pharmaceutical
research
manufacturers
america
walsh
acting
commissioner
maine
department
human
services
et
argued
january
decided
may
state
participating
medicaid
must
medical
assistance
plan
approved
secretary
health
human
services
hhs
response
increasing
medicaid
expenditures
prescription
drugs
congress
enacted
measure
requires
drug
companies
pay
rebates
medicaid
purchases
since
enacted
supplemental
rebate
programs
achieve
additional
cost
savings
medicaid
purchases
purchases
needy
citizens
purpose
maine
rx
program
reduce
prescription
drug
prices
state
residents
program
maine
attempt
negotiate
rebates
drug
manufacturers
company
enter
rebate
agreement
medicaid
sales
subjected
prior
authorization
procedure
requires
state
agency
approval
qualify
doctor
prescription
reimbursement
petitioner
association
nonresident
drug
manufacturers
challenged
program
commencement
date
claiming
medicaid
act
violates
negative
commerce
clause
without
resolving
factual
issues
district
entered
preliminary
injunction
preventing
statute
implementation
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inter
alia
obstacle
matter
modest
federal
program
administration
sufficient
establish
first
circuit
reversed
held
judgment
affirmed
affirmed
justice
stevens
delivered
opinion
respect
parts
ii
iii
vi
concluding
petitioner
carried
burden
showing
probability
success
merits
commerce
clause
claims
arguments
rebate
requirement
constitutes
impermissible
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regulation
discriminates
interstate
commerce
order
subsidize
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sales
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control
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seelig
price
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healy
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institute
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regulate
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impose
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receive
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local
pharmacists
provide
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benefit
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manufacturers
west
lynn
creamery
healy
distinguished
pp
justice
stevens
joined
justice
souter
justice
ginsburg
justice
breyer
concluded
parts
iv
vii
answer
question
whether
petitioner
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erred
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care
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choate
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program
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pp
justice
breyer
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petitioner
obtain
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since
law
grants
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legal
conclusions
whether
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program
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claim
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impose
prior
authorization
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consideration
secretary
role
administering
act
forecloses
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claim
act
provides
complete
list
restrictions
participating
may
place
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drug
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stricture
prior
authorization
program
compliance
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procedures
purpose
effect
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authority
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prior
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produce
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renders
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act
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congress
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chevron
natural
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however
act
text
read
way
indeed
secretary
adopted
interpretation
act
preclude
negotiating
prices
drug
purchases
obstacle
premise
congress
expressly
displaced
state
law
therefore
directly
spoken
question
therefore
agency
charged
administering
federal
statute
secretary
chevron
imposes
barrier
obstacle
claim
pp
stevens
announced
judgment
delivered
opinion
respect
parts
ii
iii
vi
rehnquist
kennedy
souter
ginsburg
breyer
joined
opinion
respect
parts
iv
vii
souter
ginsburg
breyer
joined
opinion
respect
part
souter
ginsburg
joined
breyer
filed
opinion
concurring
part
concurring
judgment
scalia
thomas
filed
opinions
concurring
judgment
filed
opinion
concurring
part
dissenting
part
rehnquist
kennedy
joined
pharmaceutical
research
america
petitioner
peter
walsh
acting
commissioner
maine
department
human
services
et
al
writ
certiorari
appeals
first
circuit
may
justice
stevens
announced
judgment
delivered
opinion
respect
parts
ii
iii
vi
opinion
respect
parts
iv
vii
justice
souter
justice
ginsburg
justice
breyer
join
opinion
respect
part
justice
souter
justice
ginsburg
join
response
increasing
medicaid
expenditures
prescription
congress
enacted
measure
requires
drug
companies
pay
rebates
medicaid
purchases
last
several
years
state
legislatures
enacted
supplemental
rebate
programs
achieve
additional
cost
savings
medicaid
purchases
well
purchases
made
needy
citizens
maine
rx
program
enacted
primarily
intended
provide
discounted
prescription
drugs
maine
uninsured
citizens
coverage
open
residents
state
program
maine
attempt
negotiate
rebates
drug
manufacturers
