I 

115TH CONGRESS 

2D SESSION H. R. 5867 

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

IN THE HOUSE OF REPRESENTATIVES 

MAY 17, 2018 

Mr. DOGGETT (for himself and Ms. PINGREE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

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 2018’’. 

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 dif12 ferent vial sizes in addition to those currently apVerDate Sep 11 2014 00:04 Jun 01, 2018 Jkt 079200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5867.IH H5867

lotter on DSKBCFDHB2PROD with BILLS
2 

•HR 5867 IH

1 proved and marketed in the United States could 

2 sometimes significantly reduce the amount of drug 

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

4 (2) The Office of Inspector General analyzed 20 

5 single-use vial drugs with the highest amounts of 

6 identifiable reimbursement for discarded drugs dur7 ing 2013 and 2014 and found that the Medicare 

8 part B program paid $11,600,000,000 for these 

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

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

11 $195,000,000, or nearly 10 percent, of the 

12 $2,100,000,000 billed in increments of other-than13 full vials was reimbursed for discarded drugs. 

14 (3) During the Food and Drug Administra15 tion’s review process for a drug’s safety and efficacy 

16 before a drug is approved for marketing in the 

17 United States, the Food and Drug Administration 

18 reviews the manufacturer’s proposed vial size. 

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

20 Medicare & Medicaid Services requires all physi21 cians, hospitals, and other providers submitting 

22 claims to Medicare to separately identify the dis23 carded amount of a drug from a single-use vial (the 

24 JW modifier) on its claim for reimbursement by 

25 Medicare. The new requirement does not change the 


lotter on DSKBCFDHB2PROD with BILLS
3 

•HR 5867 IH

1 amount the providers are reimbursed for single-use 

2 drugs. 

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

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

5 Food and Drugs, in coordination with the Administrator 

6 of the Centers for Medicare & Medicaid Services, shall de7 velop a joint action plan, in consultation with health care 

8 providers and patient advocates (including relevant Fed9 eral advisory committees) that— 

10 (1) utilizes data from Medicare claims on how 

11 much of a single-use drug was not administered, 

12 comparing single-use vial sizes in other countries, 

13 and through analysis during the drug approval proc14 ess of alternative vial size safety and efficacy, to re15 duce drug waste and better manage costs; and 

16 (2) includes quantifiable metrics and specific 

17 timelines. 

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

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

20 Drugs, in coordination with the Administrator of the Cen21 ters for Medicare & Medicaid Services, shall submit to 

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

23 and a report containing recommendations for any legislaVerDate Sep 11 2014 00:04 Jun 01, 2018 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5867.IH H5867

lotter on DSKBCFDHB2PROD with BILLS
4 

•HR 5867 IH

1 tive action needed to reduce drug waste and better manage 

2 costs. 

Æ 


lotter on DSKBCFDHB2PROD with BILLS