I 
114TH CONGRESS 
2D SESSION 
H. R. 4876 
To authorize the establishment of programs to prevent prescription drug 
abuse under the Medicare program, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 23, 2016 
Mr. MEEHAN (for himself and Mr. NEAL) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committee on Ways and Means, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To authorize the establishment of programs to prevent pre-
scription drug abuse under the Medicare program, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Prescription 
Drug Abuse Prevention Act of 2016’’. 
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SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG 
ABUSE UNDER THE MEDICARE PROGRAM. 
(a) DRUG MANAGEMENT PROGRAM
FOR AT-RISK 
BENEFICIARIES.— 
(1) IN GENERAL.—Section 1860D–4(c) of the 
Social Security Act (42 U.S.C. 1395w–104(c)) is 
amended by adding at the end the following: 
‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT- 
RISK BENEFICIARIES.— 
‘‘(A) AUTHORITY TO ESTABLISH.—A PDP 
sponsor may establish a drug management pro-
gram for at-risk beneficiaries under which, sub-
ject to subparagraph (B), the PDP sponsor 
may, in the case of an at-risk beneficiary for 
prescription drug abuse who is an enrollee in a 
prescription drug plan of such PDP sponsor, 
limit such beneficiary’s access to coverage for 
frequently abused drugs under such plan to fre-
quently abused drugs that are prescribed for 
such beneficiary by a prescriber (or prescribers) 
selected under subparagraph (D), and dis-
pensed for such beneficiary by a pharmacy (or 
pharmacies) selected under such subparagraph. 
‘‘(B) REQUIREMENT FOR NOTICES.— 
‘‘(i) IN
GENERAL.—A PDP sponsor 
may not limit the access of an at-risk ben-
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eficiary for prescription drug abuse to cov-
erage for frequently abused drugs under a 
prescription drug plan until such spon-
sor— 
‘‘(I) provides to the beneficiary 
an initial notice described in clause 
(ii) and a second notice described in 
clause (iii); and 
‘‘(II) verifies with the providers 
of the beneficiary that the beneficiary 
is an at-risk beneficiary for prescrip-
tion drug abuse, as described in sub-
paragraph (C)(iv). 
‘‘(ii) INITIAL
NOTICE.—An initial 
written notice 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, when possible, 
describing State and Federal public 
health resources that are designed to 
address prescription drug abuse to 
which the beneficiary may have ac-
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cess, including substance use disorder 
treatment services, addiction treat-
ment services, mental health services, 
and other counseling services; 
‘‘(III) a request for the bene-
ficiary to submit to the PDP sponsor 
preferences for which prescribers and 
pharmacies the beneficiary would pre-
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); 
‘‘(IV) an explanation of the 
meaning and consequences of the 
identification of the beneficiary as po-
tentially being an at-risk beneficiary 
for prescription drug abuse, including 
an explanation of the drug manage-
ment program established by the PDP 
sponsor pursuant to subparagraph 
(A); 
‘‘(V) clear instructions that ex-
plain how the beneficiary can contact 
the PDP sponsor in order to submit 
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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; 
‘‘(VI) contact information for 
other organizations that can provide 
the beneficiary with information re-
garding drug management program 
for at-risk beneficiaries (similar to the 
information provided by the Secretary 
in other standardized notices to part 
D eligible individuals enrolled in pre-
scription drug plans under this part); 
and 
‘‘(VII) notice that the beneficiary 
has a right to an appeal pursuant to 
subparagraph (E). 
‘‘(iii) SECOND
NOTICE.—A second 
written notice described in this clause is a 
notice that provides to the beneficiary no-
tice— 
‘‘(I) that the PDP sponsor has 
identified the beneficiary as an at-risk 
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mit such preferences to the PDP 
sponsor; and 
‘‘(VI) that includes clear instruc-
tions that explain how the beneficiary 
can contact the PDP sponsor in order 
to submit to the PDP sponsor the 
preferences described in subclause 
(V). 
‘‘(iv) TIMING OF NOTICES.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), a second written notice 
described in clause (iii) shall be pro-
vided to the beneficiary on a date that 
is not less than 30 days after an ini-
tial notice described in clause (ii) is 
provided to the beneficiary. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor, in conjunction 
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 
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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. 
‘‘(III) FORM
OF
NOTICE.—The 
written notices under clauses (ii) and 
(iii) shall be in a format determined 
appropriate by the Secretary, taking 
into account beneficiary preferences. 
‘‘(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 cri-
teria developed by the Secretary in 
consultation with PDP sponsors and 
other stakeholders described in section 
2(g)(2)(A) of the Medicare Prescrip-
tion Drug Abuse Prevention Act of 
2016 based on clinical factors indi-
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cating misuse or abuse of prescription 
drugs described in subparagraph (G), 
including dosage, quantity, duration 
of use, number of and reasonable ac-
cess to prescribers, and number of 
and reasonable access to pharmacies 
used to obtain such drug; 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 a prescription drug 
plan in which such individual was pre-
viously enrolled and such identifica-
tion 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; 
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‘‘(II) resides in a long-term care 
facility, a facility described in section 
1905(d), or other facility under con-
tract with a single pharmacy; or 
‘‘(III) the Secretary elects to 
treat as an exempted individual for 
purposes of clause (i). 
‘‘(iii) PROGRAM SIZE.—The Secretary 
shall establish policies, including the cri-
teria developed under clause (i)(I) and the 
exemptions under clause (ii)(III), to ensure 
that the population of enrollees in a drug 
management program for at-risk bene-
ficiaries operated by a prescription drug 
plan can be effectively managed by such 
plans. 
‘‘(iv) CLINICAL
CONTACT.—With re-
spect to each at-risk beneficiary for pre-
scription drug abuse enrolled in a prescrip-
tion drug plan offered by a PDP sponsor, 
the PDP sponsor shall contact the bene-
ficiary’s providers who have prescribed fre-
quently abused drugs regarding whether 
prescribed medications are appropriate for 
such beneficiary’s medical conditions. 
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‘‘(D) SELECTION OF PRESCRIBERS.— 
‘‘(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)(III) and 
(iii)(V) of subparagraph (B) if applicable, 
select— 
‘‘(I) one, or, if the PDP sponsor 
reasonably determines it necessary to 
provide the beneficiary with reason-
able access under clause (ii), more 
than one, individual who is authorized 
to prescribe frequently abused drugs 
(referred to in this paragraph as a 
‘prescriber’) who may write prescrip-
tions for such drugs for such bene-
ficiary; and 
‘‘(II) one, or, if the PDP sponsor 
reasonably determines it necessary to 
provide the beneficiary with reason-
able access under clause (ii), more 
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than one, pharmacy that may dis-
pense such drugs to such beneficiary. 
‘‘(ii) REASONABLE ACCESS.—In mak-
ing the selection under this subparagraph, 
a PDP sponsor shall ensure, taking into 
account geographic location, beneficiary 
preference, impact on cost-sharing, and 
reasonable travel time, that the beneficiary 
continues to have reasonable access to 
drugs described in subparagraph (G), in-
cluding— 
‘‘(I) for individuals with multiple 
residences; and 
‘‘(II) in the case of natural disas-
ters and similar emergency situations. 
‘‘(iii) BENEFICIARY PREFERENCES.— 
‘‘(I) IN GENERAL.—If an at-risk 
beneficiary 
for 
prescription 
drug 
abuse submits preferences for which 
in-network prescribers and pharmacies 
the beneficiary would prefer the PDP 
sponsor select in response to a notice 
under subparagraph (B), the PDP 
sponsor shall— 
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