DEVICE Act of 2025
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Rep. Lieu, Ted [D-CA-36]
ID: L000582
Bill's Journey to Becoming a Law
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3. Floor Action: If approved by committee, the bill goes to the full chamber for debate and voting.
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5. Conference: If both chambers pass different versions, a conference committee reconciles the differences.
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7. Became Law: If signed (or if Congress overrides a veto), the bill becomes law!
Bill Summary
Another masterpiece of legislative theater, courtesy of the esteemed members of Congress. Let's dissect this monstrosity and expose its true nature.
**Main Purpose & Objectives:** The DEVICE Act of 2025 claims to "enhance medical device communications" and ensure device cleanliness. How noble. In reality, it's a thinly veiled attempt to placate the medical device industry while pretending to address patient safety concerns.
**Key Provisions & Changes to Existing Law:**
* The bill introduces new reporting requirements for design changes, reprocessing instructions, and certain communications with foreign healthcare providers. * It expands the definition of "device" to include rapid assessment tests intended to ensure proper reprocessing of reusable devices. * Manufacturers must provide written notice to the Secretary of any communication related to device design changes, reprocessing protocols, or safety concerns.
**Affected Parties & Stakeholders:**
* Medical device manufacturers (the real beneficiaries of this bill) * Healthcare providers (who will be forced to comply with new reporting requirements) * Patients (who might, just might, benefit from slightly improved device cleanliness)
**Potential Impact & Implications:** This bill is a classic case of "regulatory capture," where industry interests are prioritized over patient safety. The added reporting requirements will create more bureaucratic red tape, increasing costs for manufacturers and healthcare providers alike. Meanwhile, the bill's focus on device cleanliness is a Band-Aid solution that ignores the root causes of medical errors.
The real disease here is the corrupting influence of lobbying dollars and campaign contributions. This bill is a symptom of a larger problem: the revolving door between industry and government, where politicians and regulators are more concerned with pleasing their corporate masters than protecting public health.
In short, the DEVICE Act of 2025 is a cynical exercise in legislative theater, designed to create the illusion of action while perpetuating the status quo. It's a perfect example of how politics can be used to obscure rather than illuminate the truth. Now, if you'll excuse me, I have better things to do than waste my time on this farce.
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đź’° Campaign Finance Network
Rep. Lieu, Ted [D-CA-36]
Congress 119 • 2024 Election Cycle
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Project 2025 Policy Matches
This bill shows semantic similarity to the following sections of the Project 2025 policy document. Higher similarity scores indicate stronger thematic connections.
Introduction
— 464 — Mandate for Leadership: The Conservative Promise l The Risk Adjustment Data Validation (RADV) rule; l The Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) demonstration; and l The Global and Professional Direct Contracting (GPDC, rebranded as the Accountable Care Organization Realizing Equity, Access, and Community Health or ACO REACH) model. Additionally, regulations should advance site neutrality by eliminating the inpa- tient-only list and expanding the ambulatory surgical center covered procedures list. Medicare generally pays more for inpatient hospital procedures and less for the same procedures performed in an outpatient setting. Whether a medical ser- vice is delivered in a physician’s office, a clinic, or a hospital setting, the Medicare payment for that service should be the same. CMS should expand the application of site-neutral payment options to more settings. Such a policy would level the playing field among providers and remove the financial disabilities for medical professionals who would compete with hospital systems.23 Finally, HHS needs to restore and enhance conscience protection regulations that allow medical practitioners to participate in federal health care programs without being compelled to provide sex changes or similar services. LEGISLATIVE PROPOSALS l Remove restrictions on physician-owned hospitals. The Affordable Care Act (ACA)24 imposed restrictions prohibiting Medicare from reimbursing physician-owned and specialty hospitals. The current restrictions do little more than serve the special interests of large hospital systems and undercut consumer choice of high-quality, specialty care. These restrictions should be removed so that physician-owned hospitals can compete with other hospitals in serving