Analyzing and Leveraging Existing Rx Transactions Act of 2018 or the ALERT Act of 2018
This bill requires the Food and Drug Administration to establish an electronic system to provide pharmacists with a patient's prescription and dispensing history with respect to covered drugs (i.e., those identified as having a risk of misuse or abuse).
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6688 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 6688
To provide for the establishment of the Prescription Safety Alert
System with respect to covered drug products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 28, 2018
Mr. MacArthur (for himself, Ms. Kuster of New Hampshire, and Mrs.
Comstock) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To provide for the establishment of the Prescription Safety Alert
System with respect to covered drug products, 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 ``Analyzing and Leveraging Existing Rx
Transactions Act of 2018'' or the ``ALERT Act of 2018''.
SEC. 2. PRESCRIPTION SAFETY ALERT SYSTEM TO HELP PREVENT ABUSE AND
MISUSE OF PRESCRIPTION DRUGS.
The Federal Food, Drug, and Cosmetic Act is amended by inserting
after section 505-1 of such Act (21 U.S.C. 355-1) the following new
section:
``SEC. 505-2. PRESCRIPTION SAFETY ALERT SYSTEM TO PREVENT ABUSE AND
MISUSE.
``(a) In General.--For the purpose of combating the national
prescription drug abuse epidemic, the Secretary shall, with respect to
covered drug products, establish and maintain an electronic system, to
be known as the Prescription Safety Alert System, that--
``(1) reviews patient prescription and dispensing history
through pharmaceutical claims data transactions described in
section 1173(a)(2) of the Social Security Act and developed by
a standard setting organization;
``(2) collects, maintains, and is capable of providing to
dispensers, within a dispenser's ordinary clinical workflow,
information about a patient's prescription and dispensing
history;
``(3) delivers information about a patient's prescription
and dispensing history in summary form, that allows the
dispenser to evaluate the risk of misuse, abuse, addiction,
overdose, and drug-drug interactions associated with filling
the prescription sought by a patient based upon such patient's
prescription and dispensing history for covered drug products;
``(4) provides to dispensers the information described in
paragraphs (2) and (3) in real-time;
``(5) allows dispensers to obtain access to a patient's
prescription and dispensing history; and
``(6) requires dispensers as a condition on using such
System to have a written use agreement with such System to--
``(A) allow such System to access required data
elements about the dispenser's patients to ensure that
the prescribing and dispensing history of such patients
is updated on a real-time basis in such System; and
``(B) receive information about a patient's
prescription and dispensing history in summary form
from such System.
``(b) Implementation.--Beginning not later than 12 months after the
date of enactment of this Act, the Secretary shall require, pursuant to
section 505-1, that covered drug products be dispensed using the
Prescription Safety Alert System to help combat the national
prescription drug abuse epidemic.
``(c) Purposes of Collecting and Making Available Information.--The
Prescription Safety Alert System shall collect and make available
information only for the following purposes:
``(1) Providing dispensers with information to evaluate the
risk of misuse, abuse, addiction, overdose, and drug-drug
interactions associated with a covered drug product based upon
a patient's prescription and dispensing history.
``(2) Providing the Secretary with aggregate information on
an annualized basis regarding the number of patients or
prescriptions flagged by such System or a dispenser as
potentially presenting a risk of misuse, abuse, addiction,
overdose, or drug-drug interactions, and other aggregate
information, where the Secretary deems the provision of such
information to be appropriate.
``(d) Rule of Construction on Liability.--Nothing in this section
shall be construed to create or serve as the basis for additional
liability for any entity connecting to the System, beyond existing
applicable State and Federal laws and regulations.
``(e) Waivers.--
``(1) In general.--The Secretary may waive the requirements
of this section in whole or in part if the Secretary determines
that compliance with such requirements is not feasible due to--
``(A) a public health emergency declared pursuant
to a section 319 of the Public Health Service Act; or
``(B) a natural disaster, a power disruption, or
other extenuating circumstances.
``(2) Guidance.--Not later than 12 months after the date of
enactment of this section, the Secretary shall issue guidance
to clarify the circumstances under which waivers will be
granted under paragraph (1).
``(f) Relation to Privacy Law.--
``(1) Appropriate safeguards.--The Secretary shall take
appropriate measures to safeguard the privacy and cybersecurity
of the data in the Prescription Safety Alert System.
``(2) Dispensers.--The use of protected health information,
or the disclosure to the Prescription Safety Alert System of
protected health information, by a dispenser pursuant to
requirements prescribed under this section is deemed to be a
use or disclosure, as applicable, required by law and therefore
permitted, without the authorization of the individual, under
section 164.512(a) of title 45, Code of Federal Regulations (or
any successor regulations).
``(3) Disclosure by prescription safety alert system.--The
use of protected health information, or the disclosure to a
dispenser of protected health information, by the Prescription
Safety Alert System pursuant to requirements prescribed under
this section is deemed to be a use or disclosure, as
applicable, required by law and therefore permitted, without
authorization of the individual, under section 164.512(a) of
title 45 of the Code of Federal Regulations (or any successor
regulations).
``(4) Definitions.--In this subsection:
``(A) The term `protected health information' has
the meaning given to that term in section 160.103 of
title 45, Code of Federal Regulations (or any successor
regulations).
``(B) The term `required by law' has the meaning
given to that term in section 164.103 of title 45 of
the Code of Federal Regulations (or any successor
regulations).
``(g) Definitions.--In this section:
``(1) The term `covered drug product' means any drug
product that--
``(A) has been approved for any use under section
505 of this Act or section 351 of the Public Health
Service Act; and
``(B) has been included in a list of drugs
published by the Secretary in the Federal Register as
presenting a risk of misuse, abuse, addiction,
overdose, or drug-drug interactions necessitating
inclusion in the Prescription Safety Alert System, so
long as the Secretary provided no less than 30 days for
public comment before finalizing the inclusion of such
drug product in such list.
``(2) The term `dispenser' means a person who is licensed
in accordance with State law to engage in the practice of
pharmacy to dispense covered drug products directly to patients
or their caregivers, except such term does not include a
closed-system pharmacy.
``(3) The term `closed system pharmacy' means any facility,
including a nursing home, correctional facility, adult
congregate living facility, or other custodial care facility,
that is licensed by law to engage in the practice of pharmacy
that distributes or dispenses covered drug products utilizing a
closed delivery system where prescriptions are individually
prepared for a custodial consumer.
``(4) The term `prescription and dispensing history' means
a patient's history, dating back a minimum of 12 months, or
such period as the Secretary deems appropriate, of receiving,
filling, or attempting to receive or fill, prescriptions for
covered drug products, including specific data elements, as
applicable to any particular patient or prescription,
including--
``(A) a description of the drug dispensed or
attempted to be filled;
``(B) pharmacy national provider identifier (NPI);
``(C) prescription (Rx) number;
``(D) fill number;
``(E) other applicable coverage code;
``(F) date or dates of service;
``(G) prescriber identifiers;
``(H) patient information;
``(I) third party identifiers; and
``(J) such other information the Secretary deems
appropriate by guidance.
``(5) The term `standard setting organization' has the
meaning given to such term in section 1171(8) of the Social
Security Act.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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