[Congressional Record Volume 167, Number 69 (Wednesday, April 21, 2021)]
[Senate]
[Pages S2124-S2127]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTION

      By Mr. PADILLA (for himself, Mr. Warnock, Ms. Smith, Mr. Sanders, 
        Mrs. Feinstein, Mr. Markey, Mr. Wyden, Mr. Merkley, and Ms. 
        Stabenow):
  S. 1271. A bill to reauthorize the Clean School Bus Program, and for 
other purposes; to the Committee on Environment and Public Works.
  Ms. FEINSTEIN. Mr. President, I rise to speak in support of the 
``Clean Commute for Kids Act,'' which I introduced today.
  I know firsthand how outdated diesel school buses expose our children 
to harmful and unnecessary pollution. I grew up in the San Fernando 
Valley and for many years, I rode a bus to school. I can still smell 
the diesel exhaust that my classmates and I would breathe in on our way 
to and from school.
  Before the COVID-19 pandemic, nearly 25 million American children 
were exposed to this same diesel exhaust when they ride over 500,000 
predominantly diesel buses to school nationwide. This pollution not 
only harms our children's health, but it also impacts student 
achievement. Studies show that transitioning to cleaner bus fleets can 
spur both health and academic improvements.
  As we work to build back better and combat climate change, we must 
help school districts accelerate the deployment of zero-emission buses 
to reduce the exposure of our children to pollutants and cut greenhouse 
gas emissions.
  That is why I am proud to introduce this bill together with Senator 
Warnock to authorize $25 billion for a new grant program to help school 
districts replace existing buses with clean, zero-emission buses.
  This funding represents an essential aspect of building more 
equitable, sustainable transportation infrastructure, and it represents 
an investment in our children, our environment, and our future.
  This legislation recognizes the disproportionate impact this 
pollution has on underserved populations by setting aside 40 percent of 
the grant funding for replacing school buses serving environmental 
justice communities.
  Some of California's school districts have already begun the 
transition to zero-emission buses. The California Air Resources Board 
has leveraged federal funding to assist school districts and local air 
boards with the costs of school bus replacements. This bill will 
accelerate this transition and provide funding to reach more schools in 
California and across the nation.
  I want to thank Senator Warnock for co-leading this bill with me, and 
I hope our colleagues will join us in support of this bill that would 
transform our nation's school bus fleet, protect air quality, and 
improve the health and wellbeing of our children.
  Thank you, Mr. President. I yield the floor.
                                 ______
                                 
      By Mr. THUNE (for himself and Mr. Brown):
  S. 1274. A bill to limit the authority of States or other taxing 
jurisdictions to tax certain income of employees for employment duties 
performed in other States or taxing jurisdictions, and for other 
purposes; to the Committee on Finance.
  Mr. THUNE. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1274

       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 ``Remote and Mobile Worker 
     Relief Act of 2021''.

     SEC. 2. LIMITATIONS ON WITHHOLDING AND TAXATION OF EMPLOYEE 
                   INCOME.

