RSDSA’s Concerns With the Project Rare Act and the Promising Pathways Act 2.0

To our friends and colleagues in the CRPS Community, those in the wider Rare Disease Community and to the Representatives and Senators of Congress who are concerned for the welfare of people who suffer rare diseases:

The Reflex Sympathetic Dystrophy Syndrome Association (RSDSA) represents the interests of people with Complex Regional Pain Syndrome (CRPS). Pursuant to its mission of support, advocacy, education, and research, RSDSA seeks to promote safe and effective treatments for CRPS and to advocate for insurance coverage for such treatments. Therefore, RSDSA is encouraged by two pieces of proposed legislation, the Protect Rare Act, which mandates insurance coverage for FDA-approved treatments for rare and life-threatening diseases, and the Promising Pathways Act 2.0 (PPA2.0), which amends Title 21 to provide for time-limited FDA approval of treatments for rare and life-threatening diseases, which have phase 1 evidence of safety, complete or ongoing phase 2 evidence of safety and a minimum of pilot (probable) evidence of efficacy.

RSDSA supports both bills in principle. RSDSA holds that our concerns over the weaknesses of these bills can be resolved. RSDSA is concerned by the disagreement that has arisen between Senator Braun’s office, a sponsor of PPA2.0, and the National Organization of Rare Diseases (NORD). NORD opposes some features of PPA2.0, and, therefore, its passage. RSDSA contends that a cooperative, conciliatory resolution to any conflict is possible. NORD has been a steadfast and respected leader of the rare disease community, and its concerns must be considered seriously.

RSDSA’s concerns with Protect Rare and PPA2.0 are twofold:

First: Both Protect Rare and PPA2.0 mandate insurance coverage for FDA-approved treatments. On the other hand, rare diseases are often treated with treatments off-label. Ketamine is a particularly important example of a drug that is approved by the FDA, but not for CRPS. Protect Rare specifies “approved” treatments only. The wording of PPA2.0 is ambiguous, but a reasonable interpretation of the text indicates that only new drugs are eligible for the time-limited approval that PPA2.0 provides. Neither Protect Rare nor PPA2.0 provide a mechanism to repurpose and relabel ketamine (or any other treatment for any rare or life-threatening disease) to mandate insurance coverage.

A resolution to this concern would be the deletion of the word “new” [drug] from the legislation, so that PPA2.0 provides a pathway for FDA approval of any drug, currently used off-label, for the treatment of CRPS (or any rare disease). Consequently, the relabeling of such drugs would make them eligible for insurance coverage under Protect Rare.

Second: The limited evidence of safety and efficacy required for FDA approval of treatments under PPA2.0, a dispositive concern for NORD, can result in potential or real danger to patients and wasted time when ineffective treatments have not been properly, and repeatedly studied in scientifically robust trials.

A potential resolution of this concern lies in PPA2.0’s requirement that applicants for approval of a drug or device maintain a registry of patients receiving the treatment. This is an ideal application for artificial intelligence (AI), which continually monitors the registries (faster and probably more accurately than a human “patient safety committee”). Using a comprehensive set of outcome measures, AI monitors symptoms and signs of treatment response and adverse effects of the treatment. This real-time monitoring is inferior to evidence generated from randomized, controlled trials of safety and efficacy, but it may suffice.

RSDSA desires both approval of safe and effective treatments and mandated insurance coverage for them. RSDSA calls on all stakeholders in the rare disease community and Congress to come together to resolve differences and concerns to entail full, universal support of this groundbreaking legislation.

Sincerely,

RSDSA Board of Directors

Feel free to send any feedback on this topic to RSDSA directly via [email protected].

Ten Questions With Jim Broatch

Written by RSDSA Intern Samantha Rose

How did you start working for the organization?
In the 1990s, I was working on the board of the National Organization for Rare Diseases (NORD). During this time, Dr. Robert J. Schwartzman convinced Roe Davis, Frank Davis, and Audrey Thomas to start the RSDSA Organization to support CRPS warriors. In search of a skilled and compassionate person to lead the organization, Mrs. Davis called Abbey Meyers, the founder of NORD, who recommended me for the position that I feel grateful to have had for the past twenty-five years. We then brought the organization to Milford, Connecticut.

