Patricia Pinckombe
Private Practice, Philadelphia, PA, US
PatPinckombe@gmail.com

The legal basis for preventive service coverage in the US

The US healthcare system is characterised by a mixed financing structure. Individuals may obtain coverage through private health insurance, most commonly employer-sponsored plans, or through public programs such as Medicare, which primarily covers individuals aged 65 and older as well as certain individuals with disabilities, and Medicaid, which provides coverage for certain low-income populations. These parallel systems operate under different legal and reimbursement rules, contributing to variation in access to preventive care.

Private health insurance

Preventive services are addressed most directly in section 2713 of the Public Health Service Act, as amended by the Patient Protection and Affordable Care Act.² This provision requires most private health plans to cover, without cost-sharing to the patient, preventive services that receive an ‘A’ or ‘B’ recommendation from the US Preventive Services Task Force (USPSTF), such as breast cancer screening (mammography), certain immunisations, and women’s and children’s health services.³

Section 2713 marked a significant expansion of mandatory preventive coverage. However, its scope is limited to services that meet formal evidence-based thresholds and are explicitly recommended. Preventive interventions outside USPSTF recommendations are not required to be covered without cost-sharing and may result in out-of-pocket expenses or no coverage at all for the patient. As a result, legal definitions of prevention directly influence which services are financially accessible in practice.

Public health insurance

In parallel, the Centers for Medicare & Medicaid Services (CMS) oversees preventive service coverage within both Medicare and Medicaid, although the structure of these programs differs significantly. Medicare Part B covers certain preventive services, including annual wellness visits and specified screenings, with coverage guided by the statutory requirement that services meet a medical necessity standard, specifically that they be ‘reasonable and necessary for the diagnosis or treatment of illness or injury’, reflecting a historically reactive approach to care.⁴

Medicaid, by contrast, is jointly administered by federal and state governments and operates within a federal framework that allows for significant state-level variation in coverage and program design. Preventive services may be covered under Medicaid, including those recommended by the USPSTF, and federal law provides incentives for states to offer such services without cost-sharing for the patient. Although Medicaid does not apply a single uniform standard in the same way as Medicare, coverage decisions are still shaped by medical necessity determinations as defined at the state level.

The concept of ‘medical necessity’ therefore plays a central role in defining reimbursable prevention under Medicare and Medicaid. In practice, this standard functions as a legal boundary between prevention and treatment, shaping which interventions are recognised – and paid for – as medically justified. Private insurers similarly rely on medical necessity determinations, though these are defined through plan terms and may be influenced by state insurance law.

Preventive coverage requirements have also been subject to legal challenge. In Kennedy v Braidwood (2025), the US Supreme Court addressed the constitutionality of the Affordable Care Act’s preventive services mandate, which incorporates recommendations from the USPSTF. The Court largely upheld the statutory framework, preserving the federal requirement that certain preventive services be covered without cost-sharing. Accordingly, preventive coverage requirements remain in force, although their legal foundation has been actively contested.

Uninsured populations

Individuals without private or public insurance – estimated at 25 to 27 million in the US – have no guaranteed access to preventive services, relying instead on safety-net providers and community-based care.⁵ This gap further illustrates how access to prevention is mediated not only by clinical need, but by coverage design.

Reimbursement structures and incentive design

Fee-for-service (FFS) reimbursement remains a central payment model in the US.⁶ Under FFS, providers are compensated for individual, billable services, including procedures, diagnostic testing, and acute interventions.

Preventive counselling is reimbursable, but at lower rates than procedural care. Empirical analyses of Medicare payment structures show that procedures such as colonoscopies can generate more than three times the revenue of comparable physician time spent on cognitive care.⁷ This differential may incentivise procedural intervention over time-intensive preventive management. Which, in turn, can shape resource allocation, staffing decisions, and patterns of care delivery.

In response to these structural incentives, policymakers have advanced alternative payment models under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).⁸ These include value-based care arrangements such as Accountable Care Organizations (ACOs), which are groups of healthcare providers that coordinate care for a defined patient population and share in cost savings if quality and spending targets are met, as well as shared savings programs.

Value-based care models link reimbursement to quality metrics and cost containment rather than service volume, with the aim of encouraging prevention. These models are intended to realign incentives toward earlier intervention and improved population health outcomes. In practice, however, these models often operate alongside fee-for-service structures and rely on short-term performance metrics, limiting their impact on long-term health outcomes.

