340B Rebate Pilot Can Provide Valuable Lessons for Future Reform

April 20, 2026

U.S. Department of Health and Human Services
Health Resources and Services Administration
Office of Pharmacy Affairs
Attn: Chantelle Britton, Director

Posted on regulations.gov and sent via email: 340Bpricing@HRSA.gov

Re: Request for Information: 340B Rebate Model Pilot Program, HHS Docket No. HRSA-2026-03042

On behalf of National Taxpayers Union (NTU), the nation’s oldest taxpayer advocacy organization, we write with brief remarks on HRSA-2026-03042, which seeks comments regarding the “potential use of rebates to effectuate the ceiling price under the 340B Program, including the standards and procedures that should govern the approval of manufacturer rebate plans and the impacts on all stakeholders.” Much as NTU noted in its September 2025 comments on HHS Docket No. HRSA-2025-14619, this docket has potential to benefit taxpayers, who have been increasingly burdened by the fiscal liabilities of the 340B program.

Introduction

NTU was founded in 1969 to achieve favorable policy outcomes for taxpayers with Congress and the executive branch. Our experts and advocates engage federal policymakers on important matters affecting taxpayers in a variety of settings, including tax administration, health care, and product regulation. All these matters intersect and provide NTU with an opportunity to offer its views today.

For most of NTU’s 55-year history, our team has analyzed and provided commentary on important questions surrounding the fiscal impact of federal legislation and regulations on the health care space. We have noted with great concern the decades-long cost spiral in federal health care programs, which has seemed to defy attempts at reducing or at least controlling the burden on current and future taxpayers. According to the Congressional Budget Office, between Fiscal Years 2024 and 2054 the share of federal noninterest outlays consumed by major health care programs is projected to rise from 30% to 38%. By contrast, Social Security, another cost driver in the budget, will see its share of non-interest outlays increase from 26% to 29%.¹ Even with the passage of the One Big Beautiful Bill Act (OBBBA), which NTU strongly supported, outlays for the federal share of the Medicaid program are projected to increase between Fiscal Years 2025 and 2034 by 31%. It should be noted that, without the reforms contained in OBBBA, federal Medicaid outlays would have risen at roughly double that rate.²

To NTU, it is abundantly clear that innovative approaches to reducing health care costs must be explored and implemented to reorient this unsustainable trajectory toward a more realistic and affordable direction. We believe that thoughtful deployment of prescription drugs (both branded and generic/biosimilar) in more settings, as longer-term alternatives to costlier treatments, can be a vital part of this necessary exercise. Taxpayers, therefore, have a significant stake in how federal and state governments approach prescription drug development, deployment, and payment. The federal government either directly purchases prescription drugs or subsidizes prescription drug coverage for tens of millions of Americans through the Medicare and Medicaid programs. Regulations on both health insurance plans and manufacturers impact when drugs are available to the majority of Americans with private coverage and how much those products will cost. Finally, undertakings such as the 340B Drug Pricing Program have taken prescription drug markets in often-unexpected directions.

We commend the Health Resources and Services Administration (HRSA) for its continued engagement in strengthening the 340B Drug Pricing Program through the exploration of a rebate model pilot initiative. Seeking stakeholder input through this Request for Information (RFI) is a positive step forward following legal challenges to previous efforts to reform 340B’s opaque payment practices. While the lawsuit brought by interests representing health care providers paused implementation of HRSA’s rebate model pilot program on administrative and procedural grounds, it did not resolve the underlying issues that led to the need for reform in the first place.

The court decisions that effectively ended the 2025 pilot program highlight the need for any future initiative to be rolled out on sound legal footing. At the same time, addressing 340B’s weaknesses around transparency, oversight, and program growth remains as urgent as ever. Taxpayers stand to benefit from replacing the current upfront discount structure with a rebate-based payment system that reduces the risk of duplicate discounts between 340B and Medicaid. It is therefore entirely appropriate for HRSA to proceed with a rebate model pilot program to assess the feasibility of this approach.

