Category: ACR

The ACR and the Arthritis Foundation Present New Guidelines Offering Therapeutic Approaches and Treatment Options for JIA

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The following is from a press release sent out on April 29th:

Today, the American College of Rheumatology (ACR), in partnership with the Arthritis Foundation (AF), released two guidelines on juvenile idiopathic arthritis (JIA). One guideline aims to provide therapeutic approaches for non-systemic polyarthritis, sacroilitis and enthesitis; and the other focuses on the screening, monitoring and treatment of JIA with associated uveitis.

Juvenile arthritis (JA) is a common, chronic childhood disease that affects nearly 300,000 children in the United States. According to the AF, juvenile arthritis is not a disease in itself, but is an umbrella term used to describe the autoimmune and inflammatory conditions or pediatric rheumatic diseases, like JIA, that can develop in children younger than 16.

With JIA, the term idiopathic means “of unknown origin.” All forms of JIA are associated with a decreased health-related quality of life, a risk for permanent joint damage, and the likelihood that the disease may persist into adulthood.

A few of the recommendations from the JIA polyarthritis guideline include:

  • Conditional recommendations that NSAIDs and intraarticular glucocorticoids should each be used as adjunct therapy.
  • A strong recommendation against adding chronic low-dose glucocorticoid, regardless of risk factors or disease activity.
  • A conditional recommendation to get physical therapy and/or occupational therapy for children and adolescents with JIA and polyarthritis who have, or are at risk for, functional limitations.

“These recommendations highlight the importance of prompt and effective treatment for children with JIA and polyarthritis, sacroiliitis, and enthesitis,” said Sarah Ringold, MD, MS, a pediatric rheumatologist at Seattle Children’s Hospital and the principal investigator on this guideline.  “They also support relatively tight disease control, with inactive disease as the goal. While it is anticipated that these recommendations will lead to improved outcomes for children with JIA and these phenotypes, they also emphasize the ongoing need to generate high-quality data about treatment effectiveness in JIA.”

As noted, JIA can impair a child’s quality of life—especially when extra-articular manifestations occur. A common manifestation is uveitis, which can be a chronic or acute disease. Chronic anterior uveitis (CAU) develops in 10-20 percent of children with JIA, is usually asymptomatic, and there is rarely external evidence of inflammation. On the other hand, acute anterior uveitis (AAU) is a distinctly different form of uveitis and typically occurs in children with spondyloarthritis (i.e., those with enthesitis related or psoriatic arthritis).

Important recommendations from the JIA-associated uveitis guideline include:

  • A strong recommendation to get ophthalmologic monitoring within one month after each change of topical glucocorticoids rather than monitoring less frequently for children and adolescents with controlled uveitis who are tapering or discontinuing topical glucocorticoids.
  • A conditional recommendation to start methotrexate and a monoclonal antibody TNFi immediately rather than methotrexate as a monotherapy in children and adolescents with severe, active CAU and sight-threating complications.
  • A strong recommendation for education regarding the warning signs of AAU for the purpose of decreasing delay in treatment, duration of symptoms, or complications of iritis for children and adolescents with spondyloarthritis.

“Prevention of sight-threatening complications from uveitis is most important. It is crucial that children with JIA undergo scheduled ophthalmology screening to detect uveitis early since children are usually asymptomatic,” said Sheila T. Angeles-Han, MD, MSc, a rheumatologist at the Cincinnati Children’s Hospital and principal investigator for this guideline.

The JIA guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, which provides rigorous standards for judging the quality of the literature available and assigns strengths to the recommendations that are largely based on the quality of the available evidence. The guideline process also included significant input from patients and parents, which was made possible through the ACR and AF partnership. “We are proud to have been involved in this work and to witness the important contributions of the patient and parent partners,” said M. Suz Schrandt, JD, who serves as the director of patient engagement for AF. “Their lived experiences truly helped to guide the project.”

Although the quality of evidence was low or very low and most recommendations were therefore conditional for both, these guidelines fill an important clinical gap in the care of children with JIA, including non-systemic polyarthritis, sacroilitis and enthesitis, and JIA-associated uveitis, and may be updated as better evidence becomes available.