Beyond payment design, liability frameworks also shape how preventive services are delivered. The federal False Claims Act further reinforces medical necessity boundaries by imposing liability for claims submitted for services that are not reasonable and necessary under federal healthcare programs. As a result, providers may exercise caution in adopting novel preventive interventions absent clear coverage guidance, given potential exposure to repayment obligations and civil penalties.

Limits of value-based payment models

Within Medicare and Medicaid, payment and performance frameworks further influence preventive care. CMS incorporates quality metrics – such as screening rates and chronic disease management – into value-based purchasing programs, linking reimbursement to measurable performance indicators. However, these metrics are typically tied to short-term reporting cycles, making it difficult to capture long-term outcomes such as delayed disease onset. As a result, even value-based models tend to prioritise measurable, near-term indicators over long-term prevention.

Preventive technologies and coverage determinations

Emerging technologies further highlight the interaction between innovation and reimbursement law. Genomic testing, advanced biomarkers, and pharmacological interventions offer preventive potential, but coverage for payment typically depends on established clinical criteria.

For example, GLP-1 receptor agonists are approved for obesity treatment, but coverage often requires specific BMI thresholds and comorbidities.⁹ While these medications may be accessible through private or direct-to-consumer models, such access frequently falls outside insurance coverage.

Similarly, genetic testing is generally reimbursed only when linked to documented clinical indications rather than broad population screening.¹⁰ As with other preventive interventions, reimbursement is tied to demonstrable clinical need rather than population-level risk reduction.

Coverage law thus functions as a gatekeeping mechanism, balancing innovation, cost, and clinical necessity. This gatekeeping role is reinforced by the Federal Food, Drug, and Cosmetic Act (FDCA), which shapes reimbursement indirectly. Because payer policies often align with FDA-approved indications, treatments approved for diagnosed conditions may not be reimbursed when used preventively. Where coverage is limited, access may shift to self-pay markets, raising equity concerns.

Social determinants of health and structural constraints

Preventive health is also shaped by social determinants of health (SDOH), including housing, nutrition, and transportation. CMS has begun integrating SDOH screening into payment models, though reimbursement remains focused on clinical services.

Section 1115 waivers – mechanisms under federal law that allow states to test alternative Medicaid coverage and payment models – enable states to test approaches that address social needs.¹¹ For example, programs in North Carolina and California provide housing support, nutrition assistance, and care coordination for high-risk populations.

Despite these developments, integration of social factors into reimbursement remains limited. Payment systems that undercompensate preventive counselling and do not address social risk factors may limit long-term improvements in population health.

Conclusion

Preventive health and longevity in the US depend not only on scientific advances, but on how care is financed and regulated. Legal and reimbursement frameworks determine which interventions are adopted, under what conditions, and for whom.

Future developments may expand definitions of preventive care, refine medical necessity standards, and incorporate social determinants into payment models. Even so, the structure of reimbursement will continue to shape which forms of prevention are prioritised and which remain underutilised in clinical practice.

Notes

1     International Journal of Multidisciplinary Research and Growth Evaluation, ‘Preventative Medicine and Chronic Disease Management: Reducing Healthcare Costs and Improving Long-Term Public Health’ (Nov–Dec 2024), available at: www.researchgate.net/profile/Olakunle-Soyege/publication/390694904_Preventative_Medicine_and_Chronic_Disease_Management_Reducing_Healthcare_Costs_and_Improving_Long-Term_Public_Health/links/67fb28eadf0e3f544f4102e5/Preventative-Medicine-and-Chronic-Disease-Management-Reducing-Healthcare-Costs-and-Improving-Long-Term-Public-Health.pdf.

2     Patient Protection and Affordable Care Act, Public Law No 111–148 (2010), available at: www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf.

3     42 USC s 300gg–13 (Section 2713, PHSA).

4     42 USC s 1395y(a)(1)(A) (‘reasonable and necessary’).

5     ‘Key Facts about the Uninsured Population’ (9 April 2026) KFF, available at: www.kff.org/uninsured/key-facts-about-the-uninsured-population.

6     MedPAC March 2026 ‘Report to the Congress: Medicare Payment Policy’: www.medpac.gov/wp-content/uploads/2026/03/Mar26_MedPAC_Report_To_Congress_SEC.pdf.

7     PubMed, ‘Medicare payment for cognitive vs procedural care: minding the gap’ (October 2013): https://pubmed.ncbi.nlm.nih.gov/23939411.

8     Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

9     FDA News Release, ‘FDA Approves New Medication for Chronic Weight Management’ (November 2023): www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management.

10    Seewww.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=372.

11    Medicaid, State Waivers List, available at:| www.medicaid.gov/medicaid/section-1115-demo/demonstration-and-waiver-list.