[House Report 118-497]
[From the U.S. Government Publishing Office]


118th Congress }                                          { Report 
                        HOUSE OF REPRESENTATIVES
  2d Session   }                                          { 118-497

======================================================================
 
                     YOUTH POISONING PROTECTION ACT

                                _______
                                

  May 10, 2024.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

Mrs. Rodgers of Washington, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 4310]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 4310) to ban the sale of products with a high 
concentration of sodium nitrite to individuals, and for other 
purposes, having considered the same, reports favorably thereon 
without amendment and recommends that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     1
Background and Need for Legislation..............................     2
Committee Action.................................................     3
Committee Votes..................................................     3
Oversight Findings and Recommendations...........................     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................    14
Statement of General Performance Goals and Objectives............    14
Duplication of Federal Programs..................................    15
Related Committee and Subcommittee Hearings......................    15
Committee Cost Estimate..........................................    15
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    15
Advisory Committee Statement.....................................    15
Applicability to Legislative Branch..............................    15
Section-by-Section Analysis of the Legislation...................    15
Changes in Existing Law Made by the Bill, as Reported............    16

                          PURPOSE AND SUMMARY

    H.R. 4310, the ``Youth Poisoning Protection Act'' was 
introduced by Representative Trahan on June 22, 2023, and 
referred to the Committee on Energy and Commerce. H.R. 4310 
bans the sale of high-concentrate sodium nitrite to individuals 
by adding such products to the list of banned hazardous 
products in the Consumer Product Safety Act (15 U.S.C. 2057). 
H.R. 4310 does not ban the sale of sodium nitrite for business-
to-business sales or sales to universities and schools for the 
purpose of education and research.

                  BACKGROUND AND NEED FOR LEGISLATION

    Sodium nitrite is a substance that is generally used to 
cure meat and can be used medically to reverse cyanide 
poisoning. Swallowing a spoonful of sodium nitrite dissolved in 
a cup of water is likely to lead to a rapid death, and it is 
approximately 100 times more lethal than other poisoning 
methods used with suicidal intent.\1\ Sodium nitrite causes 
hypotension, or low blood pressure, and methemoglobinemia, 
which inhibits the ability of blood to carry oxygen.
---------------------------------------------------------------------------
    \1\Sean D. McCann, et al., Rising Incidence and High Mortality in 
Intentional Sodium Nitrite Exposures Reported to U.S. Poison Centers, 
Clinical Toxicology (Mar. 31, 2021).
---------------------------------------------------------------------------
    Amazon stated that it stopped selling the chemical to home 
consumers and offers it only on its Amazon business 
marketplace.\2\ Still, online suicide assistance forums provide 
detailed instructions and real-time guidance on how to die by 
suicide using sodium nitrite. These sites are responsible for a 
sharp increase of deaths by sodium nitrite ingestion in the 
past few years, a trend expected to continue.\3\ Data from the 
National Poison Data System shows a rise in self-poisonings 
using sodium nitrite in the United States since 2017.\4\ 
Experts emphasize that high-concentration sodium nitrite is 
only appropriate for commercial purposes--not individual or 
household use.\5\
---------------------------------------------------------------------------
    \2\Kaustuv Basu, Chemical Used in Suicides Faces Sales Ban Under 
Proposed Law, Bloomberg Law (June 22, 2023).
    \3\Yub Raj Sedhai, et al., The use of sodium nitrite for deliberate 
self-harm, and the online suicide market: Should we care?, The Medico-
Legal Journal (June 2022).
    \4\See Note 1.
    \5\Commonwealth of Australia, Delegate's final decision and reasons 
for decision--sodium nitrite (Joint ACMS-ACCS #28, June 2021).
---------------------------------------------------------------------------
    Sodium nitrite has a wide variety of valuable and important 
commercial and industrial uses. Large amounts of sodium nitrite 
are used by the chemical and pharmaceutical industries. Sodium 
nitrite has uses in the industrial production of organonitrogen 
compounds. Sodium nitrite enables manufacturing of certain dyes 
and rubber products, and it is also used in metallurgy 
applications, such as phosphatizing and detinning. Sodium 
nitrite is also used as a corrosion inhibitor, an industrial 
grease additive, and in cooling and heat transfer systems. It 
is also used as an emergency medication in certain poisoning 
cases. This legislation does not affect access to or use of 
sodium nitrite in any of these commercial and industrial uses, 
including small business uses.
    The Act seeks to address this consumer harm with a narrowly 
tailored prohibition on sale of consumer products that contain 
sodium nitrite at concentrations greater than 10 percent, which 
precludes consumer access to Consumer Product Safety Act-
regulated products. The 10 percent threshold allows consumer 
products with small or de minimis residuals of sodium nitrite, 
which do not otherwise present a safety concern, to be sold.
    The prohibition applies only to a ``consumer product,'' 
which is defined in the Consumer Product Safety Act (15 U.S.C. 
2052(a)(5)), and thus expressly does not apply to products 
exempted from the definition, including but not limited to 
Federal Food, Drug, and Cosmetic Act-regulated foods and food 
additives, and drugs, devices, or cosmetics.
    H.R. 4310 is needed to ensure that sodium nitrite is no 
longer accessible to consumers at a percentage greater than 10 
percent. There are no known consumer products that need to 
contain sodium nitrite above this level. At the same time, H.R. 
4310 will preserve access to sodium nitrite for businesses and 
educational institutions.

