Category: ACR

Fifth Update of ACR COVID-19 Vaccine Guidance Supports Fourth Doses for High-Risk Rheumatic Disease Patients

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The following is a press release issued by ACR today:

The American College of Rheumatology has issued an updated version of its COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases that includes support for supplemental and booster doses (often patients’ third or fourth doses), recommendations for timing of those injections in relation to immunomodulatory medication use, and revised guidance for pre- and post-exposure prophylaxis with monoclonal antibody treatment.

The guidance recommends that all rheumatic disease patients receive a booster dose after their primary vaccine series, as recommended by the CDC. Patients who are expected to have mounted an inadequate vaccine response due to using immunosuppressant treatments (as outlined in Table 3 of the guidance), should take a third mRNA vaccine dose as part of their primary vaccination series prior to their booster, for a total of four doses. These recommendations for primary vaccination, supplemental dosing, and booster doses apply regardless of whether patients have experienced natural COVID-19 infection.

The CDC currently recommends third mRNA doses be taken at least 28 days after the first two mRNA doses and booster doses be taken at least five months after completion of the primary vaccination series. Based on the availability of evidence, patients should try to take the same mRNA vaccine for their third dose but may use either if the initial brand is unknown or unavailable. No additional primary shot for the Johnson & Johnson (J&J) vaccine is approved at this time, but a booster dose of an mRNA vaccine is recommended at least two months following the primary J&J shot.

“It remains important for rheumatology providers to assess the vaccination status of all patients with rheumatic diseases,” said Dr. Jeffrey Curtis, Chair of the ACR COVID-19 Vaccine Guidance Task Force. “Initially, it might have been acceptable to just ask a patient if they have been vaccinated. There is now more nuance with supplemental and booster dose recommendations that should prompt us to ask patients not only whether they have been vaccinated, but with what, how many times, and how recently.”

The guidance also continues to support the use of pre-exposure and post-exposure monoclonal antibody prophylaxis for high-risk autoimmune and inflammatory rheumatic disease patients when/if available for use, noting that the FDA has limited the use of some monoclonal antibody therapies in light of the current conditions. For example, neither bamlanivimab and etesevimab (administered together) nor casirivimab and imdevimab, are licensed nor available under emergency use authorization (EUA) given their lack of activity against the Omicron variant, the dominant strain circulating in the U.S.

The updated recommendations can be found on the ACR website. Statements in bold are those that have been revised or added in the most current version of the document. These changes are also summarized in the Appendix Table. An important set of guiding principles, foundational assumptions and limitations are mentioned in the Supplemental Table.

A peer-reviewed manuscript with additional details on the clinical studies, data, and discussion points that influenced the recommendations has been submitted for publication to Arthritis & Rheumatology. It will be made available on the ACR website once published.

ACR Applauds Bipartisan Letter Urging Congressional Action to Avoid Looming “Medicare Cliff”

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The following is a press release from the ACR that came out today.

The American College of Rheumatology (ACR) applauds the 247 Members of Congress who signed a letter urging Congressional leadership to address several cuts that would reduce Medicare reimbursements for health care providers by nearly 10 percent starting Jan. 1, 2022. These cuts would severely impact rheumatology practices already straining to recover from the COVID-19 pandemic, potentially jeopardizing patient access to care.

“The ACR thanks Reps. Bera and Bucshon, and all the other members of Congress who are calling on Congressional leadership to address the looming ‘Medicare cliff,’” said David Karp, MD, PhD, president of the ACR. “Extending physician payment adjustments for an additional year will help maintain providers’ operational stability that is still affected by the pandemic and ensure people living with rheumatic diseases do not see their care disrupted.”

Spearheaded by Representatives Ami Bera (D-CA) and Larry Bucshon (R-IN), the letter calls on Congress to addresses the imminent payment cuts stemming from an expiring adjustment to the Medicare Physician Fee Schedule (PFS) as well as the Medicare sequester and the Statutory Pay-As-You-Go (PAYGO) Act that cumulatively would cut reimbursements by a total of 9.75 percent next year.

