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The US Medicare Prescription Drug, Improvement, and Modernization Act (MMA) implemented in 2006 introduced outpatient prescription drug (Part D) coverage for Medicare beneficiaries. The Part D programme was implemented to reduce out-of-pocket prescription drug expenses, lower the cost of prescription drugs and improve access.[1, 2] To ensure appropriate medication management, the Centers for Medicare and Medicaid Services (CMS) have created a quality evaluation system called Star Ratings to indicate the quality of Medicare Part D. This rating is based on a scale of one to five stars, with five stars being the highest rating. One of the measures included in the Medicare Part D Star Rating is the appropriate treatment of hypertension in patients with diabetes. This is one of the six measures under the domain of Patient Safety and Accuracy of Drug Pricing. The measure indicates the percentage of patients with diabetes and hypertension who receive angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (ACEs/ARBs). The use of ACEs/ARBs has been shown to reduce cardiovascular disease and progression of nephropathy[4-6] and has been recommended as the first-line therapy for patients with diabetes and hypertension.
It has been found that the percentage of patients with diabetes and hypertension among adults 65 and older increased from 9 to 15% from 2000 to 2010. However, previous studies found low rates of utilization of ACEs/ARBs in patients with diabetes and hypertension.[9-11] Because of the overall increase in medication utilization after Medicare Part D implementation,[12-14] it is important to determine the status of the receipt of ACEs/ARBs among Medicare beneficiaries with diabetes and hypertension after Part D implementation. The specific objectives of this study were (1) to determine the rate of receipt of ACEs/ARBs in physician-office and outpatient visits by Medicare beneficiaries with diabetes and hypertension and (2) to identify the patient- and community-level characteristics that predict the receipt of ACEs/ARBs.
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Our analysis of US national survey data revealed that fewer than half of the outpatient visits were associated with receiving ACEs/ARBs. This relatively low level of receipt of ACEs/ARBs during visits by the Medicare population is a major concern, because ACEs/ARBs are considered the first-line therapy and are one of the CMS's quality measures for medication management to rate Medicare Part D plans.[3, 7] A recent report from the CMS showed the rate of utilization of ACEs/ARBs to be between 56.5 and 91.9% in 2011 for Medicare Advantage Prescription Drug Plans (MAPDs) and Prescription Drug Plans (PDPs). The CMS annually raises the required threshold for the plans to achieve higher ratings for this measure with the objective of continuous quality improvement. For 2011 the four-star threshold for the rate of ACE/ARB use for MAPDs was ≥86% and for PDPs was ≥83%. The proposed four-star threshold for 2012 data for MAPDs was >87% and for PDPs was >84%.
The lower rates of receiving ACEs/ARBs in the present study in comparison to the rates reported by the CMS may partly be explained by different methods of calculating these rates. The CMS defines appropriate treatment of hypertension in patients with diabetes as the proportion of patients who receive an ACE/ARB among patients who fill a prescription for diabetes and hypertension. However, the sample in this study was selected based on a diagnosis for diabetes and hypertension and was not limited to individuals with a medication filled for diabetes and hypertension. Previous population-based studies found the use of ACEs/ARBs among patients with diabetes and hypertension to be between 46 and 64%.[9-11, 19] Although studies conducted after implementation of Medicare Part D have shown an overall increase in medication use,[12-14] the present study found that ACEs/ARBs were not received during the majority of physician-office and outpatient department visits made by Medicare beneficiaries with diabetes and hypertension.
The lower rates of receiving these medications might also be due to physicians failing to prescribe ACEs/ARBs. The 2010 US Patient Protection and Affordable Care Act (ACA) has directed efforts at physicians to promote the practice of evidence-based medicine. One ACA provision is to allow providers organized as Accountable Care Organizations (ACOs) that voluntarily meet quality thresholds to share in the cost savings they achieve for the Medicare programme. To qualify as an ACO organizations must agree to be accountable for the overall care of their Medicare beneficiaries, have adequate participation of primary care physicians, define processes to promote evidence-based medicine, report on quality and costs, and coordinate care. This provision may increase the receipt of ACEs/ARBs among patients with diabetes and hypertension.
