Family Vaccine Protection Act

— 501 — Department of Health and Human Services 54. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, Office of Civil Rights, and Office of the Secretary, “Special Responsibilities of Medicare Hospitals in Emergency Cases and Discrimination on the Basis of Disability in Critical Health and Human Service Programs or Activities,” draft of Proposed Rule, January 14, 2021, https://www.hhs.gov/sites/default/files/infants-nprm.pdf (accessed March 17, 2023). 55. H.R. 26, Born-Alive Abortion Survivors Protection Act, 118th Congress, introduced January 9, 2023, https:// www.congress.gov/118/bills/hr26/BILLS-118hr26pcs.pdf (accessed March 17, 2023). 56. H.R. 7, No Taxpayer Funding for Abortion and Abortion Insurance Full Disclosure Act of 2023, 118th Congress, introduced January 9, 2023, https://www.congress.gov/118/bills/hr7/BILLS-118hr7ih.pdf (accessed March 17, 2023). 57. S. 401, Conscience Protection Act of 2021, 117th Congress, introduced February 24, 2021, https://www.congress. gov/117/bills/s401/BILLS-117s401is.pdf (accessed March 17, 2023). 58. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, and Office of the Secretary, “Nondiscrimination in Health Programs and Activities,” Notice of Proposed Rulemaking; Notice of Tribal Consultation, Federal Register, Vol. 87, No. 149 (August 4, 2022), pp. 47824–47920, https://www.govinfo. gov/content/pkg/FR-2022-08-04/pdf/2022-16217.pdf (accessed March 17, 2023). 59. Ibid., p. 47916. 60. The regulation was not finalized before the end of the Administration. U.S. Department of Agriculture, Food and Nutrition Services, “Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP),” Proposed Rule, Federal Register, Vol. 84, No. 142 (July 24, 2019), pp. 35570–55581, https:// www.federalregister.gov/documents/2019/07/24/2019-15670/revision-of-categorical-eligibility-in-the- supplemental-nutrition-assistance-program-snap (accessed March 17, 2023). 61. 45 Code of Federal Regulations § 75.300(c) and (d), https://www.ecfr.gov/current/title-45/subtitle-A/ subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.300 (accessed March 17, 2023). 62. H.R. 1750, Child Welfare Provider Inclusion Act of 2021, 117th Congress, introduced March 10, 2021, https:// www.congress.gov/117/bills/hr1750/BILLS-117hr1750ih.pdf (accessed March 17, 2023), and S. 656, Child Welfare Provider Inclusion Act of 2021, 117th Congress, introduced March 10, 2021, https://www.congress.gov/117/bills/ s656/BILLS-117s656is.pdf (accessed March 17, 2023). 63. S. 3949, Trafficking Victims Protection Reauthorization Act of 2022, Public Law No. 117-348, 117th Congress, January 25, 2023, https://www.congress.gov/117/plaws/publ348/PLAW-117publ348.pdf (accessed March 17, 2023). 64. Kelsey Y. Santamaria, “Child Migrants at the Border: The Flores Settlement Agreement and Other Legal Developments,” Congressional Research Service In Focus No. IF11799, April 1, 2021, https://crsreports.congress. gov/product/pdf/IF/IF11799 (accessed March 17, 2023). 65. Report, Building a Happy Home: Marriage Education as a Tool to Strengthen Families, Social Capital Project Report No. 1-22, March 2022, p. 17, https://www.jec.senate.gov/public/_cache/files/3d102525-6f0d-48ed- 92f4-d71edd468ad6/building-a-happy-home.pdf (accessed March 17, 2023). The cover of the report reflects that the Social Capital Project is “[a] project of the Joint Economic Committee – Republicans.” 66. See, for example, Alan J. Hawkins, “Are Federally Supported Relationship Education Programs for Lower-Income Individuals and Couples Working? A Review of Evaluation Research,” American Enterprise Institute, September 2019, https://www. congress.gov/117/plaws/publ228/PLAW-117publ228.pdf (accessed March 17, 2023). 67. H.R. 8404, Respect for Marriage Act, Public Law No. 117-228, 117th Congress, December 13, 2022, https://www. congress.gov/117/plaws/publ228/PLAW-117publ228.pdf (accessed March 17, 2023). 68. Madison Marino, “Over 1,000 Safety Violations Mar Head Start. Children Deserve Better,” Heritage Foundation Commentary, November 10, 2022, https://www.heritage.org/education/commentary/over-1000-safety- violations-mar-head-start-children-deserve-better. 69. American Hospital Association v. Becerra, 596 U.S. ___ (2022), https://www.supremecourt.gov/ opinions/21pdf/20-1114_09m1.pdf (accessed March 17, 2023). 