Update on the Mega Rule

Update on the Mega Rule What is it looking like already? Joanne Hirshfield, RPh, FASCP, MBA, BCGP President-Elect American Society of Consultant Pharmacists Texas State Chapter ASCP January 27, 2017 Disclosure / Contact Information Joanne Hirshfield President, Pharmacy Solutions Consulting, LLC Board Member: ASCP johirshfield@gmail.com 315-796-6868 Nothing to disclose at this time Credits to: Arnie Clayman, VP Pharmacy Practice & Government Affairs, ASCP Jennifer Hardesty, Chief Clinical Officer and Corporate Compliance Officer, Remedi SeniorCare William Vaughan, VP Education and Clinical Affairs, Remedi SeniorCare 1111111111 Learning Objectives Compare and contrast the regulatory language of the Mega Rule and the guidance for surveyors. Produce a timeline for the consultant pharmacist which meets the regulations as they pertain to reviews. Educate a fellow health care professional or administrator about psychotropics as outlined in the guidance to surveyors and what constitutes continued need for PRN psychotropics. List and discuss current legislation and specific regulatory changes affecting the long term care sector. Mega Rule Background Medicare Conditions first published in 1989 Set standards for health care and safety First comprehensive update since 1991 Proposed rule published July, 2015 CMS received nearly 10,000 comments Final rule published October 4, 2016 Phased Implementation Phase 1 11/28/2016 Phase 2 11/28/2017 (see moratorium notes) Phase 3 11/28/2019 CMS Memo November 24, 2017 Ref: S&C 18-04-NH Temporary (18-mo) moratorium on specific Phase 2 requirements: F758 Psychotropic Medications related to PRN limitations 483.45(e)(3)-(e)(5) F881 Antibiotic Stewardship Program 483.80(a)(3) F865 QAPI Program and Plan related to the development of the QAPI Plan 483.75(a)(2) CMS Memo November 24, 2017 CMS will hold constant the current health inspection star ratings on the Nursing Home Compare (NHC) website for any surveys occurring between November 28, 2017 and November 27, 2018. Surveys under the new LTC survey process will be published on the NHC but will not be incorporated into the calculations for the Five-Star Quality Rating System for 12 months. In early 2018, NHC health inspection star ratings will be based on the two most recent cycles of findings for standard health inspection surveys and the two most recent years of complaint inspections. 1

F Tag Number Changes Pharmacy Related Old Tag Tag # RegulationText that Regulatory (Taken from Tag Title CFR was Moved to (As of Groupings App PP 03-08- Nov. 28, 2017) New Tag 2017) F552 Right to be Informed/Make Treatment Decisions 483.10(c)(1)(4)(5) 483.10 Resident Rights F154 483.10(c)(1)(4)(5) F154 483.10(c)(2)(iii) F553 Right to Participate in Planning Care 483.10(c)(2)(3) 483.10 Resident Rights F280 483.10(c)(2)(i)(ii)(iv)(v)(3)(i)-(iii) Pharmacy F425 483.45(a)(b)(1) F755 Svcs/Procedures/Pharmacist 483.45(a)(b)(1)-(3) 483.45 Pharmacy Services F431 483.45(b)(2)(3) /Records Drug Regimen Review, Report F756 483.45(c)(1)(2)(4)(5) 483.45 Pharmacy Services F428 483.45(c)(1)(2)(4)(5) Irregular, Act On Drug Regimen is Free From F757 483.45(d)(1)-(6) 483.45 Pharmacy Services F329 483.45(d) Unnecessary Drugs F329 483.45(e)(1)-(5) F758 483.45(c)(3)(e)(1)-(5) 483.45 Pharmacy Services F428 483.45(c)(3) Free from Unnec Psychotropic Meds/PRN Use Free of Medication Error Rates F759 483.45(f)(1) 483.45 Pharmacy Services F332 483.45(f)(1) of 5% or More Residents Are Free of Significant F760 483.45(f)(2) 483.45 Pharmacy Services F333 483.45(f)(2) Med Errors Label/Store Drugs & F761 483.45(g)(h)(1)(2) 483.45 Pharmacy Services F431 483.45(g)-(h) Biologicals F580 Notify of Changes (Injury/Decline/Room, Etc.) 483.10(g)(14)(i)-(iv) 483.10 Resident Rights F157 483.10(g)(14) F881 Antibiotic Stewardship Program 483.80(a)(3) 483.80 Infection Control No Associated Tag Why the Mega Rule? The requirements for participation were recently revised to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. The revisions were published in a final rule that became effective on November 28, 2016. The survey protocols and interpretive guidelines serve to clarify and/or explain the intent of the regulations. All surveyors are required to use them in assessing compliance with Federal requirements. Deficiencies are based on violations of the regulations, which are to be based on observations of the nursing home s performance or practices. Why the Mega Rule? Two different survey processes existed to review for the Requirements of Participation (Traditional and QIS) Surveyors identified opportunities to improve the efficiency and effectiveness of both survey processes. The two processes appeared to identify slightly different quality of care/quality of life issues. CMS set out to build on the best of both the Traditional and QIS processes to establish a single nationwide survey process. Why the Mega Rule Same survey for entire country Strengths from Traditional & QIS New innovative approaches Effective and efficient Resident-centered Balance between structure and surveyor autonomy Regulation vs. Guidance F 756 (Drug Regimen Review) Regulation: 245 words Guidance: 4,055 words Surveyors must base all cited deficiencies on a violation of statutory and/or regulatory requirements, rather than sections of the interpretive guidelines. The deficiency citation must be written to explain how the entity fails to comply with the regulatory requirements, not how the facility fails to comply with the guidelines for the interpretation of those requirements. Bottom Line Must versus should Abnormal or toxic serum concentrations must be evaluated for dosage adjustments. (F 757: Unnecessary Drugs) The facility should have a procedure for how to resolve situations where the attending physician does not concur with or take action on identified irregularities and the attending physician is also the medical director. (F 756: Drug Regimen Review) Strict compliance with guidance not required, not easy to accomplish, but will likely immunize against deficiencies 2