This framework is not about cutting benefits for patients—it is about creating a transparent transaction trail to avoid overlapping discounts that drain taxpayer dollars and erode public trust in government. NTU appreciates the opportunity to file comments on this RFI and stand ready to assist HRSA with our expertise as it moves forward on efforts to improve 340B.

Comments

Taxpayers Can Benefit from Testing 340B Rebate Concepts

As of this date, many comment filers regarding HRSA-2026-03042 represent Covered Entities (CEs) that currently benefit from 340B, along with a few representing other interests in the health care sector. Yet, it is vital to consider 340B’s impact on taxpayers, and how HRSA-2026-03042 could serve to benefit his often-overlooked constituency.

While 340B is regarded as primarily a price discount program for Medicaid providers, the program’s breadth and depth is much greater. Medicare Part B and Part D, for example, are not direct participants in 340B, nor do they partake in the discount process. Nonetheless, covered entities can, under certain circumstances, bill Part B and Part D for specified drugs at the lower 340B price and, in turn, get reimbursed from Medicare at the Average Sales Price plus 6% (thereby pocketing a not-inconsiderable profit). It is notable that attempts during the first Trump Administration in 2018 to ratchet down the ASP plus 6% formula to a more reasonable rate were met with lawsuits and a 2022 Supreme Court ruling that struck down the proposed reform. As a result, the Center for Medicare and Medicaid Services decided to provide $10.6 billion in lump sum payments to 340B CEs “that [were] paid less due to the now-invalidated policy.”³ Taxpayers were the unfortunate guarantors of this windfall.

Nowhere is 340B’s adverse impact on taxpayers more acutely felt than at the state level, a fact NTU has uniquely highlighted. Former Wisconsin State Senator Leah Vukmir, NTU’s Senior Vice President of State Affairs, has crisscrossed the country to defend taxpayers against state legislation that would force manufacturers to offer 340B prices to contract pharmacies of CEs— thereby exacerbating the well-known, longstanding problem of CEs pocketing large differentials between 340B discounts and what they actually charge patients and providers. This pernicious fiscal effect seeps not just into state-level Medicaid systems, but also health insurance plans for state and local government employees that are often heavily taxpayer-subsidized.

Vukmir’s warnings last year in comments to Tennessee’s governor provide a vivid illustration of the risks to state taxpayers from 340B expansion. She has repeated similar warnings in 2026 across the country, from Florida and Georgia to Minnesota:

The 340B program has expanded significantly over the years with little transparency or accountability, allowing entities that receive discounted drugs from manufacturers to profit from the price difference—rather than passing those savings on to patients.

Instead of primarily benefiting low-income communities, there has been a proliferation of 340B pharmacies in wealthier neighborhoods, often affiliated with for-profit Pharmacy Benefit Managers (PBMs) and chain drugstores. A 2024 Pioneer Institute Report found 46% of 340B pharmacies supposedly serving the poor are in affluent neighborhoods in Tennessee.

I urge you to carefully scrutinize the potential financial implications of SB 1414 for Tennessee’s state-funded health care programs. Three separate fiscal notes issued on SB 1414 provide contradictory assessments of the bill’s financial implications. It is my humble opinion that many serious questions have not been asked, and a more thorough investigation of this policy’s impact on your state budget must take place. Depending on the fiscal note, SB 1414 could cost the state between $7.4 million and $29.8 million. The latest fiscal note claims the bill’s impact on the state is “not significant” and then proceeds to report the bill will result in increased expenditures to the State Group Insurance Program. These are glaring inconsistencies that must be addressed before moving forward.

Lessons can be learned from other states that have introduced similar 340B legislation. A recent fiscal analysis in Utah found that a 10% increase in drugs purchased through 340B would result in a loss of nearly $2 million in drug rebates—a cost that ultimately falls on taxpayers. 

In North Carolina, state health plan patients covered under 340B contracts are being charged significantly higher prices, with copays based on inflated list prices rather than the discounted acquisition costs. A recent report from North Carolina State Treasurer Dale Folwell found that hospitals in the 340B program were overcharging cancer patients at rates averaging five times the cost of the actual drugs—a burden borne not just by patients but by taxpayers as well. The North Carolina State Health Plan now faces an unfunded health care liability of $32 billion.

