[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43206-43208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13ZZ]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 
and send comments to LeRoy Richardson, 1600 Clifton Road, MS-D74, 
Atlanta, GA 30333 or send an email to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection 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 on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Evaluation of the SAMHSA PDMP Electronic Health Record (EHR) 
Integration and Interoperability Expansion Program--New--National 
Center for Injury Prevention and Control (NCIPC), Center for Disease 
Control and Prevention (CDC).

[[Page 43207]]

Background and Brief Description

    In 2009, drug overdose deaths became the leading cause of injury 
death in the United States (U.S.), exceeding motor vehicle traffic 
crash deaths for the first time, a trend that continued in 2010. 
Prescription drugs, particularly opioid pain relievers, have been 
identified as the main driver of this increase. The number of overdose 
deaths per year involving opioid pain relievers increased more than 
four-fold from 1999 to 2010 (from 4,030 to 16,651), outnumbering 
overdose deaths involving all illicit drugs combined. Morbidity 
associated with opioid pain reliever abuse increased in parallel. The 
rate of emergency department visits associated with the misuse or abuse 
use of opioid pain relievers increased 153% from 2004 to 2011, while 
rates for illicit drugs remained largely stable.
    Concurrent to this rise in overdose death rates, the sales of 
opioid pain relievers have increased four-fold since 1999. According to 
the National Survey of Drug Use and Health, the primary source of 
prescription drugs for non-medical use is from prescribed and dispensed 
prescriptions; more than 70% of those who reported non-medical use of 
pain relievers said they obtained the pain reliever they most recently 
used from a friend or relative. Moreover, multiple studies have found 
an association between increased opioid prescribing--in the amount 
prescribed per prescription, the total days' supply, and the number of 
prescriptions per patient--and increased morbidity and mortality in the 
U.S. over the last 10 to 15 years.
    Prescription Drug Monitoring Programs (PDMPs) are now recognized as 
a key tool in federal, state, and local efforts to address prescription 
drug abuse and misuse. PDMPs are state databases to which pharmacies 
and other dispensers report dispensed outpatient controlled substance 
prescription information. Forty-nine states have passed legislation 
authorizing a PDMP, and 45 states currently have an operational 
program. In the vast majority of these programs, prescribers and 
pharmacists (herein referred to collectively as providers) can register 
to become an authorized user of the PDMP. Following authorization, 
users can then conduct online queries to obtain prescription histories 
for their patients, a process that may take up to several minutes. For 
many providers, accessing patient prescription histories offers 
critical input that can inform their clinical decision-making. This 
process has shown promise in preventing prescribing to patients who 
appear to be abusing prescription medications or obtaining controlled 
substances prescribed by multiple providers without knowledge of the 
other prescriptions (referred as doctor shopping) while enabling 
appropriate prescribing and dispensing for legitimate patients, 
especially for pain medication.
    However, for many providers, even the few minutes required to log 
on to the PDMP and query a patient's prescription history present a 
barrier to regular use. Moreover, gaps in patients' prescription 
histories due to limited interstate sharing of PDMP data has 
contributed to relatively slow rates of provider registration with and 
use of PDMPs. PDMP reports show that it often takes four or more years 
following the implementation of online PDMP access for registration in 
the state to reach 50% of the prescribers who write controlled 
substance prescriptions, thus limiting the potential impact of these 
programs. Various strategies have been proposed to increase provider 
use of PDMPs. For example, several states have recently passed 
legislation mandating provider registration with and use of the PDMP 
under certain circumstances. Many states have also initiated efforts to 
enroll providers in educational training programs on the value of using 
PDMP data to counteract the prescription drug overdose epidemic. The 
project described below takes a different approach to increasing 
provider use of PDMPs.
    In an effort to increase provider utilization of PDMPs and to 
effectively reduce prescription drug abuse and overdose, the Substance 
Abuse and Mental Health Services Administration (SAMHSA) funded 
projects in nine states beginning in fiscal year (FY) 2012 and lasting 
for a period of two years through its PDMP Electronic Health Records 
(EHRs) Integration and Interoperability Expansion (PEHRIIE) cooperative 
agreement program. The goals of this program are to:
    (1) Increase provider utilization of their state's PDMP by 
improving real-time access to PDMPs via the integration of PDMP data 
and/or access thereof within health information technologies (HIT) such 
as health information exchanges (HIEs), EHR systems, and/or pharmacy 
dispensing software (PDS). Ultimately, when providers access a 
patient's EHR, s/he will have automatic access to that patient's up-to-
date prescription history within the course of their normal clinical 
workflow, thereby obviating the time and effort otherwise needed to 
access the PDMP and obtain this information separately from the 
patient's medical record. Similarly, when a pharmacist calls up patient 
information via the PDS, the patient's prescription history from the 
PDMP will be automatically compiled, allowing for expedited access and 
review prior to dispensing.
    (2) Increase provider utilization of PDMP data by increasing the 
comprehensiveness and quality of PDMP data by increasing the 
interoperability of PDMPs across state lines. When providers access a 
patient's prescription history from his or her state PDMP (either 
directly or via the systems described above), data from other state 
PDMPs with which the home state PDMP is interoperable will be 
automatically included. By providing a more complete prescription 
history, PDMP data is expected to have greater utility in clinical 
decision-making, thus offering an inducement for providers to access 
and utilize PDMP data more frequently.
    Both of these goals are expected to contribute to improving 
prescribing and dispensing practices, resulting in decreased 
prescription drug abuse and misuse and related health consequences such 
as fatal and non-fatal overdoses as well as lead to improvements in 
care.
    Under the cooperative agreements issued by SAMHSA, the CDC is 
responsible for conducting a comprehensive process and outcomes 
evaluation of the PEHRIIE program. The evaluation team consists of 
health scientists on the Prescription Drug Overdose team within the 
Division of Unintentional Injury Prevention, National Center for Injury 
Control and Prevention at CDC, and two subject matter experts at the 
PDMP Center of Excellence at Brandeis University. The primary goals of 
the qualitative evaluation component of this work are:
    (1) To understand the processes, challenges, and successes in 
implementing and sustaining integration of PDMP data with Health 
Information Technology (HIT) systems and interoperability of PDMP 
systems across states; and
    (2) To understand the experiences of clinical end users with the 
systems being upgraded under the PEHRIIE program and to capture their 
recommendations, if any, for how the goals of the PEHRIIE could have 
been better accomplished.
    To achieve these evaluation goals, the CDC evaluation team will 
conduct qualitative interviews with those individuals involved in the 
planning and implementation of the PEHRIIE projects (i.e., key project 
staff and stakeholders) as well as with the clinical end users (i.e., 
prescribers and

