Medication therapy management (MTM) is a mandated component of the 2003 Medicare Modernization Act for Part D prescription drug plans and Medicare Advantage plans, whereby the pharmacist or other qualified provider identifies, resolves, and prevents medication-related problems to optimize the therapeutic outcomes for individual patients.1 MTM programs typically involve a comprehensive review of all medications, both prescription and nonprescription (including natural and herbal products), that a patient is currently taking. In addition, an evaluation of the patient’s medication-taking behavior is conducted, as well as an assessment of the patient’s understanding, concerns, and expectations regarding his or her current medication regimen and health.1
MTM differs greatly from traditional counseling offered by community pharmacists that occurs as part of the drug dispensing process. As part of non-MTM medication dispensing, pharmacists review the drug and identify its indications, directions for use, storage requirements, side effects, long-term toxicity, drug interactions, food interactions, and medication adherence factors. Depending on the number of medications, and whether the patient accepts or denies counseling by a pharmacist at the point of prescription pickup, this service may take approximately 5 to 10 minutes. By contrast, MTM may take 30 to 60 minutes and is a service that is independent of, but can occur in conjunction with, the provision of a medication product.2
MTM promotes collaboration with other healthcare providers, which is especially important as patients undergo transitions in care environments.2 The pharmacist reviews the complete medication profile to explore ways to optimize the patient’s medication therapy. Strategies to optimize medication therapy may include interventions to resolve medication interactions, inappropriate dosing or formulation (eg, tablet vs patch), therapeutic duplication, and ways to improve adherence.2 These strategies are then discussed with the patient’s prescriber for his or her consideration. On prescriber approval, the pharmacist will inform the patient of any medication changes and will then educate the patient on the appropriate medication self-management.2
MTM programs and services have been shown to improve drug therapy goal attainment and medication adherence, as well as to reduce medication errors while reducing overall costs in patients with cardiovascular (CV) disease; however, MTM has been greatly underutilized for chronic diseases, including CV conditions.2-7
Beginning in 2010, Medicare Part D plans were required to implement covered MTM programs that target beneficiaries who have multiple chronic diseases, take multiple medications, and had an anticipated annual drug spending of $4000 in 2009 and $3000 beginning in 2010.8 Health insurance plans cannot require patients to have more than 3 chronic diseases to meet MTM eligibility, and the plans must target at least 4 of 7 core chronic diseases, including hypertension, heart failure, type 2 diabetes, dyslipidemia, respiratory disease, bone disease–arthritis, or mental health.8
National surveys of payers offering MTM programs conducted by the American Pharmacists Association (APhA) indicate that payers believe that the most common challenge to implementing MTM programs is that patients are not interested in these programs or they decline to participate in them, as was indicated by 47% of respondents in a 2010 survey conducted by the APhA.9
The purpose of this present study was to identify the proportion of patients who are eligible for, and who could potentially benefit from, participating in MTM, based on Medicare beneficiaries who were enrolled in a large nationally representative outpatient cardiac registry.
The PINNACLE Registry and Study Population
The PINNACLE Registry is a voluntary registry of the National Cardiovascular Data Registry (NCDR) that was initiated by the American College of Cardiology Foundation (ACCF) and that collects data from outpatient cardiology practices to enhance quality improvement. The registry has a standard data set with written definitions, uniform data entry and transmission requirements, and data quality checks. Details on the data collection process have previously been published.10,11
Within participating practices, a variety of patient data are collected at the point of care, including patients’ symptoms, vital signs, comorbidities, selected laboratory tests, medication classes, and health insurance. In addition, data for established performance measures for myocardial infarction, heart failure, dyslipidemia, and atrial fibrillation are collected.11
Data were collected through paper forms that were completed at the time of the clinic visits, or via modification of a practice’s electronic medical record data collection system to comprehensively capture the requisite PINNACLE Registry data elements. Data from practices are routinely submitted to the NCDR, and data quality checks and analyses for this study were performed at Saint Luke’s Mid America Heart Institute (Kansas City, MO), the primary analytical center for the PINNACLE program. The PINNACLE Registry has been reviewed and approved by the ACCF’s contracted Institutional Review Board.
