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August 2023

How Blue Cross and BCN are handling prior authorizations for Makena following FDA announcement

In an April 6 news release,** the U.S. Food and Drug Administration announced it has withdrawn its approval of Makena® (hydroxyprogesterone caproate), HCPCS codes J1726 and J1729. The decision also applies to generic Makena products.

This means Makena and its generic products are now unapproved and can’t lawfully be distributed in interstate commerce.

For Blue Cross Blue Shield of Michigan and Blue Care Network commercial members, here’s how we’re handling prior authorizations for Makena:

  • We’re honoring prior authorization requests that have already been approved for this medical benefit drug through their end dates.
  • We’re denying prior authorization requests submitted for dates of service on or after April 6, 2023.

These changes apply to:

  • All Blue Cross and BCN commercial members
  • All versions of Makena, including compounded and generic versions

We’ve updated the pertinent drug lists to reflect this change.

**Blue Cross Blue Shield of Michigan and Blue Care Network don’t own or control this website.

No portion of this publication may be copied without the express written permission of Blue Cross Blue Shield of Michigan, except that BCBSM participating health care providers may make copies for their personal use. In no event may any portion of this publication be copied or reprinted and used for commercial purposes by any party other than BCBSM.

*CPT codes, descriptions and two-digit numeric modifiers only are copyright 2022 American Medical Association. All rights reserved.