Preserving Patient Access to Long-Term Care Pharmacies Act

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Bill ID: 119/s/3159

Last Updated: November 10, 2025

Preserving Patient Access to Long-Term Care Pharmacies Act

S. 3159, 119th Congress — read as touching Long-Term Care & Nursing Homes.

The sponsor

Sen. Lankford, James [R-OK]

Every bill has someone who introduced it. That name is where the paper trail starts.

The money

$112,600 raised

22 itemised contributions to this sponsor, pulled from FEC filings.

The alignment

55% match to Project 2025

This bill's text tracks the "Department of Health and Human Services" section, p. 497-499 of the Mandate for Leadership.

Bill's Journey to Becoming a Law

Track this bill's progress through the legislative process

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Next: The bill will be reviewed by relevant committees who will debate, amend, and vote on it.

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Committee Review

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Floor Action

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Passed Senate

🏛️

House Review

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Passed Congress

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Presidential Action

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Became Law

📚 How does a bill become a law?

1. Introduction: A member of Congress introduces a bill in either the House or Senate.

2. Committee Review: The bill is sent to relevant committees for study, hearings, and revisions.

3. Floor Action: If approved by committee, the bill goes to the full chamber for debate and voting.

4. Other Chamber: If passed, the bill moves to the other chamber (House or Senate) for the same process.

5. Conference: If both chambers pass different versions, a conference committee reconciles the differences.

6. Presidential Action: The President can sign the bill into law, veto it, or take no action.

7. Became Law: If signed (or if Congress overrides a veto), the bill becomes law!

Bill Summary

Summary Style:

**Bill Analysis: S 3159 - Preserving Patient Access to Long-Term Care Pharmacies Act**

As a visionary entrepreneur and thought leader, I'll dissect this bill through the lens of its impact on my interests and the broader landscape of wealth creation.

**Main Purpose & Objectives:** This bill aims to temporarily provide long-term care pharmacy supply fees in connection with the dispensing of certain drugs. The primary objective is to ensure patient access to essential medications while maintaining a profitable ecosystem for pharmacies.

**Key Provisions & Changes to Existing Law:**

1. Amends Section 1860D-4(b)(1) of the Social Security Act to introduce long-term care pharmacy supply fees, payable by PDP sponsors and MA organizations. 2. Establishes a reimbursement structure, with supply fees set at $30 for plan year 2026 and increasing annually based on the annual percentage increase described in Section 1860D-2(b)(6). 3. Introduces civil money penalties for non-compliance, ranging from $10,000 to an unspecified maximum amount. 4. Provides subsidies to PDP sponsors and MA organizations offering MA-PD plans to offset supply fees paid to long-term care pharmacies.

**Affected Parties & Stakeholders:**

1. Long-term care pharmacies 2. PDP sponsors 3. MA organizations offering MA-PD plans 4. Patients relying on long-term care pharmacies for essential medications

**Potential Impact & Implications:** This bill has significant implications for the pharmaceutical industry and, by extension, my interests.

* **Increased costs:** The introduction of supply fees will lead to increased costs for PDP sponsors and MA organizations, potentially affecting their bottom line. * **Consolidation opportunities:** As smaller pharmacies struggle with the new reimbursement structure, larger players may capitalize on consolidation opportunities, further concentrating market power. * **Regulatory hurdles:** The bill's emphasis on compliance and civil money penalties creates an environment where regulatory capture becomes more likely, allowing well-connected entities to navigate the system more effectively.

In conclusion, this bill presents a nuanced landscape of opportunities and challenges. As a forward-thinking entrepreneur, I will continue to monitor its progress and adapt my strategies accordingly. By doing so, I can ensure that my interests remain aligned with the evolving regulatory environment, ultimately driving growth and innovation in the pharmaceutical sector.

💰 Campaign Finance Network

Sen. Lankford, James [R-OK]

Congress 119 • 2024 Election Cycle

Total Contributions

$112,600

19 donors

PACs

Organizations

$2,000

Committees

Individuals

$110,600

No PAC contributions found

MUSCOGEE CREEK NATION

1 transaction

$1,000

HUNTON ANDREWS KURTH LLP

1 transaction

$1,000

No committee contributions found

SAMPLES, RYAN

3 transactions

$16,500

KAY, ALISON

1 transaction

$6,600

KANADY, CHRISTIAN

1 transaction

$6,600

MANDELBLATT, DANIELLE

1 transaction

$6,600

MANDELBLATT, ERIC

1 transaction

$6,600

ROWAN, CAROLYN

1 transaction

$6,600

ROWAN, MARC J.

1 transaction

$6,600

ARMSTRONG, SINCLAIR WALKER JR.

1 transaction

$6,600

LOWELL OSHMAN, LISHA K.

1 transaction

$6,600

MASSEY, GREGORY LEWIS

1 transaction

$6,600

VIELEHR, BYRON

2 transactions

$6,600

KIMBER, SHELDON

1 transaction

$5,800

NATION, THE CHEROKEE

1 transaction

$5,000

PACE, CHARLES

1 transaction

$5,000

CANTRELL, MIKE

1 transaction

$5,000

JONES, BILL

1 transaction

$4,000

BODE, DENISE A.