                            COMMITTEE ACTION

    On September 27, 2023, the Subcommittee on Innovation, 
Data, and Commerce held a hearing on H.R. 4310. The 
Subcommittee received testimony from:
           Kathleen Callahan, Owner, Xpertech Auto 
        Repair;
           Scott Benavidez, Chairman, Automotive 
        Service Association;
           Steven Michael Gentine, Counsel, Arnold & 
        Porter, LLP;
           John Breyault, Vice President of Public 
        Policy, Telecommunications and Fraud, National 
        Consumers League; and
           David Touhey, Principal, Connett Consulting, 
        appearing on behalf of International Association of 
        Venue Managers.
    On November 2, 2023, the Subcommittee on Innovation, Data, 
and Commerce met in open markup session and forwarded H.R. 
4310, without amendment, to the full Committee by a voice vote.
    On December 6, 2023, the full Committee on Energy and 
Commerce met in open markup session and ordered H.R. 4310, 
without amendment, favorably reported to the House by a record 
vote of 42 yeas and 0 nays.

                            COMMITTEE VOTES

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. The following reflects the record votes taken during 
the Committee consideration:


                 OVERSIGHT FINDINGS AND RECOMMENDATIONS

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

              NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY,
                          AND TAX EXPENDITURES

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 4310 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  CONGRESSIONAL BUDGET OFFICE ESTIMATE

    Pursuant to clause 3(c)(3) of rule XIII, the following is 
the cost estimate provided by the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974:


    Summary: On December 6, 2023, the House Committee on Energy 
and Commerce ordered 41 pieces of legislation to be reported. 
This document provides estimates for 21 bills in that package 
that are related to health care and consumer protection.
    Generally, the bills in this group that would affect direct 
spending would:
           Limit beneficiary cost sharing for certain 
        prescription drugs and add certain drugs to the group 
        of products covered by the Medicare home infusion 
        benefit;
           Prohibit pharmacy benefit managers (PBMs) 
        from collecting certain fees from prescription drug 
        manufacturers and require PBMs to provide additional 
        information to Medicare Part D plans (which provide 
        prescription drug coverage);
           Allow Part D plans more flexibility to add 
        biosimilar biological products to their formularies and 
        to change the cost-sharing status of reference 
        biological products;
           Temporarily increase Medicare payment rates 
        for durable medical equipment (DME); and
           Provide mandatory funding for implementation 
        of certain provisions in several bills.
    Estimated Federal cost: The costs of the legislation fall 
within budget functions 550 (health) and 570 (Medicare).
    Basis of estimate: For this estimate, CBO assumes that the 
bills will be enacted near the middle of fiscal year 2024 and 
that the estimated amounts will be appropriated each year. This 
cost estimate does not include any effects of interactions 
among the bills. If all 21 bills were combined and enacted as a 
single piece of legislation, the effects could be different 
from the sum of the separate estimates.
    Direct spending: Enacting 10 bills in the group would 
affect direct spending over the 2024-2034 period (see Table 1).

