Association of a Blood Glucose Test Strip Quantity-Limit Policy With Patient Outcomes: A Population-Based Study.
Given their high costs, payers have considered implementing quantity limits for reimbursement of blood glucose test strips. The effect of these limits on patient outcomes is unknown.



To determine whether the introduction of quantity limits for blood glucose test strips in August 2013 was associated with changes in clinical outcomes.



Cross-sectional time series analysis from April 2008 to March 2015 of residents of Ontario, Canada, aged 19 years and older with diabetes who were eligible for public drug coverage. In a sensitivity analysis, we studied high-volume users of test strips, who were most likely to be affected by the quantity limits.



Eligible patients were stratified into 4 mutually exclusive groups based on diabetes therapy: insulin, hypoglycemia-inducing oral diabetes agents, nonhypoglycemia-inducing oral diabetes agents, and no drug therapy.



The primary outcome was emergency department visits for hypoglycemia or hyperglycemia, and the secondary outcome was mean hemoglobin A1c (HbA1c) levels. Outcomes were measured for all patients in each quarter, stratified by age group (<65 vs ≥65 years) and diabetes therapy.



By the end of the study period, 834 309 people met inclusion criteria. Among those younger than 65 years, the rate of hypoglycemia and hyperglycemia declined over the study period (from 4.9 to 3.0 visits per 1000 Ontario drug benefit [ODB]-eligible patients and from 4.2 to 3.6 visits per 1000 ODB-eligible patients, respectively) and was not significantly associated with the introduction of quantity limits (P = .67 and P  = .37, respectively). Similarly, among those aged 65 years and older, rates of hypoglycemia and hyperglycemia declined over the study period (from 2.9 to 1.3 visits per 1000 eligible patients and from 0.8 to 0.5 visits per 1000 eligible patients, respectively) and was not significantly associated with the introduction of quantity limits (P = .12 and P = .24, respectively). Results were consistent for the secondary outcome of mean HbA1c levels and in the sensitivity analysis of high-volume test strip users.



The imposition of quantity limits for blood glucose test strips was not associated with worsening short-term outcomes, suggesting that these policies can reduce costs associated with test strips without causing patient harm.
Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada2The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada3Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada4Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Tara
T
Gomes
The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada.
Diana
D
Martins
Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada2The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada3Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Mina
M
Tadrous
The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada4Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada5Department of Family Medicine, McMaster University, Toronto, Ontario, Canada.
J Michael
JM
Paterson
The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada4Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada6Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada7Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Baiju R
BR
Shah
The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada4Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada7Department of Medicine, University of Toronto, Toronto, Ontario, Canada8Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Jack V
JV
Tu
The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada4Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada6Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada7Department of Medicine, University of Toronto, Toronto, Ontario, Canada9Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
David N
DN
Juurlink
The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada7Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Anna
A
Chu
Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada2The Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada3Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada4Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada7Department of Medicine, University of Toronto, Toronto, Ontario, Canada10St Michael's Hospital, Toronto, Ontario, Canada.
Muhammad M
MM
Mamdani
D000368:Aged; D015190:Blood Glucose Self-Monitoring / Q000191:economics* / Q000295:instrumentation*; D017046:Cost Savings; D003365:Costs and Cost Analysis; D003430:Cross-Sectional Studies; D003920:Diabetes Mellitus / Q000097:blood* / Q000191:economics*; D005260:Female; D006291:Health Policy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009864:Ontario