[[Page 43208]]

pharmacists) of the PDMPs in the states where these projects are taking 
place.
    This evaluation is consistent with CDC's strategic goals of 
improving surveillance, informing policy, and improving clinical 
practice. CDC believes that the most effective interventions in 
combating the prescription drug overdose epidemic include those 
designed to identify and address high-risk patients at a stage when 
their risky behaviors can be most effectively addressed. Strong yet 
accessible PDMPs that promote proactive patient interventions are a 
critical component of this high-risk focused strategy. By enabling 
providers to identify high-risk patients at the point of care, via 
improved access to and use of PDMPs and improved comprehensiveness of 
PDMP data, providers can intervene with patients and address their 
high-risk behaviors, including providing or redirecting patients to 
substance abuse treatment as necessary. Through this evaluation, CDC 
will better understand the impact of PDMP integration and 
interoperability in the funded states.
    The total annual estimated burden hours for the planned qualitative 
information collection are 235 hours. Total burden time includes the 
time to conduct interviews with key project staff/stakeholders and 
clinical end users, and the time spent by recruiters at the PEHRIIE 
implementation sites to identify potential clinical end user 
interviewees.
    It will take 79 hours of interviewee time to complete all of the 
key project staff/stakeholder interviews necessary for the planned 
evaluation of the PEHRIIE program. Interviews will be conducted with 91 
key project staff members/stakeholders across the nine PEHRIIE-funded 
states (range: 6-16 interviews per state) as well as 14 key project 
staff/stakeholders representing five companies working with multiples 
states involved in the PEHRIIE program, for a total of 105 key project 
staff/stakeholders interviewees. Based on pilot testing with three 
individuals, each key project staff/stakeholder interview will take 
approximately 45 minutes to complete. Therefore, 105 key project staff/
stakeholder interviews at 45 minutes each will require 79 hours of 
interviewee time.
    It will take 117 hours of interviewee time to complete all of the 
clinical end user interviews necessary for the planned evaluation of 
the PEHRIIE program. Each interviewee will be interviewed once. End 
user interviews will be conducted at 39 implementation sites 
distributed across all nine PEHRIIE states (range: 3-8 sites per 
state). Interviews will be conducted with three clinical end users per 
implementation site for a total of 117 clinical end user interviews. 
Based on pilot testing with three individuals, each clinical end user 
interview will take one hour to complete. Therefore, 117 clinical end 
users at 1 hour each will require 117 hours of interviewee time.
    It will take 39 hours of recruiter time to identify potential 
clinical end user interviewees, to collect the contact information from 
these clinical end users, and to disseminate this collected information 
to the CDC evaluation time. The CDC will work with one recruiter per 
implementation site to complete these tasks. Based on the time required 
to complete similar tasks during the planning of the clinical end user 
pilot interviews, each recruiter is expected to spend approximately one 
hour on these tasks. Therefore, 39 recruiters spending one hour each on 
this information collection will require 39 hours of recruiter time.
    There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs)        (in hrs)
----------------------------------------------------------------------------------------------------------------
Key Project Staff/Stakeholders  Key Project                  105               1           45/60              79
                                 Staff/
                                 Stakeholders
                                 Interview Guide.
Clinical End Users............  Clinical End                 117               1               1             117
                                 Users Interview
                                 Guide.
Clinical End User Recruiters..  N/A.............              39               1               1              39
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    Total.....................  ................  ..............  ..............  ..............             235
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2013-17295 Filed 7-18-13; 8:45 am]
BILLING CODE 4163-18-P