ACR Leads Group Urging CMS to Implement Patient Step Therapy Safeguards and Clarify Existing Protections

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The following is a press release from the American College of Rheumatology sent out yesterday:

The American College of Rheumatology (ACR) today led a group of 25 patient and provider organizations in urging the Centers for Medicare and Medicaid Services (CMS) to immediately add patient safeguards to the agency’s proposal allowing Medicare Advantage plans to utilize step therapy for Part B drugs. These safeguards, which were included in last year’s Medicare Part D and Medicare Advantage proposed rule, are currently set to take effect at the beginning of 2020, leaving a nearly year-long gap where beneficiaries may experience care delays or denials due to step therapy restrictions.

“The proposed guardrails would not go into effect until 2020, leaving vulnerable patients unprotected from harmful step therapy practices. For patients with severe or complex diseases, this can result in irreversible damage, disability, and even death,” the groups wrote in a letter to CMS Administrator Seema Verma. “We urge CMS to immediately publish guidance to plans that lays out, at a minimum, the patient safeguards proposed in the Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses proposed rule so that beneficiaries have some protections in 2019.”

Step therapy, sometimes known as “fail first”, is a technique used by health insurers in an attempt to control costs—often at the expense of patient choice and physician expertise. Patients are required to first try medications that are preferred by the insurance company before being approved for the medication prescribed by the patient’s doctor – even when it is clear to the prescribing physician that the insurer preferred option will not be effective. This practice undermines the clinical judgement of physicians and often leads to delays in patient care. Step therapy can also disrupt continuity of care by requiring patients to halt an effective therapy due to formulary or protocol changes to their plan. While common practice among commercial insurers, Medicare Advantage plans had been barred from using step therapy until the Administration issued a memo last year giving plans the option to do so at the start of 2019.

In addition to calling for proposed safeguards to be immediately implemented, the groups also urged CMS to go further to protect patients.

“Although we are pleased to see these safeguards, such as step therapy requirements only applying to new starts of medication, the safeguards do not go far enough to protect patients,” the letter continued.

Specifically, the groups urged CMS to make the following patient protections explicitly clear:

  • That the provider determines if a patient “fails” a treatment, not another entity such as the insurance company;
  • That patients can receive exceptions to step therapy if:
    • The treatment is contraindicated
    • The provider determines the treatment is likely to be ineffective
    • The provider determines the treatment is likely to cause a harmful reaction
    • The provider believes the treatment would impede the patient’s ability to perform daily activities or responsibilities and/or adhere to the treatment plan
    • The provider believes the new treatment will put the patient’s life in jeopardy or irreparably harm his/her physical or sensory functions; and
  • That any unwritten, implicit step therapy that is handled through a different utilization management process such as prior authorization is precluded.

“We hope that CMS will publish guidance to the plans as soon as possible so that patients will have safeguards for the 2019 plan year,” the groups concluded. “We welcome the opportunity to work with CMS to ensure that no patient is left without the ability to get the treatment that can improve or save their lives.”

ACR Targets Step Therapy and Drug Pricing in New Position Statements

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The following is a press release the ACR released today:

The American College of Rheumatology (ACR) has released new drug pricing and step therapy position statements that they hope legislators will consider as they continue to explore policy and regulatory options to make drugs more affordable and accessible.

“We continue to emphasize these topics because they are so critical to the well-being of millions of Americans living with rheumatic diseases, some of which can be quite debilitating and even lead to death,” said Colin Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the ACR’s Committee on Rheumatologic Care. “The need for patients to have access to prompt, affordable, and medically necessary treatments is ongoing and should be considered at every step of the policy making process.”

To make medication more affordable for patients, the ACR recommends:

  • Transparency in the policies used by pharmaceutical manufacturers, pharmacy benefit managers and health insurance companies to determine prescription drug prices.
  • A safe and efficient biosimilar approval pathway and marketplace that will improve access to treatment by lowering costs.
  • Any comprehensive proposal that deals with rising drug prices that address these primary concerns: cost to the healthcare system, continuity of care, and out of pocket affordability to patients.

