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Published March 30, 2012
The AIM Coalition held its first meeting of coalition members earlier this month. The meeting was an opportunity to examine the science and treatment challenges around sarcopenia and functional decline in older patients. The group also mapped out its strategies for pushing forward on its agenda with the FDA and CMS to accelerate research and development around sarcopenia, age-related functional decline and related, muscle-wasting conditions.
The meeting led off with Dr. Jack Guralnik, professor of epidemiology and public health at the University of Maryland School of Medicine, and head of the AIM Scientific Advisory Committee, who described the challenges of understanding sarcopenia, or the progressive, age-related loss of muscle mass, as well as the difficulties in objectively measuring muscle strength and disability onset. As the musculoskeletal system deteriorates with age, older patients often face difficulties associated with activities of daily living, such as eating, dressing, and taking vital medications. Dr. Guralnik reviewed a number of studies that reveal correlations of such measures as grip strength with lower extremity function and risk of disability onset.
In spite of the research interests in the area of functional decline and sarcopenia and a growing body of research that point to possible solutions for assessment, there are no defined guidelines for screening and diagnosis, making it very difficult to translate these discoveries into treatment solutions. As Dr. Guralnik pointed out, muscle mass itself is not a sufficient marker of strength or functional status.
A standardized measure like the Short Physical Performance Battery (SPPB) is the most efficient and accurate manner to determine one’s functional status or risk of disability. The SPPB physical performance test score, adjusted for age and sex, reflect underlying diseases status. The SPPB has been the focus of a growing body of research that has found it to be highly predictive of disability onset, mortality and functional status in both clinical and hospital settings, and an assessment that is able to transcend differences in individual environments. One of the most remarkable aspects of the SPPB is its ability to grade the risk level of patients who, at the time, do not self-report any disability.
Pushing to establish the SPPB test as a standardized, FDA-qualified set of outcomes measures to be used in randomized clinical trials around sarcopenia and functional decline is a key component of the AIM Coalition’s work. Under the guidance of the AIM Scientific Advisory Committee and in accordance with the FDA’s Guidance for Industry, the Coalition will submit a Letter of Intent to the FDA outlining the capabilities and success of the SPPB in measuring physical performance and risk of disability onset. Seeking this qualification will open doors to greater research, development and collaboration around the chronic health care challenge of sarcopenia.
Once diagnostic tools for sarcopenia and functional decline are established, the focus of AIM will turn to expanding access to sarcopenia screening under Medicare. The second major component of the AIM Coalition’s work will be to establish a coding pathway around sarcopenia screenings (the SPPB) and any resulting treatments, and to educate key stakeholders and physicians on these practices. This process is crucial to ensuring that patients and physicians will have access to the most effective treatments and assessment tools
Mr. Jim Scott, president and CEO of Applied Policy and an expert in CMS issues, explained that patients who meet the screening criteria should have a body composition assessment using DXA scan, which can help to identify low muscle-mass due to sarcopenia. As it stands, there is no specific ICD code for sarcopenia diagnosis. “Muscle wasting” is the current catch-all ICD code; however, this often does not support payable claims. Establishment of clinical guidelines for the diagnosis and treatment of the disease would be helpful in convincing CMS to create a sarcopenia specific ICD code. Hopefully this would aid in eliminating claim denials, barriers to non-pharmaceutical treatments, and create a pathway for future drug therapy development, and will certainly be an area in which the AIM Coalition will continue to press forward.
The meeting helped to map out this novel work – the first of its kind in the area of sarcopenia and functional decline in older patients. Collaboration among the Coalition members and other patient and advocacy groups will be crucial to build the Coalition’s message and increase recognition of sarcopenia as an important health care challenge.
To read more about the SPPB test, click here