Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 18821 

TOTAL ESTIMATED ANNUALIZED BURDEN—DOLLARS

Title Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

.103(b)(4), .109(d) IRB Actions, .116 and .117 Informed Consent ................. 6,000 39.33 1 235,980 

.115(a) IRB Recordkeeping ............................................................................. 6,000 15 10 900,000 

.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting .... 6,000 0.5 45/60 2,250 

Total .......................................................................................................... ........................ ........................ ........................ 1,138,230 

Keith A. Tucker, 

Paperwork Reduction Act Clearance Officer, 

Office of the Secretary. 

[FR Doc. 2012–7464 Filed 3–27–12; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality; Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Adapting Best Practices for Medicaid 

Readmissions.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

DATES: Comments on this notice must be 

received by May 29, 2012. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Adapting Best Practices for Medicaid 

Readmissions 

One particular mission of AHRQ is to 

improve the efficiency of health care 

through reducing unnecessary health 

care costs while maintaining or 

improving quality. The proposed data 

collection supports this goal through 

developing strategies to assist safety net 

hospitals in reducing readmissions for 

Medicaid patients. Previous research 

has shown that a focus on transitional 

care, including needs assessment, 

discharge planning, post-discharge 

intervention, and care coordination can 

reduce avoidable readmissions. Based 

on this evidence, there have been a 

number of strategies and resources 

developed for hospitals to reduce 

avoidable readmissions, including: 

• The Aging & Disability Resource 

Centers Evidence-Based Care 

Transitions program by the 

Administration on Aging & CMS to 

support state efforts in implementing 

evidence-based care transition models 

for older adults and individuals with 

disabilities. 

• The State Action on Avoidable 

Rehospitalizations (STAAR) initiative 

by the Institute for Healthcare 

Improvement to improve care 

transitions and care coordination 

through state-based multi-stakeholder 

collaborative efforts. 

• The Hospital-to-Home (H2H) 

initiative by the American College of 

Cardiology to reduce readmissions for 

patients with cardiovascular conditions. 

• Project Re-Engineered Discharge 

(RED), funded by AHRQ and the 

National Institutes of Health (NIH) 

National Heart, Lung, and Blood 

Institute, to reduce re-hospitalizations 

by improving hospital discharge 

processes. 

However, the majority of these 

strategies and resources focuses on 

general patient populations or 

specifically targets the elderly and/or 

disabled, primarily Medicare 

populations. Recent research finds that 

rates of readmission among Medicaidinsured non-elderly adults equals that of 

the elderly, Medicare-insured 

population and is 60 percent higher 

than a privately-insured population. It is 

not known whether existing resources 

and strategies to reduce readmissions 

address the circumstances and 

characteristics of Medicaid-insured 

patients. Particular socio-demographic 

characteristics more prevalent in 

populations insured through Medicaid, 

such as low-income, racial and ethnic 

minority, low literacy, housing 

instability, mental illness, substance 

abuse disorders, chronic and disabling 

conditions, language barriers, and 

discontinuous insurance coverage may 

mean that strategies for reducing 

readmissions need to be tailored 

specifically to the unique needs of this 

population. 

Additionally, safety net hospitals, 

which serve large populations of the 

most vulnerable in society and where 

Medicaid is often a major payer, face 

unique conditions. Not only do they 

serve more vulnerable populations, they 

are often constrained by their financing 

and governance structures. Safety net 

hospitals generally operate on lower 

financial margins than other hospitals 

because they are often underpaid for 

many services provided to Medicaid 

recipients and the uninsured. Faced 

with declining contributions from state 

and local governments and payment 

reduction from both public and private 

payers, many are struggling to meet the 

growing demand for their services with 

stagnant or declining revenues. 

Resources addressing hospital 

readmissions may also have to be 

tailored to meet the unique 

circumstances of safety net settings. 