The letter also calls for a future effort to establish broader, long-term reforms to ensure stability within the Medicare payment system as well as adequately incentivize high-quality care. Noting that the Physician Fee Schedule has failed to keep up with inflation over the years, the lawmakers argue that cuts to specialty providers could seriously jeopardize the stability of America’s health care delivery system at a time when so many providers are still only beginning to recover from the disruption caused by COVID-19.

Background on the “Medicare Cliff”

The looming payment cuts, which have been colloquially referred to as the “Medicare Cliff” stem from a confluence of three separate provisions that are all set to be implemented at the same time.

At the end of 2020, Congress attempted to mitigate the financial impact of the pandemic on health care providers by including a one-time 3.75 percent payment increases for all PFS services in the Consolidated Appropriations Act of 2021. This payment adjustment afforded some short-term stability for health care professionals struggling with the impact of the COVID-19 pandemic but is expiring at the end of the calendar year while providers still struggle with COVID’s impact.

At the same time, providers are also facing a 2 percent cut due to the expiring moratorium on the Medicare sequester. The sequester – which automatically cuts Medicare spending across-the-board – has been in place since 2013 but has almost always been suspended by Congress. The current suspension expires at the end of this year.

Finally, providers are facing an additional 4 percent payment cut due to the Pay-As-You-Go (PAYGO) budget rule, which requires mandatory spending increases to be offset by tax increases or cuts to other areas of mandatory spending. Because the American Rescue Plan that Congress passed earlier this year did not include such an offset, the PAYGO rule will be triggered unless Congress decides to waive it.

View the letter here.

ACR Responds to 2022 Medicare Physician Fee Schedule Proposed Rule

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The following is a press release from ACR dated Weds, September 15.

In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) shared its perspective on the CY 2022 Medicare Physician Fee Schedule and Quality Payment Program proposed rule.

“We are especially appreciative of CMS’ continued recognition of the value of complex care provided by rheumatologists and other cognitive care specialists by continuing to operationalize the Evaluation and Management (E/M) coding changes that were set in motion over the last few years. As our nation’s healthcare system continues to navigate the challenges of a global pandemic, we also appreciate the policies and flexibilities set forth by CMS to help alleviate these challenges while we all work to provide quality care for our patients,” said David Karp, MD, PhD, president of the ACR. “In light of ongoing volatility and unknowns in the healthcare system, we would also like to share our concerns with some other aspects of the proposed rule – especially the proposed decrease in the conversion factor, CMS’ proposed implementation of the rheumatology MIPS Value Pathway and a new proposal for EHR interoperability and digital quality measures.”

The ACR’s specific comments and concerns are outlined as follows:

Evaluation and Management Services

The ACR appreciates CMS’ ongoing commitment to implementing recent changes to E/M codes that more appropriately reflect the value of cognitive specialists and urges the agency to continue monitoring how the updated codes are operationalized. The ACR also appreciates the proposed rule’s revisions to the long-standing policy on billing for split (or shared) visits but wants to ensure that these changes don’t become burdensome for providers, especially as it relates to time tracking for the “substantive performance” of the provider, as this can introduce the potential for billing errors.

Telehealth Flexibilities

CMS has proposed extending several of the telehealth flexibilities that were implemented at the start of the public health emergency through the end of 2023.  The ACR appreciates this additional flexibility and recommends that the direct supervision waiver allowing a supervising physician to serve patients using real-time, interactive audio-video technology be made permanent. This would immediately provide timely access to cognitive services for Medicare beneficiaries and relieve an undue burden to an aging population.

The ACR also supports CMS’ proposal to permanently adopt a code (G2252) for an extended virtual check-in. This allows a provider to briefly check in with an established patient using any form of synchronous communication technology, including audio-only, and will be especially beneficial to patients in rural areas.

Conversion Factor Reduction, Physician Work and Practice Expense (PE) Relative Value Changes

The ACR shares the concerns raised by many specialty provider groups about CMS’ proposal to reduce the conversion factor by 3.75% in 2022 and urges the agency to maintain the current rate at least through 2023. The proposed reduction comes at a time when physician practices and hospitals are facing unprecedented uncertainty about their futures amid the COVID-19 pandemic. Implementing reductions now would have a damaging impact on an already strained system.

