I 
115TH CONGRESS 
2D SESSION 
H. R. 5773 
To amend title XVIII of the Social Security Act to require Medicare prescrip-
tion drug plans to establish drug management programs for at-risk 
beneficiaries, require electronic prior authorization for covered part D 
drugs, and to provide for other program integrity measures under parts 
C and D of the Medicare program. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 11, 2018 
Mr. ROSKAM (for himself, Ms. SEWELL of Alabama, Mr. KNIGHT, and Ms. 
SINEMA) introduced the following bill; which was referred to the Com-
mittee 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 provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to require 
Medicare prescription drug plans to establish drug man-
agement programs for at-risk beneficiaries, require elec-
tronic prior authorization for covered part D drugs, and 
to provide for other program integrity measures under 
parts C and D of the Medicare program. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Preventing Addiction 
for Susceptible Seniors Act of 2018’’ or the ‘‘PASS Act 
of 2018’’. 
SEC. 2. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS 
UNDER 
MEDICARE 
TO 
ESTABLISH 
DRUG 
MANAGEMENT 
PROGRAMS 
FOR 
AT-RISK 
BENEFICIARIES. 
Section 1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(c)) is amended— 
(1) in paragraph (1), by inserting after sub-
paragraph (E) the following new subparagraph: 
‘‘(F) With respect to plan years beginning 
on or after January 1, 2021, a drug manage-
ment program for at-risk beneficiaries described 
in paragraph (5).’’; and 
(2) in paragraph (5)(A), by inserting ‘‘(and for 
plan years beginning on or after January 1, 2021, 
a PDP sponsor shall)’’ after ‘‘A PDP sponsor may’’. 
SEC. 3. ELECTRONIC PRIOR AUTHORIZATION FOR COV-
ERED PART D DRUGS. 
(a) INCLUSION IN ELECTRONIC PRESCRIPTION PRO-
GRAM.—Section 1860D–4(e)(2) of the Social Security Act 
(42 U.S.C. 1395w–104(e)(2)) is amended by adding at the 
end the following new subparagraph: 
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‘‘(E) 
ELECTRONIC
PRIOR
AUTHORIZA-
TION.— 
‘‘(i) IN
GENERAL.—Not later than 
January 1, 2021, the program shall pro-
vide for the secure electronic transmittal 
of— 
‘‘(I) a prior authorization request 
from the prescribing health care pro-
fessional for coverage of a covered 
part D drug for a part D eligible indi-
vidual enrolled in a part D plan (as 
defined in section 1860D–23(a)(5)) to 
the PDP sponsor or Medicare Advan-
tage organization offering such plan; 
and 
‘‘(II) a response, in accordance 
with this subparagraph, from such 
PDP sponsor or Medicare Advantage 
organization, respectively, to such pro-
fessional. 
‘‘(ii) ELECTRONIC TRANSMISSION.— 
‘‘(I) EXCLUSIONS.—For purposes 
of this subparagraph, a facsimile, a 
proprietary payer portal that does not 
meet standards specified by the Sec-
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retary, or an electronic form shall not 
be treated as an electronic trans-
mission described in clause (i). 
‘‘(II) STANDARDS.—In order to 
be treated, for purposes of this sub-
paragraph, as an electronic trans-
mission described in clause (i), such 
transmission shall comply with tech-
nical standards adopted by the Sec-
retary in consultation with the Na-
tional Council for Prescription Drug 
Programs, other standard setting or-
ganizations determined appropriate by 
the Secretary, and stakeholders in-
cluding PDP sponsors, Medicare Ad-
vantage organizations, health care 
professionals, and health information 
technology software vendors.’’. 
(b) SENSE OF CONGRESS REGARDING ELECTRONIC 
PRIOR AUTHORIZATION.—It is the sense of the Congress 
that— 
(1) there should be increased use of electronic 
prior authorizations for coverage of covered part D 
drugs for part D eligible individuals enrolled in pre-
scription drug plans under part D of title XVIII of 
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the Social Security Act and MA–PD plans under 
part C of such title to reduce access delays by re-
solving coverage issues before prescriptions for such 
drugs are transmitted; and 
(2) greater priority should be placed on increas-
ing the adoption of use of such electronic prior au-
thorizations among prescribers of such drugs, phar-
macies, PDP sponsors, and Medicare Advantage or-
ganizations. 
SEC. 4. PROGRAM INTEGRITY TRANSPARENCY MEASURES 
UNDER MEDICARE PARTS C AND D. 
