Pharmacy Related Regulatory Changes in LTC. By: Anastasia Sidor, PharmD, BCGP Consultant Pharmacist Director Brockie Pharmatech

Transcription

1 Pharmacy Related Regulatory Changes in LTC By: Anastasia Sidor, PharmD, BCGP Consultant Pharmacist Director Brockie Pharmatech

2 Objectives 1. Contrast the difference between regulation and guidance within the State Operations Manual - Appendix PP Guidance to Surveyors 2. List the components of the unnecessary drug definition 3. Identify new psych regulations and changes to previous psych regulations

3 Application questions Use Socrative app or website Room: REGS

4 State Operations Manual

5 State Operations Manual Appendix PP Guidance to Surveyors for Long Term Care Facilities 749 pages Interpretation of regulations for the survey team Provides consistency in evaluating a nursing home s compliance with regulations Mega Rule Changes to the State Operations Manual Implemented in 3 phases Phase 1 Nov 28, 2016 Phase 2 Nov 28, 2017 Phase 3 Nov 28, 2019

6 Regulation vs. guidance All citations must be based on regulatory or statutory requirements May not be cited on interpretive guidelines Guidance to surveyors Must and shall indicative of requirements May and should suggest best practices, considered permissive standards Often the regulations are a few sentences, and guidance is paragraphs/pages long

7 Friendly advice Although citations are supposed to be based on regulation, not guidance, the surest way of avoiding citation is to follow the regulation and guidance as closely as possible Appeal any citations based on guidance rather than regulation Keep memo on hand during survey if you receive a citation based on guidance (link below) Certification/SurveyCertificationGenInfo/Downloads/SCLet ter08-10.pdf

8 F757 Unnecessary drug

9 Unnecessary drug Defined as a medication used in one or more of the following ways Excessive dose Guidance includes duplication of therapy Excessive duration Without appropriate monitoring Without appropriate indication for use Use in presence of adverse effects where dose should be reduced or discontinued

10 Question 1 Which of the following is NOT a component of the unnecessary drug definition? A) Excessive dose B) Use in absence of adverse effects C) Excessive duration D) Without appropriate monitoring

11 Unnecessary drug examples Citalopram 40mg qd in 88 yo w/ a. fib Excessive dose Amiodarone 400mg BID (has been on this dose for 2 months) Excessive duration, dose

12 Unnecessary drug examples Spironolactone 25mg qd with K=5.6mmol/L Presence of adverse effects Carvedilol 25mg qd with SBP consistently below <100 Presence of adverse effects

13 Question 2 Mrs. Jones is a 75 yo resident with HTN, a. fib, edema, and HLD. She takes metoprolol succinate 25mg qd, furosemide 20mg qd, digoxin 125mcg qd, and simvastatin 40mg qd. Routine lab monitoring includes BMP q 6 months, and lipid panel & LFTs annually. BP and HR are monitored and are WNL. Which medication could be considered an unnecessary drug according to the CMS definition? A) Metoprolol B) Furosemide C) Digoxin D) Simvastatin

14 F756 Drug regimen review (DRR)

15 Irregularity definition Definition of irregularity (c) Inconsistent with the standard of practice Not supported by evidence Inhibits intended outcomes from being achieved Untreated conditions that may require initiating medication Unnecessary drug Definition updated to include unnecessary drug

16 Irregularity examples Eliquis 5mg BID for a. fib in a 92 yo with a Scr=1.74mg/dL, weight=65kg (143 lbs) Inconsistent with standard of practice & not supported by evidence Donepezil 10mg for dementia and tolterodine 2mg BID for OAB Inhibits intended outcomes from being achieved

17 Irregularity examples 75 yo with a. fib not on anticoagulation with high risk for embolism Untreated conditions that may require drug initiation Amitriptyline 100mg qd for depression in a rehab resident experiencing sedation, confusion, blurry vision Inhibits intended outcomes from being achieved

18 Question 3 Mr. Jenkins is a 82 yo male with Parkinson s disease, Parkinson s psychosis, depression, and hypertension. His medication list consists of carbidopa/levodopa 25/100mg q 4 hours, olanzapine 5mg BID, sertraline 75mg qd, and metoprolol tartrate 50mg BID. Despite changes to Sinemet order, he persists with gait issues and falls. The consultant pharmacist is doing a monthly medication regimen review. Which medication order may be considered an irregularity and should be reported to the prescriber? A) Carbidopa/ levodopa B) Olanzapine C) Sertraline D) Metoprolol