Concerning the proposed updates to the Relative Value Units (RVUs), the ACR recognizes that CY 2022 is the final year of a four-year transition period to update the practice expense (PE) component with the latest pricing data for supplies and equipment. In conjunction with this final year of the equipment pricing update, CMS is also proposing an update to the clinical labor pricing component in CY 2022, which could result in temporary distortions for provider reimbursement. To minimize disruptions to physician practices, the ACR recommends CMS use a similar four-year transition to implement the clinical labor pricing update.

EHR Interoperability & Digital Quality Measures

While the ACR is overall encouraged by CMS’ efforts to broaden the standardization of clinical data and increase electronic health record (EHR) interoperability, the ACR has several concerns with how the agency’s proposed recommendations will impact practices – particularly smaller practices with fewer financial resources. As a next step for moving forward, the ACR recommends CMS conduct an environmental landscape assessment of EHR software capabilities that should consider factors such as costs to practices, specialty-specific templates and reports, registry participation and patient portal access. This should help establish a clearer picture of practices’ reasonable ability to meet CMS’ proposed digital health goals and avoid a situation where providers are held accountable for factors that are beyond their control.

Rheumatology MIPS Value Pathway (MVP)

The ACR is pleased that the proposed rule includes a new MIPS Value Pathway (MVP) for rheumatology as proposed by the ACR and looks forward to working with the agency to ensure that it is implemented successfully. However, the ACR has several concerns with the proposed rollout of the MVP program and the lack of details that have been provided thus far. In particular, the ACR recommends delaying setting a deadline for sunsetting traditional MIPS until the agency can evaluate the success of implementing MVPs.

For more details, view the ACR’s full comment letter (PDF).

ACR Webinar: Reproductive Health & Rheumatic Disease – Sept 14 @ 7 pm ET

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The following is an upcoming webinar from the ACR. Please note that this post has a major focus on cisgender folks and contains binary gendered language. It’s likely the webinar will as well.

Rheumatic diseases are lifelong conditions that affect over 54 million Americans, often during their childbearing years. Rheumatic diseases disproportionately impact women and certain rheumatic diseases are more prevalent in minority populations than they are in the general population.

On Tuesday, September 14, 2021, at 7 pm EDT, the American College of Rheumatology (ACR) and its Simple Tasks campaign will host a FREE webinar for patients, health care professionals, media and the general public on reproductive health and rheumatic disease. Attendees can expect discussion and resources from a panel of leading experts in rheumatology care, reproductive health, and parenting.

To register for the webinar, please visit rheum4you.org.

During the 90-minute webinar, experts will cover:

  • Family planning with rheumatic disease, including fertility, contraception, male reproductive health, treatment considerations for men and women, and medication compatibility.
  • Pregnancy and rheumatic disease, including the impact of pregnancy on rheumatic disease, the role of the rheumatology provider in your care during pregnancy, genetic factors, and medication compatibility.
  • Parenting with rheumatic disease, including tips for managing the treatment of a child with rheumatic disease, parenting while managing a chronic disease, breastfeeding, compatible medications, and occupational and physical therapy tips for caring for your child.

Panelists:

Webinar Moderator:

  • Cheryl Crow – Occupational Therapist, OTR/L and Founder of “Arthritis Life” multi-media platform and Podcast Host

You can view the recording below:

https://youtu.be/oW3F3HMmCFg

ACR Update on Tocilizumab/Actemra Shortages

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The following is a press release issued by the ACR as of yesterday, August 17, 2021:

The American College of Rheumatology (ACR) is actively engaged with the FDA Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra). Demand for tocilizumab has outpaced supply, with demand increasing after the FDA’s June 24 Emergency Use Authorization (EUA) for tocilizumab to be used for the treatment of COVID-19 in some hospitalized adult and pediatric patients.

The manufacturer has indicated in an Aug. 16 update that providers may currently find tocilizumab IV supplies to be unavailable due to high demand, but they expect IV stock replenishments by the end of August. Measures are being taken to expedite replenishments and increase manufacturing capacity and supply wherever possible, but they have indicated additional intermittent shortage periods may occur in the months ahead if the COVID-19 pandemic continues at the current pace.

According to their statement, subcutaneous formulations (pens and pre-filled syringes) continue to be available for patients prescribed tocilizumab for FDA-approved indications, and these are not authorized for treatment of COVID-19 patients under the EUA.

