• BREAKING: CMS Releases Step Therapy Rule; Academy Comments Net Impact on New-Starts Requirement  


    The Centers for Medicare & Medicaid Services today released its final rule governing step therapy in Medicare. The policy applies to current Medicare Advantage and Part D plan utilization tools – for example, prior authorization and step therapy – for Part B drugs. As such, it affects those used by ophthalmologists for treating age-related macular degeneration and other retinal conditions. The rule outlines requirements, including specific patient protections for plans starting in 2020.

    The Academy is working with a law firm to review the final rule and will keep the membership advised as we analyze this new policy in-depth.

    Our early review of the rule concludes that CMS has agreed to an Academy request that it adjust its definition of new starts of treatment. When the proposed rule was released, CMS limited step therapy to new starts, which included a 108-day lookback period for determining when treatment with a certain drug therapy began. Now, CMS is setting that lookback period at one year.