Definitions:

  1. Adverse Event: An undesirable experience associated with the use of a medical product in a patient, including adverse drug reactions and medication errors.
  2. At-Risk Beneficiary: As defined in § 423.100, a Part D eligible individual who is determined to be at-risk for misuse or abuse of frequently abused drugs.
  3. Chronic Disease: A long-lasting condition that can be controlled but not cured, such as diabetes, hypertension, or asthma.
  4. CMS: Centers for Medicare and Medicaid Services
  5. Comprehensive Medication Review (CMR): An interactive, person-to-person, or telehealth consultation performed by a pharmacist or other qualified provider to review a beneficiary’s medications and health conditions.
  6. Drug Take-Back Program: A program that allows for the safe disposal of unused or expired prescription medications.
  7. Medication Action Plan: A document that may result from a CMR, outlining recommended actions for the beneficiary to better manage their medications and health conditions.
  8. Medication Therapy Management Program (MTMP): A program designed to ensure that covered Part D drugs are appropriately used to optimize therapeutic outcomes through improved medication use and reduce the risk of adverse events.
  9. Opt-Out Enrollment: A method of enrollment where targeted beneficiaries are automatically enrolled in the MTMP but can choose to opt out if they do not wish to participate.
  10. Part D Drugs: Prescription drugs covered under Medicare Part D.
  11. Qualified Provider: A healthcare professional, such as a pharmacist, physician, or nurse, who is qualified to perform MTM services.
  12. Standardized Format: The CMS-approved template for providing written summaries of CMRs to beneficiaries.
  13. Targeted Beneficiaries: Enrollees in the Part D plan who meet specific criteria for inclusion in the MTMP, including multiple chronic diseases, multiple Part D drugs, and likelihood of incurring high annual drug costs.
  14. Targeted Medication Review (TMR): A review of specific medications or classes of medications, conducted quarterly, to address actual or potential medication-related problems.
  15. Telehealth: The use of electronic information and telecommunications technologies to support long-distance clinical health care and patient education.

Policy:

It is the policy of the Qualexa Family of Companies (“Company”), which includes all entities administered by Qualexa as listed in the Companies in Scope section, to implement and manage a Medication Therapy Management (MTM) program in full compliance with 42 CFR 423.153(d) and all applicable CMS regulations and guidance.

Our MTM program is designed to:

  1. Improve medication use and adherence
  2. Reduce the risk of adverse events
  3. Optimize therapeutic outcomes for targeted beneficiaries

Goals

To achieve these goals, our MTM program:

  1. Ensures appropriate use of covered Part D drugs prescribed to targeted beneficiaries
  2. Minimizes the risk of adverse events, including adverse drug interactions
  3. Is provided by pharmacists or other qualified healthcare providers
  4. Is developed collaboratively with licensed, practicing pharmacists and physicians
  5. Enrolls targeted beneficiaries using an opt-out method quarterly

Minimum Services

The MTM program must offer a minimum level of services to targeted beneficiaries, including:

  1. Interventions for beneficiaries and prescribers
  2. Annual comprehensive medication review (CMR) with written summaries
      • Interactive consultation (in-person or telehealth) by a pharmacist or qualified provider
      • May result in a recommended medication action plan
      • If beneficiary unavailable, may be conducted with prescriber, caregiver, or authorized individual
  3. Quarterly targeted medication reviews with follow-up as needed
  4. Standardized action plans and summaries compliant with CMS requirements
  5. Annual information on safe disposal of controlled substance prescription drugs (from 2022)

Targeted Beneficiaries

Enrollees who meet at least one of these criteria:

  1. Traditional criteria (all three required):
      • Multiple chronic diseases (max 3 required for enrollment)
      • Taking multiple Part D drugs (max 8 required for enrollment)
      • Members must be likely to incur annual costs of $1,623 for all covered chronic Part D medications.
  2. At-risk beneficiaries (from January 1, 2022)

The Company annually will provide enrollees with information about safe disposal of controlled substance prescription drugs.

The Company is committed to maintaining an MTM program that meets all regulatory requirements while prioritizing the health and safety of our beneficiaries.

Procedure:

1.         Program Management

  • The MTMP will be managed by the contracted Pharmacy Benefit Manager (PBM).
  • The Organization will oversee the PBM’s performance to ensure compliance with CMS regulations and organizational standards.

2.         Targeted Beneficiaries

  1. The Organization will annually define criteria for targeted beneficiaries and submit this information to the PBM. Targeted beneficiaries will be selected based on drug claims.
  2. Criteria will include:
      • Minimum number of chronic disease states (not to exceed 3)
      • Minimum number of Part D medications, including maintenance medications (not to exceed 8)
      • Annual Part D drug cost threshold (as specified by CMS, $5,330 for 2024)
      • Additional chronic disease states not already defined by CMS (if applicable)
      • Inclusion of at-risk beneficiaries as defined in § 423.100
  3. The PBM will use an opt-out method of enrollment for beneficiaries meeting the targeting criteria.
  4. The PBM will target beneficiaries for enrollment at least quarterly during each plan year.

3.         Program Services

  1. The MTMP will offer the following minimum services to each enrolled beneficiary:
      • Interventions for both beneficiaries and prescribers
      • Annual comprehensive medication review (CMR) with written summaries
      • Quarterly targeted medication reviews (TMRs) with follow-up interventions when necessary
      • Standardized action plans and summaries that comply with CMS requirements
      • Annual provision of information about safe disposal of prescription drugs that are controlled substances
  2. CMRs will be conducted as interactive, person-to-person, or telehealth consultations by a pharmacist or other qualified provider.
  3. If a beneficiary is unable to accept the offer to participate in the annual CMR, the review may be performed with the beneficiary’s prescriber, caregiver, or other authorized individual.

4.         Reporting and Monitoring

  1. The PBM will provide monthly reports to the Organization, including:
      • Completion rates
      • Number of completed CMRs
      • Star Ratings data related to MTMP
  2. The Organization will review these reports monthly to assess program performance and identify areas for improvement.
  3. The Organization will submit required MTMP information to CMS through HPMS by the specified annual deadlines.

5.         Website and Communication

  1. The Organization will maintain a separate section on its website about the MTMP, including:
      • Explanation of the program, eligibility requirements, and benefits
      • Information on how to obtain MTM service documents
      • Statement that the service is free
      • Summary of services
      • Information on how beneficiaries will know they are eligible and enrolled
      • Description of CMRs and TMRs
  2. The Organization will ensure all MTMP materials comply with CMS marketing and communication requirements.

6.         Program Updates

  1. The Organization will review and update the MTMP annually as part of the bid submission process.
  2. Any changes to the CMS-approved program will be submitted during designated Update Cycle windows and implemented upon approval.

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