Similar concerns have been raised in Minnesota, where a 2023 report from the Minnesota Department of Health revealed that 340B hospitals generated at least $630 million in net revenue—likely only half of the true amount—with the state’s largest 340B hospitals benefiting the most.⁴

Whether at the federal, state, or local level, a fundamental flaw of many benefit programs is persistent: various categorical and other loosely defined coverage provisions allow recipients to obtain their largesse upfront, leaving government oversight entities to police payment systems after the money has left taxpayer-funded coffers. This arrangement, often described as “pay and chase,” is a major contributor to some of the worst improper payment rates at all levels of government.

Major examples of pay and chase are legion in Medicare and Medicaid, leading to results that leave taxpayers with massive bills for improper payments:

• In Fiscal Year 2024, the Government Accountability Office (GAO) identified a total of at least $162 billion of improper payments—a conservative estimate since some entities and programs do not track improper payments.
• Roughly 84% of the improper payments represent overpayments, many of which are losses that taxpayers cannot easily recover without time-consuming and costly audits, benefit reviews, and even civil actions.
• More than half of the improper payments for Fiscal Year 2024 come from Medicare ($54.3 billion) and Medicaid ($51.1 billion).⁵

As GAO has pointed out, “[w]hile program managers should prioritize prepayment controls, postpayment controls, such as recovery audits, are also important. However, the ‘pay and chase model,’ where efforts are made to identify and recover improper payments after they are made, can be difficult and expensive.”⁶

While not strictly “pay and chase,” 340B shares some traits with the wasteful programs that wholly embrace this scheme. The covered entity designation involves a vetting process that can offer some level of protection against improper payments (sometimes, but not always, fraudulent), but the system affords less such protection when day-to-day claims are involved. In 2018⁷ and again in 2020,⁸ GAO noted the problem of duplicate discounts, whereby manufacturers end up providing the same medication at a 340B markdown price as well as a Medicaid rebate. The proliferation of contract pharmacies participating in 340B, which increased 20-fold over the space of nine years (2010–2019) due to relaxed restrictions in the Patient Protection and Affordable Care, created numerous points of entry where duplicate discounts could occur. Worse, as GAO and others⁹ have pointed out, federal oversight has been especially deficient, with GAO noting in 2018 that “HRSA had not issued guidance as to how covered entities should prevent duplicate discounts in Medicaid managed care and thus, did not include reviews of covered entities’ processes to prevent duplicate discounts for drugs dispensed through Medicaid managed care in its audits of the entities.”

A subsequent 2023 GAO investigation¹⁰ into a COVID-era program granting fast-track exceptions to Disproportionate Share Hospital eligibility requirements for hospitals to more quickly and fully participate as 340B covered entities indicated some progress—from HRSA, the hospitals themselves, and state officials in attempting to identify duplicate discounts. As of mid-2022, GAO reported, HRSA had audited just under half of the excepted hospitals (25 out of 53 total) in this exception carve-out program, noting that:

[T]he agency issued a total of 19 findings related to noncompliance for 14 of these hospitals as a result of these audits. Five of the hospitals had more than one finding of noncompliance. The most common finding among the excepted hospitals that were audited related to the potential for duplicate discounts . . .

Our review of HRSA documentation found that the 14 hospitals for which HRSA had audit findings all submitted corrective action plans to address these findings, as required by HRSA. However, as we previously reported, HRSA does not require all covered entities (including all hospitals) to provide evidence of successful implementation of the corrective actions prior to GAO-23-106095 340B Drug Discount Program closing audits and instead relies on the entities to self-attest that the audit findings have been addressed. Of the 25 hospitals that were audited, HRSA also issued a total of 39 areas for improvement for 22 of the hospitals. Areas for improvement are based on a covered entity’s failure to follow best practices that may reflect applicable guidance, but not statutory requirements and do not require corrective action plans.

