[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 <a href="/cdn-cgi/l/email-protection#36524350504f4576585f525718585f5e18515940"><span class="__cf_email__" data-cfemail="6c08190a0a151f2c0205080d42020504420b031a">[email protected]</span></a>.

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

[[Page 1923]]

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:
    <bullet> 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?
    <bullet> 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?
    <bullet> 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?
    <bullet> 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.

[[Page 1924]]

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.

[[Page 1925]]

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

[[Page 1926]]

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]
BILLING CODE 4140-01-P


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