O&P Rehabilitation Research Thrives at the Federal Level

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By Peter W. Thomas, JD, and Joseph Nahra

As the Biden administration has settled into its executive role, and the White House and federal government continue to fight the COVID-19 pandemic and related public health emergency, the administration's overarching and ongoing priorities are becoming clear. In particular, the federal government has demonstrated a recognition of the importance of rehabilitation research (and federal research science more broadly) as not only a driver of COVID-related solutions, but as a field to enhance the lives of Americans with disabilities, injuries, illnesses, and chronic conditions nationwide.

The O&P profession has certainly benefitted from the additional focus on rehabilitation and medical research funding at the federal level, and many exciting initiatives are underway that should energize the O&P community. This article provides an overview of the research priorities for the Biden administration, the current state of rehabilitation research at the National Institutes of Health (NIH), and updates on notable projects related to O&P research.

 

White House Budget Priorities

Federal Research Funding

On April 9, the Office of Management and Budget released Biden's fiscal year (FY) 2022 request for discretionary funding, also known as the administration's skinny budget. Like many new presidents at the beginning of their terms, Biden issued this document without the full budget request that is typically submitted to Congress on the first Tuesday in February of each year. The discretionary funding request provides topline numbers for a wide range of policy areas and an overview of some key elements of the administration's policy priorities. A more detailed, comprehensive budget for FY 2022, which begins on October 1, 2021, is expected to be released in May.

The skinny budget makes clear that the Biden administration will continue to emphasize the importance of medical research. The budget notes that the Biden will request $51 billion in funding for the NIH, an increase of $9 billion that equates to more than 20 percent over FY 2021 funding levels. While the detailed policy proposals for NIH will be included with the release of the full budget, the discretionary request notes that this significant increase will be used to fund and support "research that enhances health, lengthens life, and reduces illness and disability." Of course, the National Center for Medical Rehabilitation Research (NCMRR) that conducts and supports rehabilitation research, including O&P research and development, will see a marked funding increase if Congress funds NIH consistent with the President's request.

 

Advanced Research in Healthcare

The discretionary request unveiled a major research proposal to create a new agency within NIH to be known as the Advanced Research Projects Agency for Health (ARPA-H). This entity would utilize more than two-thirds of the recommended NIH funding increase ($6.5 billion) to direct federal research and development spending in targeted healthcare areas, drive transformational innovation in research, and speed the application and implementation of related scientific breakthroughs. If enacted, ARPA-H would initially focus on cancer, diabetes, and Alzheimer's disease, with the potential to expand to additional priorities in future years.

While Congress determines government spending, the proposals in the administration's skinny budget are an important window into Biden's priorities and a roadmap for potential future action under a Democrat-led Congress for the coming fiscal year.

National Institutes of Health

The O&P community should also recognize the great strides that NIH has made in the past several years to advance rehabilitation research at the agency, particularly in the field of O&P science. Since the inception of NCMRR in 1990, O&P research has been significantly funded through the Small Business Innovation Research program, but several other funding mechanisms are now in play for O&P research at NIH. In the past fiscal year, NIH reported spending over $700 million on rehabilitation research across all of its 29 institutes and centers, which is a clear sign that rehabilitation science has experienced a renaissance at NIH in recent years.

One of NIH's O&P research initiatives is jointly funded by the NIH and the Department of Defense (DOD) and is known as the Limb Loss and Preservation Registry. This quality-of-care registry should be of particular interest to O&P providers and consumers. It has been under development for the past two years under a contract with the Mayo Clinic.

Rehabilitation Research Plan

Since 1993, NIH has conducted its rehabilitation research under an agency-wide Research Plan on Rehabilitation. Many years elapsed before NIH revisited the research plan and updated its priorities. The most recent version was updated in 2016, a project jointly implemented by NCMRR, the NIH Medical Rehabilitation Coordinating Committee (MRCC), and the National Advisory Board on Medical Rehabilitation Research. This plan outlines current priority areas, future plans of action, and recommendations for NIH to build capacity in the workforce and infrastructure that supports rehabilitation and disability research.

The Research Plan on Rehabilitation must be revised and updated at least every five years. This was a requirement of the Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act, which was enacted into law when Congress passed the 21st Century Cures Act in 2016. The Act also requires an NIH rehabilitation research conference every five years. These statutory requirements have been a major driver of the proliferation of robust, well-funded, and well-coordinated rehabilitation research across NIH, especially in the O&P profession.