Similarly, the ACR suggests incorporating the following to improve access to appropriate treatments:

  • Strategies that lower the cost of expensive therapies and oppose cost savings plans that compromise quality of care or safe clinical practices.
  • The removal of step therapy, fail-first policies, or ranking of medications based solely on cost. Additionally, non-medical switching between branded products and across therapeutic classes, in a medically stable patient, solely for cost savings and without the consent of the patient and his/her provider is inappropriate and potentially harmful to patients’ health.
  • Pharmacy review committees that include rheumatologists to help develop formulary benefits programs. The ACR welcomes the opportunity to provide expertise regarding rheumatic therapies to insurers.

Step therapy and drug pricing are spotlighted in the ACR’s Rheumatic Disease Report Card, which shows how easy it is to live with a rheumatic disease in each state. The report card highlights adequate access to rheumatology care, the affordability of rheumatic disease care, and healthy lifestyle habits that ease the burden of rheumatic disease. The full report is viewable HERE.

The ACR remains steadfast in its support of legislation that keeps drug pricing reasonable for those who need it most, while also protecting patient access to needed therapies that keep more than 54 million Americans with rheumatic diseases living well.

ACR Responds to CMS Medicare Part D and Medicare Advantage Proposed Rule

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The following is today’s press release from the American College of Rheumatology:

In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) expressed its continuing concern with a recent CMS policy allowing Medicare Advantage (MA) plans to utilize step therapy for Part B drugs. In the comment letter, rheumatology leaders urged the agency to establish safeguards to protect beneficiaries from potential harm.

 

“While we appreciate the agency’s efforts to make prescription medications more affordable, we have serious concerns regarding the decision to allow Medicare Advantage plans to implement step therapy for Part B drugs and cross-manage Part B and D drug utilization,” said Paula Marchetta, MD, MBA, president of the ACR. “We begin the 2019 benefit year with no safeguards in place to protect beneficiaries from changes that could seriously threaten their access to needed medications. At a minimum, CMS should immediately issue updated guidance that will clarify patient protections for the current year and beyond.”

 

Step therapy, sometimes known as “fail first,” is a utilization management technique employed by most health insurers that forces patients to try medications preferred by the insurance company before approving the medication prescribed by the patient’s doctor – even when there is no evidence the “insurer preferred” option will be effective. This practice often leads to delays in patient access to appropriate, evidence-based treatment and undermines the clinical expertise and judgment of health care providers.
In its comments to the agency, the ACR urged CMS to establish the following safeguards before moving forward with its step therapy policy:
  • Make clear that a patient’s provider must determine if a patient “fails” a treatment. This decision should not be made by another entity such an insurance company.
  • Provide exceptions to step therapy if:
    • The treatment is contraindicated for a patient’s specific condition.
    • The provider determines, based on medical evidence, that the treatment is likely to be ineffective, likely to cause a harmful reaction, or impede the patient’s ability to perform daily activities or responsibilities and/or adhere to the treatment plan.
    • The provider believes the new treatment will put the patient’s life in jeopardy or irreparably harm his/her physical or sensory functions.
  • Require MA plans to disclose that Part B drugs may be subject to step therapy in the plan’s Annual Notice of Change and Evidence of Coverage Documents.
  • Implement a 365-day “lookback” period for Part B therapies instead of the current 108-day period used in Medicare Part D plans.
  • Preclude plans from implementing step therapy via a different utilization management process such as prior authorization.
  • Increase monitoring of plans’ usage of utilization management practices and require that all denials include the clinical rationale for the decision while making clear a beneficiary’s appeal rights.
The ACR also commented on CMS’ decision to make changes to the Part D program, namely the agency’s new requirement that drug pricing information and lower-cost therapeutic alternatives be included in the plan’s Explanation of Benefits document. The ACR commended CMS for implementing a ban on “gag clauses” that prevent pharmacies from disclosing if a drug’s cash price is lower than the price with insurance. It also urged the agency to consider establishing common definitions for terms used during plan negotiations with Pharmacy Benefit Managers.

 

“The ACR is dedicated to ensuring that rheumatologists and rheumatology care professionals have the resources they need to provide patients with appropriate, high-quality care and that safe and effective treatments be available to all patients at the lowest possible cost,” Dr. Marchetta concluded. “We appreciate the opportunity to respond to this proposed rule and look forward to serving as a resource for the agency as it continues its work.”

