The Centers for Medicare & Medicaid Services aims to enlist the help of Medicare Part D plan sponsors in fighting opioid abuse, under a proposed rule scheduled for publication in the Federal Register on Nov. 28.
The agency is proposing to expand monitoring of patients taking opioids in its current Part D Opioid Drug Utilization Review (DUR) and Overutilization Monitoring System (OMS). To do so, officials would like to extend the use the criteria for overutilizers to identify at-risk beneficiaries. Part D plans then would be allowed to restrict at-risk beneficiaries’ access to opioids to a selected prescriber and/or network pharmacy, according to a fact sheet on proposal, which is part of the proposed 2018 update to regulations governing Medicare Advantage and Medicare Part D.
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Under the proposal, plans would not be required to use these tools. However, CMS expects they will.
“While plan sponsors would have the option to implement a drug management program, our proposal codifies a framework that would place requirements upon such programs,” according to the proposal. “We foresee that all plan sponsors will implement such drug management programs based on our experience that all plan sponsors’ are complying with the current policy as laid out in guidance, the fact that our proposal largely incorporates the CARA [Comprehensive Addiction and Recovery Act of 2016] drug management provisions into existing CMS and sponsor operations, and especially, in light of the national opioid epidemic and the declaration that the opioid crisis is a nationwide Public Health Emergency.”
According to the proposal, potentially at-risk and at-risk beneficiaries would be identified based on the type and frequency of prescriptions. Those include the use of opioids with an average daily morphine milligram equivalent (MME) greater than or equal to 90 mg for any duration during the most recent 6 months and either four or more opioid prescribers plus four or more opioid-dispensing pharmacies or six or more opioid prescribers, regardless of pharmacies.
CMS notes in the regulation that, if the proposed 2019 criteria were used against those enrolled in Medicare Part D in 2015, it would have identified as at-risk about 33,000 Part D beneficiaries, or 0.08% of the 42 million people enrolled at that time. The agency said this population should be manageable for oversight by Part D plan sponsors, noting that, in Medicaid in 2015, 0.37% were included in some kind of pharmacy/prescriber lock-in program.
The proposed regulation includes an exemption for patients diagnosed with cancer, those in hospice, and those in a long-term care facility. CMS also plans to limit the availability of the special enrollment period for dual-eligible beneficiaries (those who qualify for both Medicare and Medicaid) and those who receive the low-income subsidy who are identified as at risk or potentially at risk.
Beneficiaries would be allowed to appeal their at-risk/potential at-risk determination under the proposal.