On its own, HRSA-2026-03042 cannot rectify all of these oversight shortcomings. More codification from Congress and HRSA of how and when audits should be conducted, and the obligations of covered entities to implement remedies, is vital to taxpayers. Statutory and regulatory responses are also needed to get a handle on the involvement of contract pharmacies in this process.

Yet, a rebate model pilot program can have a salutary impact on both imperatives, by offering the opportunity to determine whether a system that provides timely rebates will allow for better cost control. With so many contract pharmacies and covered entities operating in a regulatory environment that leaves HRSA at an oversight disadvantage amid continuing program growth, it is wise for HRSA to test methods of discount processing that will provide more near-term, near real-time data on program integrity that 340B does not currently foster.

Operational and Logistical Aspects of a Rebate Model Pilot Program Can Be Drawn from Successes and Failures Elsewhere in Government

Although NTU does not profess wide expertise in the intricacies of 340B discounts and their associated transactions, we have witnessed programmatic approaches to administration of government programs that range from the promising to the problematic. We humbly offer the following suggestions for measuring paperwork burdens consistently and accurately.

The medical world is no stranger to electronic transaction processing and recordkeeping, and the same can be said for the tax world in which NTU often deeply participates as a policy advocate. As part of our mission, we have devoted a great deal of effort toward exploring the compliance burdens of various government regulations, chiefly those resulting from tax laws. Since 1999, NTU’s research arm (NTUF) has published an annual report on the time, material, and other costs to the public and private sectors associated with administration of the complex tax system.¹¹ However, we have also provided analysis and commentary on regulatory burdens in other areas, including rulemakings issued by the Federal Trade Commission, the Department of Energy, the Surface Transportation Board, and the Federal Housing Finance Agency, to name a few.¹²

In our experience, these rulemakings, guidance documents, and pilot programs have diverse intentions and mechanics, but can reflect common drawbacks:

• Whether they are initially the product of robust stakeholder input or not, they tend to lack ongoing input to help improve their effectiveness over time.
• Paperwork burden and information collection estimates concentrate on the design of products such as forms or payment platforms, without also devoting attention to recordkeeping requirements, training, and legitimate private sector concerns over exposure to new enforcement actions.
• Implementation periods and learning curves vary from sector to sector and often among regulated businesses and individuals that appear to be similarly situated to regulators but actually are quite different.

HRSA can at least minimize these problems by adapting solutions that have proven useful to other agencies, or at least instructive to agencies whose processes are evolving. This is especially true for tools employed in the tax realm, where regulations, notices, guidance, and other pronouncements rival or exceed those confronted by stakeholders in the health care industry. While CMS and HRSA already have several advisory panels (e.g., the Pharmaceutical and Therapeutics Committee) and other consultation processes at their disposal closely resembling several of the following suggested remedies, we nonetheless believe these are useful starting points:

• Adequate implementation periods, which can be further adjusted as feedback informs the pace of change, should be provided. While seemingly simplistic, the element of time not only affords the private sector adequate planning to institute new systems, but it also allows the public sector to discover and address the “unknowns” while the process is underway rather than attempt to “de-bug” a process that has been hastily completed.
• Successful projects proposing major changes can still start from a common and familiar knowledge base. In the case of HRSA-2026-03042, that knowledge base already exists to some degree for actors in the 340B universe. If CMS is to learn the most from a rebate model pilot program, it must ensure that the most widely understood procedures those actors now use are initially promulgated.
• Mechanisms are available to provide more regular feedback from stakeholders. One technique that NTU would recommend for HRSA’s study is the Internal Revenue Service’s “Job Aid” concept. While they can vary in their composition and operation, Job Aids are generally initiated by the IRS for either members of its own staff or the practitioner community as “how-to” guides for ensuring best practices in carrying out the intent of tax regulations. In HRSA’s case, well-designed pilots for 340B rebates might be net labor-savers when all the value of time spent by providers, covered entities, manufacturers, and regulators themselves is taken into account. The key here is to realistically appraise that value based on the specialties involved. For example, those who would most often come into contact with the pilots’ operations on a daily basis may require a sophisticated knowledge of complex 340B law that exceeds the normal requirements that a health insurance claims clerk might face. HRSA needs an accurate view into how these professions are compensated to determine labor costs or savings to the whole private sector of the pilots.