How has the organization and its mission changed over the years?
When RSDSA first began, it had a newsletter, just as it does today. However, the newsletter today looks much different, and serves a very different purpose. Back then, it was filled with personal stories of “woah” about the struggles of CRPS. However, we have since changed the newsletter to make it a more informative and supportive outlet for CRPS patients, focusing on educating and giving hope to those with CRPS. “Hope” has become an integral part of our message and mission, one that we have– and will continue to– expand over the years.

Which aspect of the organization’s progress are you most proud of?
The courses that we have provided for doctors and nurses have been transformative in creating a medical world where more doctors are aware of, have interest in, and have the tools to help CRPS warriors. Additionally, the way that our organization has grown into the national, go-to organization for CRPS is incredible. We have built a patient-friendly community where everyone tries to help each other, regardless of physical distance. Planting seeds of hope has become much easier and more widespread with new social media outreach programs, much thanks to our social media manager, Alexis Johnson. In addition to increasing engagement on our virtual platforms, our Facebook Lives since the pandemic have educated and supported the RSDSA community. This is an improvement from before the pandemic, when we often had in-person conferences with 140-200 people attending. Now, we are able to have 1,400+ people from all around the country listen to guest speakers in their own homes. I am particularly proud of the Jenkins Patient System Program to memorialize Brad Jenkins, whose mom helped to start a fund for people to avoid eviction and get much-needed medications.

Which aspect of being executive director did you enjoy the most?
Often, new CRPS patients spend a quick fifteen minutes with their doctor discussing CRPS when they first are diagnosed, not receiving nearly the kind of education that they need in order to seek help and support. Therefore, being able to educate them, support them, and give them hope throughout their journey has been an incredibly rewarding experience. Whether it be through linking patients with financial support, service dogs, legal aid, medical professionals, or accommodations at work, I loved helping and supporting people. I specifically remember an instance where I was able to get a tank of propane filled for a warrior who could not afford it during a blizzard, and how the simple act created a huge difference in somebody’s life.

Which aspect of being executive director did you least enjoy?
While I loved being able to help people, the hardest moments of my day-to-day job were those when I was not able to provide the kind of help that somebody needed. Often, this came in the form of family members doubting their CRPS and abandoning them, diminishing the web of support and encouragement necessary throughout this journey. It also disappointed me when people did not find RSDSA until they were months and years into their diagnosis with no hope– we must try to reach people earlier in their illness to provide the kind of support they need.

What was your day-to-day life like as the executive director of RSDSA?
Before COVID, I often participated in many calls a day to help warriors when they sought more direction. This has changed, as most inquiries and responses now are sent through email. Every day on the job is a learning experience, as hearing people’s stories and needs allows me to explore what is lacking and how to improve our services. I also look for thought leaders and try to help curate treatment teams of doctors, physical therapists, occupational therapists, and aids for warriors to lead them in the correct direction.

How has the CRPS science changed over time?
Previously, scientists lumped all CRPS patients together for clinical trials, only differentiating subjects by Type I and Type II classifications. However, we no longer conceptualize CRPS as a homogeneous disease, largely due to a subset study conducted by Dr. Stephen Bruehl and Dr. Norman Harden. These doctors are the thought leaders of CRPS science, and have formed a collaborative team with which I have had great pleasure engaging. Through their work, we have been able to create five versions of clinical practice guidelines for CRPS. We also have used science to debunk the evidence-less theory that CRPS is solely psychological, validating the struggles of CRPS patients.

How can we expect the CRPS science to change in the future?
There currently is a study being conducted regarding neuroplasticity and treatments that are brain-based as opposed to targeting the afflicted limb. The Cleveland Clinic also recently received a multi-million dollar grant to evaluate a stem cell treatment for CRPS, with animal and human trials. We are also extremely hopeful about our CRPS subset study, which involves a consortium of three centers in Europe. My hope is that an international CRPS research consortium will come to fruition in the future; of course, this requires overcoming the long-standing challenge of not finding enough patients to participate in these studies.

