CMS and the Revised Pharmacy Standards: What Every Hospital Should Know

October 14th, 2016

CMS has issued a 45-page advance survey memo, which revises the hospital pharmacy conditions of participation (CoPs) in 2016.

The changes were made to bring the pharmacy interpretive guidelines into alignment with accepted standards of practice, such as the U.S. Pharmacopeia/National Formulary (USP/NF). CMS also recommends hospitals follow prescribed best practices, such as those from the American Society of Health System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP).

This CMS memo also amends Appendix A, which is the manual for larger hospitals, as well as provide for changes to 10 tag numbers or sections: 489, 490, 491, 492, 500, 501, 502, 505, 507, and 510.

These new interpretive guidelines address compounding medication, especially compounded sterile preparations (CSP).

Additionally, the CMS memo includes determining beyond-use dates (BUDs), changes regarding safe and appropriate storage and use of medications, and addresses tag number 405, which is located in the nursing section.

AHC Media is hosting a webinar to cover the revised pharmacy interpretive guidelines from 3:30-5:30 PM EST on Jan. 28. For more information about this event, please visit here.

The CMS Memo is available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-01.pdf.

The OIG Memo on Medicare’s Oversight of Compounded Pharmaceuticals Used in Hospitals, January 2015 OEI-01-13-00400, is available at: http://oig.hhs.gov/oei/reports/oei-01-13-00400.pdf.