[Federal Register Volume 74, Number 124 (Tuesday, June 30, 2009)]
[Notices]
[Pages 31281-31283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15086]



[[Page 31281]]

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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.

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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: ``Building an Implementation Toolset for E-Prescribing.'' In 
accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 
(44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this 
proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on April 24th, 2009 and allowed 60 days for public 
comment. No comments were received. The purpose of this notice is to 
allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by July 30, 2009.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
e-mail at <a href="/cdn-cgi/l/email-protection#105f5942514f6365727d796363797f7e507f7d723e757f603e777f66"><span class="__cf_email__" data-cfemail="703f3922312f0305121d190303191f1e301f1d125e151f005e171f06">[email protected]</span></a> (attention: AHRQ's desk 
officer).
    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 e-mail at 
<a href="/cdn-cgi/l/email-protection#41252e3328326f2d24272a2e3628353b01202933306f2929326f262e37"><span class="__cf_email__" data-cfemail="6d09021f041e4301080b06021a0419172d0c051f1c4305051e430a021b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Building an Implementation Toolset for E-Prescribing''

    AHRQ proposes to develop and test an electronic prescribing (e-
prescribing) toolset to provide information and tools of sufficient 
detail to act as a ``how-to guide'' for implementing e-prescribing 
across various organizational settings.
    The current system of prescribing and dispensing medications in the 
United States poses widespread safety and efficiency problems. E-
prescribing systems have the potential to avert some of the more than 2 
million adverse drug events (ADEs) annually, of which 130,000 are life 
threatening. E-prescribing also has enormous potential to create 
savings in health care costs, both through reducing ADEs and through 
more efficient work processes of prescribers and pharmacists. One 
recent study estimated the potential savings at $27 billion per year in 
the United States. [Johnston D, Pan E, Middleton B, Walker J, Bates DW. 
The value of computerized provider order entry in ambulatory settings. 
2003 [cited 2003/12/10]. Available from: http://www.citl.org/research/ACPOE_Executive_Preview.pdf.]
    The Medicare Prescription Drug Improvement and Modernization Act 
(MMA) of 2003, Public Law 108-173, provided that Medicare Part D 
sponsors are required to establish electronic prescription drug 
programs to provide for electronic transmittal of certain information 
to the prescribing provider and dispensing pharmacy and the dispenser. 
There is no requirement that prescribers or dispensers implement e-
prescribing, but those who do electronically transmit prescription and 
certain other prescription-related information for Medicare Part D 
covered drugs prescribed for Medicare Part D eligible individuals, 
either directly or through an intermediary, are required to comply with 
any applicable final standards that are in effect.
    However, adoption of e-prescribing technology remains limited. On 
the surface, e-prescribing involves getting a prescription from point A 
to point B. In reality, the complexity of e-prescribing reflects all 
aspects of the process from appropriate prescribing, through 
dispensing, to correct patient use.
    Much current work has been on the adoption of technical standards 
that establish a common language, contain technical specifications, and 
provide other specific criteria designed to be used consistently as 
rules or definitions. While standards are a necessary foundation for e-
prescribing systems, they are insufficient in themselves to insure a 
successful implementation. Of equal importance to successful e-
prescribing implementations are appropriate workflows and sustainable 
commitment from the various organizations that must participate in such 
a system.
    This Accelerating Change and Transformation in Organizations and 
Networks (ACTION) project will produce a toolset to help a diverse 
range of provider organizations, from small independent offices to 
large medical groups to ``safety net'' clinics, to adopt e-prescribing 
systems and use them effectively in ways that advance the 
organization's goals. By enabling the greater adoption of e-prescribing 
systems that are effective in improving safety, quality and reducing 
prescription drug costs, the project will advance each of the 
priorities embodied in AHRQ's mission, which is to improve the quality, 
safety, efficiency, and effectiveness of health care for all Americans.
    This work is being conducted by the RAND Corporation under AHRQ 
ACTION contract HHSA290200600017, Task Order <greek-i>4, period of 
performance--8/1/08-1/31/10. It is being conducted pursuant to AHRQ's 
statutory authority to conduct research and evaluations (1) on health 
care and systems for the delivery of such care, including activities 
with respect to health care technologies, facilities and equipment, 42 
U.S.C. 299a(a)(5), and (2) to advance training for health care 
practitioners and researchers in the use of information systems. 42 
U.S.C. 299b-3(a)(2).

