Medication Related Changes – Phase 1&2Medicare and Medicaid ProgramsReform of Requirements for Long-Term Care FacilitiesPublished January 23, 2017

Medication-Related Changes*

Changes will be implemented in three phases

Effective dates:November 28, 2016 (Phase 1)November 28, 2017 (Phase 2)November 28, 2019 (Phase 3)

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*This summary is focused on medication-related requirements and is not a comprehensive list of all new LTC facility requirements in the CMS Final Rule. This summary also is not intended to represent legal advice, but instead provide a general overview of medication-related provisions. Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities; https://www.gpo.gov/fdsys/pkg/FR-2016-10-04/pdf/2016-23503.pdf

1)2)3)

Pharmacy RelatedF-Tags

Old New

F309 F675 – Quality of LifeF684 – Quality of CareF697 – Pain ManagementF698 – DialysisF744 – Dementia Care

F329 F757 – Unnecessary DrugsF758 – Psychotropic Drugs

F334 F883 – Influenza & Pneumococcal Immunizations

F425 F755 – Pharmacy Services

F428 F756 – Drug Regimen ReviewF758 – Psychotropic Drugs

F431 F761 – Labeling/Storage of Drugs & Biologicals

F441 F880 – Infection ControlF881 – Antibiotic StewardshipF882 – Infection Preventionist

** Centers for Medicare and Medicaid Services. State Operations Manual Appendix PP: Guidance to Surveyors for Long Term Care Facilities. 2017 June 30.

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Phase 1: started 11/28/2016

Pharmacist must report irregularities on a separate, written report that is sent to:

Attending Physician

Director of Nursing

Medical DirectorReport must include resident’s name, relevant drug & irregularity

Respond to Pharmacist Reports – attending physician must document in medical record:

The irregularity that has been reviewedThe action that has been taken to address the irregularityIf no change, document the rationale in medical record

P&P for Drug Regimen ReviewFacility must develop & maintain:

1. Policies and Procedures for the monthly Drug Regimen Review

2. Policy must identify timeframes for different steps in the procedures

3. Identify steps the consultant pharmacist must take when an irregularity is identified that requires urgent action

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Phase 1: started 11/28/2016

Updated definition of “Irregularity”Irregularity includes but not limited to unnecessary drug. F757

**Unnecessary drug is any drug when used in:Excessive dose (including duplication of therapy)

Excessive duration

Without adequate monitoring

Without adequate indication for its use

In the presence of adverse consequences which indicate dose should be reduced or discontinued

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**(Rev. 168, Issued: 3-08-17, effective: 3/08/17, Implementation: 3/08/17)

Phase 1 started 11/28/16

Phase 2started11/28/17

Phase 1: Began 11/28/16

Phase 2: Begins 11/28/17

Updated definition of Psychotropic Drug – F758 (Phase 1)

PRN Psychotropic Drugs (Phase 2)

PRN Antipsychotics (Phase 2)

Monthly review of residents medical record (Phase 2)

Antibiotic Stewardship (Phase 2)

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Updated definition of Psychotropic Drug

Phase 1

Any drug that affects brain activities associated with mental processes and behavior

Includes, but not limited to:AntipsychoticsAntidepressantsAnti-AnxietyHypnotics

*opioid analgesics are excluded from this definition

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PRN Psychotropic Medications

Phase 2

All psychotropic drugs will be held to the same standards

GDR’s, behavioral interventions for allpsychotropics

Based on a comprehensive assessment of a resident the facility must ensure that:

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 medical recordResidents who receive these drugs must receive gradual dose reductions and behavioral interventions, unless otherwise contraindicated, in an effort to discontinue these drugs

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F758Psychotropic Drugs –Gradual Dose Reductions

Other Psychotropic MedsMood stabilizersAnticholinergic medsOTC’sMuscle RelaxantsAntihistaminesETC

When attempting to decrease an antipsychotic med – other psychotropic medications should not increase

A GDR is required for any psychotropic med being used for a psychiatric diagnosis – or for expressions or indications of distress related to dementia.

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PRN Psychotropic drugs

PRN orders for psychotropic drugs are limited to 14 days*

Includes:AntidepressantsAntianxietyHypnotics

To extend a PRN order past 14 days, the prescriber must:

Document their rationale in the medical recordEvaluate for appropriateness of the medicationIndicate the duration for the PRN order

*PRN orders for Antipsychotic drugs are limited to 14 days, NO EXCEPTIONS

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PRN Antipsychotics

PRN orders for antipsychotics drugs are limited to 14 days and cannot be renewed unless the prescriber evaluates the resident for the appropriateness of that medication.

After evaluation, a new order could be written for 14 days

No exclusions (Haldol EOL Care)

Guidance –“the required evaluation of a resident before writing a new PRN order for an antipsychotic entails the attending physician or prescribing practitioner directly examining the resident and assessing the resident’s current condition and progress to determine if the PRN antipsychotic medication is still needed. (note: Report of the resident’s condition from facility staff to the attending physician or prescribing practitioner does not constitute an evaluation.)”

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Monthly Review of Residents Medical Record

With regard to Drug Regimen Review (DRR) – F756 , Consultant Pharmacist is required to review the residents medical records concurrently with the DRR when:

Resident is new to the facility – whether short or long stay without exception

A prior resident returns or is transferred from a hospital or other facility

During each monthly DRR when the resident has been prescribed or is taking a psychotropic drug, and antibiotic, or any drug the QAA committee has requested be in the Consultant Pharmacist Monthly Drug Reviews.

