I 
113TH CONGRESS 
2D SESSION 
H. R. 5780 
To amend title XVIII of the Social Security Act to improve the integrity 
of the Medicare program, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 2, 2014 
Mr. BRADY of Texas (for himself, Mr. MCDERMOTT, Mr. CAMP, Mr. LEVIN, 
Mr. RANGEL, Mr. LEWIS, Mr. SAM JOHNSON of Texas, Mr. BLU-
MENAUER, Mr. PASCRELL, Mr. GERLACH, Mr. BOUSTANY, Mr. 
BUCHANAN, Mr. ROSKAM, Mr. REED, Mrs. BLACK, Mr. GRIFFIN of Ar-
kansas, Mr. KELLY of Pennsylvania, Mr. RENACCI, and Mr. VAN HOL-
LEN) introduced the following bill; which was referred to the Committee 
on Ways and Means, and in addition to the Committee on Energy and 
Commerce, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to improve 
the integrity of 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Protecting the Integrity of Medicare Act of 2014’’. 
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(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Prohibition of inclusion of Social Security account numbers on Medicare 
cards. 
Sec. 3. Preventing wrongful Medicare payments for items and services fur-
nished to incarcerated individuals, individuals not lawfully 
present, and deceased individuals. 
Sec. 4. Consideration of measures regarding Medicare beneficiary smart cards. 
Sec. 5. Modifying medicare durable medical equipment face-to-face encounter 
documentation requirement. 
Sec. 6. Reducing improper Medicare payments. 
Sec. 7. Improving senior Medicare patrol and fraud reporting rewards. 
Sec. 8. Requiring valid prescriber National Provider Identifiers on pharmacy 
claims. 
Sec. 9. Option to receive Medicare Summary Notice electronically. 
Sec. 10. Renewal of MAC contracts. 
Sec. 11. Study on pathway for incentives to States for State participation in 
medicaid data match program. 
Sec. 12. Programs to prevent prescription drug abuse under Medicare part D. 
Sec. 13. Guidance on application of Common Rule to clinical data registries. 
Sec. 14. Eliminating certain civil money penalties; gainsharing study and re-
port. 
Sec. 15. Modification of Medicare home health surety bond condition of partici-
pation requirement. 
Sec. 16. Oversight of Medicare coverage of manual manipulation of the spine 
to correct subluxation. 
Sec. 17. Limiting payment amount under Medicare program for vacuum erec-
tion systems. 
Sec. 18. National expansion of prior authorization model for repetitive sched-
uled non-emergent ambulance transport. 
Sec. 19. Repealing duplicative Medicare secondary payor provision. 
Sec. 20. Plan for expanding data in annual CERT report. 
Sec. 21. Rule of construction. 
SEC. 2. PROHIBITION OF INCLUSION OF SOCIAL SECURITY 
ACCOUNT NUMBERS ON MEDICARE CARDS. 
(a) IN GENERAL.—Section 205(c)(2)(C) of the Social 
Security Act (42 U.S.C. 405(c)(2)(C)) is amended— 
(1) by moving clause (x), as added by section 
1414(a)(2) of the Patient Protection and Affordable 
Care Act, 6 ems to the left; 
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(2) by redesignating clause (x), as added by 
section 2(a)(1) of the Social Security Number Pro-
tection Act of 2010, and clause (xi) as clauses (xi) 
and (xii), respectively; and 
(3) by adding at the end the following new 
clause: 
‘‘(xiii) The Secretary of Health and Human Services, 
in consultation with the Commissioner of Social Security, 
shall establish cost-effective procedures to ensure that a 
Social Security account number (or derivative thereof) is 
not displayed, coded, or embedded on the Medicare card 
issued to an individual who is entitled to benefits under 
part A of title XVIII or enrolled under part B of title 
XVIII and that any other identifier displayed on such card 
is not identifiable as a Social Security account number (or 
derivative thereof).’’. 
