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 company with a broad portfolio of hospital-use drugs faced the loss of Medicare reimbursement for several products commonly used in outpatient settings. The Centers for Medicare & Medicaid Services (CMS) determined that these products were not eligible for reimbursement under Medicare when administered in outpatient care, discouraging providers from purchasing them and jeopardizing patient access to essential therapies used to treat serious infections and cancer.

Applied Policy reviewed the impacted products payment information provided by hospitals, Medicare Administrative Contractors, and the client, and determined the reimbursement issue was due to CMS errors in the Medicare hospital outpatient payment status indicators. Applied Policy reviewed other products with similar payment status indicator assignments and ways in which CMS status indicators have been successfully changed in the past to develop a strategy to correct the status indicator assignment. With this strategy, Applied Policy staff connected with several CMS policy contacts to inform the agency of the error and work with CMS staff on resolving the issue by correcting with the client’s products’ payment status indicators.

After engaging with several key CMS staff members, the agency corrected the error in payment status indicators for all of the client’s products. As a result, the company’s products are no longer denied payment and will be reimbursed fully. In addition, as a result of these efforts, CMS made the correction retroactive to prior quarters, so that previously denied provider claims for these products could be resubmitted, reprocessed, and finally paid. CMS also placed a notice on the agency’s landing page for the ASP website, prominently displaying corrected information on the payment status indicators for our client’s products. When CMS issued communications advising the public of the correction, Applied Policy developed internal communications to be distributed within the company and to the field team to be used in educating providers on the change and next steps to bill and receive reimbursement for prior denials.

Today, our client’s products are fully reimbursed, and patients again have access to potentially life-saving products.