What do you envision as the future direction of the organization?
For sixty years, ketamine has been known to be an effective treatment for chronic pain, but we have been barred by outrageous prices and legislative issues. This must change, hopefully through the work of the dedicated Jim Doulgeris with the RARE Act. Since 2016, there has been a war on people with pain because of misapplication of CDC and opiate guidelines, and we must fight back. This involves more research on CRPS and other rare diseases, which often is difficult because there is not adequate money to continually fund research grants. In the future, we might need to decide if the organization will mainly focus on research grants or support and education, or find other avenues for continued funding.

What are you most looking forward to during retirement?
I am excited to have more freedom and more time to explore the outdoors and go birdwatching and kayaking. In fact, my wife and I are going to see Christian Cooper, a famous birdwatcher and author, in Central Park. I am also an avid reader. I am excited to continue to give back to the community: my wife and I volunteer at a soup kitchen, and we look forward to other opportunities to help. Overall, I am looking forward to being present each day and treasuring every moment.


FROM THE AUTHOR

Jim, the RSDSA community and my family are so grateful for everything you have achieved and how much support you have provided over the past twenty-five years. Your passion for helping others and creating a better life for people never fails to shine through, whether it be in phone calls, emails, Facebook Lives, and everything in between. We wish you the best of luck and happiness in your retirement.

Best,
Samantha

Gratitude in Leadership: A Heartfelt Tribute to Our Exceptional Executive Director

As announced earlier this month, our Executive Vice President & Director, James W. Broach, MSW, has decided to retire after 25 years of dedicated service and outstanding leadership to the CRPS/RSD community.

Jim’s legacy will continue through the numerous Warriors he has helped over the years. Take a look at the kind words and generous feedback we received since announcing his retirement.

“If it was not for Jim and rsds.org, I would not be alive.” – Patty S.

“Jim answered the phone 17 yrs ago to begin my CRPS journey of education, advocacy. Over the years, Jim and I presented in a variety of forums including Hofstra medical school, Long Island Pain Management Nursing Association, National Conference of Pain Management Nurses, ran educational booths, spoke in podcasts, radio, etc. Honestly, a true champion to RSDSA and the CRPS community (medical, patients, caregivers). His endless energy has created tremendous differences for all. Thank you doesn’t express the enormity of it all. God bless you my friend.” – Beth S.

“Thank you Jim. I spoke with you personally and you made a huge impact on my life. Your help with my CRPS diagnosis meant so much to me and my family.” – Libby M.

“Jim and RSDSA have been a tremendous advocate for RSD/CRPS warriors for decades. In addition, his organization was one of the first I am aware of who generously acknowledged alternative treatment modalities as a viable consideration to reduce or even eliminate the neuropathy and physical symptoms of the disease. I am personally indebted to Jim for his support. These are indeed big shoes to fill. Wishing Jim much joy (and well deserved relaxation) in his next chapter.” – Michael C.

“Dear Jim! Thank you for your part in my journey with CRPS over the last 2 decades. It was a pleasure meeting you in person in 2013. Happy retirement!” – TV

“Congratulations!! You’ve been a light to so many and for that we are grateful! Enjoy your retirement!!” – Bonnie W.

“Congratulations, Jim! Thank you isn’t enough. Your tireless work in CRPS awareness and education saved my life. That’s not hyperbole. When I was diagnosed, I was at the absolute end of my rope. Then I miraculously found RSDSA online and you changed the course of my life. Here I am, seven years after finding a treatment plan I would never have imagined, still standing, still moving, still helping others find RSDSA. Thank you will have to do, but it hardly covers the gratitude I have for your work.” – Cory

“Jim, I spoke to you on a few occasions and I know for a fact that you helped changed lives for the better. While I hate to see you go, I think that you deserve a well deserved retirement. I hope you get to enjoy it and live life to its fullest!” – Merrie C.

If you are interested in sharing your story about how Jim has helped you navigate RSD/CRPS, please email [email protected].

RSDSA Executive Vice President & Director To Retire

To the RSDSA Community,

We hope this message finds you well. Today, we are reaching out with an important announcement regarding a change within our organization.