(b) IMPLEMENTATION.—In implementing clause (xiii) 
of section 205(c)(2)(C) of the Social Security Act (42 
U.S.C. 405(c)(2)(C)), as added by subsection (a)(3), the 
Secretary of Health and Human Services shall do the fol-
lowing: 
(1) IN
GENERAL.—Establish a cost-effective 
process that involves the least amount of disruption 
to, as well as necessary assistance for, Medicare 
beneficiaries and health care providers, such as a 
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process that provides such beneficiaries with access 
to assistance through a toll-free telephone number 
and provides outreach to providers. 
(2) CONSIDERATION
OF
MEDICARE
BENE-
FICIARY
IDENTIFIED.—Consider implementing a 
process, similar to the process involving Railroad Re-
tirement Board beneficiaries, under which a Medi-
care beneficiary identifier which is not a Social Secu-
rity account number (or derivative thereof) is used 
external to the Department of Health and Human 
Services and is convertible over to a Social Security 
account number (or derivative thereof) for use inter-
nal to such Department and the Social Security Ad-
ministration. 
(c) FUNDING FOR IMPLEMENTATION.—For purposes 
of implementing the provisions of and the amendments 
made by this section, the Secretary of Health and Human 
Services shall provide for the following transfers from the 
Federal Hospital Insurance Trust Fund under section 
1817 of the Social Security Act (42 U.S.C. 1395i) and 
from the Federal Supplementary Medical Insurance Trust 
Fund established under section 1841 of such Act (42 
U.S.C. 1395t), in such proportions as the Secretary deter-
mines appropriate: 
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(1) To the Centers for Medicare & Medicaid 
Program Management Account, transfers of the fol-
lowing amounts: 
(A) For fiscal year 2015, $65,000,000, to 
be made available through fiscal year 2018. 
(B) For each of fiscal years 2016 and 
2017, $53,000,000, to be made available 
through fiscal year 2018. 
(C) For fiscal year 2018, $48,000,000, to 
be made available until expended. 
(2) To the Social Security Administration Limi-
tation on Administration Account, transfers of the 
following amounts: 
(A) For fiscal year 2015, $27,000,000, to 
be made available through fiscal year 2018. 
(B) For each of fiscal years 2016 and 
2017, $22,000,000, to be made available 
through fiscal year 2018. 
(C) For fiscal year 2018, $27,000,000, to 
be made available until expended. 
(3) To the Railroad Retirement Board Limita-
tion on Administration Account, the following 
amount: 
(A) For fiscal year 2015, $3,000,000, to 
be made available until expended. 
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(d) EFFECTIVE DATE.— 
(1) IN
GENERAL.—Clause (xiii) of section 
205(c)(2)(C) of the Social Security Act (42 U.S.C. 
405(c)(2)(C)), as added by subsection (a)(3), shall 
apply with respect to Medicare cards issued on and 
after an effective date specified by the Secretary of 
Health and Human Services, but in no case shall 
such effective date be later than the date that is four 
years after the date of the enactment of this Act. 
(2) REISSUANCE.—The Secretary shall provide 
for the reissuance of Medicare cards that comply 
with the requirements of such clause not later than 
four years after the effective date specified by the 
Secretary under paragraph (1). 
SEC. 3. PREVENTING WRONGFUL MEDICARE PAYMENTS 
FOR ITEMS AND SERVICES FURNISHED TO IN-
CARCERATED 
INDIVIDUALS, 
INDIVIDUALS 
NOT LAWFULLY PRESENT, AND DECEASED IN-
DIVIDUALS. 
