CMS has issued a long-awaited guidance and clarification on the MSP recovery and MMSEA reporting of settlements, judgments, and awards in cases involving exposures (environmental  hazards/toxic substances), ingestion, and implantation of medical devices. Specifically, this  Guidance addresses the practices of Amending Complaints and the issuance of Court Orders that seek  to clarify dates of exposure (pre- or post-12/05/1980).

This Guidance clarifies that Medicare will pursue an MSP recovery claim, and will require MMSEA  reporting in the following situations:

  1. An exposure, ingestion, or alleged effects of an implant on or after 12/5/1980 is claimed,  released, or effectively released in the most recently amended operative complaint or similar  pleading; or
  2. The terms of the settlement or award require that the claimant have had an exposure,  ingestion, or implantation that continued or existed on or after 12/05/1980.

But of more strategic and practical interest, CMS also outlined the factors – all of which must be  present – to avoid an MSP recovery and MMSEA reporting obligation:

  1. All exposure or ingestion ended, or the implant removed, before 12/05/1980; and
  2. An exposure, ingestion, or implant on or after 12/05/1980 is not claimed in the most recently  amended operative complaint, nor specifically released; and
  3. There is no release for an exposure, ingestion, or implant on or after 12/05/1980, unless it  is part of a broad general release.

The Guidance also puts parameters around the amended complaint and/or court orders that may be used  to help guide the evaluation of these 12/05/1980 reporting/recovery rules:

  • “Operative Amended Complaint” must
    • occur prior to the date of settlement; and
    • cannot serve to remove any claim for medical damages, care, items and/or services that appeared  in a prior complaint or the case file.
  • CMS will defer to court orders that serve to amend complaints only if the order comports with  the guidelines set forth in this Guidance. CMS will not defer to orders that contradict governing  MSP policy, law, or regulation.


This new Guidance is effective immediately, and should be considered in your case evaluations and  settlement strategy and negotiations.