Identification of MTM-Eligible Patients
For the purpose of this study, we used patient data from 462 academic and private cardiology practices in the PINNACLE Registry between May 1, 2008, and September 30, 2010 (N = 315,973), consisting of 44 office practices representing all 5 regions of the United States. We further restricted the cohort to include only patients with Medicare insurance, which comprised 160,593 patients (Figure 1).
From the Medicare cohort of 160,593 patients, patients who were eligible for MTM were defined as (1) patients who met the criteria for the minimum number (ie, 3) of chronic diseases, and (2) patients who met the minimum drug spending requirements. Patients were included if they had ≥3 chronic diseases, including hypertension, heart failure, dyslipidemia, type 2 diabetes, or coronary artery disease. Of the total Medicare beneficiaries in the PINNACLE Registry, 93,089 (58%) had ≥3 chronic CV conditions, which constituted the final study sample.
Data extracted from the PINNACLE Registry included demographic information (ie, age, sex, race, and insurance type), CV medical history, and CV-related medications. Medication information collected in the PINNACLE Registry and used in this study included the current prescribing of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, calcium channel blockers, diuretics, statins, nonstatin lipid-lowering medications, aspirin, aspirin plus dipyridamole, or thienopyridines.
Because the PINNACLE Registry collects data only on the medication classes that are prescribed and not at the individual medication level, and overall costs by medication class are not available, we used a weighted average cost calculation to assign costs to medication classes. The weighted average cost was calculated based on the market share data for individual medications from each medication class extracted from the HealthCore Integrated Research Database (HIRD), as well as the average wholesale price (AWP). HIRD data from 2010 were collected for 14 health plans, representing regions across the United States.
The market share for each individual medication in a class was calculated by summing all of the prescriptions for that medication and dividing by the total number of prescriptions for the medication class as a whole using the HIRD for 2010. Because the most common medications made up at least 91% of all drugs for a given medication category (range, 91%-100%), only these were used to determine the weighted average cost for each medication class. The relative market share was then calculated based on the most common medications. This relative market share of the most common medications was multiplied by the AWP for the median dose of these medications and then added together to calculate the weighted average cost for each medication class.
Sensitivity analyses for determining eligibility were performed by varying drug costs using AWP for the highest cost and a 10-person multidisciplinary clinician panel–defined most frequently prescribed drug in each class. The drugs that were identified as the most frequently prescribed within each of the drug classes noted earlier were metoprolol tartrate, lisinopril, losartan, amlodipine, hydrochlorothiazide, simvastatin, fenofibrate, aspirin, aspirin plus dipyridamole, and clopidogrel. The descriptive statistics, means, medians, and frequency counts were utilized to report the results.
Table 1 lists patient demographics, clinical characteristics, and medication use for the 93,089 (58%) Medicare beneficiaries enrolled in the PINNACLE Registry who had ≥3 CV conditions. The patients in the PINNACLE Registry are at high risk for CV events, as demonstrated by the high frequency of comorbid CV conditions in this patient population. More than 90% of the patients had hypertension and dyslipidemia, and more than 80% had coronary artery disease—the top 3 conditions in this population. Almost 50% of patients had heart failure, and more than 37% had type 2 diabetes.
As shown in Figure 2, the mean number of medications for CV disease prescribed per patient was 3.5 (± 1.5).
Using the weighted average cost calculation methodology, the median annual estimated medication insurer expenditure per patient was $1329 (Table 2). In the sensitivity analysis, these costs ranged from $366 (low-cost generics identified as frequently prescribed by the clinician panel) to $3958 (highest-cost medication in the class).