TABLE 1.--ESTIMATED EFFECTS ON DIRECT SPENDING OF HEALTH CARE LEGISLATION, AS ORDERED REPORTED BY THE HOUSE COMMITTEE ON ENERGY AND COMMERCE ON DECEMBER
                                                                         6, 2023
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 By fiscal year, millions of dollars--
                                             -----------------------------------------------------------------------------------------------------------
                                               2024   2025   2026    2027    2028    2029    2030    2031    2032    2033    2034   2024-2029  2024-2034
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Increases or Decreases (-) in Direct Spending
 
H.R. 2880:
  Budget Authority..........................      0      0       0     -29     -39     -31     -31     -28     -26     -24     -18       -99       -226
  Outlays...................................      0      0       0     -29     -39     -31     -31     -28     -26     -24     -18       -99       -226
H.R. 3842:
  Budget Authority..........................      0      *       *       *       *       *       *       *       *       *       *         *          *
  Outlays...................................      0      *       *       *       *       *       *       *       *       *       *         *          *
H.R. 4881:
  Budget Authority..........................      0      0       0       0      77      88     100     106     113     134     136       165        754
  Outlays...................................      0      0       0       0      77      88     100     106     113     134     136       165        754
H.R. 5372:
  Budget Authority..........................      0     -9     -12     -12     -14     -12     -14     -16     -17     -20     -19       -59       -145
  Outlays...................................      0     -9     -12     -12     -14     -12     -14     -16     -17     -20     -19       -59       -145
H.R. 5380:
  Budget Authority..........................     15      0       0       0       0       0       0       0       0       0       0        15         15
  Outlays...................................     13      1       1       0       0       0       0       0       0       0       0        15         15
H.R. 5385:
  Budget Authority..........................     55      0       0     -55     -75     -60     -60     -55     -50     -46     -35      -135       -381
  Outlays...................................     49      4       2     -55     -75     -60     -60     -55     -50     -46     -35      -135       -381
H.R. 5386:
  Budget Authority..........................      0      0       *       *       *       *       *       *       *       *       *         *          *
  Outlays...................................      0      0       *       *       *       *       *       *       *       *       *         *          *
H.R. 5393:
  Budget Authority..........................      0      6       0       0       0       0       0       0       0       0       0         6          6
  Outlays...................................      0      6       0       0       0       0       0       0       0       0       0         6          6
H.R. 5397:
  Budget Authority..........................      0      0      -9     -13     -15     -14     -15     -17     -17     -20     -19       -37       -139
  Outlays...................................      0      0      -9     -13     -15     -14     -15     -17     -17     -20     -19       -37       -139
H.R. 5555:
  Budget Authority..........................    144      1       0       0       0       0       0       0       0       0       0       145        145
  Outlays...................................    144      1       0       0       0       0       0       0       0       0       0       145        145
--------------------------------------------------------------------------------------------------------------------------------------------------------
All amounts for outlays are estimates; except for H.R. 5380 and H.R. 5393, all amounts for budget authority are estimated;
* = between -$500,000 and $500,000.

