In what began as a draft showing as much exuberance as a Fourth of July fireworks display, the release of the 2015 Part C and D Final Call Letter by the Centers for Medicare and Medicaid Services (CMS), ended up more like sparks, rather than fireworks on the Part D side.  That is not to say it is without important and impactful changes; however, the final version is much more pared-down than its draft predecessor.   While a significant portion of the announcement concerns capitation rates and Part C changes, we will focus on some of the key policy changes that impact the Part D program.

Bids:  CMS expects plans to utilize all available resources when submitting their bids (includes formulary submission).  Incomplete bids will be rejected by CMS, while the submission of a clearly inaccurate bid will result in a compliance notice and/or corrective action.

Performance and Star Ratings:  CMS reminds plans of their intention to terminate contracts that fail for three consecutive years to achieve at least 3 stars on their Part C or D performance rating.  For MA-PD plans, the Part C and D summary ratings are independent of each other; therefore, MA-PD plans can be terminated for having a low Part D score even if their Part C score is outstanding, or vice versa. 

Star Measures:  Slated for 2015, notable changes for Part D Star Measures include:

  • High Risk Medications (HRM): Change calculation to include the use of the Pharmacy Quality Alliance (PQA) HRM list.
  • Medication Adherence for Diabetes Medications:  Addition of drug classes (meglitinides and incretin mimetic agents in 2015; sodium glucose co-transporter 2 inhibitors in 2016)
  • Medication Adherence: Adjustment to account for beneficiaries with hospice enrollment or skilled nursing facility stays (SNF changes for PDPs only) for all three measures.
  • Beneficiary Access and Performance Problems:  Move to the display page as a result of significant methodological changes to the audit process during the measurement period.


Display Measures: In addition to Star rating changes, CMS is making changes to the 2015 Part D Display Measures including, but not limited to:

  • Medication Therapy Management (MTM) Program Completion Rate: Delayed moving to a Star rating until 2016
  • Transition Monitoring: Expected introduction of two measures to the display pageDrug-Drug Interaction (DDI): Use of updated PQA (DDI) list
  • Diabetes Medication Dosing: Modification of minimum age criteria to 18


Stars Program:  After much consideration, CMS is increasing the weight of improvement measures from 3 to 5, while maintaining medication adherence measures at a weight of 3.  They are decreasing the minimum number of enrollees required for inclusion in the 2016 Star ratings from 1000 to 500.  In an act of foreshadowing, CMS discusses possible changes to the Stars’ scoring methodology and thresholds for 2016 and beyond.

Preferred Cost Sharing:   CMS intends on studying beneficiary access to preferred cost sharing and evaluating the adoption of a network adequacy standard.  In the meantime, CMS will review networks of plans offering preferred cost sharing and take appropriate action for those that appear to offer too little meaningful access.

Prior Authorization: To reduce the risk of covering non-Part D drugs, CMS established criteria for when plans are expected to implement Point of Sale (POS) prior authorization edits.

Overutilization:  In a continued effort to reduce the overutilization of acetaminophen (APAP) and Opioids, CMS made enhancements to the utilization controls currently in place.

To reduce the cumulative overutilization of acetaminophen, at a minimum, CMS expects plans to implement soft formulary-level safety edits at POS.  Hard-level safety edits are permissible; however, before proceeding plans should carefully review all the potential challenges and possible delays in beneficiary access that a hard-level safety edit may unintentionally impose.

While the Overutilization Monitoring System (OMS) implemented in 2013 has reduced opioid overutilization, CMS is concerned that the criteria used by plans to identify beneficiaries at risk is not comprehensive enough.  Therefore, CMS instructs plans to strengthen their criteria to identify beneficiaries to be no less restrictive than 120mg Morphine Equivalent Dose (MED) daily dose over at least 90 consecutive days.

MTM:  Monitoring performed by CMS in 2013 identified plans that are not fully meeting the CMS MTM program requirements.  Plans are reminded of their obligations and those found to be non-compliant may be subject to compliance actions.  CMS will develop new audit elements and pilot these as early as the 2014 or 2015 audit season.

Through its audits, increased monitoring, and expanded data reporting requirements, as well as enhanced utilization controls and strengthened Star Measures, CMS continues to raise the bar on plan performance.  In response, Part D plans and PBMs must focus their efforts to incorporate these new and evolving performance expectations from the modification of system edits to operational changes in areas such as MTM and Stars.  As CMS continues to tighten its controls, plans must respond accordingly in order to survive; otherwise, they may find themselves moving toward watching next year’s fireworks from the stands.

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