This project will recruit six safety net 

hospitals to assess the existing resources 

and strategies and suggest and test 

modifications to address the particular 

circumstances related to Medicaid 

readmissions and safety net hospital 

settings. The goals of this project are to: 

• Identify factors at the patient, 

provider, and community levels that 

especially contribute to hospital 

readmissions for Medicaid patients; 

• Assess and test existing strategies to 

reduce avoidable readmissions for their 

adequacy and applicability to Medicaidinsured populations and safety net 

hospital settings; 

• Modify and test modifications of 

existing strategies as necessary for 

applicability to Medicaid-insured 

populations and safety net hospital 

settings; and 


tkelley on DSK3SPTVN1PROD with NOTICES
18822 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 

• Develop a package of revised 

strategies for reducing avoidable 

readmissions that are specific to the 

factors contributing to Medicaid-insured 

patient readmissions in safety net 

settings. 

Four cycles of testing will be 

conducted to collect data on samples of 

patient readmissions in each of the 

participating hospitals. The data will be 

collected and analyzed by the hospital 

staff after each cycle. The first cycle will 

identify factors related to Medicaid 

readmissions, as well as establishing 

baseline measures, while the next 3 

cycles will be a quality improvement 

effort to test the existing strategies, or 

modifications to existing strategies, to 

address the factors identified in the first 

cycle. Each cycle will use a different 

sample of Medicaid readmission 

patients. 

This study is being conducted by 

AHRQ through its contractor, John 

Snow, Inc. (JSI), pursuant to AHRQ’s 

statutory authority to conduct and 

support research on healthcare and on 

systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of healthcare 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

(1) Medical records review—The 

medical records review will gather 

background information about a 

patient’s index admission and 

readmission. Data to be abstracted from 

the medical record includes patient 

demographic information, living 

arrangements, dates and timing of index 

and readmissions, lengths of stay, 

diagnoses on admission, source of 

admission, discharge disposition, and 

other transition factors, as well as the 

name and setting of the patient’s 

primary care provider (PCP), and 

whether an appointment was made with 

the PCP before discharge. 

(2) Patient/family/caregiver 

interview—After completion of the 

patient’s medical record review, 

interviews will be conducted with the 

patient and a family member or 

caretaker (using the same tool for all) 

who has permission to discuss the 

patient’s case. The purpose of the 

patient/family/caregiver interviews is to 

obtain the patient/family perspective, in 

their own words, of their index 

admission, their transition period, and 

their readmission. Data to be collected 

includes perspectives on reasons for 

readmission, discharge experience, 

extent to which they were able to follow 

any discharge instructions provided, 

setting to which they were discharged, 

and any other assistance needed. 

(3) Provider interview—Provider 

interviews will complete the patient 

readmission data. Two providers 

involved in each readmission case will 

be interviewed. Providers are likely to 

be from the hospital setting (e.g., 

hospitalists, admitting physicians, 

emergency room physicians) but also 

may be from the larger care community 

(e.g., primary care, skilled nursing 

facility, home health). Providers 

selected will change from case to case, 

although any particular provider may be 

asked about more than one readmission 

over the course of the project. Providers 

will be asked why they believe the 

patient was readmitted and what they 

think could have been done to avoid the 

readmission. 

The purpose of the primary data 

collections is to add insight and direct 

patient/family and provider input and 

experience into all phases of the project. 

The first data collection will provide 

patient/family and provider insight into 

the process of identifying factors related 

to Medicaid readmissions. Based on 

these factors, existing readmissions 

strategies will be assessed for their 

suitability in addressing these factors. 

Participating hospitals will then select 

existing or modified strategies to test in 

their settings using a rapid cycle QI 

process. Primary data collection will 

occur during each of the three testing 

cycles for purposes of gathering patient 

and provider insight into the factors 

associated with readmissions of 

Medicaid patients and gauging the 

extent to which the modified strategies 

would be able to address those factors. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden for the respondent’s 

time to participate in the project. The 

medical records review will be 

performed by one QI nurse at each of 

the 6 participating hospitals for 80 

readmission cases (20 from each of 4 

cycles) and will take about 20 minutes 

per case. In that the primary data 

collections are intended to inform the 

factors related to Medicaid readmissions 

and inform the testing of existing or 

modified strategies, there is no set 

number of readmissions cases required 

during each of the four data collection 

cycles. Participating hospitals will be 

instructed that it is a process that 

should continue until patterns of 

response converge and little new 

information is being learned, with 20 

cases as the maximum during any one 

of the four cycles of data collection. 