ACR Recommends CMS Make Drug Pricing Demonstration Voluntary

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The following is a press release from the ACR from this last Thursday:

In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) urged the agency to proceed with caution when considering the International Pricing Index (IPI) drug pricing model, which was announced in an Advance Notice of Proposed Rulemaking in October. The ACR is concerned that, without substantial changes, the demonstration program could disrupt patient access to care, worsen the rheumatology workforce shortage and exacerbate geographic disparities in access to medical care.

“We appreciate the opportunity to provide input on the proposed IPI model and are encouraged by the agency’s efforts to make needed therapies more affordable for patients,” said Paula Marchetta, MD, MBA, president of the American College of Rheumatology. “However, we believe that changes must be made to ensure the proposal does not result in significant disruptions in patient care for the 54 million Americans who live with a rheumatic disease.”

Specifically, the ACR recommends that the IPI demonstration:

  • Be voluntary. Participation in this demonstration must be voluntary for providers and must include a way for them to exit the program if they find themselves unable to meet the administrative and financial changes required. Furthermore, the proposed demonstration should be reduced in size and scope and encompass a significantly smaller percentage of Part B drug administration to avoid disruptions in patient care.
  • Reduce financial risks and administrative burdens to physicians. In order to avoid disruptions in patient access to treatments, ACR opposes any increased risk to patients and practices as a result of the demonstration. The ACR is concerned that the proposal to have providers collect patient cost-sharing payments would create serious financial risk and administrative burdens for physicians, particularly those operating small practices. Instead, the ACR recommends that if third-party vendors are tasked with drug procurement and distribution under the proposed model, that they also collect the payments themselves or pay providers a fee for the cost collection. Other administrative changes were suggested in the ACR’s comments.
  • Measure the impact on patient access to inform future developments. CMS should continuously track and report measures such as prescription adherence, out-of-pocket costs, and disease outcomes throughout the demonstration to ensure the model does not compromise patient access or health outcomes in favor of lower costs.

Over the summer, the ACR released a set of policy principles that must be at the forefront of any policy effort aimed at reducing drug costs for chronically ill Medicare patients. These principles include prioritizing patient access to affordable treatments while ensuring steps are taken to support shared decision-making between patients and providers.

“The ACR is dedicated to ensuring that rheumatologists and rheumatology care professionals have the resources they need to provide patients with appropriate, high-quality care,” Dr. Marchetta concluded. “We thank CMS for providing an opportunity to offer our input and we look forward to serving as a resource for the agency as it works to lower drug costs for Americans with chronic illnesses.”

To view the comment letter, click here.

Joint Guideline for Treating Psoriatic Arthritis Published by the NPF and ACR

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

The American College of Rheumatology (ACR) and National Psoriasis Foundation (NPF) have released a joint treatment guideline for psoriatic arthritis (PsA) that provides evidence-based pharmacologic and non-pharmacologic recommendations on caring for treatment-naïve patients with active PsA and patients who continue to have active PsA despite treatment. It also includes recommendations for vaccinations, psoriatic spondylitis, predominant enthesitis, and treatment in the presence of inflammatory bowel disease, diabetes, or serious infections.

PsA is a chronic inflammatory musculoskeletal disease most commonly found in patients with psoriasis, a skin disease that causes red, scaly patches to appear on the skin. According to the NPF, more than 8 million Americans suffer from psoriasis, and it is estimated that 30 percent of them may develop PsA.

Some key recommendations from the guideline include:

  • A conditional recommendation to use treat-to-target approach for all patients with active PsA;
  • A conditional recommendation to use tumor necrosis factor inhibitor (TNFi) biologics as a first-line therapy option in patients with active PsA; and
  • A strong recommendation for smoking avoidance/cessation.

“Treat-to-target is key, because it encompasses all clinical scenarios, rather than one particular clinical situation,” said Jasvinder Singh, MD, MPH, a rheumatologist at the University of Alabama at Birmingham who served as principal investigator for the guideline project. “The available evidence suggests the irreversible joint damage, associated functional limitations, joint deformities and disability associated with PsA could possibly be avoided/delayed with optimal disease management using a targeted approach. A targeted approach can also improve pain, function and quality of life and social participation.”

