The ACR recently issued three new position statements on key issues facing rheumatologists and patients with rheumatic diseases: step therapy, affordable prescription drug pricing and a special waived test designation for synovial fluid crystal analysis performed by rheumatologists.
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Here is a detailed look at each.
Addressing Step Therapy
Step therapy or fail first protocols require patients to try and fail one or more formulary-covered drugs before the insurer will cover other agents prescribed by the physician, even when the prescriber is certain the insurer-preferred treatment will be ineffective. The ACR’s new position statement opposes utilization management strategies based solely on cost instead of medical value; supports formulary change transparency and involvement of rheumatologists in pharmacy review committees; and calls non-medical switching, or an insurer requiring a patient to switch therapies for cost-saving purposes only and without the patient’s consent, “inappropriate.”
“This position statement continues to emphasize the ACR’s belief that utilization management strategies based solely on cost—including step therapy, fail first policies and tiering of medications—are not appropriate, and often compromise safety and quality of care,” says Colin Edgerton, MD, chair, Committee on Rheumatologic Care. “The ACR remains active with legislators and policymakers addressing the impact of step therapy on patients and their rheumatologists.”
On April 11, a bipartisan bill to place reasonable limits on step therapy’s use by insurers, the Safe Step Act (H.R. 2279), was introduced in the U.S. House of Representatives by Rep. Raul Ruiz, MD (D-Calif.), and Rep. Brad Wenstrup, MD (R-Ohio), a move applauded by the ACR.
“This bill, if enacted, would allow us to bypass step therapy restrictions when we know a drug or mechanism of action won’t work, or is contraindicated or inaccessible for a specific patient due to their comorbidities or specific disease manifestations,” says Angus Worthing, MD, Government Affairs Committee chair. “It’s a critical time to speak up about this bill, because we anticipate it will have broad bipartisan appeal. But House leadership needs to [hear] from our members of Congress [about the significance of this bill], and the Senate needs to introduce and, ultimately pass, the bill as well, in order for it to become law.”
What can you do to support the ACR’s position? Email your representatives through the ACR’s Legislative Action Center form, and encourage your patients to email their representatives through the ACR’s Simple Tasks website.
Affordable Drugs
The ACR’s new position statement on drug pricing supports “safe, convenient and affordable access” to rheumatology treatments, says Dr. Edgerton.
“This position statement could not have come at a more critical time, as we see the growing impact of high drug prices on patient access, as well as government actions and proposals to curb drug pricing,” he says. “The ACR outlines key positions in this statement, including the need for rational policies that mitigate rapid escalation of drug pricing while maintaining patient access, transparency and the rheumatologist’s role in providing specialized, continuous care.”
In this statement, the ACR proposes more transparency from pharmaceutical manufacturers, pharmacy benefit managers (PBMs) and private insurers when setting drug prices, and a safe and efficient biosimilar approval pathway to improve access to lower cost biologic therapies. It declares that any new drug pricing proposal should address these concerns: cost to the healthcare system, continuity of care and out-of-pocket affordability for patients.
Special, Waived-Test Designation
The ACR has also issued an updated position statement on synovial fluid crystal analysis credentialing for rheumatologists. The ACR statement supports the designation of this analysis as a special waived test under Clinical Laboratory Improvement Amendments regulations when it is performed by a rheumatologist with documented training and credentialing, “reducing the regulatory burden associated with performing synovial crystal fluid analysis. The ACR continues to support reimbursement for this important test” by Medicare and other insurers when it is performed and interpreted by rheumatologists, says Dr. Edgerton.
Susan Bernstein is a freelance journalist based in Atlanta.