Sunday, March 20, 2016

Observational Study Reports Competitive Bidding May Have Harmed Diabetic Patients

 In March 2016, a large observational study reported that quality outcomes were materially harmed by the DME competitive bidding demonstration with regard to diabetic supplies and meters, especially in minority populations.  Details after the break.

Trade journal Fierce Medical Devices here, original publication by Puckrein et al. in the journal Diabetes Care, here.  The journal is published by the American Diabetes Association.  The study is entitled, "Impact of CMS Competitive Bidding Program on Medicare Beneficiary Safety and Access to Diabetes Testing Supplies: A Retrospective, Longitudinal Analysis."

A sponsor of the study stated:
"We are troubled that CMS failed to detect these 'unintended' consequences and, instead, reported that the program was a success," said study author Gary Puckrein, who's the CEO of the National Minority Quality Forum, in a statement. "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."

The abstract is cut/pasted here:

OBJECTIVE In 2011, the Centers for Medicare & Medicaid Services (CMS) launched the Competitive Bidding Program (CBP) in nine markets for diabetes supplies. The intent was to lower costs to consumers. Medicare claims data (2009–2012) were used to confirm the CMS report (2012) that there were no disruptions in acquisition caused by CBP and no changes in health outcomes.
RESEARCH DESIGN AND METHODS The study population consisted of insulin users: 43,939 beneficiaries in the nine test markets (TEST) and 485,688 beneficiaries in the nontest markets (NONTEST). TEST and NONTEST were subdivided: those with full self-monitoring of blood glucose (SMBG) supply acquisition (full SMBG) according to prescription and those with partial/no acquisition (partial/no SMBG). Propensity score–matched analysis was performed to reduce selection bias. Outcomes were impact of partial/no SMBG acquisition on mortality, inpatient admissions, and inpatient costs.
RESULTS Survival was negatively associated with partial/no SMBG acquisition in both cohorts (P < 0.0001). Coterminous with CBP (2010–2011), there was a 23.0% (P < 0.0001) increase in partial/no SMBG acquisition in TEST vs. 1.7% (P = 0.0002) in NONTEST. Propensity score–matched analysis showed beneficiary migration from full to partial/no SMBG acquisition in 2011 (1,163 TEST vs. 605 NONTEST) was associated with more deaths within the TEST cohort (102 vs. 60), with higher inpatient hospital admissions and associated costs.
CONCLUSIONS SMBG supply acquisition was disrupted in the TEST population, leading to increased migration to partial/no SMBG acquisition with associated increases in mortality, inpatient admissions, and costs. Based on our findings, more effective monitoring protocols are needed to protect beneficiary safety.