New Part D Safety Policy Intends to Reduce Opioid Misuse

CMS recently announced its new Medicare Part D opioid safety policy, intended to reduce prescription opioid misuse. One aspect of the new policy is improved safety alerts at the pharmacy for Part D beneficiaries who are filling initial opioid prescriptions or receiving high doses. CMS cited the following three situations that would warrant an alert:

CMS recently announced its new Medicare Part D opioid safety policy, intended to reduce prescription opioid misuse. One aspect of the new policy is improved safety alerts at the pharmacy for Part D beneficiaries who are filling initial opioid prescriptions or receiving high doses. CMS cited the following three situations that would warrant an alert:

• Possible unsafe amounts of opioids.
• First prescription fills for opioids.
• Use of opioids and benzodiazepines at the same time.

CMS reports that if an alert is sent and if the prescription can’t be filled as written, including the full amount on the prescription, the pharmacist will give the beneficiary a notice explaining how they or their doctor can contact the plan to ask for a coverage determination.

The new policy also permits Part D plans to put drug management programs in place to help beneficiaries. One of the proposed ways that a Part D plan would accomplish this is given through the example that if a beneficiary gets opioids from multiple doctors or pharmacies, the beneficiary may be directed to receive such medications from specific providers or pharmacies to avoid overlap. However, the most notable part of this new plan is that the Part D plan will send the beneficiary a letter if it will limit their access to these medications under its drug management program. If so, the beneficiary and their doctor will have the right to appeal.

CMS acknowledges that “one size does not fit all” and that such policies do not apply to specific populations (i.e. long-term care facilities, individuals in hospice, palliative, or end-of-life care). To that end, additional material was provided for prescribers, pharmacists, and patients to clarify CMS’s interpretation of these policies.

Practitioner’s Note: While these policies are admirable in their attempt to curb the opioid issues within our country, it does beg the question as to what impact this will have in a clinical setting. With the example of the seven (7) day fill rule for new opioid users, in a majority of workers’ compensation and/or liability cases the beneficiary isn’t a beneficiary at the time of injury and the initial prescription of pain medication. As such, this policy would not apply to those individuals. Additionally, upon review of the additional materials for the providers and pharmacists, CMS specifically notes in bold “This alert is not a prescribing limit” and explains that decisions to taper or discontinue prescription opioids are individualized between patient and prescriber. How this policy may apply to the current Workers’ Compensation Medicare Set-Aside Reference Guide allocation methodology has yet to be determined.

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

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