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SeniorCarePharmacist.com
Nursing Facility Survey & Regulations


State Operations Manual Webcasts

Gradual Dose Reduction/Tapering Myths Versus Reality: A Clinical Perspective
Even though the Centers for Medicare and Medicaid Services (CMS) regulations and guidelines require or suggest tapering of medications, the clinical implementation of such a tapering attempt can be complicated in the long-term care population. This session will attempt to address the practical application of the tapering guidelines for each of the medication classes mentioned in the CMS document (i.e., psychopharmacological, antipsychotic, sedative/hypnotic) while focusing on relevant current standards of practice and recent clinical trials that inform such practice.

Gradual Dose Reduction/Tapering Myths Versus Reality: A Regulatory Perspective
The Centers for Medicare & Medicaid Services (CMS) made significant changes to the survey guidelines of the State Operations Manual (SOM) related to gradual dose reductions and tapering.  In addition, the final version of the guidelines released on December 15 contained several notable alterations from the Advance Copy released in September.  This program will outline these specific changes and clarify the correct final guidelines; define psychopharmacological medications and the rationale for tapering; describe criteria and necessary documentation for clinical contraindications; and discuss the impact of the new guidelines. 

Preparing for the New State Operations Manual Guidelines

Part 1: Overview of the Final Nursing Home Survey Guidelines for Pharmacy Services and Unnecessary Medications

Part 2: Practical Tips to Prepare for and Implement the New Pharmacy Sections of the Nursing Home Survey Guidelines
This 2-part program will discuss the Centers for Medicare & Medicaid Services (CMS) revisions of the interpretive guidelines on several key Tags in Appendix PP of the State Operations Manual (SOM). Of particular importance to the consultant pharmacist are the anticipated release of the new Pharmacy Service Tags (F425, 428, 431) and Unnecessary Drugs Tag (F329). It is anticipated that the revised Tags will not only recognize the importance of the consultant pharmacist as a member of the interdisciplinary team, but also provide guidelines for improved quality of care for nursing facility residents.


Updates


February 12, 2008
CMS releases an updated list of the poorest-performing nursing facilities on surveys nationwide, which CMS refers to as "special focus facilities (SFFs)".

January 18, 2008
CMS issues Survey & Certification Memo #08-10, reminding surveyors to cite all deficiencies based on a violation of statutory and/or regulatory requirements.  “Permissive duties (mentioned in the Interpretive Guidelines) are not requirements, and the lack of use of any particular tool does not, by itself, constitute sufficient grounds for the citation of a deficiency.”

September 28, 2007
CMS releases Survey and Certification Memo clarifying surveyors’  review of nutritional and dietary supplements and vitamins during their medication pass observation and evaluation of compliance with F-Tags 332 and 333

CMS’s summary of S&C Memo 07-39:
  • “A nursing home’s noncompliance with the administration of nutritional and dietary supplements should not be included in the calculation of the facility’s medication error rate at F332 or as a significant medication error at F333.
  • We expect that the nursing home staff, along with the prescriber and consulting pharmacist, are aware of, review for, and document any potential adverse consequences between medications, nutritional supplements, and dietary supplements that a resident is receiving.
  • Medication errors involving vitamins and/or minerals should be documented at F332 and counted towards the 5 percent error rate but would not be considered to be a significant medication error unless the criteria at F333 were met.”

ASCP Frequently Asked Questions (FAQ)
- (Members Only)
Updated March 12, 2007 

This document will be continually updated with new questions and answers, so please check back frequently.


ASCP is pleased to provide members access to the Powerpoint slides prepared for presentations on the upcoming changes to the Pharmacy Services and Unnecessary Medications sections of the State Operations Manual.  These are provided as a membership benefit to aid members in educating colleagues and nursing facility staff about the impending changes. Content may be used freely with attribution by ASCP members for presentation and controlled distribution purposes.

December 15, 2006
CMS Releases Final Version of Pharmacy Services and Unnecessary Medications Survey Guidelines
(Complete text of Nursing Facility State Operations Manual [Appendices P and PP]; new pharmacy-related sections are in red italics)


The following educational programs took place at Senior Care Pharmacy '06 in Phoenix, AZ.  Sessions were recorded and are available for purchase:

September 29, 2006
CMS S&C Letter 06-30 revises survey guidance to clarify that it is acceptable for nursing home surveyors to cite a significant medication error at F333 based upon either resident review, and/or observation of medication preparation or administration.  Previously, interpretive guidance in the State Operations Manual at F333 directed surveyors to observe a medication preparation or administration before citing significant medication errors.


September 15, 2006
CMS Releases ADVANCE COPY of Final Changes to Nursing Facility State Operations Manual for Pharmacy Services and Unnecessary Drugs

June 1, 2006
CMS Transmittal 19 - Revision to the State Operations Manual
for Nursing Facilities.  Includes changes related to pneumococcal and influenza immunization, feeding assistants, and Quality Assessment and Assurance Committee.



