ALERT Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 1845 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 MARCH 21, 2019 Ms. KUSTER of New Hampshire (for herself and Mr. MULLIN) 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Analyzing and 4 Leveraging Existing Rx Transactions Act of 2019’’ or the 5 ‘‘ALERT Act of 2019’’. 6 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 2 •HR 1845 IH SEC. 2. PRESCRIPTION SAFETY ALERT SYSTEM TO HELP 1 PREVENT ABUSE AND MISUSE OF PRESCRIP- 2 TION DRUGS. 3 The Federal Food, Drug, and Cosmetic Act is amend- 4 ed by inserting after section 505–1 of such Act (21 U.S.C. 5 355–1) the following new section: 6 ‘‘SEC. 505–2. PRESCRIPTION SAFETY ALERT SYSTEM TO 7 PREVENT ABUSE AND MISUSE. 8 ‘‘(a) IN GENERAL.—For the purpose of combating 9 the national prescription drug abuse epidemic, the Sec- 10 retary shall, with respect to covered drug products, estab- 11 lish and maintain an electronic system, to be known as 12 the Prescription Safety Alert System, that— 13 ‘‘(1) reviews patient prescription and dispensing 14 history through pharmaceutical claims data trans- 15 actions described in section 1173(a)(2) of the Social 16 Security Act and developed by a standard setting or- 17 ganization; 18 ‘‘(2) collects, maintains, and is capable of pro- 19 viding to dispensers, within a dispenser’s ordinary 20 clinical workflow, information about a patient’s pre- 21 scription and dispensing history; 22 ‘‘(3) delivers information about a patient’s pre- 23 scription and dispensing history in summary form, 24 that allows the dispenser to evaluate the risk of mis- 25 use, abuse, addiction, overdose, and drug-drug inter- 26 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 3 •HR 1845 IH actions associated with filling the prescription 1 sought by a patient based upon such patient’s pre- 2 scription and dispensing history for covered drug 3 products; 4 ‘‘(4) provides to dispensers the information de- 5 scribed in paragraphs (2) and (3) in real-time; 6 ‘‘(5) allows dispensers to obtain access to a pa- 7 tient’s prescription and dispensing history; and 8 ‘‘(6) requires dispensers as a condition on using 9 such System to have a written use agreement with 10 such System to— 11 ‘‘(A) allow such System to access required 12 data elements about the dispenser’s patients to 13 ensure that the prescribing and dispensing his- 14 tory of such patients is updated on a real-time 15 basis in such System; and 16 ‘‘(B) receive information about a patient’s 17 prescription and dispensing history in summary 18 form from such System. 19 ‘‘(b) IMPLEMENTATION.—Beginning not later than 20 12 months after the date of enactment of this Act, the 21 Secretary shall require, pursuant to section 505–1, that 22 covered drug products be dispensed using the Prescription 23 Safety Alert System to help combat the national prescrip- 24 tion drug abuse epidemic. 25 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 4 •HR 1845 IH ‘‘(c) PURPOSES OF COLLECTING AND MAKING 1 AVAILABLE INFORMATION.—The Prescription Safety 2 Alert System shall collect and make available information 3 only for the following purposes: 4 ‘‘(1) Providing dispensers with information to 5 evaluate the risk of misuse, abuse, addiction, over- 6 dose, and drug-drug interactions associated with a 7 covered drug product based upon a patient’s pre- 8 scription and dispensing history. 9 ‘‘(2) Providing the Secretary with aggregate in- 10 formation on an annualized basis regarding the 11 number of patients or prescriptions flagged by such 12 System or a dispenser as potentially presenting a 13 risk of misuse, abuse, addiction, overdose, or drug- 14 drug interactions, and other aggregate information, 15 where the Secretary deems the provision of such in- 16 formation to be appropriate. 17 ‘‘(d) RULE OF CONSTRUCTION ON LIABILITY.— 18 Nothing in this section shall be construed to create or 19 serve as the basis for additional liability for any entity con- 20 necting to the System, beyond existing applicable State 21 and Federal laws and regulations. 22 ‘‘(e) WAIVERS.— 23 ‘‘(1) IN GENERAL.—The Secretary may waive 24 the requirements of this section in whole or in part 25 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 5 •HR 1845 IH if the Secretary determines that compliance with 1 such requirements is not feasible due to— 2 ‘‘(A) a public health emergency declared 3 pursuant to section 319 of the Public Health 4 Service Act; or 5 ‘‘(B) a natural disaster, a power disrup- 6 tion, or other extenuating circumstances. 7 ‘‘(2) GUIDANCE.