ACR Commends Congress for Mitigating Medicare Cuts, Calls for Ongoing Healthcare Reforms

The following is a press release issued by the ACR on March 11, 2024:

The American College of Rheumatology (ACR) applauds Congress for passing legislation to mitigate the 3.4 percent reduction in physician payments outlined in the Medicare Physician Fee Schedule (MPFS) Final Rule for CY2024 but also calls on policymakers to seek long-term systemic policy changes that will provide more stability and predictability for providers.

“While we commend Congress for this partial fix, rheumatologists remain concerned that without long-term reform to the Medicare payment system, maintaining access to quality care for individuals managing rheumatic diseases and other chronic conditions will be in jeopardy,” remarked Deborah Dyett Desir, MD, President of the American College of Rheumatology. “The annual recurrence of MPFS cuts underscores the urgent need for comprehensive healthcare reforms. The American College of Rheumatology urges Congress to prioritize sustainable solutions, ensuring patient access to essential services and fair reimbursement for healthcare providers.”

The payment cut reduction, from 3.4 percent to 1.68 percent, was included in recently passed broader funding legislation. This reduction comes on top of cumulative cuts that, when adjusted for inflation, amount to an overall decline in Medicare physician payment of 30 percent since 2001, according to the American Medical Association.

As the nation’s leading medical specialty society representing rheumatologists, the ACR remains committed to advocating for policies that prioritize patient well-being and support the needs of rheumatology practices across the country.

ACGME and Docs with Disabilities Initiative Partner for Disability Hub

The following are excerpts from a press release issued by the Accreditation Council for Graduate Medical Education on January 23, 2024:

The ACGME, in partnership with the Docs with Disabilities Initiative (DWDI), is a recipient of the Josiah Macy Jr. Foundation Catalyst Award for Transformation in Graduate Medical Education for their project, Multimedia Resource Hub for Disability Inclusion in Graduate Medical Education. The aim of the project is to support education and enhance disability inclusion, learner safety, and accessibility in the clinical learning environment for residents and fellows.

The Multimedia Resource Hub for Disability Inclusion in Graduate Medical Education will be added to the content portfolio available on the ACGME’s distance learning portal, Learn at ACGME. The ACGME Equity Matters® program supports the development of innovative resources that increase workforce diversity, encourage adoption of equity practices, and foster inclusive learning environments.

Calls for community involvement and inclusion in the hub will be forthcoming.

Read the full press release here.

ACR Applauds Prior Authorization Rule

The following is a press release issued on January 17, 2024:

The American College of Rheumatology (ACR), on behalf of over 7,900 rheumatologists and rheumatology professional team members, applauds the Centers for Medicare and Medicaid Services (CMS) for finalizing its Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations rule recently.

“Prior authorization policies create significant undue burdens on patients and healthcare professionals and often result in significant delays to needed care, treatment abandonment, and irreversible harm to patients’ health,” said Deborah Dyett Desir, MD, president of ACR. “The ACR commends CMS for recognizing the negative impact of prior authorization on patients and the need to streamline the process to promote greater transparency between doctors’ offices and payers.”

Specifically, the rule would reduce the decision time to 24 hours for urgent requests and seven days for non-urgent requests. The rule also requires payers to provide the reason for prior authorization denials, creating greater transparency and establishing a more streamlined practice for resubmissions and appeals.

However, the ACR is concerned with the inclusion of e-prior authorization measures for merit-based incentive payment system (MIPS)-eligible providers under the performance improvement (PI) category as it will create additional burden for physicians.

While this final rule addresses many concerns about the use of utilization management tools, the ACR continues to urge Congress to pass the Improving Seniors’ Timely Access to Care Act (S. 3018/H.R. 3173) to statutorily address prior authorization issues in Medicare, Medicare Advantage and Medicaid plans.