70. U.S. Department of the Treasury, Internal Revenue Service; U.S. Department of Labor, Employee Benefits Security Administration; and U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, “Coverage of Certain Preventive Services Under the Affordable Care Act,” Notice of Proposed Rulemaking, Federal Register, Vol. 88, No. 22 (February 2, 2023), pp. 7236–7281, https://www. govinfo.gov/content/pkg/FR-2023-02-02/pdf/2023-01981.pdf (accessed March 17, 2023). — 502 — Mandate for Leadership: The Conservative Promise 71. 42 U.S. Code § 238n, https://www.law.cornell.edu/uscode/text/42/238n (accessed March 17, 2023). 72. U.S. Department of Health and Human Services, Health Resources and Services Administration, “Early Childhood Health,” last reviewed October 2022, https://mchb.hrsa.gov/programs-impact/focus-areas/early- childhood-health (accessed March 17, 2023). 73. American Pregnancy Association, “Having a Doula—What Are the Benefits?” https://americanpregnancy. org/healthy-pregnancy/labor-and-birth/having-a-doula/#:~:text=Other%20studies%20have%20shown%20 that%20having%20a%20doula,massage%20to%20reduce%20stress%20and%20anxiety%20during%20labor (accessed March 17, 2023). 74. S. 2372, VA MISSION [Maintaining Internal Systems and Strengthening Integrated Outside Networks] Act of 2018, Public Law No. 115-182, 115th Congress, June 6, 2018, https://www.congress.gov/115/plaws/publ182/ PLAW-115publ182.pdf (accessed March 17, 2023). 75. U.S. Department of Health and Human Services, “Securing Updated and Necessary Statutory Evaluations Timely,” Final Rule, Federal Register, Vol. 86, No. 11 (January 19, 2021), pp. 5694–5764, https://www.govinfo. gov/content/pkg/FR-2021-01-19/pdf/2021-00597.pdf (accessed March 22, 2023). 76. U.S. Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, “Compliance with Statutory Program Integrity Requirements,” Final Rule, Federal Register, Vol. 84, No. 42 (March 4, 2029), pp. 7714–7791, https://www.govinfo.gov/content/pkg/FR-2019-03-04/pdf/2019-03461.pdf (accessed March 18, 2023). 77. U.S. Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, “Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services,” Final Rule, Federal Register, Vol. 86, No. 192 (October 7, 2021), pp. 56144–56180, https://www.govinfo.gov/content/ pkg/FR-2021-10-07/pdf/2021-21542.pdf (accessed March 18, 2023). 78. S. 624, Title X Abortion Provider Prohibition Act, 118th Congress, introduced March 2, 2023, https://www. congress.gov/118/bills/s624/BILLS-118s624is.pdf (accessed March 18, 2023). 79. 50 U.S. Code Chapter 55, https://www.law.cornell.edu/uscode/text/50/chapter-55 (accessed March 22, 2023). 80. 18 U.S. Code § 13, https://www.law.cornell.edu/uscode/text/18/13 (accessed March 18, 2023). 81. Bowen v. American Hospital Association, 476 U.S. 610 (1986), https://tile.loc.gov/storage-services/service/ll/ usrep/usrep476/usrep476610/usrep476610.pdf (accessed 22, 2023). 82. U.S. Department of Health and Human Services, Office of the Secretary, “Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972,” Federal Register, Vol. 86, No. 99 (May 25, 2021), pp. 27984–27985, https://www.govinfo.gov/content/pkg/FR- 2021-05-25/pdf/2021-10477.pdf (accessed March 18, 2023). 83. U.S. Department of Health and Human Services, Office for Civil Rights, “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy,” March 2, 2022, https://www.hhs.gov/sites/default/files/hhs- ocr-notice-and-guidance-gender-affirming-care.pdf (accessed March 18, 2023). 84. Heckler v. Chaney, 420 U.S. 821 (1985), https://caselaw.findlaw.com/us-supreme-court/470/821.html (accessed March 18, 2022). 85. U.S. Department of Health and Human Services, Office for Civil Rights, “Guidance to Nation’s Retail Pharmacies: Obligations Under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services,” content last reviewed July 14, 2022, https://www.hhs.gov/civil-rights/for-individuals/ special-topics/reproductive-healthcare/pharmacies-guidance/index.html (accessed March 18, 2023). 86. H.R. 3103, “Health Insurance and Portability and Accountability Act of 1996, Public Law No. 104-191, 104th Congress, August 21, 1996, https://www.congress.gov/104/plaws/publ191/PLAW-104publ191.pdf (accessed March 18, 2023). 87. U.S. Department of Human Services, “HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care,” content last reviewed June 29, 2022, (accessed March 18, 2023). See also “Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet,” content last reviewed June 29, 2022, https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/ cell-phone-hipaa/index.html (accessed March 18, 2023).