    H.R. 2880, the Protecting Patients Against PBM Abuses Act, 
would modify the rules with respect to certain fees that PBMs 
collect from prescription drug manufacturers. In Medicare Part 
D (which provides prescription drug coverage), sponsors of 
private insurance plans contract with the government to deliver 
benefits to Medicare beneficiaries. Those insurance plans 
usually contract with PBMs to negotiate with drug 
manufacturers, design formularies, and perform other 
administrative functions. A PBM can be owned by the plan 
sponsor or it can be an independent corporate entity.
    H.R. 2880 would prohibit PBMs from collecting service fees 
from manufacturers that are based on drug prices, manufacturer 
discounts, or formulary placement decisions. Under the bill, 
those fees would be specific dollar amounts based on the fair 
market value of a PBM's services. Under current law, PBMs can 
be compensated for services they provide to manufacturers, but 
compensation that exceeds the fair market value of a service 
must be classified as direct and indirect remuneration and 
reported to the Centers for Medicare & Medicaid Services (CMS). 
According to the Government Accountability Office, however, CMS 
does not routinely monitor how PBMs classify those fees.\1\ 
Under the bill, CMS and the Office of Inspector General would 
more closely monitor those classifications.
---------------------------------------------------------------------------
    \1\See Government Accountability Office, Medicae Part D: Use of 
Pharmacy Benefit Managers and Efforts to Manage Drug Expenditures, GAO-
19-498 (July 2019), Appendix III, www.gao.gov/products/gao-19-498.
---------------------------------------------------------------------------
    CBO estimates that manufacturers' service fees are roughly 
1 percent of Part D retail spending under current law. CBO 
expects that under H.R. 2880, a portion of those fees would be 
reclassified as direct and indirect remuneration by PBMs and, 
because of stronger oversight, passed along to the sponsors of 
prescription drug plans. That action would reduce bid amounts 
for plans' expected benefit payments, which in turn would 
reduce spending in Part D. CBO estimates that the provision 
would decrease federal spending by $226 million over the 2024-
2034 period, or by roughly 1 percent of the amount expected to 
be collected in service fees over that period.
    H.R. 3842, the Expanding Access to Diabetes Self-Management 
Training Act of 2023, would allow more providers to refer 
eligible patients to diabetes self-management training covered 
by Medicare and would codify regulatory time limits on use of 
the training. CBO expects that enacting H.R. 3842 would result 
in more patients receiving such training, which would lead to 
increased Medicare spending. CBO expects that such training 
would reduce the use of acute-care services, at least partly 
offsetting that increase in costs. As a result, CBO estimates 
that enacting the bill would increase or decrease direct 
spending by less than $500,000 over the 2024-2034 period.
    H.R. 4881, a bill to amend title XVIII of the Social 
Security Act to limit cost sharing for drugs under the Medicare 
program, would limit cost sharing above the deductible to no 
more than the average net price for a drug, which is the list 
price minus after-sale discounts from the drug's manufacturer. 
From 2028 to 2034, CBO projects, less than 1 percent of Part D 
spending above the deductible under current law will be for 
drugs with cost sharing that exceeds net drug costs. Under the 
bill, CBO expects that some out-of-pocket spending by 
beneficiaries and some federal subsidies for low-income 
beneficiaries would shift onto Part D plans, which would 
increase the bids they submit to the federal government to 
cover expected benefits spending and therefore increase federal 
spending. CBO estimates that enacting H.R. 4881 would increase 
direct spending by $754 million over the 2024-2034 period.
    H.R. 5372, the Expanding Seniors' Access to Lower Cost 
Medications Act of 2023, would allow Part D plans to add 
biosimilar biological products to their formularies and change 
the cost-sharing status of a reference biological product after 
the first 60 days of a plan year. (A reference biological 
product is the approved product against which a proposed 
biosimilar product is compared.) Under current law, Part D 
plans must exempt beneficiaries who currently use reference 
biological products from changes in coverage and cost sharing 
for the remainder of the year. That restriction limits a plan's 
ability to promote use of a biosimilar product immediately 
following that product's entry to the market. CMS has proposed 
rules that overlap with the bill's provisions concerning 
formulary substitutions for biosimilar products.\2\ CBO's 
estimate of Medicare spending for those products under current 
law accounts for 50 percent of the effect of the proposed 
rules. As a result, CBO's estimate of the decrease in direct 
spending under H.R. 5372 is larger than it might be if CMS's 
rules had become final.
---------------------------------------------------------------------------
    \2\See Centers for Medicare & Medicaid Services, ``Medicare 
Program; Contract Year 2025 Policy and Technical Changes to the 
Medicare Advantage Program, Medicare Prescription Drug Benefit Program, 
Medicare Cost Plan Program, and Programs of All-Inclusive Care for the 
Elderly; Health Information Technology Standards and Implementation 
Specifications,'' Notice of Proposed Rulemaking, 88 Fed. Reg. 78476 
(November 15, 2023), http://tinyurl.com/wv7yprfm; and ``Medicare 
Program; Contract Year 2024 Policy and Technical Changes to the 
Medicare Advantage Program, Medicare Prescription Drug Program, 
Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment 
Provisions of the Affordable Care Act and Programs of All-Inclusive 
Care for the Elderly; Health Information Technology Standards and 
Implementation Specifications,'' Notice of Proposed Rulemaking, 87 Fed. 
Reg. 79452 (December 27, 2022), http://tinyurl.com/3754c49x,
---------------------------------------------------------------------------
    Under the bill, the addition of biosimilar products to 
formularies could lead to a shift away from the use of 
reference biological products. CBO estimates that the 
government will spend about $10 billion over the 2024-2034 
period to cover reference biological products under current 
law. CBO anticipates that under H.R. 5372 approximately 20 
percent of the current use of reference biological products 
would be replaced by biosimilar products. The prices for 
biosimilar products are estimated to be 15 percent lower, on 
average, than the prices for the reference products. Using 
information about spending on both types of products under 
current law and adjusting for current regulatory proposals by 
CMS that would streamline coverage for biosimilar products, CBO 
estimates that enacting H.R. 5372 would decrease direct 
spending by $145 million over the 2024-2034 period.
    H.R. 5380, a bill to amend title XVIII of the Social 
Security Act to increase data transparency for supplemental 
benefits under Medicare Advantage, would provide $15 million in 
2024 for the Department of Health and Human Services (HHS) to 
implement reporting requirements for supplemental benefits 
under Medicare Advantage plans. Based on historical spending 
patterns for HHS programs, CBO estimates that enacting H.R. 
