaluation, and treatment of lymphoedema.
The General Assembly in North Carolina ratified House Bill 535 of Session 2009, mandating that every health benefit plan shall provide coverage for the diagnosis, evaluation, and treatment of lymphoedema.
ImpediMed had the first medical device with an FDA clearance in the United States to aid health care professionals in the clinical assessment of secondary lymphoedema of the arm in female breast cancer patients.
ImpediMed’s L-Dex product is used as an aid in the clinical assessment of patients at risk of lymphoedema.
Chief Executive Officer of ImpediMed, Greg Brown said the legislation should encourage the adoption of a pre-emptive care approach to monitoring patients at risk of lymphoedema, by supporting medical providers in the reimbursement for the diagnosis and evaluation of lymphoedema.
Brown said, ”this is ground breaking legislation that goes further than any other US federal or state legislation has previously gone.
Further, the company said, “not only does this legislation support North Carolina medical providers today in adopting ImpediMed’s technology for use with patients at risk of lymphoedema through breast cancer treatment, it also begins to pave the way for reimbursement for patients at risk of lymphoedema through pelvic region cancers, for which the patient numbers are considerably higher than breast cancer."
ImpediMed expects to submit applications for FDA clearance of its L-Dex U400 device for use in the clinical assessment of unilateral leg lymphoedema by the 3rd quarter of 2010, and for use in the clinical assessment of bilateral leg lymphoedema by the 1st quarter of 2011.