19 Changes to the MRR process Monthly drug regimen review must include a review of the medical record (c)(2) Medical director provided with report of irregularities (c)(4) Attending physician must document response in medical record Action taken to address irregularity or Rationale provided if no changes made (c)(4) Pharmacist must report each irregularity and include resident name, drug, and specify irregularity (c)(4)

20 Changes to the MRR process Policy and procedure (P&P) must be in place for the MRR (c)(5) Regulation: Must include timeframes for steps in the process Must have P&P specific to what a pharmacist does when immediate attention is needed Guidance: Should address procedure for residents staying for 30 days or less Should address change in condition MRR

21 Changes to the MRR process Related regulation F (g)(14) Immediate notification required when treatment needs to be changed significantly Physician Resident Resident s representative (if applicable) Guidance: includes wording such as potential adverse consequence of a medication.

22 Question 4 You are writing a policy & procedure for the consultant pharmacist MRR. Identify the pieces that are not required by regulations, but suggested by guidance. A) Procedure for residents staying 30 days or less B) Procedure for what pharmacist does if immediate attention is needed C) Procedure for change in condition MRR D) Timeframes for each step in the process E) A & B F) A & C

23 F758 - Psychotropics

24 Psychotropic definition Definition psychotropic drug updated (c)(3) any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic.

25 Psychotropic drugs Guidance says Other medications which may affect brain activity such as central nervous system agents, mood stabilizers, anticonvulsants, muscle relaxants, anti-cholinergic medications, antihistamines, NMDA receptor modulators, and over the counter natural or herbal products must also only be given with a documented clinical indication consistent with accepted clinical standards of practice. Residents who take these medications must be monitored for any adverse consequences, specifically increased confusion or over-sedation.

26 Psychotropic drugs (e) Psychotropic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that (e)(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record; (e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs

27 Gradual dose reduction (GDR) frequency Guidance: Twice within the first year (of admission or of starting medication) In 2 separate quarters Separated by at least 1 month Annually after first year General accepted practice for hypnotics is to have quarterly GDRs Noteworthy words Psychotropic medications classes of medication not specified Must mentioned in guidance

28 GDRs Guidance: However, some residents with specific, enduring, progressive, or terminal conditions such as chronic depression, Parkinson s disease psychosis, or recurrent seizures may need specific types of psychotropic medications or other medications which affect brain activity indefinitely.

29 GDRs Guidance: NOTE: A medication may have been required to treat a medical symptom, and as a result, the medical symptom is no longer present. In some cases, the clinical goal of the continued use of the medication is to stabilize the symptoms of the disorder so that the resident can function at the highest level possible Although the symptom may no longer be present, the disease process is still present. For example, diseases may include: Chronic psychiatric illness such as schizophrenia or schizoaffective disorder, bipolar disorder, depression, or post-traumatic stress disorder; Neurological illness such as Huntington s disease or Tourette s syndrome; and Psychosis and psychotic episodes.

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31 What is clear about psychotropic regs Indication/appropriate diagnosis documented in clinical record Behavioral interventions necessary Prior to initiating psychotropics To facilitate discontinuation of psychotropics Document in clinical record

32 What is clear about psychotropic regs GDRs required There are no exemptions for end of life There are no exemptions for diagnoses GDRs must be attempted twice in the 1 st year of admission or initiation, in 2 separate quarters, then yearly Hypnotics are not specified as having to be done quarterly, but is still the accepted standard Classes required: antidepressants, anxiolytics, antipsychotics, hypnotics

33 ?? What is unclear about GDRs Do the drugs in the expanded definition of psychotropic drug (anticonvulsants, muscle relaxers, etc) need to have GDRs? According to regulation itself, GDRs could be expected for all psychotropic drugs which could include medications such as anticonvulsants, muscle relaxers, etc Guidance could imply for these other classes (anticonvulsants, muscle relaxants, etc) that requirements may only include Clinical indication documented Monitor for adverse effects