Providers experiencing trouble obtaining tocilizumab IV or any other issues related to COVID-19 can contact the ACR at COVID@rheumatology.org.

Rheumatology Patients on Immunosuppressive Medications Qualify for Third COVID-19 Vaccine Dose

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The following is a press release from the ACR released within half an hour of this post:

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices today recommended that rheumatology patients being actively treated with high-dose corticosteroids, alkylating agents, antimetabolites, tumor-necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory receive a third dose of the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines.

The approval came one day after the FDA announced it would be revising the current emergency use authorizations (EUA) for the two mRNA vaccines to permit a third dosage in certain immunocompromised patients. The recommendation applies for ages 12 and older for individuals receiving the Pfizer-BioNTech vaccine and18 and older for patients receiving the Moderna vaccine. The new EUA is specifically for the two mRNA vaccines and does not extend to recipients of the Johnson & Johnson vaccine currently.

“This will be enormously important for our immunocompromised patients, and we are thankful to the FDA and CDC for hearing our concerns, recognizing the needs of this population and moving forward,” stated ACR President Dr. David Karp. “We look forward to working with the agencies as they communicate this new recommendation.”

The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after completion of the primary vaccine series, and patients and providers should stick to the same brand for the third dose, if possible. No determination was made on the safety of receiving one of the mRNA vaccines if a patient initially received the Johnson & Johnson shot.

All immunocompromised patients, including those who receive an additional mRNA dose should continue to follow prevention measures, including:

  • Wearing a mask
  • Staying 6 feet apart from those they don’t live with
  • Avoiding crowds and poorly ventilated indoor spaces until advised otherwise by their healthcare provider
  • Close contacts of immunocompromised people should be strongly encouraged to be vaccinated against COVID-19.

These preventative measures remain critical due to real-world data that shows immunocompromised individuals are more likely to have a lower response to the initial vaccine dosage and are more likely to experience breakthrough infections. According to the CDC, 40-44 percent of hospitalized breakthrough cases are immunocompromised patients.

In a recent randomized trial of a third dose of Moderna vaccine in transplant recipients, 33 – 50 percent of those who had no detectable antibody response to an initial mRNA vaccine series developed one with a third dose, and the proportion of the group who are seropositive increased to 68 percent with the third dose. No serious adverse events were reported, and the symptoms reported were consistent with previous doses, with mostly mild or moderate symptoms reported.

The CDC noted that the effectiveness and accuracy of antibody testing are still being evaluated. Patients who are moderately to severely immunocompromised should discuss a third dose with their providers.

“Not all medications that our patients take have been shown to have significant effects on responses to vaccination. Patients should ask their provider if they are likely to see a beneficial effect from additional vaccination,” Dr. Karp said. “Luckily, we have not seen any safety signals in patients with autoimmune and rheumatic diseases from the COVID-19 vaccines, so there should be no concern for the third dose.”

The ACR’s COVID-19 Vaccine Clinical Guidance Task force is meeting Monday, Aug. 16 to discuss potential changes to the ACR’s clinical guidance and expect to share recommendations shortly after.

For more on this, you can also check out the recent town hall webinar from ACR now uploaded to YouTube.

Wednesday Town Hall on Effectiveness of COVID-19 Vaccination in Immunosuppressed Patients

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How effective COVID-19 vaccines have been in immunosuppressed and rheumatic disease patients remains an incompletely answered question. The American College of Rheumatology (ACR) has organized an expert panel to share details on what we are learning from real-world data collection efforts and answer questions from the audience.

Speakers include:

  • Michael R. Anderson, MD, MBA, FAAP, FCCM, FAARC, Senior Advisor at the HHS Office of the Assistant Secretary for Preparedness and Response in Washington, D.C., and a key leader on the federal COVID-19 monoclonal antibody therapeutics team
  • Marcus Snow MD, Rheumatologist at Nebraska Medicine; Assistant Professor of Internal Medicine, University of Nebraska Medical Center; and Chair of ACR Committee on Rheumatologic Care
  • Kwas Huston MD, Rheumatologist at Kansas City Physician Partners and Clinical Associate Professor of Medicine, University of Missouri Kansas City
  • Alfred Kim MD, PhD, Assistant Professor, Division of Rheumatology, School of Medicine at Washington University in St. Louis
  • Jean Liew, MD, MS, Assistant Professor, Rheumatology, Boston University School of Medicine

The webinar is scheduled for 7 pm Eastern/4 pm Pacific on Wednesday, August 4. Register Online for free access and to submit questions.

