Electronic Clinical Notes: Are They Required?

First, DEA rule 21 CFR 1311.200(f) states that pharmacists must make and retain annotations electronically when filling an electronic prescription.

Second, be aware that state laws may require electronic annotations. For example, New York controlled substance rules mirror the DEA language when it comes to electronic prescriptions and annotations.

Third, while PBMs may not explicitly require electronic annotations, not having date and time stamped notes in your pharmacy software may be detrimental for audit appeals. Many PBMs are giving preference, or requiring, electronic date and time stamped clinical notes to appeal certain discrepancies successfully. With a date/time stamp, the detail provides validation to the PBM that they existed at the time of dispensing.

Examples:

• Elixir requires electronic date and time stamped notes in a patient’s profile in order to appeal missing DAW 2 documentation.
• Humana requires a copy of pharmacy electronically stored notes for various discrepancies, including missing information on a prescription and unauthorized refills showing information was confirmed at the time of dispensing.

PAAS Tips:

• Clinical notes should contain 4 elements:
  • Date/time
  • Name and title of who you spoke with
  • Summary of discussion
  • Pharmacy staff initials
• Make annotations electronically if possible. This can help avoid later audit appeal and legibility issues
• If making handwritten annotations, ensure you rescan the prescription into your software
• See the July 2023 Newsline article, Remember to Maintain and Provide Complete Clinical Notes!