The OIG has issued a report, “CMS Has Not Promulgated Regulations To Establish Payment Requirements for Prosthetics and Custom-Fabricated Orthotics,” that calls on CMS to implement long-delayed statutory requirements and to better enforce regulatory standards for supplier documentation. By way of background, the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) directed CMS to issue regulations prohibiting Medicare payments for prosthetics and custom fabricated orthotics unless the items are: (1) furnished by a qualified practitioner, and (2) fabricated by either a qualified practitioner or a qualified supplier. More than a decade later, CMS has not promulgated these regulations, although CMS has used other legal authorities (such as the DMEPOS supplier standards) to limit who can be paid for prosthetics and custom-fabricated orthotics. Separate CMS regulations require Medicare suppliers to maintain documentation supporting that prosthetics and custom fabricated orthotics were delivered to beneficiaries. To determine whether the qualification standards and documentation requirements are being met, the OIG reviewed a sample of 1,135 Medicare-allowed claims for prosthetics and custom fabricated orthotics in 2010. The OIG found that although most Medicare claims for prosthetics and custom-fabricated orthotics were furnished and/or fabricated by practitioners and/or suppliers that were licensed, certified, or accredited in 2010, Medicare inappropriately allowed 966 claims in 2010 totaling $776,154 for such items from practitioners and suppliers that did not meet applicable state licensing requirements. Medicare also inappropriately allowed 12% of claims – totaling almost $13.6 million -- for prosthetics and custom-fabricated orthotics that did not meet delivery documentation requirements. In response to the OIG findings, CMS stated that it is developing proposed regulations to implement the BIPA payment requirements, and it will investigate findings of inappropriate payments to determine if changes to claims edits are needed.