In the Journals

Medicare competitive bidding system led to increased mortality, hospitalization for diabetes

Medicare’s Competitive Bidding Program for diabetes supplies disrupted beneficiaries’ ability to access diabetes testing equipment, leading to an increase in mortality, hospitalization rates and inpatient costs, according to a recent analysis by the National Minority Quality Forum.

This finding contrasts with reports by CMS stating that no patients were harmed during the pilot program, which was designed to reduce out-of-pocket expenses for patients as well as for the program as a whole, according to researchers. The competitive bidding system was implemented nationwide in 2013.

“Self-monitoring blood glucose supplies are a critical component of diabetes care among insulin-treated individuals and the value of safe, effective testing supplies cannot be underestimated,” Jaime Davidson, MD, clinical professor of Medicine at the University of Texas Southwestern Medical Center, said in a press release. “We are particularly concerned about the disruption we detected in our analysis given the predominant use of rapid- and short-acting insulin by Medicare beneficiaries, who are at significantly greater risk for hypoglycemia than younger individuals with insulin-treated diabetes.”

In a retrospective, longitudinal analysis of Medicare claims data from 2009 to 2012, researchers compared beneficiaries in the nine test markets included in the CMS Competitive Bidding Program (n = 43,939) with insulin-using beneficiaries in the nontest markets (n = 485,688). Researchers further subdivided beneficiaries by those with full SMBG acquisition according to prescription, and those with partial or no acquisition. Outcomes were the effect of partial or no acquisition on mortality, inpatient admissions and inpatient costs.

From 2010 to 2011, the percentage of beneficiaries with full SMBG acquisition decreased from 32.2% to 28.7% in the test market vs. an increase from 27.5% to 28.2% in the nontest markets. In addition, the percentage of beneficiaries with partial or no SMBG acquisition increased in test markets from 22.1% to 27.2% from 2010 to 2011 (P < .0001), whereas the nontest markets saw a slight increase from 22.3% to 22.7% (P = .0002)

Researchers found that 4-year survival was negatively associated with partial or no acquisition of SMBG in both cohorts (P < .0001). In both test and nontest markets, mortality was higher among beneficiaries who moved from full SMBG acquisition to partial or no acquisition between 2010 and 2011 vs. those who maintained full SMBG acquisition. Researchers observed more than twice as many inpatient hospital admissions among the test beneficiaries who moved from full to partial or no SMBG acquisition vs. nontest beneficiaries (P < .0001); inpatient costs were also twice as high vs. nontest beneficiaries (P < .0001).

Researchers also noted a shift in SMBG acquisition from mail-order to retail in the test cohort only.

David Marrero

David Marrero

“We speculate that the CBP test program created confusion among the millions of Medicare beneficiaries who live with diabetes about how to access reliable test strips, which translated into adverse health outcomes that are of considerable concern,” David Marrero, PhD, immediate past president of health care and education for the American Diabetes Association and director of the Diabetes Translational Research Center, told Endocrine Today. “The increase in these negative health outcomes questions whether the effort to reduce the cost of strips really achieved the intended goal for Medicare.” 

“We are troubled that CMS failed to detect these ‘unintended’ consequences and, instead, reported that the program was a success,” Gary A. Puckrein, PhD, president and CEO of the National Minority Quality Forum, said in a press release. “Based on our findings and employing the safety monitoring protocols commonly used to protect human subjects, we believe policymakers should immediately suspend the program until CMS can demonstrate its ability to effectively monitor the effects of the program, correct the structural flaws causing this problem and ensure that the lives of America’s greatest generation are no longer at risk.”

In a separate report, the Government Accountability Office stated that the monitoring methods used by CMS in assessing the effect of the program did not directly demonstrate whether beneficiaries received their durable medical equipment on time, or whether health outcomes were precipitated by problems accessing their equipment. – by Regina Schaffer

Disclosure: The National Minority Quality Forum, a nonprofit organization, received support for the study from Abbott, Acelity L.P. Inc., Lifescan, Roche Diabetes Care, US Healthcare Supply LLC and US MED. Please see the full study for the authors’ relevant financial disclosures.