fund
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price
drugs
offered
maine
rx
participants
drug
company
enter
rebate
agreement
medicaid
sales
subjected
prior
authorization
procedure
case
association
nonresident
drug
manufacturers
challenged
constitutionality
maine
rx
program
claiming
program
federal
medicaid
statute
violates
negative
commerce
clause
association
alleged
program
denies
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patients
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instead
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injunction
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implementation
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reversed
granted
certiorari
questions
presented
national
importance
congress
created
medicaid
program
adding
title
xix
social
security
program
authorizes
federal
financial
assistance
choose
reimburse
certain
costs
medical
treatment
needy
persons
order
participate
medicaid
program
state
must
plan
medical
assistance
approved
secretary
health
human
services
secretary
state
plan
defines
categories
individuals
eligible
benefits
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kinds
medical
services
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plan
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provide
coverage
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state
option
may
also
cover
medically
needy
prior
medicaid
statute
specifically
address
outpatient
prescription
drug
coverage
secretary
regulations
guidelines
set
upper
limits
state
aggregate
expenditures
drugs
plans
approved
secretary
designed
administered
formularies
listing
drugs
cover
also
employed
prior
authorization
programs
required
approval
state
agency
qualify
doctor
prescription
reimbursement
see
dodson
parham
supp
nd
georgia
historically
administered
prescription
drug
program
basis
drug
words
restricted
list
drugs
medicaid
reimburse
provider
pharmacists
thus
drug
specifically
included
list
reimbursed
unless
prior
approval
granted
administrator
georgia
medicaid
program
cowan
myers
cal
app
cal
rptr
describing
california
law
providing
certain
drugs
covered
california
medicaid
program
prior
authorization
programs
specifically
governed
federal
law
regulations
rather
made
part
state
medicaid
plans
approved
secretary
aided
controlling
medicaid
congress
effectively
ratified
secretary
practice
approving
state
plans
containing
prior
authorization
requirements
created
rebate
program
amendment
contained
omnibus
budget
reconciliation
act
obra
new
program
two
basic
parts
first
imposed
general
requirement
order
qualify
medicaid
payments
drug
companies
must
enter
agreements
either
secretary
authorized
secretary
individual
provide
rebates
medicaid
sales
outpatient
prescription
rebate
single
source
drug
innovator
multiple
source
drug
difference
manufacturer
average
price
best
price
average
manufacturer
price
whichever
greater
rebate
drugs
average
manufacturer
price
see
second
drug
manufacturer
enters
rebate
agreement
law
requires
state
provide
coverage
drug
plan
unless
state
complies
one
exclusion
restriction
provisions
medicaid
act
see
example
state
may
exclude
coverage
drugs
gents
used
cosmetic
purposes
hair
growth
relevant
case
congress
allowed
condition
coverage
payment
covered
outpatient
drug
require
approval
drug
dispensed
thus
obra
except
narrow
category
new
state
may
subject
prior
authorization
covered
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long
state
prior
authorization
program
provides
response
telephone
telecommunication
device
within
hours
request
prior
authorization
except
listed
excludable
drugs
provides
dispensing
least
supply
covered
drug
emergency
situation
see
omnibus
budget
reconciliation
act
congress
amended
act
allow
use
formularies
subject
strict
limitations
amendment
expressly
stated
prior
authorization
program
complies
conditions
subject
limitations
imposed
amendment
reenacted
provisions
state
prior
authorization
programs
included
obra
omitting
however
narrow
exception
new
drugs
ii
maine
legislature
established
maine
rx
program
reduce
prescription
drug
prices
residents
state
rev
stat
tit
west
supp
statute
provides
state
shall
act
pharmacy
benefit
manager
order
make
prescription
drugs
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qualified
maine
residents
thereby
increasing
overall
health
maine
residents
promoting
healthy
communities
protecting
public
health
welfare
program
intended
enable
individuals
buy
drugs
retail
pharmacies
discount
roughly
equal
rebate
medicaid
purchases
see
statute
provides
manufacturer
labeler
selling
drugs
maine
publicly
supported
financial
assistance
program
shall
enter
rebate
agreement
state
commissioner
human
services
commissioner
commissioner
directed
use
best
efforts
obtain
rebate
least
equal
rebate
calculated
federal
program
created
pursuant
obra
see
rebates
paid
fund
administered
commissioner
distributed
participating
pharmacies
compensate
selling
discounted
prices
manufacturers
enter
rebate
agreements
two
consequences
first
nonparticipation
information
department
human
services
must
release
health
care
providers
public
second
importantly
purposes
department
shall
impose
prior
authorization
requirements
medicaid
program
title
permitted
law
dispensing
prescription
drugs
provided
nonparticipating
manufacturers
labelers
ibid
statute
authorizes
department
adopt
implementing
rules
rules
proposed
limit
access
program
individuals
comparable
superior
prescription
drug
benefit
plan
proposed
rules
also
explain
maine
intends
appoint
drug
utilization
review
committee
composed
physicians
pharmacists
evaluate
drug
manufactured
company
declined
enter
rebate