The Centers for Medicare and Medicaid Services (CMS) has a project underway to revise the interpretive guidelines at several key Tags in Appendix PP and certain guidance in Appendix P. CMS plans multiple Tag revisions in fiscal years 2005 and 2006. Each Tag is proceeding through expert panel development, public comment, panel review of comments, revisions based on those comments, and then internal clearance. For this reason, each Tag is on its own time schedule for issuance. Revisions to the State Operations Manual include:


F329, F425, F428, F431 - Unnecessary Drugs and Pharmacy Services
F371 - Sanitary Conditions


F309 - Pain Management


F325 - Nutritional Status


F520 and F521 - Quality Assurance and Assessment


F248 and F249 - Activities


New Psychosocial Outcomes Severity Guidance
(Appendix P)

F501 - Medical Director


F315 - Urinary Incontinence


F314 - Pressure Ulcers



Background

All nursing facilities are subject to inspection or survey by virtue of their:
  1. certification to participate in Medicare and Medicaid, and/or
  2. licensure by the state in which they operate
State licensure standards, generally, have followed Federal certification standards, and state personnel perform the vast majority of surveys -simultaneously assessing both licensure and certification. The Federal government also provides training for state surveyors and periodically conducts inspections with federal surveyors as a check on the performance of state surveyors.  For this reason, compliance with the survey process established by the Centers for Medicare and Medicaid Services (CMS) and published in the State Operations Manual (SOM) is the primary regulatory focus for nursing facilities and consultant pharmacists.

The information contained in this section applies to both the skilled nursing facility (SNF) and the nursing facility (NF) categories of facilities. (See Glossary located in Appendix A of SOM for definitions of these categories.) Not only will these standards be reviewed during the facility’s annual survey, but they may also be reviewed during any inspection resulting from a complaint against the facility. Furthermore, any deficiency cited against the facility will result in regulatory and/or monetary penalties to the facility, will become a part of the public record about the facility, and may reflect poorly on the providers and facility.

The SOM has multiple components and sections.  Appendix P and Appendix PP of the SOM are the two appendices related to the nursing home setting.  Appendix P contains the Survey Protocol for Long-Term Care Facilities and Appendix PP contains the Interpretive Guidelines for Long-Term Care Facilities. 

It is important for the consultant pharmacist to understand all regulations and interpretive guidelines applied to these facilities, especially those that relate specifically to pharmacy. There are four main sections with which the consultant pharmacist should be familiar:

Regulations
  • Regulations are issued by CMS to carry out the intent of legislation enacted by Congress.  Legislative language is intrinsically vague and cannot speak for every factual situation to which it is applied.  Therefore, the purpose of the regulations is to interpret the legislation.  However, the regulations are still quite broad and must be further interpreted through guidelines and guidance (See below)
  • Can be found in the Code of Federal Regulations and in the State Operations Manual (Appendix PP for LTC facilities)
Interpretive Guidelines or Guidance to Surveyors
  • Similar to legislative language, regulations can still be quite general at times.  The interpretive guidelines or guidance to surveyors provides more detailed analysis of the regulatory requirements.  These guidelines are not only useful to surveyors but can also be quite helpful to providers when creating policies and procedures and evaluating the care they provide.
  • Can be found in the State Operations Manual (Appendix PP for LTC facilities) adjacent to or below the applicable regulations
Survey Protocol or Investigative Protocol
  • These protocols provide guidance and steps to help surveyors investigate and evaluate the different aspects of care and services provided by the facility.
  • Can be found in the State Operations Manual (Mostly in Appendix P for LTC facilities, but some new guidance is being provided in Appendix PP, after the regulations and interpretive guidelines)
 Deficiency Categorization or Severity Guidance
  • Once the survey team has completed its investigation, reviewed the regulatory requirements, and determined that noncompliance exists, the team must determine the severity of each deficiency, based on the resultant effect or potential for harm to the resident.  This section provides surveyors with deficiency category descriptions and examples to consider when determining the severity of the noncompliance.
  • Can be found in the State Operations Manual (Mostly in Appendix P for LTC facilities, but some new guidance is being provided in Appendix PP, after the regulations, interpretive guidelines, and investigative protocol)

Products/Resources

New and Updated Products: Order Now for December Delivery!

Policies and Procedures: Pharmacy Services for Nursing Facilities
Extensively updated to address the recent changes in the State Operations Manual.

SOM Quick Reference Cards
Pharmacy Services and Unnecessary Medications F-Tags
Gradual Dose Reductions/Tapering in the Nursing Facility

The Consultant Pharmacist’s Guide to Nursing Facility Regulations and the Survey Process
Contains complete sections of Appendix P, Appendix PP, and survey process forms related to long-term care facilities.

Unnecessary Medications in the Elderly: A Guide to Improving Therapeutic Outcomes
Focuses on effective care delivery processes for the management of medication therapy.


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