[Federal Register Volume 80, Number 9 (Wednesday, January 14, 2015)]
[Notices]
[Pages 1922-1926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00394]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Announcement of Requirements and Registration for: ``Innovations
in Measuring and Managing Addiction Treatment Quality'' Challenge
Authority: 15 U.S.C. 3719.
Award Approving Official: Dr. Nora Volkow, Director, National
Institute on Drug Abuse (NIDA)
SUMMARY: Through the ``Innovations in Measuring and Managing Addiction
Treatment Quality'' Challenge (the ``Challenge''), the National
Institute on Drug Abuse (NIDA), a component of the National Institutes
of Health (NIH), challenges the general public to make concrete
advances toward improving the quality of addiction treatment.
Specifically, through this Challenge, NIDA hopes to incentivize the
development of innovative concepts for quality measurement and quality
management systems based on the latest science of addiction and its
treatment and of quality measurement and management. These new concepts
would be game-changing because they would go beyond current performance
measurement concepts in that they would not be limited by the data
commonly available in current provider and payer data systems. Instead,
they would (a) more directly reflect the clinical effects that can and
should be expected from high-quality addiction treatment; (b) capture
what clinicians and provider organizations need to measure to help them
provide high-quality addiction treatment; and (c) provide a solid basis
for measuring clinician and provider performance that may be used by
patients and other purchasers to select and incent high-quality
treatment. NIDA believes that the development of such quality measures
and management systems has the potential to meaningfully improve the
quality of addiction treatment both by giving clinicians and providers
the information they need to assess and improve the quality of the care
they provide and by providing tools patients and purchasers can use to
shop for the highest quality providers, allowing market forces to
provide another incentive for improvement.
DATES:
(1) Submission Period begins January 14, 2015, 9:00 a.m., ET
(2) Submission Period ends June 1, 2015, 5:00 p.m., ET
(3) Judging Period June 2, 2015 and July 15, 2015, 2015
(4) Winners Announced September 30, 2015
FOR FURTHER INFORMATION CONTACT: Sarah Q. Duffy, Ph.D., Associate
Director for Economics Research, Division of Epidemiology, Services and
Prevention Research, National Institute on Drug Abuse, Phone: 301-443-
6504 Email [email protected].
SUPPLEMENTARY INFORMATION:
Subject of the Challenge
Scientific knowledge about addiction and its treatment has
increased markedly over the past several years. We have a better
understanding of the effects of drugs on the brain. We also have new,
more effective treatments. At the same time, new health care payment
and delivery models are emerging that may provide opportunities to
further enhance the quality of addiction treatment.
It has long been recognized that health care may be improved
through the development and use of quality measures and management
systems through which they can be collected, reported, monitored, and
improved [Ref.1]. Quality measures are meant to reflect aspects of the
care provided, or outcomes achieved that assess the health care
quality. Health care quality has been defined as ``the degree to which
health care services for individuals and populations increase the
likelihood of desired outcomes and are consistent with current
professional knowledge'' [Ref 2.]. In 2006 the Institute of Medicine
recommended developing and implementing a quality
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measurement and reporting infrastructure as part of an overall strategy
for enhancing the care provided in the field of addiction treatment
[Ref. 3]. It is also the case that the availability of strong quality
measures, as described below, and management systems through which they
can be reported, monitored, and acted upon, is a vital component of
payment and delivery reforms in the public and private sectors [Ref.
4].
Controlling the growth of health care costs without adversely
affecting care requires strong quality measures. Strong quality
measures are those that can be directly improved by clinicians,
treatment programs, and/or health care systems. Such quality measures
either directly or indirectly (as proxy measures) measure aspects of
patient functioning, health, or well-being, improvements in which are
strongly and causally related to desired improvements in patient
functioning, health or well-being. Strong quality measures may also be
used by patients and payers to select high-quality providers thereby
promoting change in the marketplace [Ref. 5].
Traditionally, three types of measures have been used to track
aspects of treatment quality: Structural measures, process measures,
and outcome measures [Ref. 6]. In the United States, quality
measurement in addiction treatment largely has focused on process
measures which measure the actual care provided, for example whether or
not a patient received a certain medication, and outcome measures which
measure how patients responded to treatment.
