Medical Innovation Acceleration Act of 2025

— 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,

— 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

— 452 — Mandate for Leadership: The Conservative Promise Unaccountable bureaucrats like Anthony Fauci should never again have such broad, unchecked power to issue health “guidelines” that will certainly be the basis for federal and state mandates. Never again should public health bureaucrats be allowed to hide information, ignore information, or mislead the public concerning the efficacy or dangers associated with any recommended health interventions because they believe it may lead to hesitancy on the part of the public. The only way to restore public trust in HHS as an institution capable of acting responsibly during a health emergency is through the best of disinfectants—light. Goal #5: Instituting Greater Transparency, Accountability, and Over- sight. The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomer- ates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest. All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from pri- vate biopharmaceutical funding. In this realm, “public–private partnerships” is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight. We must shut and lock the revolving door between government and Big Pharma. Regulators should have a long “cooling off period” on their contracts (15 years would not be too long) that prevents them from working for companies they have regulated. Similarly, pharmaceutical company executives should be restricted from moving from industry into positions within regulatory agencies. Finally, HHS should adopt metrics across the agency that can objectively deter- mine the extent to which the agency’s policies and programs achieve desired health and welfare outcomes (not agency outputs). What is not measured is not achieved. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) COVID and Structural Reform. COVID-19 exposed the Centers for Disease Control and Prevention (CDC) as perhaps the most incompetent and arrogant agency in the federal government. CDC continually misjudged COVID-19, from its lethality, transmissibility, and origins to treatments. We were told masks were not needed; then they were made mandatory. CDC botched the development of COVID tests when they were needed most. When it was too late, we were told to put our lives on hold for “two weeks to flatten the curve;” that turned into two years of interference and restrictions on the smallest details of our lives. Congress should ensure that CDC’s legal authorities are clearly defined and limited to prevent a recurrence of any such arbitrary and vacillating exercise of power. The CDC should be split into two separate entities housing its two distinct func- tions. On the one hand, the CDC is now responsible for collecting, synthesizing, — 453 — Department of Health and Human Services and publishing epidemiological data from the individual states—a scientific data-gathering function. This information is crucial for medical and public health researchers around the country. On the other hand, the CDC is also responsible for making public health recommendations and policies—an inescapably political function. At times, these two functions are in tension or clear conflict. In February 2022, for example, it was reported that “[t]wo full years into the pandemic, the agency leading the country’s response to the public health emergency has pub- lished only a tiny fraction of the data it has collected,” much of which “could [have helped] state and local health officials better target their efforts to bring the virus under control.” A CDC spokesman said that one of the reasons was “fear that the information might be misinterpreted.”4 These distinct functions should be separated into two entirely separate agen- cies with a firewall between them. We need a national epidemiological agency responsible only for publishing data and required by law to publish all of the data gathered from states and other sources. A separate agency should be responsible for public health with a severely confined ability to make policy recommendations. The CDC can and should make assessments as to the health costs and benefits of health interventions, but it has limited to no capacity to measure the social costs or benefits they may entail. For example, how much risk mitigation is worth the price of shutting down churches on the holiest day of the Christian calendar and far beyond as happened in 2020? What is the proper balance of lives saved versus souls saved? The CDC has no business making such inherently political (and often unconstitutional) assessments and should be required by law to stay in its lane. The CDC’s initial COVID-19 testing failures were largely the result of that agen- cy’s prioritizing its own development and production of tests using its internal staff and facilities. The private sector is much better positioned to tackle the chal- lenges inherent in developing and manufacturing novel products, as illustrated by the relative success of the alternative approach to facilitating the development of COVID-19 vaccines and therapeutics by private companies that was adopted by the Food and Drug Administration (FDA). When it comes to testing, the CDC’s role should similarly be to facilitate rather than supplant the efforts of private test developers, academic laboratories, state public health laboratories, and clinical testing providers. When responding to a novel pathogen, the CDC should focus on gathering and disseminating information, including specimens needed for development of positive controls and reference panels, and ensuring that test developers can develop and validate diagnostic tests. These changes will require a shift in priorities and culture at the CDC—and throughout HHS more broadly.5 Most problematically, the CDC presented itself as a kind of “super-doctor” for the entire nation. The CDC is a public health institution, not a medical institution. According to its mission statement, the agency focuses on “disease prevention and