Case Study

Strategic Engagement with CMS Restores Medicare Reimbursement for Critical Drugs When Used in Outpatient Settings

10.14.2025

Strategic Engagement with CMS Restores Medicare Reimbursement for Critical Drugs When Used in Outpatient Settings

An international pharmaceutical company with a broad portfolio of therapies used in hospital settings faced a significant reimbursement challenge when several products commonly administered in the hospital outpatient setting were assigned incorrect payment status indicators under the Medicare Hospital Outpatient Prospective Payment System (OPPS). As a result, providers were unable to receive Medicare reimbursement for administering these therapies, discouraging hospitals from purchasing them and threatening patient access to important treatments for serious infections and cancer.

Applied Policy conducted a comprehensive review of payment information provided by the client, hospitals, and Medicare Administrative Contractors (MACs) to identify the source of the reimbursement problem. Our analysis determined that the issue was not a change in Medicare payment policy, but rather errors in the Medicare hospital outpatient payment status indicators. Drawing on our extensive knowledge of OPPS payment policy, Centers for Medicare & Medicaid Services (CMS) payment methodologies, and prior agency payment corrections, we developed a strategy to demonstrate the error and identify the appropriate pathway for resolving it.

Applied Policy worked directly with CMS policy staff, presenting supporting analysis and collaborating with the agency throughout the correction process. As a result of these efforts, CMS corrected the payment status indicators for all affected products and applied the changes retroactively, allowing providers to resubmit previously denied claims for reprocessing and payment. The agency also updated its Average Sales Price (ASP) website to notify stakeholders of the correction.

To support implementation, Applied Policy developed internal communications and educational materials for the client’s field teams, enabling them to educate providers about the reimbursement changes and assist them in obtaining payment for previously denied claims.

Today, the client’s products are reimbursed appropriately under Medicare, providers are able to bill successfully for their use, and patients once again have access to these important therapies.