Medication Therapy Management (MTM) has been a component of Medicare Part D since the program’s inception. Until now, CMS has given plans significant leeway in terms of implementation and, for the most part, has paid little to no attention to it during audits. However, we are seeing that trend changing. One indicator of this is that the Comprehensive Medication Review (CMR) completion rate for MTM programs is being added as a new Star measure for 2016. Another indicator, most recently addressed in its 2015 Fall Conference, is that CMS will be piloting an MTM module in its audits starting in 2016 (an action previously planned for mid-2015).

The stated objectives of the MTM audit (as previewed in February 2015) are to:
• Assess a Medicare Part D sponsor’s performance with its CMS-approved MTM Program in accordance with 42 CFR § 423.153(d) and other related CMS guidance,
• Educate sponsors and correct area(s) of deficiency, and
• Initiate enforcement actions and/or identify possible performance measures for sponsors to implement.
More specifically, the MTM components that will be the focus of these audits are enrollment, CMRs and targeted medication reviews (TMRs). These are broad topics and comprise the bulk of MTM activities.

In planning ahead for MTM audits, plan sponsors will want to focus on the most likely risk areas. Our Visante managed care compliance consultants believe the following will be high-risk areas.

1. Insufficient member outreach for encouraging CMR participation

CMS expects plan sponsors to take an active approach in engaging enrollees to participate in CMRs. With the upcoming implementation of the CMR completion rate Star measure, plans will have an additional incentive to comply. The Guidance indicates that at least one additional method must be employed for enrollees who do not respond to the initial letter offering a CMR. Many plans utilize follow-up phone calls as their additional method of outreach (i.e. the method mentioned in the guidance document).

Historically, CMS has delved into returned mail policies and procedures when auditing functions that rely heavily on mailed communications. Plans should have formalized policies and procedures for promptly and appropriately handling returned CMR offer letters, and should be able to demonstrate compliance with these.

2. Inadequate Safeguards Against Discrimination

The ability to provide services employing Braille and TTY are specifically called out in CMS guidance on safeguarding MTM services against discrimination. However, sight and hearing impairment are not the only potential sources of discrimination. Other sources include enrollee inability to communicate adequately in English, cognitive deficits, and lack of a telephone and/or permanent address.

In some plans, there may be little need to address these issues, and it may become prohibitively costly and/or time-consuming to set up accommodations for them. Plans in these circumstances may be tempted to employ “one-off” strategies for the few times that they arise. However, CMS generally expects that policies and procedures be established for providing all required services, regardless of the likelihood of needing them. At a minimum, plan sponsors should consider documenting pre-established plans (e.g. arrangements with service vendors) for providing necessary accommodations, such that there is no delay in providing them when the need arises.

3. Inappropriate Disenrollment

Part D MTM programs must employ an “opt-out” enrollment methodology. Thus, members meeting the enrollment criteria are automatically enrolled, and they are to receive all MTM services, unless they specifically request not to be enrolled or to not receive a particular service (such as a CMR).

Inappropriate disenrollment can occur directly or indirectly by several means:
• Mid-year disenrollment. Once enrolled, members are to remain enrolled in the MTM program until the end of the calendar year. Members are not to be disenrolled in the middle of the year due to no longer meeting MTM eligibility requirements. Plans must be cautious not to rely solely on their quarterly (or more frequent) MTM targeting queries to define their entire enrollee roster.
• Lack of end-of-year auto-enrollment. It is the expectation of CMS that at the end of a benefit year, plans review the status of MTM program enrollees who will remain with the same contract for the upcoming year. Those who are likely to meet enrollment criteria at the beginning of the new benefit year must be “auto-enrolled” for that year. This promotes continuity of care by preventing interruption of services at the beginning of the new plan year.
• Misinterpreted “opt out.” Members can opt out of the MTM program entirely. However as noted above, members can also opt out of individual services and still remain enrolled in the program. When accepting and documenting opt-out requests, it is important to distinguish between these and provide services, as appropriate.

During audits, CMS will be on the lookout for inappropriate disenrollments. Avoiding these pitfalls may avert non-compliance in this area.

4. Deficiencies in Services for Long Term Care Residents

One approach CMS uses to avert discrimination in Medicare services is to set up special requirements for residents of long term care (LTC) facilities. There are several areas in which CMS outlines special considerations for MTM being conducted for LTC residents.