“The ACR welcomes the opportunity to be a part of this discussion as policymakers work to ensure these programs are implemented in a way that streamlines patient care and minimizes administrative burden on physicians,” Desir concluded.

ACR Applauds Dedicated Arthritis Research Funds in the NDAA

The following is a press release issued by the ACR on December 14, 2023:

Full title: ACR Applauds Lawmakers for First-Time Dedicated Arthritis Research Funds in the National Defense Authorization Act

Today, the American College of Rheumatology (ACR) celebrates the first new medical research line item in the Congressionally Directed Medical Research Program (CDMRP) in eight years for arthritis research under the Department of Defense’s (DoD) C recently passed National Defense Authorization Act (NDAA) for fiscal year 2024.

“Investment in arthritis research will not only benefit those serving in our armed forces, but also the thousands of Americans, including many veterans, living with arthritis,” said Deborah Dyett Desir, MD, president of the American College of Rheumatology. “Efforts from this program will not only help curb the costs associated with managing and treating this disease but will also spur innovations and a better understanding of arthritis in the servicemember population.”

Arthritis research has been funded through the DoD’s Peer Reviewed Medical Research Program (PRMRP) at varying levels since 2009, but given the many priorities of the PRMRP, funding is not guaranteed. The ACR and Arthritis Foundation have advocated for this CDMRP line item to designate specific funding annually to arthritis research and advance research on arthritis risks, outcomes, and treatments among service members. The ACR thanks House appropriations leaders for recognizing the necessity and value of arthritis research in the DoD with this $10M annual line item for arthritis research.

“We know that one in three veterans are diagnosed with arthritis, and it is the second-leading cause of medical dismissals from the military.  This funding is critical to advancing arthritis research and I’m optimistic that we will see the impact and benefits of this investment for years to come,” Dr. Desir concluded.

The Association of Rheumatology Professionals Selects Long Time Physical Therapist to Lead the Organization

The following is a press release issued by the ACR on Nov 14, 2023:

Today, the Association of Rheumatology Professionals (ARP), a division of the American College of Rheumatology (ACR), announced the appointment of Aileen Ledingham, PT, MS, PhD as the ARP’s  58th president during ACR Convergence 2023, the ACR’s annual meeting.

“The ARP has been a professional home for me for more than a decade—providing the support, resources and educational value needed to excel in my rheumatology career,” said Ledingham. “To now be trusted to lead this organization and all it does to serve rheumatology health professionals and their patients is a true honor.”

As an ARP member, Ledingham has held various leadership positions including co-chair of the ACR membership & awards committee and chair of the ARP eLearning subcommittee. She has also been a member of the ACR finance and education committees, and the ARP nominations and appointments committee. For the past few years, she has been a member of the ARP executive committee as secretary and president-elect leading up to her appointment as ARP president.

Ledingham earned a bachelor’s degree in physical therapy from Northeastern University, a master’s degree in pediatric physical therapy from Long Island University, and a doctorate in rehabilitation sciences from Boston University. She is currently a physical therapist clinical scientist working at Mount Auburn Hospital in Cambridge, Massachusetts. Her research interest is in the field of knee osteoarthritis, specifically on how to help patients use exercise and physical activity to improve their quality of life.

Ledingham’s term begins this month along with the recently appointed 2023-2024 ARP Executive Committee:

  • President Elect – Adam Goode, PT, DPT, PhD
  • Secretary – Becki Cleveland, PhD
  • Immediate Past President – Kori Dewing, ARNP, DNP
  • Practice Committee Chair – Annelle Reed, CPNP, MSN
  • eLearning Committee Chair – Adena Batterman, MSW
  • ARP AMPC Chair – Priscilla Calvache, MSW, LCSW
  • Member-at-Large, Finance – Jillian Rose-Smith, MSW, MPH, PhD
  • Member-at-Large – Bharati Bhardwaja, PharmD, BCPS, LSSBB
  • Member-at-Large – Yvonne Golightly, PT, MS, PhD
  • Committee on Research Liaison – Kaleb Michaud, PhD
  • Committee on Government Affairs Liaison – Donald Miller, PharmD, FASHP
  • ACR Representative – Sam Lim, MD, MPH