5380 would increase direct spending by $15 million over the 
2024-2034 period.
    H.R. 5385, the Medicare PBM Accountability Act, would 
require pharmacy benefit managers to provide plan sponsors with 
information not furnished under current law. Part D plans have 
access to certain aggregate and drug-specific information from 
PBMs concerning prescriptions, prices, rebates, and out-of-
pocket charges, but may lack information about PBM-affiliated 
entities and contractors, rationales for formulary decisions, 
and explanations for benefit designs that favor certain 
pharmacies. H.R. 5385 would require PBMs to report such 
information to Part D plans but also, subject to certain 
restrictions, would allow plans to audit PBMs' business 
practices and request other information. The bill would provide 
$55 million for HHS to implement those requirements.
    H.R. 5385 also would require PBMs to make their business 
practices clearer to Part D plans, thus promoting competition 
among PBMs. CBO estimates that the increased competition would 
reduce net spending for Part D by less than 0.1 percent over 
the 2024-2034 period--reducing federal spending by $436 million 
over that period.
    CBO estimates that the net effect of the bill would be a 
reduction in direct spending of $381 million over the 2024-2034 
period.
    H.R. 5386, the Cutting Copays Act, would prohibit cost 
sharing for generic drugs for beneficiaries who are eligible 
for the low-income subsidy, which pays most or all of their 
premium and cost-sharing requirements. Under current law, plans 
have an option but not an obligation to do so. CBO expects that 
enacting the bill would increase the use of generic drugs, 
which would increase plan bid submissions for expected benefits 
payments and, therefore, federal spending. CBO expects that 
some of the increase would be offset by reduced spending on 
brand-name drugs and certain medical services. CBO estimates 
that enacting the bill would increase direct spending by less 
than $500,000 over the 2024-2034 period.
    H.R. 5393, a bill to amend title XVIII of the Social 
Security Act to ensure fair assessment of pharmacy performance 
and quality under Medicare Part D, and for other purposes, 
would provide $4 million in in 2025 for CMS program management 
to implement pharmacy performance and quality measures for Part 
D and $2 million in that year to implement pharmacy 
transparency requirements. Based on historical spending 
patterns for CMS administrative costs, CBO estimates that 
enacting H.R. 5393 would increase direct spending by $6 million 
over the 2024-2034 period.
    H.R. 5397, the Joe Fiandra Access to Home Infusion Act of 
2023, would add drugs to the current Medicare benefit that 
allows patients to receive some drugs by infusion under nursing 
care at home. H.R. 5397 would allow other drugs to meet the 
statutory criteria for coverage in the home setting by 
establishing those products as suitable for delivery through a 
pump and requiring patients receiving those drugs also to 
receive regular nursing services.
    Based on its analysis of the beneficiary population and 
Medicare payment rates, CBO estimates that enacting the bill 
would reduce direct spending by $139 million over the 2024-2034 
period, primarily because beneficiaries would bear a larger 
share of the cost of infusions that occur at home. Under 
current law, there is a cap on beneficiary cost sharing in 
outpatient hospital settings, which is where CBO expects that 
beneficiaries receive those drugs now. There is no equivalent 
cap for the home infusion benefit.
    CBO's estimate for H.R. 5397 is subject to considerable 
uncertainty. First, it is not known how many drugs would 
qualify for coverage under the bill. CBO's estimate focused on 
three products that industry and clinical experts mentioned as 
likely candidates, but the actual number could be larger or 
smaller. In addition, given that cost sharing could increase 
significantly for patients, it is not known how many 
beneficiaries would choose to receive home infusions.\3\
---------------------------------------------------------------------------
    \3\CMS proposed a similar but not identical policy in a proposed 
rulemaking. In the regulatory impact analysis, CMS estimated that, for 
one product, beneficiaries' cost sharing would be about triple the 
amount if the product was received in a home setting. For more 
information, see Centers for Medicare & Medicaid Services, ``Medicare 
Program; Durable Medical Equipment, Prosthetics, Orthotics, and 
Supplies (DMEPOS) Policy Issues and Level II of the Healthcare Common 
Procedure Coding System (HCPCS),'' Notice of Proposed Rulemaking, 85 
Fed. Reg. 70358 (November 4, 2020), http://tinyurl.com/29djdrvz.
---------------------------------------------------------------------------
    H.R. 5555, the DMEPOS Relief Act of 2023, would temporarily 
increase Medicare rates in some areas of the country for DMEPOS 
(durable medical equipment, prosthetics, orthotics, and 
supplies). Under current law, Medicare's payments for some 
equipment are based on competitive bidding among suppliers. CMS 
uses those results to set rates (either directly or through a 
blend with the historic fee schedule) in areas of the country 
where formal bidding has not occurred. Prior legislation 
directed CMS to use a blend of fee schedule and competitively 
bid rates in some areas of the country; the use of those 
blended rates expired at the end of calendar year 2023. 
Enacting H.R. 5555 would extend the use of those blended rates 
through calendar year 2024. Based on an analysis of historic 
claim spending, CBO estimates that the DME provision of the 
bill would increase direct spending by $145 million over the 
2024-2034 period. H.R. 5555 also would reduce amounts available 
to the Medicare Improvement Fund by $177 million, however the 
Consolidated Appropriations Act, 2024 rescinded all funding 
from the Medicare Improvement Fund. As a result, the provision 
would not affect direct spending. In total, CBO estimates that 
enacting H.R. 5555 would increase net direct spending by $145 
million over the 2024-2034 period.
    Legislation with no effect on direct spending: CBO 
estimates that enacting 11 bills in this estimate would have no 
effect on direct spending over the 2024-2034 period:
           H.R. 133, the Mandating Exclusive Review of 
        Individual Treatments (MERIT) Act;
           H.R. 1797, the Setting Consumer Standards 
        for Lithium-Ion Batteries Act;
           H.R. 2365, the Dr. Emmanuel Bilirakis 
        National Plan to End Parkinson's Act;
           H.R. 4310, the Youth Poisoning Protection 
        Act;
           H.R. 5202, the Virginia Graeme Baker Pool 
        and Spa Safety Reauthorization Act;
           H.R. 5371, the Choices for Increased 
        Mobility Act of 2023;
           H.R. 5388, the Supporting Innovation for 
        Seniors Act;
           H.R. 5389, the National Coverage 
        Determination Transparency Act;
           H.R. 5396, the Coverage Determination 
        Clarity Act of 2023;
           H.R. 6132, the Awning Safety Act of 2023; 
        and
           H.R. 6364, the Medicare Telehealth Privacy 
        Act of 2023.
    Spending subject to appropriation: CBO estimates that five 
bills would increase spending subject to appropriation (see 
Table 2). Any spending would be subject to the availability of 
appropriated funds.