       (a) In General.--No part of the wages or other remuneration 
     earned by an employee who is a resident of a taxing 
     jurisdiction and performs employment duties in more than one 
     taxing jurisdiction shall be subject to income tax in any 
     taxing jurisdiction other than--
       (1) the taxing jurisdiction of the employee's residence; 
     and
       (2) any taxing jurisdiction within which the employee is 
     present and performing employment duties for more than 30 
     days during the calendar year in which the wages or other 
     remuneration is earned.
       (b) Income Tax Withholding and Reporting.--Wages or other 
     remuneration earned in any calendar year shall not be subject 
     to income tax withholding and reporting requirements with 
     respect to any taxing jurisdiction unless the employee is 
     subject to income tax in such taxing jurisdiction under 
     subsection (a). Income tax withholding and reporting 
     requirements under subsection (a)(2) shall apply to wages or 
     other remuneration earned as of the commencement date of 
     employment duties in the taxing jurisdiction during the 
     calendar year.
       (c) Operating Rules.--For purposes of determining penalties 
     related to an employer's income tax withholding and reporting 
     requirements with respect to any taxing jurisdiction--
       (1) an employer may rely on an employee's annual 
     determination of the time expected to be spent by such 
     employee in the performance of employment duties in the 
     taxing jurisdictions in which the employee will perform such 
     duties absent--
       (A) the employer's actual knowledge of fraud by the 
     employee in making the determination; or
       (B) collusion between the employer and the employee to 
     evade tax;
       (2) except as provided in paragraph (3), if records are 
     maintained by an employer in the regular course of business 
     that record the location at which an employee performs 
     employment duties, such records shall not preclude an 
     employer's ability to rely on an employee's determination 
     under paragraph (1); and
       (3) notwithstanding paragraph (2), if an employer, at its 
     sole discretion, maintains a time and attendance system that 
     tracks where the employee performs duties on a daily basis, 
     data from the time and attendance system shall be used 
     instead of the employee's determination under paragraph (1).
       (d) Definitions and Special Rules.--For purposes of this 
     Act:
       (1) Day.--
       (A) Except as provided in subparagraph (B), an employee is 
     considered present and performing employment duties within a 
     taxing jurisdiction for a day if the employee performs more 
     of the employee's employment duties within such taxing 
     jurisdiction than in any other taxing jurisdiction during a 
     day.
       (B) If an employee performs employment duties in a resident 
     taxing jurisdiction and in only one nonresident taxing 
     jurisdiction during one day, such employee shall be 
     considered to have performed more of the employee's 
     employment duties in the nonresident taxing jurisdiction than 
     in the resident taxing jurisdiction for such day.
       (C) For purposes of this paragraph, the portion of the day 
     during which the employee is in transit shall not be 
     considered in determining the location of an employee's 
     performance of employment duties.
       (2) Employee.--
       (A) In general.--
       (i) General definition.--Except as provided in clause (ii), 
     the term ``employee'' has the meaning given such term in 
     section 3121(d) of the Internal Revenue Code of 1986, unless 
     such term is defined by the taxing jurisdiction in which the 
     person's employment duties are performed, in which case the 
     taxing jurisdiction's definition shall prevail.

[[Page S2125]]

       (ii) Exception.--The term ``employee'' shall not include a 
     professional athlete, professional entertainer, qualified 
     production employee, or certain public figures.
       (B) Professional athlete.--The term ``professional 
     athlete'' means a person who performs services in a 
     professional athletic event, provided that the wages or other 
     remuneration are paid to such person for performing services 
     in his or her capacity as a professional athlete.
       (C) Professional entertainer.--The term ``professional 
     entertainer'' means a person of prominence who performs 
     services in the professional performing arts for wages or 
     other remuneration on a per-event basis, provided that the 
     wages or other remuneration are paid to such person for 
     performing services in his or her capacity as a professional 
     entertainer.
       (D) Qualified production employee.--The term ``qualified 
     production employee'' means a person who performs production 
     services of any nature directly in connection with a taxing 
     jurisdiction qualified, certified or approved film, 
     television or other commercial video production for wages or 
     other remuneration, provided that the wages or other 
     remuneration paid to such person are qualified production 
     costs or expenditures under such taxing jurisdiction's 
     qualified, certified or approved film, television or other 
     commercial video production incentive program, and that such 
     wages or other remuneration must be subject to withholding 
     under such qualified, certified or approved film, television 
     or other commercial video production incentive program as a 
     condition to treating such wages or other remuneration as a 
     qualified production cost or expenditure.
       (E) Certain public figures.--The term ``certain public 
     figures'' means persons of prominence who perform services 
     for wages or other remuneration on a per-event basis, 
     provided that the wages or other remuneration are paid to 
     such person for services provided at a discrete event, in the 
     nature of a speech, public appearance, or similar event.
       (3) Employer.--The term ``employer'' has the meaning given 
     such term in section 3401(d) of the Internal Revenue Code of 
     1986, unless such term is defined by the taxing jurisdiction 
     in which the employee's employment duties are performed, in 
     which case the taxing jurisdiction's definition shall 
     prevail.
       (4) Taxing jurisdiction.--The term ``taxing jurisdiction'' 
     means any of the several States, the District of Columbia, 
     any municipality, city, county, township, parish, 
     transportation district, or assessment jurisdiction, or any 
     other political subdivision within the territorial limits of 
     the United States with the authority to impose a tax, charge, 
     or fee.
       (5) Time and attendance system.--The term ``time and 
     attendance system'' means a system in which--
       (A) the employee is required on a contemporaneous basis to 
     record his work location for every day worked outside of the 
     taxing jurisdiction in which the employee's employment duties 
     are primarily performed; and
       (B) the system is designed to allow the employer to 
     allocate the employee's wages for income tax purposes among 
     all taxing jurisdictions in which the employee performs 
     employment duties for such employer.
       (6) Wages or other remuneration.--The term ``wages or other 
     remuneration'' may be defined by the taxing jurisdiction in 
     which the employment duties are performed.
       (e) Place of Residence.--For purposes of this section, the 
     residence of an employee shall be determined under the laws 
     of the taxing jurisdiction in which such employee maintains a 
     dwelling which serves as the employee's permanent place of 
     abode during the calendar year.
       (f) Adjustment During Coronavirus Pandemic.--With respect 
     to calendar years 2020 and 2021, in the case of any employee 
     who performs employment duties in any taxing jurisdiction 
     other than the taxing jurisdiction of the employee's 
     residence during such year as a result of the COVID-19 public 
     health emergency, subsection (a)(2) shall be applied by 
     substituting ``90 days'' for ``30 days''.

