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PPS 930 > Block 4 (2) > Flashcards

Block 4 (2) Flashcards

1
Q

What are the types of cost sharing?

A

copay
coinsurance
corridor deductibel

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2
Q

What is a flexible compensation plan (cafeteria plan)?

A

approach that allows employee to customize his insurance coverage

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3
Q

What is a 1-25 plan?

A

plan that allows you to take pretax income from your paycheck and apply it to healthcare expenses

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4
Q

What is any willing provider legislation?

A

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

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5
Q

What does PPO stand for?

A

preferred provider organization

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6
Q

What is freedom of choice legislation?

A

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

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7
Q

What is stop loss coverage?

A

employer covers out of pocket expenses up to a set point, then insurance kicks in

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8
Q

What authorized medicare?

A

Title XVIII of the social security act

a federally administered program

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9
Q

What is Medicare Part A, B, and D?

A

A: compulsory hospitalization insurance
B: voluntary supplementary medical insurance
D: outpatient pharmaceuticals

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10
Q

What is Medicare Part C?

A

medicare managed care option (medicare advantage)

private plan, slightly different coverages / extra coverage of A and B

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11
Q

How does one become eligible for Medicare?

A

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

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12
Q

Why does a plan use cost-sharing?

A

1) makes patient reconsider whether they really need the treatment
2) shifts some costs to the patient
3) reduces administrative burdens (fewer claims processed)

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13
Q

How is medicare financed?

A

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%)

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14
Q

How are Parts C/D financed?

A

premium

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15
Q

FICA stands for:

A

federal insurance contributions act

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16
Q

What does Medicare Part B cover?

A

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

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17
Q

What are DRGs?

A

Diagnosis-related groups

    • 468 disease state categories
    • provides incentive to discharge pt earlier
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18
Q

Describe wholesaler registration.

A

not with federal govt

    • KYBOP + CHFS
    • if using CS, CHFS and DEA
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19
Q

PDMA stand for:

A

Prescription Drug Marketing Act of 1987

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20
Q

Define pedigree

A

a detailed history of where a drug has been

paper or electronic supply chain record

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21
Q

3 components to a pedigree

A

traceability, licensure, pre-emption

transaction history, information, statement

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22
Q

What were the effects of PDMA 87?

A

pedigree
banned reimportation of pharmaceuticals
banned sale of drug samples
banned re-sale of products purchased at preferential prices

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23
Q

Describe wholesaler recordkeeping

A

everything received, processed, sold, destroyed

– keep 2 years, unless tied to specific rx (5 years)

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24
Q

When do pharmacy pedigree requirements go into effect?

A

march 2016

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25
Q

What is pre-emption?

A

federal law overrides state law

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26
Q

What is a presumption?

A

assumption that must be overturned by a preponderance of evidence
– ex: samples found in a pharmacy by BOP inspector

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27
Q

Describe licensing requirements of the Drug Supply Chain Security Act.

A

3PLs will be licensed under new federal requirements (Drug Supply Chain Security Act)
provisions for federal licensing of authorized trading partners (licensed wholesalers)

28
Q

How long must a pharmacy maintain pedigrees?

A

6 years from last fill or refill

29
Q

What do you do if you suspect a supply security problem with a product you ordered?

A

quarantine and investigate

    • investigate: contact wholesaler
    • contact FDA, manufacturer, and wholesaler if a problem is found
30
Q

Pedigrees apply to:

A

rx-only in finished form for humans

– exceptions: bloods, radioactive/imaging, IV, compounded drug

31
Q

In what transactions are pedigrees not required?

A

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

32
Q

Who is the executive director of the KY BOP?

A

steve hart

33
Q

What are the 4 types of formal discipline from the KY BOP?

A

can do a combo

    • dismiss complaints
      1) fine
      2) probate
      3) suspend
      4) revoke
34
Q

How long is a KY BOP member term?

A

4 years

can serve up to 2 terms

35
Q

How are KY BOP members selected?

A

appointed by governor from list submitted by the representative professional organization (KPhA)

36
Q

What minor violations can be expunged from your BOP record?

A

failure to renew in timely manner, failure to earn CE, failure to get HIV/AIDS CE

37
Q

What is the KYBOP newsletter, who publishes it, and when is it published?

A

“Kentucky Board of Pharmacy News”
NABP
quarterly (March, 6, 9, 12)

38
Q

Who has authority to inspect your pharmacy?

A

KYBOP
CHFS (PPDE)
FDA
DEA (must give informed consent, or submit Notice of Inspection to you)

39
Q

How is PRN funded?

A

$10 assessment on license renewal

40
Q

Who has authority to remove records from your pharmacy?

A

Police, attorneys, FDA (w/ court order)
KBOP, CHFS, DEA (w/ receipt)

no financial records for the DEA

41
Q

How is telehealth authorized? What do you need?

A

by statute

informed, written consent from the pt

42
Q

How are medical devices registered?

A

FDA: FDA Center for Devices and Radiological Health

43
Q

What are the requirements for medical device manufacturers?

A

1) register annually
2) provide annual list of all devices being manufactured
3) CGMP
4) labeling

44
Q

How might medical devices be adulterated?

A

marketed prior to approval

CGMP not followed

45
Q

T/F: FDA can enforce a mandatory recall of medical devices and drugs.

A

F…not drugs

devices via a “Cease Distribution Notification”

46
Q

Who determines the classes of medical devices?

A

DHHS

47
Q

What are the medical gasses?

A

O2, N2, NO, CO2, He, CO, medical air

48
Q

How are medical gasses regulated?

A

FDA (rx-only)

49
Q

Describe Class I devices.

A

simplest; general controls sufficient for safety/efficacy
not life-sustaining
pre-market notification not required, but sometimes done

50
Q

Describe Class II devices.

A

general controls insufficient but special controls are ok
pre-market notification required, sometimes an IDE is done
– special controls: tech specs, post-market surveillance

51
Q

Describe Class III devices.

A

general and special controls are insufficient for safety and efficacy
must file and gain approval (IDE, PMA)

52
Q

What is the medical device pre-market approval form?

A

510K

53
Q

IDE stands for:

A

investigational device exemption (equal to IND)

54
Q

PMA stands for:

A

pre-market approval application (equal to NDA)

55
Q

Describe the papers required in order for Class III devices (and some Class II).

A

IDE – PMA – approval

56
Q

How are problems with medical devices reported?

A
    • manufacturer must report problems to FDA

- - facility (hospital) must notify problems to FDA

57
Q

Medical devices cannot rely on…

A

metabolism or chemical rxn

58
Q

What is medical air?

A

processed air to ensure freedom from particulates

59
Q

How are vet drugs classified?

A

OTC and rx-only

– “for animal use”

60
Q

What’s the main (and one of the only) differences in vet drug labeling vs human drug labeling?

A

instead of “rx only”…

“federal law restricts the use of this drug to the order of a licensed veterinarian”

61
Q

Providers of what kind of HME must be available 24-7-365?

A

life-sustaining

– O2 concentrators, O2 tanks, nebs

62
Q

What is HME?

A

home medical equipment

– DME suitable for home use

63
Q

How are HME providers regulated?

A

KY BOP

    • licensed
    • pharmacist in pharmacy w/ permit do not need separate HME Provider Permit
64
Q

When was the last APhA Code of Ethics revision?

A

1994 (started in 1990)

65
Q

APhA was founded in…

A

1852

66
Q

What is co-insurance?

A

fixed percentage of cost per unit service

PPS 930 (4 decks)

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