Medicare Changes, Effective January 1, May Improve Biosimilar Use

In August 2018, the Centers for Medicare & Medicaid Services (CMS) said that starting January 1, 2019, Medicare Advantage plans would be permitted to implement step therapy to manage physician-administered and other Part B drugs in an effort to improve care coordination.

The recent step therapy requirements rescind September 2012 guidance that stated that plans were precluded from imposing additional requirements for access to certain Part B drugs or services, such as step therapy requirements. In the new guidance, CMS acknowledges that the use of step therapy is a recognized utilization management tool. “The allowance of step therapy practices for Part B drugs will help achieve the goal of lower drug prices, while maintaining access to covered services and drugs for beneficiaries,” according to the notice.

CMS also noted: “While step therapy requirements may reduce costs to both the enrollee and the Medicare Advantage plan, due to variances in cost-sharing for Part B and Part D drugs, there may be occasions when enrollees could experience higher out-of-pocket costs for the ‘stepped’ Part D drug. CMS reminds Medicare Advantage plans that benefits must be provided consistent with the 2019 benefit packages submitted and approved by CMS, and it is our expectation that step therapy for Part B drugs, and other utilization management practices, should not result in increased costs to enrollees.”

This new guidance should only be applied to new prescriptions or administrations of Part B drugs for enrollees who are not actively receiving the affected medication.

Subsequently, in October 2018, UnitedHealthcare announced that it will require step therapy authorization for certain biologics in Medicare Advantage Plans. The biosimilars infliximab-dyyb and infliximab-abda are listed as preferred drugs for UnitedHealthcare. They must be used first before coverage for non-preferred reference infliximab, according to the October network bulletin. In addition, biosimilar epoetin alfa-epbx is listed as a preferred agent and must be used before the non-preferred biologic agents epoetin alfa and darbepoetin alfa.

When members receive a lower cost preferred drug, the savings to the plan will be shared with the member as part of their participation in the care coordination program. Members will receive information about the shared savings program after their 2019 plan effective date, according to the bulletin.

Step therapy prior authorization requirements apply to UnitedHealthcare Medicare Advantage plans, but do not apply for members who are currently and actively receiving medications/medical devices (members with a paid claim within the past 120 days) on the list, consistent with the CMS guidance.