The ARP, which serves more than 1,200 members, exists to equip rheumatology professionals with the tools needed to provide quality care for patients with rheumatic and musculoskeletal diseases. ARP members include nurses, nurse practitioners, occupational therapists, physician assistants, physical therapists, pharmacists, practice managers, researchers, social workers and other non-physician professionals in various rheumatology and healthcare settings.

About the Association of Rheumatology Professionals

The Association of Rheumatology Professionals (ARP) is a division of the American College of Rheumatology built by rheumatology professionals, for rheumatology professionals. Our goal is to empower rheumatology professionals by providing education, advocacy, and practice management tools. For more information, visit rheumatology.org/about 

FDA Approves Actemra Biosimilar TOFIDENCE™ (tocilizumab-bavi) by Biogen

The following is a press release dated Sept 29, 2023:

Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

TOFIDENCE is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies. Spending on therapies for autoimmune diseases has consistently increased by 10%–25% each year over the past decade. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy.

“The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”

Biogen and Bio-Thera entered into a commercialization and license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen is currently evaluating the potential launch timeline for TOFIDENCE in the U.S.

The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the US and EU reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm parallel phase III study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.

Read more

EU has its first RoActemra biosimilar — Tyenne

The following is an except from an article on Pharmaphorum, dated Sept 20, 2023:

The biosimilar of IL-6 inhibitor tocilizumab, called Tyenne (formerly MSB11456), has been approved for the same indications as Roche’s brand, including rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), giant cell arteritis (GCA), CAR-T cell-induced severe or life-threatening cytokine release syndrome and severe COVID-19.

Continue reading

ACR Launches Biosimilar Patient Education Campaign for Rheumatic Disease Awareness Month

The following is a press release issued by the ACR September 12, 2023.

The American College of Rheumatology (ACR) today launched its patient education campaign, Biosimilars & You: A Guide to for Patients with Rheumatic Disease as part of Rheumatic Disease Awareness Month (RDAM). The campaign aims to help individuals diagnosed with a rheumatic disease better understand what biosimilars are and that these therapies may offer a treatment option as safe and effective as the original biologic they are based upon.

A 2023 survey looking at US patients’ attitudes about biosimilars found that patients expressed a desire to know more about biosimilars in general and specifically about how they compare with original biologics, their benefits, and their cost. The ACR, in consultation with practicing rheumatologists and rheumatology health professionals, developed resources, which include a video; an infographic; a patient fact sheet, and additional materials, to meet this need.

“Biosimilars are a class of medications that rheumatologists have long been prescribing in the US and Europe to successfully treat rheumatic conditions,” said Marcus Snow, MD, chair of the ACR Committee on Rheumatologic Care and spokesperson for RDAM 2023. “They go through a very stringent review process with the FDA and are verified to be just as safe as the biologics they are based upon. With so many new biosimilars available this year, we knew patients would have questions and providers would be seeking resources to share with their patients.”

More than 58.5 million American adults have been diagnosed with a rheumatic disease, and an estimated 300,000 children live with some type of juvenile arthritis. Prior to the advent of biosimilar therapies, there has been only one medication healthcare providers could prescribe for their patients with rheumatoid arthritis, psoriatic arthritis, lupus, and several other rheumatic diseases over the past decade. With new biosimilars available, the hope is that in addition to more options for treatment, there may also be potential for cost savings for patients. However, this has yet to be determined.