(a) REQUIREMENT FOR THE SECRETARY TO ESTAB-
LISH POLICIES AND CLAIMS EDITS RELATING TO INCAR-
CERATED INDIVIDUALS, INDIVIDUALS NOT LAWFULLY 
PRESENT, AND DECEASED INDIVIDUALS.—Section 1874 
of the Social Security Act (42 U.S.C. 1395kk) is amended 
by adding at the end the following new subsection: 
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‘‘(f) REQUIREMENT FOR THE SECRETARY TO ESTAB-
LISH POLICIES AND CLAIMS EDITS RELATING TO INCAR-
CERATED INDIVIDUALS, INDIVIDUALS NOT LAWFULLY 
PRESENT, AND DECEASED INDIVIDUALS.—The Secretary 
shall establish and maintain procedures, including proce-
dures for using claims processing edits, updating eligibility 
information to improve provider accessibility, and con-
ducting recoupment activities such as through recovery 
audit contractors, in order to ensure that payment is not 
made under this title for items and services furnished to 
an individual who is one of the following: 
‘‘(1) An individual who is incarcerated. 
‘‘(2) An individual who is not lawfully present 
in the United States and who is not eligible for cov-
erage under this title. 
‘‘(3) A deceased individual.’’. 
(b) REPORT.—Not later than 18 months after the 
date of the enactment of this section, and periodically 
thereafter as determined necessary by the Office of Inspec-
tor General of the Department of Health and Human 
Services, such Office shall submit to Congress a report 
on the activities described in subsection (f) of section 1874 
of the Social Security Act (42 U.S.C. 1395kk), as added 
by subparagraph (a), that have been conducted since such 
date of enactment. 
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SEC. 4. CONSIDERATION OF MEASURES REGARDING MEDI-
CARE BENEFICIARY SMART CARDS. 
To the extent the Secretary of Health and Human 
Services determines that it is cost effective and techno-
logically viable to use electronic Medicare beneficiary and 
provider cards (such as cards that use smart card tech-
nology, including an embedded and secure integrated cir-
cuit chip), as presented in the Government Accountability 
Office report required by the conference report accom-
panying the Consolidated Appropriations Act, 2014 (Pub-
lic Law 113–76), the Secretary shall consider such meas-
ures as determined appropriate by the Secretary to imple-
ment such use of such cards for beneficiary and provider 
use under title XVIII of the Social Security Act (42 
U.S.C. 1395 et seq.). In the case that the Secretary con-
siders measures under the preceding sentence, the Sec-
retary shall submit to the Committees on Ways and Means 
and on Energy and Commerce of the House of Represent-
atives, and to the Committee on Finance of the Senate, 
a report outlining the considerations undertaken by the 
Secretary under such sentence. 
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SEC. 5. MODIFYING MEDICARE DURABLE MEDICAL EQUIP-
MENT 
FACE-TO-FACE 
ENCOUNTER 
DOCU-
MENTATION REQUIREMENT. 
(a) IN GENERAL.—Section 1834(a)(11)(B)(ii) of the 
Social Security Act (42 U.S.C. 1395m(a)(11)(B)(ii)) is 
amended— 
(1) by striking ‘‘the physician documenting 
that’’; and 
(2) by striking ‘‘has had a face-to-face encoun-
ter’’ and inserting ‘‘documenting such physician, 
physician assistant, practitioner, or specialist has 
had a face-to-face encounter’’. 
(b) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human 
Services may implement the amendments made by sub-
section (a) by program instruction or otherwise. 
SEC. 6. REDUCING IMPROPER MEDICARE PAYMENTS. 
(a) MEDICARE ADMINISTRATIVE CONTRACTOR IM-
PROPER PAYMENT OUTREACH
AND EDUCATION PRO-
GRAM.— 
(1) IN GENERAL.—Section 1874A of the Social 
Security Act (42 U.S.C. 1395kk–1) is amended— 
(A) in subsection (a)(4)— 
(i) by redesignating subparagraph (G) 
as subparagraph (H); and 
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(ii) by inserting after subparagraph 
(F) the following new subparagraph: 
‘‘(G) IMPROPER PAYMENT OUTREACH AND 
EDUCATION PROGRAM.—Having in place an im-
proper payment outreach and education pro-
gram described in subsection (h).’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(h) IMPROPER PAYMENT OUTREACH
AND EDU-
CATION PROGRAM.— 
‘‘(1) IN
GENERAL.—In order to reduce im-
proper payments under this title, each medicare ad-
ministrative contractor shall establish and have in 
place an improper payment outreach and education 
program under which the contractor, through out-
reach, education, training, and technical assistance 
or other activities, shall provide providers of services 
and suppliers located in the region covered by the 
contract under this section with the information de-
scribed in paragraph (2). The activities described in 
the preceding sentence shall be conducted on a reg-
ular basis. 
