Medicare Compliance & Reimbursement

Stakeholders also dislike PDMP review requirement in another proposed rule.

The Centers for Medicare & Medicaid Services (CMS) is cracking down on overprescribing of opioids, and Medicare Part D plans may soon implement logjams at the point-of-sale (POS) for these controlled drugs. Here’s how prescribing, dispensing, and paying for opioids could change by next year.

CMS has been working hard at tackling the “growing opioid epidemic.” On Feb. 19, CMS released proposed updates to the Medicare Advantage (MA) and Part D programs through the 2017 Advance Notice and Draft Call Letter. Among the many updates in the draft call letter, CMS included expectations for Medicare Part D plans to implement edits to prevent opioid overutilization at the POS.

Caveat: At the same time, the draft letter reminds Part D plan sponsors that they shouldn’t subject beneficiaries who are in need of medication-assisted treatment (MAT) to unnecessary hurdles. CMS won’t approve Part D formulary and plan benefit designs that hinder access to MAT through overly restrictive utilization management strategies or high cost-sharing.

POS Edit is One More Step in the Process

This is CMS’s second try at getting Part D plan sponsors to edit their benefit designs regarding opioid overutilization, however.

Background: In its previous draft call letter, CMS included a directive for Part D plan sponsors to put in place a “soft” POS edit for opioids, but CMS nixed this item due to stakeholder concerns that beneficiaries would experience disruptions in accessing necessary prescription drugs, says Houston-based associate attorney Kameron Brackins of Baker & Hostetler LLP. Because CMS is again facing significant pushback from stakeholders on the 2017 draft call letter, there is a possibility that it will drop the provision once more.

And in building up to this most recent proposal, CMS had released an interactive online mapping tool in November 2015 that allowed providers to search claims data from 2013 of Part D opioid prescriptions at the state, county, and zip code levels. CMS intended for the tool to raise awareness of opioid overutilization in their communities and to reduce opioid use disorder among patients.

“The opioid epidemic impacts every state, county and municipality,” said CMS Acting Administrator Andy Slavitt in a statement announcing the interactive mapping tool’s release. “To address this epidemic, while ensuring that individuals with pain receive effective treatment, we need accurate, timely information about where the problems are and to what extent they exist,” he said.

Stakeholder Reactions Could Put a Damper on Efforts

But for this most recent proposal, stakeholders disagree on performance expectations for Medicare Part D regarding enhanced controls over opioid prescribing and use, Brackins notes. Moreover, stakeholders appear to disagree on exactly how CMS should approach the opioid epidemic as a whole.

Even though CMS opted to delay the POS edit recommendation last year, it still encouraged Part D plan sponsors to implement the recommended soft edit and to prepare for other POS edits that it may require in the future, according to a Feb. 8 analysis by attorneys Ankur Goel, Kate McDonald and Mary Moll with the law firm McDermott Will & Emery.

Alternative: “Many stakeholders believe that opioid overutilization could be better addressed by allowing Part D plan sponsors to ‘lock in’ Medicare beneficiaries taking certain drugs to specific prescribers and pharmacies,” noted Goel, McDonald and Moll. “Such a provision, however, is not likely to be addressed in the draft call letter, as it may require additional authority from Congress.”

And the stakeholder opposition isn’t limited to the draft call letter — Brackins points to a recent proposed rule that aims to change discharge-planning requirements, which included a proposal to require providers to consult a patient’s history on their state’s Prescription Drug Monitoring Program (PDMP). Referencing the PDMP would, according to CMS, help providers identify the patient’s risk of abusing controlled substances.

But stakeholders voiced strong concerns to this proposed rule as well, many arguing that the PDMP review wouldn’t provide a reliable snapshot of a patient’s history, Brackins says. Another concern is PDMPs (state-run electronic databases that track prescribing of controlled prescription drugs) don’t coordinate local or multi-state tracking.

CMS wrapped up the public comment period for the 2017 draft call letter on March 4 and expects to issue the final letter on April 4.

Resources: For more information on the 2017 draft call letter, go to www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-02-19.html. You can access the online interactive mapping tool at http://go.cms.gov/opioidheatmap. The proposed rule on discharge-planning requirements is also available at www.gpo.gov/fdsys/pkg/FR-2015-11-03/pdf/2015-27840.pdf.