Medication Related Changes Phase 1&2 Medicare and Medicaid Programs Reform of Requirements for Long-Term Care Facilities Published 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) *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 2
Pharmacy Related F-Tags Old F309 F329 F334 F425 F428 F431 F441 New F675 Quality of Life F684 Quality of Care F697 Pain Management F698 Dialysis F744 Dementia Care F757 Unnecessary Drugs F758 Psychotropic Drugs F883 Influenza & Pneumococcal Immunizations F755 Pharmacy Services F756 Drug Regimen Review F758 Psychotropic Drugs F761 Labeling/Storage of Drugs & Biologicals F880 Infection Control F881 Antibiotic Stewardship F882 Infection Preventionist ** Centers for Medicare and Medicaid Services. State Operations Manual Appendix PP: Guidance to Surveyors for Long Term Care Facilities. 2017 June 30. 3
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 Phase 1: started 11/28/2016 Respond to Pharmacist Reports attending physician must document in medical record: The irregularity that has been reviewed The action that has been taken to address the irregularity If no change, document the rationale in medical record 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 4
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 **(Rev. 168, Issued: 3-08-17, effective: 3/08/17, Implementation: 3/08/17) 5
Phase 1 started 11/28/16 Phase 2 started 11/28/17 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) 6
Phase 1 Updated definition of Psychotropic Drug 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 7
Phase 2 All psychotropic drugs will be held to the same standards PRN Psychotropic Medications GDR s, behavioral interventions for all psychotropics 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 record Residents who receive these drugs must receive gradual dose reductions and behavioral interventions, unless otherwise contraindicated, in an effort to discontinue these drugs 8
F758 Psychotropic Drugs Gradual Dose Reductions 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 A GDR is required for any psychotropic med being used for a psychiatric diagnosis or for expressions or indications of distress related to dementia. 9
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 *PRN orders for Antipsychotic drugs are limited to 14 days, NO EXCEPTIONS 11
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.) 12
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. 13
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 Monthly Review of Residents Medical Record 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 14
Infection Prevention & Control Program (IPCP) F880 Phase 2 IPCP 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 15
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. 16
Phase 2 Antibiotic Stewardship Antibiotic Stewardship F881 Leadership Commitment Accountability Drug Expertise Action Tracking Reporting Education 17
STREAMLINE EMPIRIC ANTIBIOTIC ORDERS What can long-term care facilities do? 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 *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 ) 18
Antibiotic Order Requirements DON T FORGET TO CHECK FOR MEDICATION ALLERGIES A correct antibiotic order should include: Name of medication Strength of medication Dose to be given Route of administration Frequency of dosing Indication for use Stop date Any monitoring that may be required such as vancomycin trough proactively reducing warfarin dose and checking INRs more frequently 19
Medication Errors F759 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. 20
Resident Centered Care: Medication Errors Timing of Med Administration F759 F760 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 21
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 22
Phase 3 11/28/2019 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 23
For More Information Contact your Consultant Pharmacist or Account Manager Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities Issue Section Federal Register page #; Oct. 4, 2016 Comprehensive Person-centered Care 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 CMS Nursing Home Web Page: https://www.cmas.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregualtionsinnursinghomes.html 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 24