—Not later than 12 months 8 after the date of enactment of this section, the Sec- 9 retary shall issue guidance to clarify the cir- 10 cumstances under which waivers will be granted 11 under paragraph (1). 12 ‘‘(f) RELATION TO PRIVACY LAW.— 13 ‘‘(1) APPROPRIATE SAFEGUARDS.—The Sec- 14 retary shall take appropriate measures to safeguard 15 the privacy and cybersecurity of the data in the Pre- 16 scription Safety Alert System. 17 ‘‘(2) DISPENSERS.—The use of protected health 18 information, or the disclosure to the Prescription 19 Safety Alert System of protected health information, 20 by a dispenser pursuant to requirements prescribed 21 under this section is deemed to be a use or disclo- 22 sure, as applicable, required by law and therefore 23 permitted, without the authorization of the indi- 24 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 6 •HR 1845 IH vidual, under section 164.512(a) of title 45, Code of 1 Federal Regulations (or any successor regulations). 2 ‘‘(3) DISCLOSURE BY PRESCRIPTION SAFETY 3 ALERT SYSTEM.—The use of protected health infor- 4 mation, or the disclosure to a dispenser of protected 5 health information, by the Prescription Safety Alert 6 System pursuant to requirements prescribed under 7 this section is deemed to be a use or disclosure, as 8 applicable, required by law and therefore permitted, 9 without authorization of the individual, under sec- 10 tion 164.512(a) of title 45 of the Code of Federal 11 Regulations (or any successor regulations). 12 ‘‘(4) DEFINITIONS.—In this subsection: 13 ‘‘(A) The term ‘protected health informa- 14 tion’ has the meaning given to that term in sec- 15 tion 160.103 of title 45, Code of Federal Regu- 16 lations (or any successor regulations). 17 ‘‘(B) The term ‘required by law’ has the 18 meaning given to that term in section 164.103 19 of title 45 of the Code of Federal Regulations 20 (or any successor regulations). 21 ‘‘(g) DEFINITIONS.—In this section: 22 ‘‘(1) The term ‘covered drug product’ means 23 any drug product that— 24 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 7 •HR 1845 IH ‘‘(A) has been approved for any use under 1 section 505 of this Act or section 351 of the 2 Public Health Service Act; and 3 ‘‘(B) has been included in a list of drugs 4 published by the Secretary in the Federal Reg- 5 ister as presenting a risk of misuse, abuse, ad- 6 diction, overdose, or drug-drug interactions ne- 7 cessitating inclusion in the Prescription Safety 8 Alert System, so long as the Secretary provided 9 no less than 30 days for public comment before 10 finalizing the inclusion of such drug product in 11 such list. 12 ‘‘(2) The term ‘dispenser’ means a person who 13 is licensed in accordance with State law to engage 14 in the practice of pharmacy to dispense covered drug 15 products directly to patients or their caregivers, ex- 16 cept such term does not include a closed-system 17 pharmacy. 18 ‘‘(3) The term ‘closed-system pharmacy’ means 19 any facility, including a nursing home, correctional 20 facility, adult congregate living facility, or other cus- 21 todial care facility, that is licensed by law to engage 22 in the practice of pharmacy that distributes or dis- 23 penses covered drug products utilizing a closed deliv- 24 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 8 •HR 1845 IH ery system where prescriptions are individually pre- 1 pared for a custodial consumer. 2 ‘‘(4) The term ‘prescription and dispensing his- 3 tory’ means a patient’s history, dating back a min- 4 imum of 12 months, or such period as the Secretary 5 deems appropriate, of receiving, filling, or attempt- 6 ing to receive or fill, prescriptions for covered drug 7 products, including specific data elements, as appli- 8 cable to any particular patient or prescription, in- 9 cluding— 10 ‘‘(A) a description of the drug dispensed or 11 attempted to be filled; 12 ‘‘(B) pharmacy national provider identifier 13 (NPI); 14 ‘‘(C) prescription (Rx) number; 15 ‘‘(D) fill number; 16 ‘‘(E) other applicable coverage code; 17 ‘‘(F) date or dates of service; 18 ‘‘(G) prescriber identifiers; 19 ‘‘(H) patient information; 20 ‘‘(I) third party identifiers; and 21 ‘‘(J) such other information the Secretary 22 deems appropriate by guidance. 23 VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS 9 •HR 1845 IH ‘‘(5) The term ‘standard setting organization’ 1 has the meaning given to such term in section 2 1171(8) of the Social Security Act.’’. 3 Æ VerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H1845.IH H1845 pbinns on DSK79D2C42PROD with BILLS