Researchers identify outcomes of 2011 CMS bundled payment policy on anemia care
Click Here to Manage Email Alerts
Following the Medicare reimbursement policy in 2011 that recommended erythropoietin-stimulation agent dosing changes, researchers found reduced dosing and lower hemoglobin levels in anemia care among patients on hemodialysis.
Further, investigators found the policy changes correlated with an increased risk of acute myocardial infarction.
“In 2011, the CMS implemented bundling of all services for patients receiving dialysis, including erythropoietin-stimulating agents (ESA) use, and the [FDA] recommended conservative erythropoietin-stimulating agent dosing,” Haesuk Park, PhD, from the department of pharmaceutical outcomes and policy at the University of Florida, and colleagues wrote. They added, “Given that the effect of the policy changes on clinical outcomes may not occur immediately after policy implementation, we investigated the long-term effects of these Medicare reimbursement policy and FDA regulation changes on anemia care and clinical outcomes among patients with kidney failure receiving hemodialysis.”
In a retrospective cohort study, researchers used data from the U.S. Renal Data System to examine the results of 481,564 patients (mean age was 65 years; 44% were women; 66% were white) on incident hemodialysis between January 2006 and December 2016.
Researchers separated patients into a pre-policy cohort between the years of 2006 and 2010 (n= 253,859) and a post-policy cohort between the years of 2012 and 2016 (n= 227,705). Researchers identified anemia care outcomes among the cohorts, such as the use of an ESA or IV iron or receiving a blood transfusion to maintain hemoglobin levels. Additionally, clinical outcomes were considered major adverse cardiovascular events, cardiovascular mortality and heart failure.
Researchers used interrupted time series and Cox proportional hazard regression models to compare measurements between pre-policy and post-policy periods.
Overall, ESA use decreased by 84.8 per 1,000 persons following the policy change. Blood transfusions increased by 8.34 per 1,000 persons in April 2012, then gradually decreased. While the percentage of patients with hemoglobin greater than 11 g/dL decreased from 68% in January 2006 to 28% in December 2016, those with hemoglobin less than 9 g/dL increased from 5% to 9%.
Analyses revealed major cardiovascular events, stroke, all-cause mortality, cardiovascular mortality and heart failure risks were lower after the policy was implemented. However, acute myocardial infarction risk increased.
“Medicare reimbursement policy and FDA-recommended ESA dosing changes adopted in 2011 were associated with decreased ESA use, lower hemoglobin levels and better clinical outcomes for risk of major adverse cardiovascular events, mortality and stroke but with a higher risk of acute myocardial infarction among adults receiving hemodialysis,” Park said in a press release. “Due to these significant changes in clinical outcomes, longitudinal follow-up is warranted to assess if the policy changes warrant further refinement.”
In a patient voice piece from the Clinical Journal of the American Society of Nephrology, Cher Thomas responded to the findings reported in Park’s study. Thomas pointed out potential limitations, such as the cohort made completely of an inpatient population, and considered the way changes in ESA therapy can affect different patients.
“Anemia is a debilitating illness, and all factors of how the patient is feeling should be part of the question to ensure that patient-centered care is delivered and that the patients can maintain their best quality of life,” Thomas concluded.
References:
- How have changes in anemia care affected patients with kidney failure? https://www.eurekalert.org/news-releases/952887 Published May 19, 2022. Accessed May 20, 2022.
- Thomas C. Clin J Am Soc Nephrol. 2022;doi:https://doi.org/10.2215/CJN.03540322. .
Perspective
Back to Top
In 2011, Medicare changed the reimbursement for erythropoiesis-stimulating agents to dialysis providers from fee-for-service to part of a bundled prospective payment system. This converted ESAs from a profit center to a cost center.
During the same year, the FDA changed the label for ESAs from a target hemoglobin (Hgb) level of 10 g/dL to 12 g/dL to a recommendation that the ESA dose be decreased or stopped when the Hgb level exceeds 11 g/dL for patients on dialysis and to use the lowest ESA dose possible to avoid blood transfusion.
As reported in the article by Park and colleagues, these regulatory changes were, not surprisingly, followed by more conservative ESA dosing for patients on dialysis in the United States, with a 53% reduction in mean ESA dose between April 2006 and December 2016.
Mean Hgb level decreased from 11.5 g/dL to 10.6 g/dL during the same period, and the percentage of patients with Hgb less than 9 g/dL increased from 5% to 9%.
The proportion of patients receiving at least one blood transfusion increased significantly between 2011 and 2012, then gradually decreased to pre-2011 levels by 2017.
Major adverse cardiovascular events (MACE), which have been associated with higher ESA doses and higher achieved Hgb levels in the dialysis population, decreased to a significant degree when the pre-policy period of 2006 to 2010 was compared with the post-policy period of 2012 to 2016, as did stroke, all-cause mortality, cardiovascular mortality and hospitalization for heart failure.
Of note, acute myocardial infarction increased to a significant degree (hazard ratio = 1.04-1.07, depending on the duration of follow-up) during the post-policy period. These findings are similar to those reported by Chertow and colleagues and Wang and colleagues who also reported decreased incidence of stroke in the post-policy period, although MACE and mortality were unchanged.
Wang and colleagues also reported an increased risk of blood transfusion events in the post-policy period. There are no data in any of these studies regarding changes in patient-reported outcomes that may have occurred in the post-policy period associated with the 0.9 g/dL decrease in mean Hgb concentration.
The FDA label change for ESAs was a safety decision designed to protect patients from cardiovascular events associated with high ESA doses and high achieved Hgb levels. Unlike the Kidney Disease: Improving Global Outcomes clinical practice guidelines for anemia treatment for patients with chronic kidney disease, the ESA label in the U.S. does not allow a discussion with patients who might accept the MACE risk of a higher achieved Hgb level (up to 13 g/dL, recommendations 3.52 g/dL and 3.6 g/dL) as a trade-off for improved vitality or transfusion avoidance.
Dialysis facility anemia treatment protocols, which are driven by the cost-reduction priorities of a prospective payment system, are also not patient centered and reflect a one-size-fits-all approach to anemia management. If transfusion avoidance is a top priority for a patient who wishes to avoid allosensitization and maximize chances for a successful transplant, it is not unreasonable to maintain a higher Hgb level so that an intercurrent illness that may cause an acute decrease in Hgb level is less likely to trigger a blood transfusion, assuming the patient is willing to accept the risks of higher Hgb levels, including MACE and vascular access thrombosis.
The patient voice commentary by Cher Thomas reflects the need to engage our patients more effectively to address the risk/benefit proposition of ESA therapy. Every patient is different in terms of their willingness to assume risk, and our paternalistic approach to risk aversion may ignore the patient’s priorities.
The 53% decrease in ESA use among dialysis patients resulted in cost savings for the dialysis providers, but did that money go to efforts to measure and improve the quality of our patients’ lives? The associated decrease in MACE (other than myocardial infarction) would seem to be a win for patients, but quality of life may be more important to some patients than quantity of life, especially when eligibility for transplantation is concerned. Patient-centered care should be paramount and acknowledging the numerous issues raised by Ms. Thomas is a perfect place to start.
References:
- Chertow GM, et al. J Am Soc Nephrol. 2016;doi:10.1681/ASN.2015111232.
- Wang C, et al. JAMA Intern Med. 2016;doi:10.1001/jamainternmed.2016.6520.
Collapse
Click Here to Manage Email Alerts