Category: ACR

Rheumatology Leaders Urge Lawmakers to Address Rising Costs & Access Barriers in Arthritis Care

Posted on by Grayson

This press release from the ACR just came out.

WASHINGTON, D.C. – Rheumatologists and rheumatology health professionals convened on Capitol Hill this week to urge legislative action on pressing policy issues affecting rheumatology care during the American College of Rheumatology’s Advocacy Leadership Conference, held May 16-17, 2018 in Washington, D.C.

Noting the rising costs and increasing access barriers in rheumatologic care, specialists encouraged lawmakers to support legislation that would create reasonable exceptions to the use of step therapy, grow the rheumatology workforce, increase transparency in drug pricing, and hold pharmacy benefit managers accountable for pricing practices that increase out-of-pocket costs for patients.

“We are at a critical juncture in rheumatology care,” said David Daikh, MD, PhD., President of the ACR. “According to the latest federal estimates, as many as 54 million Americans have a doctor-diagnosed rheumatic disease, and a recent academic study suggests that number could be as high as 91 million when taking into account symptoms reported by undiagnosed individuals. The rheumatology workforce is not growing fast enough to keep up with demand and too many of our patients struggle to access and afford the breakthrough therapies they need to manage their pain and avoid long-term disability. America’s rheumatologists are urging our lawmakers to act now and support bipartisan, common-sense legislation that would increase access to high-quality rheumatology care for their constituents.”

The American College of Rheumatology urged Congressional leaders to support the following legislation to address access and cost barriers in rheumatologic care:

  • Restoring the Patient’s Voice Act (H.R. 2077), bipartisan legislation which would create a clear and transparent process for patients with employer-sponsored insurance to seek exceptions to step therapy;
  • Know the Lowest Price Act of 2018 (S. 2553) and the Patient Right to Know Drug Prices Act (S. 2554), bipartisan legislation which would allow pharmacists to inform patients when the cash price of their medicines is lower than the price they would pay with insurance coverage;
  • Prescription Transparency Act of 2018 (H.R. 5343) bipartisan legislation that would allow pharmacists to inform patients about alternative options to lower out-of-pocket drug costs;
  • Ensuring Children’s Access to Subspecialty Care Act (H.R. 3767; S. 989), bipartisan legislation that would allow pediatric subspecialists to participate in the National Health Service Corps loan repayment program;
  • Conrad State 30 and Physician Access Act (H.R. 2141; S.898), bipartisan legislation which would allow international doctors trained in the U.S. to remain in the country if they practice in underserved areas; and
  • Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 (H.R. 4841), bipartisan legislation which would require the Centers for Medicare and Medicaid Services to develop electronic prior authorization standards for Medicare Part D and Medicare Advantage plans.

Rheumatology leaders also advised members of the House and Senate Appropriations Subcommittees on Defense to establish a line item in the Congressionally Directed Medical Research Program (CDMRP) for arthritis at the Department of Defense using $20 million in existing funds. Such a program would meet the growing needs of active duty military personnel and veterans, a disproportionate number of whom live with osteoarthritis and other rheumatic diseases.

pink and blue and dark blue background with pink text: " American College of Rheumatology Responds to Short-Term, Limited-Duration Insurance Proposed Rule " and white text " Not Standing Still's Disease "

American College of Rheumatology Responds to Short-Term, Limited-Duration Insurance Proposed Rule

Posted on by Grayson

The following is a press release sent today from the ACR.

Washington, D.C. – In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) expressed concern that the Short-Term, Limited-Duration Insurance (STLDI) proposed rule could weaken consumer protections that enable individuals living with rheumatic diseases to access quality, affordable care.

The ACR expressed that increasing the duration of short-term plan coverage from three months to twelve could make it more difficult for some consumers to distinguish short-term gap coverage plans from long-term plans that comply with Affordable Care Act (ACA) requirements. This is problematic, because short-term plans with limited set benefits are not required to include coverage for services rheumatology patients with inflammatory arthritis and other conditions often depend on such as preventative care, rehabilitation services, prescription medication coverage and lab testing (which is needed for the diagnosis and subsequent monitoring of disease activity and medication toxicity).

