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

The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) released the 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease. It is the first criteria developed specifically for this recently recognized disease.

A draft of the criteria was presented during the 2018 ACR/ARP Annual Meeting in Chicago. Since that time, the criteria team performed a second validation study, which confirmed the high sensitivity and specificity that was found in the first validation study.

IgG4-Related Disease (IgG4-RD) is an immune-mediated disease that may affect different organ systems and often mimics other diseases like Sjögren’s syndrome, pancreatic cancer, granulomatosis with polyangiitis (GPA), giant cell arteritis (GCA) and systemic lupus erythematosus (SLE or lupus). Only recognized in the last 10 to 15 years, IgG4-RD can cause fibro-inflammatory lesions in nearly any organ or multiple organs. Estimates suggest that IgG4-RD affects 180,000 people in the United States and many more worldwide.

“IgG4-RD is now recognized to be a worldwide condition that is seen not only by rheumatologists but also generalists and sub-specialists of nearly every kind,” said John H. Stone, MD, MPH, professor of medicine at Harvard Medical School and director of the international panel of experts who developed the new criteria. “Clinical trials are now being developed in IgG4-RD and investigators need criteria on which to base patients’ inclusion or exclusion for such trials and other types of investigation.”

Classification criteria allow researchers to accurately identify patients for inclusion in clinical, epidemiologic and basic investigations. The panel of experts who developed the new classification criteria included investigators from rheumatology and other specialties from five continents, reflecting the worldwide impact of this disease.

In the criteria, classifying patients with IgG4-RD is a three-step process that carefully assesses data from four domains, which must make sense in the context of IgG4-RD. The process includes synthesizing information from the patient’s clinical presentation, blood test results or serology, radiological findings and the pathology data. Few other diseases require such careful synthesis of various information to get an accurate diagnosis, and at this time, there is no single diagnostic test for the disease.

The 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease were validated in a large cohort of patients and demonstrated excellent test performances. Dr. Stone feels they should be a highly useful contribution to future investigations in this disease, and will ultimately help improve the lives of patients with IgG4-RD.

“IgG4-RD is a disease that tends to afflict middle-aged to elderly individuals and often affects and damages the pancreas severely, making glucocorticoids a suboptimal therapy for this condition,” Dr. Stone says. “Clinical trials will help develop targeted therapies that spare toxicities from conventional treatments. Investigators need to have criteria like this to determine whether a patient should be classified as having IgG4-RD.”

Dr. Stone is a professor of medicine for Harvard Medical School and the Edward A. Fox Chair in Medicine at Massachusetts General Hospital.

The following is a press release from ACR dated last Thursday:

The American College of Rheumatology (ACR) today commended leaders in the United States Senate for introducing the bipartisan Safe Step Act of 2019 (S. 2546), legislation that would place reasonable limits on step therapy, a troubling practice that requires patients to try—and fail—treatments preferred by their insurance company and pharmacy benefits manager before a doctor-prescribed option can be approved.

“With the Senate introduction of the Safe Step Act, we are one step closer to removing a treatment barrier that hurts patients,” said Angus Worthing, MD, FACR, FACP, a practicing rheumatologist and chair of the ACR Government Affairs Committee. “We applaud Congressional leaders for recognizing that forcing patients to ‘fail first’ through harmful step therapy practices puts them at unnecessary risk, prolongs pain and discomfort, worsens patient outcomes, and undermines the clinical judgment of medical professionals across the country. We urge Congress to quickly pass the Safe Step Act so that patients can appropriately seek exceptions to ‘fail first’ policies and quickly start accessing the treatments they need.”

Introduced in the Senate this week by Senators Lisa Murkowski (R-AK), Bill Cassidy (R-LA), Doug Jones (D-AL), and five other bipartisan co-sponsors, the Safe Step Act would implement transparent guidelines to prevent inappropriate use of step therapy in employer-sponsored health plans and create a clear process for patients and doctors to seek reasonable exceptions. The legislation builds on reforms passed in 25 states to address this pervasive practice that delays effective care and puts patients at unnecessary risk. While state efforts to limit insurers’ use of step therapy are an important development, Congressional action is needed to address the use of step therapy in employer-provided plans, which are regulated by federal law.

If enacted, the legislation will go a long way towards removing the treatment barriers created by step therapy.

According to a 2019 national patient survey conducted by the ACR, almost half (46.49%) of respondents who are receiving treatment for a rheumatic disease reported that their insurance company subjected them to step therapy.

