Pharmacies and Part D beneficiaries will start seeing new limits on opioid prescriptions starting next year.
The rule established a ceiling of 90-milligram morphine-equivalent units for opioid prescriptions under the Part D Medicare program starting in 2019. A prescription at or above 90mg will require the pharmacist to speak with the prescribing doctor regarding the dosage and determine if an override is appropriate.
The agency's initial proposal, which would have limited the prescription override to the insurer, received widespread backlash during the comment period.
“We received hundreds of letters from patients who have taken opioids for long periods of time and are afraid of being forced to abruptly reduce or discontinue their medication regimens with sometimes extremely adverse outcomes, including depression, loss of function, quality of life, and suicide,” the agency wrote in the rule. The “overall consensus was that a 90 MME-per-day hard edit threshold would have little clinical impact against opioid overuse.”
Opioid use remains a substantial problem among Part D beneficiaries.
One in every three Medicare Part D patients, or 14.4 million people, were prescribed opioids in 2016 with the vast majority of the prescribed drugs being schedule II or III controlled substances, which have the highest potential for abuse among legal substances, according to a report released last year by the Department of Health and Human Services' Office of Inspector General.
The report also noted that 90,000 Part D enrollees had been prescribed "extreme" amounts of opioids in 2016.
The CMS also finalized a new policy that will cap all new opioid prescriptions for short-term acute pain at a 7 day supply, and expected plans, pharmacists and providers to better coordinate medication plans for patients requiring large amounts of opioids.
The cap, when originally proposed, received praise from numerous advocacy groups, including the Alliance of Community Health Plans. Other changes include "lock-in" programs for patients at risk for addiction which limits their opioid access to certain prescribers or dispensers
Lawmakers had recently urged federal health officials to find ways to reduce opioid misuse, citing figures from the OIG's report.
In a letter last month, four bipartisan lawmakers on the powerful House Ways and Means Committee suggested that the agency assess how Part D plan sponsors are responding to the epidemic, push sponsors to restrict patients to a certain number of pharmacies or prescribers and expand overuse monitoring capabilities to include other drugs.