The use of TNFi biologics as a first-line therapy was one of many recommendations included to help providers and patients decide between the various pharmacologic options currently available. While current GRAPPA recommendations address the use of TNFi biologics in treatment-naïve patients, this is the first guideline that specifically recommends first trying them over oral small molecule (OSM) drugs.

“The available evidence suggested that in the absence of certain conditions, many treatment-naïve patients would benefit from trying a TNFi biologic first,” said Dafna Gladman, MD, a rheumatology professor of medicine at the University of Toronto and member of the NPF Medical Board who served as a content expert on the guideline’s core team. “This doesn’t hold true once other symptoms and comorbidities are present, so OSMs can continue to be a first-line option for patients that have contraindications to TNFi treatment, as well as patients without severe PsA or psoriasis that prefer oral therapy. Providers should take into consideration all active disease domains, comorbidities, and the patient’s functional status when choosing the optimal therapy for an individual at a given point in time.”

Tofacitinib was not included within the OSM category since its benefit/risk profile differs from that of the rest of the OSMs.

The strong recommendation for smoking cessation was based on evidence linking smoking to a reduced efficacy of biologics; the benefits of smoking cessation; and the well-established link of smoking with mortality, cancers and heart and lung diseases in the general population.

The PsA guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, which provides rigorous standards for judging the quality of the literature available and assigns strengths to the recommendations that are largely based on the quality of the available evidence. Due to limited data in some areas, the quality of evidence was often graded low or very low. This led to nearly all recommendations being conditional. A voting panel of rheumatologists, dermatologists, health professionals, and patients achieved consensus on the direction and the strength of the recommendations.

“Despite an expansion in the number of new therapies for the treatment of PsA, only limited studies comparing effectiveness exist to inform treatment decisions,” said Singh. “This indicates a need for head-to-head trials of various treatments and comparative effectiveness studies in both trial populations and PsA populations with comorbidities. We also need studies in patients with active PsA who are treatment-naïve, or who have tried and failed different treatment approaches. The presence of high-quality evidence will allow formulation of strong treatment recommendations.”

The complete guideline is available online on both the ACR website and NPF website.

ACR Cautions Against a One-Size-Fits-All Payment Approach for Medicare

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

In comments submitted to the Centers for Medicare and Medicaid Services (CMS) regarding the 2019 Medicare Physician Fee Schedule proposed rule, the American College of Rheumatology (ACR) cautioned policymakers against implementing a proposal to reduce physician reimbursement for evaluation and management (E/M) services, arguing that doing so could severely compromise patient access to care and further exacerbate the growing rheumatology workforce shortage.

“While we applaud CMS for taking steps to reduce provider documentation and reporting burdens, we have serious concerns about the impact these cuts will have on patient access to rheumatology care,” said David Daikh, MD, PhD, President of the ACR. “A one-size-fits-all approach to reimbursement is not the way to move forward, and cuts of this magnitude will not only force physicians to spend less time with patients but could also dissuade medical students from pursuing careers in rheumatology and other specialties that treat a high volume of patients with complex needs.”

CMS’ proposal, which would create a flat payment for all E/M visits regardless of complexity, would result in significant payment cuts for treating patients with complex care needs – penalizing doctors who treat sicker patients or patients with multiple chronic conditions. These cuts also go against the recommendations of the Medicare Payment Advisory Commission (MedPAC), which earlier this year found that E/M services are undervalued relative to other physician services and recommended that reimbursements be increased rather than cut. The ACR recommends that CMS implement only the documentation relief elements of the E/M proposal, while delaying the payment changes so CMS can work closely with physicians and all stakeholders to identify alternative approaches that would ensure physicians are appropriately reimbursed according to the level of care required by each individual patient’s condition.

The ACR also expressed concern that CMS’ proposal to reduce reimbursements for procedures performed on the same day and billed as a separately identifiable E/M visit could reduce quality of care and lead to higher co-pays for patients by requiring them to return on a different day for minor procedures.