34 Question 5 True or False: According to current regulations, a resident under hospice care would be exempt from a GDR on their lorazepam 0.5mg qd order. A. True B. False Reference here

35 Question 6 True or False: According to current regulations, a resident taking olanzapine 10mg qd for Tourette s is no longer exempt from GDRs. A. True B. False Reference here

36 Clarify the confusion Often confusion between psychotropic/psychoactive versus antipsychotic when speaking with facility staff Psychotropic is not an interchangeable term with antipsychotic Psychotropic/psychoactive is a broad term that encompasses the following medication classes Psychotropic/ psychoactive drugs Antipsychotics Anxiolytics Antidepressants Hypnotics Other

37 PRN antipsychotics Psychotropic drugs Antipsychotics Anxiolytics Antidepressants Hypnotics Other

38 PRN antipsychotics PRN antipsychotic order (e)(5) Strict 14 day order limit Diagnosis specified & documented in clinical record May only be ordered again for another 14 day period if the PCP evaluates the resident in person (per guidance) to assess appropriateness of the medication and provides rationale Is the antipsychotic medication still needed on a PRN basis? What is the benefit of the medication to the resident? Have the resident s expressions/indications of distress improved as a result?

39 PRN antipsychotics Regulations do not mention exceptions for diagnoses or end of life situations Example: prochlorperazine PRN n/v is a first generation antipsychotic and would be subject to this 14 day rule Example: haloperidol PRN terminal restlessness also subject to 14 day rule

40 PRN psychotropics Psychotropic drugs Antipsychotics Anxiolytics Antidepressants Hypnotics Other

41 Other PRN psychotropics Other PRN psychotropics (anxiolytics, hypnotics, antidepressants) (e)(4) Diagnosis specified & documented Initial order only limited to 14 days To continue with PRN order, the prescriber must evaluate the resident, document rationale, and provide duration for PRN order In-person evaluation NOT required Duration should be a finite period of time indefinitely not appropriate

42 Question 7 Which order must be renewed/reviewed every 14 days? A. Lorazepam 0.5mg qd prn B. Quetiapine 25mg qd C. Haloperidol 1mg BID prn D. Zolpidem 5mg qhs prn

43 Question 8 In order for haloperidol 1mg BID prn to be renewed every 14 days, what must occur and be documented? A. Rationale provided B. Nursing supervisor evaluation of resident C. Diagnosis provided D. Physician evaluation of resident E. A & C F. A, B & C G. A, C & D Reference here

44 Friendly advice PRN psychoactive orders have been a major target this year Increases in frequency of PRN orders have been considered new orders and must have a 14 day stop date For example: lorazepam 0.5mg BID prn increased to lorazepam 0.5mg q8 hrs prn Considered a new order Should have had a 14 day stop date with rationale, duration, and indicated documented in clinical record

45 F881 Antibiotic stewardship

46 Antibiotic stewardship (ABS) (a) The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements: (a)(3) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.

47 Antibiotic stewardship Guidance: protocols must: Play a role in overall infection prevention/control program Be reviewed at least yearly or as needed Establish a system to monitor and report antibiotic use and resistance patterns Establish frequency of monitoring/review of orders and how this feedback will be disseminated Utilize standardized tools and criteria Include mode of education on ABS to prescribers and staff

48 Antibiotic stewardship & the MRR Guidance: Licensed pharmacist must review antibiotic order during MRR Review may occur retrospectively Pharmacist communicate findings and must report any irregularities

49 Friendly advice Find ways to streamline your work work smarter, not harder or in this case, work smarter, not longer If you have multiple consultants, create uniformity throughout team Get the appropriate resources they are some antimicrobial apps for as low as $30/year that will simplify your reviews

50 F882 Infection Preventionist

51 Infection Preventionist Phase 3 implementation Nov 28, 2019 Part time position Professionally trained in nursing, medical technology, microbiology, epidemiology, or related profession and qualified by certification, experience, training or education Requires specialized training in infection prevention and control Must sit on QAA committee

