datamatters24/research-document-archive huggingface dataset:
States, when an online platform is not otherwise in-
volved; 
(4) how illicit funds that have been transmitted 
online and through virtual currencies are repatriated 
into the formal banking system of the United States 
through money laundering or other means; 
(5) the participants (state and non-state actors) 
throughout the entire supply chain that participate in 
or benefit from the buying, selling, or financing of 
goods and services associated with sex or drug traf-
ficking (either through online marketplaces or virtual 
currencies) destined for, originating from, or within 
the United States; 
(6) Federal and State agency efforts to impede 
the buying, selling, or financing of goods and services 
associated with sex or drug trafficking destined for, 
originating from, or within the United States, includ-
ing efforts to prevent the proceeds from sex or drug 
trafficking from entering the United States banking 
system; 
(7) how virtual currencies and their underlying 
technologies can be used to detect and deter these il-
licit activities; and 
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(8) to what extent can the immutable and trace-
able nature of virtual currencies contribute to the 
tracking and prosecution of illicit funding. 
(b) SCOPE.—For the purposes of the study required 
under subsection (a), the term ‘‘sex trafficking’’ means the 
recruitment, harboring, transportation, provision, obtain-
ing, patronizing, or soliciting of a person for the purpose 
of a commercial sex act that is induced by force, fraud, or 
coercion, or in which the person induced to perform such 
act has not attained 18 years of age. 
(c) REPORT TO CONGRESS.—Not later than 1 year 
after the date of enactment of this Act, the Comptroller Gen-
eral of the United States shall submit to the Committee on 
Banking, Housing, and Urban Affairs of the Senate and 
the Committee on Financial Services of the House of Rep-
resentatives a report summarizing the results of the study 
required under subsection (a), together with any rec-
ommendations for legislative or regulatory action that 
would improve the efforts of Federal agencies to impede the 
use of virtual currencies and online marketplaces in facili-
tating sex and drug trafficking. 
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Service employee may only enroll in a Program 
plan; 
‘‘(B) if the health benefits plan in which 
such employee is enrolled for such contract year 
becomes available as a Program plan, the Post-
al Service employee may only enroll in a Pro-
gram plan; 
‘‘(C) upon becoming a Postal Service an-
nuitant, if the Postal Service employee elects to 
continue coverage under this chapter, the Post-
al Service employee shall enroll in a Program 
plan during the open season that is— 
‘‘(i) being held when the Postal Serv-
ice employee becomes a Postal Service an-
nuitant; or 
‘‘(ii) if the date on which the Postal 
Service employee becomes a Postal Service 
annuitant falls outside of an open season, 
the first open season following that date; 
and 
‘‘(D) subparagraphs (A), (B), and (C) 
shall not apply to an employee who resides in 
a geographic area for which there is not a Pro-
gram plan in which the employee may enroll. 
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Calendar No. 592 
115TH CONGRESS 
2D SESSION 
H. R. 606 
AN ACT 
To designate the facility of the United States Post-
al Service located at 1025 Nevin Avenue in Rich-
mond, California, as the ‘‘Harold D. McCraw, 
Sr., Post Office Building’’. 
SEPTEMBER 28, 2018 
Reported without amendment 
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I 
115TH CONGRESS 
2D SESSION 
H. R. 6070 
To amend title 18, United States Code, to prohibit former Members of 
Congress from engaging in lobbying contacts. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 12, 2018 
Mr. CICILLINE (for himself and Mr. LOEBSACK) introduced the following bill; 
which was referred to the Committee on the Judiciary 
A BILL 
To amend title 18, United States Code, to prohibit former 
Members of Congress from engaging in lobbying contacts. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. PROHIBITION ON LOBBYING CONTACTS BY 
FORMER MEMBERS OF CONGRESS. 