Important Definitions: Pharmaceutical Services The process (including documentation, as applicable) of receiving and interpreting prescriber s orders; acquiring, receiving, storing, controlling, reconciling, compounding (e.g., intravenous antibiotics), dispensing, packaging, labeling, distributing, administering, monitoring responses to, using and/or disposing of all medications, biologicals, chemicals (e.g., povidone iodine, hydrogen peroxide); The provision of medication-related information to health care professionals and residents; The process of identifying, evaluating and addressing medicationrelated issues including the prevention and reporting of medication errors; and The provision, monitoring and/or the use of medication-related devices - Guidance at F 755: Pharmacy Services Notable Guidance F 755: Pharmacy Services Liquid controlled medications are often dispensed in multidose 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. Notable Guidance F 755: Pharmacy Services 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. Notable Guidance F 755: Pharmacy Services 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. Quiz true/false Medications can never be combined for crushing prior to po administration. Medications can never be combined for crushing prior to feeding tube administration. Facilities should use a person-centered, individualized approach to administering all medications. Significant (F760) vs. Non-significant Error Based on: Resident condition Drug category (narrow therapeutic index drugs) Frequency of error 3

Notable Guidance F 759: Med Errors F 760: Significant Med Errors The standard of practice is that crushed medications should not be combined and given all at once, either orally (e.g., in pudding or other similar food) or via feeding tube. Crushing and combining medications may result in physical and chemical incompatibilities leading to an altered therapeutic response, or cause feeding tube occlusions when the medications are administered via feeding tube. Notable Guidance F 759: Med Errors F 760: Significant Med Errors Additionally, a resident may not want or may be unable to finish eating the food into which combined crushed medications were added or the resident s feeding tube could malfunction, all of which could prevent complete administration of the crushed medications. In these situations, staff would not know which medications the resident actually received because they were crushed and combined but not fully administered. Update on Crushing Meds ASCP Answer from CMS, December 6, 2017 not yet clarified in SOM CMS will be revising the interpretive guidance to convey that best practice would be to separately crush and administer each medication with food to address concerns with physical and chemical incompatibility of crushed medications and ensure complete dosing of each medication. However, separating crushed medications may not be appropriate for all residents and should not be 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. Interpretive guidance related to crushed medications administered via feeding tube will remain unchanged. Quiz MRR irregularities must be reported to: a. Attending physician b. Medical Director c. Director of Nursing d. All of the above Phase 1 Irregularities Medical director F 501: The medical director is responsible for (i) Implementation of resident care policies; and (ii) The coordination of medical care in the facility. Guidance: The medical director helps the facility identify, evaluate, and address/resolve medical and clinical concerns and issues that: -Affect resident care, medical care or quality of life; or - Are related to the provision of services by physicians and other licensed health care practitioners. 4

