CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their beneficiaries. CMS’s most recent guidance to Plans regarding the opioid epidemic was included in the Advance Notice and Call Letter.

In November of 2017, in the proposed Medicare Advantage and Part D regulations for CY 2019 CMS set out a framework for Part D plans to monitor and reduce the potential misuse of prescription opioids.

At the end of 2017, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for the Medicare Advantage (MA) CMS-HCC Risk Adjustment Model. Through this, CMS announced that it intended to adjust the CMS-HCC Risk Adjustment Model to include codes relating to substance use disorders, as required by the 21^st Century Cures Act. CMS proposed renaming HCC 55 to be “Drug/Alcohol Dependence, or Abuse/Use with Complications” and adding certain diagnoses to the HCC. CMS explained that for 2019, it intends for HCC 55 to be used to report overdoses for a list of seven categories of substances, including opium and other opioids. CMS also proposed to divide current HCC 56 into three separate HCCs (HCC 56, 202 and 203), and adding the new HCC 56 “Drug Use, Uncomplicated, Non-Psychoactive Substance Abuse, and Nicotine Dependence” to the list of HCCs linked to payment for 2019. CMS explained that by adding new HCC 56 to the payment model and adding diagnoses to HCC 55 (already included in the payment model), it believes that the CMS-HCC Risk Adjustment Model for 2019 will more comprehensively capture clinically significant substance use disorder diagnoses, including those related to opioids.

And then, earlier this month, the CMS’s Advance Notice and Call Letter for CY 2019 outlined utilization review controls for Part D plans to use to address opioid misuse and abuse. Importantly, CMS used the Advance Notice and Call Letter to clarify that Part D plan sponsors are expected to:

1. Perform enhanced drug utilization review (DUR) to retrospectively identify potential opioid overuse and provide appropriate case management, and
2. Perform concurrent DUR by implementing real-time safety alerts at the point-of-sale that require pharmacists to take action on an alert before a prescription can be covered. The goal of these alerts is to ensure prescribers are aware that potentially high risk levels of prescription opioids will be dispensed to their patients.

Though these expectations were first set out in the CY 2013 Call Letter and supplemental guidance, the CY 2019 notice proposes new strategies to manage chronic overuse. These strategies include:

1. Adding additional flags to the Overutilization Management System (OMS) for beneficiaries who use drugs that increase the effects of a substance (potentiators).
2. Revising PQA opioid quality measures used by CMS and adding a new measure for the concurrent use of opioids and benzodiazapines.
3. Implementing hard edits at the point-of-sale at the pharmacy at a specific dosage level and with a 7 day supply, as well as soft edits based on duplicative therapy that can be overridden by the pharmacist.
4. Implementing a days’ supply limit for initial fills of prescription opioid for treating acute pain or without a daily dose maximum. CMS provides details on how they expect plan sponsors to implement each of these strategies and seeks comments on these proposals. Comments on both the Advance Notice and Call Letter and the Advance Notice of Methodological Changes are due March 5^th.

It is worth noting that CMS is not the only agency targeting opioid misuse. As we have been discussing, federal enforcement actions are focused on opioid-related misconduct, including DOJ and OIG’s largest national fraud takedown.