OIG Risk Areas: Comprehensive Care Plans, Restorative/Personal Care Services & Medication Management
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1 OIG Risk Areas: Comprehensive Care Plans, Restorative/Personal Care Services & Medication Management Presented by: Nan Impink, Esq. Kelly Priegnitz, Esq. Harvey Tettlebaum, Esq.
2 Where We ve Been & Today s Topics Review of prior webinar topics Mechanics of compliance programs OIG Risk Areas to date Today: Comprehensive Care Plans Nan/Kelly Restorative / Personal Care Services Nan/Kelly Medications Management Harvey
3 OIG Risk Area: Comprehensive Care Plans
4 Key Focus Areas in OIG Compliance Supplemental Guidelines (CSG) Comprehensive Care Plans
5 Comprehensive Care Plans are: OIG Focus Area Survey and Enforcement Focus Area Failure to demonstrate an effective care planning process could be the basis for fraud and abuse or false claim actions!
6 How it all works together RAI Process Care Planning MDS Assessment Quality Care, Quality of Life Survey Outcomes RUGS Customer Satisfaction Pay for Performance Claims Improved 5-Star Rating Payment
7 Care Plans must meet needs of Residents: Medical Needs Nursing Needs Mental Needs Psychosocial Needs
8 Care Plans must have Reasonable Objectives Based on specific resident diagnosis/medical psychosocial Based on resident preferences, needs and goals Timelines Must be reasonable Must be attainable
9 Key Factors Interdisciplinary Approach All disciplines must be involved and must provide input based on discipline specific needs/goals Must include documentation of disciplinary approach
10 Basic Steps for a successful care planning process: Scheduling meetings to accommodate full IDT Completing all clinical assessments before meeting Open lines of communication to direct care providers and IDT Involvement of resident and family, POA or guardian Documentation of length and content of meeting
11 Meeting Scheduling IDT must commit to care planning process by attending prescheduled meetings Don t make excuses for absences Identify backup in the event of an emergency Don t schedule other meetings/events that could interfere with participation Be prepared and make sure appropriate information is available Care planning must be a priority. It certainly is an area of focus by federal/state enforcement agencies!
12 PRIOR to the meeting IDT members should review assessments and medical record documentation (including ADL documentation, MARS, TARS, nurses notes, therapy notes, activities/social services notes, consults, labs, etc.) Speak with direct care staff, physicians, physician extenders, other providers to obtain input and information. Speak with family members/residents in advance of the meeting to better understand goals and objectives. This will help to keep the meeting on track. Assemble and organize all necessary documentation. Develop an agenda to assure all areas are addressed. Alert staff and receptionist not to interrupt during the meeting.
13 Communicate Communicate Communicate Encourage/invite direct care staff to participate at appropriate times to provide input and insight Encourage/invite other ancillary providers to participate at appropriate times to provide input and insight Encourage/invite resident and family members to actively participate to express wishes, preferences, goals and objectives An organized and well-planned agenda will assist with timing and meeting flow.
14 Document Document Document Keep minutes of care plan meetings and have all parties review and sign. Minutes should include start/top times, attendees, content of meeting. Develop and document care plan goals during the meeting. Make sure goals are specific, detailed, and understandable Include time frames and expected outcomes Update nurse assignment sheets immediately following meeting to assure timely communication.
15 Key Factors (cont.) The OIG/Enforcement Agencies are looking for: Physician Involvement Physicians must be active in the care planning process Documentation must evidence physician input and participation
16 Steps to facilitate physician involvement: Develop policies / procedures to require, accommodate, and encourage physician participation Provide advance notice of meetings Arrange for alternative approaches for participation Telephonic Attendance at the Meeting Post-meeting debriefing
17 Physician Involvement (cont.) Circulate minutes post-meeting Circulate Care Plan drafts postmeeting Solicit additional comments/suggestion Communicate final plan to physicians, other providers, direct care staff, etc.
18 The tricks to successful care planning are: Participation Communication Documentation
19 Key Facts in OIG Compliance Supplemental Guidelines (CSG) Restorative and Personal Care
20 Restorative and Personal Care OIG Goals: To improve areas such as Avoiding pressure ulcers Improving passive range of motion Improving ambulation Fall prevention Incontinence management Enhance bathing, dressing and grooming activities
21 WARNING!! Failure to provide restorative services, yet submitting claims for such services = risk of liability under Fraud and Abuse and False Claim Statutes
22 Key Strategies for Risk Avoidance: Engage in resident / staff interviews Consult with attending physicians and medical directors Consult with consulting pharmacists Make personal observation of care provided Assure complete and contemporaneous documentation of services
23 Resident/Staff Interviews Are residents receiving restorative services? What types of restorative services? Active/Passive Range of Motion Ambulation Stationary/In-bed exercises How often are services provided? Who provides services? Are the services successful? NOTE: Check documentation post-interview to assure consistency
24 Physician Involvement Contact physicians periodically to request further instruction on restorative opportunities Explain current services and progress to date Request that additional residents be included in trials to determine whether they are appropriate for restorative services Request education/consultation on new or different approaches to restorative services Document conversations as appropriate
25 Consultant Pharmacist Involvement Contact pharmacist to discuss how medications can benefit or interfere with restorative services Pain Relief vs. Lethargy Request periodic drug holidays to determine whether restorative services can serve as an alternative to pharmacologic approach Explore options for reducing pain and stiffness to enhance opportunities for participation Document conversations as appropriate
26 Observe Restorative Services as they are provided Randomly observe services based on input from resident/staff interviews Are services provided as stated? Is staff competent to provide needed service? Are residents actively participating? Do barriers exist that impede active participation? Signs of pain Failure by staff to actively engage with resident Interruptions Lack of equipment Staff pulled to other tasks
27 Document Document Document Conduct random/periodic audits of restorative services documentation. Base audits on interviews/observations Assure documentation is consistent and contemporaneous with observations Assure that documentation includes progress over time or the basis for discontinuing restorative services Assure that documentation is sufficient to support payment for services.