In addition, 21.4% of the Medicare patients enrolled in the PINNACLE Registry were eligible for MTM based on the 2010 minimum eligibility rule (ie, an annual insurer medication expenditure of ≥$3000). The percentage of Medicare beneficiaries enrolled in the PINNACLE Registry who were eligible for MTM based on the 2010 minimum eligibility rule ranged from 7.9% (low-cost generics identified as frequently prescribed by the clinician panel) to 64% (highest-cost medication in class).
Because of a lower annual expenditure requirement of $3000 for 2010 compared with $4000 for 2009, the percentage of patients eligible for MTM programs increased by more than 3-fold between 2009 and 2010 (from 6.7% in 2009 to 21.4% in 2010), based on the weighted average cost methodology.
Based on the data from the PINNACLE Registry, we conservatively estimate that 1 in 5 patients in cardiology practices who have Medicare insurance are eligible for covered MTM programs, although variability exists based on the cost method used (ie, either low-cost generics or high-cost medication in class). We regard this as a conservative estimate, because information regarding other chronic core diseases (eg, respiratory disease, bone disease–arthritis, and mental health) targeted for MTM programs by Medicare plans, as well as medications (eg, insulin for diabetes, proton pump inhibitors, and selective serotonin reuptake inhibitors) were not collected in the PINNACLE Registry and therefore are not included in our analysis. Because MTM programs have been shown to improve medication adherence and therapy goal attainment,2-7 we believe that promoting the utilization of such programs to eligible patients should be the responsibility of all healthcare providers within the framework of care advocated by the American College of Cardiology within the framework of the patient-centered medical home for CV care. To our knowledge, this is the first article that estimates MTM eligibility using non–claims-based data.
Currently, physicians cannot make determinations about insurance eligibility for reimbursement of such insurer-sponsored programs. However, patients or their designees may call their health insurance plan and request information on eligibility for such programs, and healthcare providers can directly contact plans to inquire about existing programs that their patients may be eligible for.
Examples of such programs include (1) a medication review by pharmacists, such as eliminating duplication, such as a patient taking 2 ACE inhibitors, by communicating with prescribers; (2) monitoring by pharmacists of therapy goals, such as a pharmacist measuring a patient’s blood pressure (BP) at periodic pharmacy visits and notifying the cardiologist that his or her BP remains above goal; and (3) monitoring by pharmacists for medication adverse effects, such as a pharmacist reviewing medication adherence with a patient and notifying the prescriber that a statin secondary to myalgia has been discontinued and providing assistance with formulating a new plan for managing dyslipidemia. These programs all serve to enhance the quality of care and to assist patients with meeting their health goals.
Recently, the ACCF 2012 Health Policy Statement on Patient-Centered Care in Cardiovascular Medicine highlighted the need for a CV-focused patient-centered medical home (PCMH) that includes a recommendation for nonphysician healthcare team members, such as pharmacists, to be empowered to manage medication-related problems.12
Pharmacists have been involved collaboratively with physicians to provide MTM programs that improve patients’ CV health. A controlled, cluster randomized study showed that patients with hypertension achieved better BP control through physician–pharmacist collaboration than with usual care.13 Office-based, residency-trained clinical pharmacists worked alongside the patients’ primary care physicians at the intervention clinics, whereas the control clinics had no pharmacists. All the enrolled patients had uncontrolled hypertension. At 6 months, hypertension was controlled to goal in 29.9% of patients in the usual care control group and in 63.9% of patients in the intervention group (P <.001).13
In the randomized, controlled SCRIP-HTN trial, a pharmacist-nurse–based team significantly improved the hypertension control in patients with type 2 diabetes and uncontrolled hypertension.14 Intervention with patient lifestyle counseling, 6-week visits to the pharmacy, and faxed communication with the patient’s primary care physician were associated with a 14% absolute increase and a 46% relative increase (P <.001) in the percentage of patients meeting their goal BP of ≤130/80 mm Hg at 24 weeks compared with patients receiving a one-time–only counseling session.14
