On August 7, 2018 CMS issued a memo to MA plans that rescinded the September 17, 2012 HPMS memo Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services and issued new guidance allowing MA plans to use step therapy for Part B drugs, beginning January 1, 2019. We appreciate that CMS listened to these concerns and proposed guardrails in the 2019 Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses proposed rule. Due to the timing of these regulatory guidance’s and proposed rules we have grave concerns that there will be a year gap of protections for patients in 2019. The proposed guard rails 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. We urge CMS to immediately publish guidance to plans that lays out, at 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.