Medication Related Changes – Phase 1,2, & 3Medicare 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

Phase 1 started 11/28/16

Phase 2started11/28/17

Phase 3Begins11/28/19

Phase 1: Began 11/28/16

Phase 2: Began 11/28/17

Phase 3: Begins 11/28/19

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)

QAPI (Phase 3)

Training Requirements (Phase 3)

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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 Director Report must include resident’s name, relevant drug & irregularity

P&P for Drug Regimen Review Facility 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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Updated Definition of Psychotropic Drug

Phase 1

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

Includes, but not limited to: Antipsychotics Antidepressants Anti-Anxiety Hypnotics

*opioid analgesics are excluded from this definition

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F758 Psychotropic MedicationsGradual DoseReduction

Phase 2

All psychotropic drugs will be held to the same standards

GDR’s, behavioral interventions for allpsychotropics

Other Psychotropic Meds Mood stabilizers Anticholinergic meds OTC’s Muscle Relaxants Antihistamines ETC

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

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PRN Psychotropic Drugs

PRN orders for psychotropic drugs are limited to 14 days*

Includes: Antidepressants Antianxiety Hypnotics

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

Document their rationale in the medical record Evaluate for appropriateness of the medication Indicate the duration for the PRN order

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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)

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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 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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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 guidelines Time sensitive medications

3. Resident has the right to choose health care schedules

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Phase 3F940483.95Training Requirements

Required training topics for all new/existing staff, contactors and volunteers.

Communication

Resident rights & facility responsibility (483.10) ensure staff is educated

Abuse, Neglect, & Exploitation

Quality Assurance & Performance Improvement

Infection Control

Compliance & Ethics

Required training of feeding assistants/required in-service training for nurse aides

Behavioral Health

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F865: QAPI Program –

Phase 3

Each facility “must have a comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life, including abuse, neglect & exploitation.

Identify high risk or problem prone areas

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

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F865: QAPI Program –What is QAPI11/28/2019

Quality Assurance (QA)

The specification of standards for quality of care, service and outcomes, and systems throughout the facility for assuring that care is maintained at acceptable levels in relation to those standards.

QA is on-going and both anticipatory and retrospective in its efforts to identify how the organization is performing, including where and why facilities performance is at risk or has failed to meet standards.

Performance Improvement (PI)

The continuous study and improvement of processes with the intent to improve services or outcomes, and prevent/decrease the likelihood of problems by:

Identifying opportunities Testing new approaches

PI aims to improve facility processes involved in care delivery and enhanced resident QOL.

PI can make good quality even better.

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F865: QAPI Program –Definitions11/28/2019

Phase 3

High Risk

Care or service areas associated with significant risk to the health or safety of residents

Examples: Tracheostomy care Pressure injury prevention Administration of high risk medications such as warfarin, insulin, and

opioids.

High Volume

Care or service areas performed frequently or affecting a large population, thus increasing the scope of the problem

Examples: Transcription of orders Medication administration Laboratory testing

Problem Prone

Care or service areas that have historically had repeated problems,

Examples: Call bell response times Staff turnover Lost laundry

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F865: QAPI Program –Expectations11/28/2019

Phase 3

Each facility must present its QAPI plan to:

“The State Survey Agency no later than 1 year after the promulgation of this regulation”

State or Federal Surveyors at each annual recertification and upon request during any other survey

CMS upon request

Review of the QAPI program should occur at the end of the survey

Will not be used to identify additional concerns not previously identified during the survey

Will not identify deficiencies for “good faith attempts”

May involve disclosure of certain QAA committee documents

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F865: QAPI Program –Potentially Preventable Events11/28/2019

Phase 3

Medication

Opioid or psychotropic related changes in mental status/delirium

Hypoglycemia from antidiabetic medications

Bleeding or clot related to antithrombotic

Electrolyte imbalance related to diuretics

Drug toxicity including acetaminophen, digoxin, phenytoin, lithium

Care

Falls, skin tears, or trauma related to care

Electrolyte imbalance due to inadequate fluid maintenance

Thromboembolic events

Feeding tube complications

In-house acquired/worsened stage pressure injuries

Elopement

Infection

Pneumonia

Influenza

Surgical site infections

Soft tissue and non-surgical wound infections

Catheter – and non-catheter associated urinary tract infections

Clostridium difficile

Norovirus

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Phase 3 –Infection Control

F882: Infection Control – Infection Preventionist (IP)

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

IP must be on the facility’s QAA Committee

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Phase 3 –Infection ControlF882483.95 (e)483.80 (a)(2)

Written standards in policy and procedure to include:

A system designed to identify possible communicable diseases or infections before they can spread to other persons in the facility.