‘‘(2) INFORMATION TO BE PROVIDED THROUGH 
ACTIVITIES.—The information to be provided under 
such payment outreach and education program shall 
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include information the Secretary determines to be 
appropriate which may include the following infor-
mation: 
‘‘(A) A list of the providers’ or suppliers’ 
most frequent and expensive payment errors 
over the last quarter. 
‘‘(B) Specific instructions regarding how to 
correct or avoid such errors in the future. 
‘‘(C) A notice of new topics that have been 
approved by the Secretary for audits conducted 
by recovery audit contractors under section 
1893(h). 
‘‘(D) Specific instructions to prevent fu-
ture issues related to such new audits. 
‘‘(E) Other information determined appro-
priate by the Secretary. 
‘‘(3) PRIORITY.—A medicare administrative 
contractor shall give priority to activities under such 
program that will reduce improper payments that 
are one or more of the following: 
‘‘(A) Are for items and services that have 
the highest rate of improper payment. 
‘‘(B) Are for items and service that have 
the greatest total dollar amount of improper 
payments. 
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‘‘(C) Are due to clear misapplication or 
misinterpretation of Medicare policies. 
‘‘(D) Are clearly due to common and inad-
vertent clerical or administrative errors. 
‘‘(E) Are due to other types of errors that 
the Secretary determines could be prevented 
through activities under the program. 
‘‘(4) INFORMATION
ON
IMPROPER
PAYMENTS 
FROM RECOVERY AUDIT CONTRACTORS.— 
‘‘(A) IN
GENERAL.—In order to assist 
medicare administrative contractors in carrying 
out improper payment outreach and education 
programs, the Secretary shall provide each con-
tractor with a complete list of the types of im-
proper payments identified by recovery audit 
contractors under section 1893(h) with respect 
to providers of services and suppliers located in 
the region covered by the contract under this 
section. Such information shall be provided on 
a time frame the Secretary determines appro-
priate which may be on a quarterly basis. 
‘‘(B) INFORMATION.—The information de-
scribed in subparagraph (A) shall include infor-
mation such as the following: 
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‘‘(i) Providers of services and sup-
pliers that have the highest rate of im-
proper payments. 
‘‘(ii) Providers of services and sup-
pliers that have the greatest total dollar 
amounts of improper payments. 
‘‘(iii) Items and services furnished in 
the region that have the highest rates of 
improper payments. 
‘‘(iv) Items and services furnished in 
the region that are responsible for the 
greatest total dollar amount of improper 
payments. 
‘‘(v) Other information the Secretary 
determines would assist the contractor in 
carrying out the program. 
‘‘(5) COMMUNICATIONS.—Communications with 
providers of services and suppliers under an im-
proper payment outreach and education program are 
subject to the standards and requirements of sub-
section (g).’’. 
(b) USE
OF
CERTAIN
FUNDS
RECOVERED
BY 
RACS.—Section 1893(h) of the Social Security Act (42 
U.S.C. 1395ddd(h)) is amended— 
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(1) in paragraph (2), by inserting ‘‘or section 
1874(h)(6)’’ after ‘‘paragraph (1)(C)’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(10) USE OF CERTAIN RECOVERED FUNDS.— 
‘‘(A) IN
GENERAL.—After application of 
paragraph (1)(C), the Secretary shall retain a 
portion of the amounts recovered by recovery 
audit contractors for each year under this sec-
tion which shall be available to the program 
management account of the Centers for Medi-
care & Medicaid Services for purposes of, sub-
ject to subparagraph (B), carrying out sections 
1833(z), 1834(l)(16), and 1874A(a)(4)(G), car-
rying out section 16(b) of the Protecting the In-
tegrity of Medicare Act of 2014, and imple-
menting strategies (such as claims processing 
edits) to help reduce the error rate of payments 
under this title. The amounts retained under 
the preceding sentence shall not exceed an 
amount equal to 15 percent of the amounts re-
covered under this subsection, and shall remain 
available until expended. 
