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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. While surveyors currently cite instances of psy chosocial harm, CMS believes the se 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 Ca tegorization examples to show that noncompliance at F329 can cause significant psychosocial harm . Memorandum Summary Ł F329 Draft Revision : The Centers for Medicare & Medicaid Services (CMS) ha s 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. 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.

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Page 2 ΠState Survey Agency Directors The CMS requested feedback from surveyors about the medication tables. While the tables contain useful informatio n, 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 inter actions. Additionally, s ome of the current deficiency categorization examples show a combination of psychosocial and physical harm. 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 . Contact: Please forward any questions regarding this memorandum or the guidance revisions to the CMS DNH triage team, DNH_TriageTeam@cms.hhs.gov . Effective Date: Immediately. This policy should be communicated with all survey and certification staff, their managers and the State/R egional Office training coordinator s within 30 days of this memorandum. The contents of this letter supports activities or actions to improve resident safety and increase quality and r eliability of care for better outcomes. /s/ Thomas E. Hamilton Attachment (s) РAdvanced Copy SOM Appendix PP Psychosocial Harm in Nursing Homes Advanced Copy SOM F329PSRevision Advanced Copy SOM PS harmtags cc: Survey and Certification Regional Office Management

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CMS Manual System Department of Health & Human Services (DHHS) Pub. 100 -07 State Operations Provider Certification Centers for Medicare & Medicaid Services (CMS) Transmittal Œ Advance Copy Date: SUBJECT: Revisions to the State Operations Manual (SOM) – Appendix PP Œ Guidance to Surveyors for Long Term Care Facilities I. 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) Œ (Only One Per Row. ) R/N/D CHAPTER/SECTION/SUBSECTION/TITLE R Appendix PP Guidance to Surveyors for Long Term Care Facilities/F329 §483.25(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.)

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§483.25(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. 2. Antipsychotic Drugs. Based on a comp rehensive 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: §483 .25(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 m ental, 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; 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 ca tegories of medications including

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antipsychotic medications. Although the regulatory language refers to fidrugs,fl the guidance in this document generally will refer to fimedications,fl except in those situations where the term fidrugfl has b ecome part of an established pharmaceutical term (e.g., adverse drug event, and adverse drug reaction or consequence). For purposes of this guidance, references to fithe pharmacistfl mean the facility™s licensed pharmacist, whether employed directly by th e facility or through arrangement. 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. fiAdverse consequencefl is an unpleasant symptom or event that is due to or associated with a medication, such as impairment or declin e in an individual™s mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions (e.g., 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. The term fiside effectfl is often used interchangeably with ADR; however, side effects are but one of five ADR categories, the others being hypersensitivity, idiosyncratic response, to xic reactions, and adverse medication interactions. A side effect is an expected, well -known reaction that occurs with a predictable frequency and may or may not constitute an adverse consequence. fiAnticholinergic side effectfl is an effect of a medicat ion that opposes or inhibits the activity of the parasympathetic (cholinergic) nervous system to the point of causing symptoms such as dry mouth, blurred vision, tachycardia, urinary retention, constipation, confusion, delirium, hallucinations , flushing, and increased blood pressure . Types of medications that may produce anticholinergic side effects include: o Antihistamines, antidepressants, antipsychotics, antiemetics, muscle relaxants; and o Certain medications used to treat cardiovascular conditions, Parki nson™s disease, urinary incontinence, gastrointestinal issues and vertigo.

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fiBehavioral interventionsfl are individualized non -pharmacological approaches (including direct care and activities) that are provided as part of a supportive physical and psychosoc ial environment, and are directed toward preventing, relieving, and/or accommodating a resident™s distressed behavior. fiClinically significantfl refers to effects, results, or consequences that materially affect or are likely to affect an individual™s mental, physical, or psychosocial well -being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status. fiDistressed behavi orfl is behavior that reflects individual discomfort or emotional strain. It may present as crying, apathetic or withdrawn behavior, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbi ng others. Distressed behavior may be treated with medications but should also be addressed through nonpharmacological approaches. Certain medications may also cause or contribute to distressed behavior. fiDosefl is the total amount/strength/concentration of a medication given at one time or over a period of time. The individual dose is the amount/strength/concentration received at each administration. The amount received over a 24 -hour period may be referred to as the daily dose. o fiExcessive dosefl means the total amount of any medication (including duplicate therapy) given at one time or over a period of time that is greater than the amount recommended by the manufacturer™s label, package insert, current standards of practice for a resident™s age and con dition, or clinical studies or evidence -based review articles that are published in medical and/or pharmacy journals and that lacks evidence of: Œ A review for the continued necessity of the dose; Œ Attempts at, or consideration of the possibility of, taperi ng a medication; and , Œ A documented clinical rationale for the benefit of, or necessity for, the dose or for the use of multiple medications from the same pharmacological class. fiDuplicate therapyfl refers to multiple medications of the same pharmacologica l class/category or any medication therapy that substantially duplicates a particular effect of another medication that the individual is taking. fiDurationfl is the total length of time the medication is being received.