28 Education + Monitoring / Observation + Communication + Documentation = Effective Compliance Programs
29 OIG Risk Area: Medication Management
30 F (1) Unnecessary Drugs General. Each resident s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: In excessive dose (including duplicate therapy); or For excessive duration; or Without an adequate monitoring; or Without adequate indications for its use; or In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or Any combinations of the reasons above.
31 The intent of (l): 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;
32 The intent of (l): Each resident receives only those medication, 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;
33 The intent of (l): 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.
34 Some definitions: 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 (e.g., medication-medication, medication-food, and medication-disease). Adverse drug reaction (ADR) is a form of adverse consequences. The term side effect is often used interchangeably with ADR; however, side effects are but one of five ADR categories, the others being hypersensitivity, ideosyncratic response, toxic reactions, and adverse medication interaction. A side effect is of expected, well-known reaction that occurs with a predictable frequency or may not constitute an adverse consequence. There are other definitions.
35 SOM Overview: Proper medical selection in 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 medication or the use of a medication without adequate indications, in excessive dose, for an excessive duration, or without adequate monitoring may increase the risk of a broad range of adverse consequences such as medication interactions, depression, confusion, immobility, falls, and related hip fractures.
36 Under the regulations medication management includes consideration of: Indications for use of medication (including initiation or continued use of antipsychotic medication); Monitoring for ethicacy and adverse consequences; Dose (including duplicate therapy); Duration;
37 Under the regulations medication management includes consideration of: Tapering of a medication dose/gradual dose reduction for antipsychotic medication; and Prevention, identification, and response to adverse consequences.
38 There are circumstances that warrant evaluation of resident and his or her medications which include the following: Admission or re-admission; A clinically significant change in condition/status; A new, persistent, or recurrent clinically significant symptom or problem; A worsening of an existing problem or condition;
39 There are circumstances that warrant evaluation of resident and his or her medications which include the following: An unexplained decline in function or cognition; A new medication order or renewal of orders; and An irregularity identified in the pharmacist s monthly medication regimen review.
40 Monitoring: Monitoring of the resident s response to any medication(s) is essential to evaluate the ongoing benefits as well as risks of various medications. It is important, for example, to monitor the effectiveness of medications used to address behavioral symptoms (e.g., behavioral monitoring) or to treat hypertension (e.g., periodic pulse and blood pressure). Monitoring for adverse consequences involves ongoing vigilance and may periodically involve objective evaluation (e.g., assessing vital signs may be indicated if a medication is known to affect blood pressure, pulse rate and rhythm, or temperature). Using quantitative and qualitative monitoring parameters facilitates consistent and objective collection of information by the facility.
41 Re-evaluating and updating monitoring approaches: Modification of monitoring may be necessary when the resident experiences changes, such as: Acute onset of signs or symptoms or worsening of chronic disease; Decline in function or cognition; Addition or discontinuation of medications and/or non-pharmacological interventions;
42 Re-evaluating and updating monitoring approaches: Modification of monitoring may be necessary when the resident experiences changes, such as: Addition or discontinuation of care and services such as enteral feedings; and Significant changes in diet that may affect medication absorption or effectiveness of increase adverse consequences.
43 Re-evaluating and updating monitoring approaches: Additional examples of circumstances that may indicate a need to modify the monitoring include: changes in manufacture s specifications, FDA warnings, pertinent clinical practice guidelines, or other literature about how and what to monitor.
44 Dose (Including Duplicate Therapy): A prescriber orders medication(s) based on a variety of factors including the resident s diagnoses, signs and symptoms, current condition, age, coexisting medication regimen, review of lab and other test results, input from the interdisciplinary team about the resident, the type of medication(s) and therapeutic goals being considered or used.
45 Factors influencing the appropriateness of any doses: These include the resident s clinical response, possible adverse consequences, and other resident and medication-related variables. Often, lab test results such as serum medication concentrations are only a rough guide to dosing. Significant adverse consequences can occur even when the concentration is within the therapeutic range. Serum concentrations alone may not necessarily indicate a need for dose adjustments, but may warrant further evaluation of a dose or the medication regimen.
