Title: ALERT Act of 2018
Policy area: Health

Summary:
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.''.
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