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[Federal Register Volume 78, Number 180 (Tuesday, September 17, 2013)]
[Notices]
[Pages 57159-57161]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22579]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Scientific Information Request on Medication Therapy Management

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public on 
medication therapy management Scientific information is being solicited 
to inform our review of Medication Therapy Management, which is 
currently being conducted by the Evidence-based Practice Centers for 
the AHRQ Effective Health Care Program. Access to published and 
unpublished pertinent scientific information on medication therapy 
management will improve the quality of this review. AHRQ is conducting 
this comparative effectiveness review pursuant to Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173, and Section 902(a) of the Public Health Service 
Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before October 17, 2013.

ADDRESSES: Online submissions: http://effectivehealthcareAHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the 
study for which you are submitting information from the list to upload 
your documents.
    Email submissions: /src.org">src.org">SIPS@epc-src.org.
    Print submissions:

Mailing Address: Portland VA Research Foundation, Scientific Resource 
Center, ATTN: Scientific Information Packet Coordinator, P.O. Box 
69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation, 
Scientific Resource Center, ATTN: Scientific Information Packet 
Coordinator, 3710 SW., U.S. Veterans Hospital Road, Mail Code: R&D 71, 
Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: 503-220-8262 ext. 58652 or Email: /src.org">src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete a review of the evidence 
for Medication Therapy Management.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on medication therapy management, including those that 
describe adverse events. The entire research protocol, including the 
key questions, is also available online at: http://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=1601.
    This notice is to notify the public that the EHC program would find 
the following information on medication therapy management helpful:
    [ssquf] A list of completed studies your company has sponsored. In 
the list, indicate whether results are available on ClinicalTrials.gov 
along with the ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies your company has sponsored. In 
the list, please provide the ClinicalTrials.gov trial number or, if the 
trial is not registered, the protocol for the study including a study 
number, the study period, design, methodology, indication and 
diagnosis, proper use instructions, inclusion and exclusion criteria, 
and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your company for this 
indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. The contents 
of all submissions will be made available to the public upon request. 
Materials submitted must be publicly available or can be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review, such as cross-sectional studies, case 
series, case reports, before-and-after designs without a control group, 
and program evaluation data that does not include a comparison group; 
or information on indications not included in the review cannot be used 
by the Effective Health Care Program. This is a voluntary request for 
information, and all costs for complying with this request must be 
borne by the submitter.
    The draft of this review will be posted on AHRQ's EHC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions. The entire research 
protocol, is also available online at: http://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=1601.

Question 1

    What are the components and implementation features of MTM 
interventions?

Question 2

    In adults with one or more chronic diseases who are taking 
prescription

[[Page 57160]]

medication, is MTM effective in improving the following:
    a. Intermediate outcomes, including biometric and laboratory 
measures, drug therapy problems identified, drug therapy problems 
resolved, medication adherence, goals of therapy met, and patient 
engagement in medication management?
    b. Patient-centered outcomes, such as disease-specific morbidity, 
disease-specific or all cause mortality, adverse drug events, health-
related quality of life, activities of daily living, patient 
satisfaction with health care, work or school absenteeism, and patient 
and caregiver participation in medical care and decisionmaking?
    c. Resource utilization, such as prescription drug costs, other 
health care costs, and health care utilization?

Question 3

    Does the effectiveness of MTM differ by MTM components and 
implementation features?

Question 4

    Does the effectiveness of MTM differ by patient characteristics, 
including but not limited to patient demographics and numbers and types 
of conditions and medications?

Question 5

    Are there harms of MTM, and if so, what are they?
    The PICOTS (Population(s), Interventions, Comparators, Outcomes, 
Timing, and Settings) criteria for the comparative effectiveness review 
are as follows:

Population(s)

 Patients ages 18 or older with one or more chronic conditions 
requiring the use of prescription medication to manage symptoms or 
prevent progression of chronic disease
 Patient characteristics that may influence intervention 
effectiveness:
    [cir] Age, sex, race and ethnicity, socioeconomic status, health 
insurance status, education level, health literacy status, cognitive 
impairment, number and types of chronic conditions, social support, and 
urban/rural status

Interventions

 Explicitly termed MTM services, generally provided as a bundle 
of related services, that include at a minimum four of the following 
elements:
    [cir] Comprehensive medication review
    [cir] Patient-directed medication management action plan, with or 
without an equivalent prescriber-directed action plan
    [cir] Patient-directed education and counseling or other resources 
to enhance understanding of the use of medication
    [cir] Coordination of care, including prescriber-directed 
interventions; documentation of MTM services for use by the patient's 
other providers; and referral to other providers, clinicians, or 
resources when appropriate
 MTM-like services that are provided as a bundle or 
multicomponent intervention, even if not explicitly termed ``medication 
therapy management''

    The following types of interventions generally are not considered 
MTM interventions and will not be included:

[cir] Medication reconciliation interventions
[cir] Integrated pharmacy services within inpatient settings
[cir] One-time corrective actions related to medication management
[cir] Disease management interventions
[cir] Case or care management interventions
     The following types of interventions may include MTM 
services, but MTM may represent only one component of the overall 
intervention:
[cir] Patient-centered home health care-delivery model
[cir] Fully integrated, collaborative care models involving multiple 
disciplines and specialties

