The introduction of reimbursement limits for blood glucose test strips had no impact on rates of emergency department (ED) visits for hypoglycemia or hyperglycemia, or on mean hemoglobin A1c levels, according to a Canadian study.
In the primary outcome, rates of ED visits for hypoglycemia decreased by 38.8% for individuals younger than 65, and decreased by 55.2% among the those 65 and up, according to Tara Gomes, of St. Michael's Hospital in Toronto, and colleagues.
Despite an overall trend toward lower rates over the study period, the introduction of blood glucose test strip (BGTS) quantity limits led to no significant change in rates of ED visits for hypoglycemia (P=0.67 for ramp intervention function in August 2013 for patients <65 years; P=0.12 for patients ages ≥65) or hyperglycemia (P=0.37 for patients <65 and P=0.24 for patients ≥65), they wrote in JAMA Internal Medicine.
Costs associated with blood glucose test strips is substantial, reportedly costing the U.S. over $1.3 billion in 2012 for Medicare beneficiaries, and over $250 million in Canada among public drug coverage, the authors noted.
"The Ontario provincial public drug program introduced quantity limits for blood glucose test strips in August 2013 in response to concerns about overuse of these products, which were one of the highest cost drivers in the provincial drug program," Gomes told MedPage Today. "These quantity limits were aligned with current evidence and guidance from the Canadian Diabetes Association, however there remained concern that restricting access to these products could lead to worsening of diabetes control in some patients."
Currently in the U.S., quantity limits on blood glucose monitoring strips varies across public and private insurers and plans. Patients with Medicare Part B using daily insulin may typically receive up to 100 blood glucose test strips and lancets per month, allowing for testing three times per day. Also, Medicare Part B beneficiaries not using insulin may receive 100 test strips every 3 months, allotting one strip per day.
Gomes' group analyzed the clinical implications of the policy implementation. Users of daily insulin were subsequently allotted 3,000 test strips annually, while individuals taking drugs associated with hypoglycemia were limited to 400 strips annually, and all other patients with diabetes were given a 200 annual strip allotment.
While the new policy went into affect in 2013, the 7-year long analysis spanned from April 2008 to March 2015. For the study, 834,309 Canadian patients with diabetes were divided between four groups, based on treatment status, which included an insulin group, oral hypoglycemic agent user group, oral diabetes drug not associated with hypoglycemia, and absence of drug therapy. Two age groups were included (19-64 and 65-plus).
Using several data sources, the researchers examined the rates of ED visits due to hypoglycemia, in addition to average HbA1c levels among all participants.
The authors found that average HbA1c levels were mostly stable throughout the study period, after small rises among both age groups from 2008 to 2009. In the younger group, levels averaged between 7.4 to 7.7, and were not significantly impacted by the policy (P=8.0). In the 65-plus group, levels remained stable, between 7.0 to 7.2, and were also not significantly impacted by the new quantity-limiting policy (P=0.97).
Gomes she was not surprised by the findings as "the quantity limits introduced aligned with our current understanding of optimal testing frequency for people with diabetes. However, I am reassured by these findings because they show that this cost-saving policy do not lead to short-term negative impacts on patient safety and diabetes care."
The researchers also conducted a sensitivity analysis to examine the outcomes only among patients who were "high-volume BGTS users," and reported no significant impacts due to the policy on rates of emergency department visits, or average HbA1c levels (P>.05 for all).
"Despite this evidence, clinical practice guidelines have been slow to recommend specific optimal testing frequencies in this population, and have instead recommended that testing frequency be individualized based on factors such as diabetes agents used, level of glycemic control, and history of hypoglycemia," they concluded.
The study had some limitations, such as the assessment of outcomes for only 1.5 years following implementation of the policy so the authors could not draw conclusions about long-term consequences.
The American Association of Clinical Endocrinologists (AACE) released a consensus statement in 2015 recommending that patients with type 2 diabetes test glucose levels three to five times each day. In individuals with type 1 diabetes, AACE recommended monitoring at least eight times each day.
In 2012, an Office of Inspector General report stated that the Centers for Medicare and Medicaid Services overpaid approximately $209 million in coverage for blood glucose test strips during 2007.
In 2016, Medicare announced a Competitive Bidding Program to cut costs associated with diabetes testing. Many healthcare providers panned the program, citing adverse patient outcomes, ultimately leading to higher healthcare costs long-term.
According to a 2106 AACE consensus statement, shortly after the bidding program was implemented, there was a decrease in quantity and quality of blood glucose monitoring supplies, and backlash from several healthcare providers and organizations, citing issues with decreased quality in meters and test strips. The National Minority Quality Forum (NMQF) even called for the program to be suspended.
Gomes told MedPage Today that "we plan to continue to monitor these trends to ensure that there are no longer term consequences of this policy change."