Important Definitions: Irregularity use of medication that is inconsistent with accepted standards of practice for providing pharmaceutical services, not supported by medical evidence, and/or that impedes or interferes with achieving the intended outcomes of pharmaceutical services. An irregularity also includes, but is not limited to, use of medications without adequate indication, without adequate monitoring, in excessive doses, and/or in the presence of adverse consequences, as well as the identification of conditions that may warrant initiation of medication therapy. - Guidance at F 756: Drug Regimen Review F580 483.10(g)(14) Notification of Changes (i) A facility must immediately inform the resident; consult with the resident s physician; and notify, consistent with his or her authority, the resident representative(s) when there is (A) An accident involving the resident which results in injury and has the potential for requiring physician intervention; (B) A significant change in the resident s physical, mental, or psychosocial status (that is, a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications); (C) A need to alter treatment significantly (that is, a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment); Quiz Timeline for CRPh Review Medication Regimen Review (MRR) must be done: A. Every 30 days B. Monthly C. When resident is at the facility less than 30 days D. B and C Monthly MRR Short Stays When residents discharged prior to CRPh s next routine visit Change in Condition falls, weight loss, mental status change, etc. F756 483.45(c)(5) The pharmacist must review each resident s medication regimen at least once a month in order to identify irregularities and to identify clinically significant risks and/or actual or potential adverse consequences which may result from or be associated with medications. F756 483.45(c)(5) Facilities must develop policies and procedures to address the MRR. The policies and procedures must specifically address: The appropriate time frames for the different steps in the MRR process The steps a pharmacist must follow when he or she identifies an irregularity that requires immediate action to protect the resident and prevent the occurrence of an adverse drug event. 5

F756 483.45(c)(5) MRR policies and procedures should also address, but not be limited to: MRRs for residents who are anticipated to stay less than 30 days; MRRs for residents who experience an acute change of condition and for whom an immediate MRR is requested after appropriate staff have notified the resident s physician, the medical director, and the director of nursing about the acute change. MRR Remotely?? While conducting the MRR in the facility is not required for compliance, important information about indications for use, actual or potential medication irregularities or adverse consequences may be attainable only by talking to the staff, reviewing the medical record, and observing and speaking with the resident, the resident s family and/or representative. Policy and Procedure MEDICATION REGIMEN REVIEW (MRR) WORKSHEET FOR SHORT TERM STAY RESIDENTS Policy: A medication regimen review (MRR) must be completed on all patients who have an anticipated stay of less than 30 days. Purpose: To ensure that all residents who have an anticipated stay of less than 30 days receive a medication regimen review (MRR) by a consultant pharmacist in compliance with Federal guidelines. Procedure: 1. Upon admission or readmission, an allocated staff member (i.e. social worker, charge nurse, etc) who has determined the stay of the resident will be less than 30 days, will fax to the designated phone number the completed MRR request form (see attached), the discharge summary, most recent labs and current medication list. 2. A Consultant pharmacist will obtain the faxes on a weekly basis unless the admitting physician or medical director deems the review necessary to be done in a more timely fashion. The facility will then contact the consultant pharmacist directly to request an immediate review. 3. The consultant pharmacist will email, phone or fax the completed review to the facility. The report will indicate either a recommendation or a review that states No Irregularities at this time or no recommendations at this time. If the review is completed by phone a written report will follow. 4. Upon receipt of the pharmacist s recommendation the facility will notify the appropriate medical staff. Once the recommendation is addressed by the staff it will be placed in the clinical record in the section designated for pharmacy reviews. Policy and Procedure MEDICATION REGIMEN REVIEW (MRR) FOR RESIDENTS WITH A SIGNIFICANT CHANGE Policy: A medication regimen review (MRR) must be completed on all patients who have a significant change in status that may be medication related. Purpose: To ensure that all residents who have experienced a significant status change receive a medication regimen review (MRR) by a consultant pharmacist in compliance with Federal guidelines. Procedure: 1. Upon identification of a significant change of status in a resident, an allocated staff member (i.e. social worker, charge nurse, etc) will contact the physician who will determine if a medication regimen review (MRR) by a consultant pharmacist is necessary. If a MRR is recommended the staff will fax to the designated phone number the completed MRR request form (see attached), the nursing notes pertaining to the status change, most recent labs and current medication list. 2. The nursing staff or the physician shall document in the clinical record a statement that confirms the physician has either requested or denied a pharmacy medication regimen review. 3. A Consultant pharmacist will obtain the faxes on a weekly basis unless the admitting physician or medical director deems the review necessary to be done in a more timely fashion. The facility will then contact the consultant pharmacist directly to request an immediate review. 4. The consultant pharmacist will email, phone or fax the completed review to the facility. The report will indicate either a recommendation or a review that states No Irregularities at this time or No recommendations at this time. If the review is completed by phone a written report will follow. 5. Upon receipt of the pharmacist s recommendation the facility will notify the appropriate medical staff. Once the recommendation is addressed by the staff it will be placed in the clinical record in the section designated for pharmacy reviews. Medication Regimen Review Request Facility: Resident Name: Date: Is the anticipated stay less than 30 days? Yes No Did MDS generate request: yes no. If yes what triggered significant change: Symptom(s) causing request: Current Vitals: BP: PR: Resp: Temp: Current Weight: Last Month Weight: Lab work within the last 7 days: (attach any lab results) Medication Regimen Review Request Please chart within the last 7 days: Fall(s): yes no If yes how many Has cause been determined? If yes, what was cause? Behavior Changes: Complained of pain: yes no If yes how often in last 7 days: Complained of painful urination: Yes no Bowel Function Normal: Yes No IF no explain Does this request require immediate action from consultant pharmacist? If yes, please call your consultant pharmacist and notify them. Please fax pertinent information (current physician orders, discharge summaries-if applicable, labs, nursing notes, etc.) MRR Findings CRPh must document no irregularity or nature of irregularity Timeliness of notification depends on factors including the potential for serious adverse consequences No need to document a continuing irregularity in the report each month if the attending physician has documented valid rationale Findings should be housed in a consistent location It is not acceptable for an attending physician to simply disagree must be clinical basis Facility should have a procedure for resolving situations when the attending physician does not take action and/or the attending physician is also the medical director 6

