Revised Guidance Regarding Unnecessary Medications, Pharmacy Services, Medication Regimen Review, Review and Labeling of Drugs and Biologicals

January 2007

Information Bulletin 07-01

Revised Federal Guidance Regarding Unnecessary Medications, Pharmacy Services, Medication Regimen Review and Labeling of Drugs and Biologicals

Implementation Date: April 15, 2007


The purpose of this information bulletin is to inform providers that Minnesota Department of Health surveyors and investigators effective April 15, 2007 will implement revised Center for Medicare & Medicaid (CMS) Survey Guidelines related to F329 Unnecessary Medications, F425 Pharmacy Services, F428 Medication Regimen Review and F431 Labeling of Drugs and Biologicals found in CMS Transmittal 22 dated 12/15/06.

Background Federal Changes: CMS MATERIALS

Transmittal 22: CMS Transmittals

Revisions to Appendix P Revised Task 5 and Sub-Tasks 5A, 5C, and5E. Revisions to Appendix PP: Ten Regulatory Tags & interpretive guidelines have been condensed into 4 Tags/interpretive guidelines for F329, F425, F428 and F431.

Survey and Certification Letter 06-29, revised issue date of 9/20/06. Issuance of Advance Copy of Revised Surveyor Guidance for Unnecessary Medications (F329) and entire Pharmacy section

CMS Survey & Certification

An advance copy of the Guidance (final Guidance included in Transmittal 22 above), CMS PowerPoint slides and Guidance Training for changes in Appendix P and PP are provided.

CMS Sponsored Video-on-Demand Web casts

INTERNET STREAMING - A free Survey and Certification online course delivery system. To view the webcasts, you will need Windows Media Player installed on your computer.

CMS developed a web cast program to train nursing home surveyors on the revised surveyor guidance for F329, Unnecessary Medications and revised guidance for Pharmacy Services, entitled, “Nursing Home Journal Volume IV, Unnecessary Medications”. The program was released December 15, 2006, and may be accessed at: [expired link]

MDH Training Materials

MDH has developed paginated materials extracted from CMS Transmittal 22. Materials were developed for facilities to utilize as “Train the Trainer Tools” to educate their staff regarding the implementation of the revised Guidance. MDH Training power points will be placed here after statewide training is completed on Feb. 27, 2007. These materials may be downloaded from the following web site address.

Clinical Web Window

If you have any questions regarding this Information Bulletin, please contact in writing:

Minnesota Department of Health
Health Regulation Division
Licensing and Certification Program
85 East Seventh Place, Suite 300
PO Box 64900
St. Paul, MN 55164-0900
Telephone: (651) 201-4101

Monday, February 09, 2015 at 03:00PM