Bottles and Breastfeeding Equipment Screening Enhancement Act

— 485 — Department of Health and Human Services 2022, a federal court blocked this attempt to eliminate health insurance coverage for fertility awareness–based methods of family planning from requirements that cover at least 58 million women, and the judge made his ruling permanent in December 2022. HRSA should promulgate regulations consistent with this order. HHS should more thoroughly ensure that fertility awareness–based methods of family planning are part of women’s preventive services under the ACA. FABMs often involve costs for materials and supplies, and HHS should make clear that coverage of those items is also required. FABMs are highly effective and allow women to make family planning choices in a manner that meets their needs and reflects their values. l Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA updated its women’s preventive services guidelines to include male condoms after claiming for years that it had no authority to do so because Congress explicitly limited the mandate to “women’s” preventive care and screenings. HRSA should not incorporate exclusively male contraceptive methods into guidelines that specify they encompass only women’s services. l Eliminate the week-after-pill from the contraceptive mandate as a potential abortifacient. One of the emergency contraceptives covered under the HRSA preventive services guidelines is Ella (ulipristal acetate). Like its close cousin, the abortion pill mifepristone, Ella is a progesterone blocker and can prevent a recently fertilized embryo from implanting in a woman’s uterus. HRSA should eliminate this potential abortifacient from the contraceptive mandate. l Withdraw Ryan White guidance allowing funds to pay for cross-sex transition support. HRSA should withdraw all guidance encouraging Ryan White HIV/AIDS Program service providers to provide controversial “gender transition” procedures or “gender-affirming care,” which cause irreversible physical and mental harm to those who receive them. l Ensure that training for medical professionals (doctors, nurses, etc.) and doulas is not being used for abortion training. HHS should ensure that training programs for medical professionals—including doctors, nurses, and doulas—are in full compliance with restrictions on abortion funding and conscience-protection laws. In addition, HHS should: — 486 — Mandate for Leadership: The Conservative Promise 1. Investigate state medical school compliance with the Coats–Snowe Amendment,71 which prohibits discrimination against health care entities that do not provide or undergo training for abortion. 2. Ensure that the Accreditation Council for Graduate Medical Education (ACGME) complies with all relevant conscience statutes and regulations and that states have taken the affirmative steps (for example, by issuing regulations) to assure compliance with Coats–Snowe. 3. Communicate to medical schools that any abortion-related training must be on an opt-in rather than opt-out basis. 4. Require states that receive HHS funds to issue regulations or enter into arrangements with accrediting bodies to comply with the Coats–Snowe Amendment’s prohibition of mandatory abortion training by individuals or institutions. The Coats–Snowe Amendment specifically requires such state regulations or arrangements. l Prioritize funding for home-based childcare, not universal day care. As HRSA’s Early Childhood Health page outlines, “Currently, only about half of U.S. preschoolers are on-track with their development and ready for school. And more than one in four of children (28%) who experience abuse or neglect are under 3 years old.”72 Concurrently, children who spend significant time in day care experience higher rates of anxiety, depression, and neglect as well as poor educational and developmental outcomes. Instead of providing universal day care, funding should go to parents either to offset the cost of staying home with a child or to pay for familial, in-home childcare. l Provide education and resources on early childhood health. By partnering with new organizations like the Center on Child and Family Poverty, HRSA should provide resources and information on the importance of the mother–child relationship in child well-being. This should include relationship education curricula that equip mothers and caregivers to connect with and improve their understanding of their infants, toddlers, and young children. Maternal and Child Health. Currently, the HRSA Maternal and Child Health program is collecting data on the benefits of doulas in improving the health, safety, and emotional well-being of mothers at birth. Doulas provide a patient-focused, nonmedical support system for single or married mothers that “decreases the

— 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).

— 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 — 457 — Department of Health and Human Services The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more appropriately as “lab- oratory-modified tests” because they are not truly novel tests but rather modified versions of existing tests. To avoid stifling innovation and access to medical care, the applicable statutes and regulations should be revised to facilitate greater access to such modified tests.12 Finally, the FDA has long held that it has regulatory authority over such tests, while others have argued that they should be considered clinical services regulated by the Centers for Medicare and Medicaid Services (CMS). The FDA currently has regulatory authority over in vitro diagnostics, and under the Clinical Lab- oratory Improvement Amendments (CLIA),13 the CMS ensures that labs meet analytical validity standards for test methods. Congress, the FDA, and the CMS need to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion.14 Drug Shortages. The very thin profit margins and the regulatory burdens associated with generic drug manufacturing discourage inventory and capacity investments by manufacturers and contribute to drug shortages. HHS and the FDA should encourage more dependable generic drug manufacturing. The FDA should expand its current pass/fail approach to drug facility inspec- tions into a graded system that recognizes manufacturers that exceed minimum standards by investing in improving production reliability. The FDA should also add facility codes to drug packaging and construct a searchable database that cross-references product codes and facility codes. That would enable wholesalers and pharmacy benefit managers to identify and preference drugs manufactured at more reliable facilities, thus encouraging generic drug manufacturers to compete on reliability as well as on price. For its part, HHS should exempt multi-source generic drugs from requirements to pay rebates to Medicaid and other federally funded health programs, as those provisions penalize new investments in expanding manufacturing capacity when supply is unable to meet demand.15 Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH fund- ing such trials or conducting its own. Abortion Pills. Abortion pills pose the single greatest threat to unborn chil- dren in a post-Roe world. The rate of chemical abortion in the U.S. has increased by more than 150 percent in the past decade; more than half of annual abortions in the U.S. are chemical rather than surgical. The abortion pill regimen is typically a two-part process. The first pill, mifepris- tone, causes the death of the unborn child by cutting off the hormone progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes con- tractions to induce a delivery of the dead child and uterine contents, usually into a toilet at home. The abortion-pill regimen is currently approved for up to 70 days