ATLANTA - The American College of Rheumatology (ACR) today expressed its extreme disappointment with a new Centers for Medicare and Medicaid Services (CMS) decision to allow Medicare Advantage (MA) plans to implement step therapy for Part B drugs and cross-manage Part B and D drug utilization. The policy change threatens patient access to drugs covered under Medicare Part B for the 54 million Americans living with rheumatic diseases. This policy puts insurance companies in control of patient treatment plans. Compromising medical decision making between doctors and patients prevents timely access to medications that effectively control disease.
"Put simply, this policy change is a gross affront to America's sickest Medicare patients - individuals living with diseases like inflammatory arthritis and cancer - who depend on timely access to safe, affordable, and high-quality treatments," said David Daikh, PhD, MD, President of the ACR. "Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage. At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time. We urge CMS to reconsider this policy and ensure that all Americans continue to have access to the most appropriate and effective therapy as determined by their health care team."
Step therapy - also known as "fail first" - is a troubling practice employed by a majority of insurers that forces patients to try therapies preferred by the insurance company before being approved for the therapy their doctor prescribed - even when doctors doubt the "insurer preferred" option will be effective. Utilized by both public and private insurers, step therapy undermines the clinical judgment of healthcare providers, leads to delays in effective therapy, and puts patients' health at unnecessary risk.
The ACR has long opposed utilization management techniques such as step therapy - in addition to others such as prior authorization, specialty tiering, and high cost-sharing - because they can prevent and delay important treatments for patients. In comments submitted to CMS last month, the ACR urged policymakers to protect patient access to Part B therapies and to instead address the issue of high treatment costs by facilitating the development of alternative payment models, expanding patient access to cost and coverage information at the time of treatment and improving FDA's capacity and manufacturer ability to bring safe, effective biosimilars to market, which will increase competition and lower costs. The ACR also supports practices continuing to negotiate better overall drug spending through Part B than what currently occurs in Part D, as suggested by HHS's own dashboard. Yet rather than addressing underlying causes of the high drug costs, this CMS policy seeks to reduce costs for insurers by limiting the ability of patients to receive the appropriate medications to treat their disease.
Furthermore, the ACR expressed concern over how these changes are being implemented and urged CMS to put any proposed changes through the formal rulemaking process so that patients and healthcare providers may be able to weigh in on the details of such a proposal.
"A change this seismic - one that has significant consequences for patient access to live-saving drugs - should go through the formal comment and rule-making process," Dr. Daikh concluded.