   TABLE 2. ESTIMATED INCREASES IN SPENDING SUBJECT TO APPROPRIATION UNDER HEALTH CARE LEGISLATION,AS ORDERED
                   REPORTED BY THE HOUSE COMMITTEE ON ENERGY AND COMMERCE ON DECEMBER 6, 2023
----------------------------------------------------------------------------------------------------------------
                                                         By fiscal year, millions of dollars--
                                                ------------------------------------------------------ 2024-2029
                                                   2024     2025     2026     2027     2028     2029
----------------------------------------------------------------------------------------------------------------
H.R. 1797:
    Estimated Authorization....................        *        1        1        1        1        2          6
    Estimated Outlays..........................        *        1        1        1        1        2          6
H.R. 2365:
    Estimated Authorization....................        *        1        *        1        *        1          3
    Estimated Outlays..........................        *        1        *        1        *        1          3
H.R. 4310:
    Estimated Authorization....................        *        *        *        1        *        1          2
    Estimated Outlays..........................        *        *        *        1        *        1          2
H.R. 5202:
    Authorization..............................        5        5        5        5        5        0         25
    Estimated Outlays..........................        4        4        4        5        5        0         22
H.R. 6132:
    Estimated Authorization....................        *        1        *        1        *        1          3
    Estimated Outlays..........................        *        1        *        1        *        1          3
----------------------------------------------------------------------------------------------------------------
* = between zero and $500,000.

