Federal Register / Vol. 78, No. 180 / Tuesday, September 17, 2013 / Notices 57159 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: September 10, 2013. 

Richard Kronick, 

Director. 

[FR Doc. 2013–22578 Filed 9–16–13; 8:45 am] 

BILLING CODE 4160–90–P 

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. 

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unpublished pertinent scientific 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-informationpackets/. Please select the study for 

which you are submitting information 

from the list to upload your documents. 

Email submissions: 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: SIPS@epc-src.org. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the Effective 

Health Care (EHC) Program Evidencebased 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-andreports/?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: 

D 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. 

D 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. 

D 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. 

D 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, beforeand-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.effectivehealth

care.AHRQ.gov/search-for-guidesreviews-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 


tkelley on DSK3SPTVN1PROD with NOTICES
57160 Federal Register / Vol. 78, No. 180 / Tuesday, September 17, 2013 / Notices 

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, diseasespecific 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: 

Æ 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: 

Æ Comprehensive medication review 

Æ Patient-directed medication 

management action plan, with or 

without an equivalent prescriberdirected action plan 

Æ Patient-directed education and 

counseling or other resources to 

enhance understanding of the use of 

medication 

Æ 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: 

Æ Medication reconciliation 

interventions 

Æ Integrated pharmacy services within 

inpatient settings 

Æ One-time corrective actions related to 

medication management 

Æ Disease management interventions 

Æ 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: 

Æ Patient-centered home health caredelivery model 

Æ 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: 

Æ Mode of delivery: telephonic, face to 

face, virtual (Web/online/Internet), 

and remote video 

Æ Type of professional providing initial 

and followup MTM service: 

pharmacist, nurse, physician, other 

clinician 

Æ Frequency and interval of followup 

for MTM services 

Æ Specific MTM components used 

Æ Fidelity in implementing MTM 

components: to what extent were 

services delivered as designed or 

intended 

Æ Establishing and communicating 

goals of drug therapy to patients and 

among care providers 

Æ 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]) 

Æ 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 

Æ Reimbursement characteristics (e.g., 

who is paying for cost of MTM 

services, who is reimbursed for MTM 

services, whether services are 

separately reimbursable) 

Æ 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 

Æ Disease-specific laboratory or 

biometric outcomes (e.g., hemoglobin 

A1c; blood pressure; total, lowdensity lipoprotein, or high-density 

lipoprotein cholesterol; pulmonary 

function; renal function; left 

ventricular ejection fraction; or other 

lab or biometric outcome specific to 

diseases covered) 

Æ Drug therapy problems identified as 

defined by primary studies but 

typically including the following: 


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Federal Register / Vol. 78, No. 180 / Tuesday, September 17, 2013 / Notices 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. 

Æ 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 

Æ Medication adherence 

Æ Goals of therapy met 

Æ Patient engagement (e.g., initial and 

continuing patient participation in the 

MTM program) 

• Patient-Centered Outcomes 

Æ 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) 

Æ Disease-specific or all-cause 

mortality, including fall-related 

mortality 

Æ Reduced (actual) adverse drug events 

(frequency and/or severity) 

Æ Health-related quality of life as 

measured by generally accepted 

generic health-related quality-of-life 

measures (e.g., short-form 

questionnaires, EuroQOL) or diseasespecific measures 

Æ 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 

Æ Patient satisfaction with care 

Æ Work or school absenteeism 

Æ Patient and caregiver participation in 

medical care and decisionmaking 

• Resource Utilization 

Æ Prescription drug costs and 

appropriate prescription drug 

expenditures 

Æ Other health care costs 

Æ Health care utilization 

(hospitalizations, emergency 

department visits, and physician 

office visits) 

• Harms 

Æ Care fragmentation 

Æ Patient confusion 

Æ Patient decisional conflict 

Æ Patient anxiety 

Æ Increased (actual) adverse drug events 

Æ Patient dissatisfaction with care 

Æ Prescriber confusion 

Æ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Meeting of the Community Preventive 

Services Task Force 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) 

announces the next meeting of the 

Community Preventive Services Task 

Force (Task Force). The Task Force is an 

independent, nonfederal, and 

uncompensated panel. Its members 

represent a broad range of research, 

practice, and policy expertise in 

prevention, wellness and health 

promotion, and public health, and are 

appointed by the CDC Director. The 

Task Force was convened in 1996 by the 

Department of Health and Human 

Services (HHS) to identify community 

preventive programs, services, and 

policies that increase healthy longevity, 

save lives and dollars and improve 

Americans’ quality of life. During this 

meeting, the Task Force will consider 

the findings of systematic reviews on 

existing research and issue 

recommendations. These 

recommendations provide evidencebased options from which decision 

makers in communities, companies, 

health departments, health plans and 

healthcare systems, non-governmental 

organizations, and at all levels of 

government can choose what best meets 

the needs, preferences, available 

resources, and constraints of their 

constituents. The Task Force’s 

recommendations, along with the 

systematic reviews of the scientific 

evidence on which they are based, are 

compiled in the Guide to Community 

Preventive Services (Community Guide). 

DATES: The meeting will be held on 

Wednesday, October 23, 2013 from 8:30 

a.m. to 5:30 p.m. EDT and Thursday, 

October 24, 2013 from 8:30 a.m. to 1:00 

p.m. EDT. 

ADDRESSES: The Task Force Meeting 

will be held at CDC Edward R. Roybal 

Campus, Tom Harkin Global 

Communications Center (Building 19), 

1600 Clifton Road NE., Atlanta, GA 

30333. You should be aware that the 

meeting location is in a Federal 

government building; therefore, Federal 

security measures are applicable. For 

additional information, please see 

Roybal Campus Security Guidelines 

under SUPPLEMENTARY INFORMATION. 

Information regarding meeting logistics 

will be available on the Community 

Guide Web site 

(www.thecommunityguide.org), 

Wednesday, September 25, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Andrea Baeder, The Community Guide 

Branch, Division of Epidemiology, 

Analysis, and Library Services 

(proposed), Center for Surveillance, 

Epidemiology and Laboratory Services 

(proposed), Office of Public Health 

Scientific Services (proposed), Centers 

for Disease Control and Prevention, 

1600 Clifton Road, MS–E–69, Atlanta, 

GA 30333, phone: (404) 498–498–6876, 

email: CPSTF@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The purpose of the meeting 

is for the Task Force to consider the 

findings of systematic reviews and issue 

findings and recommendations to help 

inform decision making about policy, 

practice, and research in a wide range 

of U.S. settings. 


tkelley on DSK3SPTVN1PROD with NOTICES