(a) IN GENERAL.—Section 207(e) of title 18, United 
States Code, is amended as follows: 
(1) Paragraph (1) is amended to read as fol-
lows: 
‘‘(1) MEMBERS OF CONGRESS.— 
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‘‘(A) IN GENERAL.—Any person who is a 
Senator or a Member of the House of Rep-
resentatives and who, after that person leaves 
office, knowingly makes any lobbying contact to 
a covered executive branch official, or to any 
Member, officer, or employee of either House of 
Congress, shall be punished as provided in sec-
tion 216 of this title. 
‘‘(B) DEFINITIONS.—In this paragraph, 
the terms ‘lobbying contact’ and ‘covered execu-
tive branch official’ have the meanings given 
those terms in section 3 of the Lobbying Disclo-
sure Act of 1995 (2 U.S.C. 1602).’’. 
(2) Paragraph (2) is amended— 
(A) by striking ‘‘(2) Any person’’ and in-
serting the following: 
‘‘(2) OFFICERS AND CERTAIN STAFF.— 
‘‘(A) OFFICERS AND STAFF OF THE SEN-
ATE.—Any person’’; and 
(B) by adding at the end the following: 
‘‘(B) OFFICERS OF THE HOUSE OF REP-
RESENTATIVES.—(i) Any person who is an 
elected officer of the House of Representatives 
and who, within 1 year after that person leaves 
office, knowingly makes, with the intent to in-
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fluence, any communication to or appearance 
before any of the persons described in clause 
(ii), on behalf of any other person (except the 
United States) in connection with any matter 
on which such elected officer seeks action by a 
Member, officer, or employee of either House of 
Congress, in his or her official capacity, shall be 
punished as provided in section 216 of this title. 
‘‘(ii) The persons referred to in clause (i) 
with respect to appearances or communications 
by a former elected officer are any Member, of-
ficer, or employee of the House of Representa-
tives.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to individuals who leave office 
or employment to which such amendments apply on or 
after the date of adjournment of the second session of the 
One Hundred Fifteenth Congress sine die or December 
31, 2018, whichever date is earlier. 
Æ 
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I 
115TH CONGRESS 
2D SESSION 
H. R. 6071 
To amend the Public Health Service Act to clarify the intent of the 340B 
program and provide for enhanced 340B program integrity, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 12, 2018 
Ms. MATSUI 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 the Public Health Service Act to clarify the intent 
of the 340B program and provide for enhanced 340B 
program integrity, 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 ‘‘Stretching Entity Re-
sources for Vulnerable Communities Act’’ or the ‘‘SERV 
Communities Act’’. 
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SEC. 2. SENSE OF CONGRESS RELATED TO PURPOSE OF 
THE 340B PROGRAM. 
It is the sense of Congress that— 
(1) the program under section 340B of the 
Public Health Service Act (42 U.S.C. 256b) (in this 
section referred to as the ‘‘340B program’’) enables 
covered entities to stretch scarce resources as far as 
possible, reaching more patients and providing more 
comprehensive services than without such program; 
(2) the 340B program provides health care set-
tings that serve a disproportionate share of under-
served patient populations (referred to as covered 
entities) a discount from drug manufacturers on the 
covered outpatient drugs they purchase to meet 
health care needs of the community; 
(3) covered entities that qualify for participa-
tion under the 340B program meet rigorous eligi-
bility criteria, proving they are safety net health care 
providers for many underserved patients; 
(4) such discounts are provided to such covered 
entities on the basis of meeting eligibility criteria 
under the 340B program, and not directly to indi-
vidual patients; 
(5) the 340B Program enables covered entities 
to provide comprehensive services to the commu-
nities they serve, which may include providing free 
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or discounted drugs to vulnerable populations, but 
providing free or discounted drugs to patients is not 
the sole purpose of the program; 
(6) the 340B Program is designed to help cov-
ered entities promote health for underserved commu-
nities and patients, regardless of a particular pa-
tient’s insurance status or inability to pay; 
(7) savings from the 340B program are used by 
covered entities to reach more patients and provide 
more comprehensive services, and covered entities 
are in the best position to assess the use of their 
savings for community needs; and 
(8) drugs purchased under the 340B program 
account for a small proportion of overall drug spend-
ing and the discounts described in paragraph (2) 
provided through the 340B program are not funded 
by taxpayers. 
