Justification for Nonsubstantive Change

Justification (rev 05-02-2018 by OSORA PRA).docx

Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)

Justification for Nonsubstantive Change

OMB: 0938-0976

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Non-substantive Change Justification

Notice of Denial of Medicare Part D Prescription Drug Coverage

CMS-10146, OMB 0938-0976


The Division of Appeals Policy believes that the modifications (see the Crosswalk and the Track Change versions of the notice and the instructions) are non-substantive in nature but are necessary for clarity for Part D plan sponsors who issue this notice.


The text on alternative formats that is specific to plan enrollees was not approved for use at the time the previous package went through the PRA process. The need for clarification on the other points was identified following approval of the previous package.


Burden Changes


None. The modifications do not affect our currently approved burden estimates.


Revised Documents


  • Notice of Denial of Medicare Part D Prescription Drug Coverage (English)

  • Notice of Denial of Medicare Prescription Drug Coverage (Spanish)

  • Form Instructions for the “Notice of Denial of Medicare Part D Prescription Drug Coverage”


Unchanged Documents


  • Supporting Statement part A


Added Documents


  • Non-substantive Change Justification

  • Combined Crosswalk – Denial Notice & Instructions (English)

  • Track Change – Denial Notice (English)

  • Track Change – Denial Notice Instructions (English)

  • Crosswalk - Denial Notice (Spanish)

  • Track Change – Denial Notice (Spanish)


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorKathryn McCann Smith
File Modified0000-00-00
File Created2021-01-21

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