1 transaction

$3,300

Donor Network - Sen. Lankford, James [R-OK]

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Showing 53 nodes and 22 connections (57 secondary connections hidden)

Total contributions: $112,600

Top Donors - Sen. Lankford, James [R-OK]

Showing top 19 donors by contribution amount

2 Orgs17 Individuals

Industry Impact

Which industries are materially affected by specific provisions in this bill. 2 helped.

+Long-Term Care & Nursing Homesconfidence 0.95
Section 2(a) adds a long-term care pharmacy supply fee for specified prescriptions dispensed by long-term care pharmacies to enrollees in plan years 2026 and 2027, providing a direct payment benefit to long-term care pharmacies. Section 2(b) provides subsidies to PDP sponsors and MA organizations equal to the aggregate supply fees paid, further supporting the long-term care pharmacy sector.
+Pharmaceuticalsconfidence 0.90
Section 2(a)(i) specifies that the supply fee applies to 'covered part D drug' dispensed by a long-term care pharmacy, meaning prescription drugs reimbursed under Medicare Part D. This provision increases reimbursement for pharmacies dispensing these drugs, indirectly benefiting pharmaceutical manufacturers whose drugs are dispensed and reimbursed at the maximum fair price under the fee structure.

Project 2025 Policy Matches

This bill shows semantic similarity to the following sections of the Project 2025 policy document.AI-enhanced analysis provides detailed alignment ratings.

Department of Health and Human Services

Weak

Vector: 66%

Pages: 497-499AI Enhanced

AI Analysis:

"The bill focuses on providing temporary financial support to long-term care pharmacies to maintain patient medication access, which does not directly align with Project 2025's broader Medicare reform goals such as making Medicare Advantage the default, implementing competitive bidding, or repealing the Inflation Reduction Act's drug pricing provisions. While both involve Medicare and prescription drugs, the bill's narrow, temporary subsidy approach contrasts with Project 2025's structural and sy"

Key themes:Medicareprescription drugspharmacy reimbursement

— 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 — 466 — Mandate for Leadership: The Conservative Promise the catastrophic tier, and requiring manufacturers to bear a larger share. Until the IRA is repealed, an Administration that is required to implement it must do so in a way that is prudent with its authority, minimizing the harmful effects of the law’s policies and avoiding even worse unintended consequences.30 Medicaid. Over the past 45 years, Medicaid and the health safety net have evolved into a cumbersome, complicated, and unaffordable burden on nearly every state. The program is failing some of the most vulnerable patients; is a prime target for waste, fraud, and abuse; and is consuming more of state and federal budgets. The dramatic increase in Medicaid expenditures is due in large part to the ACA (Obamacare), which mandates that states must expand their Medicaid eligibility standards to include all individuals at or below 138 percent of the federal poverty level (FPL), and the public health emergency, which has prohibited states from performing basic eligibility reviews. The overlap of available benefits among the various health agencies has led to a complex, confusing system that is nearly impossible to navigate—even for recipients. Recipients are often faced with a “welfare cliff” of benefit losses as they earn above a certain amount, which is contrary to the fundamental purpose of empowering individuals to achieve economic independence. Benefits increasingly involve nonmedical services such as air conditioning and housing, many of which are already handled by departments other than HHS. Improper payments within Medicaid are higher than those of any other federal program. These payments are evidence of the inappropriateness of Medicaid’s expansion, which, stemming largely from public health emergency maintenance of effort (MOE) requirements and the Affordable Care Act, has crowded out the primary targets of these programs: those who are most in need. True health care reform cannot be accomplished in a bureaucratic silo or only through Medicaid and health safety net programs. Reform of the tax code is also essential to genuine, effective reform of our health care system. All components of the health care system should be part of the reform efforts, and it is imperative that the system be modified to assist states with their current programs. Therefore, the next Administration should: l Reform financing. Allow states to have a more flexible, accountable, predictable, transparent, and efficient financing mechanism to deliver medical services. This system should include a more balanced or blended match rate, block grants, aggregate caps, or per capita caps. Any financial system should be designed to encourage and incentivize innovation and the efficient delivery of health care services. Federal and state financial participation in the Medicaid program should be rational, predictable, and reasonable. It should also incentivize states to save money and improve the quality of health care.

Department of Health and Human Services

Weak

Vector: 64%

Pages: 497-499AI Enhanced

AI Analysis:

"The bill focuses on providing temporary financial support to long-term care pharmacies to maintain patient medication access, which does not directly align with Project 2025's HHS priorities such as Medicare Advantage reform, site-neutral payments, or repealing the Inflation Reduction Act's drug pricing provisions. While both involve Medicare and prescription drugs, the bill's narrow, temporary subsidy mechanism lacks thematic overlap with the broader structural reforms advocated in Project 2025"

Key themes:Medicare Part Dprescription drug accesslong-term care

— 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

Department of Health and Human Services

Weak

Vector: 64%

Pages: 500-502AI Enhanced

AI Analysis:

"The bill focuses on temporary financial support for long-term care pharmacies to maintain patient medication access, while the Project 2025 policy emphasizes Medicaid reform through work requirements, benefit redesign, private insurance options, and state flexibility—particularly for able-bodied recipients. There is minimal thematic overlap, as the bill does not address work incentives, benefit caps, private accounts, or state-led innovation central to the Project 2025 vision."

