CMS RULES FOR PARTICIPATION/LTC REGULATIONS: WHAT YOU NEED TO KNOW

SATURDAY/3:15-4:15PM

ACPE UAN: 0107-9999-17-242-L04-P 0.1 CEU/1.0 hr Activity Type: Knowledge-Based Learning Objectives for Pharmacists: Upon completion of this CPE activity participants should be able to: 1. Discuss the new CMS rules of participation for long term care facilities pertaining to medication use. 2. Identify the different implementation dates for the rules. 3. Describe how the new rules will be incorporated with existing guidance. 4. Discuss implementation strategies for these rules based on rollout dates. Speaker: Joe Litsey, PharmD, CGP Joe Litsey has worked with Thrifty White Pharmacy as a consultant pharmacist for over 15 years. He is currently the Director of Consulting Services for Thrifty White Pharmacy. In this role, Dr. Litsey works with LTC communities and pharmacists developing best practice medication management programs and initiatives. Dr. Litsey earned his Doctor of Pharmacy degree from North Dakota State University in 1994 and has specialized in geriatric medication management since the onset of his professional career. Dr. Litsey is a Certified Geriatric Pharmacist, president of the American Society of Consultant Pharmacists—Minnesota Chapter, serves as a Long-Term-Care Delegate for the Minnesota Pharmacists Association, is a member of the American Medical Directors Association and routinely provides medication management educational sessions for LTC organizations, communities, facilities and fellow healthcare professionals. Speaker Disclosure: Joe Litsey reports no actual or potential conflicts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation.

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CMS Rules for Participation/LTC

Regulations: What You Need to Know

Joe Litsey, Pharm.D. BCGP

Disclosure

• Joe Litsey reports no actual or potential conflicts of interest associated with this presentation.

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Learning Objectives

• Upon successful completion of this activity, participants should be able to:

- Discuss the new CMS rules of participation for long term care facilities pertaining to medication use.

- Identify the different implementation dates for the rules.- Discuss how the new rules will be incorporated with

existing guidance.- Discuss implementation strategies for these rules based

on rollout dates.

Background• The requirements for Long-Term Care (LTC) Facilities are the

health and safety standards that LTC facilities must meet in order to participate in the Medicare or Medicaid Programs.

• Federal Register:- www.federalregister.gov/documents/2016/10/04/2016-

23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities

• Additional guidance can be found in the State Operations Manual, Appendix PP.

- www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html

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CMS regulations and the Consultant Pharmacist

The critical role of the pharmacist is written into the regulations governing nursing facility participation in the Medicare and Medicaid programs

Pharmacists provide needed expertise in the pharmacotherapy and the unique medication-related needs of the senior population in order to improve quality of care and quality of life.

Consultant pharmacists assist nursing facilities in developing and implementing comprehensive strategies to improve medication management practices.

HistoryImportant Timelines

1954 Nursing homes receive federal funding if they meet certain requirements1967 Conditions of Participation - Facilities must meet Medicare and Medicaid standards1969 American Society of Consultant Pharmacists (ASCP) founded1974 Monthly Drug Regimen Review (DRR) required in all nursing facilitiesCirca 1980 *Guidelines to Surveyors - Guidelines for DRR -Appendix N SOM

1990 OBRA 87 Implemented – Federal Nursing Home Reform Act-Regulation and survey guidance relating to psychotropics

1999 Beer's List and other quality measures added to interpretive guidelines

2006 New F-Tags (F329; 332; 333; 425; 428; 431)Circa 2011 Consultant Pharmacist Independence Proposal

2012• CMS decides NOT to implement independence of CP• Partnership to improve dementia care

• Goal to reduce AP use in NH by 30% end of 20162016 New Rules of Participation - coined "The Mega Rule"

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Changes to LTC Requirements of Participation

These requirements have not been comprehensively updated since 1991 despite significant changes in the industry.

The proposed rule received over 9,800 public comments, resulting in a number of revisions to the proposed requirements.

The finalized provisions reflect advances in the theory and practice of service delivery and safety, and implement sections of the Affordable Care Act(ACA).

CMS – Reform of Requirements for LTC Facilities

CMS themes• Person Centered Care

• Residents and representatives: informed, involved and IN CONTROL.• Care and Coordination Planning

• Quality• Quality of care• Quality Assurance and Performance Improvement (QAPI)

TRIPLE AIM• Improved outcomes• Improved patient experience• Reduced overall healthcare costs

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Align with Current HHS Initiatives

Reducing unnecessary hospital readmissions

Reducing the incidences of healthcare acquired infections

Improving behavioral healthcare

Safeguarding nursing home residents from the use of unnecessary

psychotropic (antipsychotic) medications

Phased Implementation Schedule

Regulation will be implemented in 3 phases.

• Phase 1: (November 28, 2016)• Existing requirements, relatively straightforward to implement• require minor changes to survey process.