“With more and more biosimilars becoming available, it’s important to note that they are not synonymous with a ‘generic drug’ because they are not identical to the original biologic,” Snow said. “The difference between biosimilars and the original reference biologic compares to the difference between two buildings created from the same blueprints. The buildings will look the same, be the same height and have the same number of rooms and functionality. But they might have different paint colors, doorknobs, or other small differences. However, those differences do not change how the building functions; both have a sound foundation. ”

The ACR aims to be a one-stop shop for patients and their healthcare providers to learn more about biosimilars. View all biosimilar resources from the patient education campaign at www.RDAM.org.

ACR Whitepaper Shows that Rheumatologists help Reduce Hospitalization Costs and Readmissions and Increase Quality of Care for Patients

The following is a press release from the ACR dated August 30, 2023.

The American College of Rheumatology (ACR) has developed a new whitepaper and position statement that outlines the Clinical and Economic Value of Rheumatology in various hospital and practice settings. The documents emphasize the benefit to the quality of patient care when a rheumatologist is a part of the care team and the positive financial impact rheumatologists have on healthcare systems and the economy.

“Many rheumatologists can attest to the value they bring to the care team at a healthcare system,” said Christina Downey, MD, corresponding author of the white paper and chair of the ACR’s government affairs committee. “Our goal with the paper and position statement is to emphasize what that value looks like from a preventive and financial perspective. A rheumatologist on the care team benefits patients, practices, and the economy.”

The paper, an analysis based on adjusted insurance claims data, focuses on two aspects of economic value: preventive value and direct value. The study compared markets with high and low rheumatologist supply and found that markets with an increased supply of rheumatologists had lower costs per patient. Ultimately, having an appropriate supply of rheumatologists is crucial for optimizing patient outcomes and increasing the economic benefits within healthcare systems.

Highlights from the white paper, and emphasized in the position statement, include:

  • Markets with a high supply of rheumatologists had lower average costs per patient for emergency room visits and hospitalizations than those with a low supply.
  • Rheumatologists generate $3.5M annually in revenue for healthcare systems by calculating direct and downstream billings associated with a full-time equivalent (FTE) rheumatologist. The calculation includes office visits, lab testing, radiology services, therapy referrals, consultations, etc.
  • The preventive value of rheumatology care was estimated to be $2,762 per patient per year, representing the cost savings associated with a high supply of rheumatologists.
  • The need for expensive and invasive joint replacement surgery due to rheumatoid arthritis has fallen substantially in recent years because of medications that only rheumatologists have the experience and expertise to administer.
  • Appropriate medical therapy with disease-modifying anti-rheumatic drugs (DMARDs) or biologics provided by rheumatologists can significantly decrease disease activity, modify comorbidities, and improve the quality of life for patients with rheumatoid arthritis (RA).
  • Systemic lupus erythematosus (SLE) is among the leading causes of death of young women in the United States. They have higher disease activity, morbidity, and mortality, which often leads to one of the highest 30-day hospital readmission rates among chronic diseases in the nation. Access to a rheumatology clinic post-discharge reduces rates of readmission in this group.
  • Rheumatologists have developed electronic registries, such as the Rheumatology Informatics System for Effectiveness (RISE), to nationally track and improve the quality of care administered by rheumatologists. This registry provides timely feedback on the performance of 24 quality metrics like functional status and receipt of DMARD prescriptions for RA patients.

“Emphasizing the impact rheumatologists have on the entire medical community is more important than ever, especially as we contend with an impending rheumatology workforce shortage coupled with an expected increase in patient demand for rheumatologic care” Downey said. “This paper supports our recruitment and sustainability efforts for the specialty by spotlighting the significant contributions we make every day and every year to patient outcomes, hospitals, and other healthcare practices.”

An ACR task force, commissioned by the ACR board of directors, worked with ECG Management Consultants to analyze the value of care given by rheumatologists. ECG has worked with other specialties, such as primary care, to help quantify their economic value.

View the full Clinical and Economic Value of Rheumatology: An Analysis of Market Supply and Utilization in the United States whitepaper and position statement at https://rheumatology.org/policy-position-statements.