II 

115TH CONGRESS 

1ST SESSION S. 2042 

To authorize a joint action plan and report on drug waste. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 31, 2017 

Ms. KLOBUCHAR (for herself, Mr. GRASSLEY, Mr. DURBIN, and Mrs. SHAHEEN) introduced the following bill; which was read twice and referred 

to the Committee on Finance 

A BILL 

To authorize a joint action plan and report on drug waste. 

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 ‘‘Reducing Drug Waste 

5 Act of 2017’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 

8 (1) On May 23, 2017, the Department of 

9 Health and Human Services, acting through the Of10 fice of the Inspector General in a letter to Senators 

11 Klobuchar, Durbin, and Shaheen, found that difVerDate Sep 11 2014 00:01 Nov 01, 2017 Jkt 079200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2042.IS S2042

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1 ferent vial sizes in addition to those currently ap2 proved and marketed in the United States could 

3 sometimes significantly reduce the amount of drug 

4 discards, or waste, from single-use vials. 

5 (2) The Office of Inspector General analyzed 20 

6 single-use vial drugs with the highest amounts of 

7 identifiable reimbursement for discarded drugs dur8 ing 2013 and 2014 and found that the Medicare 

9 Part B program paid $11,600,000,000 for these 

10 drugs, $2,100,000,000 of which was for drugs billed 

11 in increments of other-than-full vials, and 

12 $195,000,000, or nearly 10 percent, of the 

13 $2,100,000,000 billed in increments of other-than14 full vials was reimbursed for discarded drugs. 

15 (3) During the Food and Drug Administra16 tion’s review process for a drug’s safety and efficacy 

17 before a drug is approved for marketing in the 

18 United States, the Food and Drug Administration 

19 reviews the manufacturer’s proposed vial size. 

20 (4) As of January 1, 2017, the Centers for 

21 Medicare & Medicaid Services requires all physi22 cians, hospitals, and other providers submitting 

23 claims to Medicare to separately identify the dis24 carded amount of a drug from a single-use vial (the 

25 JW modifier) on its claim for reimbursement by 


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1 Medicare. The new requirement does not change the 

2 amount the providers are reimbursed for single-use 

3 drugs. 

4 (5) An October 2017 investigation by ProPubli5 ca found that many pharmaceutical companies 

6 produce eye-drops in over-sized doses, in some cases 

7 more than twice what the eye can hold, resulting in 

8 drug waste and excess spending. 

9 SEC. 3. JOINT ACTION PLAN AND REPORT ON DRUG WASTE. 

10 (a) JOINT ACTION PLAN.—The Commissioner of 

11 Food and Drugs, in coordination with the Administrator 

12 of the Centers for Medicare & Medicaid Services, shall de13 velop a joint action plan, in consultation with healthcare 

14 providers and patient advocates (including relevant Fed15 eral advisory committees) that— 

16 (1) utilizes data from Medicare claims on how 

17 much of a single-use drug was not administered, ex18 amines single-use vial sizes in other countries, and 

19 analyzes the drug approval process for alternative 

20 vial size safety and efficacy approaches, to reduce 

21 drug waste and better manage costs with respect to 

22 drug vial sizes and other drug delivery systems, as 

23 appropriate; and 

24 (2) includes quantifiable metrics and specific 

25 timelines. 


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1 (b) REPORT.—Not later than 1 year after the date 

2 of enactment of this Act, the Commissioner of Food and 

3 Drugs, in coordination with the Administrator of the Cen4 ters for Medicare & Medicaid Services, shall submit to 

5 Congress the joint action plan described in subsection (a) 

6 and a report containing recommendations for any legisla7 tive action needed to reduce drug waste and better manage 

8 costs with respect to drug vial sizes and other drug deliv9 ery systems, as appropriate. 

Æ 


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