Block 4 (2) Flashcards
What are the types of cost sharing?
copay
coinsurance
corridor deductibel
What is a flexible compensation plan (cafeteria plan)?
approach that allows employee to customize his insurance coverage
What is a 1-25 plan?
plan that allows you to take pretax income from your paycheck and apply it to healthcare expenses
What is any willing provider legislation?
state legislation
if any provider is willing to work on the same terms as the preferred provider, they can’t be excluded from 3rd party plans
What does PPO stand for?
preferred provider organization
What is freedom of choice legislation?
similar to any willing provider, but from the consumer’s point of view
if consumer is willing to meet the terms of the provider, the provider can’t exclude them from treatment
What is stop loss coverage?
employer covers out of pocket expenses up to a set point, then insurance kicks in
What authorized medicare?
Title XVIII of the social security act
a federally administered program
What is Medicare Part A, B, and D?
A: compulsory hospitalization insurance
B: voluntary supplementary medical insurance
D: outpatient pharmaceuticals
What is Medicare Part C?
medicare managed care option (medicare advantage)
private plan, slightly different coverages / extra coverage of A and B
How does one become eligible for Medicare?
1) 65+ (85%)
2) under 65, but receiving cash benefits under the Social Security or Railroad programs due to disability
3) under 65, but a chronic kidney patient
Why does a plan use cost-sharing?
1) makes patient reconsider whether they really need the treatment
2) shifts some costs to the patient
3) reduces administrative burdens (fewer claims processed)
How is medicare financed?
Part A: FICA employer (6.2%) + employee (6.2% of paycheck) up to $118,500 of income, and a corridor deductible
Part B: premium ($104.90, 25%) and govt (75%)
How are Parts C/D financed?
premium
FICA stands for:
federal insurance contributions act
What does Medicare Part B cover?
non-physician coverage (podiatrist, lab, xray), 20% coinsurance
medical devices
some home health services (up to 100 visits/yr)
drugs given in the doctors office
physicians charges
What are DRGs?
Diagnosis-related groups
- 468 disease state categories
- provides incentive to discharge pt earlier
Describe wholesaler registration.
not with federal govt
- KYBOP + CHFS
- if using CS, CHFS and DEA
PDMA stand for:
Prescription Drug Marketing Act of 1987
Define pedigree
a detailed history of where a drug has been
paper or electronic supply chain record
3 components to a pedigree
traceability, licensure, pre-emption
transaction history, information, statement
What were the effects of PDMA 87?
pedigree
banned reimportation of pharmaceuticals
banned sale of drug samples
banned re-sale of products purchased at preferential prices
Describe wholesaler recordkeeping
everything received, processed, sold, destroyed
– keep 2 years, unless tied to specific rx (5 years)
When do pharmacy pedigree requirements go into effect?
march 2016
What is pre-emption?
federal law overrides state law
What is a presumption?
assumption that must be overturned by a preponderance of evidence
– ex: samples found in a pharmacy by BOP inspector
Describe licensing requirements of the Drug Supply Chain Security Act.
3PLs will be licensed under new federal requirements (Drug Supply Chain Security Act)
provisions for federal licensing of authorized trading partners (licensed wholesalers)
How long must a pharmacy maintain pedigrees?
6 years from last fill or refill
What do you do if you suspect a supply security problem with a product you ordered?
quarantine and investigate
- investigate: contact wholesaler
- contact FDA, manufacturer, and wholesaler if a problem is found
Pedigrees apply to:
rx-only in finished form for humans
– exceptions: bloods, radioactive/imaging, IV, compounded drug
In what transactions are pedigrees not required?
1) tx from one pharmacy to another for a specific rx
2) tx to physician for office use
3) tx pursuant to pharmacy sale or merger
4) tx combo products (medical equipment + a drug)
5) tx pursuant to medical emergency
Who is the executive director of the KY BOP?
steve hart
What are the 4 types of formal discipline from the KY BOP?
can do a combo
- dismiss complaints
1) fine
2) probate
3) suspend
4) revoke
- dismiss complaints
How long is a KY BOP member term?
4 years
can serve up to 2 terms
How are KY BOP members selected?
appointed by governor from list submitted by the representative professional organization (KPhA)
What minor violations can be expunged from your BOP record?
failure to renew in timely manner, failure to earn CE, failure to get HIV/AIDS CE
What is the KYBOP newsletter, who publishes it, and when is it published?
“Kentucky Board of Pharmacy News”
NABP
quarterly (March, 6, 9, 12)
Who has authority to inspect your pharmacy?
KYBOP
CHFS (PPDE)
FDA
DEA (must give informed consent, or submit Notice of Inspection to you)
How is PRN funded?
$10 assessment on license renewal
Who has authority to remove records from your pharmacy?
Police, attorneys, FDA (w/ court order)
KBOP, CHFS, DEA (w/ receipt)
no financial records for the DEA
How is telehealth authorized? What do you need?
by statute
informed, written consent from the pt
How are medical devices registered?
FDA: FDA Center for Devices and Radiological Health
What are the requirements for medical device manufacturers?
1) register annually
2) provide annual list of all devices being manufactured
3) CGMP
4) labeling
How might medical devices be adulterated?
marketed prior to approval
CGMP not followed
T/F: FDA can enforce a mandatory recall of medical devices and drugs.
F…not drugs
devices via a “Cease Distribution Notification”
Who determines the classes of medical devices?
DHHS
What are the medical gasses?
O2, N2, NO, CO2, He, CO, medical air
How are medical gasses regulated?
FDA (rx-only)
Describe Class I devices.
simplest; general controls sufficient for safety/efficacy
not life-sustaining
pre-market notification not required, but sometimes done
Describe Class II devices.
general controls insufficient but special controls are ok
pre-market notification required, sometimes an IDE is done
– special controls: tech specs, post-market surveillance
Describe Class III devices.
general and special controls are insufficient for safety and efficacy
must file and gain approval (IDE, PMA)
What is the medical device pre-market approval form?
510K
IDE stands for:
investigational device exemption (equal to IND)
PMA stands for:
pre-market approval application (equal to NDA)
Describe the papers required in order for Class III devices (and some Class II).
IDE – PMA – approval
How are problems with medical devices reported?
- manufacturer must report problems to FDA
- - facility (hospital) must notify problems to FDA
Medical devices cannot rely on…
metabolism or chemical rxn
What is medical air?
processed air to ensure freedom from particulates
How are vet drugs classified?
OTC and rx-only
– “for animal use”
What’s the main (and one of the only) differences in vet drug labeling vs human drug labeling?
instead of “rx only”…
“federal law restricts the use of this drug to the order of a licensed veterinarian”
Providers of what kind of HME must be available 24-7-365?
life-sustaining
– O2 concentrators, O2 tanks, nebs
What is HME?
home medical equipment
– DME suitable for home use
How are HME providers regulated?
KY BOP
- licensed
- pharmacist in pharmacy w/ permit do not need separate HME Provider Permit
When was the last APhA Code of Ethics revision?
1994 (started in 1990)
APhA was founded in…
1852
What is co-insurance?
fixed percentage of cost per unit service