‘‘(B) LIMITATION.—Except for uses that 
support claims processing (including edits) or 
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system 
functionality 
for 
detecting 
fraud, 
amounts retained under subparagraph (A) may 
not be used for technological-related infrastruc-
ture, capital investments, or information sys-
tems. 
‘‘(C) NO REDUCTION IN PAYMENTS TO RE-
COVERY
AUDIT
CONTRACTORS.—Nothing in 
subparagraph (A) shall reduce amounts avail-
able for payments to recovery audit contractors 
under this subsection.’’. 
SEC. 7. IMPROVING SENIOR MEDICARE PATROL AND 
FRAUD REPORTING REWARDS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) shall develop a plan to revise the incentive pro-
gram under section 203(b) of the Health Insurance Port-
ability and Accountability Act of 1996 (42 U.S.C. 1395b– 
5(b)) to encourage greater participation by individuals to 
report fraud and abuse in the Medicare program. Such 
plan shall include recommendations for— 
(1) ways to enhance rewards for individuals re-
porting under the incentive program, including re-
wards based on information that leads to an admin-
istrative action; and 
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(2) extending the incentive program to the 
Medicaid program. 
(b) PUBLIC AWARENESS
AND EDUCATION CAM-
PAIGN.—The plan developed under subsection (a) shall 
also include recommendations for the use of the Senior 
Medicare Patrols authorized under section 411 of the 
Older Americans Act of 1965 (42 U.S.C. 3032) to conduct 
a public awareness and education campaign to encourage 
participation in the revised incentive program under sub-
section (a). 
(c) SUBMISSION OF PLAN.—Not later than 180 days 
after the date of enactment of this Act, the Secretary shall 
submit to Congress the plan developed under subsection 
(a). 
SEC. 8. REQUIRING VALID PRESCRIBER NATIONAL PRO-
VIDER IDENTIFIERS ON PHARMACY CLAIMS. 
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 new paragraph: 
‘‘(4) REQUIRING VALID PRESCRIBER NATIONAL 
PROVIDER IDENTIFIERS ON PHARMACY CLAIMS.— 
‘‘(A) IN GENERAL.—For plan year 2016 
and subsequent plan years, the Secretary shall 
require a claim for a covered part D drug for 
a part D eligible individual enrolled in a pre-
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scription drug plan under this part or an MA– 
PD plan under part C to include a prescriber 
National Provider Identifier that is determined 
to be valid under the procedures established 
under subparagraph (B)(i). 
‘‘(B) PROCEDURES.— 
‘‘(i) VALIDITY
OF
PRESCRIBER
NA-
TIONAL
PROVIDER
IDENTIFIERS.—The 
Secretary, in consultation with appropriate 
stakeholders, shall establish procedures for 
determining the validity of prescriber Na-
tional Provider Identifiers under subpara-
graph (A). 
‘‘(ii) INFORMING
BENEFICIARIES
OF 
REASON FOR DENIAL.—The Secretary shall 
establish procedures to ensure that, in the 
case that a claim for a covered part D 
drug 
of 
an 
individual 
described 
in 
subparagaph (A) is denied because the 
claim does not meet the requirements of 
this paragraph, the individual is properly 
informed at the point of service of the rea-
son for the denial. 
‘‘(C) REPORT.—Not later than January 1, 
2018, the Inspector General of the Department 
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of Health and Human Services shall submit to 
Congress a report on the effectiveness of the 
procedures established under subparagraph 
(B)(i).’’. 
SEC. 9. OPTION TO RECEIVE MEDICARE SUMMARY NOTICE 
ELECTRONICALLY. 