A Rebate Model Pilot Program Can and Should Be Able to Inform 340B Modernization Efforts Currently Underway in the Legislative Branch

In the current and previous congresses, lawmakers have introduced legislation that would make major changes to the 340B program. For example, HR 4581 (119^th Congress), sponsored by Rep. Matsui (D-HI) (and a Senate companion sponsored by Senator Welch, (D-VT)) “requires drug manufacturers to offer drug discount pricing pursuant to an agreement [under 340B rules] with respect to drugs purchased by a covered entity regardless of the manner or location in which the drug is dispensed,” effectively codifying that contract pharmacies are to be treated like any other intermediary in the 340B program.¹³ HR 8574 (118^th Congress), sponsored by Rep. Buchson (R-IN), would make a number of changes to 340B, including clearer definitions of what constitutes a 340B patient, guardrails on how contract pharmacies may participate, more robust and transparent data collection on how 340B operates, improvements to qualifications for 340B hospitals, and more complete program integrity authority.¹⁴

A rebate model pilot program could provide useful data that will give a better view into some of the more persistent issues surrounding 340B that this legislation intends to address—especially HR 8574, but even HR 4581 as well. These include:

• Whether contract pharmacies are more or less susceptible to erroneous or duplicative claims;
• Whether the rebate models are sufficiently responsive to provide payments within or near replenishment windows;
• Whether the rebate concept adversely affects the operations of DSH facilities or places particular burdens on rural establishments;
• Whether manufacturer-funded rebate platforms add to or subtract from administrative overhead costs compared to current procedure, for either manufacturers or covered entities;
• Whether the 340B program’s original purpose of providing discounted medications to those in need is more efficiently and effectively served under a rebate-driven model, given the finite resources available in the public and private sectors;
• And, most importantly from NTU’s perspective, whether taxpayers experience a calculable net gain (or at least fewer losses) from a pilot program compared to the status quo.

At this point, NTU wishes to make clear its longstanding position on 340B reforms. In 2020, NTU responded to a request from the Senate Health, Education, Labor, and Pensions (HELP) Committee on 340B reforms with the following summary of recommendations to support:

• A temporary moratorium on new 340B enrollees while Congress, GAO, and the HHS IG conduct oversight of program deficiencies;
• Changes to the 340B statute that clarify the definition of a “340B patient;”
• A re-evaluation of whether DSH hospitals should participate in 340B based on DSH status alone;
• Enhancements to HRSA’s regulatory, enforcement, and data collection capabilities so that the agency can better monitor hospital eligibility, duplicate discounts, and more;
• Targeted additional resources to HRSA to enable it to fully oversee the 340B program, monitor compliance, and enforce sanctions on entities that break the rules;
• Additional reporting from 340B entities to HHS, to clarify who benefits from the program, at what level, and how those trends change over time; and
• A careful study of how large, national contract pharmacies may or may not benefit from the 340B program.¹⁵

Nearly six years since NTU weighed in with its 340B recommendations, much additional work remains. Yet, another years-long investigation launched under the auspices of HELP provided a decidedly mixed picture of 340B oversight, noting that, while some hospital systems utilized the discounts as intended, others diverted 340B funds into capital and other projects. Furthermore, contract pharmacies have, in some cases, increasingly resorted to a plethora of fees to charge covered entities for their services, cumbersome inventory and replenishment models increase the chances of non-340B drugs intermixing with 340B-eligible medications, while other porous rules can allow covered entities and third-party administrators to “harvest claims.”¹⁶

While the details surrounding 340B program costs can vary due to insufficient data collection, the bottom line to taxpayers is clear—higher federal budget deficits, and, in some cases, higher state budget shortfalls. As Dan Crippen, former Director of the Congressional Budget Office (CBO) put it in a 2024 report:

Even at current levels, the 340B Program results in a large transfer of taxable income to non-profit entities. As a result, last year alone, federal and state tax revenues were reduced by as much as $17B [billion]. Other spillover effects of the discounts reduce revenue even more. The subsidies to covered entities also contribute to an increase in government spending on other health programs, including Medicare Part D . . .