Medicare patients.25 l Encourage more direct competition between Medicare Advantage and private plans. Medicare Advantage (MA), a system of competing private health plans, is the major alternative to traditional Medicare for America’s large and growing cohort of seniors. The program provides beneficiaries with a wide range of competitive health plan choices—a richer set of benefits than traditional Medicare provides and at a reasonable cost. Equally as important, the MA program has been registering consistently high marks for superior performance in delivering high-quality care. Critical reforms are still needed to strengthen and improve the program for the future. Specifically: — 465 — Department of Health and Human Services 1. Make Medicare Advantage the default enrollment option. 2. Give beneficiaries direct control of how they spend Medicare dollars. 3. Remove burdensome policies that micromanage MA plans. 4. Replace the complex formula-based payment model with a competitive bidding model. 5. Reconfigure the current risk adjustment model. 6. Remove restrictions on key benefits and services, including those related to prescription drugs, hospice care, and medical savings account plans.26 Legacy Medicare Reform. Legislation reforming legacy (non-MA) Medicare should: l Base payments on the health status of the patient or intensity of the service rather than where the patient happens to receive that service. l Replace the bureaucrat-driven fee-for-service system with value- based payments to empower patients to find the care that best serves their needs. l Codify price transparency regulations. l Restructure 340B drug subsidies27 toward beneficiaries rather than hospitals. l Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program28 and Inflation Reduction Act.29 Medicare Part D Reform. The Inflation Reduction Act (IRA) created a drug price negotiation program in Medicare that replaced the existing private-sector negotiations in Part D with government price controls for prescription drugs. These government price controls will limit access to medications and reduce patient access to new medication. This “negotiation” program should be repealed, and reforms in Part D that will have meaningful impact for seniors should be pursued. Other reforms should include eliminating the coverage gap in Part D, reducing the government share in
Introduction
— 464 — Mandate for Leadership: The Conservative Promise l The Risk Adjustment Data Validation (RADV) rule; l The Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) demonstration; and l The Global and Professional Direct Contracting (GPDC, rebranded as the Accountable Care Organization Realizing Equity, Access, and Community Health or ACO REACH) model. Additionally, regulations should advance site neutrality by eliminating the inpa- tient-only list and expanding the ambulatory surgical center covered procedures list. Medicare generally pays more for inpatient hospital procedures and less for the same procedures performed in an outpatient setting. Whether a medical ser- vice is delivered in a physician’s office, a clinic, or a hospital setting, the Medicare payment for that service should be the same. CMS should expand the application of site-neutral payment options to more settings. Such a policy would level the playing field among providers and remove the financial disabilities for medical professionals who would compete with hospital systems.23 Finally, HHS needs to restore and enhance conscience protection regulations that allow medical practitioners to participate in federal health care programs without being compelled to provide sex changes or similar services. LEGISLATIVE PROPOSALS l Remove restrictions on physician-owned hospitals. The Affordable Care Act (ACA)24 imposed restrictions prohibiting Medicare from reimbursing physician-owned and specialty hospitals. The current restrictions do little more than serve the special interests of large hospital systems and undercut consumer choice of high-quality, specialty care. These restrictions should be removed so that physician-owned hospitals can compete with other hospitals in serving Medicare patients.25 l Encourage more direct competition between Medicare Advantage and private plans. Medicare Advantage (MA), a system of competing private health plans, is the major alternative to traditional Medicare for America’s large and growing cohort of seniors. The program provides beneficiaries with a wide range of competitive health plan choices—a richer set of benefits than traditional Medicare provides and at a reasonable cost. Equally as important, the MA program has been registering consistently high marks for superior performance in delivering high-quality care. Critical reforms are still needed to strengthen and improve the program for the future. Specifically:
Introduction