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Monthly Review of Residents Medical Record

The Drug Regimen of each resident must be reviewed at least once a month by a licensed pharmacist

This review must include a review of the residents medical chart

Guidance –“Medication Regimen Review” or Drug Regiment Review is a thorough evaluation of the medication regimen of a resident, with the goal of:

Promoting positive outcomes

Minimizing adverse consequences and potential risks of medications

MRR includes review of the medical record in order to:Prevent

Identify

Report

Resolve medication related problems

Med errors or other irregularities

MRR also involves collaborating with other members of IDT, including resident, their families, and/or representative

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Phase 2IPCP

Infection Prevention & Control Program (IPCP) F880

The facility must establish and maintain an infection prevention and control program (IPCP) that must include:

An Antibiotic Stewardship Program that includes antibiotic use protocols and a system to monitor antibiotic use (Phase 2)Follows accepted national standards (Phase 1)Revision and review at least annually and as necessary (Phase 1)CDC: “up to 75% of antibiotics prescribed in nursing homes are given incorrectly meaning either the drug is unnecessary or the prescription is for the wrong drug, dose, or duration”

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Phase 2 Antibiotic Stewardship

Antibiotic Stewardship – F881

To improve resident outcomes and reduce antibiotic resistance

The facility must develop an antibiotic stewardship program which includes the development of protocols and a system to monitor antibiotic use.

Development should include leadership support and accountability via the participation of the Medical Director, Consultant Pharmacist, Nursing and Administrative Leadership, and individual with designated responsibility for the infection control program if different.

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Phase 2 Antibiotic Stewardship

Antibiotic Stewardship – F881

Leadership Commitment

Accountability

Drug Expertise

Action

Tracking

Reporting

Education

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STREAMLINE EMPIRIC ANTIBIOTIC ORDERS

Antibiotic Stewardship F881

Ensuring residents who require an antibiotic are prescribed the appropriate antibiotic

Utilization of infection assessment tools

Develop and implement systems to monitor use of antibiotics in facility

Implement timely follow up after empiric* prescribing of broad spectrum antibiotics to determine if orders can be changed to a narrower spectrum agent and/or if duration of therapy can be limited

18*Empiric: the practice of initially prescribing antibiotic treatment based on clinical experience, usually without objective data to support its use, such as a culture and sensitivity (e.g., a “best guess”)

What can long-term care facilities do?

Antibiotic Order Requirements

A correct antibiotic order should include:Name of medicationStrength of medicationDose to be givenRoute of administrationFrequency of dosingIndication for useStop dateAny monitoring that may be required such as

vancomycin trough

proactively reducing warfarin dose and checking INRs more frequently

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DON’T FORGET TO CHECK FOR MEDICATION ALLERGIES

Medication ErrorsF759 – F760

Medication Errors

Phenytoin & Enteral Nutrition Administration

Administration must be separated to minimize this interaction, according to drug and enteral formula manufacturer recommendations

Surveyor should consider the simultaneous administration of phenytoin & enteral nutritional formula a med error.

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Medication Errors –Timing of Med AdministrationF759 – F760

Resident Centered Care:

1. Resident has the right to choose medication administration times to meet individuals needs –these needs and preferences must be considered by facility

2. Please note: the physician’s orders/instructions must still be followed

Manufacturer guidelinesTime sensitive medications

3. Resident has the right to choose health care schedules

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F865: QAPI Program –11/28/2019

Each facility “must develop implement, and maintain an effective, comprehensive, data-driver QAPI program that focuses on indicators of the outcomes of care and quality of life.”

Identify high risk or problem prone areas

Exceptions must be centered around safety, quality, rights, choice & respect

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Phase 311/28/2019

F882: Infection Control – Infection Preventionist

Facilities must designate one or more individuals as the infection preventionist who are responsible for the facility's IPCP

Must have professional training in nursing, medical technology, microbiology, epidemiology, or other related field

Work at least part – time at facility

Completed specialized training in infection prevention and control

One team member must be on the facility’s QAA Committee

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For More InformationContact your Consultant Pharmacist or Account Manager

Issue SectionFederal Register page

#; Oct. 4, 2016

Comprehensive Person-centeredCare Planning

Discharge Planning § 483.21 p. 68859, 68740

Baseline Care Plan § 483.21 p. 68868

Pharmacy Services Drug Regimen Review § 483.45 p. 68863

Infection Control IPCP and Vaccines § 483.45 p. 68868-68869

Resident Rights Self Administration § 483.10 p. 68849

Quality of Care Pain Management § 483.25 p. 68861

Pharmacy Services Psychotropic Drugs § 483.45 p. 68863

Infection Control Antibiotic Stewardship § 483.80 p. 68868

QAPI Program § 483.75 p. 68868

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Dept. of Health and Human Services, Center for Medicaid and Medicare Services, LTC Regulations Team, Sheila Blackstock, Ronisha Blackstone, Diane Corning, Lisa Parker. (410) 786-6633

Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities

CMS Nursing Home Web Page: https://www.cmas.gov/Medicare/Provider-Enrollment-and-certification/GuidanceforLawsAndRegualtionsInNursingHomes.html