SEC. 3. CODIFYING DEFINITION OF PATIENT UNDER 340B 
PROGRAM. 
Section 340B(b) of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the fol-
lowing new paragraph: 
‘‘(3) PATIENT.— 
‘‘(A) IN GENERAL.—For purposes of car-
rying out this section, the term ‘patient’ shall 
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have the definition given to such term on pages 
55156 through 55158 of title 61 of the Federal 
Register published on October 24, 1996. 
‘‘(B) CLARIFICATION.—For purposes of 
this section, the Secretary shall not implement 
the definition under subparagraph (A) more 
narrowly than the definition specified in sub-
paragraph (A), including by limiting the appli-
cation of the definition to particular individuals 
based on their insurance status.’’. 
SEC. 4. NON-DISCRIMINATION WITH RESPECT TO COVERED 
ENTITIES. 
Section 340B of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(f) NON-DISCRIMINATION WITH RESPECT TO COV-
ERED ENTITIES.— 
‘‘(1) TERMS OF AGREEMENT.—Subject to para-
graph (3), no entity that reimburses a covered entity 
or its contract pharmacy for drugs that are subject 
to an agreement under this section may discriminate 
against such covered entity with respect to the terms 
of such reimbursement, including terms relating to 
the level and amount of reimbursement, on the basis 
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that the covered entity participates in the program 
under this section. 
‘‘(2) PATIENT’S CHOICE.—With respect to a pa-
tient eligible to receive drugs that are subject to an 
agreement under this section from a covered entity 
or its contract pharmacy, no entity that makes pay-
ment for such drugs shall discriminate against the 
covered entity or its contract pharmacy in a manner 
that prevents or interferes with the patient’s choice 
to receive such drugs from the covered entity or con-
tract pharmacy. 
‘‘(3) EXCEPTION.—Paragraph (1) shall not 
apply to States with respect to retail drugs that are 
reimbursed by the State on a fee-for-service basis 
pursuant to a State plan approved under title XIX 
of the Social Security Act.’’. 
SEC. 5. PROGRAM INTEGRITY. 
(a) FINDINGS.—Congress finds the following: 
(1) In response to findings by the Office of the 
Inspector General of the Department of Health and 
Human Services that nearly 100 percent of covered 
entities were overcharged by manufacturers for at 
least one of the drugs reviewed, Congress directed 
the Secretary of Health and Human Services in 
2010 to publish the ceiling prices under section 
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340B of the Public Health Service Act (42 U.S.C. 
256b) (in this section referred to as the ‘‘340B ceil-
ing price’’) via Internet website so that covered enti-
ties could verify they were being charged the correct 
price, however this website has not yet been estab-
lished, leaving covered entities vulnerable to con-
tinuing manufacturer overcharges. 
(2) In response to findings by the Office of the 
Inspector General of the Department of Health and 
Human Services of widespread overcharges by man-
ufacturers and a lack of oversight and authority by 
the Secretary of Health and Human Services to en-
sure that covered entities paid no more than the 
340B ceiling price, Congress directed the Secretary 
to develop standards for calculating 340B ceiling 
prices and civil monetary penalties to apply to man-
ufacturers that violate these rules, however those 
standards and penalties have not yet been developed, 
significantly limiting the Secretary’s ability to over-
see manufacturer compliance with such section 340B 
of the Public Health Service Act (42 U.S.C. 256b). 
(3) There is no public transparency on drug 
manufacturers’ average manufacturer price, best 
price in the marketplace, or how much the average 
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manufacturer price of a drug has increased relative 
to the rate of inflation. 