“While we recognize extending the length of time people can carry short-term insurance may provide some individuals with more gap coverage than previously available, we are concerned patients may sign up for these short-term plans not realizing they don’t offer benefits they need to successfully manage their chronic conditions,” said David Daikh, MD, PhD, president of the ACR. “It is crucial that patients with chronic conditions are able to remain on their medications and that insurers do not limit access to required care.  Treatment decisions should be left to the provider.”

Additionally, the ACR worries that if prescription drug coverage is included, it will be minimal and may only cover one drug per class – which would greatly limit patients’ ability to access their needed biologic medications. If a patient with rheumatoid arthritis is unable to access critical biologic medications, they may face irreversible joint damage and disability.

The ACR recommends that insurance agencies be required to include a notice that these short-term plans may not cover all of the ACA’s essential health benefits, graphs and tables to compare the plans’ coverage to what the enrollee would receive under an ACA-compliant plan, and to provide specific guidance regarding the plan’s prescription and specialty drug coverage.

“The ACR is committed to ensuring that all rheumatic disease patients have access to affordable, quality healthcare, and we look forward to serving as a resource to CMS as it works to finalize this proposed rule,” said Dr. Daikh. 

About the American College of Rheumatology

The American College of Rheumatology (ACR) is the nation’s leading advocacy organization for the rheumatology care community, representing more than 6,400 U.S. rheumatologists and rheumatology health professionals. As an ethically driven, professional membership organization committed to improving healthcare for Americans living with rheumatic diseases, the ACR advocates for high-quality, high-value policies and reforms that will ensure safe, effective, affordable and accessible rheumatology care.

ACR Responds to HHS Benefit and Payment Parameters Final Rule

Posted on by Grayson

The following is a press release that the American College of Rheumatology sent out yesterday.

Washington, D.C. – The American College of Rheumatology (ACR) today expressed concern that the 2019 Benefit and Payment Parameters final rule allowing states to select their own Essential Health Benefits (EHB) benchmark plans on federal health exchanges could jeopardize care access for patients with complex rheumatologic conditions.

“While we are pleased to see that the Centers for Medicare and Medicaid Services (CMS) is using this rule to reduce regulatory burdens and promote drug price transparency, we are disappointed that the agency did not heed the advice of the ACR and other health groups regarding Essential Health Benefits coverage,” said David Daikh, MD, PhD, President of the ACR. “It is absolutely critical that people living with rheumatic diseases are able to access insurance coverage on the federal exchanges without having to worry about whether the treatments they need to manage their conditions will be covered.”

In comments submitted last November regarding the agency’s proposed rule, the ACR warned CMS that allowing states to select their own EHB benchmark plans could create a “race to the bottom” where states seek cheaper, less comprehensive coverage that limits patients access to care, and particularly access to biologic therapies.  Even with CMS’s agreement to include an amendment in the final rule clarifying an appropriate balance of coverage, the ACR remains concerned that allowing states to pick their own EHBs puts patients with complex needs at risk, especially in states that may allow plans to cover only one drug per class.

Separately, the ACR applauded CMS for deciding not to move forward with a proposal to designate Children’s Health Insurance Program (CHIP) buy-in programs providing identical coverage to state Title XXI CHIP programs as “minimum essential coverage” without first undergoing an application process. The ACR had urged CMS to abandon this proposal as it would leave children who suffer from rheumatic diseases in a dangerous medical limbo with no guarantee that coverage provided under these programs would be the same.

“We remain committed to ensuring that all rheumatic disease patients are able to access high quality, affordable care and will continue to serve as a resource for CMS as it works to extend coverage, reduce barriers, and expand patient choice,” Dr. Daikh continued.

Nine Physician Specialty Groups Caution HHS Against Proposed Drug Pricing Changes

Posted on by Grayson

The following is a press release from the American College of Rheumatology sent out today.

Washington, D.C. –   Nine of the nation’s leading physician groups – including the American College of Rheumatology, American Academy of Neurology, American Academy of Opthalmology, and American Urological Association – joined together this week to urge the Trump Administration to reconsider some of the policy changes suggested in recent drug pricing proposals that would have negative effects on patient care.

