This PDF is the current document as it appeared on Public Inspection on 03/13/2015 at 08:45 am.
Administration for Community Living, Department of Health and Human Services.
Notice of Proposed Priority.
CFDA Number: 84.133B-6.
The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Outcomes Measurement for Home and Community Based Services. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved home and community based services for individuals with disabilities.
We must receive your comments on or before April 15, 2015.
Address all comments about this notice to Carolyn Baron, U.S. Department of Health and Human Services, 550 12th Street SW., Room 5134, PCP, Washington, DC 20202-2700.
If you prefer to send your comments by email, use the following address: email@example.com. You must include the phrase “Proposed Priorities for RRTCs” and the priority title in the subject line of your electronic message.
We will not accept comments submitted by fax or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once.
- Postal Mail or Commercial Delivery: If you mail or deliver your comments about these proposed regulations, address them to Carolyn Baron, U.S. Department of Health and Human Services, 400 Maryland Avenue SW., Room 5134, Potomac Center Plaza (PCP), Washington, DC 20202-2700.
Privacy Note: The Department's policy is to make all comments received from members of the public available for public viewing in their entirety. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Carolyn Baron. Telephone: (202) 245-7244 or by email: firstname.lastname@example.org.
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.End Further Info End Preamble Start Supplemental Information
This notice of proposed priority is in concert with NIDILRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the Federal Register on April 4, 2013 (78 FR 20299), can be accessed on the Internet at the following site: www.ed.gov/about/offices/list/osers/nidrr/policy.html. Start Printed Page 13570
The Plan identifies a need for research and training that can be used to improve outcomes of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.
This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.
Invitation to Comment: We invite you to submit comments regarding this proposed priority. To ensure that your comments have maximum effect in developing the final priority, we urge you to identify clearly the specific topic within the priority that each comment addresses.
We invite you to assist us in complying with the specific requirements of E.O. 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments sent to NIDILRR in Room 5142, 550 12th Street SW., PCP, Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.
Assistance to Individuals With Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.
Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).
Rehabilitation Research and Training Centers
The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at: http://www2.ed.gov/programs/rrtc/index.html#types.
Applicable Program Regulations: 34 CFR part 350.
This notice contains one proposed priority.
RRTC on Outcomes Measurement for Home and Community Based Services
Approximately $140 billion is spent nationally on Medicaid long-term services and supports (LTSS) (Eiken et al., 2014). States continue to rebalance their LTSS expenditures to decrease the reliance on nursing homes and other institutional services for individuals of all ages with disabilities. Nearly half of Medicaid's LTSS expenditures go toward home and community-based services (HCBS) compared to only 18% in 1995 (Eiken et al., 2014). The aging of the population and growing consumer demand to live in home-based settings will continue to increase the need for home and community-based services (HCBS). As more people receive LTSS in the community, there is a need for validated measures of consumer outcomes and experiences that can be used as indicators of HCBS quality (Commission on Long Term Care, 2013; Disability Rights Education & Defense Fund, 2013). Compared to measurement efforts in clinical settings, non-medical performance measures in HCBS are in the early stages of development and standardization (National Quality Forum, 2012). Accordingly, NIDILRR is sponsoring a Rehabilitation Research and Training Center on Outcomes Measurement for Home and Community Based Services.
Efforts to measure the quality of a wide variety of services, including home- and community-based LTSS, may include structural measures (whether a particular mechanism is in place), process measures (which track the performance of a particular action) and outcomes measures (the results of actions and mechanisms) (Disability Rights Education & Defense Fund, 2013; Booth & Fralich, 2006). In the long-term care context, structural indicators of quality may include the ratio of service providers to consumers, for example, and process indicators of quality may include the skill levels of providers and the timeliness of the services they deliver (Disability Rights Education & Defense Fund, 2013). User outcomes are also important indicators of service quality. In the HCBS context, health status and levels of community integration, participation, and inclusion among service recipients can be important markers of HCBS quality (Disability Rights Education & Defense Fund, 2013).
For decades, efforts to measure and improve long-term care quality have focused on nursing homes. Historically, the assessment of quality in nursing homes and other institutional long-term care settings emphasized the protection and safety of residents. As the delivery of LTSS is increasingly taking place in home and community-based settings, these institution-based quality measurement efforts have not been translated into measures that are relevant and important to individuals Start Printed Page 13571who are receiving services at home (Commission on Long-Term Care, 2013). While protection and safety are important to HCBS recipients, other factors are important and relevant in these settings, including levels of community integration, participation, and inclusion.