Similar findings exist with respect to the management of dyslipidemia. In the SCRIP-plus study, community pharmacists in Canada assessed patient risk factors for CV disease through patient interviews, measured BP and finger-stick cholesterol levels, identified high-risk patients who were not at their goal low-density lipoprotein cholesterol (LDL-C) level, and worked with family physicians to help patients meet their goal. At 6 months, 31% of patients who were previously not at LDL-C goal achieved that goal.15 Improvement in LDL-C levels, as well as lower medication costs, were demonstrated in a study comparing pharmacist-based lipid clinic management to usual care.16
Additional benefits of pharmacist MTM have been noted by physicians. McGrath and colleagues conducted focus group sessions to explore physicians’ perceptions of MTM programs led by pharmacists.17 Most physicians had not experienced pharmacist-provided MTM programs, and many physicians were not aware of pharmacist training, including a 6-year professional degree and residency, and preparation, including board certification in pharmacotherapy or ambulatory care, to provide this service.17 However, physicians believed that the greatest benefit of MTM was the receipt of an up-to-date complete medication list that is generated after a pharmacist completes an MTM encounter with a patient.17
Another benefit that physicians found was that MTM programs would address common medication issues they identified in their practices, such as patient nonadherence, side effects, drug interactions, medication costs, and incomplete patient understanding of the medication regimen.17 The potential for pharmacists to reduce hospital readmissions through provisions of MTM services during transitions in care has also been recently highlighted by the American College of Clinical Pharmacy and the American College of Cardiology.18
Pharmacists are also qualified to provide many services that are central to integrated care models, such as the PCMH and accountable care organizations. Expanding services, such as MTM, in these care delivery models presents the opportunity for improved clinical, economic, and humanistic outcomes, as well as increasing the pharmacists’ value to the evolving US healthcare system.19
Although this study involved a large sample size, the patients enrolled in the PINNACLE Registry at the time of the data collection represented 46 office practices and therefore may not necessarily be representative of the entire US cardiology patient population.
Furthermore, because drug class names (eg, ACE inhibitors) and not specific drug names (eg, enalapril, lisinopril) were provided in the registry for some medications, the exact drug costs could not be calculated. Therefore, drug costs were estimated by using a 10-person multidisciplinary clinician panel to identify the most frequently prescribed agents within each class.
Finally, because the PINNACLE Registry does not collect data on non-CV conditions and non-CV medications, the number of chronic diseases per patient and the medication costs were underestimated in this study.
This analysis serves to raise providers’ awareness of their patients’ potential eligibility to receive the benefits of MTM programs. Medicare Part D health plans often notify beneficiaries of potential eligibility for specific disease management programs, such as for hypertension, with subscriber mailings, but they do not inform cardiologists of their individual patient’s eligibility. Payers indicate that the most common barrier to implementing MTM programs is the lack of interest and willingness of patients to participate in such programs. By taking a few minutes to ask patients with multiple CV conditions who are seeing a cardiologist whether they have been contacted by their insurer to participate in an MTM program and by encouraging patients to participate, providers are in a position to explain and to encourage patients to take advantage of such programs.
PINNACLE Registry is an initiative of the American College of Cardiology Foundation, MedAxiom, and Spirit of Women. The Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership is a Founding Sponsor of the PINNACLE Registry.
This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR). The views expressed in this manuscript represent those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies as identified at www.ncdr.com.
Author Disclosure Statement
Dr Spinler, Dr Cziraky, Dr Dueñas, Dr Thomas, Dr Reinhold, Dr Willey, and Ms Tang have reported no conflicts of interest.
- Centers for Medicare & Medicaid Services. Prescription Drug Benefit Manual: Medication Therapy Management and Quality Improvement Program. Revision 11; February 19, 2010. www.cms.gov/PrescriptionDrugCovContra/Downloads/Chapter7.pdf. Accessed April 19, 2013.