• Phase 2: (November 28, 2017)• All Phase 1 requirements, and those that providers need more

time to develop.• Phase 3: (November 28, 2019)

• All Phase 1 and 2 and those requirements that need more time to implement

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Scope and SeverityS/S Scope Severity DescriptionA Isolated Level 1 No actual harm, potential for minimal harm

B Pattern Level 1 No actual harm, potential for minimal harm

C Widespread Level 1 No actual harm, potential for minimal harm

D Isolated Level 2 No actual harm, potential for more than minimal harm

E Pattern Level 2 No actual harm, potential for more than minimal harm

*F Widespread Level 2 No actual harm, potential for more than minimal harm

G Isolated Level 3 Actual harm that is not immediate jeopardy

*H Pattern Level 3 Actual harm that is not immediate jeopardy

*I Widespread Level 3 Actual harm that is not immediate jeopardy

*J Isolated Level 4 Immediate jeopardy to resident health or safety

*K Pattern Level 4 Immediate jeopardy to resident health or safety

*L Widespread Level 4 Immediate jeopardy to resident health or safety

* Substandard quality of care -one or more deficiencies with s/s levels of F, H, I, J, K, or L

483.45 Pharmacy Services: F-TagsNew Tag Corresponding Old Tag

F755 Pharmacy services, Procedures, Records F425 and F431

F756 Drug Regimen Review, Report, Action F428

*F757 Drug regimen free from unnecessary drugs F329

*F758 Free from unnecessary psychotropic medications and PRN use

F329 and F428

*F759 Free of medication error rate ≥ 5% F332

*F760 Free of significant medication errors F333

*F761 Labeling and storage of drugs and biologicals F431

* Substandard quality of care-one or more deficiencies with s/s levels of F, H, I, J, K, or L

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Other Tags –May Affect Pharmacy Services

New Tag Corresponding Old Tag

*F600 Free from Abuse and Neglect F223

F655-F661 Comprehensive Resident Centered Care Plans F483-F484

*F684 Quality of Care F309

*F744 Treatment/Service for Dementia F309

F865 – F868 Quality Assurance Performance Improvement (QAPI) F520

F880; F881;F882

Infection Prevention and Control; ABX Stewardship; Infection Preventionist

F441

* Substandard quality of care-one or more deficiencies with s/s levels of F, H, I, J, K, or L

Freedom from Abuse, Neglect and Exploitation

F600 – Abuse and Neglect combined into a single tag

• What constitutes abuse and neglect• Assessing Consent• Involuntary Seclusion• Physical and Chemical Restraints• Policies to Prohibit Abuse and Neglect• Reporting Requirements

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Comprehensive Resident-Centered Care Plan

• F655-F661• Baseline Care Plan• Discharge Planning and Discharge Summary

Process (New)- Medication Reconciliation- Setting patient up to be successful upon discharge –

patient’s entire length of stay is focused of successful discharge.

Comprehensive Person-Centered Care Planning

Care plan must focus on resident and support of making own decisions and control

Baseline care plan must be completed within 48 hours of admission.Include minimum healthcare information necessary to properly care for resident (ex: physician orders, therapy, etc.) Provide patient & representative with summary. (Phase 2)

Discharge must be part of the comprehensive care plan• Include Reconciliation of

all pre-discharge meds with post-discharge meds (RX and OTC)

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Phase 1: except – Baseline care plan (Phase 2)

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Medication Reconciliation vs. Medication Regimen Review

Home Medication

List

Hospital Medication

List

Post-Acute Medication

ListHOME

Med Rec Med Rec

Med Rec

Medication Regimen Review –can be done anytime

Medication Reconciliation vs. Medication Regimen Review

MED.REC MRR

Past medication list needed Essential Not Essential

Patient medical information needed(age, weight, labs, diagnosis, etc) Not Essential Essential

Timing Very important Less important

Labor intensive Highly variable[20-30min]

Highly variable[5-10min]

Able to utilize EMR Notconsistently

More consistently

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Quality of Care

• F684 Quality of Care Tag- Formerly F309 – Hospice, palliative care, other care

issues- Removed dementia care from this tag

Behavioral Health Services

• F744- Sufficient and Competent Staffing related to provision of

behavioral health services.- Scope of services and coordination- Services for residents with dementia

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Quality Assurance and Performance Improvement

• QAPI Plan - F865-F868- Ongoing monitoring of issues- Identifying new issues- How are we correcting those issues

• Good Faith Attempts to Correct• Patient Safety Act• Potentially Preventable Adverse Events

Quality Assurance and Performance Improvement

Facility must maintain a quality assessment and assurance committee consisting at a minimum of:

• Director of Nursing• Medical Director or his/her designee• At least 3 other members of the facility staff, one of who must be the administrator,

owner, board member or other individual in a leadership role.• The infection control and prevention officer (ICPO).

Program Activities: facility must set priorities for its performance improvement activities that focus on high-risk, high-volume, problem-prone areas.