— 455 — Department of Health and Human Services family formation. It should ensure that it is not promoting abortion as health care. It should fund studies into the risks and complications of abortion and ensure that it corrects and does not promote misinformation regarding the comparative health and psychological benefits of childbirth versus the health and psychological risks of intentionally taking a human life through abortion. The CDC oversaw and funded the development and testing of the COVID-19 vaccines with aborted fetal cell lines, insensitive to the consciences of tens of thousands to hundreds of thousands of people who objected to taking a vac- cine with such a link to abortion. As evidenced by litigation across the country, it is likely that thousands were fired unjustly because of the exercise of their consciences or faith on this question, which could have been avoided with a modicum of concern for this issue from CDC. There is never any justification for ending a child’s life as part of research, and the research benefits from splicing or growing aborted fetal cells and aborted baby body parts can easily be provided by alternative sources. All such research should be prohibited as a matter of law and policy. CDC should update its public messaging about the unsurpassed effectiveness of modern fertility awareness–based methods (FABMs) of family planning and stop publishing communications that conflate such methods with the long-eclipsed “rhythm” or “calendar” methods. CDC should fund studies exploring the evi- dence-based methods used in cutting-edge fertility awareness. Data Collection. The CDC’s abortion surveillance and maternity mortality reporting systems are woefully inadequate. CDC abortion data are reported by states on a voluntary basis, and California, Maryland, and New Hampshire do not submit abortion data at all. Accurate and reliable statistical data about abortion, abortion survivors, and abortion-related maternal deaths are essential to timely, reliable public health and policy analysis. Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion. Moreover, abortion should be clearly defined as only those procedures that intentionally end an unborn child’s life. Miscarriage management or standard ectopic pregnancy treatments should never be conflated with abortion. Comparisons between live births and abortion should be tracked across vari- ous demographic indicators to assess whether certain populations are targeted by — 456 — Mandate for Leadership: The Conservative Promise abortion providers and whether better prenatal physical, mental, and social care improves infant outcomes and decreases abortion rates, especially among those who are most vulnerable. The Ensuring Accurate and Complete Abortion Data Reporting Act of 20239 would amend title XIX of the Social Security Act and Public Health Service Act to improve the CDC’s abortion reporting mechanisms by requiring states, as a condition of federal Medicaid payments for family planning services, to report streamlined variables in a timely manner. The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities. FOOD AND DRUG ADMINISTRATION (FDA) The FDA’s mission includes ensuring the safety and efficacy of drugs, biological products, and medical devices. Federal Laws That Shield Big Pharma from Competition. Because generics generally cost far less than brand-name drugs, consumers begin to save money as soon as a generic product comes on the market. The vast majority are very afford- able with 93 percent of generic products costing $20 or less. Savings would be even higher under proposals that prevent brand-name man- ufacturers from slowing down or impeding the entrance of generic products into the marketplace. Specifically, the FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs. Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.10 Approval Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID-19 testing experience, Congress and the FDA should focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests. Commercial tests are developed with the intention of being widely marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely within one laboratory. A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a “new” laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlab- oratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories with- out the current regulatory burdens.11