As states continue to rebalance their LTSS expenditures to decrease reliance on nursing homes and increase service delivery in home and community-based settings, they have begun the process of developing person-centered HCBS measures that assess outcomes from the perspective of service users. The State of Wisconsin, for example, has developed and implemented a set of measures that assess “person-centered quality of life” outcomes that are important to HCBS users (Karon & Schlaak, 2012). By seeking extensive input from service users and other stakeholders, Wisconsin has developed quality of life concepts and measures that are used to assess the extent to which (1) individuals have choice over their living arrangements and services, (2) individuals have desired social relationships and participate in meaningful ways in society, and (3) individuals are healthy and safe (Wisconsin Department of Health Services, 2014). Within this person-centered outcomes measurement system, service users are able to choose the specific outcomes that are the most important to them and describe the extent to which the long-term care services they are receiving support their achievement of those outcomes. With this outcomes assessment system Wisconsin has developed state-wide quality of life outcomes reports that aggregate findings for all of its HCBS users, as well as reports that provide comparisons of outcomes across different HCBS programs and subpopulations (Karon & Schlaak, 2012).
Recent efforts at the Federal level have begun to address the need for HCBS quality measures. For example, the Administration for Community Living (ACL) is contracting with the National Quality Forum (NQF) to create a conceptual framework for HCBS quality measurement and to make recommendations for HCBS measure development efforts. Through this work, ACL aims to create a conceptual foundation for the development of measures that can be used to assess and ultimately support independence and community living outcomes of HCBS recipients (National Quality Forum, 2015). Much work remains to conceptualize and measure HCBS quality in terms of the outcomes that are important to long-term care recipients. These outcomes include adequacy and appropriateness of care, as well as the consumers' level of control, social integration, social participation, and general quality of life (Kaye, 2014).
Another foundation for the development of person-centered HCBS outcomes measures is the ongoing work of rehabilitation researchers to create valid and reliable measures of community participation of people with disabilities (Walker, Mellick, Brooks, & Whiteneck, 2003; Hammel, Magasi, Heinemann, Whiteneck, Bogner & Rodriguez, 2012; Whiteneck & Dijkers, 2009; Heinemann, 2010). These research and development efforts include the application of advanced item-scaling and person-centered measurement techniques that can be implemented as computerized adaptive tests (CAT) (Haley et al., 2008), thus reducing data collection burden on people with disabilities. These efforts to develop participation outcome measures for people with disabilities are highly relevant to the applied efforts to develop person-centered HCBS outcome measures.
These and other Federal and state efforts provide a strong foundation for further research on and development of person-centered HCBS outcomes measures and measurement systems that assess and promote community living, independent living and social integration of HCBS users. Accordingly, NIDILRR aims to support a Rehabilitation Research and Training Center on Outcomes Measurement for Home and Community Based Services. This RRTC will conduct research and development activities in this critical area and will serve as a national resource center on HCBS outcomes measurement for Federal and state-level policymakers, people with disabilities and other key stakeholders.
Booth, M., Fralich, J. (2006). Performance Measurement: Managing and Using Home and Community-Based Services Data for Quality Improvement. University of Southern Maine: Muskie School of Public Service. http://muskie.usm.maine.edu/Publications/DA/Performance-Measurement-HCBS.pdf.
Commission on Long Term Care. (September 30, 2013). Report to the Congress. http://ltccommission.lmp01.lucidus.net/wp-content/uploads/2013/12/Commission-on-Long-Term-Care-Final-Report-9-26-13.pdf.
Disability Rights Education & Defense Fund (2013). Identifying and Selecting Long Term Services and Supports Outcomes Measures. http://dredf.org/2013-documents/Guide-LTSS-Outcome-Measures.pdf.
Eiken, Steve, et al. (2014). Medicaid Expenditures for Long-Term Services and Supports for FFY 2012. http://www.medicaid.gov/medicaid-chip-program-information/by-topics/long-term-services-and-supports/downloads/ltss-expenditures-2012.pdf.