The most commonly used process measures in addiction treatment are
the Washington Circle treatment initiation and engagement measures,
both of which seek to measure the quality of initial care provided
within health plans or treatment systems [Ref. 7]. Under the Washington
Circle treatment initiation measure, the standard is met when a patient
receives a treatment visit within 14 days of diagnosis, while the
standard under the engagement measure is met when a patient has two or
more visits within 30 days of that initial treatment visit. Some state
substance abuse treatment agencies have used these measures to provide
feedback to providers to aid their quality improvement efforts or
incentivize improvements via performance-based contracting [Ref. 8].
Still, the most recent National Committee on Quality Assurance State of
Health Care Quality report shows that less than 15 percent of insured
patients received care that met the engagement measure standard in
commercial, Medicaid, and Medicare health plans in 2012, rates similar
to those achieved in 2004 [Ref. 9]. Moreover, there is limited evidence
of a causal relationship between having met either standard and
improvements in patients' functioning, health, or well-being.
Another commonly used process measure of addiction treatment
quality--the length of stay in treatment--has likewise shown limited
evidence of effectiveness [Ref. 10].
The most prominent outcome measure initiative is the Substance
Abuse and Mental Health Services Administration's (SAMHSA) National
Outcome Measures (NOMs). The NOMs are based on administrative data that
states are required to report to SAMHSA. They assess the extent of
changes in measures such as drug use, homelessness, and employment
between time of treatment admission and time of discharge. While
measures of initial treatment attendance, length of stay in treatment,
and changes in use and other outcomes between admission and discharge
meet important needs, they are insufficient to assess key aspects of
providers' contributions to the outcomes of care. Importantly, they do
not signal to providers and systems what they need to do clinically to
improve the quality of addiction treatment to the highest possible
level. Specifically, they do not answer the following questions
fundamental to informing providers how to improve the care they provide
to patients, many of whom have a chronic, relapsing, disorder and may
require multiple treatment episodes:
What clinical effects can reasonably be expected from
high-quality, state-of-the-art addiction treatment? How can these
clinical effects be measured? Abstinence is thought by many to be the
ultimate outcome and goal of treatment. But, to date, there is no type
of treatment that has been scientifically shown to deliver complete and
sustained abstinence, after a single episode of care, every time, even
under ideal conditions. Absent that, it is critical to determine and
measure what changes high-quality treatment can and should deliver in
patients with a condition that can be chronic and relapsing. What
clinical changes significantly improve the chances a patient will
progress toward reduced use, sustained abstinence and improvements in
other important goals often crucial to recovery, such as improved
health, employment performance, and healthy relationships, over time?
How can improvements in this measure or set of measures be
achieved, both clinically and within a provider setting or system of
care? While development and specification of measures are important,
equally important is a carefully thought-out and comprehensive
conceptual framework or model. Such a model would address the following
types of questions: What would it take for the proposed measures to be
useful in improving quality? What does a clinician need to do so the
patient can improve on this measure? What resources, including data
collection, storage, and analysis, are needed to use the measures to
assess quality and improve care? What are the likely current levels of
this measure and how much might it be improved? What unintended
consequences might result from attempts to improve this measure? What
might be the effect on the provider industry when providers begin to
improve this measure?
How could patients and payers use these measures to help
them select and incent providers? Informed purchasing by patients and
payers is key to most efforts in the United States that seek to improve
quality and control costs. Accurate quality measures are essential to
these efforts. How can the proposed measures be tailored to the
characteristics of individual patients? How can they be fairly compared
across providers? How can they be presented in a way that patients and
payers can readily obtain and use them to make decisions?
How might these measures and systems be evaluated and
improved once they are implemented? Research can provide important
information about how measures and systems are likely to work. But it
is also important to understand how measures and systems are
implemented in non-research settings and how they perform there. In
addition, quality measurement and managements systems must often be
dynamic. Measures may need to be dropped or replaced because they
either have been improved as much as possible or did not work as
intended. Measures may also need to be updated to incorporate new
knowledge about addiction and its treatment, or because of changes in
how care is delivered and paid for. How might these types of evaluation
and improvements occur within the proposed measurement and management
system?
NIDA is seeking innovative, forward-looking concepts synthesizing
the latest scientific findings from a broad array of relevant
disciplines to address these questions.