(a) IN GENERAL.—Section 1859 of the Social Secu-
rity Act (42 U.S.C. 1395w–28) is amended by adding at 
the end the following new subsection: 
‘‘(i) PROGRAM INTEGRITY TRANSPARENCY MEAS-
URES.— 
‘‘(1) PROGRAM INTEGRITY PORTAL.— 
‘‘(A) IN
GENERAL.—Not later than two 
years after the date of the enactment of this 
subsection, the Secretary shall, after consulta-
tion with stakeholders, establish a secure Inter-
net website portal (or other successor tech-
nology) that would allow a secure path for com-
munication between the Secretary, MA plans 
under this part, prescription drug plans under 
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part D, and an eligible entity with a contract 
under section 1893 (such as a Medicare drug 
integrity contractor or an entity responsible for 
carrying out program integrity activities under 
this part and part D) for the purpose of ena-
bling through such portal (or other successor 
technology)— 
‘‘(i) the referral by such plans of sub-
stantiated fraud, waste, and abuse for ini-
tiating or assisting investigations con-
ducted by the eligible entity; and 
‘‘(ii) data sharing among such MA 
plans, prescription drug plans, and the 
Secretary. 
‘‘(B) REQUIRED USES OF PORTAL.—The 
Secretary shall disseminate the following infor-
mation to MA plans under this part and pre-
scription drug plans under part D through the 
secure Internet website portal (or other suc-
cessor technology) established under subpara-
graph (A): 
‘‘(i) Providers of services and sup-
pliers that have been referred pursuant to 
subparagraph (A)(i) during the previous 
12-month period. 
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‘‘(ii) Providers of services and sup-
pliers who are the subject of an active ex-
clusion under section 1128 or who are sub-
ject to a suspension of payment under this 
title pursuant to section 1862(o) or other-
wise. 
‘‘(iii) Providers of services and sup-
pliers who are the subject of an active rev-
ocation of participation under this title, in-
cluding for not satisfying conditions of par-
ticipation. 
‘‘(iv) In the case of such a plan that 
makes a referral under subparagraph 
(A)(i) through the portal (or other suc-
cessor technology) with respect to activities 
of substantiated fraud, waste, or abuse of 
a provider of services or supplier, if such 
provider or supplier has been the subject of 
an administrative action under this title or 
title XI with respect to similar activities, a 
notification to such plan of such action so 
taken. 
‘‘(C) RULEMAKING.—For purposes of this 
paragraph, the Secretary shall, through rule-
making, specify what constitutes substantiated 
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fraud, waste, and abuse, using guidance such as 
what is provided in the Medicare Program In-
tegrity Manual 4.7.1. In carrying out this sub-
section, a fraud hotline tip (as defined by the 
Secretary) without further evidence shall not be 
treated as sufficient evidence for substantiated 
fraud, waste, or abuse. 
‘‘(D) HIPAA COMPLIANT
INFORMATION 
ONLY.—For purposes of this subsection, com-
munications may only occur if the communica-
tions are permitted under the Federal regula-
tions (concerning the privacy of individually 
identifiable health information) promulgated 
under section 264(c) of the Health Insurance 
Portability and Accountability Act of 1996. 
‘‘(2) QUARTERLY
REPORTS.—Beginning two 
years after the date of enactment of this subsection, 
the Secretary shall make available to MA plans 
under this part and prescription drug plans under 
part D in a timely manner (but no less frequently 
than quarterly) and using information submitted to 
an entity described in paragraph (1) through the 
portal (or other successor technology) described in 
such paragraph or pursuant to section 1893, infor-
mation on fraud, waste, and abuse schemes and 
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trends in identifying suspicious activity. Information 
included in each such report shall— 
‘‘(A) include administrative actions, perti-
nent information related to opioid overpre-
scribing, and other data determined appropriate 
by the Secretary in consultation with stake-
holders; and 
‘‘(B) be anonymized information submitted 
by plans without identifying the source of such 
information. 
‘‘(3) CLARIFICATION.—Nothing in this sub-
section shall be construed as precluding or otherwise 
affecting referrals described in subparagraph (A) 
that may otherwise be made to law enforcement en-
tities or to the Secretary.’’. 
(b) CONTRACT REQUIREMENT TO COMMUNICATE 
PLAN CORRECTIVE ACTIONS AGAINST OPIOID OVER-PRE-
SCRIBERS.—Section 1857(e)(4)(C) of the Social Security 
Act (42 U.S.C. 1395w–27(e)(4)(C)) is amended by adding 
at the end the following new paragraph: 
‘‘(5) COMMUNICATING
PLAN
CORRECTIVE
AC-
TIONS AGAINST OPIOIDS OVER-PRESCRIBERS.— 
‘‘(A) IN GENERAL.—Beginning with plan 
years beginning on or after January 1, 2021, a 
contract under this section with an MA organi-
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zation shall require the organization to submit 
to the Secretary, through the process estab-
lished under subparagraph (B), information on 
the investigations and other actions taken by 
such plans related to providers of services who 
prescribe a high volume of opioids. 
‘‘(B) PROCESS.—Not later than January 
1, 2021, the Secretary shall, in consultation 
with stakeholders, establish a process under 
which MA plans and prescription drug plans 
shall submit to the Secretary information de-
scribed in subparagraph (A). 
‘‘(C) REGULATIONS.—For purposes of this 
paragraph, including as applied under section 
1860D–12(b)(3)(D), the Secretary shall, pursu-
ant to rulemaking— 
‘‘(i) specify a definition for the term 
‘high volume of opioids’ and a method for 
determining if a provider of services pre-
scribes such a high volume; and 
‘‘(ii) establish the process described in 
subparagraph (B) and the types of infor-
mation that shall be submitted through 
such process.’’. 
