ACR Leads Group Urging CMS to Implement Patient Step Therapy Safeguards and Clarify Existing Protections April 08, 2019 25 Patient and Provider Groups Call on CMS to Immediately Implement Proposed Step Therapy Safeguards, Provide Additional Protections for Beneficiaries WASHINGTON, DC – The American College of Rheumatology (ACR) today led a group of 25 patient and provider organizations in urging the Centers for Medicare and Medicaid Services (CMS) to immediately add patient safeguards to the agency’s proposal allowing Medicare Advantage plans to utilize step therapy for Part B drugs. These safeguards, which were included in last year’s Medicare Part D and Medicare Advantage proposed rule, are currently set to take effect at the beginning of 2020, leaving a nearly year-long gap where beneficiaries may experience care delays or denials due to step therapy restrictions. “The proposed guardrails 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,” the groups wrote in a letter to CMS Administrator Seema Verma. “We urge CMS to immediately publish guidance to plans that lays out, at a 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.” Step therapy, sometimes known as “fail first”, is a technique used by health insurers in an attempt to control costs—often at the expense of patient choice and physician expertise. Patients are required to first try medications that are preferred by the insurance company before being approved for the medication prescribed by the patient’s doctor – even when it is clear to the prescribing physician that the insurer preferred option will not be effective. This practice undermines the clinical judgement of physicians and often leads to delays in patient care. Step therapy can also disrupt continuity of care by requiring patients to halt an effective therapy due to formulary or protocol changes to their plan. While common practice among commercial insurers, Medicare Advantage plans had been barred from using step therapy until the Administration issued a memo last year giving plans the option to do so at the start of 2019. In addition to calling for proposed safeguards to be immediately implemented, the groups also urged CMS to go further to protect patients. “Although we are pleased to see these safeguards, such as step therapy requirements only applying to new starts of medication, the safeguards do not go far enough to protect patients,” the letter continued. Specifically, the groups urged CMS to make the following patient protections explicitly clear: That the provider determines if a patient “fails” a treatment, not another entity such as the insurance company; That patients can receive exceptions to step therapy if: The treatment is contraindicated The provider determines the treatment is likely to be ineffective The provider determines the treatment is likely to cause a harmful reaction The provider believes the treatment would impede the patient’s ability to perform daily activities or responsibilities and/or adhere to the treatment plan The provider believes the new treatment will put the patient’s life in jeopardy or irreparably harm his/her physical or sensory functions; and That any unwritten, implicit step therapy that is handled through a different utilization management process such as prior authorization is precluded. “We hope that CMS will publish guidance to the plans as soon as possible so that patients will have safeguards for the 2019 plan year,” the groups concluded. “We welcome the opportunity to work with CMS to ensure that no patient is left without the ability to get the treatment that can improve or save their lives.” Read the coalition letter Media Contact: Jocelyn Givensjgivens@rheumatology.org404-929-4810 ###The American College of Rheumatology (ACR) is the nation’s leading advocacy organization for the rheumatology care community, representing more than 6,400 U.S. rheumatologists and rheumatology health professionals. 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.