Marye I. Phillips (email@example.com) is an Associate, Devon C. Christianson (firstname.lastname@example.org) is a Senior Lead Scientist, and Kayla R. Thomason (email@example.com) is Lead Scientist at Booz Allen Hamilton in McLean, VA.
The prescription drug abuse epidemic has reached tragic levels in the United States. The US government has invested tremendous resources into researching, understanding, and fighting this epidemic, with the goal of turning the tide on these trends. According to the Centers for Disease Control and Prevention (CDC), a staggering average of 130 Americans die every day from an opioid overdose, including both prescription and illicit opioids.
More than 30% of overdoses involving opioids also involve benzodiazepines, a type of prescription sedative commonly prescribed for anxiety or to help with insomnia. Benzodiazepines have long been categorized as high-risk medications for elderly patients, because studies have shown that benzodiazepines can impair cognitive abilities, driving skills, and mobility, and increase risk of patient falls; recent studies have even shown an association between benzodiazepine use and an increased risk of Alzheimer’s disease. Both long-term opioid use and long-term benzodiazepine use can result in dependence and withdrawal symptoms when the patient discontinues taking the drug. Together, opioids and benzodiazepines have been categorized as frequently abused drugs (FADs) by the Comprehensive Addiction and Recovery Act (CARA), which amends various sections of titles 42 and 21 of the United States Code.
In the Medicare beneficiary population, prescription drug abuse is particularly concerning, because older adults take more prescription medicines than other age groups. Only 13% of the US population is 65 years of age or older, but this group takes roughly 33% of all prescription drugs.
During 2018, the Centers for Medicare & Medicaid Services (CMS) began informally requesting information from Medicare Part D sponsors about their oversight processes for morphine milligram equivalent (MME) and morphine equivalent dosing (MED). Calculating the MME determines a patient’s cumulative intake over 24 hours of any drugs in the opioid class for proper dosing and to help reduce the likelihood of overdose. To help protect Medicare beneficiaries, CMS sought to enhance its understanding of how Part D sponsors are currently managing these issues and the various tactics already in place in the industry to manage and control the use of opioids and benzodiazepine drugs.
New rules for 2019
In 2019, Part D sponsors must start managing frequently abused drugs as part of their drug management programs (DMPs), which are to be integrated with CMS’s existing Overutilization Monitoring System (OMS), as announced and explained by CMS in a November 20, 2018, Health Plan Management System (HPMS) memo. Required by CARA, these DMPs will limit at-risk beneficiaries’ access to FADs by using beneficiary-specific point-of-sale claim edits. This edit or limitation could be a restriction on all FADs, or on specific drugs, amounts, quantities, etc. DMPs may also use restrictions on the prescribers and/or pharmacies that a beneficiary can use to obtain a prescription for a FAD, which is known as a “lock-in,” although beneficiaries can submit prescriber and pharmacy preferences. Beneficiaries are deemed “potentially at-risk” or “at-risk” if they are identified by clinical guidelines to be at risk for misusing or abusing FADs, or if they are identified as such by a Part D sponsor in which they were previously enrolled.
Part D sponsors need to conduct case management, obtain prescriber buy-in that the limitation is appropriate, and provide specific beneficiary notices about the limitation. However, Part D sponsors must still ensure beneficiaries who have been prescribed FADs have reasonable access to those drugs, in terms of geography, cost, emergencies, and natural disasters. Some beneficiaries will be exempt from these requirements due to the nature of their care needs (e.g., active cancer, hospice).
There will be limitations on the use of special enrollment periods (SEP) for individuals eligible for both Medicare and Medicaid and low-income subsidy (LIS) beneficiaries who are at risk for prescription drug abuse. CMS expects Part D sponsors to use the existing appeals process to manage appeals of at-risk determinations, including prescriber and pharmacy lock-in determinations.