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fiMedication Regimen Reviewfl (MRR) is a tho rough evaluation of the medication regimen by a pharmacist, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medication. The review includes preventing, identifying, reporting, and resolving medication -relat ed problems, medication errors, or other irregularities in collaboration with other members of the interdisciplinary team. 1 fiMonitoringfl is the ongoing collection and analysis of information (such as observations and diagnostic test results) and comparison to baseline data in order to: o Ascertain the individual™s response to treatment and care, including progress or lack of progress toward a therapeutic goal; o Detect any complications or adverse consequences of the condition or of the treatments; and o Support decisions about modifying, discontinuing, or continuing any interventions. fiNeuroleptic Malignant Syndromefl (NMS) is a syndrome related to the use of medications, mainly antipsychotics, that typically presents with a sudden onset of diffuse m uscle rigidity, high fever, labile blood pressure, tremor, and notable cognitive dysfunction. It is potentially fatal if not treated immediately, including stopping the offending medications. fiNon -pharmacological interventionsfl refers to approaches to ca re that do not involve medications, generally directed towards stabilizing or improving a resident™s mental, physical or psychosocial well -being. fiPsychopharmacological medicationfl is any medication used for managing behavior, stabilizing mood, or treatin g psychiatric disorders. fiSerotonin Syndromefl is a potentially serious clinical condition resulting from overstimulation of serotonin receptors. It is commonly related to the use of multiple serotonin -stimulating medications (e.g., SSRIs, SNRIs, triptans, certain antibiotics). Symptoms may include re stlessness, hallucinations, confusion, loss of coordination, fast heartbeat , rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea. fiTardive dyskinesiafl refers to abnormal, recurrent, involuntary m ovements that may be irreversible and typically present as lateral movements of the tongue or jaw, tongue thrusting, chewing, frequent blinking, brow arching, grimacing, and lip smacking, although the trunk or other parts of the body may also be affected. OVERVIEW

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Medications are an integral part of the care provided to residents of nursing facilities. They are administered to try to achieve various outcomes, such as curing an illness, diagnosing a disease or condition, arresting or slowing a disease pro cess, reducing or eliminating symptoms, or preventing a disease or symptom. A study of 33,301 nursing facility residents found that an average of 6.7 medications were ordered per resident, with 27 percent of residents taking nine or more medications. 2 Analysis of antipsychotic use by 693,000 Medicare nursing home residents revealed that 28.5 percent of the doses received were excessive and 32.2 percent lacked appropriate indications for use. 3 Proper medication selection and prescribing (including dose , duration, and type of medication(s)) may help stabilize or improve a resident™s outcome, quality of life and functional capacity. Any medication or combination of medications Šor the use of a medication without adequate indications, in excessive dose, fo r an excessive duration, or without adequate monitoring Šmay increase the risk of a broad range of adverse consequences such as medication interactions, depression, confusion, immobility, falls, and related hip fractures. Intrinsic factors including phys iological changes accompanying the aging process, multiple comorbidities, and certain medical conditions may affect the absorption, distribution, metabolism or elimination of medications from the body and may also increase an individual™s risk of adverse c onsequences. While assuring that only those medications required to treat the resident™s assessed condition are being used, reducing the need for and maximizing the effectiveness of medications are important considerations for all residents. Therefore, as part of all medication management (including antipsychotics), it is important for the interdisciplinary team to consider non -pharmacological approaches. Educating facility staff and providers in addition to implementing non -pharmacological approaches to resident conditions prior to, and/or in conjunction with, the use of medications may minimize the need for medications or reduce the dose and duration of those medications. 4 Examples of non -pharmacological interventions may include: Increasing the am ount of resident exercise, intake of liquids and dietary fiber in conjunction with an individualized bowel regimen to prevent or reduce constipation and the use of medications (e.g. laxatives and stool softeners); Identifying, addressing, and eliminating or reducing underlying causes of distressed behavior such as boredom and pain; Using sleep hygiene techniques and individualized sleep routines; Accommodating the resident™s behavior and needs by supporting and encouraging activities reminiscent of lifelong work or activity patterns, such as providing early morning activity for a farmer used to awakening early;

