Prescription opioid abuse in the US is increasing steadily, with 11.5M people misusing prescription opioids in 2016, including 2.1M who misused them for the first time. Given the scale of the problem, policymakers, health plans, provider associations, pharmacy benefits managers (PBMs), and drug manufacturers are developing policies aimed at treating and preventing opioid use disorder (OUD).

One policy that has recently gained traction is to limit the volume of opioid products that can be prescribed to specific population patients (e.g., those with limited previous exposure to opioid products) or indications (e.g., initial fills for acute pain or injury). This prescribing practice, known as a “fill limit,” is intended to reduce inappropriate exposure to opioid products both for the patient and for other members of their household.

Congress, the administration, and commercial stakeholders are already active on this front, and have introduced several policies to introduce opioid product fill limits:

The Administration

• The final Medicare Part D Call Letter, issued on April 2, requires all Medicare Part D plan sponsors implement a “hard safety edit,” which will limit initial opioid prescription fills for acute pain patients to no more than a 7-day supply.
• The FDA will host a Patient-Focused Drug Development public meeting on OUD on April 17. The agency is interested in learning patients’ perspectives on OUD, including challenges or barriers to accessing or using medical treatments for OUD.

Congress

• The Opioid Addiction Prevention Act of 2017 (introduced in both the House and Senate) would limit opioid prescriptions for initial treatment of acute pain to the lesser of a 7-day supply or an opioid prescription limit established under state law.
• Comprehensive and Recovery Act (CARA 2.0) would limit opioid prescriptions for acute pain to a 3-day supply.
• The Opioid Crisis Response Act of 2018 would require HHS to study the impact of federal and state laws and regulations that limit the length, quantity, or dosage of opioid prescriptions.

Commercial

• Some Blue Cross Blue Shield plans (e.g., RI, VT, FL) have limited initial fills for first-time opioid prescriptions.
• Express Scripts limits initial fills to a 7-day supply, requests that prescribers use a short-acting opioid not to exceed 200 mg morphine equivalent dose (MED)/day and sends a letter to patients following their first fill to educate them on the potential risks associated with opioid use and proper disposal methods.
• CVS Caremark limits opioid prescriptions to a 7-day supply and requires first-time opioid prescription fillers to be dispensed short-acting opioid products.

Further action to stem the opioid crisis is expected in the near future. The House leadership intends to pass a legislative package by Memorial Day, and the Senate has two legislative packages that could pass this year. Simultaneously, the FDA is working closely with the Hill to address regulatory challenges to treat and prevent OUD.

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