Another approach to achieving a high plan rating for the measure of receiving ACEs/ARBs among Medicare beneficiaries with diabetes and hypertension would be to provide medication therapy management (MTM) services by pharmacists and other qualified healthcare providers. Being one of the most accessible types of healthcare professional, pharmacists are in a prime position to provide these services. Studies have reported the benefit of incorporating pharmacists as a part of the healthcare team for managing chronic diseases.[23, 24] One study reported a 41.41% prescriber approval rate for guideline-adherent recommendations by pharmacists. The same study also found that primary care physicians had higher rates of approving pharmacist recommendations than specialists. Since primary care physicians are in short supply, pharmacists may take a more active role in the healthcare team. The National Quality Strategy, which is required by the ACA, addresses a range of quality concerns affecting individuals. Although there are many accepted quality measures, it has been found that inadequate measures exist in some areas, such as care coordination and patient engagement.  Providing MTM services can be one of the ways to address issues with care coordination and patient engagement.
The bivariate and multivariate findings revealed that patients who made visits to primary care physicians were more likely to receive ACEs/ARBs. This finding is consistent with other studies, which have found positive patient outcomes associated with having access to a primary care physician.[27, 28] The US healthcare system has been facing a decline in its primary care workforce. Lack of financial incentives and poor reimbursement have resulted in many physicians choosing to train and practice specialty medicine. Studies have found that although 56% of patient visits in America are to primary care, only 37% of physicians practice primary care medicine and only 8% of the nation's medical school graduates go into family medicine.[29, 30] The ACA also has several provisions aimed at improving access to primary care, including a 10% bonus for primary care providers under the Medicare fee schedule and an additional $230 million in award grants which will go to teaching health centres to start primary care residency programmes. One challenge in the successful implementation of these provisions would be the long time period required to train new primary care physicians.
This study found that visits made by patients from the zip codes with a median household income in quartile 2 were more likely to be associated with receiving ACEs/ARBs than visits made by patients from zip codes with quartile 1 median household incomes. None of the other patient- and community-level factors were associated with receiving ACEs/ARBs. In contrast, other population-based studies found the use of ACEs/ARBs to be associated with sociodemographic factors. These factors included gender, age and race in previous studies.[9-11, 19] Since this study was based on a sample of physician-office and outpatient visits, the patients already had access to health care. Additionally, unlike other population-based studies, the enabling characteristics such as education and income denote the education and income level of an area rather than the individual. These might be some reasons for the lack of significant association between sociodemographic characteristics and receiving ACEs/ARBs.
The present study has made new contributions to the existing research. First, the study updates previous research on the rate of ACEs/ARBs among Medicare beneficiaries by using data after the implementation of Medicare Part D. Second, in this study the data were collected from the patient record form completed by the provider, and were not based on recall by patients, which may provide a better assessment of the quality of care provided during routine visits to physician-office and outpatient department settings. Thus, findings from this study provide updated information to policy makers, health plans and physicians regarding the adequacy of evidence-based pharmacotherapy in patients with diabetes and hypertension. In addition, this study also highlights the positive association between visits made to primary care physicians and receiving the recommended pharmacotherapy for the treatment of hypertension among diabetic patients. The findings of this study add to the body of evidence, indicating the importance of primary care physicians, and may provide policy makers with further justification to increase the supply of these providers.
Our study has some limitations. First, the data did not contain patient identifiers so they cannot be used to determine prevalence estimates. Since the data were based on visits, it is possible that sicker patients and those making more frequent follow-up visits may have been repeated in the sample. Second, this study used the NAMCS and NHAMCS-OPD databases (2007–2009), which are secondary in nature. As a result, this study had to rely on only those variables which are available in the databases. Third, the results of this study are only applicable to patients making physician-office and outpatient visits and do not represent the entire US population. Fourth, the databases include only eight prescribed medications; thus it is possible that ACEs/ARBs could have been omitted for patients treated with more than eight drugs. Finally, the NAMCS and NHAMCS databases do not report income at the individual level, which can be a more reliable measure than income level according to zip code.