Given the five-year timeline for updating the plan, NIH is currently working to prepare the 2021 Rehabilitation Research Plan for release. In September 2020, the MRCC issued a request for information on a draft set of themes and objectives for the 2021 plan, seeking stakeholders to respond to the scope of the proposed themes and objectives, whether they adequately covered the needs and priorities of rehabilitation research consumers, and to identify any noticeable gaps or missing opportunities. The major themes for the next iteration of the plan are expected to include:

 

  • Rehabilitation across the lifespan
  • Community and family
  • Technology use and development
  • Research design and methodology
  • Translational science
  • Building research capacity and infrastructure

 

While the plan will broadly cover the goals and direction of rehabilitation research at NIH, it is not condition specific. The final version will be a key document to guide federal research in the field of O&P and related rehabilitation science. The plan will also include discussions of some critical overarching objectives applying directly to O&P research, including the involvement of consumers of rehabilitation services as partners in the research enterprise; defining new and innovative metrics and outcomes measures to link functional outcomes with physiological processes; and identifying the most promising strategies to provide and enhance independence, quality of life, and function for people with disabilities. The MRCC and the other NIH partners are currently developing the final plan and will submit the document to Congress and the public by the end of this year.


National Center for Medical Rehabilitation Research

The NCMRR has long been designated by statute as the lead agency of rehabilitation research at the NIH; founded in the same year as the Americans with Disabilities Act in 1990, it celebrated its 30th anniversary last year. Enacted in the NIH Amendments Act of 1990, NCMRR was housed under the umbrella of the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD). After a Blue Ribbon Panel on Rehabilitation Research at NIH in 2012 found that the NCMRR was "functioning, but not thriving," the NIH began to remedy that stagnation. Most recently, NCMRR Director Alison Cernich, PhD, led the center for five years, ushering in a new era of partnerships within the federal government, community and stakeholder engagement, and energy and emphasis to push federal rehabilitation science forward.

Last year, Cernich was promoted to become the deputy director of NICHD where she can promote rehabilitation science at a higher level within the massive federal agency. The new NCMRR director, Theresa Cruz, PhD, has proven to be a worthy successor. Under NCMRR's leadership, the NIH now funds nearly 2,000 rehabilitation research projects across its multiple institutes and centers. Of course, NCMRR's work has been significantly impacted by the COVID-19 pandemic, as has nearly all research at NIH. However, the center has continued to press forward, pivoting their 2020 major rehabilitation conference held into a virtual setting with tremendous participation and success.

Held in October, the "Rehabilitation Research 2020: Envisioning a Functional Future" conference provided a virtual opportunity for the rehabilitation field to report on the state of the science and for hundreds more attendees to participate than would have been able to join in person. The conference featured 25 diverse speakers, 90 research project presentations, and four exhibit booths, as well as an important forum for stakeholders to provide input and discuss the themes for the 2021 Rehabilitation Research Plan.

Common Data Elements for Limb-Loss Research

The NCMRR is also working with a federal interagency group on a project to standardize common data elements (CDEs) for lower-limb loss research. CDEs are precisely defined questions, paired with a set of specific allowable responses, used systematically across different sites, studies, or clinical trials to ensure consistent data collection—a key tool to maximize the impact of research in a given field. NIH has long encouraged the development and use of CDEs for condition-specific research, such as neurologic disorders, substance use disorders, and more. In January, the initial draft set of CDEs for limb-loss research were released for public input, developed in partnership by NICHD; the Centers for Medicare & Medicaid Services (CMS); the National Institute on Disability, Independent Living, and Rehabilitation Research; the Agency for Healthcare Research and Quality; the DOD; and the Department of Veterans Affairs. Cernich and Cruz hosted a public webinar to discuss the CDE standards as well.

The interagency group is currently reviewing public feedback on the draft standards, as the comment period ended in March. The standards are expected to advance and be finalized sometime this year, and there may be additional opportunities for public input.

Limb Loss and Preservation Registry

The Limb Loss and Preservation Registry has been talked about for years in O&P, but the registry itself is beginning to show signs of progress. The Mayo Clinic contract is to design and build the infrastructure to collect extensive data from hospitals, O&P providers, patients, and others to ultimately assess the incidence, prevalence, and quality of O&P care, including limb preservation and salvation data. This is a complex undertaking and is expected to be operational within five years from the start of the project. A group of external stakeholders meet with the Mayo team, along with federal officials, twice per year to provide ongoing input into this formidable project. The promise of the registry cannot be overstated. When functional and mature, it will be an invaluable tool to many different types of stakeholders—including practitioners, manufacturers, suppliers, and consumers—in assessing, measuring, and evaluating the quality O&P care.

 

Final Thoughts

As NIH continues to carry out its comprehensive research agenda, and as Congress embarks on the FY 2022 appropriations process, federal research will remain a key priority. The O&P community, through participation in existing efforts and ongoing advocacy at the federal level, will ensure that rehabilitation science, and O&P research and development in particular, flourishes throughout the federal government and that individuals who use orthoses and/or prostheses will continue to feel the impact of the latest advances in medical research.

 

Peter W. Thomas, JD, is the National Association for the Advancement of Orthotics and Prosthetics general counsel, O&P Alliance counsel, and managing partner, Powers Law Firm.

 Joe Nahra is director of Government Relations, Powers Law Firm.