(4) Information on the average manufacturer 
price and best price are reported to the Centers for 
Medicare & Medicaid Services, but rarely does the 
Federal Government audit the raw data underlying 
those calculations. 
(5) Such data is not submitted and reviewed by 
the Health Resources and Services Administration 
as part of a 340B program audit. 
(6) Furthermore, the Office of Pharmacy Af-
fairs has conducted only 11 total audits of manufac-
turers. 
(b) PARITY IN AUDITS BETWEEN MANUFACTURER 
AND HOSPITAL AUDITS.—Section 340B(d)(1)(B)(v) of 
the 
Public 
Health 
Service 
Act 
(42 
U.S.C. 
256b(d)(1)(B)(v)) is amended to read as follows: 
‘‘(v) Selective auditing of manufactur-
ers and wholesalers to ensure the integrity 
of the drug discount program under this 
section, consistent with the following: 
‘‘(I) Such audits shall be con-
ducted in a form and manner that, to 
the greatest extent practicable, results 
in parity between such audits and au-
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dits under subsection (a)(5)(C) of cov-
ered entities, as measured by com-
paring the percentage of total manu-
facturer audits under this clause to 
the percentage of total audits con-
ducted under such subsection of cov-
ered entities described in subsection 
(a)(4)(L). 
‘‘(II) Such audits shall include 
review of average manufacturer price, 
best price, and the inflationary pen-
alty to ensure that manufacturers are 
calculating the ceiling price accu-
rately.’’. 
(c) DEADLINE FOR INTERNET WEBSITE WITH AP-
PLICABLE CEILING PRICES FOR COVERED OUTPATIENT 
DRUGS.—Section 340B(d)(1)(B)(iii) of the Public Health 
Service Act (42 U.S.C. 256b(d)(1)(B)(iii)) is amended by 
striking ‘‘The provision’’ and inserting ‘‘Not later than 90 
days after the date of the enactment of the Stretching En-
tity Resources for Vulnerable Community Act, the provi-
sion’’. 
(d) CIVIL MONETARY PENALTY.— 
(1) IN
GENERAL.—Clause (vi)(II) of section 
340B(d)(1)(B) of the Public Health Service Act (42 
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U.S.C. 256b(d)(1)(B)) is amended to read as fol-
lows: 
‘‘(II) shall not exceed, for each 
instance of overcharging a covered en-
tity that may have occurred, the 
greater of— 
‘‘(aa) $5,000; or 
‘‘(bb) 200 percent of the 
amount of such overcharge; and’’. 
(2) CLARIFICATIONS.—Section 340B(d)(1) of 
the 
Public 
Health 
Service 
Act 
(42 
U.S.C. 
256b(d)(1)) is amended by adding at the end the 
following new subparagraph: 
‘‘(C) CLARIFICATIONS.—For purposes of 
subparagraph (B)(vi)— 
‘‘(i) an instance of overcharging de-
scribed in subclause (II) of such subpara-
graph shall— 
‘‘(I) apply to each unit of a na-
tional drug code within an order, 
whether placed directly with a manu-
facturer or through a wholesaler, au-
thorized distributor, or agent, and 
may not be offset by other discounts 
provided on any other National Drug 
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Code or discounts provided on the 
same National Drug Code on other 
transactions, orders or purchases; and 
‘‘(II) include a manufacturer’s 
failure, such as through a limited dis-
tribution network, to offer a covered 
outpatient drug to a covered entity at 
the 340B ceiling price to the same ex-
tent the manufacturer makes the drug 
available to non-340B providers, un-
less such action is taken to narrowly 
address an actual or imminent short-
age and has been approved in advance 
by the Secretary pursuant to stand-
ards issued through an appropriate 
policy or regulatory issuance; and 
‘‘(ii) in applying subclause (III) of 
such subparagraph— 
‘‘(I) the term ‘knowingly’ shall 
have the meaning given the term 
‘should know’ in section 1003.101 of 
title 42 of the Code of Federal Regu-
lations (or any successor regulation); 
and 
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‘‘(II) the term ‘intentionally’ 
means, with respect to an overcharge, 
that such overcharge is not due to in-
advertent error.’’. 
