REGULATORY

The Durable Medical Equipment, Prosthetics/Orthotics & Supplies ("DMEPOS") industry, which includes manufacturers, pharmaceutical companies, suppliers, vendors and providers is regulated by the Centers for Medicare and Medicaid Services (“CMS”), which oversees the rules, regulations, and provisions for reimbursement, all of which drive the companies within this industry.

In order to maximize reimbursement, strict criteria set forth by CMS must be met by DMEPOS suppliers, including proper coding, claim preparation and certifications. Suppliers of DMEPOS must also comply with the quality standards set forth by CMS to furnish items for which payment is made under Medicare Part B. DMEPOS providers must retain a provider number in order to submit claims for reimbursement under Medicare. In addition, many states have licensure requirements that further regulates DMEPOS suppliers.

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Hygeia is in full compliance with all licensing requirements mandated by CMS and applicable state laws.

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