     SEC. 3. STATE AND LOCAL TAX CERTAINTY.

       (a) Status of Employees During Covered Period.--
     Notwithstanding section 2(a)(2) or any provision of law of a 
     taxing jurisdiction, with respect to any employee who is 
     working remotely within such taxing jurisdiction during the 
     covered period--
       (1) except as provided under paragraph (2), any wages 
     earned by such employee during such period shall be deemed to 
     have been earned at the primary work location of such 
     employee; and
       (2) if an employer, at its sole discretion, maintains a 
     system that tracks where such employee performs duties on a 
     daily basis, wages earned by such employee may, at the 
     election of such employer, be treated as earned at the 
     location in which such duties were remotely performed.
       (b) Status of Businesses During Covered Period.--
     Notwithstanding any provision of law of a taxing 
     jurisdiction--
       (1) in the case of an out-of-jurisdiction business which 
     has any employees working remotely within such jurisdiction 
     during the covered period, the duties performed by such 
     employees within such jurisdiction during such period shall 
     not be sufficient to create any nexus or establish any 
     minimum contacts or level of presence that would otherwise--
       (A) subject such business to any registration, taxation, or 
     other related requirements for businesses operating within 
     such jurisdiction; or
       (B) cause such business to be deemed a resident of such 
     jurisdiction for tax purposes; and
       (2) except as provided under subsection (a)(2), with 
     respect to any tax imposed by such taxing jurisdiction which 
     is determined, in whole or in part, based on net or gross 
     receipts or income, for purposes of apportioning or sourcing 
     such receipts or income, any duties performed by an employee 
     of an out-of-jurisdiction business while working remotely 
     during the covered period--
       (A) shall be disregarded with respect to any filing 
     requirements for such tax; and
       (B) shall be apportioned and sourced to the tax 
     jurisdiction which includes the primary work location of such 
     employee.
       (c) Definitions.--For purposes of this section--
       (1) Covered period.--The term ``covered period'' means, 
     with respect to any employee working remotely, the period--
       (A) beginning on the date on which such employee began 
     working remotely; and
       (B) ending on the earlier of--
       (i) the date on which the employer allows, at the same 
     time--

       (I) such employee to return to their primary work location; 
     and
       (II) not less than 90 percent of their permanent workforce 
     to return to such work location; or