A 2016 survey by the Arthritis Foundation found that most respondents experienced negative health effects from treatment delays caused by step therapy. According to the survey:

• More than 50% of all patients reported having to try two or more different drugs prior to getting the one their doctor had originally ordered;
• Step therapy was stopped in 39% of cases because the drugs were ineffective;
• Step therapy was stopped in 20% of cases due to worsening conditions; and
• Nearly 25% of patients who switched insurance providers were required to repeat step therapy with their new carrier.

A version of the Safe Step Act (H.R. 2279) was introduced in the House of Representatives in April by Representatives Raul Ruiz, MD (D-CA) and Brad Wenstrup, DPM (R-OH), two physicians who have encountered step therapy in their own practices.

The following is a press release from the ACR released yesterday:

In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) applauded a provision in the CY2020 Physician Fee Schedule proposed rule that would increase Medicare reimbursement for evaluation and management (E/M) services to more appropriately reflect the time and expertise these face-to-face services require. The ACR also urged CMS to make additional changes that would facilitate the delivery of high-quality rheumatology care.

“We applaud CMS for taking steps to ensure rheumatologists and other cognitive specialists are adequately reimbursed for the time-intensive, high-value services they provide,” said Paula Marchetta, MD, MBA, president of the ACR. “These proposed changes will help ensure Medicare beneficiaries living with rheumatic disease can continue to receive the healthcare services they need and deserve.”

The proposed changes to E/M coding represent a welcome reversal from a previous CMS proposal that would have significantly cut reimbursement for specialists who provide care to patients with complex conditions. According to a 2018 report from the Medicare Payment and Advisory Commission (MedPAC), healthcare services billed under E/M codes – which include examinations, disease diagnosis, risk assessments, and care coordination – are grossly under-compensated by Medicare.

The new changes align with the American Medical Association’s recommendations that were developed in collaboration with the ACR and other organizations representing cognitive specialties.

The ACR also urged CMS to adopt a number of other changes in the final rule, including:

• Clarify that proposed documentation reduction requirements take place in calendar year 2020. The proposed rule includes modifications to CMS’ documentation policy so that, for established patients, physicians and healthcare professionals are not required to document information in the provider’s note that is already present in a patient’s medical record. This change would greatly alleviate the paperwork burden on physicians and will enable them to focus more of their attention towards patients. The ACR is asking that CMS clarify that these changes take effect at the beginning of 2020 so that physicians can benefit from immediate relief.
• Implement the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) program in a manner that is voluntary and based on measures that are meaningful to clinical care. The ACR expressed concerns about CMS’ intent to move forward with the new program without more robust vetting and stakeholder input. In particular, the ACR urged CMS to include, at a minimum, an opt-in policy for the potential MVP pilot program and reiterated its opposition to the agency’s proposal to layer population health of administrative claims-based measures into the MVP since they do not provide a granular enough level of information for physicians to make improvements in practice.
• Reverse the removal of specific Qualified Clinical Data Registry Measures. The ACR believes that CMS’ plan to remove measures 178: Rheumatoid Arthritis: Function Status Assessment and 182: Functional Outcome Assessment would significantly undermine efforts to lay the necessary groundwork to establish additional rheumatology outcome measures. The ACR hopes to work with CMS on this issue before the rule is finalized.
• Work with the Center for Medicare and Medicaid Innovation (CMMI) to adopt Alternative Payment Model (APM) options that would encourage more providers to participate in disease-specific Physician Focused APMs. The ACR notes that there are few APMs that are feasible for rheumatologists and that the current nominal risk criteria make it difficult for smaller practices to attempt the APM track.  The ACR is submitting its rheumatoid arthritis APM in the coming weeks and hopes that CMS and CMMI will consider expanding APM options for rheumatology professionals.

“The ACR remains dedicated to ensuring that rheumatologists and rheumatology interprofessional team members have the resources they need to work with CMS and provide patients with high-quality care,” Dr. Marchetta concluded. “In order to achieve those objectives, payment programs must be designed to reflect the way clinicians treat patients. We hope to continue serving as a resource to the agency as it moves forward with the rulemaking process.”

The following is a press release from the ACR:

The American College of Rheumatology (ACR), along with 369 other leading patient, physician, and healthcare professional organizations, sent a letter to Congress urging passage of the Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107), a bipartisan bill to protect Medicare Advantage beneficiaries from prior authorization requirements that needlessly delay or deny access to medically necessary care.

