Test 2 Flashcards

0
Q

Define social justice

A

Idea of collectivism and restraining of markets applied to health care. Role of distributing social (collective) goods assigned to govt. national healthcare programs

National - supply side rationing. Planned rationing

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1
Q

Define market justice

A

Capitalism and free markets applied to health care. Role of distributing economic goods is assigned to the market
US - demand and price rationing

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2
Q

Limits of market justice

A

Social justice becomes unavoidable when dealing with human populations
(Housing transportation education healthcare)
People in ill health place economic burden on society.
Critical care provide to the uninsured
Human problems have broader implications for society

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3
Q

Define health economics

A

Study of supply and demand of health care resources and impacts on population

Efficient allocation of scarce resources

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4
Q

Forces shaping medication use policy

A
Govt
Private
Accredited and QI
Science
Patients
Specialty organizations
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5
Q

Supply and demand

A

Market equilibrium
Buyer determines demand
Seller determines supply

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6
Q

Types of markets

A
Perfectly competitive
Oligopoly
Monopoly
Monopolistic competition
Monopsony
Oligopsony
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7
Q

Oligopoly

A

Small number of competitors

Not always aggressive competition

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8
Q

Monopoly

A

One seller which controls price

Sole supplier

Cost dictated by supplier

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9
Q

Monopolistic competition

A

Many competitors with slightly differentiated products

Each seller may set price for own product

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10
Q

Monopsony

A

One buyer which controls price. Like electric boat and subs

Buyer has market power

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11
Q

Law of demand

A

Other things equal then quantity demanded of a good falls when the price rises

Movement along the curve when change price

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12
Q

Demand curve - substitutes

A

When fall in the price of one good reduces the demand for another good

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13
Q

Demand curve - complements

A

When the fall in price of one good increases the demand for another good.

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14
Q

Supply

A

Quantity of goods that a seller is willing and able to sell

As quantity supplied increases price increases

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15
Q

Elasticity

A

Measure of the sensitivity of change in one variable to another

% change in one variable given a 1% change in another.

E= %change in quantity/ % change in price

Sign positive or negative tells the directionality

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16
Q

Elasticity of demand

A

E > 1 elastic demand
E < 1 relative inelastic
E = 1 unit elastic
E = 0 perfectly inelastic

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17
Q

Inelastic demand

A

Change in price have little impact on quantity demanded

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18
Q

Highly elastic demand

A

Small changes in price impact quantity demanded

Ex automobiles. Groceries

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19
Q

Types of production costs

A
Fixed
Variable
Average
Marginal/incremental
Opportunity
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20
Q

Define fixed costs

A

Costs to keep doors open
Overhead
Not affected by changes in production

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21
Q

Variable costs

A

Change with level of output

Ex supplies and staffing

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22
Q

Average costs

A

Total costs/quantity produced

Total costs = fixed + variable

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23
Q

Marginal costs

A

Cost per additional unit produced increases

Cost to make one more unit of output

Diminishing marginal returns

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24
Q

Opportunity costs

A

Costs of what you sacrifice to get it

Cost of other alternative forgone

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25
Q

Perfect competition

A

Many firms selling same product
Many buyers
No restrictions on entry to industry
Firms in industry have no advantage over new entrants

All firms must accept market price
Price takers
Firms and buyers have complete info about the market

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26
Q

Economics of health

A
Inelastic demand
Universal demand
Unpredictability of illness
Health care as a right
Supplier-induced demand
Third party insurance and patient-induced demand
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27
Q

Functional components of health care delivery

A

Financing-employer Medicaid
Insurance- self insurance companies blue cross to protect against catastrophic risk
Delivery - providers like doctors hospitals any entity that delivers health care and receives insurance payments directly
Payment - insurance companies or third party claims processors

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28
Q

Before managed care

A
Direct access to any provider
Itemized billing to insurer
Few controls over the amt of payment
Sickness coverage only (no wellness)
Insurers just passive payers of claims
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29
Q

Define managed care

A

Body of clinical financial and organizational activities designed to ensure the provision of appropriate health care services in a cost efficient manner
Make health care more efficient and less wasteful.

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30
Q

Features of managed care

A

Negotiated fees (prefer prospective payment)
Gatekeeping - need referral to see specialist
Patient cost sharing or shifting (premiums increased. Deductibles increased)
Coordination of benefits
Preventative care and wellness programs
plan designs and coverage options

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31
Q

HMO

A

Health maintenance organization

Assumes or shares both financial risks and delivery risks associated with providing medical services

Usually for a fixed prepaid price

Gate keeping. Need prior authorization.