PHASE 2 F 758: Psychotropic Drugs F758 483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic F 758: Psychotropic Drugs Indications for Antipsychotics 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; Behavioral symptoms present danger to the resident or others Expressions or indications of distress that cause significant distress to the resident If not clinically contraindicated, multiple nonpharmacological approaches have been attempted, but did not relieve the symptoms which are presented a significant distress and/or GDR was attempted, but clinical symptoms returned GDR Timetable Within the 1 st year in which a resident is admitted on a psychotropic or after a psychotropic is initiated Must attempt GDR in 2 separate quarters with at least 1 month between attempts, unless clinically contraindicated After the 1 st year, a GDR must be attempted annually, unless clinically contraindicated Clinically Contraindicated Target symptoms returned or worsened after the most recent attempt at GDR The physician has documented the clinical rationale for why an additional attempted GDR at that time would be likely to impair the resident s function or increase distressed behavior Treatment of disorder other than distress related to dementia 7

F 758: Psychotropic Drugs F 758: Psychotropic Drugs 483.45(e)(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in 483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident s medical record and indicate the duration for the PRN order. PRN orders for antipsychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication. Guidance: No exclusion 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.) Further Guidance Use of psychotropic medications, other than antipsychotics, should not increase when efforts to decrease antipsychotic medications are being implemented, unless the other types of psychotropic medications are clinically indicated. OTC natural or herbal products must also only be given with a documented clinical indication Further Guidance Enduring Conditions Enduring: non-acute, chronic, or prolonged Before initiating or increasing a psychotropic for enduring conditions, the resident s symptoms and therapeutic goals must be clearly and specifically identified and documented Further Guidance Enduring Conditions The facility must ensure that the resident s expressions or indications of distress are: Not due to medical condition Not due to environmental stressors alone Not due to psychological stressors alone Persistent Quiz True/False Melatonin requires a consent for administration. An initial prn order for a psychotropic requires direct examination and assessment of the resident. Under certain conditions, prn psychotropic medications can be ordered indefinitely. 8