agreement
decide
whether
clinically
appropriate
subject
drug
prior
state
represents
certainly
subject
drug
fulfills
unique
therapeutic
function
prior
authorization
process
even
manufacturer
enter
rebate
determination
whether
particular
drug
subjected
prior
authorization
requirement
based
firmly
upon
considerations
medical
necessity
compliance
state
responsibilities
administrator
maine
medicaid
program
iii
several
months
january
intended
commencement
date
maine
rx
program
commissioner
kevin
concannon
sent
form
letter
drug
manufacturers
enclosing
proposed
rebate
although
individual
manufacturers
elected
participate
executing
proposed
agreement
petitioner
pharmaceutical
research
manufacturers
america
association
representing
manufacturers
account
percent
brand
name
drug
sales
responded
bringing
action
challenging
validity
statute
complaint
accompanied
motion
preliminary
injunction
supported
seven
affidavits
four
affidavits
describe
nature
association
companies
methods
distribution
emphasizing
fact
exception
sales
two
resident
distributors
prescription
drug
sales
occur
outside
three
comment
operation
prior
authorization
programs
administered
private
managed
care
organizations
describing
actual
potential
adverse
impact
manufacturers
patients
thus
one
executive
stated
imposition
prior
authorization
pa
requirement
respect
particular
drug
severely
curtails
access
drug
covered
patients
sharply
reduces
drug
market
share
sales
pa
causes
shift
patients
competing
drugs
manufacturers
subject
pa
imposes
additional
procedural
burdens
physicians
prescribing
manufacturer
drug
retail
pharmacies
dispensing
effect
pa
diminish
manufacturer
goodwill
helped
foster
demand
drug
competing
drugs
produced
manufacturers
shift
physician
patient
loyalty
competing
drugs
perhaps
permanently
another
affidavit
described
prior
authorization
managed
care
organization
nevada
sharply
reduced
market
share
four
smithkline
drugs
example
market
share
augmentin
drug
used
treat
bacterial
infections
declined
six
months
program
third
affidavit
howell
smithkline
beecham
corporation
expressed
opinion
prior
authorization
never
required
one
program
purpose
influencing
manufacturer
pricing
behavior
another
program
use
without
regard
safety
efficacy
lead
drugs
prescribed
less
safe
efficacious
respondents
opposition
motion
supported
concannon
affidavit
affidavits
two
doctors
dispute
factual
assertions
concerning
impact
prior
authorization
drug
companies
market
shares
instead
comment
benefits
prior
authorization
patients
state
medicaid
medical
director
clifford
explained
hysicians
maine
already
well
acquainted
extensive
prior
authorization
programs
four
programs
collectively
cover
nearly
half
state
residents
state
taken
steps
ensure
physicians
always
able
prescribe
safest
efficacious
drugs
medicaid
patients
second
doctor
richardson
stated
prescribed
augmentin
second
line
drug
drug
amoxicillin
effective
treating
ear
infections
time
augmentin
times
expensive
concannon
affidavit
described
composition
committee
physicians
pharmacists
make
final
determination
clinical
appropriateness
recommendation
prior
authorization
requirement
imposed
respect
particular
prescription
drug
manufactured
manufacturer
entered
maine
rx
rebate
agreement
without
resolving
factual
issues
district
granted
petitioner
motion
preliminary
injunction
relying
healy
beer
institute
first
held
maine
power
regulate
prices
paid
drug
manufacturers
transactions
occur
state
recognizing
sales
made
two
distributors
maine
held
medicaid
act
maine
rx
program
insofar
threatened
impose
prior
authorization
requirement
nonparticipating
manufacturers
holding
assumed
purpose
decision
human
services
deny
single
medicaid
recipient
access
safest
efficacious
prescription
drug
therapy
indicated
individual
medical
circumstances
view
nevertheless
required
maine
point
medicaid
purpose
new
prior
authorization
requirement
maine
added
medicaid
prescription
drugs
maine
passed
law
might
conflict
objectives
federal
law
actually
taken
federal
medicaid
program
altered
serve
maine
local
purposes
district
view
fact
alteration
served
purposes
outside
scope
medicaid
program
created
obstacle
administration
federal
program
sufficient
establish
matter
modest
obstacle
new
prior
authorization
amounts
parties
disagree
severity
obstacle
obstacle
drugs
list
must
approved
state
medicaid
medical
director
dispensed
appeals
disagreed
district
analysis
issue
three
reasons
first
since
federal
statute
expressly
authorizes
use
prior
authorization
found
conflict
maine
act
medicaid
structure
purpose
view
long
compliance
federal
conditions
state
motivation
imposing
requirement
irrelevant
second
given
absence
actual
conflict
found
mere
fact
maine
rx
fails
directly
advance
purpose
federal
program
insufficient
basis
inflicting
medicine
preemption
state
statute
third
stated
assuming
relevance
state
motivation
maine
rx
program
furthers
medicaid
aim
providing
medical
services
whose
resources
insufficient
meet
costs
necessary
medical
services
even
individuals
covered
maine
rx
program
poor
enough
qualify
medicaid
ibid
moreover
held
evidence
making
prescription
drugs
accessible
uninsured
may
keep
medicaid
thereby
minimizing
state
medicaid
expenditures
appeals
also
reviewed
affidavits
concluded
fall
short
establishing
act
inflict
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center
medicare
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agency
administering
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categorically
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groups
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individuals
eligible
cash
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aid