HMO act of 1973. Nixon. Allow to go out of network. Response to people saying plans too restrictive.

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32
Q

Managed care continuum

A
Indemnity
Indemnity plus cost containment
Ppo
Pos (point of service plans)
HMO

Manage quality cost and access

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33
Q

PBM

A

Pharmacy benefit manager

Provide external management of health plan or pharmacy benefits by applying managed care principles and procedures to contain cost and enhance quality

Arranges for rebates

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34
Q

AWP

A

Average wholesale price.

Roughly reflected actual acquisition costs
20% mark up on what retailers paid to wholesale r&d
AWP= 1.2xWAC
Sticker price. Price reported by mfg to publishing firms

Used for the last 20 years

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35
Q

WAC

A

Wholesale acquisition price

Manufacturers reported list price for Rx drug for sale to wholesale r&d
Does not include MFG discounts
Approximates costs for brands but not generics
Wholesalers sell to pharmacy about 2-3% above WAC

List price

Price sold to wholesalers

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36
Q

ASP

A

Average sale price

Under Medicare in 2003
Break from AWP
Based on MFG selling price including discounts and rebates
 Substantially Less than AWP
Pay 104-106% above ASP (Medicare)
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37
Q

AMP

A

Average manufacture price

Medicaid 1990. Important to state.

Avg price paid to manufacturers for drugs through retail pharmacies

Reflects rebates paid to wholesale r&d and retail pharmacies BUT not PBMs Medicaid and 3 parties

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38
Q

MAC

A

Maximum allowable costs

Upper limit for reimbursement

Typically used for generics

Federal upper limit 150% of published price of least costly equivalent

Updated quarterly

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39
Q

U/C

A

Usual and customary

What the cash customer pays

Never less than contracted price

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40
Q

Public Health Service pricing 340B

A

Equal to price state Medicaid would pay (does not include discount or rebate)

Highest price a 340B could be charged

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41
Q

US health care expenditures - public vs private - 1960 vs today

A

1960 about 25% public
Today about 50% public

Public is federal state and local govt

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42
Q

National health care expenditure per capita. 1990 to 2019

A

1990 was $3000
Now about $10000
2019 expected to be $13000

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43
Q
How much of health care spent on
Hospital care
Physicians services
Other health care
Other personal health care
Prescription drugs
A
Hospital = $850B 30%
Physicians = $540B 20%
Other = $420B 15%
Other = $400B 15%
Prescription drugs = $260B  10%
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44
Q

Percent change in national spending on health services

A

Peaked during 2001-2006 (5-15%)

While still increasing not increases as much (3-5%)

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45
Q

Prescription drug spending. 1980-2010

A
  1. About 15B

2010 $100-260B

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46
Q

Growth in prescription drug spending as total of health

A

1999 peaked around 20%

Now around 4%

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47
Q

Prescription drug expenditures bt payer type 1990 to 2008

A

Consumer out if pocket decreased from 56% to about 21%

This 30% difference split between private insurers and public fimunds with about 20% picked up by public funds (from 18% to 37%)

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48
Q

Pharmaceutical sales 1997 - 2008

A

80B in 1997 to over $200B in 2007

But not growing as rapidly as in late 90s

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49
Q

Number if blockbuster drugs with sales $1B

A

1996 about 7
Peak in 2006 with over 50
Biggest increase 1996 to 2002

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50
Q

Biggest blockbuster drug

A

Lipitor in 2006 with over $13B

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51
Q

2011 top product by total dollars

A

Lipitor

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52
Q

2011 top product by total prescriptions

A

Hydrocodone (over 58M scripts)

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53
Q

Brand name vs generics tend

A

Generics being prescribed more frequently
About 50% of scripts in 1998
In 2008 about 75%
In 2011 about 80%

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54
Q

Info on generics

A

Now 80% of all prescriptions

If generic available dispensed 94% of the time

Generics represent 27% of total spending

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55
Q

Specialty medicines

A

Increase by 15% from 2010-2011
Cost more than traditional meds
Some cost more than $10K per month
Not as frequently used by Medicare

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56
Q

Avg copayment with tiers

A

Generic $10
Preferred $20
Non preferred $30-40
Fourth tier $60-85

57
Q

Prescription drug benefit cost and plan design by employer size

A

Larger employers use step therapy and quantity limits more than smaller ones
Also tend to have more controls in place

58
Q

Medicare drug plan 2007

A

$265 deductible
Enrollee pays 25% up to $2400 plan pays 75%
Gap where enrollee pays 100% up to $5500
Then pay 5% and Medicare picks up 80% plan pays 15%

59
Q

Brand drugs gap fix 2010-2020

A

Deductible $320
Enrollee pays 25% upto $2900
Then pays 25% and manufacturer picks up 50% discount and plan pays 25% up to $6730

Phase in plan coverage increase

60
Q

Gap coverage plan for generics

A

Plan to pick up 75% by 2020 while enrolle goes from paying 100% to 25%.

