- Representing a manufacturer and distributor of device systems used in wound treatment
- Assisted the company with coverage advocacy and met with the Centers for Medicare & Medicaid Services (CMS) regarding scope of coverage
- Assisting the company with negotiations in Medicare jurisdictions regarding coding and coverage issues
Mintz represented the company in analyzing the Medicare coverage opportunities when an existing National Coverage Decision (NCD) was opened for review. Our team prepared an extensive public comment and met directly with CMS.
Mintz reviewed hundreds of literature sources, analyzed the impact of an FDA reclassification hearing, and established an exhaustive clinical, regulatory, and coverage timeline relating to the safety and efficacy of topical oxygen for the treatment of wounds. The company presented this information in a public comment to CMS and was then asked to meet with CMS to further discuss the data and arguments for coverage. We have since assisted the client with data analysis and met with CMS regarding options for coverage. CMS issued a unique coverage determination that eliminated the prohibition against coverage but did not grant affirmative coverage, leaving Medicare coverage determinations to local jurisdictions. We have assisted the company with negotiations in two local jurisdictions regarding coding and coverage options, and currently represent the company in a Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) process to review coverage of the technology and establish local coverage determination. This aspect of the representation requires submission of clinical and scientific information in addition to advocacy regarding the billing and coding practices for the procedure. In addition, our team represented the company in front of the New York committee in reviewing the Medicaid coverage and successfully advocated for coverage to continue. We continue to pursue Medicare and Medicaid coverage options throughout the country.