p. 508 of Appendix PP: Herbal and alternative products are considered to be dietary supplements. They are not regulated by the Food and Drug Administration (e.g., they are not reviewed for safety and effectiveness like medications) and their composition is not standardized (e.g., the composition varies among manufacturers). If a dietary supplement is given to a resident between meals and has a vitamin(s) as one or more of its ingredients, it should be documented and evaluated as a dietary supplement, rather than a medication. For clinical purposes, it is important to document a resident s intake of such substances elsewhere in the clinical record and to monitor their potential effects, as they can interact with other medications. NOTE: Because nutritional and dietary supplements are not considered to be medications for purposes of the medication administration observation, noncompliance with the administration of these products should not be included in the calculation of the facility s medication error rate. The exception to this would be vitamins and minerals which are generally considered a category of dietary supplements. Medication errors involving vitamins and/or minerals should be documented at F759 and counted towards the error rate calculation. Medication errors involving vitamins and minerals would not be considered to be a significant medication error unless the criteria at F760 were met. It is expected that the facility staff, along with the prescriber and consulting pharmacist, are aware of, review for, and document any potential adverse consequences between medications, nutritional supplements, and dietary supplements that a resident is receiving. F 881: Infection Prevention & Control Program The facility must establish 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. Protocols: CDC: Up to 75 percent 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. F 881: Infection Prevention & Control Program Guidance Antibiotic Stewardship Improve resident outcomes and reduce antibiotic resistance CDC / AHRQ protocols referenced but not mandated The facility must develop an antibiotic stewardship program which includes the development of protocols and a system to monitor antibiotic use. This development should include leadership support and accountability via the participation of the medical director, consulting pharmacist, nursing and administrative leadership, and individual with designated responsibility for the infection control program if different. The term drug expertise does not appear in appendix PP The assessment, monitoring, and communication of antibiotic use shall occur by a licensed pharmacist in accordance with 483.45(c), F756, Drug Regimen Review. Antibiotic Stewardship Tools Antibiotic Reports Drug class Drug Route Days of therapy Orders > 14 days Orders with no stop dates Possible IV to PO conversion Orders by prescribers Antimicrobial Stewardship Toolkit A quick primer can be found at: https://www.youtube.com/watch?v=dhdecnjekyw&feature=youtu.be ASCP-SIDP Long-Term Care Antimicrobial Stewardship Certificate Program Practice-based certificate program focused on the role that pharmacists play in the appropriate use of antimicrobial agents Influenza and Pneumococcal Vaccinations F883 483.80(d) Influenza and pneumococcal immunizations Guidance to Surveyors: Review facility policies regarding the provision of vaccines in order to determine if the policies reflect current standards of practice. Refer to 483.21(b)(3)(i)the services provided or arranged by the facility must meet professional standards of quality (F658). Also, refer to F880 for concerns with infection prevention and control. As of the date of publication of this guidance, ACIP recommends that both 23-valent pneumococcal polysaccharide vaccine (PPSV23) and 13- valent pneumococcal conjugate vaccine (PCV13) vaccines should be administered routinely in series to all adults aged 65 years. Controlled Substances F755 483.45 Pharmacy Services 483.45(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who 483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility. 483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and 483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. Guidance to Surveyors: The facility, in coordination with the licensed pharmacist, provides for: A system of medication records that enables periodic accurate reconciliation and accounting for all controlled medications; Prompt identification of loss or potential diversion of controlled medications; and Determination of the extent of loss or potential diversion of controlled medications. Records of personnel access, usage, and disposition of all controlled medications with sufficient detail to allow reconciliation Periodic reconciliation of records of receipt, disposition, usage, and inventory for all controlled medications Secure and safe method of disposal to prevent diversion and/or accidental exposure Used fentanyl patches by folding the patch in half with the sticky sides together and flushing the patch down the sink or toilet 9