(3) NON-APPLICATION OF 340B CEILING PRICE 
AND CMP REGULATION.—The Secretary of Health 
and Human Services shall not take any action to im-
plement, administer, or enforce the provision of the 
final regulation titled ‘‘340B Drug Pricing Program 
Ceiling Price and Manufacturer Civil Monetary Pen-
alties Regulation’’ published on June 5, 2018 (83 
Fed. Reg. 25943 et seq.), that changes the effective 
date of the 340B Drug Pricing Program Ceiling 
Price and Manufacturer Civil Monetary Penalties 
Regulation from July 1, 2018 to July 1, 2019. The 
effective date shall be determined as if such final 
regulation published on June 5, 2018, did not apply. 
(4) 
IMPLEMENTATION.—The 
Secretary 
of 
Health and Human Services shall implement the 
amendments made by paragraphs (1) and (2) by 
program instruction or otherwise such that such 
amendment applies to instances of overcharges oc-
curring on or after the date that is 60 days after the 
date of the enactment of this Act. 
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(5) GAO REPORT.—Not later than one year 
after the date of the enactment of this Act, the 
Comptroller General of the United States shall sub-
mit to Congress a report evaluating the extent to 
which the Secretary of Health and Human Services 
is carrying out the provisions of clause (vi) of section 
340B(d)(1)(B) of the Public Health Service Act (42 
U.S.C. 256b(d)(1)(B)), as amended by this sub-
section. 
(e) 
MANUFACTURER
TRANSPARENCY.—Section 
340B(d)(1)(B) of the Public Health Service Act (42 
U.S.C. 256b(d)(1)(B)) is amended by adding at the end 
the following new clauses: 
‘‘(vii) The requirement that the appli-
cable ceiling price described in clause (iii) 
for a covered outpatient drug, with respect 
to a calendar quarter, shall be equal to the 
average manufacturer price under section 
1927(k)(1) of the Social Security Act from 
the preceding calendar quarter for the 
smallest unit of measure minus the unit 
rebate amount and will be calculated using 
six decimal places and will be published by 
the Secretary rounded to two decimal 
places, in accordance with the following: 
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‘‘(I) In the case that the ceiling 
price calculation results in an amount 
less than $0.01, the ceiling price will 
be $0.01. 
‘‘(II) For a new covered out-
patient drug— 
‘‘(aa) manufacturers shall 
estimate the ceiling price as of 
the date the new drug is first 
available for sale; 
‘‘(bb) the estimation shall be 
calculated as wholesale acquisi-
tion cost minus the appropriate 
rebate percentage until an aver-
age manufacturer price is avail-
able, which shall occur no later 
than the 4th quarter that the 
drug is available for sale; and 
‘‘(cc) manufacturers shall 
calculate the actual ceiling price 
and shall offer to refund or credit 
the covered entity the difference 
between the estimated ceiling 
price and the actual ceiling price 
within 120 days of the deter-
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mination by the manufacturer in-
volved that an overcharge oc-
curred. 
‘‘(viii) The prohibition against dis-
criminatory distribution of drugs, con-
sistent with the following: 
‘‘(I) A manufacturer shall make 
available each covered outpatient drug 
to covered entities on the same terms 
and conditions that the covered out-
patient drug is offered to purchasers 
that are not covered entities except 
that the manufacturer will charge the 
covered entity for the covered out-
patient drug at or below the ceiling 
price. 
‘‘(II) If the Secretary finds, after 
audit as described in subparagraph 
(B)(v) and after notice and hearing, 
that a manufacturer is in violation of 
the requirement described in sub-
clause (I), the manufacturer shall be 
liable to the covered entity that was 
not able to purchase the covered out-
patient drug involved at a discounted 
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