Update: if you missed this webinar, the recording is below:

New ACR White Paper Highlights Health Care Challenges Affecting the Rheumatic Disease Community

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The following is a press release from ACR released on May 11:

The American College of Rheumatology (ACR) today announced the launch of a new white paper, “Rheumatic Diseases in America: Confronting the Challenge,” which provides an overview of the current health care challenges facing the rheumatic disease community and highlights the importance of receiving timely and appropriate treatment from a rheumatology health professional.

Released during Arthritis Awareness Month, the white paper aims to educate policymakers, health care professionals, members of the media and the general public about rheumatic diseases, which affect approximately 54 million adults and at least 300,000 children in the United States alone.

“Rheumatology is a broad discipline that covers a wide variety of diseases that affect a person’s joints, musculoskeletal systems, immune system and many other organs,” said Dr. Suleman Bhana, Chair of the ACR’s Communications and Marketing Committee. “With this white paper, we aim to create an accessible, introductory resource for those interested in learning more about rheumatic disease, current treatment options, and the health care and lifestyle challenges patients with rheumatic disease face.”

The white paper is written and designed to appeal to multiple audiences and consists of four key sections:

I. Rheumatology 101

This section provides an introduction to what a rheumatic disease is, describes the role of a rheumatologist, and discusses the importance of early and appropriate treatment. Patients and their family members – particularly those who may have been recently diagnosed with a rheumatic disease – may find this section helpful in understanding what to expect after a diagnosis. Health care professionals may also find this section to be an important resource for conversations with patients to reinforce the importance of timely and accurate diagnosis, and why coordinating care between specialists is so important.

There are over 100 different rheumatic diseases and conditions, some of the most common include: rheumatoid arthritis, lupus, gout, scleroderma, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and Sjögren’s syndrome. This white paper discusses what some of these diseases are and how they affect different parts of the body.

II. Rheumatic Diseases: Prevalence & Impact

Rheumatic diseases in America are extremely common. According to the CDC, an estimated 54 million Americans – 1 in 4 – have a doctor-diagnosed rheumatic disease and some studies have suggested that the actual number of Americans living with these diseases is even higher when accounting for symptoms reported by undiagnosed individuals. The economic toll of rheumatic diseases is also significant. The total cost of rheumatic diseases was recently estimated to be as high as $304 billion annually – greater than the total cost of cancer care in the United States.

For policymakers, the media and the general public, this white paper provides useful statistics that call attention to rheumatic diseases as a public health issue, why solutions are urgently needed to improve patients’ quality of life, and why rheumatology health care professionals are uniquely equipped to help patients manage these diseases.

III. Emerging Trends in Rheumatology

Providers may find the white paper’s discussion of emerging trends in rheumatology – including biosimilars and telehealth – to be helpful in their practice. Rheumatology is a constantly changing field of medicine and these issues will become increasingly important for patients, providers, and the public to understand.

Biosimilars (copies of biologic drugs that are intended to work in the same way as their reference products) represent a new and promising area of rheumatic disease treatment. However, educating patients and providers about their use will continue to be crucial to ensuring their uptake. While recent research has shown that rheumatologists generally have a good understanding and acceptance of biosimilar products, a recent survey found that 29 percent of rheumatic disease patients were unsure whether they had been prescribed a biosimilar drug.

Telehealth, the adoption of which has been catalyzed by the COVID-19 pandemic, represents another important emerging trend in the practice of rheumatology. As many as 66 percent of rheumatic disease patients had an appointment via telehealth in 2020 and these services have been shown to especially benefit individuals with disabilities, those who are in a nursing home, and those living in an area where they would have to travel long distances for treatment.

IV. Access, Affordability & Lifestyle Challenges for People Living with Rheumatic Disease

People living with rheumatic diseases face a variety of access, affordability, and lifestyle challenges associated with their disease. This white paper provides an overview to the public policy issues related to these challenges such as a growing rheumatology workforce shortage, insurer practices that restrict access to care, and rising drug prices that threaten to make treatment unaffordable for many who rely on specialty medications to manage their symptoms.