    Studies should contain the same level of overall medical care/
health care services among different study arms such that the effect of 
MTM interventions can be isolated. For example, a study with two arms 
that has one arm with a care management intervention that includes MTM 
services and the other arm that has the care management intervention 
without MTM services could be included. A study that includes a care 
management intervention with MTM in one arm and usual medical care (no 
care management intervention) in the other arm would not be included.
     Implementation features that may influence intervention 
effectiveness include the following:

[cir] Mode of delivery: telephonic, face to face, virtual (Web/online/
Internet), and remote video
[cir] Type of professional providing initial and followup MTM service: 
pharmacist, nurse, physician, other clinician
[cir] Frequency and interval of followup for MTM services
[cir] Specific MTM components used
[cir] Fidelity in implementing MTM components: to what extent were 
services delivered as designed or intended
[cir] Establishing and communicating goals of drug therapy to patients 
and among care providers
[cir] Method of identifying patients for enrollment (e.g., population 
health data, provider referral for services, enrollment during a 
transition in care, targeting highly activated patients, targeting 
patients at time of high risk for event [e.g., when prescribing a new 
drug])
[cir] Level of integration of MTM with usual care, which includes 
access to real-time clinical information and laboratory values, and 
regular and consistent communication among prescribers and persons 
providing MTM services
[cir] Reimbursement characteristics (e.g., who is paying for cost of 
MTM services, who is reimbursed for MTM services, whether services are 
separately reimbursable)
[cir] Health system characteristics (e.g., are services being provided 
within an accountable care organization, patient-centered medical home, 
or some other unique system setting [e.g., the VHA, the Indian Health 
Service, non-U.S. single-payer system])

Comparators

 Usual care, as defined by the studies
 Individual components of MTM services (e.g., MTM services with 
four components vs. a single component)
 Different bundles of MTM services
 Same MTM services provided by different health care 
professionals (e.g., pharmacist, physician, nurse, other)
 Same bundles of MTM services delivered by different modes 
(e.g., telephone or in person)
 Same MTM services provided at different intensities, 
frequencies, or level of integration with prescribers

Outcomes

 Intermediate Outcomes
[cir] Disease-specific laboratory or biometric outcomes (e.g., 
hemoglobin A1c; blood pressure; total, low-density lipoprotein, or 
high-density lipoprotein cholesterol; pulmonary function; renal 
function; left ventricular ejection fraction; or other lab or biometric 
outcome specific to diseases covered)
[cir] Drug therapy problems identified as defined by primary studies 
but typically including the following:

[[Page 57161]]

medications being taken but not indicated; medications indicated but 
not prescribed; patient adherence issues; supratherapeutic doses; 
subtherapeutic doses; generic, formulary, or therapeutic substitution 
issues; complex regimen that can be simplified with same therapeutic 
benefit; and potential for drug-drug interactions or adverse events.
[cir] Drug therapy problems that resolved as defined by primary studies 
but typically including the following: needed drug initiated; 
unnecessary drug discontinued; change in drug dose, form, or frequency; 
or generic, formulary, or therapeutic substitution
[cir] Medication adherence
[cir] Goals of therapy met
[cir] Patient engagement (e.g., initial and continuing patient 
participation in the MTM program)
 Patient-Centered Outcomes
[cir] Disease-specific morbidity, including falls and fall-related 
morbidity and outcomes specific to the patient's underlying chronic 
conditions (e.g., Patient Health Questionnaire 9 [PHQ9], disease-
specific symptoms, reduced number of disease-specific acute 
exacerbations or events)
[cir] Disease-specific or all-cause mortality, including fall-related 
mortality
[cir] Reduced (actual) adverse drug events (frequency and/or severity)
[cir] Health-related quality of life as measured by generally accepted 
generic health-related quality-of-life measures (e.g., short-form 
questionnaires, EuroQOL) or disease-specific measures
[cir] Activities of daily living as measured by generally accepted 
standardized measures of basic and/or instrumental activities of daily 
living (e.g., Katz, Lawton, or Bristol instruments) or with instruments 
that have demonstrated validity and reliability
[cir] Patient satisfaction with care
[cir] Work or school absenteeism
[cir] Patient and caregiver participation in medical care and 
decisionmaking
 Resource Utilization
[cir] Prescription drug costs and appropriate prescription drug 
expenditures
[cir] Other health care costs
[cir] Health care utilization (hospitalizations, emergency department 
visits, and physician office visits)
 Harms
[cir] Care fragmentation
[cir] Patient confusion
[cir] Patient decisional conflict
[cir] Patient anxiety
[cir] Increased (actual) adverse drug events
[cir] Patient dissatisfaction with care
[cir] Prescriber confusion
[cir] Prescriber dissatisfaction

Timing

     Interventions should have at least two separately 
identifiable episodes of care (either patient or provider directed or 
both), but there is no certain amount of time in between those 
episodes.
     For studies that report outcomes at different points in 
time, we will only consider outcomes measured after the second episode 
of care.

Settings

     Patients must have been seen in ambulatory settings (e.g., 
outpatient clinics or private physician offices, long-term care, or 
retail pharmacy settings).
     However, the MTM intervention itself may be delivered by 
telephone, via the Web, or in other non-face-to-face modalities, such 
as video teleconferencing.
     MTM services that are delivered mostly in inpatient 
settings will not be included.
     Interventions conducted in the United States and other 
countries and are published in English will be included.

    Dated: September 6, 2013.
Richard Kronick,
AHRQ Director.
[FR Doc. 2013-22579 Filed 9-16-13; 8:45 am]
BILLING CODE 4160-90-P
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