Center for Clinical Standards and Quality/Survey ...

1 DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C2-21-16 Baltimore, Maryland 21244-1850 Center for Clinical Standards and Quality/Survey & Certification Group Ref: S&C: 16-15-NH DATE: March 25, 2016 TO: State Survey Agency Directors FROM: Director Survey and Certification Group SUBJECT: State Operations Manual (SOM) Surveyor Guidance Revisions Related to Psychosocial Harm in Nursing Homes Background In 2006, CMS issued the Psychosocial Outcome Severity Guide in Appendix P of the SOM. The guide provided instructions, definitions, and criteria to help surveyors determine the correct levels of negative psychosocial outcomes that developed, continued, or worsened because of a facility s noncompliance.

2 While surveyors currently cite instances of psychosocial harm, CMS believes these revisions will help guide surveyors to identify psychosocial harm or potential harm. The revisions also support activities or actions to improve resident safety and increase quality and reliability of care for better outcomes. Psychosocial Harm Revisions The CMS has revised guidance at F329 in Appendix PP. Revisions include: Removing medication tables to make F329 easier to use. Replacing medication tables with up-to-date medication resources. Revising Deficiency Categorization examples to show that noncompliance at F329 can cause significant psychosocial harm. Memorandum Summary F329 Draft Revision: The Centers for Medicare & Medicaid Services (CMS) has revised guidance to surveyors in Appendix PP of the SOM under F329 to enhance ease of use for surveyors and to include language related to how unnecessary use of medications may cause psychosocial harm to residents.

3 Psychosocial Outcome Severity Guide: CMS has revised language in the Psychosocial Outcome Severity Guide in Appendix P of the SOM. Revisions to Selected F tags: CMS has added language to selected F tags to emphasize the risk of psychosocial harm associated with noncompliance with specific regulations. The regulatory language remains unchanged. Page 2 State Survey Agency Directors The CMS requested feedback from surveyors about the medication tables. While the tables contain useful information, they have not been routinely updated and CMS determined that providing up-to-date medication resources would be more helpful to surveyors. The new resources provide information on use, side effects, adverse consequences, drug classifications, and interactions. Additionally, some of the current deficiency categorization examples show a combination of psychosocial and physical harm.

4 The revised examples show how surveyors may cite F329 when psychosocial harm alone occurs. The CMS has also added language to other F tags listed below. While surveyors may find negative psychosocial outcomes related to any regulations, these areas may be more susceptible to a negative psychosocial outcome or contain a psychosocial element that may be greater in severity than the physical outcome: F221/222 F223/224/225/226 F241 F242 F246 F248 F250 F310 F320 F353 The new language in each tag emphasizes the risk of psychosocial harm associated with noncompliance at specific regulations and refers surveyors to the Psychosocial Outcome Severity Guide. Lastly, language has been added to the Psychosocial Outcome Severity Guide in Appendix P to reference F tags where residents may be more at risk for actual or potential psychosocial harm.

5 Contact: Please forward any questions regarding this memorandum or the guidance revisions to the CMS DNH triage team, Effective Date: Immediately. This policy should be communicated with all survey and certification staff, their managers and the State/Regional Office training coordinators within 30 days of this memorandum. The contents of this letter supports activities or actions to improve resident safety and increase quality and reliability of care for better outcomes. /s/ Thomas E. Hamilton Attachment (s)- Advanced Copy SOM Appendix PP Psychosocial Harm in Nursing Homes Advanced Copy SOM F329 PSRevision Advanced Copy SOM PS harmtags cc: Survey and Certification Regional Office Management CMS Manual System Department of Health & Human Services (DHHS) Pub. 100-07 State Operations Provider Certification Centers for Medicare & Medicaid Services (CMS) Transmittal Advance Copy Date: SUBJECT: Revisions to the State Operations Manual (SOM) - Appendix PP Guidance to Surveyors for Long Term Care Facilities I.

6 SUMMARY OF CHANGES: This instruction revises interpretive guidance for F329 to provide additional information to surveyors about consideration of psychosocial harm when assessing compliance related to unnecessary medications. NEW/REVISED MATERIAL - EFFECTIVE DATE*: Upon Issuance IMPLEMENTATION DATE: Upon Issuance Disclaimer for manual changes only: The revision date and transmittal number apply to the red italicized material only. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents. II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual not updated.) (R = REVISED, N = NEW, D = DELETED) (Only One Per Row.)

7 R/N/D CHAPTER/SECTION/SUBSECTION/TITLE R Appendix PP Guidance to Surveyors for Long Term Care Facilities/F329 (l) III. FUNDING: No additional funding will be provided by CMS; contractor activities are to be carried out within their operating budgets. IV. ATTACHMENTS: Business Requirements X Manual Instruction Confidential Requirements One-Time Notification One-Time Notification -Confidential Recurring Update Notification *Unless otherwise specified, the effective date is the date of service. F329 (Rev.) (l) Unnecessary Drugs 1. General. Each resident s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: (i) In excessive dose (including duplicate therapy); or (ii) For excessive duration; or (iii) Without adequate monitoring; or (iv) Without adequate indications for its use; or (v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (vi) Any combinations of the reasons above.

8 2. Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that: (i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the Clinical record; and, (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. INTENT: (l) Unnecessary drugs The intent of this requirement is that each resident s entire drug/medication regimen be managed and monitored to achieve the following goals: The medication regimen helps promote or maintain the resident s highest practicable mental, physical, and psychosocial well-being, as identified by the resident and/or representative(s) in collaboration with the attending physician and facility staff; Each resident receives only those medications, in doses and for the duration clinically indicated to treat the resident s assessed condition(s); Non-pharmacological interventions (such as behavioral interventions) are considered and used when indicated, instead of, or in addition to, medication.

9 Clinically significant adverse consequences are minimized; and The potential contribution of the medication regimen to an unanticipated decline or newly emerging or worsening symptom is recognized and evaluated, and the regimen is modified when appropriate. NOTE: This guidance applies to all categories of medications including antipsychotic medications. Although the regulatory language refers to drugs, the guidance in this document generally will refer to medications, except in those situations where the term drug has become part of an established pharmaceutical term ( , adverse drug event, and adverse drug reaction or consequence). For purposes of this guidance, references to the pharmacist mean the facility s licensed pharmacist, whether employed directly by the facility or through arrangement.

10 The surveyor s review of medication use is not intended to constitute the practice of medicine. However, surveyors are expected to investigate the basis for decisions and interventions affecting residents. DEFINITIONS Definitions are provided to clarify terminology related to medications and to the evaluation and treatment of residents. Adverse consequence is an unpleasant symptom or event that is due to or associated with a medication, such as impairment or decline in an individual s mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions ( , medication-medication, medication-food, and medication-disease). NOTE: Adverse drug reaction (ADR) is a form of adverse consequences. It may be either a secondary effect of a medication that is usually undesirable and different from the therapeutic effect of the medication or any response to a medication that is noxious and unintended and occurs in doses for prophylaxis, diagnosis, or treatment.