    H.R. 1797, the Setting Consumer Standards for Lithium-Ion 
Batteries Act, would require the Consumer Product Safety 
Commission (CPSC) to issue a final safety standard to reduce 
the risk of fire from rechargeable lithium-ion batteries that 
are used to power electric-assist bicycles and electric 
scooters, for example. Based on information provided by the 
commission, CBO expects that CPSC would need less than two 
employees for the first two years after enactment and six 
employees thereafter, at an average annual cost of $190,000 per 
employee, to issue and enforce the standard. In total, CBO 
estimates that it would cost $6 million over the 2024-2029 
period for CPSC to implement H.R. 1797, assuming appropriation 
of the necessary amounts.
    H.R. 2365, the Dr. Emmanuel Bilirakis National Plan to End 
Parkinson's Act, would require HHS to establish an advisory 
council and to create and update several plans and reports as 
part of a national project to prevent, diagnose, treat, and 
cure Parkinson's disease. Using information about similar 
activities, CBO expects that HHS would need two employees for 
the first year after enactment and three employees thereafter, 
at an average annual cost in 2024 of $160,000 per employee, to 
carry out activities required under the act. In total, CBO 
estimates that it would cost $3 million over the 2024-2029 
period for HHS to implement H.R. 2365, assuming appropriation 
of the necessary amounts.
    H.R. 4310, the Youth Poisoning Protection Act, would ban 
the sale of consumer products containing 10 percent or more of 
sodium nitrite by weight. Using information from CPSC, CBO 
expects the commission would need less than one employee for 
the first two years after enactment and around two employees 
thereafter, at an average annual cost of $190,000 per employee, 
to enforce the standard. In total, CBO estimates it would cost 
about $2 million over the 2024 2029 period for CPSC to 
implement H.R. 4310, assuming appropriation of the necessary 
amounts.
    H.R. 5202, the Virginia Graeme Baker Pool and Spa Safety 
Reauthorization Act, would authorize the appropriation of $5 
million annually over the 2024-2028 period for CPSC to continue 
a grant program and public outreach concerning the safety of 
children in pools and spas. The bill would require CPSC to 
extend grant eligibility to nonprofit organizations, appoint a 
Director of Drowning Prevention, and report to the Congress 
annually on the program's results. Using information from CPSC, 
CBO estimates that the cost of implementing the bill would be 
$22 million over the 2024-2029 period, assuming appropriation 
of the necessary amounts.
    H.R. 6132, the Awning Safety Act of 2023, would require 
CPSC to issue a final safety standard for retractable awnings. 
Using information from that agency, CBO expects the commission 
would need an average of two employees per year, at an average 
annual cost of $190,000 per employee, to issue and enforce the 
standard. In total, CBO estimates it would cost about $3 
million over the 2024-2029 period for CPSC to implement H.R. 
6132, assuming appropriation of the necessary amounts.
    Pay-as-you-go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending or 
revenues. The net changes in outlays for the 10 bills that are 
subject to those pay-as-you-go procedures are shown in Table 1.
    Increase in long-term net direct spending and deficits: CBO 
estimates that enacting H.R. 4881 would increase long-term net 
direct spending and that such spending would increase by more 
than $5 billion in at least one of the four consecutive 10-year 
periods beginning in 2035.
    CBO estimates that none of the other bills discussed in 
this estimate would increase net direct spending or deficits in 
any of the four consecutive 10-year periods beginning in 2035.
    Mandates: H.R. 1797 would impose a private-sector mandate 
as defined in the Unfunded Mandates Reform Act (UMRA) by 
requiring manufacturers of electric-assist bicycles and 
electric scooters, for example, to comply with a prospective 
CPSC safety standard concerning the risk of fire in lithium-ion 
batteries. Limited data are available about the extent of 
industry compliance with the current voluntary standards or 
about the cost of bringing products into compliance. Therefore, 
CBO cannot determine whether the cost of the mandate would 
exceed the private-sector threshold established in UMRA ($200 
million in 2024, adjusted annually for inflation).
    H.R. 1797 would not impose any intergovernmental mandates.
    H.R. 4310 would impose a private-sector mandate as defined 
in UMRA by banning the sale of consumer products containing 10 
percent or more of sodium nitrite by weight. The prohibition 
would not apply to industrial uses or to food preservation. 
Because there is only a small market for consumer products 
containing more than 10 percent by weight and some states 
already have curtailed the sale of products containing sodium 
nitrite, CBO estimates that the cost of the mandate would not 
exceed the private-sector threshold established in UMRA.
    H.R. 4310 would not impose any intergovernmental mandates.
    H.R. 6132 would impose a private-sector mandate as defined 
in UMRA by requiring awning manufacturers to comply with a 
prospective CPSC safety standard concerning fixed and 
freestanding retractable awnings. CBO expects that the standard 
could require awnings to be equipped with safety clips and to 
issue visual or audible alerts when in motion. Based on the 
cost of such additional equipment and the number of such 
awnings likely to be sold, CBO estimates that the cost of the 
mandate would not exceed the private-sector threshold 
established in UMRA.
    H.R. 6132 would not impose any intergovernmental mandates.
    CBO has determined that none of the other bills in this 
estimate would impose intergovernmental or private-sector 
mandates as defined in UMRA.
    Estimate prepared by: Federal Costs: Austin Barselau 
(Medicare), Ezra Cohn (public health), Cornelia Hall 
(Medicare), Hudson Osgood (Medicare), Lara Robillard 
(Medicare), Sarah Sajewski (Medicare), Katie Zhang (public 
health), Noah Zwiefel (Medicare); Mandates: Andrew Laughlin.
    Estimate reviewed by: Sean Dunbar, Chief, Low-Income Health 
Programs and Prescription Drugs Cost Estimates Unit; Kathleen 
FitzGerald, Chief, Public and Private Mandates Unit; Sarah 
Masi, Senior Adviser, Budget Analysis Division; Asha Saavoss, 
Chief, Medicare and Health Systems Cost Estimates Unit; Chad 
Chirico, Director of Budget Analysis.
    Estimate approved by: Phillip L. Swagel, Director, 
Congressional Budget Office.

