law exam 3 Flashcards
OBRA ‘90: Overview
First federal law directly regulating pharmacy practice standards
Primary goal to save money
Adopts the “pharmaceutical care” or “pharmacist care” model that pharmacy developed for itself
The law establishes minimal requirements that states must adopt and requires that states must actually establish the standards in order to continue receiving federal funds for Medicaid.
A huge bill
Revolutionize pharmacy
Pages 2,000, a paragraph on pharmacy
Patient counselling is part of OBRA 90, keeping patient profiles to screen for DDI or contradiction
Federal law for the most part does not regulate pharmacy, but mostly DEA & FDA
Indirectly the federal law can tell state to act a certain way, by messing with funding
Jointly funded between state and federal program
National speed limit, 55 mph, federal govt will say that if you want our money for your roads then you need to obey us
State must do something to receive funds:
For a product to be covered under Medicaid: rebate (at best price, lowest price)
Rebate: average price and best price
Check NDC #: every time you bill Medicaid is specific to the manufacturer
OBRA ‘90: Basic Framework rebates
Requires manufacturers to provide drug products to the Medicaid program at their “best price”
“Best price” is the lowest price at which they sell the product to any customer.
Accomplished by requiring the manufacturer to rebate to the state the difference between the average manufacturer’s price and the “best price”
OBRA ‘90 demonstration projects
OBRA funded demonstration projects to evaluate whether the DUR requirements would result in improved patient care and decreased costs.
OBRA ‘90: Drug Use Review (DUR)
Establishes two types of DUR programs:
Retrospective review: on a already filled Rx and look back to see how they can better patient outcome
Prospective DUR
In a pharmacy, use prospective DUR
Retrospective DUR
Each state must establish a DUR board composed of physicians and pharmacists to oversee retro-DUR.
The board reviews medication use data and compares to target criteria– look to see how certain drug X is being prescribed, is it prescribed according to package insert
The board has authority to recommend and establish educational programs for providers who are not meeting target criteria.
- Pick oxycodone XL: who is prescribing drug, is this being prescribed twice a day, 4x a day
Prospective DUR (Pro-DUR)
Provides opportunity to evaluate the prescribed drug therapy before the Rx is dispensed
The DUR board can examine data generated from pro-DUR to determine if drug use problems are being resolved or continuing.
Screening for drug use before it is dispensed like DDI
Drug disease contraindication, early or late refills
Look at a list of programs
Early refils
Components of Pro-DUR(1 of 3)
Screening
Pharmacists must detect potential drug use problems before Rx is dispensed.
OBRA lists seven general categories of potential problems that should be screened.
Computer software does not replace the professional judgment of a pharmacist.
Computer cannot replace pharmacist
Computer can notify you by your judge is key
Aspirin and warfarin can fill but it depends on the level of DDI
May override an interact that might cause death, which is good
OBRA ‘90 Counseling
Requires an “offer to counsel” patient or caregiver
Lists several points of information counseling could include, but allows pharmacist to determine the content of the counseling based on professional judgment
Meaning of phrase “common severe side effect” generally believed to mean common or severe
An offer to counsel may be made by ancillary personnel or other means in some states, while some states require counseling.
Patient has the right to waive counseling.
n pharmacy
Do you have q’s for the pharmacist to any patient – Medicaid and non Medicaid
Counsel depends on state: for mass. Counsel for new Rx and if –pharmacist has a reason
Who can make the offer to counsel
Who can make the offer to counsel: pharmacist, technician, intern
Pharmacist or intern can counsel
Technician cannot counsel patient
Patient profile
Requires pharmacy to obtain, record, and maintain a record of specified information about the patient
Review of the patient profile prior to dispensing is critical to effective screening and counseling.
fed. Vs state law, different in counselling
Under OBRA 90 it is with Medicaid
Open ended questions for counseling if patient asks to be
OBRA requires pharmacy to obtain, record and maintain info on patient: DOB, allergies, weight to determine dose of medication, current generic or brand drugs they are on– always update it
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
The general purpose is to improve the efficiency and effectiveness of the healthcare system.
Particular purpose to regulate the privacy and security of health information
Enforced by the Department of Health and Human Services
- Each pharmacy is a covered entity on HIPPA and each one has a different policy
What HIPAA Targets
Transaction and code sets
—-Intent to establish uniform standards for electronic claims and data transmission to improve efficiency and lower costs
National provider identities
—–Intent of uniformity, simplicity, reduced cost
Security of health information
Privacy of health information
Security Requirements
Requires covered entities to develop physical, technical, and organizational procedure safeguards in order to protect health information from being improperly accessed, altered, deleted, or transmitted
Entities have considerable latitude to develop their own security measures, provided they achieve HIPAA objectives and standards.
- Security requirements of HIPPA: privacy screen, your own password and user ID, dispose of trash that has info.
Privacy Requirements
Concerned with patient’s rights and how and when the patient’s information may be used
Most of remainder of HIPAA discussion concerned with privacy requirements
Who Must Comply
Covered entities: including health plans and healthcare providers that conduct transactions electronically
A covered entity may exempt non-healthcare parts of its operation.
Business associates of covered entities
XYZ pharmacy chain, requires a bag with any patient information to make sure trash is in HIPPA compliant manner
Business associates
Information CoveredProtected Health Information (PHI)
Includes electronic and hard copy health information that both:
—Relates to past, present, or future physical or mental health, provision of care, or payment for care
—Could identify the patient
In a hospital or pharmacy, comply with companies policies and procedures for HIPPA
In case studies, follow studies upon initials, some may be identifiable