(a) IN GENERAL.—Section 1806 of the Social Secu-
rity Act (42 U.S.C. 1395b–7) is amended by adding at 
the end the following new subsection: 
‘‘(c) FORMAT OF STATEMENTS FROM SECRETARY.— 
‘‘(1) 
ELECTRONIC
OPTION
BEGINNING
IN 
2016.—Subject to paragraph (2), for statements de-
scribed in subsection (a) that are furnished for a pe-
riod in 2016 or a subsequent year, in the case that 
an individual described in subsection (a) elects, in 
accordance with such form, manner, and time speci-
fied by the Secretary, to receive such statement in 
an electronic format, such statement shall be fur-
nished to such individual for each period subsequent 
to such election in such a format and shall not be 
mailed to the individual. 
‘‘(2) LIMITATION ON REVOCATION OPTION.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Secretary may determine a max-
imum number of elections described in para-
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graph (1) by an individual that may be revoked 
by the individual. 
‘‘(B) MINIMUM OF ONE REVOCATION OP-
TION.—In no case may the Secretary determine 
a maximum number under subparagraph (A) 
that is less than one. 
‘‘(3) NOTIFICATION.—The Secretary shall en-
sure that, in the most cost effective manner and be-
ginning January 1, 2017, a clear notification of the 
option to elect to receive statements described in 
subsection (a) in an electronic format is made avail-
able, such as through the notices distributed under 
section 1804, to individuals described in subsection 
(a).’’. 
(b) ENCOURAGED
EXPANSION
OF
ELECTRONIC 
STATEMENTS.—To the extent to which the Secretary of 
Health and Human Services determines appropriate, the 
Secretary shall— 
(1) apply an option similar to the option de-
scribed in subsection (c)(1) of section 1806 of the 
Social Security Act (42 U.S.C. 1395b–7) (relating to 
the provision of the Medicare Summary Notice in an 
electronic format), as added by subsection (a), to 
other statements and notifications under title XVIII 
of such Act (42 U.S.C. 1395 et seq.); and 
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(2) provide such Medicare Summary Notice and 
any such other statements and notifications on a 
more frequent basis than is otherwise required under 
such title. 
SEC. 10. RENEWAL OF MAC CONTRACTS. 
(a) IN GENERAL.—Section 1874A(b)(1)(B) of the 
Social Security Act (42 U.S.C. 1395kk–1(b)(1)(B)) is 
amended by striking ‘‘5 years’’ and inserting ‘‘10 years’’. 
(b) APPLICATION.—The amendments made by sub-
section (a) shall apply to contracts entered into on or 
after, and to contracts in effect as of, the date of the en-
actment of this Act. 
(c) CONTRACTOR PERFORMANCE TRANSPARENCY.— 
Section 1874A(b)(3)(A) of the Social Security Act (42 
U.S.C. 1395kk–1(b)(3)(A)) is amended by adding at the 
end the following new clause: 
‘‘(iv) 
CONTRACTOR
PERFORMANCE 
TRANSPARENCY.—To the extent possible 
without compromising the process for en-
tering into and renewing contracts with 
medicare administrative contractors under 
this section, the Secretary shall make 
available to the public the performance of 
each medicare administrative contractor 
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with respect to such performance require-
ments and measurement standards.’’. 
SEC. 11. STUDY ON PATHWAY FOR INCENTIVES TO STATES 
FOR STATE PARTICIPATION IN MEDICAID 
DATA MATCH PROGRAM. 
Section 1893(g) of the Social Security Act (42 U.S.C. 
1395ddd(g)) is amended by adding at the end the fol-
lowing new paragraph: 
‘‘(3) INCENTIVES FOR STATES.—The Secretary 
shall study and, as appropriate, may specify incen-
tives for States to work with the Secretary for the 
purposes described in paragraph (1)(A)(ii). The ap-
plication of the previous sentence may include use of 
the waiver authority described in paragraph (2).’’. 
