The next 15 months will determine the fate of the Limb Loss and Preservation Registry (LLPR), the longitudinal database that has been jointly funded by the National Institutes of Health (NIH) and the Department of Defense (DOD) over the past four years. The investment will have reached $5 million by the time federal funding runs dry. The registry’s infrastructure and intellectual property have been built, the data elements to be collected have been identified, and the security for the data site meets a higher federal standard than most clinical registries. In short, the LLPR is open for business.
Open for business means the registry is actively pursuing O&P clinical practices and hospitals to begin submitting clinical data on their patients in a confidential manner so the data can be aggregated, de-identified, and organized into a useful database. The LLPR is defined as a quality registry, one designed to be actively used by professionals in the field to advance O&P care, but the registry offers numerous other benefits to O&P clinicians, other providers in the rehabilitation continuum, researchers, and eventually and most importantly, O&P patients.
Call to Action!
One issue facing the LLPR is perhaps a lack of awareness of the existence of the registry or a reluctance to participate. Since the registry opened for participation in March, only a small portion of the O&P field (92 O&P clinics) has agreed to share data with the registry, and only 17 hospitals from one chain provider have done the same. In an effort to encourage O&P providers large and small to participate in the registry, with the goal of advancing the O&P profession and the patients it serves, the External Collaborative Panel (EPC) of the LLPR will be hosting regular calls with key members of the O&P Alliance, large O&P multi-site providers, hospitals and hospital systems, and other leaders to answer questions and ensure that each provider who signs on to the registry can be confident in the safety, efficacy, and overall benefit of the registry. It is expected that as larger providers sign on, there will be a domino effect of participants all across the O&P field. The time is now to get the ball rolling as only 15 months remain on the NIH contract.
The status of the LLPR is not as dire as it may sound. In fact, there are a number of major hospitals and large O&P businesses on the cusp of joining the registry. A few O&P leaders could step forward to prime the pump, and the registry could have a bright future. This article clarifies the facts surrounding the LLPR, dispels some of the myths, and encourages all readers to take up the mantle of the registry and actively engage in making it an enduring success.
For all those who are willing to help be part of the solution, contact Kathie Bernhardt at the LLPR today at [email protected]
What is the purpose of clinical data registries?
Registries have proliferated since the 1990s, although some registries started decades earlier. Participation in registries got a huge boost with enactment of the Merit-based Incentive Payment System (MIPS) that began in 2017. MIPS is a federal program that provides financial incentives to individual clinicians (i.e., physicians) or groups of clinicians who report their performance according to certain quality measures. Participation in qualified clinical registries is one way that clinicians may receive incentive payments for achievement of quality metrics. Most registries are created and operated by national medical societies, hospital associations, or other healthcare associations that tend to be financially stable enough to devote significant funding on a sustained basis.
The LLPR is a quality registry to assist providers in improving clinical practice and, eventually, assist consumers in making evidence-based care decisions. Because the LLPR is designed as a quality registry and not a research registry, the federal government provided significant funding to develop and launch it, recognizing that the O&P profession would not likely be able to finance the start-up of a registry on its own. Specifically, the NIH and DOD funded its development through a contract with the Mayo Clinic, which will soon launch the registry to become a free-standing entity.
What is the real value of the LLPR?
There has been a growing importance of registries to build longitudinal data to accomplish numerous objectives, including the performance of research on patient outcomes, use of data to improve clinical practice, and use of evidence-based medicine to improve the quality of care. MIPS’ quality incentive payment program does not extend to orthotists and prosthetists and, therefore, payment incentives in the short term will not be a driver for O&P clinicians to participate in the LLPR. But there are other major benefits to registries that should weigh heavily with O&P clinicians, namely, the usefulness of the LLPR to demonstrate the efficacy of interventions, services, and devices; aid in determining appropriate coverage policies; and assistance in recalling malfunctioning components.
How will the registry advance the O&P profession?
Over the years, how many O&P practitioners have asked questions such as:
■ Why can’t we get compensated for our services and not just the delivery of devices?
■ Why can’t we be paid for the complexity of the patients we serve?
■ How can we demonstrate a link between O&P licensure and certification as surrogates for high-quality practitioners?
■ How can we demonstrate that K2 ambulators should have access to microprocessors and other effective O&P technologies?
■ Which prosthetic component is most effective for certain types of amputees with a given set of comorbid conditions and goals for rehabilitation?