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Individualizing toileting schedules to prevent incontinence and avoid the use of incontinence medications that may have significant adverse consequences (e.g., anticholinergic effects); Developing interventions that are specific to resident™s interests, abilities, strengths and needs, such as simplifying or segmenting tasks for a resident who has trouble following complex directions; Using m assage, hot/warm or cold compresses to address a resident™s pain or discomfort; or Enhancing the taste and presentation of food, assisting the resident to eat, addressing food preferences, and increasing finger foods and snacks for an individual with deme ntia, to improve appetite and avoid the unnecessary use of medications intended to stimulate appetite. Arranging staffing to optimize familiarity and consistency for a resident with symptoms of dementia . The indications for initiating, withdrawing, or withholding medication(s), as well as the use of non -pharmacological approaches, are determined by assessing the resident™s underlying condition, current signs and symptoms, and preferences and goals for treatment. This includes, where possible, the ident ification of the underlying cause(s), since a diagnosis alone may not warrant treatment with medication. Orders from multiple prescribers can increase the resident™s chances of receiving unnecessary medications. Many residents receive orders for medicati ons from several practitioners, for example, attending and on -call physicians, consultants, and nurse practitioner(s). It is important that the facility clearly identify who is responsible for prescribing and identifying the indications for use of medicat ion(s), for providing and administering the medication(s), and for monitoring the resident for the effects and potential adverse consequence of the medication regimen. This is also important when care is delivered or ordered by diverse sources such as con sultants, providers, or suppliers (e.g., hospice or dialysis programs). Staff and practitioner access to current medication references and pertinent clinical protocols helps to promote safe administration and monitoring of medications. One of the existin g mechanisms to warn prescribers about risks associated with medications is the Food and Drug Administration (FDA) requirement that manufacturers include within the medication labeling warnings about adverse reactions and potential safety hazards identifie d both before and after approval of a medication, and what to do if they occur (Visit: www.fda.gov/medwatch/safety.htm ). Manufacturers are required to update labels to warn about newly identified safe ty hazards Šregardless of whether causation has been proven and whether the medication is prescribed for a disease or condition that is not included in the fiIndications and Usagefl section of the labeling (so -called fioff -labelfl or unapproved use). The FDA m ay require manufacturers to place statements about serious

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problems in a prominently displayed box (so -called boxed or fiblack boxfl warnings), which indicates a need to closely evaluate and monitor the potential benefits and risks of that medication. The facility™s pharmacist is a valuable source of information about medications. Listings or descriptions of most significant risks, recommended doses, medication interactions, cautions, etc. can be found in widely available, standard references, and comp uter software and systems that provide up -to-date information. It is important to note that some of the medication information found in many of these references is not specific to older adults or institutionalized individuals. Clinical standards of prac tice and clinical guidelines established by professional groups are useful to guide clinicians. Some of the recognized clinical resources available for understanding the overall treatment and management of medical problems, symptoms and medication consequ ences and precautions include the: American Geriatrics Society http:// www.americangeriatrics.org ; American Medical Directors Association , hhtp:// www.amda.com ; American Psychiatric Association , http://www.psychiatry.org/ American Society of Consultant Pharmacists , http:// www.ASCP.com ; Agency for Healthcare Research and Quality (AHRQ) http:// www.ahrq.gov ; American Association for Geriatric Psychiatry , http://www.aagponline.org/ ; Association for Practitioners in Infection Control and Epidemiology , www.apic.org ; National Guideline Clearinghouse , http://www.guideline.gov/ ; Quality Improvement Organizations, http://qioprogram.org/ ; U.S. Department of Health and Human Services, Food and Drug Administration Web site hhtp:// www.fda.gov/medwatch/safety.htm ; U.S. Department of Health and Human Services, National Institute of Mental Health Web site, which includes publications and clinical research information http:// www.nimh.nih.gov ; NOTE: References to non -CMS sources or sites on the Internet included above or later in this document are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S.

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