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Statutory Authority of the Funding Source
This Challenge is consistent with and advances the mission of NIDA
as described in 42 U.S.C. 285o. The general purpose of NIDA is to
conduct and support biomedical and behavioral research and health
services research, research training, and health information
dissemination with respect to the prevention of drug abuse and the
treatment of drug abusers. Consistent with this authority, one of
NIDA's strategic goals is to support research to improve the quality of
addiction treatment. Novel measures, conceptual models, and related
research agendas that achieve the goals underlying this Challenge will
rely on the latest science and help set priorities for future research
and, accordingly, will support this strategic goal.
Rules for Participating in the Challenge
1. To be eligible to win a prize under this Challenge, an
individual or entity:
a. Shall have registered to participate in the Challenge under the
rules promulgated by NIDA and published in this Notice;
b. Shall have complied with all the requirements in this Notice;
c. In the case of a private entity, shall be incorporated in and
maintain a primary place of business in the United States, and in the
case of an individual, whether participating singly or in a group,
shall be a citizen or permanent resident of the United States. However,
non-U.S. citizens and non-permanent residents can participate as a
member of a team that otherwise satisfies the eligibility criteria.
Non-U.S. citizens and non-permanent residents are not eligible to win a
monetary prize (in whole or in part). Their participation as part of a
winning team, if applicable, may be recognized when the results are
announced.
d. In the case of an individual, whether participating singly or in
a group, must be at least 18 years old at the time of entry;
e. May not be a Federal entity.
f. May not be a Federal employee acting within the scope of his/her
employment, and further, in the case of HHS employees, may not work on
their submission(s) during assigned duty hours;
g. May not be an employee of the National Institutes of Health
(NIH), a judge of the Challenge, or any other party involved with the
design, production, execution, or distribution of the Challenge or the
immediate family of such a party (i.e., spouse, parent, step-parent,
child, or step-child).
2. Federal grantees may not use Federal funds to develop their
Challenge submissions unless use of such funds is consistent with the
purpose of their grant award and specifically requested to do so due to
the Challenge design.
3. Federal contractors may not use Federal funds from a contract to
develop their Challenge submissions or to fund efforts in support of
their Challenge submission.
4. Submissions must not infringe upon any copyright or any other
rights of any third party. Each participant warrants that he or she is
the sole author and owner of the work and that the work is wholly
original.
5. By participating in this Challenge, each individual (whether
competing singly or in a group) and entity agree to assume any and all
risks and waive claims against the Federal Government and its related
entities (as defined in the COMPETES Act), except in the case of
willful misconduct, for any injury, death, damage, or loss of property,
revenue, or profits, whether direct, indirect, or consequential,
arising from their participation in the Challenge, whether the injury,
death, damage, or loss arises through negligence or otherwise.
6. Based on the subject matter of the Challenge, the type of work
that it will possibly require, as well as an analysis of the likelihood
of any claims for death, bodily injury, or property damage, or loss
potentially resulting from Challenge participation, no individual
(whether competing singly or in a group) or entity participating in the
Challenge is required to obtain liability insurance or demonstrate
financial responsibility in order to participate in this Challenge.
7. By participating in this Challenge, each individual (whether
competing singly or in a group) or entity agrees to indemnify the
Federal Government against third party claims for damages arising from
or related to Challenge activities.
8. An individual or entity shall not be deemed ineligible because
the individual or entity used Federal facilities or consulted with
Federal employees during the Challenge if the facilities and employees
are made available to all individuals and entities participating in the
Challenge on an equitable basis.
9. Each individual (whether competing singly or in a group) or
entity retains title and full ownership in and to their submission and
each participant expressly reserves all intellectual property rights
(e.g., copyright) in their submission. However, each participant grants
to NIDA, and others acting on behalf of NIDA, a royalty-free non-
exclusive worldwide license to use, copy for use, and display publicly
all parts of the submission for the purposes of the Challenge. This
license may include posting or linking to the submission on the
official NIDA Web site and making it available for use by the public.
10. The NIH reserves the right, in its sole discretion, to (a)
cancel, suspend, or modify the Challenge, and/or (b) not award any
prizes if no entries are deemed worthy.
11. Each individual (whether competing singly or in a group) or
entity agrees to follow applicable local, State, and Federal laws and
regulations.
12. Each individual (whether participating singly or in a group)
and entity participating in this Challenge must comply with all terms
and conditions of these rules, and participation in this Challenge
constitutes each such participant's full and unconditional agreement to
abide by these rules. Winning is contingent upon fulfilling all
requirements herein.