52 Phase 2 CMS memo issued 11/24/17 Moratorium on certain Phase 2 requirements F758 Psychotropic medications related to PRN psych limitations F881 Antibiotic stewardship Other non-pharmacy related requirements included 18 month moratorium on financial penalties F-tags incurred from specified requirements will not be used to calculate Star Rating for 12 months Facilities required to follow Phase 2 requirements and may be cited on all F-tags Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and- Regions-Items/Survey-and-Cert-Letter html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending

53 F759 & F760 Medication errors

54 Medication errors Guidance: Crushing Oral Medications To address concerns with physical and chemical incompatibility and complete dosing, best practice would be to separately crush each medication and separately administer each medication with food. However, separating crushed medications may not be appropriate for all residents and is generally not counted as a medication error unless there are instructions not to crush the medication(s). Facilities should use a personcentered, individualized approach to administering all medications. If a surveyor identifies concerns related to crushing and combining oral medications, the surveyor should evaluate whether facility staff have worked with the resident/representative and appropriate clinicians (e.g., the consultant pharmacist, attending physician, medical director) to determine the most appropriate method for administering crushed medications which considers each resident s safety, needs, medication schedule, preferences, and functional ability.

55 Person-centered care F760 guidance: Resident has right to choose health care schedules Medication administration times must be considered Some medications have flexible administration times Some medications remain time-critical to achieve therapeutic effect

56 Odds & ends F (c)(2) - pre/post discharge medication reconciliation **Phase 3 F Each LTC facility, including a facility that is part of a multiunit chain, must develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life F (d) guidance that recommends that PPSV23 & PVC13 be administered in appropriate time frames to all adults older than 65 per ACIP

57 F755 Pharmacy services

58 Liquid controlled medications Guidance: Liquid controlled medications are often dispensed in multi-dose containers which indicate approximate volume. The containers may also be opaque to protect the medication from light. It should be noted that absolute accuracy in tracking volume and use of liquid controlled medications may not be possible. The actual volume in these containers may be slightly over or under the manufacturer s stated volume depending on the shape and material of the container and the formulation of the medication such as thick liquid suspensions. The opaque container, measurement markings, manufacturer fill volume variation, and method for recording usage all make detection of diversion for liquid controlled medications more difficult. The general standard of practice for documenting usage of liquid controlled medications is to record the starting volume from the label, record each dose administered, subtract the dose administered from the previously recorded volume, and record the remaining amount. Any observed discrepancy between the recorded amount and what appears to be remaining in the container should be reported according to facility policy. Manufacturer s instructions may list the estimated volume variance (e.g., 30 ml plus or minus 2.5 ml). For liquid controlled medications, signs of diversion may include: an observable discrepancy between the written balances of remaining medication compared to the remaining amount in the bottle upon visual inspection; changes in the viscosity or color of the medication; reports of spills; and, as with other controlled medications, statements from a resident that the medication is not working.

59 Impact Act: Improving Medicare Post- Acute Care Transformation Act

60 Impact Act Passed in 2014 Implementation date of Oct 1, 2018 Goal is to standardize assessment data over post-acute care Not exclusive to SNFs (home health, rehab, SNFs, etc all included)

61 Impact Act Pharmacist is not specified to participate in the activities of the Impact Act Pharmacy-related components: Medication reconciliation (domain) DRR (measure) Definition inconsistent with DRR definition in State Operations Manual DRR focuses on identifying clinically significant medication issues Must be reported to physician and responded to before midnight of next day For SNFs, results and compliance must be reported in Minimum Data Set (MDS)

62 References 1) Centers for Medicare and Medicaid Services. (2008). Use of Interpretive Guidance by Surveyors for Long Term Care Facilities. Retrieved from: Certification/SurveyCertificationGenInfo/Downloads/SCLetter08-10.pdf 2) Centers for Medicare and Medicaid Services. (2017). State Operations Manual. Retrieved from: 3) American Geriatrics Society. (2015). American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Retrieved from: 4) Centers for Medicare and Medicaid Services. (2017). Temporary Enforcement Delays for Certain Phase 2 F- Tags and Changes to Nursing Home Compare. Retrieved from: Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Surveyand-Cert-Letter html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending 5) Centers for Medicare and Medicaid Services. (2018). IMPACT Act of 2014 Data Standardization & Cross Setting Measures. Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting- Measures.html

63 Questions?