DEA Order Clearinghouse Act of 2018
This bill requires the Drug Enforcement Administration to establish a national clearinghouse to collect and analyze controlled substance orders in order to identify potentially suspicious orders.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6600 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 6600
To amend the Controlled Substances Act to require that orders subject
to review be submitted through a clearinghouse, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 26, 2018
Mr. Lance (for himself and Ms. Matsui) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on the Judiciary, 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 Controlled Substances Act to require that orders subject
to review be submitted through a clearinghouse, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``DEA Order Clearinghouse Act of
2018''.
SEC. 2. REQUIRED CLEARINGHOUSE FOR REGISTRANT ORDERS.
(a) In General.--The Controlled Substances Act (21 U.S.C. 801 et
seq.) is amended--
(1) in section 303(f), in the matter preceding paragraph
(1), by striking ``The Attorney General'' and inserting
``Subject to section 303A, the Attorney General''; and
(2) by inserting after section 303 the following:
``SEC. 303A. REQUIRED CLEARINGHOUSE FOR REGISTRANT ORDERS.
``(a) In General.--Not later than 2 years after the date of
enactment of this section, the Attorney General shall--
``(1) establish a clearinghouse that would subject all
orders of controlled substances and listed chemicals to the
clearinghouse for recording and review, prior to final review
by the registrant;
``(2) amend the regulations relative to controlled
substances in schedule II ordering requirements that would
allow for uniform electronic ordering of controlled substances
in schedule II, III, IV, and V electronically to the
clearinghouse; and
``(3) may deny, suspend, or revoke a registration issued
under section 303(f), or the registration of a distributor
under section 303(b) or 303(e), if the practitioner or
distributor, as applicable, is not substantially in compliance
with the requirements of this section.
``(b) Clearinghouse.--
``(1) In general.--An order for a controlled substance may
not be filled by the registrant unless--
``(A) the order is first transmitted electronically
to the Attorney General, acting through the
Administrator of the Drug Enforcement Administration
(referred to in this section as the `Administrator');
``(B) the Administrator uses the algorithm
described in paragraph (2) to determine if the order is
an outlier and is potentially suspicious;
``(C) the Administrator relays the order to the
registrant with whom the order is placed, regardless of
whether the algorithm was exceeded, for further
analysis of the order under section 1301.74(b) of title
21, Code of Federal Regulations; and
``(D) the registrant has received a waiver from the
Administrator exempting the registrant from this
section.
``(2) Algorithm.--
``(A) In general.--The clearinghouse established
under this section shall use an input-based algorithm,
including techniques such as artificial intelligence,
machine learning, and other methods of analyzing large
data, that--
``(i) automatically identifies orders that
exceed the metrics of the algorithm;
``(ii) notifies the registrant if the order
is an outlier and is potentially suspicious;
``(iii) is informed by all data available
to the Administrator and uses pharmacy best
practices;
``(iv) takes into consideration existing
State and Federal law; and
``(v) establishes different parameters for
different registrants using relevant
information based on pharmacy type, location,
and size.
``(B) Refinement.--The Administrator of the Drug
Enforcement Administration (referred to in this section
as the `Administrator') shall review, update, and
revise the algorithm biannually based on feedback from
industry and relevant stakeholders to ensure
functionality.
``(3) Consultation.--The Administrator shall consult with
the Director of the National Institute of Standards and
Technology for technical assistance in establishing the
clearinghouse.
``(c) Responsibilities of Distributors and Manufacturers Regarding
Suspicious Orders.--This section may not be construed as relieving any
distributor or manufacturer from the requirements established in
section 1301.74(b) of title 21, Code of Federal Regulations, or any
successor regulation, with respect to suspicious orders.
``(d) Contractor Regarding Data Analytics.--
``(1) In general.--The Administrator shall award a contract
to a public or private entity enabling the Administrator to
carry out the technological aspects of tracking, processing and
evaluating orders under this section.
``(2) Eligible entities.--An entity is eligible for an
award under paragraph (1) if the entity has significant
experience in data analytics and in processing the volume of
electronic data involved in reviewing orders under this section
within the timeframe required in subsection (c).
``(3) Capabilities.--A contract awarded under paragraph (1)
shall--
``(A) provide a data management and configurable
visual analytics solution capable of ingesting and
managing data entities, including manufacturers, and
distributors, retail dispensers across relevant data
maintained by the Administrator;
``(B) standardize the data format, with the ability
to flexibly model data for analyses and link data
across sources; and
``(C) provide an environment for analysis that is
interoperable.
``(4) Commercial items.--The Administrator shall comply
with section 3307 of title 41, United States Code, in awarding
a contract under paragraph (1). The Administrator may not enter
into a contract for any capabilities sought under paragraph (1)
that are not for commercial items unless the Administrator
first determines in writing that no commercial items are
suitable to meet the needs of the Drug Enforcement
Administration.
``(5) Timeline of contract.--Any contract awarded under
paragraph (1) for a data management and visual analytics
solution shall require the public or private entity awarded
such contract to deliver a functioning solution sufficient to
fulfill the purposes of this section not later than 180 days
after the date on which the contract is awarded, unless the
Administrator grants an extension for unforseen delays.
``(6) Federal acquisition regulation.--A contract awarded
under this subsection shall be in accordance with the Federal
Acquisition Regulation.
``(7) Access to data.--An entity that is awarded a contract
under this subsection shall have access to the relevant data to
create the system.
``(e) Waiver.--
``(1) In general.--Beginning on the date on which the 36-
month period described in subsection (b)(1)(A)(ii) expires, a
pharmacy may submit to the Administrator an application for a
waiver from the requirements of subsection (b)(1)(A) if the
pharmacy is unable to transmit orders electronically.
``(2) Response.--The Administrator shall approve or deny an
application submitted under paragraph (1) not later than the
90-day period beginning on the date on which the application is
received.
``(3) Liability.--No waiver issued under paragraph (1)
shall mitigate the liability of the pharmacy for any drugs
diverted that did not pass through the clearinghouse.
``(f) Funding.--
``(1) Diversion control fee account.--The activities
performed under this section shall be considered to be elements
of the diversion control program for purposes of this section.
``(2) Prohibition.--No registrant may pass on the cost of
the clearinghouse to its customers.''.
(b) Technical and Conforming Amendment.--The table of contents for
the Controlled Substances Act (21 U.S.C. 801 et seq.) is amended by
inserting after the item relating to section 303 the following:
``Sec. 303A. Required clearinghouse for registrant orders.''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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.
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
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