“While are we are supportive of some concepts recently presented, we do have serious concerns regarding other policy suggestions,” stated the groups. “We believe HHS should make policy proposals designed to reflect the needs of complex care patients, reduce administrative burdens, and increase access to care.”

In a letter sent to U.S. Department of Health and Human Services Secretary Alex Azar, the groups cautioned that the Administration’s proposal to consolidate certain physician-administered drugs covered under Medicare Part B into the Part D program while reducing physician reimbursements for new drugs below the current payment rates would create access issues and force patients to seek treatment in higher-cost sites of care.

Medicare Part B and D are distinctly different programs with differing formulary structures and cost sharing that would be difficult to consolidate without significantly increasing out-of-pocket costs for patients – particularly those who have no other option but to rely on biologics. And because Medicare Part D does not allow for supplemental coverage, patients would be on the hook for larger portions of these expensive biologic therapies.

The groups also warned that changing Medicare Part D formulary standards to require a minimum of only one drug per class rather than the current two could limit patient’s access to the medical therapies judged to be the most effective choice by their physician.

Additional concerns centered on how the Administration’s proposal to reduce physician reimbursements for in-office treatment from the current ASP +6%  (which is actually 4.3% due to sequestration) to Average Sales Price (ASP) +3%  would be damaging to patient access. By reducing physician reimbursements below the cost of obtaining and providing these complex therapies, many practices – especially small and rural practices that are unable to negotiate bulk discounts from manufacturers – may be forced to stop administering biologic therapies to Medicare patients altogether, the specialty groups warn. This would drive patients into more expensive and less convenient settings to receive needed therapies – if such alternatives even exist.

In their letter, the groups are supportive of policies that would lower drug prices while increasing access to vital medications, including:

  • Requiring Medicare Part D plans to apply a substantial portion of rebates at the point of sale;
  • Establishing a beneficiary out-of-pocket maximum in the Medicare Part D catastrophic phase providing beneficiaries with better protection against high drug costs;
  • Decreasing the concentration in the pharmacy benefit manager (PBM) market and other segments of the supply chain; and
  • Providing guidance from CMS on how drug-related value-based contracts and price reporting would affect other price regulations.

“Our organizations are dedicated to ensuring that physicians have the resources they need to provide patients with high-quality care,” the letter concludes. “We look forward to being a resource to you and we welcome the opportunity to meet with HHS to discuss our concerns and positions in more detail.”

pink background with teal heartbeat line above black text: "ACR Awarded Grant to Focus on Projects That Curb Health Disparities" and "Not Standing Still's Disease"

ACR Awarded Grant to Focus on Projects That Curb Health Disparities

Posted on by Grayson

The following is a press release I received this week from ACR:

ATLANTA – The American College of Rheumatology’s (ACR) new program, Uniting Collaborators for Innovation (UCOIN), was named one of five recipients of the American Society of Association Executives Foundation Innovation Grants Program, which awards $10,000 to programs that demonstrate engagement in innovation efforts within the association community. UCOIN is being developed by the ACR’s Collaborative Initiatives department as a platform for member-led projects that reduce health disparities.

The program’s initial phase will focus on creating initiatives that diminish racial and ethnic disparities for patients with rheumatic diseases. Research indicates that certain rheumatic conditions – including lupus and scleroderma – disproportionately affect minority populations in the United States, and UCOIN sees an opportunity for ACR and ARHP members to collectively problem solve. One example of a potential project is addressing the need for increased participation of ethnically diverse participants in clinical trials.

“We know how prevalent rheumatic diseases are in people of color, and we also know that Americans are more racially and ethnically diverse than ever,” said Sheryl McCalla, UCOIN Project Director and ACR Senior Director, Collaborative Initiatives. “Societal consequences of inequities will continue to grow, so we at the ACR want to ensure that we’re doing our part to eliminate these by creating a broad platform for innovation.”

Program organizers cite barriers to health care access and a lack of representation in clinical studies as two problems that can result in negative disease outcomes for minority populations with rheumatic conditions. Through UCOIN, ACR and ARHP members will have an opportunity to identify such areas of need and implement strategies to eliminate critical gaps.

“Addressing health disparities is important for the sustainability of our profession and for the health of the patients we serve,” said Dr. Sam Lim, MD, UCOIN Working Group Chair and Professor of Medicine at Emory University. “In order to serve all patients to the best of our ability, we must figure out why outcomes for some are dramatically different than outcomes for others, especially when we know that some of those disparate outcomes can be prevented.”