Key themes:Medicaidlong-term carestate flexibilitybenefit design

— 468 — Mandate for Leadership: The Conservative Promise and consumer choice for Medicaid recipients must go together as standard components of the safety net, especially for able-bodied recipients. Medicaid recipients, like the rest of Americans, should be given both the freedom to choose their health plans and the responsibility to contribute to their health care costs at a level that is appropriate to protect the taxpayer. l Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups. For example, CMS should launch a robust “personal option” to allow families to use Medicaid dollars to secure coverage outside of the Medicaid program. CMS should also: 1. Clarify that states have the ability to adopt work incentives for able- bodied individuals (similar to what is required in other welfare programs) and the ability to broaden the application of targeted premiums and cost sharing to higher-income enrollees. 2. Add targeted time limits or lifetime caps on benefits to disincentivize permanent dependence.34 l Allow private health insurance. Congress should allow states the option of contributing to a private insurance benefit for all members of the family in a flexible account that rewards healthy behaviors. This reform should also allow catastrophic coverage combined with an account similar to a health savings account (HSA) for the direct purchase of health care and payment of cost sharing for most of the population. l Increase flexible benefit redesign without waivers. CMS should add flexibility to eliminate obsolete mandatory and optional benefit requirements and, for able-bodied recipients, eliminate benefit mandates that exceed those in the private market. This should include flexibility to redesign eligibility, financing, and service delivery of long-term care to serve the most vulnerable and truly needy and eliminate middle-income to upper- income Medicaid recipients. l Eliminate current waiver and state plan processes. CMS should allow providers to make payment reforms without cumbersome waivers or state plan amendment processes where possible. More broadly, the federal government’s role should be oversight on broad indicators like cost effectiveness and health measures like quality, health improvement, and — 469 — Department of Health and Human Services wellness and should give the balance of responsibility for Medicaid program management to states. This reform would include adding Section 111535 waiver requirements in some cases (such as imposing work requirements for able-bodied adults) while rescinding requirements in others (such as non–health care benefits and services related to climate change). AFFORDABLE CARE ACT AND PRIVATE HEALTH INSURANCE l Remove barriers to direct primary care. Direct primary care (DPC) is an innovative health care delivery model in which doctors contract directly with patients for their care on a subscription basis regardless of how or where the care is provided. The DPC model is improving patient access, driving higher quality and lower cost, and strengthening the doctor– patient relationship. DPC has faced many challenges from government policymakers, including overly exuberant attempts at regulation and misclassification. Changes should clarify that DPC’s fixed fee for care does not constitute insurance in the context of health savings accounts.36 l Revisit the No Surprises Act on surprise medical billing. The No Surprises Act37 protected consumers against balance bills, but it also established a deeply flawed system for resolving payment disputes between insurers and providers. This government-mandated dispute resolution process has sown confusion among arbiters and regulators as judges have sought to ascertain its meaning. The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.38 l Facilitate the development of shared savings and reference pricing plan options. Under traditional insurance, patients who choose lower- cost care do not benefit financially from that choice. Barriers to rewarding patients for cost-saving decisions should be removed. CMS should ensure that shared savings and reference pricing models that reward consumers are permitted. l Separate the subsidized ACA exchange market from the non- subsidized insurance market. The Affordable Care Act has made insurance more expensive and less competitive, and the ACA subsidy scheme simply masks these impacts. To make health insurance coverage more affordable for those who are without government subsidies, CMS should develop a plan to separate the non-subsidized insurance market

Department of Health and Human Services

Weak

Vector: 61%

Pages: 533-535AI Enhanced

AI Analysis:

"The bill focuses on financial support for long-term care pharmacies to maintain patient medication access, while the Project 2025 HHS section emphasizes civil rights, conscience protections, abortion-related policies, and nondiscrimination in health programs. There is minimal thematic overlap, as the bill does not address the core issues in the Project 2025 policy such as abortion, gender-affirming care, or civil rights enforcement in healthcare settings."

Key themes:Department of Health and Human Serviceshealthcare accessMedicare

— 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).

Department of Health and Human Services

Minimal

Vector: 63%

Pages: 488-490AI Enhanced

AI Analysis:

"The bill focuses on long-term care pharmacy supply fees and medication access for patients in long-term care facilities, while the Project 2025 policy excerpt addresses abortion data reporting, gender identity data collection, FDA regulatory reforms, drug shortages, and abortion pills. There is no thematic or policy overlap between the two."

— 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

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About These Correlations

Policy matches are calculated using a hybrid approach: initial candidates are found using semantic similarity between bill summaries and Project 2025 policy text, then an AI model (Llama 3.1 70B) provides detailed alignment ratings and analysis. Ratings range from 1 (minimal alignment) to 5 (very strong alignment). This analysis does not imply direct causation or intent.

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Preserving Patient Access to Long-Term Care Pharmacies Act