,i #aafth ,,congress #ast ,session ,h4 ,r4 #ahde ,,in ,,the ,,house ,,of ,,representatives ,march #ba1 #bjai ,ms4 ,kuster of ,new ,hampshire 7for herself and ,mr4 ,mullin7 introduced the following bill2 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 products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,analyzing and ,leveraging ,existing ,rx ,transactions ,act of #bjai or the ,,alert ,act of #bjai4 #b4 ,prescription ,safety ,alert ,system to help prevent abuse and misuse of prescription drugs ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje-a of such ,act 7#ba ,u4,s4,c4 #cee-a7 the following new section3 #eje-b4 ,prescription ,safety ,alert ,system to prevent abuse and misuse 7a7 ,in general ,for the purpose of combating the national prescription drug abuse epidemic1 the ,secretary shall1 with respect to covered drug products1 establish and maintain an electronic system1 to be known as the ,prescription ,safety ,alert ,system1 that-- 7#a7 reviews patient prescription and dispensing history through pharmaceutical claims data transactions described in section #aagc7;a77#b7 of the ,social ,security ,act and developed by a standard setting organization2 7#b7 collects1 maintains1 and is capable of providing to dispensers1 within a dispenser's ordinary clinical workflow1 information about a patient's prescription and dispensing history2 7#c7 delivers information about a patient's prescription and dispensing history in summary form1 that allows the dispenser to evaluate the risk of misuse1 abuse1 addiction1 overdose1 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 products2 7#d7 provides to dispensers the information described in paragraphs 7#b7 and 7#c7 in real-time2 7#e7 allows dispensers to obtain access to a patient's prescription and dispensing history2 and 7#f7 requires dispensers as a condition on using such ,system to have a written use agreement with such ,system to-- 7,a7 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 ,system2 and 7,b7 receive information about a patient's prescription and dispensing history in summary form from such ,system4 7b7 ,implementation ,beginning not later than #ab months after the date of enactment of this ,act1 the ,secretary shall require1 pursuant to section #eje-a1 that covered drug products be dispensed using the ,prescription ,safety ,alert ,system to help combat the national prescription drug abuse epidemic4 7c7 ,purposes of collecting and making available information ,the ,prescription ,safety ,alert ,system shall collect and make available information only for the following purposes3 7#a7 ,providing dispensers with information to evaluate the risk of misuse1 abuse1 addiction1 overdose1 and drug-drug interactions associated with a covered drug product based upon a patient's prescription and dispensing history4 7#b7 ,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 misuse1 abuse1 addiction1 overdose1 or drug-drug interactions1 and other aggregate information1 where the ,secretary deems the provision of such information to be appropriate4 7d7 ,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 ,system1 beyond existing applicable ,state and ,federal laws and regulations4 7e7 ,waivers 7#a7 ,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-- 7,a7 a public health emergency declared pursuant to section #cai of the ,public ,health ,service ,act2 or 7,b7 a natural disaster1 a power disruption1 or other extenuating circumstances4 7#b7 ,guidance ,not later than #ab months after the date of enactment of this section1 the ,secretary shall issue guidance to clarify the circumstances under which waivers will be granted under paragraph 7#a74 7f7 ,relation to privacy law 7#a7 ,appropriate safeguards ,the ,secretary shall take appropriate measures to safeguard the privacy and cybersecurity of the data in the ,prescription ,safety ,alert ,system4 7#b7 ,dispensers ,the use of protected health information1 or the disclosure to the ,prescription ,safety ,alert ,system of protected health information1 by a dispenser pursuant to requirements prescribed under this section is deemed to be a use or disclosure1 as applicable1 required by law and therefore permitted1 without the authorization of the individual1 under section #afd4eab7;a7 of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7#c7 ,disclosure by ,prescription ,safety ,alert ,system ,the use of protected health information1 or the disclosure to a dispenser of protected health information1 by the ,prescription ,safety ,alert ,system pursuant to requirements prescribed under this section is deemed to be a use or disclosure1 as applicable1 required by law and therefore permitted1 without authorization of the individual1 under section #afd4eab7;a7 of title #de of the ,code of ,federal ,regulations 7or any successor regulations74 7#d7 ,definitions ,in this subsection3 7,a7 ,the term protected health information has the meaning given to that term in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7,b7 ,the term required by law has the meaning given to that term in section #afd4ajc of title #de of the ,code of ,federal ,regulations 7or any successor regulations74 7g7 ,definitions ,in this section3 7#a7 ,the term covered drug product means any drug product that-- 7,a7 has been approved for any use under section #eje of this ,act or section #cea of the ,public ,health ,service ,act2 and 7,b7 has been included in a list of drugs published by the ,secretary in the ,federal ,register as presenting a risk of misuse1 abuse1 addiction1 overdose1 or drug-drug interactions necessitating inclusion in the ,prescription ,safety ,alert ,system1 so long as the ,secretary provided no less than #cj days for public comment before finalizing the inclusion of such drug product in such list4 7#b7 ,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 caregivers1 except such term does not include a closed-system pharmacy4 7#c7 ,the term closed-system pharmacy means any facility1 including a nursing home1 correctional facility1 adult congregate living facility1 or other custodial care facility1 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 consumer4 7#d7 ,the term prescription and dispensing history means a patient's history1 dating back a minimum of #ab months1 or such period as the ,secretary deems appropriate1 of receiving1 filling1 or attempting to receive or fill1 prescriptions for covered drug products1 including specific data elements1 as applicable to any particular patient or prescription1 including-- 7,a7 a description of the drug dispensed or attempted to be filled2 7,b7 pharmacy national provider identifier 7,,npi72 7,c7 prescription 7,rx7 number2 7,d7 fill number2 7,e7 other applicable coverage code2 7,f7 date or dates of service2 7,g7 prescriber identifiers2 7,h7 patient information2 7,i7 third party identifiers2 and 7,j7 such other information the ,secretary deems appropriate by guidance4 7#e7 ,the term standard setting organization has the meaning given to such term in section #aaga7h7 of the ,social ,security ,act4 4