— 497 — Department of Health and Human Services l OCR should withdraw its Health Insurance Portability and Accountability Act (HIPAA)86 guidance on abortion. OCR should withdraw its June 2022 guidance87 that purports to address patient privacy concerns following the Dobbs decision but is actually a politicized statement in favor of abortion and against Dobbs. HIPAA covers patients in the womb, but this guidance treats them as nonpersons contrary to law. The guidance is unnecessary and contributes to ideologically motivated fearmongering about abortion after Dobbs. AUTHOR’S NOTE: The preparation of this chapter was a collective enterprise of selfless individuals involved in the 2025 Presidential Transition Project. All contributors to this chapter are listed at the front of this volume and include former officials in the U.S. Department of Health and Human Services and other agencies, as well as academics, attorneys, and experts in the health care and insurance fields. — 498 — Mandate for Leadership: The Conservative Promise ENDNOTES 1. U.S. Department of Health and Human Services, Strategic Plan, FY 2018–2022, p. 50, https://aspe.hhs.gov/ sites/default/files/documents/feac346aca967bfadc446398679e14ec/hhs-strategic-plan-fy-2018-2022.pdf (accessed February 7, 2023). 2. “Strategic Goal 1: Protect and Strengthen Equitable Access to High Quality and Affordable Healthcare” in ibid. “In the context of HHS, this Strategic Plan adopts the definition of underserved communities listed in Executive Order 13985: Advancing Racial Equity and Support for Underserved Communities through the Federal Government to refer to ‘populations sharing a particular characteristic, as well as geographic communities, who have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life’; this definition includes individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality. Individuals may belong to more than one underserved community and face intersecting barriers. This definition applies to the terms underserved communities and underserved populations throughout this Strategic Plan.” Ibid. Emphasis in original. 3. Karen Weintraub, “Americans’ Life Expectancy Continues to Fall, Erasing Health Gains of the Last Quarter Century,” USA Today, December 22, 2022, https://www.usatoday.com/story/news/health/2022/12/22/us-life- expectancy-continues-fall-erasing-25-years-health-gains/10937418002/ (accessed February 6, 2023). 4. Apoorva Mandavilli, “The C.D.C. Isn’t Publishing Large Portions of the Data It Collects,” The New York Times, updated February 22, 2022, https://www.congress.gov/117/meeting/house/114450/documents/HHRG-117- IF02-20220302-SD004.pdf (accessed March 22, 2023). 5. Zachary B. Sluzala and Edmund F. Haislmaier, “Lessons from COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing,” Heritage Foundation Backgrounder No. 3696, March 28, 2022, https://www. heritage.org/public-health/report/lessons-covid-19-how-policymakers-should-reform-the-regulation-clinical. 6. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Centers for Disease Control and Prevention (C),” https://www.cdc.gov/maso/pdf/cdcmiss.pdf (March 16, 2023). 7. Judith Garber, “CDC ‘Disclaimers’ Hide Financial Conflicts of Interest,” Lown Institute Accountability Blog, November 6, 2019, https://lowninstitute.org/cdc-disclaimers-hide-financial-conflicts-of-interest/ (accessed February 6, 2023). See also U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “CDC Foundation Active Programs (October 1, 2014–September 30, 2015),” https://www. cdcfoundation.org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2015.pdf (accessed February 7, 2023); “CDC Active Programs (October 1, 2015–September 30, 2016),” https://www.cdcfoundation. org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2016.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2016–September 30, 2017),” https://www.cdcfoundation.org/ sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2017.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2017–September 30, 2018),” https://www.cdcfoundation.org/sites/default/ files/upload/pdf/CDCFoundation-ActivePrograms-FY2018.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2018–September 30, 2019,” https://www.cdcfoundation.org/sites/default/files/upload/ pdf/CDCFoundation-ActivePrograms-FY2019.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2029–September 30, 2020,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY20?inline (accessed February 7, 2023); and “CDC Foundation Active Programs, October 1, 2020–September 30, 2021,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY21?inline (accessed February 7, 2023). 8. Joel White and Doug Badger, “In Order to Defeat COVID-19, the Federal Government Must Modernize Its Public Health Data,” Heritage Foundation Backgrounder No. 3527, September 3, 2020, https://www.heritage. org/sites/default/files/2020-09/BG3527_0.pdf. 9. S. 15, Ensuring Accurate and Complete Abortion Data Reporting Act of 2023, 118th Congress, introduced January 23, 2023, https://www.congress.gov/118/bills/s15/BILLS-118s15is.pdf (accessed March 22, 2023), and H.R. 632, Ensuring Accurate and Complete Abortion Data Reporting Act of 2023, 118th Congress, introduced January 30, 2023, https://www.congress.gov/118/bills/hr632/BILLS-118hr632ih.pdf (accessed March 22, 2023). 10. Doug Badger, “How Congress Can Make Real Progress on Drug Prices,” Heritage Foundation Issue Brief No. 5016, December 9, 2019, https://www.heritage.org/sites/default/files/2019-12/IB5016_1.pdf.