The GAO has issued a report entitled “End-Stage Renal Disease:  CMS Should Assess Adequacy of Payment When Certain Oral Drugs Are Included and Ensure Availability of Quality Monitoring Data." By way of background, effective January 1, 2011, CMS provides a single bundled payment to dialysis facilities covering dialysis treatments and supplies, certain ESRD-related drugs, and ESRD-related clinical laboratory tests. In 2014, the bundle will be expanded to include ESRD-related oral drugs without injectable equivalents (so-called “oral-only” drugs). The GAO reports that both large and small dialysis organizations it interviewed expressed concern about whether the bundled payment for dialysis care would adequately cover the costs of providing oral-only ESRD drugs. The GAO suggests that currently-available data may understate the costs that dialysis organizations would incur to provide oral-only ESRD drugs, which “raises questions about the adequacy of the overall bundled payment rate” and could “impair the ability of providers such as dialysis organizations to furnish beneficiaries with access to high-quality care.” The GAO therefore recommends that CMS assess payment adequacy when oral-only ESRD drugs are included in the bundled payment and ensure the availability of reliable data for monitoring treatment of mineral and bone disorder. CMS agreed with the GAO’s recommendations.