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CMS, after a summer of audits, released it’s first guidance on MTM Pilot Audits – Part D Medication Therapy Management Program Area PILOT Audit Process and Data Request.  The MTM Program area, beginning in 2017, will be included in Medicare Part D program audits.

The guidance document appears relatively transparent.  CMS is seeking to determine if the program sponsor is pursuing MTM in a compliant manner.  The audit guidance provides a nice roadmap for monitoring the compliance and quality of an MTM program.

I have highlighted a few key areas from the guidance and the “take aways” CSS identified for MTM program operations.


The CMS audit requires two universes.  One that the plan is required to prepare (MTM Universe) and one that CMS will prepare (PDE Universe).  The MTM Universe consists of members identified as MTM eligible.  The PDE Universe consists of members that were not identified (for the MTM program), but are potentially eligible.  The MTM universe needs to cover the previous program year and must be submitted to CMS within 15 business days.  CMS provides a tech spec for the universe in it’s guidance.

CSS Take Away:  Configure the MTM Universe as a part of program implementation.  Practice producing the MTM Universe on a monthly basis.  Even if the plan is not audited, the MTM Universe can be used for mock audits.

CSS Take Away: Even though the plan will not be responsible for producing a PDE Universe, it may be worthwhile to replicate the Universe CMS will be producing on your behalf.  In a mock audit this PDE Universe will help a plan to identify members who are being inappropriately missed by identification rules.


CMS will sample 10 patients from the plan’s MTM Universe and 10 from the PDE Universe and ask for supporting documentation to determine if the MTM program was administered appropriately.  The key elements of program administration are MTM eligibility determination (were members identified in accordance with the CMS submission), attempts to deliver a CMR (were CMR offers made and documented, how was cognitive status determined), CMR delivery (was the CMR reduced to a standard format and fulfilled within 14 days) and TMR delivery (was a TMR attempted in accordance with the CMS submission).

CSS Take Away: Dry runs are important.  Sample like CMS would and attempt to pull together the relevant documentation.


As part of the audit engagement sponsors will be asked to provide a description of disclosed program non-compliance and status of correction.  An issue is considered disclosed only if it has been disclosed prior to the plan receiving it’s program audit letter.  You must provide your disclosures within 5 days of receiving the audit engagement letter from CMS.

CSS Take Away: Use your mock audits to find program non-compliance issues.  Conduct an RCA and develop a corrective action plan.  This has two benefits: 1) You can use these RCAs for disclosure prior to being audited.  CMS prefers monitoring and self-disclosure.  2) These corrective actions “harden” your programs processes and procedures for the current program year.


As always I am happy to discuss any of these thoughts in greater detail. Feel free to reach out by phone or e-mail.

Jim Notaro

716.541.0273 x101

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