UCOIN is currently in the planning stages and will be officially unveiled in October 2018 at the ACR/ARHP Annual Meeting in Chicago. ACR and ARHP members are invited to contribute ideas and suggestions as the program develops. Those interested in participating in UCOIN should contact Sheryl McCalla at smccalla@rheumatology.org.

About the American College of Rheumatology

The American College of Rheumatology is an international medical society representing over 9,400 rheumatologists and rheumatology health professionals with a mission to empower rheumatology professionals to excel in their specialty. In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit www.rheumatology.org.

mas session

Macrophage Activation Syndrome Session #ACR17

Posted on by Grayson
This morning, I was lucky enough to attend a session all about one of my biggest fears – Macrophage Activation Syndrome (MAS).

 

The first thing I found interesting was that the physician who presented this session – Rayfel Schneider from the University of Toronto – believes that SJIA and AOSD are essentially a spectrum. A person may have juvenile or adult onset and present essentially the same. Newer research over the last few years from leading pediatric rheumatologists – like Dr. Alexei Grom and others – have proven through various pieces of research that SJIA more closely resembles periodic fever syndromes and is autoinflammatory rather than autoimmune.

 

What is MAS?

For those of you who aren’t familiar, MAS is one of the leading causes of death for people with Systemic Juvenile Idiopathic Arthritis (SJIA) or Adult Onset Still’s Disease (AOSD). This can also be a worry for people with SLE lupus or Kawasaki Disease. Otherwise, it’s rare to see MAS in conditions like other JIA subtypes, IBD, etc.

 

Macrophage Activation Syndrome isn’t well understood. Essentially, though, what MAS is a product of is a “highly stimulated but ineffective immune response.” This can be due to an infection or the underlying disease (SJIA, for example) itself.

 

Symptoms of MAS include increased fevers, higher ferritin levels, liver issues, cytopenia (low white and/or red blood cells), coagulopathy (difficulty to form blood clots), and hepatosplenomegaly (enlargement of both liver and spleen). Additionally, lymph nodes may swell and a patient’s mental state may change. They may also experience issues in a wide range of bodily systems, including neurological (from seizures to a coma), cardiac, pulmonary, and renal. Schneider explained MAS as a hyperinflammation and cytokine storm, leading to organ damage, multisystem failure, and, potentially, death. In fact, mortality in kids sits at 8-22%. For adults, that’s about 9%.

 

MAS is related to another condition – Hemophagocytic Lymphohistiocytosis (HLH). I won’t talk much about that for now, but MAS is thought to be one form of secondary HLH brought on as a part of another condition (again, SJIA). There are many types of secondary conditions like SJIA that could cause MAS, such as Epstein-Barr Virus and even some kinds of cancers. The thing I found most interesting about this was that one type of cancer Schneider pointed out was leukemia. In my personal journey, I was misdiagnosed with leukemia and given six weeks to live. It always seemed to me that my physicians had been grasping at straws to find a diagnosis, but this link makes much more sense now – especially when the majority of MAS cases present at SJIA onset. Research shows that 7-17% of SJIA patients will experience MAS.

 

Recognizing and treating MAS

From a lab standpoint, the following can be considered as potential situations for MAS development:
Decreasing
  • Platelets
  • WBC
  • Hemoglobin
  • ESR
  • Fibrinogen
  • Albumin
  • Sodium

 

Increasing
  • Ferritin
  • CRP
  • Transaminases
  • LDH
  • Triglycerides
  • D-dimers, INR, PTT
  • Bilirubin

 

Only recently has there been an effort to revamp the guidelines to diagnose MAS in SJIA patients. Unfortunately, while helpful, these guidelines may not be sensitive enough. Schneider says we should also look to the AOSD diagnostic criteria to make sure we’re paying closer attention to some of these lab values and symptoms.

 

Schneider played with some lab values, asking providers to think about how we can diagnose MAS earlier and get a head start on treating it. Possible treatments are an IL-1 inhibitor – Anakinra/Kineret has been shown to help a lot in higher doses during MAS episodes. Steroids may need to be given in high doses initially to help get the inflammation under control. A calcineurin inhibitor, such as cyclosporine, is a great tool to add as well.