Additionally, the ACR urged CMS to:

  • Maintain the Merit-Based Incentive Payment System (MIPS) small practice bonus at 5 percent of the final score rather than move it to the quality performance category as is currently proposed.
  • Not move forward with a proposal to increase the weight of the cost performance category to 15 percent in the 2021 MIPS payment year. The ACR also urged CMS to use the best 90 days in the Cost category when calculating MIPS payment bonuses rather than the entire calendar year and exclude Part B medication costs from the cost performance category.
  • Provide physicians with more credit for participating in specialty clinical data registries under MIPS, such as the ACR RISE Registry which uses electronic health records to improve patient care, outcomes, and practice efficiency.
  • Rely on input from all stakeholders about inappropriate and excessive reduction in practice expense reimbursement for diagnostic ultrasound and other services.

“The ACR remains dedicated to ensuring that rheumatologists and rheumatology health professionals have the resources they need to provide patients with high quality care and will continue to advocate for payment reforms that reflect the way practices treat patients,” Dr. Daikh said. “We look forward to serving as a resource for CMS as it develops and implements its final 2019 Physician Fee Schedule rule.”

To view the comment letter, click here.

ACR Releases First-Ever Rheumatic Disease Report Card

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The following is a press release issued by the American College of Rheumatology today.

The American College of Rheumatology (ACR) today released the Rheumatic Disease Report Card: Raising the Grade on Rheumatology Care in America, a first-of-its-kind report that evaluates just how difficult it can be to live well with a rheumatic disease in the United States.

The Rheumatic Disease Report Card provides actionable information to healthcare consumers and policymakers in all 50 states and the District of Columbia by answering the question, “How easy is it to live with a rheumatic disease in my state?” The report assigns states letter grades according to their progress in providing adequate access to rheumatology care, ensuring rheumatic disease care is affordable, and encouraging healthy lifestyle habits that ease the burden of rheumatic disease.

The average state grade was a “C,” with Maryland earning the highest grade and Oklahoma and Alabama earning the lowest grades in the report.

“This report comes at a critical time, as countless Americans living with chronic rheumatic diseases are finding it increasingly difficult to afford their prescription medications and even have access to specialized rheumatologic care,” said David Daikh, MD, PhD, President of the ACR. “This report card is an opportunity for Americans to advocate for themselves and their loved ones by raising awareness and encouraging policymakers to enact policies that improve rheumatic disease care access and affordability.”

The report findings indicate that all states have room to improve the access, affordability, and lifestyle factors associated with an individual’s ability to live well with a rheumatic disease.

A severe rheumatology workforce shortage, lack of insurance coverage and delays caused by restrictive insurer practices make it difficult for patients in many states to access rheumatic disease care. Even in states where patients can find a rheumatologist, their prescribed treatment costs are often exorbitantly expensive, as few states have taken measures to curb secretive pricing practices employed by Pharmacy Benefit Managers (PBMs) or put limits on insurers’ use of specialty tiers that implement high cost-sharing models. Furthermore, the report shows that policymakers at all levels of government can do more to make funds available for evidence-based rheumatology intervention programs like those funded by the CDC, and to support access to these programs in rural and underserved communities.

Of the 50 states and one federal district featured in the report, several states stood out as examples that others should look to as models for improving the lives of Americans with rheumatic diseases:

  • Maryland was the only state to receive an overall “A” grade due to its success in having a high concentration of rheumatologists, a low uninsured rate, laws in place to keep rheumatology care affordable, and several CDC-funded arthritis intervention programs operating in the state, including those offered by the YMCA and the National Recreation and Parks Association (NRPA).
  • Arkansas scored well in the affordability category due to state lawmakers’ recent efforts to address PBM transparency by enacting legislation that should serve as a model for future action in other states looking to address this issue.
  • Arizona received distinction for its efforts to educate primary care physicians in remote areas about rheumatic diseases so these frontline healthcare workers can better monitor and treat minor cases locally while referring more severe cases to a practicing rheumatologist. Arizona has one of the lowest concentrations of rheumatologists in the country, with only one practicing rheumatologist for every 139,000 people. Meanwhile, in Massachusetts and Maryland, there is one rheumatologist for approximately every 20,000 people – a ratio nearly seven times higher.

Rheumatic diseases are painful autoimmune and inflammatory diseases that affect a person’s joints, muscles, bones, and organs. There are more than 100 types of rheumatic diseases, including the more commonly known diseases of osteoarthritis, rheumatoid arthritis, lupus and gout.

