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On November 28th, the Centers for Medicare and Medicaid Services (CMS) published “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” in the Federal Register (the full text of this document can be found at –  This publication proposes revisions to the Medicare Advantage and Prescription Drug Benefit programs.  A number of these revisions are germane to medication therapy management (MTM) and MTM-like activities.


The Comprehensive Addiction and Recovery Act of 2016 (CARA) amended the Social Security Act to include new authority for the establishment of opioid drug management programs in Medicare Part D.  CARA requires CMS to establish a framework by which Part D plans may establish a drug management program for beneficiaries at-risk of opioid abuse.   CMS is proposing that, in 2019, Part D sponsors may limit at-risk beneficiaries’ to specific providers and pharmacies.  While these ‘‘lock-in” programs have been allowed in state Medicaid programs, there was no statutory authority to allow Part D plan sponsors to require beneficiaries to obtain controlled substances from a certain pharmacy or prescriber.

CARA Part D drug management program provisions would be integrated with the current Part D Opioid Drug Utilization Review (DUR) Policy and Overutilization Monitoring System (OMS).   This integration would mean that Part D sponsors could limit an at-risk beneficiary’s access to coverage of opioids through a point-of-sale (POS) claim edit and/or by requiring the beneficiary to obtain opioids from a selected pharmacy(ies) and/or prescriber(s) after case management and notice to the beneficiary.

  • CSS Take-Away:  Opioid Case Management efforts will now require integration with prior authorization programs.

CMS has confirmed that the current Part D Opioid Overutilization policy and OMS has been successful at reducing high risk opioid overutilization.  Under the current policy, plans retrospectively identify beneficiaries at high risk of an adverse event due to opioids and use of multiple prescribers and pharmacies. CMS is exploring the operational definition of a “high-risk” beneficiary and has proposed a number of options.

Option Average MME No. Prescribers No. Pharmacies Est. Medicare At-Risk Beneficiaries
1 ≥ 90 4 4 33,053
6 1
2 ≥ 90 4 4 52,998
5 1
3 ≥ 90 3 3 103,832
5 1
4 ≥ 90 3 3 152,652
4 1
5 ≥ 90 3 3 319,133
3 1
6 ≥ 50 5 5 153,880
Any MME level 7 7
  • CSS Take-Away:  CMS will try to include more beneficiaries into the OMS without creating substantially more false positives for case management.


CMS is proposing to codify the STAR rating system used to measure the quality of health care delivery provided by Medicare Advantage and Part D sponsors.  Currently, the STAR rating system is operated using a set of guiding principals.  These guiding principals would be set into regulation and more clearly delineate the rules for adding, updating and removing measures and  modifying how CMS calculates STAR ratings for consolidated contracts.

CMS STAR rules will define rules for display measures, the time-line for making adjustments to STAR measures and the definition for major and minor changes.  In addition CMS will codify the calculation of the Categorical Adjustment Index – the index that adjusts STAR measures for plans who enroll disproportionate numbers of vulnerable beneficiaries which are systematically disadvantaged by a current STAR measure.

CMS will not codify the measures to be included in the program but provided a table of  STAR measures that will be included in the 2019 program.  CMS outlined 34 Part C measures and 14 Part D measures.

  • CSS Take-Away:  Of the 48 STAR measures, 17 could be impacted by MTM activity.  Eleven (11) measures are drug related, 3 measures are indirectly drug related and 3 measures could be improved as a care management component of an MTM program.
    • Directly Drug Related
      • Annual Flu Vaccine
      • Care for Older Adults (COA) – Medication Review
      • Rheumatoid Arthritis Management (ART)
      • Medication Reconciliation Post-Discharge (lv1RP)
      • Stalin Therapy for Patients with Cardiovascular Disease (SPC)
      • Medication Adherence for Diabetes Medications
      • Medication Adherence for Hypertension (RAS antagonists)
      • Medication Adherence for Cholesterol (Statins)
      • MTM Program Completion Rate for CMR
      • Statin Use in Persons with Diabetes (SUPD)
      • Osteoporosis Management 1n Women who had a Fracture (OMVV)
    •  Indirectly Drug Related
      • Care for Older Adults (COA)- Pain Assessment
      • Diabetes Care (CDC) – Blood Sugar Controlled
      • Controlling Blood Pressure (CBP)
    • Improved as a component of an MTM Program
      • Care for Older Adults (COA) – Functional Status Assessment
      • Diabetes Care (CDC) – Eye Exam
      • Diabetes Care (CDC) – Kidney Disease Monitoring


CMS has held since 2013 that MTM programs which comply with CFR 423.153(d) are considered quality improvement activities (QIA).  However, the regulations as written are ambiguous and plans have been reluctant to account for program costs as QIA.  To resolve these ambiguities or uncertainties, CMS is proposing to specifically address MTM programs in the MLR regulations.  CMS is proposing to add a new paragraph that specifies that all MTM programs that comply with § 423.153(d) and are offered by Part D sponsors (including MA organizations that offer MA–PD plans (described in § 422.2420(a)(2)) are QIA.  In its proposals, CMS states that they believe that MTM programs improve quality and care coordination for Medicare beneficiaries.

By overtly allowing Part D sponsors to include compliant MTM programs as QIA in the calculation of the Medicare MLR, CMS is hoping to encourage sponsors to ensure that MTM is better utilized, particularly among standalone PDPs that may currently lack strong incentives to promote MTM.

Furthermore, CMS notes that they are concerned that Part D sponsors may be restricting MTM eligibility criteria to limit the number of qualified enrollees, and they believe that explicitly including MTM program expenditures in the MLR numerator as QIA-related expenditures could provide an incentive to reduce any such restrictions. They point out that robust MTM programs can be particularly important in providing individualized disease management in conjunction with the ongoing opioid crisis.  By “removing any restrictions or uncertainty about whether compliant MTM programs will qualify for inclusion in the MLR numerator as QIA, the proposed changes will encourage Part D sponsors to strengthen their MTM programs by implementing innovative strategies for this potentially vulnerable population”.

  • CSS Take-Away:  CMS is seeking to encourage MTM programs which extend past the traditional MTM eligible population and impact STAR measures and opioid monitoring.

As always I am happy to discuss your medication therapy management program.  CSS supports Medicare, Medicaid, ACOs in the design, implementation and management of medication therapy management programs.  Feel free to reach out by phone or e-mail.

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