When and to whom possible incidents of communicable disease or infections should be reported.

Standard and transmission-based precautions to be followed to prevent spread of infections.

When and how isolation should use used for: The type and duration of the isolation, depending upon the

infectious agent or organism involved, and A requirement that the isolation should be the least restrictive

possible for the resident under the circumstances.

The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and

The hand hygiene procedures to be followed by staff involved in direct resident contact.

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483.95 (f)483.85Compliance & Ethics

Phase 3

Required components for all facilities

Each facility must develop, implement, and maintain an effective compliance and ethics program that contains the following components

1. Establish in writing ethics and compliance standards, policies & procedures to reduce criminal, civil, & administrative violations

• Promote quality of care by including a contact point by which individuals may report suspected violations and alternate methods of reporting suspected violations anonymously without fear of retribution

• Implement disciplinary standards with clear consequences for violations for entire staff

• Consistent enforcement2. Ensure specific individuals (high level personnel)

Oversee compliance with the compliance & ethics programs Annual review

3. Effectively communicate compliance & ethics program to: Entire staff Contractual individuals Volunteers

4. Additional requirements for organizations with 5 or more facilities

1. Mandatory annual training2. Designated compliance officer for whom this program is a

major responsibility – reporting directly to the operating organization’s governing body and not be subordinate to the general counsel, chief financial officer or chief operating officer.

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483.95 (g)Required In-service Training for Nurse Aides

Phase 3

Required in-service training for nurse aides.

In service training must -1. Be sufficient to ensure the continuing

competence of nurse aides, but must be no less than 12 hours per year.

2. Include dementia management training and resident abuse prevention training.

3. Address areas of weakness as determined in nurse aides’ performance reviews and facility assessment at 483.70(e) and may address the special needs of residents as determined by the facility staff.

4. For nurse aides providing services to individuals with cognitive impairments, also address the care of the cognitively impaired.

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483.95 (h)483.160Requirements for Training of Paid Feeding Assistants

Phase 3

Requirements for training of paid feeding assistants.

Minimum training course contents. A State-approved training course for paid feeding assistants must include, at a minimum, 8 hours of training in the following:

1. Feeding techniques2. Assistance with feeding and hydration3. Communication and interpersonal skills4. Appropriate responses to resident behavior5. Safety and emergency procedures, including the

Heimlich maneuver.6. Infection control7. Resident rights8. Recognizing changes in residents that are

inconsistent with their normal behavior and the importance of reporting those changes to the supervisory nurse.

Maintenance of records. A facility must maintain a record of all individuals, used by the facility as feeding assistants, who have successfully completed the training course for paid feeding assistants.

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483.95 (i)483.40Behavioral Health

Phase 3

Behavioral health encompasses a resident’s whole emotional and mental well-being, which includes, but is not limited to, the prevention and treatment of mental and substance use disorders.

1. Sufficient staff who provide direct services to residents with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility’s resident population in accordance with 483.70(e). These competencies and skills sets include, but are not limited to, knowledge of and appropriate training and supervision for: Care for and treat residents with mental, psychosocial disorders, of

trauma and/or post-traumatic stress disorder that have been identified in the facility assessment.

Implementing non-pharmacological interventions. If assessment/diagnosis did not reveal a mental or psychosocial

adjustment difficulty or show a documented history of trauma and/or post-traumatic stress disorder, ensure resident does not display:

Decreased social interaction Increased withdrawn behaviors Anger Depression behaviors

A resident who displays or is diagnosed with dementia, receives the appropriate treatment and services to attain or maintain his or her highest practicable physical, mental, and psychosocial well-being.

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483.21 b(3)F659F699Cultural Competency and Trauma Informed Care

Phase 3

Trauma – Informed Approach (SAMHSA) Realizes the widespread impact of trauma and

understands potential paths for recovery. Recognizes the signs/symptoms of trauma Responds through policies, procedures and

practices Re-traumatization – actively seek to resist

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F699Six Key Principles of Trauma-Informed Approach

Phase 3

1. Safety

2. Trustworthiness & Transparency

3. Peer Support

4. Collaboration and Mutuality

5. Empowerment, Voice, and Choice

6. Cultural, Historical, and Gender Issues

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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

CMS Resources

CMS Resources

1. CMS Nursing Home Web Page:https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html

2. Survey and Certification Memos: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html

3. Training Website:https://surveyortraining.cms.hhs.gov/index.aspx Select “I am a Provider” and go to the Course

Catalog

4. CMS Regulations and Guidance Updateshttps://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf

5. Trauma-Specific Interventions (SAMHSA)https://www.samhsa.gov/nctic/trauma-interventions

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