Psychophysiologic Disorders

Patrick J. Kennedy, former U.S. Representative and founder of the Kennedy Forum, is a leading voice on mental health and addiction. During his 16 years in the U.S. House of Representatives serving Rhode Island's First Congressional District he coauthored and sponsored the Mental Health Parity and Addiction Equity Act, which requires insurers to cover mental health and substance use disorders the same way they cover physical illnesses. The Act was signed into law by President Bush in 2008. Still, Kennedy says much needs to be done to ensure proper mental health coverage, so he joined global behavioral health data platform Holmusk as a strategic advisor. Kennedy and Nawal Roy, founder and CEO of global behavioral health data platform Holmusk, sat down with MobiHealthNews to discuss their partnership and how they plan to leverage clinical data for policy change in the U.S. MobiHealthNews: How will your personal experience tackling behavioral health issues and your experience from your time in office allow you to help create more informed industry-wide measurement standards for behavioral health? Patrick J. Kennedy: So I founded the Kennedy Forum, which principally is fighting to ensure the full implementation of the Mental Health Parity and Addiction Equity Act. However, we have, if you've seen on our website, set forth a bunch of kinds of policies that we're also pursuing. We want parity not only in access, which means we want to obviously increase reimbursement to provide more access in the system by ensuring that there's a greater supply of clinicians that are practicing in the space, none of which will happen if we don't improve reimbursements to the space. And happy to report the Biden administration just released a proposed rule enforcing the Parity Law that will tackle the disparity in pay amongst mental health clinicians vis-à-vis the rest of medicine. But as I said, we're not just looking to have parity and access, we want parity in outcomes, meaning we want clinicians to be practicing evidence-based interventions that give patients the best opportunity to recover and find stability in their lives. And that means that we need to not only focus on quantity, but we also have to focus on quality. And underlying this whole challenge is making sure that we can actually measure outcomes so that we can validate our assumption, which is, if we upskill providers, they will provide a better kind of behavioral therapy, evidence-based interventions, which will result in better outcomes. The real big picture is about how do we value various interventions so that we can start to understand what social drivers of health also contribute to improving outcomes. If we step back and look at all of that, we'll appreciate that being able to measure outcomes is at the crux of all of this, because, if you can't get better data, you can't make better policy decisions about where to invest the dollars in healthcare that obviously, we want to increase writ large, but which we also want to make sure that when we're spending, we're spending in ways that have the greatest return on investment in terms of improved symptom reduction and generally improved outcomes all around. So, data is where it's at. Holmusk has data from all of their work, frankly, globally. They have really understood, in ways that our country has yet to really embrace, the impact of social drivers of health in terms of overall health outcomes, and I really see that as the new frontier in our move in the United States towards value-based contracting. Value-based contracting in mental health really has not been experimented with. We have not had CMMI [Capability Maturity Model Integration], for example, to any demonstration project that shows the value of mental health even across savings and total cost of care. These challenges are really at the essence of our fight to improve our overall system, and Holmusk is right in the middle of all of these battles and in a crucial spot, because they are about understanding what are the levers that we need to move in order to improve patient experience and outcomes. So that's why it's really synergistic for me to be working with an enterprise solution, but that is also going to have a huge impact in terms of policy improvement as well. MHN: What type of data are you collecting that's going to make an impact on the mental health community? Nawal Roy: In the data itself, there are multiple kinds of data – data that comes from the claims, data that comes from social determinants, data that comes from a clinical nature. So, we capture clinical nature. At the acute level, say a person suffering from acute depression, usually it's a clinical problem. The earliest days are at the anxiety level. It can be a wellness factor, and the wellness factor can be heavily influenced by many. But the moment you get into what I call stage two or stage three … these are nothing but fundamental clinical problems. And understanding of that clinical problem with clinical data is what we have done. Traditionally, everyone else has tried to do it with either claims data or process data. Process data is how many times you have seen a psychiatrist or how many times you have gone to rehab or what are the different tests that you have taken, things of that nature. But truly understanding what you have done, what medication you have taken, what is the side effects, was is the indication of the mode and the full longitudinal nature of your clinical behavior is fundamental to understanding how an individual is doing clinically and whether it is on a path to improvement or path of decline. That is what is a hardcore science problem, you know, or plumbing problem, and if you are not able to measure it, you will not be able to determine the outcome. And if you are not able to determine the outcome, you will not be able to set the rules by which either a private or a public sector can reimburse it. MHN: Do you have an idea of the type of policies you want to implement? Roy: The very first on the list should be, let's drive towards CMS rules and the private insurance rules by which the coverage for physical health is equivalent to coverage of mental health. So, first, the very coverage itself. Now, to drive that coverage, it should be a function of indicators or the risk measures that can come on the back, but actually defining those standard measures that could drive this. If you want to go a step down and to really make it much wider, include the HITECH Act [Health Information Technology for Economic and Clinical Health Act], and have behavioral health as part of the subsidy for the HITECH Act. Because the moment we have the HITECH Act, including behavioral health, all of a sudden you will fundamentally change the amount of data that gets captured currently within the country itself. But it can go from everything from defining standard measures to defining the rules for investment and literally having a digitization of the HITECH Act that gives subsidies for behavioral health. These three are the major fundamental regulatory changes that can really make it. But at the core, it is primarily what Patrick is doing is all around making parity of mental health. In part two of our two-part series, Kennedy and Roy discuss how mental health parity has changed since the Act was signed and the collaborator's actions to transform mental healthcare coverage in the U.S.

