Bcacp - Managed Care, Regulatory Exam Questions And Answers 2024.

Pharmacist mission improve public health through ensuring the safe, effective, and appropriate use of medications 4 main clinical pharmacy practice models pharmaceutical care MTM comprehensive med mgmt CDTM Morisky Questionnaire predictive adherence measurement tool - 1+ drugs in a regimen for a particular disease - screen for knowledge gaps and motivational issues Adherence Estimator Used only for individual drugs Pt Ed Materials Assessment (PEMAT) tool usability of audiovisual tools Suitability Assessment of Materials (SAM) tool designed for written materials PQRST Provocative/palliative Quality/quantity Region/Radiation Severity Timing/Temporal BATHE method Background, affect, troubling, handling, empathy - gather info with an emotional component Goal of pharmaceutical care? optimize health related quality of life, achieve positive clinical outcomes MTM definition? CMS servive(s) that optimizes therapeutic outcomes for individual pts, through improved med use, reduce AE and drug interactions, improve adherence How often for comprehensive med review (CMR)? Targeted med review (TMR)? annually, quarterly Other CMS MTM requirements? need MTM info on plan's website, must have process to meaure analyze and report MTM outcomes CPT codes for MTM? No revenue at this time. 99605 initial face to face 15 mins, 99606 established 15 mins, 99607 is any add'tl 15 min blocks Who developed the pt centered medical home (PCMH) definition/standards? National Committee for Quality Assurance (NCQA) 3 elements of comprehensive medication management (CMM)? Assessment Care plan Follow-up What pts are good for CMM? high cost, adherence issues, risk of hospital admin what sort of CMM communication? Needs to be bi-directional, written is one direction (so answer is face to face, telephonic, or virtual) How often should Collaborative Drug Therapy Management (CDTM) be reviewed and updated? every 2 years, keep agreement on file Key elements of CDTM success? access to pt medical records, knowledge, documentation in the medical records, accountability for quality measures, ability to be reimbursed, committed time and resources Definition of credential vs privilege credent: documented evidence of professional qualification privileging: process to grant practitioner the auth to provide specific services For vaccinations, does medicare part B have deductable or copays? no Transitional care management codes? 99495 (moderate complexity), 99496 (high complexity) Vaccines covered under Medicare part B pneumococcal influenza hep B any vaccine necessary to treat an injury/illness What is necessary before being able to administer Part B vaccines? enroll as a mass immunizer with Medicare admin contractor before influenza season, need NPI number before enrollment - can bill only for pneumococcal and influenza vaccines Billing for medicare B? roster billing, centralized billing How are other vaccines billed? part D What established Medicare coverage for Annual Wellness Visit (AWV)? 2011 Affordable Care Act When are pts eligible for AWV? after 12 months of part B coverage Key components of AWV? Health risk assessment, evaluate cognitive impairment, list of current providers, written screening schedule established Billing for AWV? G0438 is initial, G0439 is subsequent, no copayment or deductable What is not necessary for AWV? Changing therapy Does credentialing and privilaging increase or decrease legal liability of organization? Decrease (still liable if allowing unqualified practitioner) What is medwatch FDA form 3500 and 3500 A 3500 is voluntary health care professional reporting, 3500 A for mfgr, distributers Can I disclose PHI to govt entities for public health purposes? Yes What must a generic drug do in order to be approved as a generic? Approval pathway? demonstrate bioequivalence; ANDA (abbreviated) When must med guides be provided for REMS? ALL settings, hospital, admin by health care provider, etc When does an IND application need to be submitted? after preclinical studies and before a clinical study What needs an IND application? new drug, new indication, off-label use 45 CFR part 46 protection of human subjects Title 45 HIPPA privacy rule Title 21 bioavail, bioequivalenc Title 42 vaccines Def of adverse drug rxn? Adverse drug event? Preventable adverse drug event? Potential adverse drug event? non-preventable; injury casued by medication use; injury caused by medication error, injury potential d/t med error Compounding, beyond use date for freezer (any risk)? room temp? refrig 45 days; 48-24 hours; 3-14 days based on risk Hatch-Waxman Act Authorized FDA to create an abbreviated regulatory pathway (ANDA) for generic drugs Kefauver-Harris amendment required drug to show efficacy in addition to safety Durham-Humphrey Amendment differentiated prescription drugs from nonprescription drugs Biologics Price Competition and Innovation Act of 2009 Provision of ACA that created abbreviated approval path for biologic products or biosimilars Drug Quality and Security of 2013 allow outsourcing facility to register with the FDA Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) amends the federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user-fee programs for prescription drugs and medical devices to establish user-fee programs for generic drugs, biosimilars, and other purposes - Addresses drug shortages RF for suspected spinal injury? 65 or older, motor vehicle involvement or bicycle crash, fall greater than standing height, pain in neck or back, altered consciousness etc If a pt is having an MI, what is the intervention that must occur if not contraindications? ASA 162 - 325 Chewable Correct CPR sequence for both adults and children? start with what? then what? Chest compression, then airway opened, and rescue breaths administered Ratio for children? 1 vs 2 workers? Adults? Depth? 30:2, 15:2 30:2 about 2 inches depth Main functions of the FDA? Recalls, med guides, REMS , drug and medical device safety alerts, boxed warnings, drug shortages, compounding pharmacies Recall types? Class I: reasonable prob that exposure to product will cause serious adverse health consequences; Class II: may cause temp or medically reversible AE, prob of serious issue is remote; Class III: exposure not likely to cause a problem; unclassified: still in process of being classified but announced; market withdrawal: minor violation that subject to FDA legal action Agency for Healthcare Research and Quality (AHRQ)? Lead federal agency for pt safety research pt safety resource, safety culture survey, safety network, pharmacy health literacy, PSO's supports research that helps people make better- informed decisions and improves the quality of health care services NCC MERP? National Coordinating Council for Medication Error Reporting and Prevention - promoted reporting discussion and communication about safe medication use - provides strategies, understanding and prevention, taxonomy based on possible meidcation harm HEDIS measures? - developed and maintained by the National Committee for Quality Assurance (NCQA) - designed to allow consumers to compare health plan performance - increasingly used to track yr-to-yr performance what is FDA Medwatch? voluntary report product problems or unexpected AE (NOT ERROR) If you wish to improve the pharmacy process to lead to internal improvements need to use pharmacy internal voluntary reporting system What does FDA do? approves new medication and issues warnings or other recommendations for already approved meds What does CDC do? determines rules and procedures for POC testing, immunizations, and mgmt of patients with transmittable diseases