SEC. 12. PROGRAMS TO PREVENT PRESCRIPTION DRUG 
ABUSE UNDER MEDICARE PART D. 
(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–10(c)), as 
amended by section 8, is further amended by adding 
at the end the following: 
‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT- 
RISK BENEFICIARIES.— 
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‘‘(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 selected under 
subparagraph (D), and dispensed for such bene-
ficiary by a pharmacy selected under such sub-
paragraph. 
‘‘(B) REQUIREMENT FOR NOTICES.— 
‘‘(i) IN
GENERAL.—A PDP sponsor 
may not limit the access of an at-risk ben-
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 
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‘‘(II) verifies with the providers 
of the beneficiary that the beneficiary 
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 
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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); 
‘‘(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 
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‘‘(VII) contact information for 
other organizations that can provide 
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 and phar-
macy selected for such individual 
under subparagraph (D); 
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‘‘(IV) of, and information about, 
the beneficiary’s right to appeal such 
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. 
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‘‘(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 
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 guidelines developed by the 
Secretary in consultation with PDP 
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sponsors and other stakeholders de-
scribed in section 12(f)(2)(A) of the 
Protecting the Integrity of Medicare 
Act of 2014; 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; or 
‘‘(II) the Secretary elects to treat 
as an exempted individual for pur-
poses of clause (i). 
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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)(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. 
‘‘(ii) REASONABLE ACCESS.—In mak-
ing the selection under this subparagraph, 
a PDP sponsor shall ensure that the bene-
ficiary continues to have reasonable access 
to drugs described in subparagraph (G), 
taking into account geographic location, 
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beneficiary preference, affordability, and 
reasonable travel time. 
‘‘(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— 
‘‘(aa) 
review 
such 
pref-
erences; 
‘‘(bb) select or change the 
selection of a prescriber or phar-
macy for the beneficiary based on 
such preferences; and 
‘‘(cc) inform the beneficiary 
of such selection or change of se-
lection. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor determines that 
a change to the selection of a pre-
scriber or pharmacy under item (bb) 
by the PDP sponsor is contributing or 
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would contribute to prescription drug 
abuse or drug diversion by the bene-
ficiary, the PDP sponsor may change 
the selection of a prescriber or phar-
macy for the beneficiary without re-
gard to the preferences of the bene-
ficiary described in subclause (I). 
‘‘(iv) CONFIRMATION.—Before select-
ing a prescriber or pharmacy under this 
subparagraph, a PDP sponsor must re-
quest and receive confirmation from the 
prescriber or pharmacy acknowledging and 
accepting that the beneficiary involved is in 
the drug management program for at-risk 
beneficiaries. 
‘‘(E) TERMINATIONS AND APPEALS.—The 
identification of an individual as an at-risk ben-
eficiary for prescription drug abuse under this 
paragraph, a coverage determination made 
under a drug management program for at-risk 
beneficiaries, and the selection of a prescriber 
or pharmacy under subparagraph (D) with re-
spect to such individual shall be subject to re-
consideration and appeal under subsection (h) 
and the option of an automatic escalation to ex-
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ternal review to the extent provided by the Sec-
retary. 
‘‘(F) TERMINATION OF IDENTIFICATION.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall develop standards for the termination 
of identification of an individual as an at- 
risk beneficiary for prescription drug abuse 
under this paragraph. Under such stand-
ards such identification shall terminate as 
of the earlier of— 
‘‘(I) the date the individual dem-
onstrates that the individual is no 
longer likely, in the absence of the re-
strictions under this paragraph, to be 
an at-risk beneficiary for prescription 
drug abuse described in subparagraph 
(C)(i); or 
‘‘(II) the end of such maximum 
period of identification as the Sec-
retary may specify. 
‘‘(ii) 
RULE
OF
CONSTRUCTION.— 
Nothing in clause (i) shall be construed as 
preventing a plan from identifying an indi-
vidual as an at-risk beneficiary for pre-
scription drug abuse under subparagraph 
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