61
Q

Typical pricing algorithm

A
"Lower of"
AWP -%+dispensing fee
MAC + dispensing fee
Usual and customary
  If move from AWP to AMP Then would increase dispensing fee
62
Q

Medicaid drug rebate program

A

Requires drug mfgs to have a national rebate agreement with HHS to be on Medicaid formulary
15-23% of AMP or difference between AMP and best per unit price
Result of Medicare part D

63
Q

Obamacare and drug pricing

FUL

A

Federal upper limit no less than 175% of the weighted average of the AMP for multidirectional drug products
Expands access to 340b programs
Extends rebate program to Medicaid managed care

64
Q

Evolution of pharmacy benefits management

A
Direct pay
Access oriented 3rd party admin
Price conscious 3rd party admin
Influence drug use process
Manage diseases
65
Q

Components of pharmacy benefit

A
Benefit design
Network management
Claims processing
Customer & provider service
Formulary management
Drug utilization review
Pharmacy care services
66
Q

Benefit design

A
Co-payments co-insurance
Step therapy
Therapeutic class management
Expenditure caps and deductibles
Provider communication 
Contracting
67
Q

Trends in benefit design

A
Stepped tiered copays
Stepped therapy
Value-based designs
Mail order incentive
OTC Incentive
Therapeutic class management
Lifestyle incentives
68
Q

Value-based benefit design

A

Identify subgroups that benefit most from a given treatment and cost sharing is reduced. Maybe even to zero

Ex heart attack patients and cholesterol lowering drugs vs just patients with high cholesterol

Charge patients lesser amt for drugs that offset other costs.

69
Q

Network management

A

Inclusion
Reimbursement

To manage costs and drive utilization

Any willing provider must be allowed in if willing to accept rate
Restricted network - limited options

70
Q

Claims processing

A

Computerized system
Data management
(Forecasting payment utilization review)

Real time. Electronic data interchange

71
Q

National drug codes

A
NDC
unique number 
Universal for human drugs
#####-####-##
Labeled-product-package
72
Q

Customer and provider service

A

Provide knowledge of benefit design and mechanics

Ensures satisfaction

73
Q

Drug utilization review

A

Prospective
Concurrent
Retrospective

Formulary adherence
Quality. ADR
Cost containment
Identify abuse

Medication related problems

74
Q

Formulary management

A

Up to date list of meds based on current evidence bases med. physicians pharmacists experts to treat disease and preserve health

Encourage use of safe effective most affordable meds

75
Q

Pharmacy and therapeutic committee

A

Committee for determining formulary

Evaluate new drugs
Devise coverage policies copays
Devise management strategies
Negotiate price

76
Q

Pharmacy care services

A

Drug utilization review
Med oriented disease management
Interdisciplinary care and care transitions
Medication therapy management

77
Q

Methods for managing specialty pharmaceuticals

A
Medical vs pharmacy benefit
Co-insurance - pay % or fixed copayment
Prior authorization or step therapy
Supply channel management
Provider and patient education
Outcomes based reimbursement
(Compare outcomes to clinical trial results)
78
Q

Ideal drug reimbursement benchmark

A
Transparent
Accessible
Comprehensive
Timely
Immune to manipulation
79
Q

AAC

A

Actual acquisition cost

Final price paid by pharmacy after all discounts

Used by state Medicaid programs

80
Q

NADAC

A

National average drug acquisition cost

Costs collected by CMS from pharmacies to be averaged into single price

Idea not yet in practice

81
Q

Dimensions of quality

A
Technical performance
Access to services
Effectiveness of care
Efficiency of service delivery
Interpersonal relations
Continuity of services
Safetphysical infrastructure and comfort
Choice
82
Q

Aims for improvement in redesign of health care

A
Six aims
Safe
Timely
Effective
Efficient
Equitable
Patient-centered
83
Q

WHO definition of adverse drug reaction

A

Any noxious and unintended effect of a drug which occurs at doses used in humans

Excludes therapeutic failures
Intentional or accidental overdose
Errors in admin or adherence

84
Q

Types if ADRs

A

Type A
Predictable
Often dose dependent

Type B
Unpredictable
Unrelated to drugs known action

85
Q

WHO definition of adverse drug event

A

Any injury resulting from admin if a drug

Includes events that are preventable
Overdose and admin errors. Adherence

86
Q

What drugs most commonly implicated in ADE treated in ER?