The LLPR can help build the foundation to answer all of these questions, and many more. A successful registry that addresses limb loss and preservation is a key building block of the profession in providing evidence-based medicine for years to come. The promise of the LLPR, if it is nurtured and matures as intended, cannot be overstated.
How will the LLPR advance patient care?
A key element of the LLPR is the future capacity to inform patients, as well as providers, as to prosthetic, orthotic, surgical, and medical treatment options involving limb preservation, limb loss, and limb difference. The registry has the potential to become the backbone of O&P outcomes data and evidence-based practice. The platform lends itself to the collection from practitioners of standardized outcome measures. A patient portal would allow the direct collection of patient-reported outcome measures to enhance the richness of functional outcomes data, but another revenue source is needed to fund this work. A consumer organization such as the Amputee Coalition or one of many disability organizations representing the needs of orthotic users would serve this function well.
Why is it critical to get involved now?
The LLPR infrastructure must comply with a very high security level while federal funding continues, but once federal funding lapses, the security standard will revert to the level of security commonly associated with clinical registries. This should make joining and participating in the registry easier on providers without compromising privacy and confidentiality of the data. All data analysis available to participants or the public will only be available in a format that de-identifies patient and provider data, ensuring confidentiality.
Data sites are now being actively pursued, particularly hospitals, hospital systems, rehabilitation hospitals and units, and O&P practices. There is a critical need to continue linking these providers to the registry to make the data as robust as possible over the course of the next 15 months and beyond. As the LLPR matures, more and more types of provider data sources may be pursued, including ambulatory surgery centers, physician practices, rehabilitation therapy outpatient practices, and even pharmacies.
A key next step is for the LLPR to become a free-standing entity outside of the Mayo network (e.g., a limited liability corporation under a nonprofit organization). This presents new opportunities for leaders in the field to emerge and help maximize the robustness of the data and the effectiveness of the registry in terms of limb loss and limb preservation.
Why does the registry include a focus on limb preservation?
NIH was interested in funding a registry to improve O&P outcomes. DOD was interested in limb preservation to address the military’s need to understand this issue for the benefit of wounded soldiers. O&P outcomes can be addressed by harnessing O&P clinic data as well as data from physicians, therapists, and the rehabilitation continuum, while limb preservation can be addressed by harnessing data from hospitals, hospital systems, and surgical centers. However, if the data from hospitals is matched with data from O&P clinics and other rehabilitation providers in the same geographic regions, a picture can be painted of the journey some patients take from limb management and preservation strategies through orthotic supports and, eventually, limb loss and rehabilitation. Together, patient data can be matched across the continuum of care to improve treatment in both areas.
Why have some O&P clinics been slow to join the registry?
The LLPR was delayed in its development throughout the COVID-19 experience. In addition, the high level of security demanded by the federal government for the LLPR slowed progress further. Additional barriers may include a general lack of awareness of how important registries are and how the O&P profession can gain from the LLPR. Another challenge is getting the word out that the LLPR is currently in the process of recruiting providers to join the registry. Finally, once a critical mass of O&P clinics joins the registry, the ripple effect that is expected could dramatically accelerate participation. But whatever headwinds blow against the registry, the limb loss and limb difference community must rise to the occasion. The time is now to engage with the LLPR.
What if the registry is not sustainable?
If the LLPR is not ultimately sustainable, the NIH will host the registry as a static database and make the de-identified data available to researchers and clinicians who wish to use the data in a variety of ways to achieve quality and research objectives. This would be valuable in and of itself but would pale in comparison to the value of an ongoing registry that matures over the years into a data platform that will help achieve key quality and clinical outcome goals for the O&P profession, and dramatically benefit O&P patients.
Whether the LLPR becomes fully viable as a free-standing registry or the database is offered to the public as a snapshot in time, the short-term action plan is the same: Encourage as many O&P practices, hospitals, and hospital systems to join the registry as possible and build the database into the most robust set of data available on limb loss, limb difference, and limb preservation.
US taxpayers have contributed the resources to build the infrastructure of the LLPR. It is now time for the O&P profession to embrace the registry and invest in its future through participation and support. Please consider joining the LLPR as soon as possible to be part of this exciting new data source for people with limb loss and limb difference.
Peter W. Thomas, JD, is managing partner, Powers Law; general counsel for the National Association for the Advancement of Orthotics and Prosthetics and the Orthotic and Prosthetic Alliance; and member of the External Collaborative Panel of the Limb Loss and Preservation Registry.