F 552: Planning and Implementing Care The resident has the right to be informed of, and participate in, his or her treatment, including: The right to be fully informed in language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition. The right to be informed, in advance, of the care to be furnished and the type of care giver or professional that will furnish care. The right to be informed in advance, by the physician or other practitioner or professional, of the risks and benefits of proposed care, of treatment and treatment alternatives or treatment options and to choose the alternative or option he or she prefers. F 552: Planning and Implementing Care Guidance Treatment refers to medical care, nursing care, and interventions provided to maintain or restore health and well-being, improve functional level, or relieve symptoms. Person-Centered Med Pass Guidance: Residents have the right to choose health care schedules consistent with their interests and preferences, and the nursing home should gather this information in order to be proactive in assisting residents to fulfill their choices. The adjustment of medication administration times, to meet the individual needs and preferences of residents, must be considered by the nursing home. However, medication administration scheduling must still consider physician prescription, manufacturer s guidelines, and the types of medication, including time-critical medications. Resident Rights versus Facility Responsibility While Federal regulations affirm a resident s right to participate in care planning and to refuse treatment, the regulations do not require the facility to provide specific medical interventions or treatments requested by the resident, family, and/or resident representative that the resident s physician deems inappropriate for the resident s medical condition. (Guidance F 553) Permission given by or a request made by the resident and/or representative does not serve as a sole justification for the medication itself. (Guidance F 758) ANTIBIOTICS & PSYCHOTROPICS While the resident also has the right to refuse any treatment or services, the resident s refusal does not absolve facility staff from providing other care that allows him/her to attain or maintain his or her highest practicable physical, mental, and psychosocial well-being. For example, facility staff would still be expected to provide appropriate measures for pressure injury prevention, even if a resident has refused food and fluids and is nearing death. (Guidance 578) When the resident request is something that facility staff feels would place the individual at risk (i.e., the resident chooses not to use the walker, recommended by therapy), is there a process in place to examine the risk/benefit and guide decisionmaking? (Guidance - Procedures F 553) Current Legislative and Regulatory Focus Provider Status CMS Mega Rule, Transitions of Care, IMPACT Act, DRR Pilot, MTM Pilot, CMMI: Innovations Center, Bundled Payment & other Risk Sharing Models FDA Proposed Rules on Compounding & Repackaging EPA Proposed Rule on Pharmaceutical Waste ONC Interoperability EHR, Pharmacy HIT Collaborative, LTPAC HIT Collaborative USP Chapter <800> Hazardous Drug Compounding, Proposed Chapter <797> Sterile Compounding DEA access to CDS for patients while preventing diversion Federal Legislative Advocacy Provider Status for Pharmacists - The Patient Access to Pharmacists Care Coalition s (PAPCC) mission is to develop and help enact a federal policy proposal that would enable patient access to, and payment for, Medicare Part B services by state-licensed pharmacists in medically underserved communities. Our primary goal is to expand medically-underserved patients access to pharmacist services consistent with state scope of practice law. PAPCC organizations representing patients, pharmacists, pharmacies & interested stakeholders (around 40 groups) 10

Provider Status in 115 th Congress Senate-S.109 introduced in January by Sen. Charles Grassley (R-IA) with 51 co-sponsors Referred to the Senate Finance Committee House-H.R.592 (same bill number as 114th Congress, but totally new bill) introduced by Brett Guthrie (R-KY) with 241 co-sponsors. Vote depends on the official cost estimate from the Congressional Budget Office, which has not yet been released. (Updated 1/18/18) Plus - AMDA 2018 House of Delegates supports provision of CMS Provider Status for the CRPh to LTC facilities submit to AMA for an item of business at the 2018 Annual Meeting Impact Act 2014 Improving Medicare Post-Acute Care Transformation Act Standardized patient assessment data across all four PAC settings Quality Measures Defined by CMS Impact Act Standardization Inpatient Rehabilitation Facilities - Patient Assessment Instrument (IRF- PAI) IRF-PAI Medication Reconciliation Skilled Nursing Facilities - Minimum Data Set (MDS) MDS Medication Reconciliation Home Health Agencies - Outcome & Assessment Information Set (OASIS) OASIS Medication Reconciliation Long-Term Care Hospitals - Continuity Assessment Record & Evaluation (CARE) Data Set (LCDS) LCDS Medication Reconciliation CMS Quality Strategy Goals Six Priorities Making Care Safer Strengthen person and family engagement Promote effective communication and coordination with care Promote effective prevention and treatment Work with communities to promote best practices of healthy living Make care affordable ASCP and the DEA ASCP established its DEA Task Force in 1998 to address ambiguities within the CSA (Controlled Substances Act) Hospital vs. Community vs. LTC Pharmacy CSA and the practice standards of LTCPs represented a potential regulatory compliance risk DEA Task Force - mission of working with the DEA to resolve issues and challenges - Balance patient care vs. regulatory compliance Changes for LTC: 7 day allowance for signature vs. 72hr and faxing as original in LTC & hospice ASCP and the DEA 2004-2005: ASCP worked with the National Association of Boards of Pharmacy (NABP) on a joint task force to identify model language addressing legal access to controlled medications for LTC patients Model language focused on recognizing chart orders as legal prescriptions for ordering controlled substances ASCP made multiple presentations to Boards of Pharmacy across the country and encouraged them to update their regulations to include LTC specific rules 11