A

Insulin

Warfarin

87
Q

Definition of medication related problem

A

An event involving a patients drug treatment that does or could interfere with the achievement of optimal outcome

3 categories - overuse, underuse and misuse

88
Q

Underuse MRP

A

Untreated indication
Sub-therapeutic dosage
Failure to receive or take drug
Prescribing and adhering

89
Q

Examples of overuse MRP

A

Overdose
Drug use without indication
Drugs of abuse

90
Q

Examples of misuse MRP

A
Adverse drug reaction
Drug interactions
Improper drug selection
Inappropriate drug in elders
Inadequate therapeutic monitoring
91
Q

Costs of MRPs

A

Fit every dollar spent on drugs spend >$1 on drug-related problem so

Underuse a huge problem

92
Q

MedWatch

A

FDA program
Healthcare professionals and consumers can report serious problems
Make easier to report ADE
make it clear what FDA wants
More visible actions taken by FDA resulting from reports
Awareness if drug-induced disease

93
Q

Efficiency

A

Generic substitutes
Therapeutic substitutes
Therapeutic duplication

94
Q

Safety in Rx utilization

A

Drug drug interactions
Drug disease interactions
Therapeutic duplication
Drug age contraindications

95
Q

Effectiveness in Rx utilization

A

Adherence to therapy
Use clinically important therapies where evidence indicates
Appropriate dose and formulation

96
Q

Joint commission

A

Looks at hospitals
Aspirin at arrival for heart attack
Avoid polytherapy with antipsychotics

97
Q

Pharmacy quality alliance

A

Improve quality of meds used across health care settings through collaboration - key stakeholders agree on strategy to measure and report performance info related to meds

Being developed

98
Q

URAC

A

Utilization review accreditation commission
Promote improvement through accreditation and education for PBMs
Health care quality

99
Q

Pure food and drug act

A

1906
Standards for traded drugs
Labeling
Misbranding punishable by law

100
Q

Harrison narcotic act of 1914

A

Upper limits on amounts of cocaine morphine etc

101
Q

Food drug and cosmetic act of 1938

A
Standards for inert ingredients
Safety
FDA authority to regulate promotional materials
Prohibits misbranding
Interstate commerce only if FDA approved
102
Q

Durham Humphrey act of 1951

A

Created legend drugs

Rx only

103
Q

Kefauver Harris amendment of 1962

A

In response to thalidomide
Advertising claims questioned by medical community
Need to report all side effects to FDA
Needs to be safe and effective
Substantial evidence that a drug is efficacious. Causes increase in r&d costs

Efficacy standard.

104
Q

Phases of drug development

A

Preclinical - lab animals. To assess safety and biological activity. 1-2 years. 100% pass

File IND.

Phase 1 - 20-100 healthy volunteers. Determine safety and dosage. Year 3. 70% of INDs

Phase 2 - 100-300 patient volunteers. Efficacy and side effects. Years 4-5. 33% of INDs.

Phase 3 - 1000-5000 patient volunteers. Verify efficacy. Years 6-8. 27% of INDs.

Then file NDA

Phase IV - where do pharmaecomomic analysis. Not randomized

105
Q

PDUFA

A

Prescription drug user fee act. Of 1993

Used to bring in more people to approve drugs. Speed up process.

Result 60% at >2 years. Down to less than 10%

106
Q

Estimated cost to bring new drug to market

A

$200M in 1979 to $2B in 2003

More expensive clinical trials
Specialty drugs and biologics
Personalized medicine

107
Q

Promoted claims

A

2 or more controlled studies (randomized)
Real world effectiveness data
Specific to product label
Substantiation standards. Want population based outcomes

108
Q

FDA regulates health economic info

A

All promotional materials
Need regulation because
Poor quality of studies
Unsubstantiated cost-effectiveness claims
Scientific exchange or promotion
Pharmacoeconomics methods not standardized and complex

109
Q

Types of study outcomes

A

Economic outcomes
Clinical outcomes-intermediate indicators like blood sugar
Final outcomes
Other outcomes (pain compliance)

110
Q

DDMAC 1995

A

Division of drug marketing and communication. DRAFT
Don’t care about costs
Care about efficacy/effectiveness
Need substantial evidence
Argues impedes dissemination if useful info.