Medicare’s Competitive Bidding Program for diabetes supplies disrupted beneficiaries’ ability to access diabetes testing equipment, leading to an increase in mortality, hospitalization rates and inpatient costs, according to a recent analysis by the National Minority Quality Forum.

This finding contrasts with reports by CMS stating that no patients were harmed during the pilot program, which was designed to reduce out-of-pocket expenses for patients as well as for the program as a whole, according to researchers. The competitive bidding system was implemented nationwide in 2013.

“Self-monitoring blood glucose supplies are a critical component of diabetes care among insulin-treated individuals and the value of safe, effective testing supplies cannot be underestimated,” Jaime Davidson, MD, clinical professor of Medicine at the University of Texas Southwestern Medical Center, said in a press release. “We are particularly concerned about the disruption we detected in our analysis given the predominant use of rapid- and short-acting insulin by Medicare beneficiaries, who are at significantly greater risk for hypoglycemia than younger individuals with insulin-treated diabetes.”

In a retrospective, longitudinal analysis of Medicare claims data from 2009 to 2012, researchers compared beneficiaries in the nine test markets included in the CMS Competitive Bidding Program (n = 43,939) with insulin-using beneficiaries in the nontest markets (n = 485,688). Researchers further subdivided beneficiaries by those with full SMBG acquisition according to prescription, and those with partial or no acquisition. Outcomes were the effect of partial or no acquisition on mortality, inpatient admissions and inpatient costs.

From 2010 to 2011, the percentage of beneficiaries with full SMBG acquisition decreased from 32.2% to 28.7% in the test market vs. an increase from 27.5% to 28.2% in the nontest markets. In addition, the percentage of beneficiaries with partial or no SMBG acquisition increased in test markets from 22.1% to 27.2% from 2010 to 2011 (P < .0001), whereas the nontest markets saw a slight increase from 22.3% to 22.7% (P = .0002)

Researchers found that 4-year survival was negatively associated with partial or no acquisition of SMBG in both cohorts (P < .0001). In both test and nontest markets, mortality was higher among beneficiaries who moved from full SMBG acquisition to partial or no acquisition between 2010 and 2011 vs. those who maintained full SMBG acquisition. Researchers observed more than twice as many inpatient hospital admissions among the test beneficiaries who moved from full to partial or no SMBG acquisition vs. nontest beneficiaries (P < .0001); inpatient costs were also twice as high vs. nontest beneficiaries (P < .0001).

Researchers also noted a shift in SMBG acquisition from mail-order to retail in the test cohort only.

David Marrero

David Marrero

“We speculate that the CBP test program created confusion among the millions of Medicare beneficiaries who live with diabetes about how to access reliable test strips, which translated into adverse health outcomes that are of considerable concern,” David Marrero, PhD, immediate past president of health care and education for the American Diabetes Association and director of the Diabetes Translational Research Center, told Endocrine Today. “The increase in these negative health outcomes questions whether the effort to reduce the cost of strips really achieved the intended goal for Medicare.” 

“We are troubled that CMS failed to detect these ‘unintended’ consequences and, instead, reported that the program was a success,” Gary A. Puckrein, PhD, president and CEO of the National Minority Quality Forum, said in a press release. “Based on our findings and employing the safety monitoring protocols commonly used to protect human subjects, we believe policymakers should immediately suspend the program until CMS can demonstrate its ability to effectively monitor the effects of the program, correct the structural flaws causing this problem and ensure that the lives of America’s greatest generation are no longer at risk.”

In a separate report, the Government Accountability Office stated that the monitoring methods used by CMS in assessing the effect of the program did not directly demonstrate whether beneficiaries received their durable medical equipment on time, or whether health outcomes were precipitated by problems accessing their equipment. – by Regina Schaffer

Disclosure: The National Minority Quality Forum, a nonprofit organization, received support for the study from Abbott, Acelity L.P. Inc., Lifescan, Roche Diabetes Care, US Healthcare Supply LLC and US MED. Please see the full study for the authors’ relevant financial disclosures.