ASCP and the DEA In 2010, the DEA suggested that NABP convene a second national task force to go through the entire CSA and identify areas that needed modernization ASCP participated with NABP and identified items related to LTC pharmacy practice October 6, 2010 DEA issues Policy Statement that addressed the nurse as an agent of the prescriber Changed the way that controlled substance prescriptions are handled in LTC Nurses in a facility today remain the agent of the prescriber for non-controlled medications Current Nurse Agent Overview Agents are employed by the authorized prescriber and may be: A nurse located in the prescribers office A non-licensed receptionist Hospital employees (b/c hospitals are DEA registrants) NOT LTCF Nurses LTCF employees may become agents but only through a very prescriptive and detailed process that documents such delegation Authority of Agent (under current guidance) Prepare CII-CV prescription for practitioner to sign Transmit CII-CV prescription that is signed by practitioner to pharmacy via fax Take a verbal CIII-CV prescription from the physician and communicate that prescription via telephone to the pharmacy ASCP DEA Task Force Pathway to Resolution A Policy Approach Task Force working directly with DEA staff since 2015 on list of issues, focused on Nurse Agent issue. Recommend that DEA issue a revised Nurse Agent Policy which specifically addresses an alternative approach for the LTC setting Benefits:» No legislative or regulatory action needed» Shortened timeframe to drive change ASCP understands that any changes have to be carefully crafted so they do not create unintended consequences or affect other practice areas ASCP- DEA Task Force Update Obtained written clarification from DEA: Electronic e-kits: use for 1 st dose only do not require separate DEA registration (11/30/16). Comprehensive Addiction & Recovery Act (CARA) DEA Clarification: CARA 30-day fill limitation does not apply to long-term care and hospice patients (1/13/17) DEA verified, partial-fills for CII prescription medications with up to 60-days to complete. ASCP - NABP Model Rules TF Updated/Revised LTC Rules and presented to NABP at meeting in August 2017 Collaboration is the Key to Effective Advocacy ASCP has representation on over 30 coalitions and collaborative groups Collaboration is the Key to Effective Advocacy Access and collaboration with other post-acute care groups and associations 12

2017 Memo, Appendix PP, Crosswalk https://www.cms.gov/medicare/provider-enrollment-and- Certification/GuidanceforLawsAndRegulations/Downloads/Surv ey-and-cert-memo-revision-som-appendix-pp-phase-2.pdf https://www.cms.gov/medicare/provider-enrollment-and- Certification/GuidanceforLawsAndRegulations/Downloads/Adva nce-appendix-pp-including-phase-2-.pdf https://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationEnforcement/Downloads/F-Tag- Crosswalk.xlsx New survey process https://www.cms.gov/medicare/provider-enrollment-and- Certification/GuidanceforLawsAndRegulations/Downloads/New-Long- term-care-survey-process%e2%80%93slide-deck-and-speaker- Notes.pptx The vision of the American Society of Consultant Pharmacists is optimal medication management and improved health outcomes for all older persons. Mission - The American Society of Consultant Pharmacists empowers Pharmacists to enhance quality of care for all older persons through the appropriate use of medication and the promotion of healthy aging. Advocacy For Senior Care Pharmacists ASCP s members manage and improve drug therapy and improve the quality of life of geriatric patients and other individuals residing in a variety of environments, including nursing facilities, subacute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community-based care. In addition, pharmacy student members of ASCP demonstrate their identification with and support of ASCP's mission and vision to serve seniors wherever they reside. 1. Certificate Program 2. Online Directory 3. Virtual Network 4. Path to BCGP 5. Focus Groups New Opportunities for Pharmacists New Certificate Program: Business Skills for Private Practice Entrepreneur overview Business planning Financial management Sales & marketing 13

Senior Care Pharmacist Directory Senior Care Virtual Pharmacy Network Get listed Someone finds you New ASCP Membership Category Includes credentialing & monitoring required by payors Access to patients eligible for MTM/CMR Includes billing administration by Xchangelabs, LLC Contact Carol Sirianni at csirianni@ascp.com 412-491-9888 ASCP Pilot Patients Thank you! Questions? May 3, 2017: Hill Prep at Crowell & Moring, Over 100 members and over 300 congressional office visits, Fund-raising event in the evening followed by opening of the Forum with Congressman Buddy Carter's Keynote: Perspectives from Congress' Only Pharmacist 14