For each readmission case interviews 

will be conducted by the QI nurse with 

a total of 120 patients and family 

member or care giver (20 of each from 

each of the 6 hospitals) during each of 

the 4 cycles of data collection. The 

interviews are estimated to require 10 

minutes each. The QI nurse will also 

conduct interviews with 2 providers 

associated with the readmission case (a 

total of 12 providers across the 6 

hospitals) during each of the 4 cycles 

and will take about 5 minutes. The total 

burden is estimated to be 640 hours 

annually. 

Exhibit 2 shows the estimated cost 

burden associated with the respondent’s 

time to participate in this project. The 

total cost burden is estimated to be 

$23,398 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Medical records review .................................................................................... 6 80 20/60 160 

Patient/family/caregiver interviews 

Patient interview ....................................................................................... 120 4 10/60 80 

Family/caregiver interview ........................................................................ 120 4 10/60 80 

QI Nurse to conduct interviews ................................................................ 6 160 10/60 160 

Provider interviews 

Provider interviews ................................................................................... 12 80 5/60 80 

QI Nurse to conduct interviews ................................................................ 6 160 5/60 80 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 18823 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Total ................................................................................................... 384 na na 640 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Medical records review .................................................................................... 120 160 $32.56 $5,210

Patient/family/caregiver interviews 

Patient interview ....................................................................................... 120 80 21.35 1,708 

Family/caregiver interview ........................................................................ 120 80 21.35 1,708 

QI Nurse to conduct interviews ................................................................ 6 160 32.56 5,210 

Provider interviews 

Provider interviews ................................................................................... 12 80 86.96 6,957 

QI Nurse to conduct interviews ................................................................ 6 80 32.56 2,605 

Total ................................................................................................... 384 640 na 23,398 

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S. Department of Labor, Bureau of Labor Statistics;’’ 29–1111 (Registered Nurse, $32.56/hr); 00–0000 (All Occupations, $21.35/hr); 29–1069 (Physicians and Surgeons, All Other, $86.96/hr). 

Estimated Annual Costs to the Federal 

Government 

The total cost to the government is 

estimated to be $253,033, which 

includes costs for project development, 

data collection, data analysis, 

publication, project management, and 

overhead as shown in Exhibit 3. The 

data collection occurs throughout the 

2.5 year project term (30 month); thus, 

it has an estimated annual cost of 

$101,212. 

EXHIBIT 3—ESTIMATED ANNUAL AND TOTAL COSTS TO THE FEDERAL GOVERNMENT

Task/activity Estimated 

annual cost 

Estimated total 

cost 

Project Development ............................................................................................................................................... $7,438 *$18,596 

Data collection ......................................................................................................................................................... 30,866 77,165 

Data analysis ........................................................................................................................................................... 9,470 23,676 

Publication ............................................................................................................................................................... 5,606 14,016 

Project Management ................................................................................................................................................ 15,086 37,716 

Overhead ................................................................................................................................................................. 32,746 81,864 

Total .................................................................................................................................................................. 101,212 253,033 

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 healthcare 

research and healthcare 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: March 14, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–7270 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Solicitation for Nominations for 

Members of the U.S. Preventive 

Services Task Force (USPSTF) 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Solicits nominations for new 

members of USPSTF. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) invites 

nominations of individuals qualified to 

serve as members of the U.S. Preventive 

Services Task Force (USPSTF). 

Qualification Requirements: Qualified 

applicants and nominees must at a 

minimum demonstrate knowledge, 


tkelley on DSK3SPTVN1PROD with NOTICES