After 25 years of dedicated service and outstanding leadership to the CRPS/RSD community, our Executive Vice President & Director, James W. Broach, MSW, has decided to retire effective March 31, 2024. Jim’s leadership and contributions have been invaluable, and we are immensely grateful for his unwavering commitment to the CRPS community.

Under Jim’s guidance, RSDSA has achieved remarkable milestones and grown in ways that have positively impacted countless lives. During his 25 years of service, RSDSA became the go-to patient advocacy organization for people with CRPS. It invested more than $2.2 million in basic and clinical research, conducted numerous conferences and educational presentations on the diagnosis, treatment, and management of CRPS, published evidence-based Treatment Guidelines, established an emergency financial assistance program, offered accredited CME courses on adult and pediatric CRPS to healthcare professionals, and created a compassionate patient-centered culture.

His vision, passion, and dedication have set a high standard for excellence, and he will be deeply missed in this role. His skills are not entirely lost to us, however, as he has promised to remain available to our incoming Executive Director, and ease her transition into the position.

While we bid farewell to Jim, we are excited to announce that current RSDSA Board Vice President, Sharon L. Weiner, will assume her new role as Executive Director. In addition to having CRPS for over 25 years, Sharon was also a founder and the president of Living with RSDS, Inc., a New Jersey not-for-profit that offers multiple support groups. Sharon is a co-founder of our Young Adult Weekend Retreat, a member of our Executive Committee, and the chair of our Support and Board Nomination Committees. She brings a wealth of personal and professional experience, including her numerous presentations at RSDSA conferences, that we believe will continue to honor our mission and give vision to RSDSA’s future.

We are organizing a special farewell fundraiser to honor Jim’s legacy. Please consider supporting the campaign by clicking here. RSDSA will also organize a virtual meet and greet in March to introduce Sharon to our community. Details about this event will be shared in the coming weeks.

Again, we express our heartfelt gratitude to Jim and our warmest wishes to Sharon in her new position. We are confident that together they will effect a seamless transition which will enable Sharon to expand upon the strong foundation built by Jim and his 25 years of RSDSA stewardship.

Thank you for your ongoing support, and we look forward to the exciting journey ahead.

Sincerely,

The RSDSA Board of Directors

The Veterans Health Administration Approves and Pays for Ketamine Infusions for Retired Military

Infusions cover depression, PTSD and Chronic Pain including CRPS

A Special Thank You to Shara Wilkey (Capt., USMC, Ret.)

By James Doulgeris, Chairman, RSDSA Advisory Committee

The Veterans Health Administration, Military News and independent contracted clinics have confirmed that the VHA has approved and will pay for ketamine infusions, including travel expenses in certain circumstances, to treat treatment resistant depression, PTSD and chronic pain including CRPS. Your physician’s approval is required, of course.

While this program has been in effect for some time, it has not been made well known. In fact, we had no idea it existed until Shara Wilkey (Capt., USMC, Ret.) brought it to our attention.

Finding an infusion center near you may be as simple as an Internet search (be sure to use a search engine using an advanced AI engine like Google or Microsoft). You may, however, need to contact the one nearest you, and that may require air travel. The VA does pay for travel expenses; however, it may require the assistance of your U.S. House Representativ’s or Senator’s Office to cut through the red tape according to Capt. Wilkey.

It’s worth mentioning that having a companion accompany you during the infusion is mandatory. However, information regarding whether the expenses related to the companion are covered remains unclear, as we couldn’t find concrete details. The VA did not have this information readily available when contacted, and they are yet to respond to our inquiry. We will keep this report updated if any further information becomes available.

As always, we express our gratitude for your service and want to emphasize that we are here to assist. You can reach out to us at [email protected] for any inquiries or assistance you may need.

Join us for Treating the Whole Person: Optimizing Wellness 2023

RSDSA’s free virtual Treating the Whole Person: Optimizing Wellness conference is taking place Monday, November 6, 2023 through Thursday, November 9, 2023!

