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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Analyzing and 

5 Leveraging Existing Rx Transactions Act of 2019’’ or the 

6 ‘‘ALERT Act of 2019’’. 


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1 SEC. 2. PRESCRIPTION SAFETY ALERT SYSTEM TO HELP 

2 PREVENT ABUSE AND MISUSE OF PRESCRIP3 TION DRUGS. 

4 The Federal Food, Drug, and Cosmetic Act is amend5 ed by inserting after section 505–1 of such Act (21 U.S.C. 

6 355–1) the following new section: 

7 ‘‘SEC. 505–2. PRESCRIPTION SAFETY ALERT SYSTEM TO 

8 PREVENT ABUSE AND MISUSE. 

9 ‘‘(a) IN GENERAL.—For the purpose of combating 

10 the national prescription drug abuse epidemic, the Sec11 retary shall, with respect to covered drug products, estab12 lish and maintain an electronic system, to be known as 

13 the Prescription Safety Alert System, that— 

14 ‘‘(1) reviews patient prescription and dispensing 

15 history through pharmaceutical claims data trans16 actions described in section 1173(a)(2) of the Social 

17 Security Act and developed by a standard setting or18 ganization; 

19 ‘‘(2) collects, maintains, and is capable of pro20 viding to dispensers, within a dispenser’s ordinary 

21 clinical workflow, information about a patient’s pre22 scription and dispensing history; 

23 ‘‘(3) delivers information about a patient’s pre24 scription and dispensing history in summary form, 

25 that allows the dispenser to evaluate the risk of mis26 use, abuse, addiction, overdose, and drug-drug interVerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845

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1 actions associated with filling the prescription 

2 sought by a patient based upon such patient’s pre3 scription and dispensing history for covered drug 

4 products; 

5 ‘‘(4) provides to dispensers the information de6 scribed in paragraphs (2) and (3) in real-time; 

7 ‘‘(5) allows dispensers to obtain access to a pa8 tient’s prescription and dispensing history; and 

9 ‘‘(6) requires dispensers as a condition on using 

10 such System to have a written use agreement with 

11 such System to— 

12 ‘‘(A) allow such System to access required 

13 data elements about the dispenser’s patients to 

14 ensure that the prescribing and dispensing his15 tory of such patients is updated on a real-time 

16 basis in such System; and 

17 ‘‘(B) receive information about a patient’s 

18 prescription and dispensing history in summary 

19 form from such System. 

20 ‘‘(b) IMPLEMENTATION.—Beginning not later than 

21 12 months after the date of enactment of this Act, the 

22 Secretary shall require, pursuant to section 505–1, that 

23 covered drug products be dispensed using the Prescription 

24 Safety Alert System to help combat the national prescrip25 tion drug abuse epidemic. 


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1 ‘‘(c) PURPOSES OF COLLECTING AND MAKING

2 AVAILABLE INFORMATION.—The Prescription Safety 

3 Alert System shall collect and make available information 

4 only for the following purposes: 

5 ‘‘(1) Providing dispensers with information to 

6 evaluate the risk of misuse, abuse, addiction, over7 dose, and drug-drug interactions associated with a 

8 covered drug product based upon a patient’s pre9 scription and dispensing history. 

10 ‘‘(2) Providing the Secretary with aggregate in11 formation on an annualized basis regarding the 

12 number of patients or prescriptions flagged by such 

13 System or a dispenser as potentially presenting a 

14 risk of misuse, abuse, addiction, overdose, or drug15 drug interactions, and other aggregate information, 

16 where the Secretary deems the provision of such in17 formation to be appropriate. 

18 ‘‘(d) RULE OF CONSTRUCTION ON LIABILITY.— 

19 Nothing in this section shall be construed to create or 

20 serve as the basis for additional liability for any entity con21 necting to the System, beyond existing applicable State 

22 and Federal laws and regulations. 

23 ‘‘(e) WAIVERS.— 

24 ‘‘(1) IN GENERAL.—The Secretary may waive 

25 the requirements of this section in whole or in part 


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1 if the Secretary determines that compliance with 

2 such requirements is not feasible due to— 

3 ‘‘(A) a public health emergency declared 

4 pursuant to section 319 of the Public Health 

5 Service Act; or 

6 ‘‘(B) a natural disaster, a power disrup7 tion, or other extenuating circumstances. 

8 ‘‘(2) GUIDANCE.—Not later than 12 months 

9 after the date of enactment of this section, the Sec10 retary shall issue guidance to clarify the cir11 cumstances under which waivers will be granted 

12 under paragraph (1). 

