Pharmacy Related Regulatory Changes in LTC

By: Anastasia Sidor, PharmD, BCGP

Consultant Pharmacist Director

Brockie Pharmatech

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

Application questions

• Use Socrative app or website

• Room: “REGS”

State Operations Manual

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

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

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)

https://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/SurveyCertificationGenInfo/Downloads/SCLet

ter08-10.pdf

F757 – Unnecessary drug

Unnecessary drug

Defined as a medication used in one or more of the following ways - §483.45

• 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

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

Unnecessary drug examples

• Citalopram 40mg qd in 88 yo w/ a. fib

• Amiodarone 400mg BID (has been on this dose for 2 months)

Excessive dose

Excessive duration, dose

Unnecessary drug examples

• Spironolactone 25mg qd with K=5.6mmol/L

• Carvedilol 25mg qd with SBP consistently below <100

Presence of adverse effects

Presence of adverse effects

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

F756 – Drug regimen review (DRR)

Irregularity definition

• Definition of irregularity §483.45(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

Irregularity examples

• Eliquis 5mg BID for a. fib in a 92 yo with a Scr=1.74mg/dL, weight=65kg (143 lbs)

• Donepezil 10mg for dementia and tolterodine 2mg BID for OAB

Inconsistent with standard of practice & not supported by evidence

Inhibits intended outcomes from being achieved

Irregularity examples

• 75 yo with a. fib not on anticoagulation with high risk for embolism

• Amitriptyline 100mg qd for depression in a rehab resident experiencing sedation, confusion, blurry vision

Untreated conditions that may require drug initiation

Inhibits intended outcomes from being achieved

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

Changes to the MRR process

• Monthly drug regimen review must include a review of the medical record §483.45(c)(2)

• Medical director provided with report of irregularities §483.45(c)(4)

• Attending physician must document response in medical record • Action taken to address irregularity or

• Rationale provided if no changes made §483.45(c)(4)

• Pharmacist must report each irregularity and include resident name, drug, and specify irregularity §483.45(c)(4)

Changes to the MRR process

• Policy and procedure (P&P) must be in place for the MRR - §483.45(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

Changes to the MRR process

• Related regulation F580 483.10(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.”

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

F758 - Psychotropics

Psychotropic definition

Definition psychotropic drug updated 483.45(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.”

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.”

Psychotropic drugs

Ҥ483.45(e) Psychotropic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that--

• §483.45(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;

• §483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs…”

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

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.”

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.”

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

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 1st 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

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

??

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

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

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

PRN antipsychotics

Psychotropic drugs

Antipsychotics Anxiolytics Antidepressants Hypnotics Other

PRN antipsychotics

PRN antipsychotic order 483.45(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?

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

Psychotropic drugs

Antipsychotics Anxiolytics Antidepressants Hypnotics Other

PRN psychotropics

Other PRN psychotropics

Other PRN psychotropics (anxiolytics, hypnotics, antidepressants) §483.45(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

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

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

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

F881 – Antibiotic stewardship

Antibiotic stewardship (ABS)

• “§483.80(a) The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:

• §483.80(a)(3) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.”

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

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

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

F882 – Infection Preventionist

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

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

https://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-

Regions-Items/Survey-and-Cert-Letter-18-

04.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending

F759 & F760 – Medication errors

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 person-centered, 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.”

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

Odds & ends

• F661 483.21(c)(2) - pre/post discharge medication reconciliation **Phase 3

• F865 483.75 “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…”

• F880 483.80(d) – guidance that recommends that PPSV23 & PVC13 be administered in appropriate time frames to all adults older than 65 per ACIP

F755 – Pharmacy services

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.”

Impact Act: Improving Medicare Post-

Acute Care Transformation Act

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)

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)

References

1) Centers for Medicare and Medicaid Services. (2008). Use of Interpretive Guidance by Surveyors for Long Term Care Facilities. Retrieved from: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter08-10.pdf

2) Centers for Medicare and Medicaid Services. (2017). State Operations Manual. Retrieved from: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf

3) American Geriatrics Society. (2015). American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Retrieved from: https://geriatricscareonline.org/ProductTypeStore/clinical-guidelines-recommendations/8/

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: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-18-04.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. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures.html

Questions? Email: asidor@brockie.biz