Diabetes Patients in Round One Saw Decreased Access to Supplies

Study: reports patients in Round One of bidding saw disrupted access to supplies; coincided with increased number of hospitalizations, deaths.

Medicare beneficiaries with diabetes located in the nine CBAs of Round One of competitive bidding received only a portion of the blood glucose monitoring supplies they needed, according to a new study conducted by leading endocrinologists. The study also noted that the decreased access coincidented increased hospitalization and mortality for those diabetes patients.

Using a propensity score matched analysis, the study, which was undertaken but the National Minority Quality Forum (the Forum), assessed CMS data from 2009 to 2012, and found the number of beneficiaries with only partial glucose monitoring supplies access increased by 23 percent in the test markets compared to 1.7 percent in the non-test markets. (The study opted to use propensity score matching in order to reduce selection bias due to imbalance in study covariates.)

Chillingly, the study reports that partial blood glucose monitoring equipment access coincided with a higher number of deaths and hospitalizations in the test markets in 2011, the year the competitive bidding program was implemented.

Two key points of detail from the report:

  • The number of deaths in the propensity score matched analysis was nearly twice as high in the nine Round One CBAs compared with the rest of the Medicare population (102 deaths in test markets vs. 60 deaths in non-test markets).
  • Nearly 1,000 beneficiaries in the nine CBAs were admitted to the hospital at a cost of $10.7 million compared to 460 beneficiaries in non-test markets at a cost of $4.7 million in the propensity score matched analysis.

“Based on our findings, our original hypothesis regarding the potential benefits of the program was incorrect and it is quite clear that access to diabetes testing supplies was somehow disrupted in the test markets,” said Jaime Davidson, MD, clinical professor of Medicine at the University of Texas Southwestern Medical Center, and an author of the study. “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.

“Results of the study show that beneficiaries are suffering following the implementation of the CMS program, and this disruption will be perpetual, as the process requires suppliers to resubmit bids every three years,” Davidson added.

“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 Puckrein, PhD, president and CEO of the Forum and lead study author. “Given the prospective approach taken in implementing competitive bidding, CMS should be held to the same standards as the managers of any other clinical trial.

“A clinical trial’s safety review board looking at these findings would stop a trial out of an abundance of caution for patients,” Puckrein continued. “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.”

The study’s authors also included Farhad Zangeneh, MD, George Washington University School of Medicine; Gail Nunlee-Bland, MD, Howard University Hospital; Liuo Xu, PhD, National Minority Quality Forum; and Christopher Parkin, MS, CGParkin Communications.

About the Author

David Kopf is the Publisher and Executive Editor of HME Business and DME Pharmacy magazines. Follow him on Twitter at @postacutenews.

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