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aged
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disabled
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medically
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protection
income
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incurred
medical
expenses
falls
sic
medically
needy
standards
house
subcommittee
health
environment
committee
energy
commerce
medicaid
source
book
background
data
analysis
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print
ford
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complaint
affidavit
george
bilyk
janssen
pharmaceutica
affidavit
david
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beecham
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care
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pet
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use
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highway
bridge
construction
school
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note
cms
acting
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secretary
see
supra
sent
letter
september
state
medicaid
directors
letter
cms
director
indicated
establishment
prior
authorization
program
medicaid
covered
drugs
secure
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benefits
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populations
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plan
therefore
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program
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review
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plan
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brief
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curiae
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kaiser
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mar
see
supra
current
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imposing
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authorization
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assure
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quality
care
new
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law
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preferred
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pharmaceutical
manufacturers
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lawsuit
civ
app
pet
cert
internal
quotation
marks
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resources
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set
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need
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funds
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footnotes
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see
supra
footnotes
neither
plurality
dissent
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prior
authorization
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basis
text
medicaid
act
discuss
dissent
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reliance
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maine
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also
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purpose
control
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costs
medicaid
safe
find
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federal
statutory
supremacy
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whether
state
legislature
recited
deems
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fact
secretary
power
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funds
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act
terms
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act
contemplates
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plans
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title
provides
secretary
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opportunity
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agency
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plan
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plan
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provisions
section
title
administration
plan
failure
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secretary
shall
notify
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agency
payments
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state
secretary
satisfied
longer
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medicaid
act
meaningfully
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invalidate
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laws
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rx
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pose
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plans
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finds
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directive
state
plans
breach
contract
federal
government
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cf
part
infra
view
directive
exists
free
deviate
medicaid
act
requirements
subject
sanctions
secretary
federal
statute
ambiguous
respect
whether
state
law
presumption
ordinarily
prevent
concluding
state
law
therefore
conclusion
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rx
require
rejection
secretary
contrary
construction
statute
chevron
first
step
second
asks
whether
agency
construction
reasonable
interpretation
upheld
district
district
columbia
pharmaceutical
research
mfrs
america
thompson
wl
mar
petitioner
arguments
provide
answer
careful
analysis
offered