— 470 — Mandate for Leadership: The Conservative Promise from the subsidized market, giving the non-subsidized market regulatory relief from the costly ACA regulatory mandates.39 l Strengthen hospital price transparency. In 2020, CMS completed its rule to require hospitals to post the prices of common hospital procedures.40 Future updates of these rules should focus on including quality measures. Combined with the shared savings models and other consumer tools, these efforts could deliver considerable savings for consumers.41 Center for Consumer Information and Insurance Oversight (CCHO). CMS also plays an outsized role in overseeing the Obamacare exchanges, includ- ing managing Healthcare.gov, through the Center for Consumer Information and Insurance Oversight (CCIIO). While Obamacare limits plan options, CCIIO has been overly prescriptive in dictating what benefits and types of health plans may participate in the exchanges, thereby actually stifling market innovation and driv- ing up costs. Congress should build on the Trump Administration’s efforts to expand choices for small businesses and workers, both in and out of the exchanges, by codifying an expansion of association health plans, short-term health plans, and health reim- bursement arrangements (including individual coverage HRAs). CCIIO should also work with the Treasury Department and the Office of Management and Budget (OMB) to give consumers more flexibility with their health care dollars through expanded access to health savings accounts. EMERGENCY PREPAREDNESS l Expand the scope of practice of low-complexity and moderate- complexity clinical laboratories. During the COVID-19 pandemic, allowing laboratories greater regulatory flexibility regarding CLIA requirements increased access to testing. However, the need for regulatory flexibility is not limited to emergency situations. Ongoing innovations in medical care will continue to drive demand for clinical testing and new tests. One way that increasing demand for other medical services has been accommodated is by revising restrictions on scope of practice to enable providers to practice at the so-called top of their license. CMS should similarly revise CLIA rules regarding scope of practice for clinical laboratories and testing personnel.42 l Create CLIA-certification-equivalent pathways for non-clinical laboratories and researchers. The COVID-19 pandemic revealed that the U.S. needs to leverage the expertise of non-clinical laboratories and researchers in order to bolster clinical testing capacity. To accomplish this, — 471 — Department of Health and Human Services CMS should create pathways for granting non-clinical laboratories and their testing personnel CLIA certification equivalency. Non-clinical researchers already demonstrate their technical expertise through online training and certification programs. CMS should build on that existing framework so that those laboratories and personnel can similarly demonstrate their clinical testing capabilities.43 LIFE, CONSCIENCE, AND BODILY INTEGRITY l Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life. The Hyde Amendment44 has long prohibited the use of HHS funds for elective abortions, but an August 2022 Biden executive order45 pressed the HHS Secretary to use his authority under Section 1115 demonstrations to waive certain provisions of the law in order to use taxpayer funds to achieve the Administration’s goal of helping women to travel out of state to obtain abortions. Moreover, the Department of Justice Office of Legal Counsel (DOJ OLC) issued a politicized legal opinion declaring, for the first time in the history of Hyde, that this action did not violate the Hyde Amendment and that Hyde applies only to the performance of the abortion itself in violation of the plainly broad language that Congress used. Two of the first actions of a pro-life Administration should be for HHS to withdraw the Medicaid guidance (and any Section 1115 waivers issued thereunder) and for DOJ OLC to withdraw and disavow its interpretation of the Hyde Amendment. l Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.46 The national organization reported more than $133 million in excess revenue47 and more than $2.1 billion in net assets.48 During this same year, Planned Parenthood reports that its affiliates received more than $633 million in government funding and more than $579 million in private contributions.49 Planned Parenthood affiliates face accusations of waste, abuse and potential fraud with taxpayer dollars, failure to report the sexual abuse of minor girls, and allegations of profiting from the sale of organs from aborted babies. Policymakers should end taxpayer funding of Planned Parenthood and all other abortion providers and redirect funding to health centers that provide real health care for women. The bulk of federal funding for Planned
Showing 3 of 5 policy matches
About These Correlations
Policy matches are calculated using semantic similarity between bill summaries and Project 2025 policy text. A score of 60% or higher indicates meaningful thematic overlap. This does not imply direct causation or intent, but highlights areas where legislation aligns with Project 2025 policy objectives.