• Must track medical errors• Must track adverse resident events

Phase 1 -Participation in QAA Committee - Phase 2 –QAPI Plan as required ACA - Phase 3 –Full QAPI + “ICPO”

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Infection Control

• F880-F882• Infection Prevention and Control Program (IPCP)

- Requires facilities to have a system for preventing, identifying, reporting, investigating and controlling infections and communicable diseases for all residents, staff, volunteers, visitors.

• An ABX stewardship program that includes ABX use protocols and a system to monitor antibiotic use. (Phase 2)

• Infection Preventionist (IP): (Phase 3)- Facility must designate one or more individual(s) as the IP who is

responsible for the facility’s IPCP – with specialized training.

Pharmacy Services

F755 - Pharmacy Services

F756 - Drug Regimen Review

F757 -Unnecessary Medications

F758 -Psychotropic

(Unnecessary and PRN Usage)

F759 and F760 -Med errors

F761 - Labeling and Storage

F759 and F760Medication Errors

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Pharmacy Services

Pharmacy Services (F755)• Nothing really new here• Facility must provide routine and emergency drugs to its residents

• Establish a system of records and receipts and disposition of controlled meds.

• Expended controlled medication accountability language.

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Phase 1: unless indicated otherwise

Pharmacy Services

Medication Regimen Review (F756)• A pharmacist must review resident’s medical chart

monthly (Phase 2)• Irregularities must be reported to attending physician,

medical director and director of nursing• Attending physician must document in resident’s medical

record that the identified irregularity has been reviewed.

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Pharmacy Services

Medication Regimen Review and Unnecessary Drugs• Facility must develop policies and procedures addressing time frames for the different

steps in the process of MRR follow up• Example: an irregularity that requires urgent action to protect the resident.

• Irregularities include any drug meeting criteria of an unnecessary drug (F757)

excessive dose excessive duration

Without adequate monitoring Without adequate indication

in the presence of adverse consequence any combination of the reasons stated

Psychotropic Medications

Antipsychotics

Antidepressants

Antianxiety medications

Hypnotics

• F758• A psychotropic drug is any drug that affects brain activities associated with

mental processes and behavior. These drugs include, but are not limited to:

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Psychotropic Medications

Residents who have not used psychotropic drugs are not given these drugs unless necessary to treat a specific condition as diagnosed and documented in the clinical record.

Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs

Facilities must ensure:

PRN Psychotropic MedicationsResidents do not receive a PRN psychotropic unless medication is necessary to treat a diagnosed specific condition documented in clinical record

PRN orders for psychotropics are limited to 14 days

• If prescriber believes appropriate for PRN to be extended > 14 days, rationale must be documented in medical record and indicate the duration for the PRN

PRN orders for antipsychotic drugs are limited to 14 days and cannot be renewed unless the prescribing practitioner evaluates the resident for appropriateness.

Phase 2

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Medication Errors

• F759-F760• The standard of practice is that crushed medications

should not be combined and given all at once, either orally or via feeding tube. - Crushing and combining may result in physical and

chemical incompatibilities leading to an altered therapeutic response. Additionally, a resident may not want or may be unable to finish eating the food into which combined crushed medications were added, all of which could prevent complete administration of the crushed medications.

Crushing-Interpretive Guidance Revised

• Best practice: separately crush and administer each medication with food to address concerns with physical and chemical incompatibility and complete dosaging.

• However, separating crushed medications may not be appropriate for all residents and is generally not counted as a medication error.

- Facilities should use a person-centered, individualized approach to administering all medications. If concerns related to crushing and combining oral medications are identified, 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).

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Pharmacy Services

Labeling (and storage) of Drugs (F761)

• “Nothing really new here”• Drugs must be labeled in accordance with currently

accepted professional standards• Accessory and cautionary instructions, expiration

dates. Nothing really new here• Dating of multi-use medications (e.g. vials)

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Pharmacy ServicesLabeling (and storage) of Drugs (F761)

• The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.

• Under “Guidance”: MEDICATION ACCESS AND STORAGE (page 515)• Schedule II-V medications must be maintained in separately locked, permanently affixed compartments.

The access system (e.g. key, security codes) used to lock Schedule II-V medications and other medications subject to abuse, cannot be the same access system used to obtain the non-scheduled medications. The facility must have a system to limit who has security access and when access is used.

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Take Home Points of New Rules

• Patient centric• New rules are patient centric with focus on quality

- Triple Aim

• Continued focus on psychotropic medications• Continued expansion of the Consultant Pharmacist’s

role

Post Test Question ONE

• A PRN Quetiapine order may be renewed via telephone order as long as nursing staff has assessed the patient for continued need.

- True or False

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Post Test Question Two

• Which of the following are required to be a QAPI member (circle all that apply)

1. Director of Nursing2. Medical Director3. Consultant Pharmacist4. Infection Control and Preventionist Officer

Questions?

Joe Litsey, Pharm.D. BCGPjlitsey@thriftywhite.com612-965-4883

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