2024-2025 Self-Audit Series #11: Controlled Substance Prescriptions
The opioid epidemic continues to make controlled substance prescriptions an increased focus for PBM audits. The potential for fraud, diversion, overdoses, and abuse remains high and pharmacies must stay vigilant when dispensing these prescriptions.
Due to federal and state requirements, controlled substance prescriptions have an increased risk of audit discrepancies. When found discrepant, PBMs typically cite as “law violations”, which are very difficult to overturn on audit appeal. Taking time to look over controlled prescriptions closely could prevent audit recoupment. Be sure to share the following tips with your pharmacy staff:
PAAS Tips:
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- Refer to this month’s Newsline article, Can Pharmacists Continue to Fill Controlled Substance Prescriptions that are NOT Sent Electronically
- Federal DEA requirements:
- Manner of issuance – As per Title Code 21 Code of Federal Regulations §1306.05(a) all controlled substance prescriptions must contain:
- Full name and address of the patient
- Drug name, strength, dosage form and quantity
- Directions for use
- Full name, address and DEA number of practitioner
- Dated, and signed on, the day when issued
- Partial filling CII prescriptions – Title Code 21 Code of Federal Regulations § 1306.13
- Short supply – dispense completion within 72 hours, see § 1306.13(a)
- LTC/Hospice – dispense completion within 60 days, see § 1306.13(c)
- Patient/Prescriber Request (per Section 702 of CARA) – dispense completion within 30 days, see §1306.13(b)(3 & 4)
- Refer to the following September 2023 Newsline article, Recent DEA Rule Change-Partial Fills for Schedule II Controlled Substances
- Issuance of multiple CII prescriptions – Title Code 21 of Federal Regulations § 1306.12
- Must be issued on the same date (not post-dated)
- Must be an indication of the earliest fill date on each prescription other than the first
- Be sure to document prescriber approval to dispense early (where allowed by state law)
- Refer to the following June 2023 Newsline article, Audit Risks with Schedule II Laddered Prescriptions
- Manner of issuance – As per Title Code 21 Code of Federal Regulations §1306.05(a) all controlled substance prescriptions must contain:
- While not all inclusive, here are considerations for various State requirements:
- Alpha-numeric quantity
- Tamper-resistant prescription pads
- Pre-printed DEA number
- Quantity checkboxes
- Pharmacist signing, defacing or initialing hard copy
- Not combining controlled and non-controlled on same prescription
- Include the number of medications issued on prescription blank
- Verify what your state law allows regarding changes that can be made on Schedule II prescriptions
- Supervising prescriber requirements for mid-level practitioner
- Verify if any Drug Utilization Review (DUR) or Submission Clarification Codes (SCC) and document appropriately
- Refer to the following December 2023 Newsline article, Documentation Deep Dive: Meeting Auditors’ Standards in DUR and SCC
Analyst at PAAS National®
As a Certified Pharmacy Technician at PAAS, I am here to assist and provide you with pre- and post-audit advice. I can also provide product and billing information.
I attended Madison College in nearby Madison, WI (PAAS headquarters are in the Madison suburb of Stoughton). Prior to coming to work at PAAS, I worked as a Certified Pharmacy Technician in a retail setting for 25+ years. Pharmacy has been my life’s work.
Helping our members have a successful audit experience is very rewarding. Celebrating with them, when PAAS often helps generate positive post-audit results, is the best part of my work.
I attended Madison College in nearby Madison, WI (PAAS headquarters are in the Madison suburb of Stoughton). Prior to coming to work at PAAS, I worked as a Certified Pharmacy Technician in a retail setting for 25+ years. Pharmacy has been my life’s work.
Helping our members have a successful audit experience is very rewarding. Celebrating with them, when PAAS often helps generate positive post-audit results, is the best part of my work.
Latest posts by Dana Westberg, CPhT (see all)
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