Unlike many other off-budget programs, the indirect impacts of the 340B Program on the federal budget and the deficit have not been documented. The effects of the 340B Program, however, are nonetheless contributing to the federal deficit. Any legislation that has an impact on the budget, now or in the future, is implicitly included in current budget baselines, including CBO’s baseline. Accordingly, any legislated reduction in 340B subsidies would result in a decrease in the federal deficit. Any increase in the subsidies would increase the federal deficit.¹⁷

A rebate model pilot program cannot serve as a replacement or surrogate for larger policy agendas surrounding 340B; however, it can and should serve to provide vital empirical evidence that can better inform regulatory and legislative paths forward on the future of 340B for all stakeholders.

America’s Flourishing Pharmaceutical Environment Has Been Polluted with Toxic Policy, and a Rebate Model Pilot Program Must Serve as One of Many Necessary Clean-up Efforts

Policymakers need to recognize that the U.S. already benefits from a strong pharmaceutical ecosystem. Nearly 90% of all blockbuster drugs are available to patients, and more than 90% of prescriptions are filled via generics, both of which serve taxpayers well. This balance of access and affordability means that government health care programs benefit over the long term from drug breakthroughs that reduce costly hospital stays and other treatments, and benefit over the nearer term from the price competition that generics provide.

Unfortunately for U.S. patients, federal policy in recent years has singled out drug manufacturers with price controls while leaving other actors such as pharmacy benefit managers, insurers, and hospitals out of comprehensive, balanced policy solutions. Setting drug prices below the cost of research and development doesn’t lead to increased efficiency, it simply discourages private investment in pharmaceutical innovation.

It is no coincidence that pharmaceutical firms have already discontinued 26 drugs and 56 research programs¹⁸ since the enactment of the Inflation Reduction Act’s drug price negotiation program, which effectively functions as a government-mandated price control. And, because some drugs falling under coercive negotiation have generic equivalents under development but not yet marketed, there can be a strong deterrent effect on private investment in generics as well.

Moreover, Most-Favored-Nation (MFN) drug pricing initiatives will similarly result in shortages that harm patients and taxpayers alike. By tying Medicare and Medicaid’s drug reimbursement to prices set in European health systems that rely heavily on government mandates instead of market competition, MFN effectively imports foreign price controls that result in delayed patient access to new therapies. This would only further exacerbate the burden federal health programs impose on taxpayers by increasing reliance on expensive hospital stays and other treatments that could be avoided with access to effective drugs.

These price controls risk jeopardizing the delicate balance of access and affordability for drugs that exists in the U.S., a balance not found anywhere else in the world. The current state of 340B adds insult to injury. Initially created as a backstop for safety-net hospitals, 340B has morphed into a subsidy for tax-exempt health care providers that comes at the expense of drug developers and ultimately patients who depend on those treatments.

A coalition of organizations and individuals (including senior advisors to the Trump Administration) have developed a policy blueprint known as “Most Favored Patient” that harnesses free-market ideas on behalf of a health care system that is “affordable, innovative, and puts patients first.” One plank of Most Favored Patient is to “require insurer-PBMs and hospitals to pass all drug rebates and discounts directly to patients, families, and those most in need”¹⁹— a goal that can align with the precepts of HRSA-2026-03042.

Hospitals that currently benefit from the 340B program are certain to object to HRSA-2026-03042, just as they did to this RFI’s previous iteration. Nonetheless, we would urge HRSA to bear in mind the overall federal policy context in which the RFI is being issued. As one of the authors of these comments has noted:

[R]ising prices for hospital services aren’t the result of a functioning free market, but rather of perverse incentives created by the government that reward hospitals for their size instead of the value they provide patients . . . As a result of distortive policies that encourage hospitals to merge and consolidate, nearly half of all metropolitan areas across the country had just one or two hospital systems controlling the market for inpatient care in 2022.

