A Patchwork in Need of Permanent Repair: the U.s. Framework for Recommending and Covering Preventive Care

• Jurisdiction: United States,Federal
• Citation: Vol. 1 No. 3
• Publication year: 2023

[Page 175]

Richard Hughes IV and Kevin Lutes ^*

This article reviews the inconsistent structure for recommending and covering clinical preventive interventions in the United States. It describes the various federal agencies and advisory bodies responsible for making these recommendations and their varied criteria, processes, and approaches. It also discusses the uneven market applicability of preventive services coverage requirements and resulting access barriers. Finally, it envisions a new framework for preventive recommendations.

In late 2021, the Food and Drug Administration (FDA) approved a long-acting, injectable (LAI) pre-exposure prophylaxis (PrEP) for at-risk adolescents and adults. ¹ Experts heralded this novel intervention as a critical tool to reduce the transmission of HIV. Yet, our nation's fragmented preventive services coverage framework creates hurdles and delays that prevent patients from timely accessing PrEP and other preventive services. A patchwork of bodies recommending first-dollar coverage for preventive services results in unclear recommendations, which are then exacerbated by uneven market applicability and hurdles created by the implementing rules of the Affordable Care Act (ACA). While this collectively affects access to many preventive services, PrEP in particular is an exemplar of the systemic shortcomings we address.

The recent and ongoing litigation ² in the U.S. District Court for the Northern District of Texas in Braidwood v. Becerra (formerly Kelly v. Becerra) highlights the structural weakness of the nation's patchwork preventive services recommendation and coverage framework.

Specifically, Judge Reed O'Connor held that the recommendations of the U.S. Preventive Services Task Force (USPSTF or Task Force) for requiring payors to provide first-dollar coverage for PrEP violated the Appointments Clause of the U.S. Constitution because

[Page 176]

the Task Force's members exercise powers akin to officers of the United States yet are not nominated by the president or confirmed by the Senate. While undermining the Task Force's authority could threaten access to preventive health care for millions of Americans, the ruling comes at a time when the Task Force's own insularity and lengthy processes stand in the way of timely access. ³

Thus, while we are not suggesting our agreement with the court, its ruling underscores a larger structural problem—the Task Force, and other recommending bodies, were designed with a degree of inconsistency that meaningfully affects access to preventive health care. The federal government delegates its responsibility to recommend coverage for preventive services not only through inconsistent appointment processes, but to bodies whose criteria and process for developing recommendations are incongruent. This lack of uniformity creates inconsistencies that undermine access to preventive care and potentially perpetuate health inequities. Moreover, these recommendations are translated inconsistently into coverage policy, resulting in access challenges.

Coverage Fragmentation: The Imperfect ACA Preventive Services Coverage Provision

As part of its larger aim of increasing access to health care coverage and improving the content of said coverage for millions of Americans, Congress included various benefit requirements under the ACA. One of the most prominent requirements is that which requires commercial health insurance plans to provide first-dollar coverage of recommended preventive services, which Congress adopted through Section 2713 of the Public Health Service Act (2713). Via the ACA's Essential Health Benefits (EHB) provision, this requirement also applies to Medicaid expansion populations but does not apply to traditional Medicaid or Medicare.

Despite its popularity, ⁴ the ACA's preventive services coverage requirement stops short of providing comprehensive assurances of coverage and access. Statutorily, the ACA does not apply 2713 to all markets, leaving an unevenness in market applicability and in the substance of preventive services coverage across private health insurance, Medicaid, and Medicare. Moreover, 2713's implementing rules provide for lengthy implementation periods and substantial payor latitude that may undermine access.

[Page 177]

Uneven Market Applicability

Perhaps most glaringly, 2713's coverage requirements do not apply evenly across all sources of health coverage, applying only to commercial health plans and states that expanded Medicaid eligibility under the ACA. ⁵ This means that Section 2713 does not apply to traditional Medicaid or Medicare.