- American Pharmacists Association, National Association of Chain Drug Stores Foundation. Medication therapy management in pharmacy practice: core elements of an MTM service model. Version 2.0. March 2008. www.pharmacist.com/mtm/coreelements2. Accessed April 19, 2013.
- Chapman RH, Kowal SL, Cherry SB, et al. The modeled lifetime cost-effectiveness of published adherence-improving interventions for antihypertensive and lipid-lowering medications. Value Health. 2010;13:685-694.
- Carter BL, Foppe van Mil JW. Comparative effectiveness research: evaluating pharmacist interventions and strategies to improve medication adherence. Am J Hypertens. 2010;23:949-955.
- Nkansah N, Mostovetsky O, Yu C, et al. Effect of outpatient pharmacists’ non-dispensing roles on patient outcomes and prescribing patterns. Cochrane Database Syst Rev. 2010;(7):CD000336.
- Machado M, Bajcar J, Guzzo GC, Einarson TR. Sensitivity of patient outcomes to pharmacist interventions: part II: systematic review and meta-analysis in hypertension management. Ann Pharmacother. 2007;41:1770-1781.
- Gonzalez J, Noga M. Medication therapy management. J Manag Care Pharm. 2008;14(suppl S-c):S8-S11.
- Centers for Medicare & Medicaid Services. Issuance of the 2010 Call Letter. March 30, 2009. www.cms.gov/PrescriptionDrugCovContra/Downloads/2010CallLetter.pdf. Accessed April 19, 2013.
- Schommer JC, Doucette WR, Johnson KA, Planas LG. Positioning and integrating medication therapy management. J Am Pharm Assoc (2003). 2012;52:12-24.
- Chan PS, Oetgen WJ, Buchanan D, et al. Cardiac performance measure compliance in outpatients: the American College of Cardiology and National Cardiovascular Data Registry’s PINNACLE (Practice Innovation And Clinical Excellence) program. J Am Coll Cardiol. 2010;56:8-14.
- Chan PS, Oetgen WJ, Spertus JA. The Improving Continuous Cardiac Care (IC3) program and outpatient quality improvement. Am J Med. 2010;123:217-219. Erratum in: Am J Med. 2010;123:e13.
- Walsh MN, Bove AA, Cross RR, et al, for the American College of Cardiology Foundation. ACCF 2012 health policy statement on patient-centered care in cardiovascular medicine: a report of the American College of Cardiology Foundation Clinical Quality Committee. J Am Coll Cardiol. 2012;59:2125-2143.
- Carter BL, Ardery G, Dawson JD, et al. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. 2009;169:1996-2002.
- McLean DL, McAlister FA, Johnson JA, et al, for the SCRIP-HTN Investigators. A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN). Arch Intern Med. 2008;168:2355-2361.
- Tsuyuki RT, Olson KL, Dubyk AM, et al. Effect of community pharmacist intervention on cholesterol levels in patients at high risk of cardiovascular events: the Second Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP-plus). Am J Med. 2004;116:130-133.
- DiTusa L, Luzier AB, Brady PG, et al. A pharmacy-based approach to cholesterol management. Am J Manag Care. 2001;7:973-979.
- McGrath SH, Snyder ME, Dueñas GG, et al. Physician perceptions of pharmacist-provided medication therapy management: qualitative analysis. J Am Pharm Assoc (2003). 2010;50:67-71.
- Wiggins BS, Rodgers JE, DiDomenico RJ, et al. Discharge counseling for patients with heart failure or myocardial infarction: a best practices model developed by members of the American College of Clinical Pharmacy’s Cardiology Practice and Research Network based on the Hospital to Home (H2H) Initiative. Pharmacotherapy. 2013;33:558-580.
- Smith M, Bates DW, Bodenheimer T, Cleary PD. Why pharmacists belong in the medical home. Health Aff (Millwood). 2010;29:906-913.