ATLANTA - In August 2018, the CMS announced that Medicare Advantage (MA) plans would be allowed to utilize step therapy for Part B drugs. The American College of Rheumatology (ACR) expressed strong concerns about this proposal. The rheumatology community received some good news in this week's final rule from CMS, which makes changes to the original proposal and addresses several of the community's recommendations.
"We were pleased to see that CMS included the ACR's suggestion to implement a 365-day 'lookback' period for Part B therapies, to determine if the enrollee has been actively taking a Part B medication," said Angus Worthing, MD, chair of the ACR's Government Affairs Committee. "The originally proposed 108-day lookback period would have put many of our patients at risk for having to go through step therapy all over again. Extending this period to 365 days will help to protect these patients, and we appreciate CMS listening to our feedback."
In this way, patients who are stable on their current medication will be able to remain on their prescribed therapy under the final rule. The ACR is also encouraged by CMS' decision to require plans to respond to appeals within 24-72 hours.
While these are positive changes to the original proposal, additional clarity and transparency is needed to put patients in the driver's seat. The ACR asks that CMS require MA plans to make the step therapy exception process readily available and understandable on its website for providers, patients, and caregivers. The College would also appreciate more detail on how CMS will ensure MA plans follow this direction and encourages CMS to increase monitoring of MA plans' implementation of utilization management practices. Utilization review entities should provide detailed explanations for denials of requests for prior authorization or step therapy override, including whether there was any missing information which resulted in the denial.
CMS also finalized regulations related to the Part D Explanation of Benefits to require the inclusion of drug pricing information and lower-cost therapeutic alternatives in the Explanation of Benefits that Part D plans send members.
"The ACR agrees that this information is helpful and beneficiaries should have access to any possible ways to lower their out-of-pocket costs," said Worthing. "However, we would not support this information being used to force a stable patient to switch to another biologic medication for the sake of cost control. This switch would needlessly disrupt continuity of care and put patients at significant risk for loss of disease control and potentially life-threatening complications."
Ideally, the ACR hopes that CMS will monitor plans closely for non-medical switching and will require plans to ensure transparency about any utilization management requirements.
The ACR is dedicated to ensuring that rheumatology patients have access to safe, effective and affordable therapies under the Medicare Part B program and will continue to serve as a resource to the agency on this topic.
The American College of Rheumatology (ACR) is the nation's leading advocacy organization for the rheumatology care community, representing more than 7,700 U.S. rheumatologists and rheumatology health professionals who are committed to improving healthcare for Americans living with rheumatic diseases. As an ethically driven, professional membership organization committed to improving healthcare for Americans living with rheumatic diseases, the ACR advocates for high-quality, high-value policies and reforms that will ensure safe, effective, affordable and accessible rheumatology care.