BOSTON — The competitive bidding program implemented by the Centers for Medicare and Medicaid Services (CMS) has reduced beneficiaries’ access to self-monitoring blood glucose (SMBG) supplies, resulting in increased mortality rates, according to a study presented at the American Diabetes Association (ADA) 75th Scientific Sessions in Boston.
CMS implemented a competitive bidding program for diabetes supplies in nine pilot markets in 2011. CMS intended for this program to help reduce costs for Medicare beneficiaries while still ensuring access to devices and services, including SMBG supplies. The program was officially implemented in July 2013 after CMS reported that there were no negative health care consequences from the pilot program.
The National Minority Quality Forum joined with top endocrinologists to determine the accuracy of the CMS’s conclusions about Medicare beneficiaries with diabetes who require access to SMBG supplies.
“For people with diabetes — especially those older adults in the Medicare population — consistent access to a quality glucose meter, sterile finger lancets and enough test strips is absolutely critical to managing their disease, and this study shows that this disruption in access to life saving medical supplies has been detrimental to patient care.” Jamie Davidson, MD, clinical professor of Medicine at the University of Texas Southwestern Medical Center, said in a press release.
The researchers used CMS data from 2009-2012 to determine the impact of competitive bidding on beneficiaries’ ability to acquire SMBG supplies. Participants acquired insulin at more than 80% of days covered (n=529,627).
Participants were divided into two cohorts: inclusions in test sites (test; n=43,939) and all other non-test sites (non-test; n=485,688).
From 2009 to 2011, the percentage of test participants with reduced SMBG acquisition increased by 23.0% compared with a 1.7% increase in non-test participants. During this period, the percentage of test participants with no SMBG record increased by 16.7% compared with 1.2% for the non-test group.
In both test groups, switching from full to reduced acquisition or no SMBG was associated with increased mortality. However, the researchers noted, this switch was made significantly more often in the test group.
The results of this study indicate that beneficiaries in the test group experienced disruptions in their access to SMBG supplies, resulting in adverse effects. These results stand in contrast to those of the CMS report, which stated that competitive bidding did not cause any disruptions or adverse effects.
In light of their results, the researchers urge CMS to more carefully monitor how competitive bidding programs affect beneficiaries’ access to SMBG supplies.
“In human clinical trials, investigators have an obligation to monitor the safety of study participants and terminate the study immediately whenever risk to patients is detected,” said Gary A. Puckrein, PhD, president and CEO of The Forum, in a press release.
“CMS undertook the competitive bidding program without an independent safety review board so policymakers have to assume the responsibility. They should suspend the competitive bidding process until CMS can effectively monitor the program and ensure that Medicare beneficiaries — a population critically vulnerable to the acute and chronic complications of diabetes — are protected from potentially harmful consequences.”
- Puckrein GA et al. Abstract 139-LB: CMS Competitive Bidding Program Disrupted Access to Diabetes Supplies with Resultant Increased Mortality. Presented at: American Diabetes Association (ADA) 75th Scientific Sessions; June 5-9, 2015; Boston.