This event will stream for free here on our Facebook Page and YouTube Channel at the same time. There is no registration required.

Join us live to interact with other CRPS Warriors and our speakers. If you miss a session or want to watch it again, the sessions will be available on our Facebook Page and YouTube Pages immediately after they end!

→ Monday, November 6th at 12:00 pm Eastern | An Update on Neuroplasticity and TrainPain with Dr. Elan Schneider

→ Monday, November 6th at 8:00 pm Eastern | A Conversation with Disability Activist, Author, and CRPS Warrior Tara Moss

→ Tuesday, November 7th at 7p Eastern | Lessons We Can Take Away from the Tragic Story of Maya Kowalski (Take Care of Maya) with Bryan Pope

→ Wednesday, November 8th at 7p Eastern | KarunaHOME Program – CRPS Treatment Success with Matthew Sheers, NBC-HWC, CPMC

→ Wednesday, November 8th at 8:15p Eastern | Abbott’s DRG Therapy – Understanding Your Options for Targeted Pain Relief with Denis G. Patterson, DO

→ Thursday, November 9th at 7p Eastern | Qigong – A Natural Remedy for Pain and Stress Relief with Marie Theriault

→ Thursday, November 9th at 8:15p Eastern | Understanding Suicides after Prescription Opioids are Stopped: The CSI:OPIOIDs Research Study with Stefan G Kertesz, MD and Allyson Varley, PhD

What Do You Mean Denied? I Can’t Do My Old Job!

Written by Jeffrey A. Rabin, Esq., for the RSDSA blog.

This is a common question from new clients. Often it is followed by: “The company has gone out of business anyway!” Unfortunately, this is often not meaningful in a Social Security Disability application.

Social Security is considered to be a “total disability” program and whether someone can work is determined by their age, education, work experience, and most important, their Residual Functional Capacity (RFC) determination – that is, what is the most that they can still do in a full time work setting despite their medical problems.

In the Regulations, Social Security has a 5 step analytical process called the “Sequential Evaluation Procedure” which is applied by every decision maker in the system.

The first step asks whether the Claimant is working – if they are not, the analysis goes to Step Two.

Step Two asks whether the medical evidence documents a “severe” impairment – one that at least minimally impacts on work function. For example, high blood pressure is a serious medical problem but does not impact on work function until there is severe end organ damage so it is usually a “non-severe”impairment for SSD purposes.

Assuming there is, then Step Three asks whether the medical proof indicates the medical condition “meets or equals” the Listings of Impairments. This is very severe medical criteria set out for many medical problems. If that is met, disability is awarded.

If not, then Step Four asks what is the Claimant’s RFC, and does that allow for performance of any of the “types of work” that were done in the last 15 years. That does not ask whether the old job is available or whether the Claimant would be hired. It simply asks, can the Claimant “function” at any of the types of jobs performed in the last 15 years. If yes, the case is denied. Therefore, at the outset of filing the application careful consideration needs to be made of all past work in the last 15 years.

If at Step Four it is determined that the Clamant can not perform past relevant work then at Step Five SSA asks: Considering the age, education, work skills and Residual Functional Capacity, are there other jobs this person could do on a full time basis in the national economy? If yes, the application is denied. If no, the benefits will be paid.

The state agencies hire vocational experts at the initial and reconsideration level to give reports on the kinds of jobs a Claimant could perform considering their medical limitations . At hearings many Judges hire vocational experts to testify as to the existence of other jobs the Claimant can perform given their RFC and the other factors. This testimony, and the cross-examination of these “experts” often decide whether an application will be approved.

Social Security has some guidelines that help – these are called the “Grid Regulations” and they guide decision makers in the application of RFC, age and education issues.

For example, if an ALJ finds that a Claimant older than 55 cannot perform past relevant work, has no transferable skills, less than a GED education, and has a RFC for light work, that person is disabled under the Grid. However, if that same person has a high school degree and can perform light work, their application is denied.

If you change the facts to state that at most this person can do is sedentary work then benefits are awarded. But, if that same person has transferable skills to other sedentary jobs then the application is denied.

The point of these examples is to show that these determinations are complex and that simply the inability to do past work does not mean that benefit will be awarded.