111
Q

FDAMA 1997

A

Food and drug administration modernization act of 1997

Extends PDUFA
Encourages pediatric indications
Encourages submission of supplemental indications
Sec 144 Health care economic info

112
Q

Health care economic info

FDAMA 1997

A

Analysis that Ids measures or compares the economic consequences including costs of the health outcomes of the use of a drug to the use of another drug to another health care intervention or to no intervention

113
Q

FDAMA 1997

A

Provide to formulary committee or similar entity.
Directly relates to an indication
Competent and reliable scientific evidence. No longer randomized clinical trial

114
Q

FDAMA 1997 and off label use

A

Can provide articles if
If sNDA to be filed
FDA pre-review of promotional activity

115
Q

Off label use

A

Physicians may use drugs for indications not approved by FDA

Scientific knowledge may outpace FDA approval process

What about safety and efficacy
Distort info
Avoid costs of sNDA

116
Q
  1. WLF vs Henney Shalala
A

FDA cannot regulate speech
Regulate conduct not speech
Judge Lambeth. Preposterous

117
Q
  1. FDA v WLF appeal
A

No longer about speech
Now about interstate commerce

No issue. No debate

Uncertainty

118
Q

2009 FDA guidance.

A

Can distribute info on off-label
No requirement for sNDA
must be separate from promotional brochures
Need statement identifying article about off label use
No relationship between firm and author
Need to be from peer-reviewed journals and disclose finding

119
Q
  1. FDA guidance to unsolicited requests about off label info
A

Flow chart. What is allowed.

Cannot give unsolicited info. Or info on different company’s product.

No public response on off label.

Included social media.

120
Q

Comparative effectiveness research

A

Look at all evidence of alternative methods to prevent treat diagnose monitor condition
To assist consumers clinicians purchasers policy makers to make informed decisions

121
Q

PCORI

A

Patient centered outcomes research institute

$1.1B from ARRA to do CER

Qualitative research involves patient perspective.

122
Q

CER and pharmacy benefits complexities

A
Off label use
Conditional coverage
Value based Rx benefit designs
Provider contracting and payments
Manufacturer focused
123
Q

Ways to use CER

Tools and tactics to deer mine which drug has higher value and incorporate into health care

A

Conditional coverage
Consumer cost sharing
Provider contracting
Drug payment policy

124
Q

Distributive justice

A

How goods are allocated within society

Mix of market justice and social justice

125
Q

Intersection of supply and demand curve

A

Efficient allocation based on perfectly competitive model

Overage and shortage

126
Q

Elasticity related to total revenue

A

Inelastic. Increase price demand goes down but revenue still up.

Elastic. Increase price demand goes down and revenue goes down.

Unitary. Price goes up demand goes down and revenue unchanged.

127
Q

Moral hazard

A

Tend to consume more if isolated from actual price tag

May need to sensitize consumers to price

128
Q

Capitation

A

Pay provider upfront for services per patient. Prospective payment. Global payment

129
Q

Risk underwriting

A

Pay more if you are at higher risk

Smoker. Age. Gender. Geographic region

130
Q

Indemnity

A

Visit doctor. Submit to insurance. Get paid back

Little control of price
Little use of utilization tactics

Also known as conventional.

131
Q

Managed care manages…

A

Cost
Quality
Access

132
Q

POS PLAN

A

Point of service plan
Like HMO but consumer allowed to opt out and see out if network providers for a large fee.

Core network of providers with incentives

133
Q

PPO PLAN

A
Preferred provider organizations
Providers agree to certain costs/fees. 
Some oversight
No gate keeping
Less managed by insurance company
134
Q

CMS

A

Center for Medicare and Medicaid services

135
Q

Medicare prescription drug plans

A

PDP - standalone thru PBMS like entity

MA-PD - Medicare advantage Whole managed care plan

136
Q

CER

A

How do all drugs compare for a specific condition

All methods to prevent treat diagnose monitor a clinical condition

Use to make informed decisions

137
Q

Conditional coverage

A

Need pre-approval
May be restrictions on use
For adding data to clinical trial

Limit access to service that would not be effective

138
Q

Consumer cost sharing

A

Tiered formulary
PPOs increases deductibles
Percent coinsurance/copay for specialty meds
Value based benefit design

139
Q

Provider contracting and payment methods

A

Network designs

Pay for performance bonuses for efficiency and quality.

140
Q

Pharmaceutical company contracting and payment methods

A

Step therapy
Reimburse only if drug deemed appropriate
Reimbursement linked to outcome and comparison to clinical trial results