 

It’s important to note that some medications – notably Ilaris and Actemra – can alter how MAS presents due to the effects of the drugs on the body. This must be kept in mind by the treating physicians in order to recognize the signs and treat MAS effectively.

 

New research is showing that interferon gamma (IFNγ) plays a pivotal role in MAS, most specifically CXCL9. Additionally, this can be linked to research that shows higher levels of IL-18 in the bloodstream of SJIA patients dealing with/who have gone through MAS. Understanding the links between CXCL9 and IL-18 – and how we can lower IL-18 – will be pivotal in treating MAS in the future.

 

Takeaways

The biggest takeaway for me is that MAS doesn’t show up as quickly as I’ve always personally feared. Watching friends and other SJIA patients struggle with MAS is scary, but knowing that we may be able to monitor and predict pre-MAS status is comforting. Furthermore, knowing that my rheumatologist will be open to this information and act upon it if/as needed really helps me feel less anxious. That’s part of why it’s important to snag a HCP that listens as well as mine does.

 

My secondary takeaway is to start monitoring my own labs more. When I get home, I’ll spend a while and plot my relevant labs into Excel and graph them. While it will help me keep tabs on things – especially concern over heading into MAS territory – maybe it’ll help me find more data around whatever weird neuro-ish thing I’ve been experiencing as well.

 

The world of rheumatic disease is one that’s ever-changing and improving. I think it will become incredibly important to focus on changing alongside it instead of staying stuck in the old ways like many providers and patients often do.

 

 

Opening Lecture #ACR17

Posted on by Grayson
The ACR/AHRP Annual Meeting kicked off last night with an opening lecture that had me in tears a few times.

 

Opening Remarks

Dr. Sharad Lakhanpal, current head of the ACR, started the opening lecture off by sharing more about what’s gone on in the last year for the ACR. One of the things that many may not know is that the ACR’s annual meeting is the largest of its kind in the world, with over a hundred countries in attendance. ACR has started a fellowship program as well, allowing newer physicians abroad the opportunity to come to ACR in addition to spending time in American clinics seeing patients. This exchange goes both ways, too, with American physicians heading to other countries. This exchange allows providers to develop a variety of problem-solving skills, learn about cultural importance, and more.

 

Lakhanpal then went on to talk about ACR/AHRP’s place in fighting against the repeal of the Affordable Care Act. Cue teary-eyed me in the audience. Dr. L echoed things I’ve always felt around the ACA – that we know it isn’t perfect and aspects do need to be fixed, but that scrapping it doesn’t fix anything. They truly have been fighting for their patients, reaching out just as we have. The fact that they have been using the same methods as patients to fight the same bills is comforting. We haven’t been the only ones using Resistbot, social media, and more to fight for our own rights.

 

One of their biggest focuses for the next five years is on technology. With the amount of technology in the world growing exponentially each day, it’s changed how we learn, teach, and grow as humans. Thankfully, the ACR is working to utilize technology for more. My hope is that patients will have access to some of these tools as well, making our learning process – and participation in research – even better.

 

Dr. L touched on the importance of viewing issues through a global lens as well. We’re all in this together. The more we fight for better access to care and lower costs in one place, the more we learn about how to fight it in other areas. As a “global community of learners” and rheumatology nerds, what we do matters. I say ‘we’ because he also highlighted the importance of utilizing patients to improve public awareness around RMDs.

 

Awards were handed out to a variety of impressive providers for their efforts on research, teaching, patient care, and more.

 

Emerging and Re-Emerging Infectious Diseases: From AIDS to Zika

Dr. Anthony Fauci is the director of the National Institute of Allergy and Infectious Diseases (NIAID), a role he’s been in since 1984. This man has testified more times before Congress than anyone else! He moved from doing more rheumatology-related work to focusing on IDs when the first cases of HIV/AIDS came about, back when they didn’t know what this even would be. Fauci could see that this would be something far bigger than anyone else could predict.

