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Issues in CMS 2010 Draft Call Letter: MTM Program Standards and LTC Transition Issues
Click here to read the CMS Draft 2010 Call Letter.

 
A. PROPOSED NEW MANDATORY STANDARDS FOR PART D MEDICATION THERAPY MANAGEMENT (MTM) PROGRAMS
  • Eligibility - Beginning in 2010, all Part D sponsors will be required to implement MTM programs that
- Enroll targeted beneficiaries using an opt-out method only,
- Target beneficiaries for enrollment at least quarterly;
- Target beneficiaries who:  (a) have multiple chronic diseases - however, sponsors cannot require more than three chronic diseases and must target at least four of seven core chronic diseases.  The seven core chronic diseases are: hypertension, heart failure, diabetes, dyslipidemia, respiratory disease, bone disease-arthritis, and mental health, (b) take multiple part D drugs (however - sponsors cannot require more than 8 part D drugs as a minimum), and (c) are likely to include covered part D drug costs that exceed $3,000.  (The current requirement is $4,000 in drug-spend).

  • Minimum Service Criteria: 3 Required MTM Components
Beginning in 2010, all Part D sponsors will be required to offer a minimum level of MTM services that includes three components: 
  1. An annual comprehensive medication review (CMR),
  2. targeted quarterly reviews,
  3. and offered interventions targeted to providers. 
The three required MTM components are further defined as follows:

Annual Comprehensive Medication Review (CMR) for each participating beneficiary: a CMR is a review of a beneficiary's medications, including prescription, over-the counter medications, herbal therapies and dietary supplements, that is intended to aid in assessing medication therapy and optimizing patient outcomes.  This includes the following components:
  • A review of medications to assess medication use and identify medication-related problems.  This may be conducted 'behind the scenes' by a qualified provider and/or using computerized, clinical algorithms.
  • An offer to provide to each beneficiary participating in the MTM program an interactive person-to-person consultation performed by a qualified provider.  This real-time interaction may be face-to-face or through interactive methods such as the telephone.  This interaction may include further assessment of the beneficiary's medication history and use, health status, clinical information, adverse events or other issues that could affect medication use or outcomes.
  • A process to summarize the interactive consultation and provide an individualized written takeaway to the beneficiary such as a personal medication record, reconciled medication list, action plan, recommendations for monitoring, education or self-management, etc.
Targeted Medication Reviews for each participating beneficiary, no less often than quarterly, to assess medication use and monitor whether any unresolved problems need attention or new drug therapy problems have arisen since the CMR.  Part D sponsors must assess these findings to determine if a follow-up intervention with the beneficiary or the provider is necessary.  The follow-up interventions should be interactive, if possible, but may be delivered via mail or other means.

Provider Interventions: Sponsors may offer interventions targeted to providers to resolve medication-related problems or other opportunities to optimize the targeted beneficiary's medication use.  These interactions may be passive (e.g. faxed, mailed) or interactive when determined necessary.
  • OTHER MTM ISSUES
    • MTM in Long-Term Care Settings: For participating beneficiaries in a LTC settings, sponsors are not required to offer the interactive CMR component but must still perform quarterly medication reviews and offer interventions to the beneficiaries providers.  There is no discussion of how these quarterly targeted reviews are to be coordinated with consultant pharmacist reviews mandated by statute.
    • Outreach: CMS expects that sponsors will have procedures in place to drive participation and follow-up with beneficiaries that do not respond to initial offers for MTM services.  Sponsors are also expected to use more than one approach when possible to reach all eligible patients who may wish to receive MTM services.
    • Outcome Measurement: Part D sponsors will be required to measure and report the number of comprehensive and targeted reviews, the number of provider interventions and the changes in therapy directly resulting from the MTM interventions.
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2.    TRANSITION NOTICES IN LONG TERM CARE SETTINGS

The 2007 Transition Guidance requires plans to provide a written notice, via U.S. mail, to each enrollee who receives a transition fill within three business days of the temporary fill. The notice must include the following elements: 
  1. an explanation of the temporary nature of the transition supply an enrollee has received;
  2. instructions for working with the plan sponsor and the enrollee's prescriber to identify appropriate therapeutic alternatives that are on the plan's formulary;
  3. an explanation of the enrollee's right to request a formulary exception; and (4) a description of the procedures for requesting a formulary exception.
The 2010 Call Letter states that for contract year 2010, CMS is permitting Part D sponsors the option of sending required transition fill notices to network long-term care pharmacies.  The LTC pharmacy must then ensure delivery of the notice to the beneficiary within 3 business days of the fill.  If a Part D sponsor elects this option, it must update its existing transition policy prior to the start of the 2010 contract year to specifically address that:
  • The sponsor maintains documentation of the LTC pharmacies' willingness to be delegated transition notice responsibilities; 
  •  the sponsor maintains a fully functionally electronic communications process with the LTC pharmacy once a transition fill has occurred (within three business days),
  • and the LTC pharmacy will maintain a process that demonstrates notice has been provided to the beneficiary (or his/her representative) within the 3-day period.
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