Medicare Reimbursement For Erythropoiesis-Stimulating Agents Changed

Ruzanna Harutyunyan's picture

Researchers today report that after the implementation of Medicare coverage limitations for erythropoiesis-stimulating agents (ESAs), a significantly greater proportion of anemic cancer patients who were on chemotherapy and who received ESAs needed blood transfusions and utilized more units of blood per patient than those patients who received ESAs prior to implementation of coverage limitations.

In July 2007, the Centers for Medicare and Medicaid Services (CMS) issued coverage limitations, in the form of a National Coverage Determination (NCD), for the use of ESAs in anemic cancer patients receiving chemotherapy. An ongoing, prospective, observational study [Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) registry] is evaluating ESA-treated anemic cancer patients receiving chemotherapy. The present analyses were conducted using data from this study, focused on patients covered by Medicare before and after implementation of the CMS NCD for ESAs.

"We wanted to examine the potential impacts on transfusion patterns and hematologic changes in anemic Medicare patients receiving chemotherapy treated with ESAs before and after implementation of the ESA coverage limitations," said study director Chris L. Pashos, PhD, Vice President, Abt Bio-Pharma Solutions, Inc. "Our analyses found increased transfusion rates and greater blood utilization in anemic Medicare patients receiving chemotherapy and treated with ESAs after implementation of the ESA NCD compared with before implementation of the ESA NCD."


Study Methods and Results

Data from 288 Medicare patients (pre-NCD: 230, post-NCD: 58) from 41 sites included in the DOSE registry were analyzed. Data were categorized into two timeframes based on date of initial ESA administration (pre-NCD: April 2006 through April 2007; post-NCD: October 2007 through May 2008). Baseline characteristics of pre-NCD and post-NCD patients were similar for age, gender, weight and tumor type.

Compared to the pre-NCD patient group, a significantly greater proportion of Medicare patients in the post-NCD group received blood transfusions (post-NCD 32.8 percent vs. pre-NCD 18.3 percent, p= 0.0157), with greater blood utilization per patient (mean units of blood/patient: post-NCD 1.1 vs. pre-NCD 0.5, p= 0.0089). Significantly lower mean Hb levels (g/dL) were reported in the post-NCD group at all time points [Hb level (g/dL): post-NCD vs. pre-NCD: 9.6 vs. 10.6, 9.9. vs. 11.1, 10.4 vs. 11.2, 9.8 vs. 11.1 and 9.7 vs. 11.0 at baseline, Week 4, Week 8, Week 12 and Week 16, respectively].

The post-NCD ESA dosing guideline that impacts ESA utilization for anemic cancer patients receiving chemotherapy is the requirement to discontinue ESA dosing for Hb levels exceeding 10 g/dL. Safety, including thrombovascular events, was not examined in this analysis. An increased relative risk of thrombovascular events has been observed in ESA-treated patients; physicians should use the lowest dose needed to avoid red blood cell transfusion.