Study unveils drop in adherence to cardiovascular meds during 'doughnut hole' gap

WOONSOCKET, R.I. — Medicare Part D beneficiaries with cardiovascular conditions who had no financial assistance during the "doughnut hole" coverage gap were 57% more likely to discontinue their cardiovascular medications than those beneficiaries who had consistent drug coverage, according to a study conducted by researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark.

The study, entitled "Beneficiaries with Cardiovascular Disease and the Part D Coverage Gap," was published Tuesday in the journal Circulation: Cardiovascular Quality and Outcomes.

While the study found no increase in short-term negative health issues during the coverage gap, the long-term health impact of nonadherence to cardiovascular drugs during the coverage gap is unclear.

The study examined prescription drug usage for cardiovascular conditions (i.e., hypertension, high cholesterol, atrial fibrillation, congestive heart failure or cardiovascular disease) among more than 122,000 Medicare beneficiaries who reached the Medicare Part D doughnut hole in 2006 or 2007.

The researchers concluded that cost-sharing mechanisms, such as the coverage gap, disrupted the beneficial effects of drug coverage expansion under Part D for elderly beneficiaries with cardiovascular conditions, instead prompting them to discontinue their medications more frequently than beneficiaries who had stable drug coverage. In addition, the results showed that beneficiaries were no more likely to switch to generic medications during the doughnut hole.

"Consistent with other research on the impact of the Medicare Part D coverage gap on medication adherence, we found that exposure to 100% of drug costs in the gap led to abrupt discontinuation of essential cardiovascular medications, even among those with cardiovascular conditions who might experience more immediate consequences as a result of drug discontinuation," said Jennifer Polinski, of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital and Harvard Medical School, and lead author of the study. "While the results did not demonstrate any short-term health issues as a result of this dramatic drop-off in medication adherence, it is not clear whether coverage gap-related lapses in financial assistance for drugs affects patient health outcomes for this high risk population over the long term."

"This study is part of our ongoing research collaboration with Harvard and Brigham and Women's Hospital to help better understand those factors that can improve pharmacy care," added Troyen Brennan, EVP and chief medical officer of CVS Caremark, who heads the research initiative that conducted the study. "The Affordable Care Act incrementally eliminates the 'doughnut hole' by 2020, but until that time we want to make sure beneficiaries are making the best decisions to promote good health. For our part, we will continue to advocate for plan strategies that promote the use of low cost medications, because cost remains a big issue in helping patients stay on their medications as directed."

When Congress created the Medicare Part D program, the standard benefit design included a coverage gap, known widely as the "doughnut hole." Under the standard benefit, Medicare Part D enrollees receive financial assistance to pay for drugs until plan and out-of-pocket spending reaches an initial threshold of $2,830 (2010). At that point, the Medicare beneficiary is financially responsible for 100% of medication costs until they have spent more than $4,550 (2010), when the program's financial benefits begin again. The research team notes that cardiovascular drugs account for the largest proportion of spending (25%) and prescription volume (36%) in the Part D program.

The study is a product of a research collaboration between CVS Caremark, Harvard and Brigham and Women's Hospital that is focused on understanding why many consumers do not take their prescriptions as directed, and developing solutions to assist patients in using their medications effectively. Annual excess healthcare costs because of medication nonadherence in the United States are estimated to be as much as $300 billion annually.

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