Introduced by Representatives Suzan DelBene (D-WA), Mike Kelly (R-PA), Roger Marshall, MD (R-KS), and Ami Bera, MD (D-CA), the Improving Seniors’ Timely Access to Care Act would make it easier for patients to access medically necessary treatments by requiring the Centers for Medicare & Medicaid Services (CMS) to regulate the use of prior authorization by Medicare Advantage plans. The bill would also increase transparency by mandating that health insurance plans report to CMS their prior authorization usage rate and the frequency with which they approve or deny coverage.

“While intended to control costs, the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies,” said Paula Marchetta, MD, MBA, president of the ACR. “Many healthcare plans now use prior authorization indiscriminately, ensnaring the treatment delivery process in webs of red tape and creating gratuitous hurdles for patients and providers. Patients, physician groups, hospital associations and other key stakeholders all agree that reform is needed.”

According to a study conducted by the American Medical Association, over a quarter of doctors surveyed said prior authorization has led to a “serious adverse event” for patients, such as hospitalization and permanent bodily damage. The same study found that 91 percent of doctors say that prior authorization is associated with treatment delays.

As part of the Regulatory Relief Coalition – a group of national physician specialty organizations – the ACR has been a staunch advocate for reducing regulatory burdens in the Medicare program to assure patients have access to timely and medically necessary treatment.

The full letter is available here.

The following is a press release from ACR from earlier this week:

World champion tennis player, Venus Williams, is teaming up with the American College of Rheumatology (ACR) to share important information about rheumatic diseases in a new public service announcement (PSA) set to air nationwide this fall.

Williams is the official spokesperson for September’s Rheumatic Disease Awareness Month (RDAM), an annual event sponsored by the ACR and its public awareness campaign, Simple Tasks™. In the PSA, Williams discusses her experience living with a rheumatic disease and journey to diagnosis. After six years of swollen joints, fatigue, and eye and mouth dryness, Williams was finally diagnosed with Sjögren’s syndrome in 2011. After working with a rheumatologist and making some lifestyle changes, she was able to manage her disease and continue playing professional tennis.

“As a professional athlete, I know what it feels like to want your body to perform at its best, but I also know what it’s like to be one of the 54 million Americans battling a rheumatic disease,” says Williams. “Today, I follow my rheumatologist’s treatment plan and am feeling healthy and energized.”

Throughout the month of September, Americans living with rheumatic disease are encouraged to visit www.RDAM.org  to learn more about how to better manage their disease and sign up to join the Simple Tasks community. Individuals who sign up during the month will be entered into a drawing to receive an item signed by Venus. Community members will receive bi-monthly updates from the ACR’s Simple Tasks team with health and wellness articles, policy updates, and special events/opportunities for patients from Simple Tasks’ Rheum4You blog. Interested individuals can sign up at http://simpletasks.org/join/.

RDAM was created by the ACR in 2016 to increase public understanding and awareness of the symptoms, risk factors, treatment options, economic impact, and lifestyle or healthcare challenges associated with rheumatic diseases. An estimated 54 million U.S. adults––or one in four Americans over the age of 18––have been diagnosed with a rheumatic disease, an umbrella term that includes diseases like rheumatoid arthritis, lupus, gout, osteoarthritis, Sjögren’s syndrome, juvenile idiopathic arthritis, and hundreds of lesser-known conditions.

Rheumatic diseases do not just affect the elderly.  Hundreds of thousands of children live with arthritis and other rheumatic diseases. The CDC estimates that as many as 300,000 children have some type of juvenile arthritis. Rheumatic diseases are the nation’s leading cause of disability and generate $140 billion in annual health costs. Although there is no cure for rheumatic disease, early intervention and diagnosis by a rheumatologist can help patients manage symptoms and lifestyle limitations to live more healthy and normal lives.

“The sooner a person is diagnosed and referred to the correct specialist to receive proper treatment for rheumatic disease, the better a patient’s chances are of managing their disease and enjoying a fuller, healthier life,” said Paula Marchetta, MD, MBA, president of the ACR. “During this September’s awareness month and beyond, I encourage all Americans living with rheumatic disease to join our community, learn about how to manage their disease, and participate in the ACR’s ongoing efforts to enact policies that promote safe, effective, affordable and accessible care and treatments. Everyone’s voice matters.”

Rheumatic Disease Awareness Month and the Rheum4You Newsletter are sponsored by Simple Tasks, a public awareness campaign from the American College of Rheumatology. To learn more about rheumatic diseases and Rheumatic Disease Awareness Month, visitRDAM.org.