Solutions are needed to address these issues – and others – that affect the rheumatic disease community. This white paper presents readers with the latest opportunities to get involved with the ACR and Simple Tasks to advocate for better public policy.

To download and read the white paper, CLICK HERE.

ACR COVID-19 Vaccine Guidance Recommends Vaccination, Addresses Immunosuppressant Drugs & Patient Concerns

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The following is a press release from ACR dated February 11.

The American College of Rheumatology (ACR) has released its COVID-19 Vaccine Clinical Guidance Summary that provides an official recommendation to vaccinate rheumatology patients with musculoskeletal, inflammatory and autoimmune diseases.

“Although there is limited data from large population-based studies, it appears that patients with autoimmune and inflammatory conditions are at a higher risk for developing hospitalized COVID-19 compared to the general population and have worse outcomes associated with infection,” said Dr. Jeffrey Curtis, chair of the ACR COVID-19 Vaccine Clinical Guidance Task Force. “Based on this concern, the benefit of COVID-19 vaccination outweighs any small, possible risks for new autoimmune reactions or disease flare after vaccination.”

The guidance was developed by a multi-disciplinary panel of nine rheumatologists, two infectious disease specialists, and two public health experts and is intended to give direction to providers treating rheumatology patients on how to best use COVID-19 vaccines, as well as facilitate implementation of vaccination strategies for rheumatology patients.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” said Dr. David Karp, President of the ACR. “We hope the guidance will provide them evidence-based reassurance that their patients will benefit from being vaccinated and guidance on how to best incorporate it into their treatment plans to maximize vaccine efficacy.”

Important considerations and caveats on how to approach vaccination are included for patients with high disease activity and/or those taking immunosuppressant treatments. These include recommendations to modify certain treatments such as methotrexate, JAK inhibitors (e.g., baricitinib, tofacitinib, upadacitinib) and some biologics (e.g., abatacept and rituximab) that alter the immune system’s response in ways that might affect vaccine response.

The panel based their recommendations on the use and timing of immunomodulatory medications on evidence extrapolated from their immunologic effects as they relate to other vaccines and vaccine types. As such, these and other recommendations made by the task force should be considered ‘conditional.’

“There was vigorous debate on several topics such as the expected magnitude of benefit of vaccination for patients receiving therapies that substantially alter or suppress the immune system (e.g., high dose steroids),” said Curtis. “Ultimately, the task force agreed that in almost all cases, proceeding with vaccination and obtaining at least a partial response would be better than deferring vaccination, since deferring provides no protection at all. Given the lack of direct evidence for these vaccines in rheumatology patients, the panel applied general immunologic principles observed with other vaccines to make recommendations on how to increase the likelihood of a favorable vaccine response.”

“For example, an RA patient with well-controlled disease may benefit from holding a dose of methotrexate immediately following vaccination,” added Karp. “In the case of drugs with long dosing intervals such as rituximab, there are some circumstances where it may be beneficial to time the vaccine around when the last dose was given to maximize the vaccine’s efficacy. We encourage clinicians to study the charts we’ve provided in the summary for details on how they can time various medications to ensure maximum success.”

Given the uncertainty surrounding when alternative vaccine types will become available, the task force focused on the two mRNA COVID-19 vaccines available in the U.S. at the time of their deliberation. No preference for one vaccine over another was stated, and patients are recommended to receive whichever of the mRNA vaccines is available to them.

“With efficacy about the same for both vaccines, we felt it was not important which brand patients received. Realistically, many individuals will not have a choice, as availability varies by site and region. Therefore, it was important to assure providers and patients this was not a factor to consider when discussing vaccination. However, patients should stick to the same vaccine brand for both injections,” stated Curtis.

The ACR has voiced that recommendations in the guidance should not replace clinical judgement, and decisions about individual patients should be made as part of shared decision-making with patients that considers their underlying health condition(s), disease activity level, current treatments, risk of exposure to SARS-CoV-2 and geography. Patients are also encouraged to continue following all public health guidelines regarding mask wearing, physical distancing and other preventive measures even after vaccination.

Future changes are expected to the guidance as more safety and efficacy data about the existing two mRNA vaccines, other vaccine platforms, and vaccine response specific to rheumatic disease patients become available.