Haley, S., Gandek, B., Siebens, H., Black-Schaffer, R., Sinclair, S., Tao, W., Coster, W., Ni, P., & Jette, A. (2008). Computerized Adaptive Testing for Follow-Up After Discharge From Inpatient Rehabilitation: Participation Outcomes. Archives of Physical Medicine and Rehabilitation. 89(2): 275-283.
Hammel, J., Magasi, S., Heinemann, A., Whiteneck, G., Bogner, & Rodriguez, E. (2008). What Does Participation Mean? An Insider Perspective From People With Disabilities. Disability and Rehabilitation. 30(19): 1445-1460.
Heinemann, A. (2010). Measurement of Participation in Rehabilitation Research. Archives of Physical Medicine and Rehabilitation. 91(9): S1-S4.
Karon, S., and Schlaak, M. (2012). PEONIES Member Interviews, State Fiscal Year 2012, Final Report. Madison, WI: Center for Health Systems Research and Analysis. http://www.chsra.wisc.edu/peonies/documents/PEONIES%20Final%20Report%20SFY2012%20-%20rev%2011-9-2012.pdf.
Kaye, H. Stephen. Toward a Model Long-Term Services and Supports System: State Policy Elements. The Gerontologist. (October 2014). http://gerontologist.oxfordjournals.org/content/54/5/754.full.pdf+html.
National Quality Forum (2015). Home and Community Based Services Quality. http://www.qualityforum.org/ProjectDescription.aspx?projectID=77692.
National Quality Forum, “Measuring Healthcare Quality for the Dual Eligible Beneficiary Population, Measure Application Partnership, Final Report to HHS,” June, 2012.
Walker, N., Mellick, D., Brooks, CA, Whiteneck, G. (2003). Measuring Participation Across Impairment Groups Using the Craig Handicap Assessment Reporting Technique. American Journal of Physical Medicine and Rehabilitation. 82(12): 936-941.
Whiteneck, G., & Dijkers, M. (2009). Difficult to Measure Constructs. Conceptual and Methodological Issues Concerning Participation and Environmental Factors. Archives of Physical Medicine and Rehabilitation. 90(11) S22-S35.
Wisconsin Department of Health Services (2014). Measuring Person-Centered Quality. November 11, 2014: https://www.dhs.wisconsin.gov/familycare/reports/peonies.htm.
The research that is proposed under this priority must be focused on one or more stages of research. If the RRTC is to conduct research that can be categorized under more than one research stage, or research that Start Printed Page 13572progresses from one stage to another, those research stages must be clearly specified. For purposes of this priority, the stages of research are from the notice of final priorities and definitions published in the Federal Register on June 7, 2013 (78 FR 34261).
(a) Exploration and Discovery means the stage of research that generates hypotheses or theories by conducting new and refined analyses of data, producing observational findings, and creating other sources of research-based information. This research stage may include identifying or describing the barriers to and facilitators of improved outcomes of individuals with disabilities, as well as identifying or describing existing practices, programs, or policies that are associated with important aspects of the lives of individuals with disabilities. Results achieved under this stage of research may inform the development of interventions or lead to evaluations of interventions or policies. The results of the exploration and discovery stage of research may also be used to inform decisions or priorities.
(b) Intervention Development means the stage of research that focuses on generating and testing interventions that have the potential to improve outcomes for individuals with disabilities. Intervention development involves determining the active components of possible interventions, developing measures that would be required to illustrate outcomes, specifying target populations, conducting field tests, and assessing the feasibility of conducting a well-designed interventions study. Results from this stage of research may be used to inform the design of a study to test the efficacy of an intervention.
(c) Intervention Efficacy means the stage of research during which a project evaluates and tests whether an intervention is feasible, practical, and has the potential to yield positive outcomes for individuals with disabilities. Efficacy research may assess the strength of the relationships between an intervention and outcomes, and may identify factors or individual characteristics that affect the relationship between the intervention and outcomes. Efficacy research can inform decisions about whether there is sufficient evidence to support “scaling-up” an intervention to other sites and contexts. This stage of research can include assessing the training needed for wide-scale implementation of the intervention, and approaches to evaluation of the intervention in real world applications.