 

As a sex educator, Fauci’s talk hit me hard – in a good way. I was born at a time when we knew that HIV/AIDS was an infectious disease that could be transmitted a number of ways. Having a disease that wasn’t diagnosed right away meant that I faced a lot of stigma. Rumors went around that maybe I had something like HIV/AIDS. Even before I realized I was pansexual and genderfluid, I felt so much like a part of the LGBT+ community. It’s definitely not the same and I’m certainly not equating SJIA to HIV/AIDS, but there was a kinship there. It was my first exposure, too, to just how homomisic people are.

 

I could never understand how people could be happy about others dying due to a horrible undertreated disease – especially when it took quite a long time for many to realize this was a public health issue. I just remember so much about stigma and discrimination.

 

Dr. Fauci echoed those sentiments while discussing how our reactions to infectious diseases have changed massively since the early 1980s. He related some amazing stories around his interactions with past presidents. Perhaps the most surprising, to me, was George H. W. Bush. When he was Vice President, Bush seemed to share Fauci’s concerns around HIV/AIDS much more than Ronald Reagan had. One of the most impactful points in Fauci’s talk was him sharing how Bush asked to tour the NIAID’s facilities as he was working on running for President. He came with members of his staff (including George W. Bush!) and sat in a support group for patients Fauci helped facilitate. Since this was early on and before newer medications, every single patient in that group was dead within two years.

 

Cue me crying for a second time.

 

By the time Clinton came into office, he asked Fauci to start work on a vaccine for HIV. This helped push vaccine-related research around infectious diseases further. The center built for this purpose now works on vaccine and treatment development for many conditions, from HIV/AIDS to Zika.

 

George W. Bush helped push forward the notion that the US could do more to fight infectious diseases – especially HIV/AIDS – in other countries. Fauci traveled to several countries in Africa and observed the realities of living with HIV/AIDS there. Patients were eager for medications and focused on taking them daily (when possible), fighting some extremely racist notions around the ability of people of color to ‘adhere’ to medical treatments. The only real thing that holds many back is a lack of access to medications, including costs – and that’s a universal problem.

 

Bush and Fauci worked together, then, to develop PEPFAR – the President’s Emergency Plan for AIDS Relief. To date, over 11 MILLION people have received antiretroviral medications through this program. If I recall correctly, Fauci said that over 2 million children were protected from transmission during pregnancy.

 

There were so many lessons to take from Dr. Fauci’s talk and experience. The thing that hits me the most, though, is how far we’ve come – and how people work towards amazing feats while receiving very little press for it. Fauci touched upon the improvements in vaccine development. Zika vaccines in the works have been developed in a matter of a few months versus years. There’s a lot of work to be done on a variety of infectious diseases, but the ways technology has allowed us to improve our processes is fascinating.

 

With regards to rheumatology, the biggest takeaway for me is that technology and persistence continue to push us forward to a world with better treatments. The number of patients who have helped with research and clinical trials is not lost on me, either. It’s only through the sacrifices and work of our fellow patients, in addition to work from scientists and providers, that we have the treatments we rely on every single day.

 

I would be remiss to not mention the many animals who have been subject to testing as well. As I reflect on what fellow patients have given to the cause, I can’t even begin to quantify the number of animals who have been harmed through our scientific processes. Like, I’m sitting here in a comfortable bed and bawling because the weight of that harm is just so much. I quite literally owe my life to lab rats and mice and guinea pigs.

 

And people wonder why I have piggies.

 

four photos arranged in a square; top left is an illustration of Kirsten feeding piggies; top right is a photo of Oreo (black and white and grey piggie) with hay all over his head looking happily up at the camera; bottom left is a photo of Jaq (brown and white piggie) on the floor near a zebra striped blanket eating lettuce; bottom right is a picture of Gus (black piggie with white nose stripe) snuggling on my chest under a blue Tardis blanket

 

 

Heading to ACR

Posted on by Grayson
This afternoon, I board the first of two flights on my way to San Diego for the American College of Rheumatology annual meeting!
I’m incredibly excited to be attending this year. It’ll be my first year there. I’m unsure what exactly to expect. I’ll be covering sessions I attend here (where relevant). There are a number of SJIA/Still’s/MAS related sessions, and I’m excited to be able to bring you news from those.
If you’re in San Diego, hit me up! I leave Wednesday morning.