One in four Americans are diagnosed with a rheumatic disease, and a recent academic study suggested that the number of Americans living with rheumatic disease may be as high as 91 million when taking into account reported symptoms of undiagnosed individuals. The prevalence and cost of rheumatic diseases represent a growing public health crisis. As the nation’s leading cause of disability, rheumatic diseases generate more than $140 billion in medical costs each year in the United States – surpassing the annual medical costs of cancer care.

“Rheumatic diseases can be debilitating—but they don’t have to be if a diagnosis is made without delay and appropriate treatment is started,” said Dr. Daikh. “We hope this report will help people understand that they have the power to turn the tide on this public health crisis by taking steps to raise their state’s grade on rheumatic disease care.”

The Rheumatic Disease Report Card is a project from the American College of Rheumatology (ACR) and its Simple Tasks™ public awareness campaign. Its development was guided by a national task force comprised of leading rheumatology researchers, clinicians and policy experts.

To view the Rheumatic Disease Report Card, please visit SimpleTasks.org/ReportCard.

ACR Statement Regarding the Recent CMS Guidance on Indication-Based Formulary Design

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The following is a press release just issued by the American College of Rheumatology:

“While we appreciate the agency’s efforts to make prescription medications more affordable, we have serious concerns about a new CMS guidance to allow Medicare Part D plan sponsors to implement indication-based formulary designs that allow plans to select drugs for their formularies based only on the disease indications they want to use.

“These changes are a departure from current policy, which requires plans to cover each on-formulary drug for all indications that are approved by the FDA. It takes clinical decision making out of the hands of providers and puts insurance companies in control of patient treatment plans.

“Furthermore, the proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy. Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. The ACR calls on the Trump administration not to go forward with this plan, or at a minimum to clarify the process for allowing exemptions for patients for whom a specific therapy is medically necessary. This process should be straightforward and not place an undue burden on the physician or patient in gaining access to needed medications.

“We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.

“We remain steadfast in our support for policies that lower costs while protecting patient access to needed therapies and look forward to continued dialogue with CMS about the proposed changes.”

Rheumatology Leaders Meet with HHS Secretary Azar to Discuss Concerns with Step Therapy in Medicare Advantage Plans

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The following is a press release that just came through from ACR. The below statement is from David Daikh, MD, PhD, President of the American College of Rheumatology:

“Yesterday, the American College of Rheumatology met with U.S. Department of Health and Human Services Secretary Alex Azar for a productive discussion about the rheumatology community’s concerns with a new policy that will allow Medicare Advantage plans to utilize step therapy in Medicare Part B. While we support the goal of decreasing the cost of medications, the ACR has long opposed step therapy and other utilization management techniques that undermine the clinical judgement of providers, delay access to needed treatments and put our patients’ health at unnecessary risk.”

 

“During the meeting, Secretary Azar expressed a willingness to provide clarifying language to Medicare Advantage plans that would further define the definition of ‘grandfathering.’ We hope this clarification will state that patients currently stable on their treatment will not be subjected to step therapy if they switch between Medicare Advantage plans. Such a clarification should also explain that if a patient has previously been through step therapy to arrive at an effective medication under a different health plan, they will not be subject to step therapy again when they switch plans.  Similarly, if a patient goes into remission and is able to stop taking a drug, but later needs to go back on to treatment, they will not be subject to step therapy again. We believe the aforementioned clarification would be a positive step in protecting our patients’ ability to continue with therapies that work, and urge HHS to move swiftly to provide that guidance.  We also encourage HHS to provide additional information on what this policy will mean for patients transitioning into Medicare.”

 

“We remain concerned that the provider burden will increase with this policy change but are encouraged by the Administration’s willingness to accept input and proposals on how to reduce burden. Further, we appreciate the Administration’s expressed willingness to engage with the provider community regarding the appeals process and the value of defining clinically appropriate treatment pathways as part of step therapy.  We hope that the Administration will consider making the prior authorization and appeals process in Medicare Advantage more transparent and streamlined, as this is critical for patient access.”
“While we continue to have concerns about the impact of this policy on our rheumatology patients’ ability to access timely and effective therapies, I want to thank Secretary Azar and his staff for engaging with ACR leaders and the rheumatology provider community on these issues. We look forward to continued dialogue on policy modifications that will improve patient access.”