(d) Scale-Up Evaluation means the stage of research during which a project analyzes whether an intervention is effective in producing improved outcomes for individuals with disabilities when implemented in a real-world setting. During this stage of research, a project tests the outcomes of an evidence-based intervention in different settings. It examines the challenges to successful replication of the intervention, and the circumstances and activities that contribute to successful adoption of the intervention in real-world settings. This stage of research may also include well-designed studies of an intervention that has been widely adopted in practice, but that lacks a sufficient evidence-base to demonstrate its effectiveness.
The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Outcomes Measurement for Home and Community Based Services. The RRTC will engage in research, development, and testing of measures to assess the quality of HCBS in terms of the person-centered outcomes achieved by people with disabilities who use the services in home and community settings. The RRTC will also engage in knowledge translation, development of informational products, and dissemination to enhance the field's capacity to measure the extent to which HCBS leads to improved outcomes in community living and independent living areas that are important to people with disabilities and other stakeholders. Ultimately, the RRTC's development of non-medical, person-centered outcome measures is intended to inform the design, implementation, and continuous improvement of Federal and state policies and programs related to the delivery of HCBS to people with disabilities. The RRTC must contribute to these outcomes by:
(a) Identifying or developing measures, and then testing the proposed measures to assess the person-centered outcomes of individuals with disabilities who are receiving home and community-based services. HCBS measures developed under this priority must be non-medical and must focus on the end-users' experience of community living, independent living, social integration, community participation, and other similar outcomes. The measures developed under this priority must also be designed to minimize data collection burden on HCBS recipients. Possible methods for minimizing this burden include, but are not limited to, use of relevant administrative data, modifying administrative data to include person-centered goals as well as fields to assess progress toward those goals, and use of advanced item-scaling and person-centered measurement techniques that can be implemented as computerized adaptive tests (CAT).
(b) Increasing incorporation of the RRTC's HCBS outcome measures into practice and policy. The RRTC must contribute to this outcome by—
(1) Working closely with NIDILRR and the Administration for Community Living (ACL) at each stage of the measure development and testing processes to ensure that its activities are informing and informed by other HCBS quality initiatives taking place within ACL and other relevant Federal and state agencies. This specifically includes the work taking place under the National Quality Forum's work with the Department of Health and Human Services (http://www.qualityforum.org/ProjectDescription.aspx?projectID=77692).
(2) Developing procedures and mechanisms for applying HCBS outcome measures in policy and service delivery settings to maximize quality and appropriateness of HCBS from the end-user perspective.
(3) Collaborating with stakeholder groups to develop, evaluate, or implement strategies to increase utilization of new HCBS outcome measures. Stakeholder groups include but, are not limited to, people with disabilities, Federal- and state-level policymakers; home and community based service providers; advocacy organizations; and Centers for Independent Living.
(4) Collaborating with relevant NIDILRR-sponsored knowledge translation grantees to help promote the uptake of RRTC products by relevant stakeholders and embed the outcome measures into the overall health care measurement system.
(c) Serving as a national resource center related to person-centered measurement of HCBS outcomes:
(1) Disseminating information and providing technical assistance related to HCBS outcome and quality measurement to policymakers, service providers, people with disabilities and their representatives, and other key stakeholders; and
(2) Providing relevant and appropriate training, including graduate, pre-service, and in-service training, to HCBS providers, researchers and quality-measurement personnel, and other Start Printed Page 13573disability service providers, to facilitate more effective delivery of HCBS to people with disabilities. This training may be provided through conferences, workshops, public education programs, in-service training programs, and similar activities.
We will announce the final priority in a notice in the Federal Register. We will determine the final priority after considering responses to this notice and other information available to the Department. This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.
This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register or in a Funding Opportunity Announcement posted at www.grants.gov.
Executive Orders 12866 and 13563
Regulatory Impact Analysis
Under E.O. 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of E.O. 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the E.O.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of E.O. 12866.
We have also reviewed this regulatory action under E.O. 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in E.O. 12866. To the extent permitted by law, E.O. 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
E.O. 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in E.O. 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve outcomes for individuals with disabilities in the area of home and community based services.
Intergovernmental Review: This program is not subject to E.O. 12372.
Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.
You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.Start Signature
Dated: March 11, 2015.
[FR Doc. 2015-05989 Filed 3-13-15; 8:45 am]
BILLING CODE 4154-01-P