Since the beginning of the pandemic, SARS-CoV-2 has been suspected of causing chronic fatigue syndrome (ME/CFS). A well-controlled study has now shown that, even after mild COVID-19, a subset of patients will develop symptoms which meet the diagnostic criteria for ME/CFS. Their findings also describe a second subset of post-COVID patients with similar symptoms. Differences in laboratory results between these groups may indicate differences in underlying mechanisms. Since the beginning of the pandemic, SARS-CoV-2 has been suspected of causing chronic fatigue syndrome (ME/CFS). A well-controlled study conducted by a group of researchers from Charité -- Universitätsmedizin Berlin and the Max Delbrück Center for Molecular Medicine (MDC) has now shown that, even after mild COVID-19, a subset of patients will develop symptoms which meet the diagnostic criteria for ME/CFS. Their findings also describe a second subset of post-COVID patients with similar symptoms. Differences in laboratory results between these groups may indicate differences in underlying mechanisms. The researchers' findings have been published in Nature Communications. "Suspicions that COVID-19 might trigger ME/CFS initially arose as early as during the first wave of the pandemic," says Prof. Dr. Carmen Scheibenbogen, Acting Director of Charité's Institute of Medical Immunology on Campus Virchow-Klinikum. Prof. Scheibenbogen also oversees the work of the 'Charité Fatigue Center', which specializes in the diagnosis of ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), a debilitating condition characterized by severe physical fatigue. The Center received its first requests from patients after SARS-CoV-2 infection as early as the summer of 2020. Since then, there has been accumulating evidence of a causal link between COVID-19 and ME/CFS, a disease which often causes severe physical impairments. "Providing the scientific evidence to confirm these assumptions, however, is anything but a trivial task," explains Prof. Scheibenbogen. She continues: "This is partly due to the paucity of research into ME/CFS and the fact that there are no universally accepted diagnostic criteria. Thanks to an extremely thorough diagnostic process and a comprehensive comparison with patients who developed ME/CFS following non-COVID-related infections, we have now been able to show that COVID-19 can trigger ME/CFS." As part of this study, experts from Charité's Post-COVID Network examined 42 individuals who presented at the Center with persistent, severe fatigue and impaired day-to-day functioning six months after their SARS-CoV-2 infection. Most of the study participants were unable to perform light work for more than two to four hours a day; some were unable to work and struggled to look after themselves. Only three out of the 42 patients examined needed hospital care during their initial (acute) SARS-CoV-2 infection, but none required oxygen. 32 of the patients met the WHO classification of mild COVID-19, meaning they did not develop pneumonia, but had fairly severe symptoms including fever, cough, muscle pain and joint pain for between one and two weeks. As all of the participants' infections occurred during the first wave of the pandemic, none of them had been vaccinated. At Charité, all of the individuals concerned were examined by an interdisciplinary team of neurologists, immunologists, rheumatologists, cardiologists, endocrinologists and pulmonologists with many years' experience in the diagnosis of ME/CFS. For comparison, the researchers then examined 19 age- and gender-matched individuals who had developed ME/CFS following a similar period of illness due to a non-COVID-related infection. The researchers used the 'Canadian Consensus Criteria' to establish a diagnosis of ME/CFS. "In addition to having been scientifically developed, this catalog of criteria has been proven as a reliable diagnostic tool for chronic fatigue syndrome in clinical practice," explains the study's other co-lead, Dr. Judith Bellmann-Strobl, who heads the multidisciplinary outpatient department at the Experimental and Clinical Research Center (ECRC), a facility jointly operated by Charité and the MDC. According to the Canadian Consensus Criteria, approximately half of the post-COVID patients examined met the diagnostic criteria for ME/CFS. While the other half presented with similar symptoms, their post-exertional malaise was milder and only lasted for a few hours. In contrast, ME/CFS patients reported post-exertional malaise which persisted into the following day. Summarizing the researchers' findings, Dr. Bellman-Strobl says: "We can therefore distinguish between two groups of post-COVID patients with severely impaired physical functioning." In addition to collating data on symptoms, the researchers also determined various laboratory parameters. They then compared these with hand grip strength, which was reduced in the majority of the participants examined. "We furthermore found that individuals with milder exertional intolerance had reduced hand grip strength if they had elevated levels of the cytokine interleukin 8. In these cases, reduced muscular strength may be caused by a persistent inflammatory response," says Prof. Scheibenbogen. "In the ME/CFS group, however, hand grip strength was correlated with the hormone NT-proBNP, which can be released by muscle cells when oxygen supply is insufficient. This suggests that, in these individuals, muscle weakness may be caused by an impaired blood supply." According to the researchers' preliminary observations, the two groups may also be distinguishable in terms of disease progression. "In many people whose symptoms are indicative of ME/CFS but who do not meet diagnostic criteria, symptoms appear to improve over time," explains Prof. Scheibenbogen. These new findings may help researchers to develop specific treatments for post-COVID syndrome ('Long Covid') and ME/CFS. "Our data also provide further evidence that ME/CFS is not a psychosomatic disorder but a severe physical disease which can be measured and diagnosed using objective methods," emphasizes Prof. Scheibenbogen. "Unfortunately, current treatments for ME/CFS are purely symptomatic in nature. I would therefore urge even young people to protect themselves against SARS-CoV-2 by getting vaccinated and wearing an FFP2 mask."