Method of Collection

    In order to evaluate the draft toolset's usability and usefulness, 
we will pilot test the toolset by studying its effects among 6 
practices that are attempting to implement e-prescribing for the first 
time. Field researchers will visit each practice before and after the 
e-prescribing implementation effort to conduct semi-structured 
interviews and observations of work processes. Finally, selected 
members of the practices will be surveyed via a Web-based instrument 
regarding the effort's success and the degree to which elements of the 
toolset were helpful.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent's time to participate in this project. Pre-test and post-
test interviews will be conducted with 3 physicians, 3 nurses or 
clinical support staff and 3 other staff from each of the 6 test sites. 
The pre-test and post-test observations will involve no more than 1 
physician, 1 nurse or clinical support staff and 2 other staff from 
each of the 6 test sites. Eight physicians from each of the 6 test 
sites will complete the physician survey and 12 other staff from each 
site will complete the other staff survey. The total annual burden is 
estimated to be 186 hours.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondent's time to participate in this project. The total 
cost burden is estimated to be $8,297.

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                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                       sites           site          response          hours
----------------------------------------------------------------------------------------------------------------
                                  Pre-Test Interviews and On-Site Observations
----------------------------------------------------------------------------------------------------------------
Pre-test interview guide........................               6               9               1              54
Pre-test on-site observation guide..............               6               4           15/60               6
----------------------------------------------------------------------------------------------------------------
                                  Post-Test Interviews and On-Site Observations
----------------------------------------------------------------------------------------------------------------
Post-test interview guide.......................               6               9               1              54
Post-test on-site observation guide.............               6               4           30/60              12
----------------------------------------------------------------------------------------------------------------
                                                Web-Based Survey
----------------------------------------------------------------------------------------------------------------
Physician questionnaire.........................               6               8           30/60              24
Other staff questionnaire.......................               6              12           30/60              36
                                                 ---------------------------------------------------------------
    Total.......................................              36              na              na             186
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                          sites           hours       wage rate\*\       burden
----------------------------------------------------------------------------------------------------------------
                                  Pre-Test Interviews and On-Site Observations
----------------------------------------------------------------------------------------------------------------
Pre-test interview guide........................               6              54          $41.79          $2,257
Pre-test on-site observation guide..............               6               6           41.79             251
----------------------------------------------------------------------------------------------------------------
                                              Post-Test Interviews
----------------------------------------------------------------------------------------------------------------
Post-test interview guide.......................               6              54           41.79           2,257
Post-test on-site observation guide.............               6              12           41.79             501
----------------------------------------------------------------------------------------------------------------
                                                Web-Based Survey
----------------------------------------------------------------------------------------------------------------
Physician questionnaire.........................               6              24           79.33           1,904
Other staff questionnaire.......................               6              36           31.31           1,127
                                                 ---------------------------------------------------------------
    Total.......................................              36             186              na           8,297
----------------------------------------------------------------------------------------------------------------
\*\ Based upon the national average hourly wages for physicians and surgeons, all others (29-1069; $79.33),
  registered nurses (29-1111; $31.31), and health care support workers, all others (31-9099; $14.74), National
  Compensation Survey: Occupational wages in the United States May 2008, U.S. Department of Labor, Bureau of
  Labor Statistics.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the estimated total and annual costs of this 
project. Since data collection will not exceed one year, the total and 
annual costs are the same. The total cost is estimated to be $119,976.

               Exhibit 3--Estimated Total and Annual Cost
------------------------------------------------------------------------
         Cost component               Total cost        Annualized cost
------------------------------------------------------------------------
Instrument Development..........             $12,533             $12,533
Data Collection Activities......              33,422              33,422
Data Processing and Analysis....              16,711              16,711
Report Preparation/Publication..              16,711              16,711
Project Management..............               4,178               4,178
Overhead........................              36,421              36,421
                                 ---------------------------------------
    Total.......................             119,976             119,976
------------------------------------------------------------------------

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, 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

[[Page 31283]]

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: June 22, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-15086 Filed 6-29-09; 8:45 am]
BILLING CODE 4160-90-P


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