No opioid hard edits requirement for 2018 MA-PD, Part D plans

CMS’s final call letter addresses several issues raised by APhA

While still encouraging their implementation, CMS’s final call letter does not require sponsors to incorporate hard opioid safety edits at the 200-mg morphine equivalent dose (MED) into the design of 2018 Medicare Advantage prescription drug (MA-PD) and Part D plans. CMS will continue to expect plans to implement a soft opioid safety edit at a minimum threshold of greater than 90-mg MED.

The call letter, which MA-PD and Part D plans use to craft their bids for the upcoming year, also nods to other issues that APhA addressed in its comments on the draft version of the letter.

In comments submitted to CMS in response to the draft call letter, APhA expressed concerns requiring formulary-level hard edits on opioid prescriptions at the 200-mg MED would harm patients with chronic pain. Community pharmacists have echoed that sentiment.

Travis Hale, PharmD, president of Apothecary Solutions Inc. in Remington, VA, says he has seen hard edits at 120-mg MED, indicating that some plans have already adopted limits stricter than CMS recommendations.

Most patients reach the limit because they take more than one opioid medication. “Almost every single one of our chronic care patients has had to choose whether to fill their long-acting or their short-acting medication,” Hale said. “Then they figure out whether they can afford to pay cash for the med that isn’t covered.”

Hale is also concerned that most written prescriptions state that patients cannot refill the prescription until the day they run out of the drug. “It leaves no time for a doctor’s office to complete an authorization with the third party. The patient has to decide there and then to go without or go through some form of withdrawal.”

Brian Komoto, PharmD, president and CEO of Komoto Pharmacy in Delano, CA, worries that patients whose daily dose is over the MED limit might seek relief through illegal means. “It’s not simple to take them off these drugs,” Komoto said.

Both pharmacists are pleased that CMS will take into account the experiences of patients who are already subject to soft and hard edits at 90-mg MED and 200-mg MED, respectively, before making its decisions for 2019 plans.

Michael Baxter, APhA director of regulatory affairs, cautions that just because the edits aren’t required yet “doesn’t mean it’s over. It means [CMS is] listening. We need to stay engaged to make sure they understand the need to balance [patients] with legitimate pain and those struggling with addiction.”

Another change in the final call letter is that CMS will shift from the use of MED calculations to morphine milligram equivalent (MME) dosage, aligning with CDC’s opioid prescribing guidelines.


For the full article, visit for the May 2017 issue of Pharmacy Today.