13 ‘‘(f) RELATION TO PRIVACY LAW.— 

14 ‘‘(1) APPROPRIATE SAFEGUARDS.—The Sec15 retary shall take appropriate measures to safeguard 

16 the privacy and cybersecurity of the data in the Pre17 scription Safety Alert System. 

18 ‘‘(2) DISPENSERS.—The use of protected health 

19 information, or the disclosure to the Prescription 

20 Safety Alert System of protected health information, 

21 by a dispenser pursuant to requirements prescribed 

22 under this section is deemed to be a use or disclo23 sure, as applicable, required by law and therefore 

24 permitted, without the authorization of the indiVerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845

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1 vidual, under section 164.512(a) of title 45, Code of 

2 Federal Regulations (or any successor regulations). 

3 ‘‘(3) DISCLOSURE BY PRESCRIPTION SAFETY

4 ALERT SYSTEM.—The use of protected health infor5 mation, or the disclosure to a dispenser of protected 

6 health information, by the Prescription Safety Alert 

7 System pursuant to requirements prescribed under 

8 this section is deemed to be a use or disclosure, as 

9 applicable, required by law and therefore permitted, 

10 without authorization of the individual, under sec11 tion 164.512(a) of title 45 of the Code of Federal 

12 Regulations (or any successor regulations). 

13 ‘‘(4) DEFINITIONS.—In this subsection: 

14 ‘‘(A) The term ‘protected health informa15 tion’ has the meaning given to that term in sec16 tion 160.103 of title 45, Code of Federal Regu17 lations (or any successor regulations). 

18 ‘‘(B) The term ‘required by law’ has the 

19 meaning given to that term in section 164.103 

20 of title 45 of the Code of Federal Regulations 

21 (or any successor regulations). 

22 ‘‘(g) DEFINITIONS.—In this section: 

23 ‘‘(1) The term ‘covered drug product’ means 

24 any drug product that— 


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1 ‘‘(A) has been approved for any use under 

2 section 505 of this Act or section 351 of the 

3 Public Health Service Act; and 

4 ‘‘(B) has been included in a list of drugs 

5 published by the Secretary in the Federal Reg6 ister as presenting a risk of misuse, abuse, ad7 diction, overdose, or drug-drug interactions ne8 cessitating inclusion in the Prescription Safety 

9 Alert System, so long as the Secretary provided 

10 no less than 30 days for public comment before 

11 finalizing the inclusion of such drug product in 

12 such list. 

13 ‘‘(2) The term ‘dispenser’ means a person who 

14 is licensed in accordance with State law to engage 

15 in the practice of pharmacy to dispense covered drug 

16 products directly to patients or their caregivers, ex17 cept such term does not include a closed-system 

18 pharmacy. 

19 ‘‘(3) The term ‘closed-system pharmacy’ means 

20 any facility, including a nursing home, correctional 

21 facility, adult congregate living facility, or other cus22 todial care facility, that is licensed by law to engage 

23 in the practice of pharmacy that distributes or dis24 penses covered drug products utilizing a closed delivVerDate Sep 11 2014 17:35 Apr 06, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1845.IH H1845

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1 ery system where prescriptions are individually pre2 pared for a custodial consumer. 

3 ‘‘(4) The term ‘prescription and dispensing his4 tory’ means a patient’s history, dating back a min5 imum of 12 months, or such period as the Secretary 

6 deems appropriate, of receiving, filling, or attempt7 ing to receive or fill, prescriptions for covered drug 

8 products, including specific data elements, as appli9 cable to any particular patient or prescription, in10 cluding— 

11 ‘‘(A) a description of the drug dispensed or 

12 attempted to be filled; 

13 ‘‘(B) pharmacy national provider identifier 

14 (NPI); 

15 ‘‘(C) prescription (Rx) number; 

16 ‘‘(D) fill number; 

17 ‘‘(E) other applicable coverage code; 

18 ‘‘(F) date or dates of service; 

19 ‘‘(G) prescriber identifiers; 

20 ‘‘(H) patient information; 

21 ‘‘(I) third party identifiers; and 

22 ‘‘(J) such other information the Secretary 

23 deems appropriate by guidance. 


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1 ‘‘(5) The term ‘standard setting organization’ 

2 has the meaning given to such term in section 

3 1171(8) of the Social Security Act.’’. 

Æ 


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