```

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2042 Introduced in Senate (IS)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Reducing Drug Waste Act of 2017''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) On May 23, 2017, the Department of Health and Human 
        Services, acting through the Office of the Inspector General in 
        a letter to Senators Klobuchar, Durbin, and Shaheen, found that 
        different vial sizes in addition to those currently approved 
        and marketed in the United States could sometimes significantly 
        reduce the amount of drug discards, or waste, from single-use 
        vials.
            (2) The Office of Inspector General analyzed 20 single-use 
        vial drugs with the highest amounts of identifiable 
        reimbursement for discarded drugs during 2013 and 2014 and 
        found that the Medicare Part B program paid $11,600,000,000 for 
        these drugs, $2,100,000,000 of which was for drugs billed in 
        increments of other-than-full vials, and $195,000,000, or 
        nearly 10 percent, of the $2,100,000,000 billed in increments 
        of other-than-full vials was reimbursed for discarded drugs.
            (3) During the Food and Drug Administration's review 
        process for a drug's safety and efficacy before a drug is 
        approved for marketing in the United States, the Food and Drug 
        Administration reviews the manufacturer's proposed vial size.
            (4) As of January 1, 2017, the Centers for Medicare & 
        Medicaid Services requires all physicians, hospitals, and other 
        providers submitting claims to Medicare to separately identify 
        the discarded amount of a drug from a single-use vial (the JW 
        modifier) on its claim for reimbursement by Medicare. The new 
        requirement does not change the amount the providers are 
        reimbursed for single-use drugs.
            (5) An October 2017 investigation by ProPublica found that 
        many pharmaceutical companies produce eye-drops in over-sized 
        doses, in some cases more than twice what the eye can hold, 
        resulting in drug waste and excess spending.

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

    (a) Joint Action Plan.--The Commissioner of Food and Drugs, in 
coordination with the Administrator of the Centers for Medicare & 
Medicaid Services, shall develop a joint action plan, in consultation 
with healthcare providers and patient advocates (including relevant 
Federal advisory committees) that--
            (1) utilizes data from Medicare claims on how much of a 
        single-use drug was not administered, examines single-use vial 
        sizes in other countries, and analyzes the drug approval 
        process for alternative vial size safety and efficacy 
        approaches, to reduce drug waste and better manage costs with 
        respect to drug vial sizes and other drug delivery systems, as 
        appropriate; and
            (2) includes quantifiable metrics and specific timelines.
    (b) Report.--Not later than 1 year after the date of enactment of 
this Act, the Commissioner of Food and Drugs, in coordination with the 
Administrator of the Centers for Medicare & Medicaid Services, shall 
submit to Congress the joint action plan described in subsection (a) 
and a report containing recommendations for any legislative action 
needed to reduce drug waste and better manage costs with respect to 
drug vial sizes and other drug delivery systems, as appropriate.
                                 <all>
```