The research puts data behind long-simmering complaints from patients and clinicians about availability of diabetes test strips.
A competitive bidding program designed to save Medicare money has instead put beneficiaries with diabetes in the hospital, driving up costs for both patients and taxpayers and causing the untimely death of some, according to a study published today in the journal Diabetes Care.1
Study authors called on CMS to halt bidding for diabetes test strips until the program’s flaws can be fixed, with one author saying that the rock bottom prices and lack of standards have left beneficiaries low-quality strips from “off shore” suppliers, which can give inaccurate results.
Research by the National Minority Quality Forum puts data behind long-simmering complaints about the availability of diabetes test strips for Medicare patients, which have increased since CMS switched to a competitive bidding program for these critical supplies. Those who use insulin to regulate their diabetes use test strips monitor blood glucose levels several times a day, which help them decide how much insulin they need, to manage their diet, and to avoid episodes of hypoglycemia. CMS started the pilot in 9 test markets in 2011; after CMS declared it a success it was expanded nationwide in 2013.
But the study published today reaches a shocking conclusion: armed with the same data available to CMS, the team found that the low reimbursement levels during the pilot program—which fell from $34 to $14 per vial—led to disruptions in supplies, causing some patients to monitor their blood sugar less frequently or not at all.
“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 … and ensure that the lives of America’s greatest generation are no longer at risk,” said Gary A. Puckrein, PhD, president and CEO of the National Minority Quality Forum and the lead author of the study.
Bids are so low that the government has altered the market. Some strips are so low-quality a patient testing more than once at the same time will get different results, said study co-author David G. Marrero, PhD, of the Diabetes Translational Research Center in Indianapolis, in an interview with The American Journal of Managed Care. Marrero knows this—he has type 1 diabetes himself.
Marrero said CMS’ analysis failed to pick up on the pilot program’s flaws because it wasn’t designed to find them—so the agency declared success and moved ahead with a nationwide bidding program. He doesn’t feel this was done on purpose, but he said steps must be taken to correct the program.
“When the government decides to do an experiment that could have potentially serious effects, they need to have a structure that monitors the experiment and looks for negative outcomes,” Marrero said. “They just didn’t do that in this case.”
An earlier report from the Government Accountability Office raised red flags about the CMS bidding program, the researchers noted. Researchers presented an earlier version of the findings as a poster in June 2015 at the Scientific Sessions of the American Diabetes Association in Boston.
The study published today found that not only did the bidding test program cause higher rates of hospitalization and out-of-pocket costs for Medicare beneficiaries in 2011, but also that survival rates dipped for those with diabetes in test markets compared with the rest of the country. Researchers calculated this using matched cohorts of patients from the nine test markets and those outside those markets.
The researchers studied 43,939 insulin users who lived in the 9 test markets in 2011 and compared them with 485,688 beneficiaries in the rest of the country. They picked up a trend in which patients in the test markets, who had been testing regularly with strips obtained through a reliable mail order program, could not use the same vendors. Instead of testing at recommended levels, the researchers found a 23% increase among those in the test markets who switched to testing at less than recommended intervals or no testing at all, compared with a 1.7% increase among patients outside the test markets. Women and African American beneficiaries seemed to bear the brunt of the effects in the test markets, the study found.
Also, more than twice as many inpatient hospital admissions were seen among beneficiaries in the test markets, who switched from frequent testing to limited or no testing, compared with beneficiaries outside the test markets, the study found. Inpatient hospital costs were also more than twice as high for those in the test market who started testing less frequently or not at all.
Puckrein GA, Nunlee-Bland G, Zangeneh F, et al. Impact of CMS competitive bidding program on Medicare beneficiary safety and access to diabetes testing supplies: a retrospective, longitudinal analysis [published online March 18, 2016]. Diabetes Care. 2016; doi: 10.2337/dc15-1264.