“This is very much a ‘living document,’ and the task force already has plans to evaluate additional data in the coming weeks,” said Curtis. “We desperately need direct evidence from high quality research. To reach that goal, we would issue a call to action for patients, providers and researchers to mobilize and support the important research efforts that are underway to study vaccine effectiveness and safety in rheumatology patients.”

The ACR is hosting a town hall with members of the task force on Tuesday, Feb. 16, at 7:30 p.m. EST to discuss the guidance and answer questions about the recommendations. Members of the press are invited to attend and encouraged to register online. Questions about the guidance can be submitted when registering.

A peer-reviewed manuscript with additional details on the clinical studies, data, and discussion points that influenced the recommendations has been submitted for publication to Arthritis & Rheumatology. It will be made available on the ACR website once published.

American College of Rheumatology Launches Digital Health Coaching Program for Black and Latina Women with Lupus

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The following is a press release from the ACR dated today:

The American College of Rheumatology (ACR), in partnership with Pack Health, launched two digital health coaching programs to reduce health disparities among Black women and Latinas living with systemic lupus erythematosus (lupus). The ACR’s Collaborative Initiatives (COIN) department, which houses The Lupus Initiative, will lead the efforts.

The ACR is launching the programs to address a lack of digital health coaching options for the lupus community. The ACR’s COIN department, which concerns itself with advancing health equity and eliminating health disparities, sought funding and community support to create tools that will assist Black women and Latinas living with the disease. Hopefully, having a digital health coaching program specific to this population will help with navigating daily barriers and issues they face in self-management.

The first program is a one-year, $100,000 medical education grant. It runs until Oct.15, 2021, and will provide digital health coaching for 15 individuals with lupus for three months.

The goals are to:

  • Increase patient self-efficacy to engage in recommended lifestyle behaviors and adhere to treatment recommendations;
  • improve adherence to recommended lifestyle and behaviors; and
  • produce insights into program acceptability, patient barriers and lupus disease burden, among other things.

The second program, known as Lupus Engagement through Activity and Digital Resources (LEADR), is a two-year, $299,000 grant-funded through the Office of Minority Health. It will run until Oct. 30, 2022 and plans to reach 200 Black and Latina women in Georgia. LEADR aims to:

  • Encourage more medical providers to discuss and refer their patients to a digital health coaching program,
  • increase physical activity among Black women and Latinas with lupus, reduce negative health outcomes associated with lupus, and ultimately reduce lupus health disparities.

“Building on evidence-based approaches, LEADR’s community-driven health equity model is a unique way to address the complex, multi-faceted need for more providers to recommend physical activity and adherence among African American women and Latinas with lupus,” said Rosalind Ramsey-Goldman, MD, chair of the ACR’s Collaborative Initiatives Committee. “The ACR is singularly qualified, and positioned, to develop and implement a lasting program that improves physical activity among this particular population.”

The ACR has partnered with Pack Health, a health coaching company specializing in providing digital support to people with chronic conditions, to execute the programs. Pack Health will create curriculums and deliver one-on-one health coaching to the target populations. The ACR will lead the programs and leverage its membership, collaborations and TLI resources to achieve the outcomes.

“The focus of these programs is to develop and provide meaningful, data-driven, one-on-one support to improve the self-management skills for people with lupus,” said Kelly Brassil, PhD, RN, Pack Health’s Director of Medial Affairs. “Pack Health’s key objectives are to conduct literature reviews and collect qualitative data to understand patient needs and experiences, use what we learn to inform program development, and, in turn, better serve the needs of the lupus community. Additionally, we plan to enhance and specialize our physical activity content for individuals living with lupus, with a special emphasis on Black and Latina women.”

Lupus is a chronic disease that causes systemic inflammation affecting the skin, joints and multiple organs like the kidneys, heart and brain. It is estimated that 1.5 million Americans have a form of the condition.  According to the Centers for Disease Control and Prevention, Black women are three times more likely to get lupus than white women, and lupus is also more common in Hispanic, Asian, and Native American and Alaskan Native women. Additionally, Black and Hispanic women usually get lupus at a younger age and have more severe symptoms, including kidney problems, than women of other groups.