       (ii) December 31, 2021.
       (2) Employee.--The term ``employee'' has the meaning given 
     such term in section 3121(d) of the Internal Revenue Code of 
     1986, unless such term is defined by the taxing jurisdiction 
     in which the person's employment duties are deemed to have 
     been performed under subsection (a), in which case the taxing 
     jurisdiction's definition shall prevail.
       (3) Employer.--The term ``employer'' has the meaning given 
     such term in section 3401(d) of the Internal Revenue Code of 
     1986, unless such term is defined by the taxing jurisdiction 
     in which the person's employment duties are deemed to have 
     been performed under subsection (a), in which case the taxing 
     jurisdiction's definition shall prevail.
       (4) Out-of-jurisdiction business.--The term ``out-of-
     jurisdiction business'' means, with respect to any taxing 
     jurisdiction, any business entity which, excepting any 
     employees of such business who are working remotely within 
     such jurisdiction during the covered period, would, under the 
     existing law of such taxing jurisdiction, not otherwise--
       (A) be subject to any registration, taxation, or other 
     related requirement for businesses operating within such 
     jurisdiction; or
       (B) be deemed a resident of such jurisdiction for tax 
     purposes.
       (5) Primary work location.--The term ``primary work 
     location'' means, with respect to an employee, the address of 
     the employer where the employee is regularly assigned to work 
     when such employee is not working remotely during the covered 
     period.
       (6) Taxing jurisdiction.--The term ``taxing jurisdiction'' 
     has the same meaning given such term under section 2(d)(4).
       (7) Wages.--The term ``wages'' means all wages and other 
     remuneration paid to an employee that are subject to tax or 
     withholding requirements under the law of the taxing 
     jurisdiction in which the employment duties are deemed to be 
     performed under subsection (a) during the covered period.
       (8) Working remotely.--The term ``working remotely'' means 
     the performance of duties by an employee at a location other 
     than the primary work location of such employee at the 
     direction of his or her employer due to conditions resulting 
     from the public health emergency relating to the virus SARS-
     CoV-2 or coronavirus disease 2019 (referred to in this 
     paragraph as ``COVID-19''), including--
       (A) to comply with any government order relating to COVID-
     19;
       (B) to prevent the spread of COVID-19; and
       (C) due to the employee or a member of the employee's 
     family contracting COVID-19.
       (d) Preservation of Authority of Taxing Jurisdictions.--
     This section shall not be construed as modifying, impairing, 
     superseding, or authorizing the modification, impairment, or 
     supersession of the law of any taxing jurisdiction pertaining 
     to taxation except as expressly provided in subsections (a) 
     through (c).

     SEC. 4. EFFECTIVE DATE; APPLICABILITY.

       (a) Effective Date.--This Act shall apply to calendar years 
     beginning after December 31, 2019.
       (b) Applicability.--This Act shall not apply to any tax 
     obligation that accrues before January 1, 2020.
                                 ______
                                 
      By Ms. COLLINS (for herself and Mr. Warner):
  S. 1272. A bill to amend the Internal Revenue Code of 1986 to promote 
retirement savings on behalf of small business employees by making 
improvements to SIMPLE retirement accounts and easing the transition 
from a SIMPLE plan to a 401(k) plan, and for other purposes; to the 
Committee on Finance.
  Ms. COLLINS. Mr. President, I rise to introduce two bipartisan bills 
that would help improve Americans' retirement security. Together, these 
bills would make it easier for more small employers to offer retirement 
plans and encourage employees to save more for their retirement.

