Category: ACR

The following is a statement from Angus Worthing, MD, ACR Government Affairs Committee Chair:

“As policy makers and healthcare professionals continue to work together on ways to lower drug costs for patients, the ACR has worked to educate leaders in Congress about the lack of transparency from pharmacy benefits managers (PBMs) on the savings they are negotiating and whether those are being passed to patients. Though PBMs claim to use their position to negotiate lower drug prices, there has been no proof that rebates have been used to reduce the burden on patients and the healthcare system at large.

In recent years, several states have enacted legislation to hold PBMs accountable and crack down on secretive practices that drive up costs for consumers. State legislation has included gag clause bans, restrictions on claw-back provisions in PBM-insurer contracts, licensure of PBMs in states where they operate, and provisions that protect community pharmacies from unfair PBM auditing practices. These are positive developments, but without the full disclosure of rebates and discounts it is not possible to determine how the rebate system impacts drug prices and patient costs.

The ACR is concerned that the federal district court’s recent decision to approve the merger of CVS Health Corporation and Aetna hinders progress that has been made towards creating transparency and will make it easier for costs savings to remain secret. We hope that regulators will now actively watch the conduct of the merged company to ensure patients are protected.”

The following is a press release issued by ACR as of last week Friday:

WASHINGTON, D.C. – The American College of Rheumatology (ACR) today applauded the introduction of the Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107), a bipartisan bill to protect patients enrolled in Medicare Advantage plans from prior authorization requirements that needlessly delay or deny access to medically necessary care.

The bipartisan legislation, which is sponsored by Representatives Suzan DelBene (D-WA), Mike Kelly (R-PA), Roger Marshall (R-KS), and Ami Bera (D-CA) would require the Centers for Medicare and Medicaid Services (CMS) to regulate the use of prior authorization by Medicare Advantage plans, including establishing a process to make ‘real-time decisions’ for services that are routinely approved. These plans would also be required to offer an electronic prior authorization process and report to CMS on how extensively they use prior authorization, as well as how often they approve or deny medications and services.

“For far too long, patients have faced unnecessary and unreasonable care delays due to insurers’ overzealous use of prior authorization,” said Paula Marchetta, MD, MBA, president of the ACR. “This practice creates significant burdens for physicians and can put patient’s health in jeopardy. We applaud Congressional leaders for standing up to ensure America’s Medicare beneficiaries are able to get the care they need and deserve.”

Prior authorization is a process used by many insurers, including Medicare Advantage plans, whereby a prescribing physician must obtain approval from the insurer before the patient can begin treatment. This is a time-consuming process that often involves a patient facing weeks-long delays before being able to start life-altering therapies.

While originally intended to control costs by reducing unnecessary tests and procedures, many health plans are now indiscriminately using prior authorization, creating additional hurdles for patients and physicians that can lead to delays in treatment that may endanger patients’ health. The process for obtaining this approval can be lengthy and typically requires a physician or their staff to spend many hours each week negotiating with insurance companies – time that could be better spent taking care of patients.

The ACR has been working to advance this legislation as part of the Regulatory Relief Coalition, a group of national physician specialty organizations advocating for a reduction in Medicare program regulatory burdens to protect patients’ timely access to care.

This week, the Coalition released a national survey of 1602 physicians detailing the extent to which prior authorization places burdens on physicians and puts patients at risk. The survey found that 87 percent of physicians report that prior authorization has a significant (40 percent) or somewhat (47 percent) negative impact on patients’ clinical outcomes. Nearly a third of physicians surveyed said their patients often abandon treatment due to prior authorization. Furthermore, 84 percent of survey respondents said that the regulatory burdens associated with prior authorization has significantly increased over the past five years with half of all practices reporting 11 or more requests per week.

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

Physician and health professional leaders with the American College of Rheumatology (ACR) convened on Capitol Hill this week to urge lawmakers to act on a range of policy issues affecting patient access to care.

Rheumatology advocates asked lawmakers to support legislation that would reform step therapy and prior authorization practices, strengthen the rheumatology workforce, and preserve patient access to osteoporosis testing. They also educated offices on the need for arthritis research funding through the Department of Defense and the importance of addressing the physician workforce shortage.

“As the demand for rheumatology care continues to grow, rheumatology leaders are committed to advancing policies that will improve care access and quality for the one in four Americans living with a rheumatic disease,” said Paula Marchetta, MD, MBA, president of the ACR. “We had productive conversations with lawmakers about bipartisan, common-sense policy solutions that will ensure patients continue to receive timely and appropriate care for their disease.”

The American College of Rheumatology asked legislators to support the following legislation to improve patient access to care:

• Safe Step Act of 2019 (H.R. 2279) – Introduced by Representatives Raul Ruiz, MD (D-CA) and Brad Wenstrup, DPM (R-OH), two physicians who have encountered step therapy in their own practices, this bipartisan legislation would place reasonable limits on the use of step therapy in employer-sponsored health plans and create a clear process for patients and doctors to seek exceptions. The legislation builds on reforms passed in 22 states to address this pervasive practice that delays effective care and puts patients at unnecessary risk. While state efforts to limit insurer use of step therapy are an important step forward, Congressional action is needed to address the use of step therapy in employer-provided plans which are regulated by federal law.
• Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act (S. 283) – Introduced by Senator Susan Collins (R-ME), this legislation would restore a sustainable Medicare payment for DXA bone density scans performed in a physician’s office, which are essential to diagnose osteoporosis and prevent fractures in the Medicare patient population.
• Prior Authorization reform legislation – Bipartisan legislation is expected to be introduced by Representatives Mike Kelly (R-PA), Suzan DelBene (D-WA), Roger Marshall (R-KS) and Ami Bera (D-CA) that would improve the transparency and efficiency of prior authorization processes, ensuring patients can access care without health-jeopardizing delays.

The American College of Rheumatology also looks forward to working with legislators on the following issues and related policies:

• Dedicated arthritis research funds through the Department of Defense’s Congressionally Directed Medical Research Program – Using the existing budget at the Department of Defense to establish dedicated funding for arthritis research would better serve the needs of current and former service members living with arthritis and other rheumatic diseases during and after service. Arthritis is the leading cause of disability and a leading cause of medical discharge among service members.
• Addressing the pediatric medical workforce shortage through the Strengthening our Pediatric Workforce Act (H.R. 1656) and the Reauthorization of the Pediatric Specialty Loan Repayment Program. Introduced by Representative Lloyd Smucker (R-PA), H.R. 1656 would amend the Public Health Service Act to provide support for initiatives that address pediatric public health disparities in children’s hospitals’ graduate medical education programs. Legislation is needed to reauthorize the now expired Pediatric Specialty Loan Repayment Program, which provided loan repayment for pediatric subspecialists.

For additional information about the ACR’s legislative priorities, please visit: https://www.rheumatology.org/Advocacy/Federal-Advocacy/Key-Issues

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.

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.