The following is a statement by Leslie Fried, Senior Director of the National Council on Aging (NCOA), on the publication of proposed regulations, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Costs:

“The National Council on Aging (NCOA) is critically concerned about the Centers for Medicare and Medicaid Services (CMS) proposal to allow Medicare Advantage and Medicare Part D prescription drug plans to utilize step therapy.

"Since the beginning of the Medicare drug benefit, Congress and CMS have accepted that certain seriously ill and medically compromised Medicare beneficiaries must have access to the drugs prescribed to them in order to adequately manage their condition. That’s one of the reasons why there are six protected classes in Part D. Requiring chronically ill and frail individuals to ‘fail first’ before allowing them to ‘step up’ to a prescribed medication could have major and life-threatening consequences for these individuals. Restricting treatment options places an emphasis on initial cost over efficacy, which undermines the basic principal of health care providers to ‘do no harm.’ 

"We have similar concerns about the proposal to allow Medicare Advantage plans to use step therapy for Part B drugs, including in the treatment of life-threatening conditions like cancer. CMS even acknowledges that it expects this change to lead to consumer pushback by including changes to the adjudication time periods for Medicare Advantage appeals for Part B treatments. This reliance on the appeals process is insupportable. The Medicare appeals process does not provide adequate safeguards to protect beneficiaries from these harmful and detrimental proposals. As a matter of fact, flaws in the Medicare Advantage appeals process were highlighted in a report by the HHS Office of Inspector General in September 2018.

“These two proposals will affect our frailest citizens who may not have the wherewithal to engage with a difficult appeals process – even if they know it's an option. We urge CMS to reconsider and withdraw any proposals that will cause harm to the health and well-being of Medicare beneficiaries.”