Want to learn more? Our in-service sessions on Social Security Disability benefits usually qualify for Free CEU credits for staff that attend. Give us a call and get on our calendar for a free in-service at your location, or on Zoom, soon.

Prepared by Jeffrey Rabin, Esq.
Jeffrey A. Rabin & Associates, Ltd.
2604 Dempster St. Suite 508
Park Ridge, IL 60068
847-299-0008
[email protected]

Sending Condolences to the Family of R. Steven Shisler, Esq.

It is with deep sadness that we share the news of the passing of RSDSA board member, R. Steven Shisler, Esq. His unexpected departure has left us all in a state of profound sorrow and loss.

Steve Shisler’s loss will be felt keenly throughout the entire CRPS community. He was a fierce & compassionate defender of those who suffer from this debilitating syndrome. Unfortunately, he knew all-too-well the havoc CRPS can wreak on a body and a spirit, having dealt with its ravages himself as the result of a motorcycle accident many years ago.

While the CRPS community at large marks his passing, we at RSDSA are especially saddened. He served on our Board in several different capacities throughout his long tenure here.

He always provided ad hoc legal advice, and in recent years, functioned as the Board Secretary. Instead of a more traditional and formal roll call, Steve often began meetings with greeting each member by name as he recorded the Minutes.

More importantly, however, we could always rely on Steve to transform our divergent opinions into one cogent voice which enabled us to advocate successfully for our members. His was the voice of reason and the heart of understanding to which we all aspired. He will be sorely missed.

Learn more about Steven via the Wilde Funeral Home website.

Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition 

Originally published on June 10, 2022

This is the fifth edition of the Diagnostic and Treatment Guidelines for Complex Regional Pain Syndrome (CRPS; also known as Reflex Sympathetic Dystrophy [RSD], causalgia). These guidelines have been sponsored by the Reflex Sympathetic Dystrophy Syndrome Association and are written by expert practitioners in each discipline that is traditionally utilized in the treatment of CRPS [1]. There is a fairly recent, excellent, rigorous systematic review of the treatment literature in CRPS [2] which confirmed there is only modest high-quality research in the area. Nonetheless, in this “evidence vacuum” we still have a responsibility to treat. Certainly, we must develop better evidence, but our patients cannot wait for that. Thus, although the authors of these practical guidelines all utilized a systematic approach to reviewing the available and relevant literature, they have also included less rigorous, preliminary research reports, often supplemented by extensive empirical experience. The authors perforce must also extrapolate from “related conditions” (e.g., neuropathy [3]). The research quality, clinical relevance and “state of the art” of diagnostic criteria or treatment modalities are discussed, sometimes in considerable detail. Where there have been no discernable updates in areas since the 4th edition, text from that has been kept, sometimes verbatim.

These guidelines are intended to serve as an aid to the informed practitioner. They are not intended to replace or supplant the clinician’s best judgment, experience, training and/or a careful consideration of the clinical context. Although every reasonable attempt has been made to minimize the bias of the authors, it must be recalled that, in context, all the experts are to a degree biased to “their” therapeutic approach.

Detailed sections are provided as a guide and informational source not only to the “expert” in CRPS therapy but also the primary practitioner who is interested. Levels of evidence are mentioned when appropriate (Table 1), so that the practitioner can better assess the modality under discussion and, if desired, to personally review the citations in detail. In the humanitarian spirit of making the most of all current thinking in the area, balanced by a careful case by case analysis of the risk/cost versus benefit analysis, we offer these “practical” guidelines.

View the full article here.

“PEOPLE Magazine” Focuses on a Tragic Injustice Experienced by a Family Living With CRPS

In a recent article by PEOPLE Magazine, Maya Kowalski shares how her CRPS diagnosis was classified as Munchausen syndrome by proxy, a mental disorder in which a caretaker of a child either makes up fake symptoms or causes real symptoms to make it appear that the child is injured or ill.

RSDSA is working with other rare disease organizations to quantify how many rare disease families have been accused of medical child abuse.

If you want to share your story, please email us at [email protected].