| Nursing Facility Survey & Regulations Quick Links | Updates | Background | December 2006 Changes to Pharmacy Sections of SOM | Products/Resources Quick Links
August 14, 2009 CMS Releases Memo to Surveyors Regarding Surveying Facilities with Electronic Health Records (EHRs) In the memo, CMS states that they support use of electronic health records and that providers have the right to use whatever system of medical records they choose as long as that system complies with Medicare participation requirements. During the entrance conference, surveyors will verify with the facility the process they will follow in order to have unrestricted access to the medical record. While surveyors are expected to enforce the specific health and safety regulatory requirements for providers to protect the confidentiality of medical records, they are not expected to assess EHRs to determine whether they satisfy the requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. To view the memo, visit: http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter09_53.pdf August 7, 2009 CMS Releases Timeline for States' Implementation of QIS CMS announced it is pushing forward with nation-wide implementation of the new Quality Indicator Survey (QIS). The QIS replaces the current survey process. To date, the QIS is in various stages of implementation in 11 States: Connecticut, Kansas, Ohio, Louisiana, Florida, Minnesota, North Carolina, New Mexico, West Virginia, Maryland, and Washington. QIS training starts this summer in Delaware, Maine and Vermont, and training is scheduled to begin in Georgia and Arizona early this winter. Training for States in band two (Colorado, Maine, Nebraska, Vermont, District of Columbia, Georgia, Indiana, Arizona, Oregon, Utah, New York) is expected to begin in late 2010 or early 2011, while the remaining states will begin implementation in 2011 and beyond. To view CMS' latest memo, which includes background information about the QIS process, visit: http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter09_50.pdf. July 20, 2009 CMS Releases New Interpretive Guidelines for F-Tag 441 (Infection Control) Significant new guidance from CMS on infection control with many implications for consultant pharmacists and dispensing pharmacies servicing nursing facilities. Effective date is September 30, 2009.
CMS Releases Results of QIS Evaluation The purpose of the Quality Indicator Survey (QIS) Study was to assess whether the QIS has beneficial effects on certain aspects of the survey process, such as improving the accuracy of citations. Interestingly, evaluation of this question found that the QIS did not improve accuracy. While being mindful of the limitations of the study, CMS has concluded that improvement of accuracy of citations must derive primarily from non-QIS factors, including (a) survey guidance clarification, (b) training of surveyors, and (c) surveyor supervision. Based on this information, CMS will continue to issue improved surveyor guidance (revised interpretive guidelines) as well as strengthen surveyor training. CMS also concluded from the evaluation that future QIS development efforts should concentrate on building upon the QIS strengths relative to consistency improvement, and giving supervisors more tools to assess performance of surveyor teams. Click here to view the results. April 10, 2009 CMS Releases New Interpretive Guidelines for Environment that Mention Alternatives to Medication Carts Revised Interpretive Guidelines were released for several Quality of Life and Environment Tags in response to public recommendations from the 2008 CMS/Pioneer Network Environment Symposium. These revisions reflect a new approach to care that focuses more on residents' social and personal needs and less on institutional processes; also known as "culture change." Of particular note, F-Tag 252 - Environment mentions medication carts. When describing practices that serve to decrease the institutional character of the environment, they mention elimination of medication carts and alternative storage of medications in locked areas within resident rooms. Download the information at this link. March 31, 2009 Effective Date for new Pain Management guidance at F-Tag 309 Click here to download ASCP's Summary of the New Interpretive Guidelines pertaining to Pain Management. January 23, 2009 CMS Releases New Interpretive Guidelines for F-Tag 309 (Quality of Care, Pain Management) Significant new guidance from CMS on pain management, including a new pain management investigative protocol to be used by surveyors. Effective date is March 31, 2009. Download the information at this link. September 29, 2008 Office of Inspector General (OIG) Releases Report: "Trends in Nursing Home