[[Page S2126]]

  There are many reasons why American households struggle to save for 
retirement, including the shift away from employer-based ``defined 
benefit'' plans and rising health care and long-term care costs. Longer 
life spans increase the risk of outliving retirement savings. The 
economic and health impacts of the COVID-19 crisis may also pose a 
threat to retirement security.
  Increasing access to employer-sponsored retirement plans is one way 
to help improve the financial security of many Americans. According to 
the Georgetown University Center for Retirement Initiatives, nationwide 
only about 54 percent of private sector workers had access to a 
retirement plan through their employer in 2020. In Maine, the 
percentage is a bit higher; approximately 59 percent of private sector 
employees had access to a retirement plan at work. But that still 
leaves more than 200,000 employees without access to a plan.
  In December 2019, provisions from my bipartisan Retirement Security 
Act were signed into law as part of the Setting Every Community Up for 
Retirement Enhancement or ``SECURE'' Act. These provisions will help to 
expand access to employer-provided retirement plans by reducing their 
cost and complexity, especially for small businesses. This law 
represents an important step forward, but more is needed.
  Congress established SIMPLE (Savings Incentive Match Plan for 
Employees) retirement plans in 1996 to encourage small businesses to 
provide their employees with retirement plans. These plans are less 
costly and easier to navigate than traditional 401(k) plans and provide 
an alternative approach for employers to help their employees save for 
retirement.
  The SIMPLE Plan Modernization Act, which I am introducing today with 
my colleague, Senator Mark Warner, would provide greater flexibility 
and access to employees and employers seeking to save for retirement by 
using SIMPLE plans.
  This legislation would expand access to SIMPLE plans by increasing 
the contribution limit for most small businesses. In addition, the bill 
includes incentives to encourage small businesses to move from a SIMPLE 
plan to a 401(k) plan when they are able to make this change.
  Like many Americans, spouses of active duty service members often 
face challenges when it comes to saving for retirement. Military 
spouses also face one hurdle that many others do not: frequent moves 
and changes in employment.
  According to the Department of Defense, about one-third of military 
service members experience a permanent change of station move every 
year. When a service member moves, their spouse usually relocates with 
them. The military spouse may face periods of unemployment, where they 
are not able to participate in an employer-sponsored retirement plan. 
When they do find a new job, they often work part-time, despite seeking 
full-time work, or are only able to spend a few years with their 
employer before moving again. These factors often preclude them from 
being eligible to receive employer contributions to their retirement 
plan or from being fully vested in their plan.
  The second bill I am introducing today focuses on helping to address 
this need by providing a tax credit to small employers who provide 
military spouses with accelerated eligibility for retirement plan 
participation, employer contributions, and vesting.
  In particular, the Military Spouses Retirement Security Act, which I 
am introducing with my colleague Senator Maggie Hassan, would make 
small employers--those with up to 100 employees--eligible for a tax 
credit of up to $500 per year per military spouse. The credit would be 
available for three years per military spouse. The amount of the credit 
would be equal to $200 per military spouse, plus 100 percent of all 
employer contributions for that spouse, up to $300.
  To receive the tax credit, small employers must make a military 
spouse immediately eligible for retirement plan participation within 
two months of hire. Upon plan eligibility, a military spouse must be 
eligible for any matching or non-elective contribution available to a 
similarly situated employee with at least two years of service, and 
must be 100 percent immediately vested in all employer contributions.
  In light of the positive effects these bills would have on 
strengthening retirement security for millions of Americans, I urge my 
colleagues to support the SIMPLE Plan Modernization Act and the 
Military Spouses Retirement Security Act.
  Thank you, Mr. President.
                                 ______
                                 
      By Mr. DURBIN (for himself and Mr. Portman):
  S. 1287. A bill to amend title XVIII of the Social Security Act to 
require manufacturers of certain single-dose vial drugs payable under 
part B of the Medicare program to provide refunds with respect to 
amounts of such drugs discarded, and for other purposes; to the 
Committee on Finance.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                S. 1287

       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 ``Recovering Excessive Funds 
     for Unused and Needless Drugs Act of 2021'' or the ``REFUND 
     Act of 2021''.

     SEC. 2. REQUIRING MANUFACTURERS OF CERTAIN SINGLE-DOSE 
                   CONTAINER OR SINGLE-USE PACKAGE DRUGS PAYABLE 
                   UNDER PART B OF THE MEDICARE PROGRAM TO PROVIDE 
                   REFUNDS WITH RESPECT TO DISCARDED AMOUNTS OF 
                   SUCH DRUGS.