It’s not just the federal government reducing competition in hospital markets. State-level certificate of need laws require health care providers to obtain government approval before expanding facilities or offering new services. While these laws aim to reduce waste, in effect they let local bureaucrats shield established hospitals from new competition. A study found that overall health care costs were approximately 11% higher in states with certificate of need laws versus those without them.

NTU’s point here is that there are many government-driven factors that impact the fiscal state of hospitals, and HRSA should not be deterred from experiments that address just one area of 340B hospitals’ operations. HRSA should take every opportunity to make incremental gains to the body of policy knowledge that will be necessary to approach larger 340B reforms from an informed and thoughtful perspective.

Thank you for your consideration of these comments, and, should you have any questions on this or any other fiscal or regulatory matter before HRSA, we are at your service.

Sincerely and respectfully,

Pete Sepp, President
National Taxpayers Union

Alexander Ciccone, Policy and Government Affairs Manager
National Taxpayers Union

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¹  See the Congressional Budget Office report at: The Long-Term Budget Outlook Data: 2026 to 2056 | Congressional Budget Office.

²  See early projections of OBBBA’s effects on Medicaid spending from the Economic Policy Innovation Center at OBBB Myth vs. Fact: Medicaid “Cuts” Are Just Washington Math - EPIC for America.

³  For further explanation and analysis, see the CMS announcement at: Hospital Outpatient Prospective Payment System (OPPS): Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Final Rule (CMS 1793-F) | CMS

⁴  The full text of Vukmir’s comments to the governor are available at: 340B Expansion in Tennessee Will Exacerbate Drug Prices and Lead to Legal Challenges - Publications - National Taxpayers Union

⁵  See the GAO improper payments report at: 876591.pdf.

⁶  See GAO’s recommendations for strategies to control improper payments at: https://www.gao.gov/assets/gao-23-105876.pdf.

⁷  See the GAO report at: gao-18-480.pdf.

⁸  See the GAO report at: gao-20-212.pdf

⁹  GAO’s 2020 report helpfully provides the following background material that could inform HRSA’s pilot design: Department of Health and Human Services, Office of Inspector General, State Efforts To Exclude 340B Drugs From Medicaid Managed Care Rebates, Report Number OEI-05-14-00430 (Washington, D.C.: June 2016); National Association of Medicaid Directors, NAMD Working Paper Series, Medicaid and the 340B Program: Alignment and Modernization Opportunities, (Washington, D.C.: May 13, 2015); and Medicaid and CHIP Payment and Access Commission, Issue Brief, The 340B Drug Pricing Program and Medicaid Drug Rebate Program: How They Interact, (Washington, D.C.: May 2018).

¹⁰  See the GAO report at: gao-23-106095.pdf.

¹¹  See, for example, The Hidden Cost of the Tax Code: 6.93 Billion Hours and More Than $477 Billion in Total Compliance Burdens - Foundation - National Taxpayers Union.

¹²  See, for example, https://www.ntu.org/publications/detail/ntu-comments-on-irs-proposed-rule-for-supervisory-approval-of-penalties; https://www.ntu.org/publications/detail/ntu-offers-comments-to-the-surface-transportation-board-on-reciprocal-switching; and https://www.ntu.org/publications/detail/ntu-comments-to-the-ftc-on-the-contact-lens-rule.

¹³  See the text of the legislation at: Text - H.R.4581 - 119th Congress (2025-2026): 340B PATIENTS Act of 2025 | Congress.gov | Library of Congress

¹⁴  See the text of the legislation at: Text - H.R.8574 - 118th Congress (2023-2024): 340B ACCESS Act | Congress.gov | Library of Congress

¹⁵  For further details on NTU’s recommendations, see our memo to the Committee at: 340B Program Must Be Reformed to Achieve Its Intended Purpose - Publications - National Taxpayers Union.

¹⁶  For a full copy of the Senate report, see: final_340b_majority_staff_reportpdf.pdf.

¹⁷  See Director Crippen’s memo on this topic at: AIR340B-CBO-Memo.pdf.

¹⁸  https://lifesciencetracker.com/

¹⁹  See the Most Favored Patient blueprint at: Most Favored Patient.