46 Duplicate Therapy: Duplicate therapy is generally not indicated, unless current clinical standards of practice and documented clinical rationale confirm the benefits of multiple medications from the same class or with similar therapeutic effects.
47 Duplicate Therapy: Some examples of potentially problematic duplicate therapy include: Use of more than one product containing the same medication can lead to excessive doses of a medication, such as concomitant use of acetaminophen/hydrocodone and acetaminophen, which may increase the risk of acetaminophen toxicity; Use of multiple laxatives to improve or maintain bowel movements, which may lead to abdominal pain or diarrhea;
48 Duplicate Therapy: Some examples of potentially problematic duplicate therapy include: Concomitant use of multiple benzodiazepines such as lorazepam for anxiety and temazepam for sleep, which may increase fall risk; or Use of medications from different therapeutic categories that have similar effects or properties, such as multiple medications with anticholinergic effects (e.g., oxybutynin and diphenhydramine), which may increase the risk of delirium or excessive sedation.
49 Duplicate Therapy: Documentation is necessary to clarify the rationale for and benefits of duplicate therapy and the approach to monitoring for benefits and adverse consequences. This documentation may be found in various areas of the resident s clinical record.
50 Duration: Periodic re-evaluation of the medication regimen is necessary to determine whether prolonged or indefinite use of a medication is indicated. The clinical rationale for continued use of a medication(s) may have been demonstrated in the clinical record, or the staff and prescriber may present pertinent clinical reasons for the duration of use.
51 Duration: Common considerations for appropriate duration may include: A medication initiated as a result of a timelimited condition (for example, delirium, pain, infection, nausea and vomiting, cold and cough symptoms, or itching) is then discontinued when the condition has resolved, or there is documentation indicating why continued use is still relevant. Failure to review whether the underlying cause has resolved may lead to excessive duration.
52 Duration: Common considerations for appropriate duration may include: A medication is discontinued when indicated by facility stop order policy or by the prescriber s order, unless there is documentation of the clinical justification for its extended use. A medication administered beyond the stop date established in the prescriber s order or by facility policy, without evidence of clinical justification for continued use of the medication, may be considered excessive duration.
53 Tapering of a Medication Dose/Gradual Dose Reduction (GDR): The requirements underlying this guidance emphasize the importance of seeking an appropriate dose and duration for each medication and minimizing the risk of adverse consequences. The purpose of tapering a medication is to find an optimal dose or to determine whether continued use of the medication is benefiting the resident. Tapering may be indicated when the resident s clinical condition has improved or stabilized, the underlying causes of the original target symptoms have resolved, and/or non-pharmacological interventions, including behavioral interventions, have been effective in reducing the symptoms.
54 Opportunities to Evaluate: Opportunities during the care process to evaluate the effects of medications on a resident s function and behavior and to consider whether the medication should be continued, reduced, discontinued or otherwise modified can include the following:
55 Opportunities to Evaluate: Can include the following: During the monthly medication regimen review, the pharmacist evaluates resident-related information for dose, duration, continued need, and the emergence of adverse consequences for all medications;
56 Opportunities to Evaluate: Can include the following: When evaluating the resident s progress, the practitioner reviews the total plan of care, orders, the resident s response to the medication(s), and determines whether to continue, modify, or stop a medication; and During the quarterly MDS review, the facility evaluates mood, function, behavior, and other domains that may be affected by medications.
57 Adverse Consequences: Any medication or combination of medications can cause adverse consequences. Adverse consequences may become evident at any time after the medication is initiated. When reviewing medications used for a resident, it is important to be aware of the medication s recognized safety profile, tolerability, dosing, and potential medication interactions. Although a resident may have an unanticipated reaction to a medication that is always preventable, many ADRs can be anticipated, minimized, or prevented.
58 Some adverse consequences may be avoided by: Following relevant clinical guidelines and manufacturer s specifications for use, dose, administration, duration, and monitoring of the medication; Defining appropriate indications for use; and
59 Some adverse consequences may be avoided by: Determining that the resident: Has no known allergies to the medication; Is not taking other medications, nutritional supplements or foods that would be incompatible with the prescribed medications; and Has no condition, history, or sensitivities that would preclude use of that medication.
60 Pain and Other Medications: Commonly used medications are those to reduce pain or to thin the blood. With respect to each, note the following: With respect to pain medication, the CMS and the state survey agencies have made this an extremely high priority. Frequently, physician orders for pain medications are PRN (as needed). When charted that way, it can be confusing to the caregivers. You may wish to consider requesting physicians to order these types of medications for routine administration so they are more likely to be given on a regular schedule even if it is for a limited period of time to take care of the interim problem.
61 Pain and Other Medications: Commonly used medications are those to reduce pain or to thin the blood. With respect to each, note the following: Blood thinners such as Coumadin can have serious side effects and because they are used so frequently in nursing facilities staff should be educated and reeducated on some of these side effects and the need to have the resident s physician check the time it takes for the blood to start the clotting process (post-trothrombin time).
62 Conclusion: Do you have a medication administration system in place? Is it an accountable system? Is it tested and evaluated?
DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES
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