       Section 1847A of the Social Security Act (42 U.S.C. 1395-
     3a), as amended by section 405 of division CC of the 
     Consolidated Appropriations Act, 2021, is amended--
       (1) by redesignating subsection (h) as subsection (i); and
       (2) inserting after subsection (g) the following:
       ``(h) Refund for Certain Discarded Single-Dose Container or 
     Single-Use Package Drugs.--
       ``(1) Secretarial provision of information.--
       ``(A) In general.--For each calendar quarter beginning on 
     or after January 1, 2022, the Secretary shall, with respect 
     to a refundable single-dose container or single-use package 
     drug (as defined in paragraph (8)), report to each 
     manufacturer (as defined in subsection (c)(6)(A)) of such 
     refundable single-dose container or single-use package drug 
     the following for the calendar quarter:
       ``(i) Subject to subparagraph (C), information on the total 
     number of units of the billing and payment code of such drug, 
     if any, that were discarded during such quarter, as 
     determined using a mechanism such as the JW modifier used as 
     of the date of enactment of this subsection (or any such 
     successor modifier that includes such data as determined 
     appropriate by the Secretary).
       ``(ii) The refund amount that the manufacturer is liable 
     for pursuant to paragraph (3).
       ``(B) Determination of discarded amounts.--For purposes of 
     subparagraph (A)(i), with respect to a refundable single-dose 
     container or single-use package drug furnished during a 
     quarter, the amount of such drug that was discarded shall be 
     determined based on the amount of such drug that was unused 
     and discarded for each drug on the date of service.
       ``(C) Exclusion of units of packaged drugs.--The total 
     number of units of the billing and payment code of a 
     refundable single-dose container or single-use package drug 
     of a manufacturer furnished during a calendar quarter for 
     purposes of subparagraph (A)(i) shall not include such units 
     that are packaged into the payment amount for an item or 
     service and are not separately payable.
       ``(2) Manufacturer requirement.--For each calendar quarter 
     beginning on or after January 1, 2022, the manufacturer of a 
     refundable single-dose container or single-use package drug 
     shall, for such drug, provide to the Secretary a refund that 
     is equal to the amount specified in paragraph (3) for such 
     drug for such quarter.
       ``(3) Refund amount.--
       ``(A) In general.--The amount of the refund specified in 
     this paragraph is, with respect to a refundable single-dose 
     container or single-use package drug of a manufacturer 
     assigned to a billing and payment code for a calendar quarter 
     beginning on or after January 1, 2022, an amount equal to 90 
     percent (or, in the case of a refundable single-dose 
     container or single-use package drug described in subclause 
     (I) or (II) of subparagraph (B)(ii), the percent determined 
     for such drug under subparagraph (B)(i)) of the product of--
       ``(i) the total number of units of the billing and payment 
     code for such drug that were discarded during such quarter 
     (as determined under paragraph (1)); and
       ``(ii)(I) in the case of a refundable single-dose container 
     or single-use package drug that is a single source drug or 
     biological, the

[[Page S2127]]

     amount determined for such drug under subsection (b)(4); or
       ``(II) in the case of a refundable single-dose container or 
     single-use package drug that is a biosimilar biological 
     product, the average sales price determined under subsection 
     (b)(8)(A).
       ``(B) Treatment of drugs that require filtration or other 
     unique circumstances.--
       ``(i) In general.--The Secretary, through notice and 
     comment rulemaking--

       ``(I) in the case of a refundable single-dose container or 
     single-use package drug described in subclause (I) of clause 
     (ii), shall adjust the percentage otherwise applicable for 
     purposes of determining the refund amount with respect to 
     such drug under subparagraph (A) as determined appropriate by 
     the Secretary; and
       ``(II) in the case of a refundable single-dose container or 
     single-use package drug described in subclause (II) of clause 
     (ii), may adjust the percentage otherwise applicable for 
     purposes of determining the refund amount with respect to 
     such drug under subparagraph (A) as determined appropriate by 
     the Secretary.