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(c) REFERENCE UNDER PART D TO PROGRAM IN-
TEGRITY TRANSPARENCY MEASURES.—Section 1860D–4 
of the Social Security Act (42 U.S.C. 1395w–104) is 
amended by adding at the end the following new sub-
section: 
‘‘(m) PROGRAM INTEGRITY TRANSPARENCY MEAS-
URES.—For program integrity transparency measures ap-
plied with respect to prescription drug plan and MA plans, 
see section 1859(i).’’. 
SEC. 5. EXPANDING ELIGIBILITY FOR MEDICATION THER-
APY MANAGEMENT PROGRAMS UNDER PART 
D. 
Section 1860D–4(c)(2)(A)(ii) of the Social Security 
Act (42 U.S.C. 1395w–104(c)(2)(A)(ii)) is amended— 
(1) by redesignating subclauses (I) through 
(III) as items (aa) through (cc), respectively, and 
adjusting the margins accordingly; 
(2) by striking ‘‘are part D eligible individuals 
who—’’ and inserting ‘‘are the following: 
‘‘(I) Part D eligible individuals 
who—’’; and 
(3) by adding at the end the following new sub-
clause: 
‘‘(II) 
Beginning 
January 
1, 
2021, at-risk beneficiaries for pre-
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scription drug abuse (as defined in 
paragraph (5)(C)).’’. 
SEC. 6. MEDICARE NOTIFICATIONS TO OUTLIER PRE-
SCRIBERS OF OPIOIDS. 
Section 1860D–4(c)(4) of the Social Security Act (42 
U.S.C. 1395w–104(c)(4)) is amended by adding at the end 
the following new paragraph: 
‘‘(D) OUTLIER
PRESCRIBER
NOTIFICA-
TION.— 
‘‘(i) NOTIFICATION.—Beginning not 
later than two years after the date of the 
enactment of this subparagraph, the Sec-
retary shall, in the case of a prescriber 
identified by the Secretary under clause 
(ii) to be an outlier prescriber of opioids, 
provide, subject to clause (iv), an annual 
notification to such prescriber that such 
prescriber has been so identified and that 
includes resources on proper prescribing 
methods and other information specified in 
accordance with clause (iii). 
‘‘(ii) IDENTIFICATION
OF
OUTLIER 
PRESCRIBERS OF OPIOIDS.— 
‘‘(I) IN
GENERAL.—The Sec-
retary shall, subject to subclause (III), 
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using the valid prescriber National 
Provider Identifiers included pursuant 
to subparagraph (A) on claims for 
covered part D drugs for part D eligi-
ble individuals enrolled in prescription 
drug plans under this part or MA–PD 
plans under part C and based on the 
threshold established under subclause 
(II), conduct an analysis to identify 
prescribers that are outlier opioid pre-
scribers for a period specified by the 
Secretary. 
‘‘(II) 
ESTABLISHMENT
OF 
THRESHOLD.—For purposes of sub-
clause (I) and subject to subclause 
(III), the Secretary shall, after con-
sultation with stakeholders, establish 
a threshold, based on prescriber spe-
cialty and geographic area, for identi-
fying whether a prescriber in a spe-
cialty and geographic area is an 
outlier prescriber of opioids as com-
pared to other prescribers of opioids 
within such specialty and area. 
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‘‘(III) EXCLUSIONS.—The Sec-
retary may exclude the following indi-
viduals and prescribers from the anal-
ysis under this clause: 
‘‘(aa) Individuals receiving 
hospice services. 
‘‘(bb) Individuals with a 
cancer diagnosis. 
‘‘(cc) Prescribers who are 
the subject of an investigation by 
the Centers for Medicare & Med-
icaid Services or the Office of In-
spector General of the Depart-
ment of Health and Human 
Services. 
‘‘(iii) CONTENTS OF NOTIFICATION.— 
The Secretary shall, based on input from 
stakeholders, specify the resources and 
other information to be included in notifi-
cations provided under clause (i). 
‘‘(iv) MODIFICATIONS
AND
EXPAN-
SIONS.— 
‘‘(I) FREQUENCY.—Beginning 5 
years after the date of the enactment 
of this subparagraph, the Secretary 
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may change the frequency of the noti-
fications described in clause (i) based 
on stakeholder input. 
‘‘(II) 
EXPANSION
TO
OTHER 
PRESCRIPTIONS.—The Secretary may 
expand notifications under this sub-
paragraph to include identifications 
and notifications with respect to con-
current prescriptions of covered Part 
D drugs used in combination with 
opioids that are considered to have 
adverse side effects when so used in 
such combination, as determined by 
the Secretary. 
‘‘(v) OPIOIDS
DEFINED.—For pur-
poses of this subparagraph, the term 
‘opioids’ has such meaning as specified by 
the Secretary through program instruction 
or otherwise.’’. 
Æ 
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