288 
is an at-risk beneficiary for prescrip-
tion drug abuse. 
‘‘(ii) INITIAL NOTICE.—An initial no-
tice described in this clause is a notice that 
provides to the beneficiary— 
‘‘(I) notice that the PDP sponsor 
has identified the beneficiary as po-
tentially being an at-risk beneficiary 
for prescription drug abuse; 
‘‘(II) information describing all 
State and Federal public health re-
sources that are designed to address 
prescription drug abuse to which the 
beneficiary has access, including men-
tal health services and other coun-
seling services; 
‘‘(III) notice of, and information 
about, the right of the beneficiary to 
appeal such identification under sub-
section (h) and the option of an auto-
matic escalation to external review; 
‘‘(IV) a request for the bene-
ficiary to submit to the PDP sponsor 
preferences for which prescribers and 
pharmacies the beneficiary would pre-
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289 
fer the PDP sponsor to select under 
subparagraph (D) in the case that the 
beneficiary is identified as an at-risk 
beneficiary 
for 
prescription 
drug 
abuse as described in clause (iii)(I); 
‘‘(V) an explanation of the mean-
ing and consequences of the identi-
fication of the beneficiary as poten-
tially being an at-risk beneficiary for 
prescription drug abuse, including an 
explanation of the drug management 
program established by the PDP 
sponsor pursuant to subparagraph 
(A); 
‘‘(VI) clear instructions that ex-
plain how the beneficiary can contact 
the PDP sponsor in order to submit 
to the PDP sponsor the preferences 
described in subclause (IV) and any 
other communications relating to the 
drug management program for at-risk 
beneficiaries established by the PDP 
sponsor; and 
‘‘(VII) contact information for 
other organizations that can provide 
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290 
the beneficiary with assistance regard-
ing such drug management program 
(similar to the information provided 
by the Secretary in other standardized 
notices provided to part D eligible in-
dividuals enrolled in prescription drug 
plans under this part). 
‘‘(iii) SECOND NOTICE.—A second no-
tice described in this clause is a notice that 
provides to the beneficiary notice— 
‘‘(I) that the PDP sponsor has 
identified the beneficiary as an at-risk 
beneficiary 
for 
prescription 
drug 
abuse; 
‘‘(II) that such beneficiary is 
subject to the requirements of the 
drug management program for at-risk 
beneficiaries established by such PDP 
sponsor for such plan; 
‘‘(III) of the prescriber (or pre-
scribers) and pharmacy s(or phar-
macies) elected for such individual 
under subparagraph (D); 
‘‘(IV) of, and information about, 
the beneficiary’s right to appeal such 
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291 
identification under subsection (h) 
and the option of an automatic esca-
lation to external review; 
‘‘(V) that the beneficiary can, in 
the case that the beneficiary has not 
previously submitted to the PDP 
sponsor preferences for which pre-
scribers and pharmacies the bene-
ficiary would prefer the PDP sponsor 
select under subparagraph (D), sub-
mit such preferences to the PDP 
sponsor; and 
‘‘(VI) that includes clear instruc-
tions that explain how the beneficiary 
can contact the PDP sponsor. 
‘‘(iv) TIMING OF NOTICES.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), a second notice de-
scribed in clause (iii) shall be provided 
to the beneficiary on a date that is 
not less than 60 days after an initial 
notice described in clause (ii) is pro-
vided to the beneficiary. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor, in conjunction 
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292 
with the Secretary, determines that 
concerns 
identified 
through 
rule-
making by the Secretary regarding 
the health or safety of the beneficiary 
or regarding significant drug diversion 
activities require the PDP sponsor to 
provide a second notice described in 
clause (iii) to the beneficiary on a 
date that is earlier than the date de-
scribed in subclause (II), the PDP 
sponsor may provide such second no-
tice on such earlier date. 
‘‘(C) AT-RISK
BENEFICIARY
FOR
PRE-
SCRIPTION DRUG ABUSE.— 
‘‘(i) IN
GENERAL.—For purposes of 
this paragraph, the term ‘at-risk bene-
ficiary for prescription drug abuse’ means 
a part D eligible individual who is not an 
exempted individual described in clause (ii) 
and— 
‘‘(I) who is identified through the 
use of clinical guidelines developed by 
the Secretary in consultation with 
PDP sponsors and other stakeholders 
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293 
described in section 3141(f)(2)(A) of 
the 21st Century Cures Act; or 
‘‘(II) with respect to whom the 
PDP sponsor of a prescription drug 
plan, upon enrolling such individual in 
such plan, received notice from the 
Secretary that such individual was 
identified under this paragraph to be 
an at-risk beneficiary for prescription 
drug abuse under the prescription 
drug plan in which such individual 
was most recently previously enrolled 
and such identification has not been 
terminated under subparagraph (F). 
‘‘(ii) 
EXEMPTED
INDIVIDUAL
DE-
SCRIBED.—An exempted individual de-
scribed in this clause is an individual 
who— 
‘‘(I) receives hospice care under 
this title; 
‘‘(II) is a resident of a long-term 
care facility, of an intermediate care 
facility for the mentally retarded, or 
of another facility for which fre-
quently abused drugs are dispensed 
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294 
for residents through a contract with 
a single pharmacy; or 
‘‘(III) the Secretary elects to 
treat as an exempted individual for 
purposes of clause (i). 
‘‘(D) SELECTION
OF
PRESCRIBERS
AND 
PHARMACIES.— 
‘‘(i) IN
GENERAL.—With respect to 
each at-risk beneficiary for prescription 
drug abuse enrolled in a prescription drug 
plan offered by such sponsor, a PDP spon-
sor shall, based on the preferences sub-
mitted to the PDP sponsor by the bene-
ficiary pursuant to clauses (ii)(IV) and 
(iii)(V) of subparagraph (B), select— 
‘‘(I) one or more individuals who 
are authorized to prescribe frequently 
abused drugs (referred to in this 
paragraph as ‘prescribers’) who may 
write prescriptions for such drugs for 
such beneficiary; and 
‘‘(II) one or more pharmacies 
that may dispense such drugs to such 
beneficiary. 
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