Submission Requirements
Each submission for this Challenge should consist of a white paper
describing a concept for an innovative quality measurement and
management system to measure, manage, and improve the quality of
clinical care in addiction treatment. The white paper must describe a
novel concept based on the latest findings from relevant areas of
science. It must include the following two sections:
1. A description of candidate clinical effects of addiction
treatment and how these effects could be measured (directly or by
proxy); a discussion of the likely level of these measures in the
current treatment system, how much improvement might be achievable, how
the measure(s) could conceivably be implemented, now or in the future,
to improve the quality of care; how the resulting information could
conceivably be used to help patients and payers select providers; and
how the proposed measures and systems might be evaluated and improved
once implemented.
2. A research agenda addressing the current state of relevant
scientific knowledge; the gaps that need to be addressed to support the
development, testing, and use of these novel concepts, measures, and
systems; and a plan and an estimated timeframe for filling those gaps.
The white paper must not contain any information directly
identifying the participants.
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Registration and Submission Process
To register for this Challenge, participants must go to
www.challenge.gov and search for ``Innovations in Measuring and
Managing Addiction Treatment Quality Challenge''. Click on the title to
go to the Challenge platform Web site, which contains instructions on
how to register and submit.
All submissions must be in English. Each submission must consist of
a PDF file, containing the white paper document. The PDF documents must
be formatted to be no larger than 8.5'' by 11.0'', with at least 1 inch
margins. The white paper must be no more than 20 pages long. Font size
must be no smaller than 11 point Arial. The participant must not use
HHS's logo or official seal or the logo of NIH or NIDA in the
submission, and must not claim federal government endorsement.
Amount of the Prize
Up to four monetary prizes may be awarded: $35,000 for 1st Place,
$30,000 for 2nd Place, $25,000 for 3rd Place, and $10,000 for Honorable
Mention for a total prize award pool of up to $100,000. The names of
the winners and the titles of their submissions will be posted on the
NIDA Web site. In addition, NIDA may work with winners and a peer-
reviewed journal to publish articles based on the white papers in a
special issue on the future of quality measurement and management
systems in the field of addiction treatment. The award approving
official for this Challenge is the Director of the National Institute
on Drug Abuse.
Payment of the Prize
Prizes awarded under this Challenge will be paid by electronic
funds transfer and may be subject to Federal income taxes. The NIH will
comply with the Internal Revenue Service withholding and reporting
requirements, where applicable.
Basis Upon Which Winner Will Be Selected
The judging panel will make recommendations to the Award Approving
Official based upon the following five criteria and point allocation:
1. Novelty of the concept (5 points): Concepts are to move beyond
the existing quality measurement and management paradigms and
administrative data elements commonly used in the addiction treatment
field. They are to focus on clinical effects that can be obtained as a
direct result of treatment in the context of what is often a chronic,
relapsing condition. How novel is the concept? Does it address
important clinical effects that are not currently or adequately
considered in existing quality measurement and improvement efforts in
the addiction treatment field?
2. Clinical effectiveness of the concept (5 points): Are changes in
the identified effects something that high-quality treatment could
conceivably affect in a meaningful way? How effective would
improvements in these clinical effects likely be in addressing
addiction and improving other outcomes important to patients and other
purchasers of care?
3. Scientific basis for the concept (5 points): Concepts must rely
on the latest scientific understanding of addiction and its treatment
from a broad range of fields, as well as the latest science of quality
measurement and management. How meaningfully, comprehensively, and
effectively does the concept incorporate these latest advances in areas
of science relevant to addiction, its treatment, and quality
improvement?
4. Quality of the conceptual model (5 points): How well is the
conceptual framework or model developed? How well does it consider
factors relevant to the ultimate success of the concept? How well does
it address the clinical means for improving the candidate measures and
potential unintended consequences of implementing the measures and
using them to inform, gauge, and reward improvement? How well does it
address the likely impact of improvements in these measures on the
provider industry?
5. Potential for the concept to be implemented and evaluated (5
points): Concepts, and the measures and systems derived from them, must
have the potential to be implemented and used in at least some types of
treatment programs or other settings once all relevant research gaps
have been addressed. Is it within the realm of possibility that these
concepts, measures, or quality improvement systems could be implemented
in at least some organizations once all of the research gaps have been
addressed? How useful would the measures be to patients and payers
making purchasing decisions? How reasonable is the plan for how the
measures and systems could be evaluated and improved once implemented?
