Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

1. Which patients benefit the most from MTM services?

1.1. Which factors, or combinations of factors, are most predictive of the clinical benefit of MTM services?

1.1.1. Disease factors (e.g., diabetes vs COPD ; multi-morbidity vs single disease; recent diagnosis vs long-standing illness)

1.1.2. Patient characteristics (e.g., age, gender, cognitive function, race/ethnicity, education level, health literacy, income)

1.1.3. Medication factors (e.g., number of medications, total expenditures on medications, patient out-of-pocket expenditures on medications, or type of medication [high-risk drugs])?

1.1.4. System factors (e.g., number of prescribers for patient, geographic location [rural vs urban], dual-eligibility for Medicaid/Medicare, undergoing transition in care)?

1.2. What is the relative importance of disease state vs patient characteristics vs socioeconomic vs medication variables in predicting the cost-effectiveness of MTM services? What are the interactive effects of these variables? 2. What is the optimal structure and process for delivering MTM services?

2.1. What are the relative clinical effectiveness and cost-effectiveness of different delivery modes (e.g., telephonic vs face-to-face vs blended)? How does the delivery mode interact with the characteristics of the population in predicting the effectiveness of MTM?

2.2.What is the optimal timing of MTM services relative to events or diagnosis (e.g., initiation of drug therapy; gap in adherence; care transition; time from diagnosis) and what are the most successful approaches to patient enrollment in each of these situations?

2.3. What are the key components of MTM services and how can these be matched appropriately to the needs of the patient (e.g., comprehensive medication review upon addition of new therapy; medication reconciliation during care transition)?

2.4.What is the optimal frequency of follow-up consultations after the in

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

The research would compare different models for assisting patients in managing their medications for chronic diseases. See response to item #1 regarding specific research questions.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Although the research may be pertinent to all patients with chronic conditions, it would be most important to study the effectiveness of MTM services for Medicare beneficiaries with multiple chronic conditions. Medicare Part D benefits include a requirement for prescription drug plans to offer MTM services to Medicare beneficiaries with 2 or more chronic conditions and high drug expenditures. However, we believe that an important aspect of this research is that it will help to identify the patients who would most greatly benefit from the MTM services so that the Medicare requirements for MTM can direct the services to patients in greatest need. This may improve both the effectiveness and efficiency of the Part D benefit.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

There is a growing body of evidence that MTM services (including pharmacists’ clinical recommendations to patient-care teams) may lead to more appropriate prescribing of medications and improved patient adherence to medication regimens. In turn, the improved use of medications may lead to improved clinical outcomes (e.g., blood pressure¸ A1c, LDL), reduced incidence of adverse drug-related events and lower rates of hospitalizations, re-hospitalizations or nursing home admissions.

Describe any health-related risks, side effects, or harms that you are concerned about.

The risks associated with prospective studies of MTM services should be minimal and can be managed through appropriate coordination of services with the patient’s physician(s). If retrospective analyses or evidence syntheses are conducted, there would be no risks to patients.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Arthritis and nontraumatic joint disorders
• Cancer
• Cardiovascular disease, including stroke and hypertension
• Dementia, including Alzheimer's disease
• Depression and other mental health disorders
• Diabetes mellitus
• Infectious diseases, including HIV/AIDS
• Peptic ulcer disease and dyspepsia
• Pulmonary disease/asthma

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Children
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Chronic diseases are highly prevalent in the United States where nearly 1 in 2 adults live with at least 1 chronic disease (CDC, 2009). Recent analyses have shown that over 75% of healthcare spending is due to chronic disease and that two-thirds of the rise in healthcare expenditures has been due to the increased prevalence of treated chronic disease. (Partnership to Fight Chronic Disease, 2009). Medications are a key component of treating chronic disease, yet research has shown that the quality of medication use is far from optimal. Congress recognized the need for better management of medication therapy by including provisions for medication therapy management (MTM) within the Medicare Part D drug benefit. Although there are small studies that demonstrate the potential benefit of MTM services, there is a dearth of evidence on the comparative effectiveness of different models for MTM services or the best methods for engagement of patients in these services or for evaluation of these services.

There is a need for better evidence to guide the refinement of statutory requirements, and CMS guidance, for prescription drug plans regarding the provision of MTM services. The current eligibility criteria limit the inclusion of patients to those with multi-morbidity and high drug expenditures. These limitations may preclude enrollment of patients with poor adherence to their chronic medications (since patients who do not refill their medications are unlikely to meet the threshold for drug expenditures), and also preclude enrollment of patients with only one chronic disease. It is possible that some patients who do not currently meet the eligibility criteria may benefit from MTM services more so than some patients who are currently eligible.

There is also a need to determine the optimal structures and processes for providing MTM services to patients. Given the wide variety of MTM services being implemented and the uncertainties as to the relative effectivenes

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

Many of the member organizations of PQA are seeking to optimize the effectiveness and cost-effectiveness of MTM services. PQA coordinates a workgroup on MTM services and brings together clinicians, payers and researchers to discuss crucial issues in MTM including how to measure the impact of MTM and the quality of MTM services. This workgroup is limited in its ability to provide specific guidance on the optimal structure and process of MTM due to a lack of comparative evidence on different models of MTM.

Another significant factor that has prompted this recommendation to the Effective Health Care Program is the passage of the healthcare reform act with provisions related to MTM. Congress included an authorization for “MTM grants” to be coordinated by AHRQ (Section 3503), but has not appropriated the funds to carry out the MTM grants program in the current fiscal year. Even if Congress does provide funding for Section 3503 at some point in the future, there will still be great value in having AHRQ’s Effective Health Care Program synthesize the existing evidence on MTM and identify the existing gaps in knowledge. We also believe that there is a wealth of retrospective data from health plans, drug plans and MTM providers that could be analyzed to begin filling the gaps in the evidence base and to identify best practices.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

As noted in items 8 and 9, there is significant uncertainty in how to optimally deliver MTM services and how to structure enrollment and payment policies for MTM.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

The evidence will help CMS refine its policies on MTM for Medicare beneficiaries, and will also be useful to CMS and the states for Medicaid policies regarding medication use. Health plans and employers can also use this evidence to create more appropriate services to optimize the health of patients in the private sector. Furthermore, it will help PQA provide specific recommendations to MTM providers on best practices in MTM.

Describe the timeframe in which an answer to your question is needed.

As soon as possible.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

We believe it is important that a research program on MTM services include studies to determine the best practices for engaging different sub-populations of patients in MTM to reduce disparities in medication use and health outcomes.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

The evidence will help CMS refine its policies on MTM for Medicare beneficiaries, and will also be useful to CMS and the states for Medicaid policies regarding medication use. Health plans and employers can also use this evidence to create more appropriate services to optimize the health of patients in the private sector. Furthermore, it will help PQA provide specific recommendations to MTM providers on best practices in MTM.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program