                       FEDERAL MANDATES STATEMENT

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to ban 
high-concentrate sodium nitrite to individuals by adding such 
products to the list of banned hazardous products in the 
Consumer Product Safety Act (15 U.S.C. 2057).

                    DUPLICATION OF FEDERAL PROGRAMS

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 4310 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

              RELATED COMMITTEE AND SUBCOMMITTEE HEARINGS

    Pursuant to clause 3(c)(6) of rule XIII, the following 
related hearing was used to develop or consider H.R. 4310:
           On September 27, 2023, the Subcommittee on 
        Innovation, Data, and Commerce held a hearing on H.R. 
        4310. The Subcommittee received testimony from:
                   Kathleen Callahan, Owner, 
                Xpertech Auto Repair;
                   Scott Benavidez, Chairman, 
                Automotive Service Association;
                   Steven Michael Gentine, Counsel, 
                Arnold & Porter, LLP;
                   John Breyault, Vice President of 
                Public Policy, Telecommunications and Fraud, 
                National Consumers League; and,
                   David Touhey, Principal, Connett 
                Consulting, appearing on behalf of 
                International Association of Venue Managers.

                        COMMITTEE COST ESTIMATE

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

       EARMARK, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 4310 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                      ADVISORY COMMITTEE STATEMENT

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  APPLICABILITY TO LEGISLATIVE BRANCH

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title

    Section 1 provides that the Act may be cited as the ``Youth 
Poisoning Protection Act.''

Section 2. Banning of products containing a high concentration of 
        sodium nitrite

    Section 2 requires any consumer product containing a high 
concentration of sodium nitrite be considered a banned 
hazardous product under section 8 of the Consumer Product 
Safety Act. This section also defines key terms and sets an 
effective date of 90 days after enactment.

         CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    This legislation does not amend any existing Federal 
statute.

                                  [all]