       ``(ii) Drug described.--For purposes of clause (i), a 
     refundable single-dose container or single-use package drug 
     described in this clause is either of the following:

       ``(I) A refundable single-dose container or single-use 
     package drug for which preparation instructions required and 
     approved by the Commissioner of the Food and Drug 
     Administration include filtration during the drug preparation 
     process, prior to dilution and administration, and require 
     that any unused portion of such drug after the filtration 
     process be discarded after the completion of such filtration 
     process.
       ``(II) Any other refundable single-dose container or 
     single-use package drug that has unique circumstances 
     involving similar loss of product.

       ``(4) Frequency.--Amounts required to be refunded pursuant 
     to paragraph (2) shall be paid in regular intervals (as 
     determined appropriate by the Secretary).
       ``(5) Refund deposits.--Amounts paid as refunds pursuant to 
     paragraph (2) shall be deposited into the Federal 
     Supplementary Medical Insurance Trust Fund established under 
     section 1841.
       ``(6) Enforcement.--
       ``(A) Audits.--
       ``(i) Manufacturer audits.--Each manufacturer of a 
     refundable single-dose container or single-use package drug 
     that is required to provide a refund under this subsection 
     shall be subject to periodic audit with respect to such drug 
     and such refunds by the Secretary.
       ``(ii) Provider audits.--The Secretary shall conduct 
     periodic audits of claims submitted under this part with 
     respect to refundable single-dose container or single-use 
     package drugs in accordance with the authority under section 
     1833(e) to ensure compliance with the requirements applicable 
     under this subsection.
       ``(B) Civil money penalty.--
       ``(i) In general.--The Secretary shall impose a civil money 
     penalty on a manufacturer of a refundable single-dose 
     container or single-use package drug who has failed to comply 
     with the requirement under paragraph (2) for such drug for a 
     calendar quarter in an amount equal to the sum of--

       ``(I) the amount that the manufacturer would have paid 
     under such paragraph with respect to such drug for such 
     quarter; and
       ``(II) 25 percent of such amount.

       ``(ii) Application.--The provisions of section 1128A (other 
     than subsections (a) and (b)) shall apply to a civil money 
     penalty under this subparagraph in the same manner as such 
     provisions apply to a penalty or proceeding under section 
     1128A(a).
       ``(7) Implementation.--The Secretary shall implement this 
     subsection through notice and comment rulemaking.
       ``(8) Definition of refundable single-dose container or 
     single-use package drug.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     in this subsection, the term `refundable single-dose 
     container or single-use package drug' means a single source 
     drug or biological (as defined in section 1847A(c)(6)(D)) or 
     a biosimilar biological product (as defined in section 
     1847A(c)(6)(H)) for which payment is established under this 
     part and that is furnished from a single-dose container or 
     single-use package.
       ``(B) Exclusions.--The term `refundable single-dose 
     container or single-use package drug' does not include a drug 
     or biological that is either a radiopharmaceutical or an 
     imaging agent.
       ``(9) Report to congress.--
       ``(A) In general.--Not later than 3 years after the date of 
     enactment of this subsection, the Office of the Inspector 
     General of the Department of Health and Human Services, in 
     consultation with the Centers for Medicare & Medicaid 
     Services and the Food and Drug Administration, shall submit 
     to the Committee on Energy and Commerce and the Committee on 
     Ways and Means of the House of Representatives and the 
     Committee on Finance of the Senate, a report on any impact 
     this subsection is demonstrated to have on--
       ``(i) the licensure, market entry, market retention, or 
     marketing of biosimilar biological products; and
       ``(ii) vial size changes, label adjustments, or 
     technological developments.
       ``(B) Updates.--At the direction of the Committees referred 
     to in subparagraph (A), the Office of the Inspector General 
     of the Department of Health and Human Services, in 
     consultation with the Centers for Medicare & Medicaid 
     Services and the Food and Drug Administration, shall 
     periodically update the report under such subparagraph.''.

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