Pengxiang Li, PhD; Sean McElligott, MS; Henry Bergquist, BS; J. Sanford Schwartz, MD; Jalpa A. Doshi, PhD
Disclaimer: Drs. Li and Doshi had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Grant Support: By investigator-initiated grants from the Penn–Pfizer Alliance and the American Heart Association.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2255.
Reproducible Research Statement:Statistical code: Available from Dr. Li (e-mail, firstname.lastname@example.org). Study protocol and data set: Not available.
Requests for Single Reprints: Jalpa A. Doshi, PhD, Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Blockley Hall, Room 1222, Philadelphia, PA 19104-6021; e-mail, email@example.com.
Current Author Addresses: Dr. Li: Blockley Hall, Room 1215, Philadelphia, PA 19104-6021.
Mr. McElligott: Blockley Hall, Room 1208, Philadelphia, PA 19104-6021.
Mr. Bergquist: 3641 Locust Walk, Philadelphia, PA 19014-6218.
Dr. Schwartz: Blockley Hall #1101, 423 Guardian Drive, Philadelphia, PA 19104-6021.
Dr. Doshi: Blockley Hall, Room 1222, Philadelphia, PA 19104-6021.
Author Contributions: Conception and Design: P. Li, S. McElligott, J.S. Schwartz, J.A. Doshi.
Analysis and interpretation of the data: P. Li, S. McElligott, H. Bergquist, J.S. Schwartz, J.A. Doshi.
Drafting of the article: P. Li, S. McElligott, H. Bergquist, J.S. Schwartz, J.A. Doshi.
Critical revision of the article for important intellectual content: P. Li, S. McElligott, J.S. Schwartz, J.A. Doshi.
Final approval of the article: P. Li, S. McElligott, J.S. Schwartz, J.A. Doshi.
Provision of study materials or patients: J.A. Doshi.
Statistical expertise: P. Li, S. McElligott, J.S. Schwartz, J.A. Doshi.
Obtaining of funding: J.S. Schwartz, J.A. Doshi.
Administrative, technical, or logistic support: P. Li, S. McElligott, H. Bergquist, J.A. Doshi.
Collection and assembly of data: P. Li, S. McElligott, J.A. Doshi.
Li P, McElligott S, Bergquist H, Schwartz JS, Doshi JA. Effect of the Medicare Part D Coverage Gap on Medication Use Among Patients With Hypertension and Hyperlipidemia. Ann Intern Med. 2012;156:776-784. doi: 10.7326/0003-4819-156-11-201206050-00004
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Published: Ann Intern Med. 2012;156(11):776-784.
Prior studies of the Medicare Part D coverage gap are limited in generalizability and scope.
To determine the effect of the coverage gap on drugs used for asymptomatic (antihypertensive and lipid-lowering drugs) and symptomatic (pain relievers, acid suppressants, and antidepressants) conditions in elderly patients with hypertension and hyperlipidemia.
Quasi-experimental study using pre–post design and contemporaneous control group.
Medicare claims files from 2005 and 2006 for 5% random sample of Medicare beneficiaries.
Part D plan enrollees with hypertension or hyperlipidemia aged 65 years or older who had no coverage, generic-only coverage, or both brand-name and generic coverage during the gap in 2006. Patients who were fully eligible for the low-income subsidy served as the control group.
Monthly 30-day supply prescriptions available, medication adherence, and continuous medication gaps of 30 days or more for antihypertensive or lipid-lowering drugs; monthly 30-day supply prescriptions available for pain relievers, acid suppressants, or antidepressants before and after coverage gap entry.
Patients with no gap coverage had a decrease in monthly antihypertensive and lipid-lowering drug prescriptions during the coverage gap. Nonadherence also increased in this group (antihypertensives: odds ratio [OR], 1.60 [95% CI, 1.50 to 1.71]; lipid-lowering drugs: OR, 1.59 [CI, 1.50 to 1.68]). The proportion of patients with no gap coverage who had continuous medication gaps in lipid-lowering medication use and antihypertensive use increased by an absolute 7.3% (OR, 1.38 [CI, 1.29 to 1.46]) and 3.2% (OR, 1.35 [CI, 1.25 to 1.45]), respectively, because of the coverage gap. Decreases in use were smaller for pain relievers and antidepressants and larger for acid suppressants in patients with no gap coverage. Patients with generic-only coverage had decreased use of cardiovascular medications but no change in use of drugs for symptomatic conditions. No measures changed in the brand-name and generic coverage groups. Results of sensitivity analyses were consistent with the main findings.
Because this study was nonrandomized, unobserved differences may still exist between study groups.
The Part D coverage gap was associated with decreased use of medications for hypertension and hyperlipidemia in patients with no gap coverage and generic-only gap coverage. The proposed phasing out of the gap by 2020 will benefit such patients; however, use of low-value medications may also increase.
Penn–Pfizer Alliance and American Heart Association.
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Cardiology, Nephrology, Dyslipidemia, Hypertension, Healthcare Delivery and Policy.
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