Deficiencies and Complaints" This report describes the nature and extent of nursing home deficiencies and complaints in 2007 and identifies trends from 2005 to 2007. From 2005-2007, over 91 percent of nursing homes surveyed were cited for deficiencies. The most common deficiency categories cited were quality of care, resident assessment, and quality of life. "Pharmacy Services" was the 7th most frequently cited category, and it was the one category that experienced the greatest increase in deficiencies from 2005-2007, largely due to the new Interpretive Guidelines that went into effect in December 2006. In 2005, 23.8% of nursing homes were cited for deficient "Pharmacy Services," whereas in 2007, 28.8% of facilities were cited. The report also provides state-specific deficiency statistics. Click here to download the report. June 20, 2008 CMS Releases New Interpretive Guidelines for F-Tags 325 (Nutrition) and 371 (Sanitary Conditions) F-Tag 325 (Nutriton) mentions pharmacists and medications frequently throughout the new Interpretive Guidelines. Consultant pharmacists should be familiar with these new guidelines to help their facilities identify ways in which medications may impact nutrition. June 18, 2008 CMS Announces New Ranking System for Nursing Facilities Using 5-Start System. The ratings will be posted on the agency's Nursing Home Compare Web site by the end of 2008. A sample screen shot of the proposed star ratings is available. The Nursing Home Compare website can be found at http://www.medicare.gov/nhcompare. February 12, 2008 CMS Releases an Updated List of Nursing Facilities Who Performed Poorest on Surveys (also referred to as Special Focus Facilities) January 18, 2008 CMS Issues S&C Memo (S&C-08-10) Reminding Surveyors to Cite Deficiencies Based on Regulations, not Permissive Activities Mentioned in Interpretive Guidelines The memo reminds surveyors that all survey deficiencies cited must be based on a violation of statutory and/or regulatory requirements. The memo states: “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.” Changes to SOM Survey Guidance Within Past 5 Years
Background All nursing facilities are subject to inspection or survey by virtue of their:
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. Appendices P, PP, and R of the SOM are the three appendices related to the nursing home setting.
For example, SOM Appendix PP contains CFR Section 483.60 dealing with the standards for providing pharmacy services to a long-term care nursing facility. This section of the regulations is divided into three F-Tags: F-425, F-428, and F-431. The “F” preceding the term “Tag” indicates that the section pertains to long-term care facilities and can be found in Appendix PP. Each SOM Appendix has its own Tag designation (e.g., W-Tags for ICFs, G-Tags for Home Health Agencies, etc.). When a survey identifies a deficient practice and non-compliance with the regulations and guidelines, the surveyor must name the specific Tag under which the deficient practice falls. This is how the citation is officially classified and documented. 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. The major pharmacy-related F-Tags include:
December 2006 Changes to Pharmacy Sections of SOM On December 18, 2006, CMS implemented revised versions of the pharmacy-related sections of SOM Appendices P and PP. The changes affected the:
Archived Webcast: “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. Archived Webcast: “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 in December 2006 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. Summary of Changes and Answers to Frequently Asked Questions The Consultant Pharmacist journal article: “Changes in the State Operations Manual: Implications for Consultant Pharmacy Practice” – December 2006 The Consultant Pharmacist journal article: “Implementing Changes to the State Operations Manual” - February 2007 The Consultant Pharmacist journal article: “Gradual Dose Reduction and Medication Tapering: A Clinical Perspective” – August 2007 Products/Resources Policies and Procedures: Pharmacy Services for Nursing Facilities Extensively updated in 2006 to address the changes to the pharmacy sections of the CMS State Operations Manual SOM Quick Reference Cards
Contains Appendix P and Appendix PP from the CMS State Operations Manual along with forms used by surveyors during their survey of nursing facilities Unnecessary Medications in the Elderly: A Guide to Improving Therapeutic Outcomes Focuses on effective care delivery processes for the management of medications The Consultant Pharmacist Handbook: A Guide for Consulting to Nursing Facilities Includes sections on:
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