One such consideration pertains to cognitive impairment. It is important to note that cognitively impaired enrollees will comprise one third (or 10 out of 30) of the enrollment sample examined by CMS during the upcoming MTM audits. Plans must identify afflicted enrollees and ensure that MTM services are rendered in a way that is effective for them. Cognitive impairment occurs both within and outside of LTC settings, and CMS guidance cautions against limiting identification efforts to just enrollees in LTC settings. But for LTC residents, the 2016 MTM guidance memo describes how to use data collected during CMS LTC surveys to determine whether an enrollee is “interviewable.” Although that particular method of evaluation is not required, plan sponsors are required, when asked, to be able to provide information about how they determine enrollees’ capability to participate in interviews.

Another consideration unique to LTC involves collaboration with the other health care professionals involved in an enrollee’s care. For example, MTM services have some degree of overlap with the required monthly drug regimen reviews (DRRs) performed for LTC residents. It makes sense to not only use information collected through these DRRs in performing MTM, but also to collaborate with those conducting them. This will ensure that the two activities augment and complement each other rather than duplicate or conflict with one another. The 2016 MTM guidance memo states that “the MTM provider should coordinate the recommendations for drug therapy changes as a result of an MTM encounter with the beneficiary’s treating physician and healthcare team at the facility, their caregiver or authorized representative, when applicable, and consultant pharmacist” (emphasis added).

CMS expects that processes for offering and delivering CMRs include measures to address enrollees’ particular settings and needs. Residency in an LTC facility implies enrollee characteristics that impact the emphasis in CMRs and TMRs. Residents typically do not self-administer medications, for example, so adherence is not a major concern. On the other hand, the relative ease with which prescriptions can be obtained may lead to overmedicating. MTM procedures should include provisions to ensure that CMRs for LTC residents are prepared with these considerations in mind.

Addressing enrollees’ particular settings and needs may also include special consideration of the parties who participate in CMRs. This is particularly important for the LTC population, for whom the existence of authorized representatives is relatively likely. Fortunately, LTC residents are unique in that their health is monitored on an ongoing basis by a relatively consistent team who can provide reliable information on the residents’ health and cognition status. Facility staff can also provide information on caregivers and healthcare proxies who may be appropriate to include in CMRs and interventions, and may themselves be appropriate participants in CMR delivery.

At this point there are few firm requirements specific to MTM provision for LTC residents. However, based on the tone and content of this year’s MTM guidance, it seems evident that CMS is looking to plan sponsors to leverage LTC infrastructure to enhance services wherever possible. Plans should carefully consider the special circumstances of LTC residents when developing MTM policies and procedures.

5. Flawed Methodology for TMRs

To seasoned pharmacy benefit managers, “targeted medication reviews” may sound like “target DUR.” The fact is that the two are actually quite different. Rather than targeting a pre-identified issue among a population (as with target DUR), TMRs are intended to detect any type of issue that might impact an individual enrollee’s drug therapy (including access issues). The distinction is important because plans are required to perform TMRs on all beneficiaries, as opposed to a population subset that would be identified through a traditional target DUR.

One specific goal of TMRs is to “monitor whether any unresolved issues need attention…”. This implies tracking over time and reviewing enrollees’ current circumstances in the context of past issues. For this reason, plan sponsors must ensure that TMRs include a review of each enrollee’s history and the results from past interventions.

There are many approaches to carrying out TMRs. When designing their TMR processes, plans must keep in mind that:
• all enrollees must be included,
• each enrollee’s situation must be assessed for any and all types of drug therapy issues, and
• careful records of interventions and intervention results must be kept and documented in such a way as to enable review during subsequent TMRs.


While the general parameters for pilot MTM audits were described in the June 2015 CMS Audit Conference, experience suggests that there will be specific “hot spots” arising during the audits that are not readily apparent from published documents. Only time will tell what those hot spots may be for MTM, but you can put Visante’s experience to work in helping to anticipate these areas of special concern. Visante has leveraged its Part D experience to tease out likely “hot spot” candidates.

Contact us at to learn more about how we can assist you in optimizing your MTM program, as well as other services we offer to support your compliance with Medicare requirements.

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