6. Quality of the research agenda (5 points): How well does the
research agenda describe the gaps in the relevant areas of science that
need to be addressed for this novel quality measurement and management
concept to be achieved and implemented? Does the agenda describe a
logical, feasible plan and timeframe for addressing those gaps?
Scores from each criterion will be weighted equally. The score for
each submission will be the sum of the scores from each of the 5 voting
judges, for a maximum of 150 points. NIH reserves the right to make an
award to submissions scoring less than 150 points if NIH deems any
sufficiently meritorious. All submissions will be held until after the
deadline is reached for a simultaneous judging process. NIH reserves
the right to disqualify and remove any submission that is deemed, in
the judging panel's discretion, inappropriate, offensive, defamatory,
or demeaning.
The evaluation process will begin by anonymizing and removing those
that are not responsive to this Challenge or not in compliance with all
rules of eligibility. Submissions that are responsive and in compliance
may then undergo a review by NIH program staff with expertise in the
relevant areas of science. These program staff would be asked to
comment specifically on the soundness of the scientific basis for the
project, the likelihood that any scientific advances needed for the
concept to meet fruition are within the realm of possibility, and the
quality of the research agenda, all as they relate to the program
official's area of expertise. Judges will examine all responsive and
compliant submissions, as well comments from program staff, if any, and
score the entries in accordance with the judging criteria outlined
above. Judges will meet to discuss the most meritorious submissions.
Final recommendations will be determined by a vote of the judges.
Challenge Judges
Director, National Institute on Drug Abuse--Ex Officio
Deputy Director, Center for Clinical Trials Network, National Institute
on Drug Abuse
Acting Director, Division of Epidemiology, Services, and Prevention
Research, National Institute on Drug Abuse
Chief, Science Policy Branch, Office of Science Policy and
Communication, National Institute on Drug Abuse
Program Officer, Behavioral and Integrative Treatment Branch (BITB),
Division of Clinical Neuroscience and Behavioral Research, National
Institute of Drug Abuse
Program Director for Health Services Research, Division of Treatment
and Recovery Research, National Institute on Alcohol Abuse and
Alcoholism
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Additional Information (References)
1. Eddy, 1998. ``Performance Measurement: Problems and Solutions.''
Health Affairs 17(4): 7-25.
2. Institute of Medicine, 1999. Measuring the Quality of Health
Care: A Statement by the National Roundtable on Health Care Quality.
Washington, DC: National Academy Press.
3. Institute of Medicine (US) Committee on Crossing the Quality
Chasm Adaptation to Mental Health and Addictive Disorders, 2006.
Improving Quality of Health Care for Mental and Substance-Use
Conditions. Washington, DC: National Academies Press.
4. Fisher et al., 2011. ``Building a Path to Accountable Care'', New
England Journal of Medicine 365:2445-2447.
5. McClellan, 2011. ``Reforming Payments to Healthcare Providers:
The Key to Slowing Healthcare Cost Growth while Improving Quality?''
The Journal of Economic Perspectives 25(2): 69-92.
6. Donabedian A, 1980. Explorations in Quality Assessment and
Monitoring: The Definition of Quality and Approaches to its
Assessment. Ann Arbor, MI. Health Administration Press.
7. Garnick DW, et al., 2002. ``Establishing the Feasibility of
Performance Measures for Alcohol and Other Drugs.'' Journal of
Substance Abuse Treatment 23(4):375-385.
8. Garnick, DW, et al., 2011. ``Lessons from Five States: Public
Sector Use of the Washington Circle Performance Measures.'' Journal
of Substance Abuse Treatment. 40(3):241-254.
9. National Committee on Quality Assurance, 2013. Improving Quality
and Patient Experience: The State of Health Care Quality 2013.
Washington, DC.
10. Harris, AHS, et al., 2012 Longer LOS is Not Associated with
Better Outcomes in VHA's Substance Abuse Residential Rehabilitation
Treatment Programs. Journal of Behavioral Health Services Research
39(1): 68-79.
Dated: January 5, 2015.
Nora D. Volkow,
Director, National Institute on Drug Abuse, National Institutes of
Health.
[FR Doc. 2015-00394 Filed 1-13-15; 8:45 am]
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