Instead, under Medicare, preventive services coverage entails a limited and ossified selection of covered services. It exists as its own patchwork of congressionally prescribed screenings and services, listed at length in Section 1861 of the Social Security Act under Part B of Medicare's outpatient medical benefit. ⁶ This includes coverage for an annual wellness visit, certain vaccines, pelvic and pap smear screenings, prostate cancer screening tests, colon cancer screening tests, cardiovascular screening blood tests, and diabetes screening tests. The Secretary of the Department of Health and Human Services (HHS) has discretion to add additional preventive services listed under Section 1861(ddd). Medicare has created exceptions for some interventions that allow nontraditional beneficiaries to receive first-dollar coverage for certain preventive services, such as colorectal screening beginning at age 45, ⁷ and HIV screening for individuals age 15 and older, and at-risk populations younger than 15 or older than 65. ⁸ Adding to the complexity, vaccines not covered under Medicare Part B are covered under the program's prescription drug benefit or Part D.

This approach of statutorily prescribing specific benefits is starkly different from 2713's deference to recommending bodies. Absent the Secretary's proactive use of Section 1861(ddd) authority, it makes for a static approach to covering clinical preventive interventions, one that does not evolve alongside scientific innovation and advancements in preventive modalities.

Under Medicaid, beneficiaries under the age of 21 are assured access to certain preventive services under the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit. ⁹ EPSDT includes comprehensive screening and diagnostic services and vaccines among other services. Yet, there is no comparable preventive coverage requirement for adults in Medicaid, meaning that low-income pregnant women in traditional Medicaid, along with low-income individuals in the current 11 states that have not expanded Medicaid coverage, do not have the assurance of receiving preventive care.

[Page 178]

2713's Implementing Rules

While the statute itself merely enumerates a list of bodies and specifies that the recommendations of each must be covered without patient cost sharing, 2713's implementing rules at 45 CFR § 147.130 provide the parameters of this coverage. The implementing rules inherently and unnecessarily limit the circumstances in which the requirements apply. For example, the section specifies that first-dollar coverage only applies in situations involving in-network providers. Further, Section 2713 permits payors to employ "reasonable medical management" and delays payor requirements to provide first-dollar coverage. As implemented, these provisions leave otherwise covered preventive services subject to cost-sharing or noncoverage, inhibiting patient access.

Out-of-Network Coverage

Under the implementing rules, payors may impose cost sharing for preventive services delivered by out-of-network providers. ¹⁰ But payors are required to provide first-dollar coverage for out-of-network services if their network lacks a provider who can provide the recommended service. This means that a person seeking a vaccine or PrEP for HIV from a provider, perhaps a retail pharmacy, that is out-of-network may encounter cost sharing that may discourage uptake, unless the person can demonstrate the lack of an available in-network provider. This barrier in need of a solution was acknowledged when Congress passed the Coronavirus Aid, Relief, and Economic Security Act or CARES Act, which requires reimbursement parity for out-of-network providers delivering COVID-19 diagnostic testing and forbids cost sharing for the same. ¹¹

Delayed Implementation of Coverage

Under 2713's implementing rules, payors must provide coverage for recommended services for plan or policy years beginning the year after the one-year anniversary of a new recommendation or guideline. ¹² For example, in 2022 the Task Force published its recommendation for screening anxiety in children and adolescents. ¹³

[Page 179]

As a result, payors are not required to provide first-dollar coverage for this screening until January 2024. Again, during the COVID-19 pandemic, Congress sought to address problematically prolonged implementation under 2713 by requiring expedited payor coverage of COVID-19-related preventive services and vaccines, shortening the above time frame to a mere 15 days following a recommendation. ¹⁴

Reasonable Medical Management

The rules also state that "nothing prevents a plan or issuer from using reasonable medical management techniques to determine the frequency, method, treatment or setting for an item or service" if not otherwise specified in the recommendation or guideline. ¹⁵ In doing so, payors are permitted to make their own determination based on relevant evidence and "established medical management techniques" to determine when to cover a recommended service. This means that if a recommendation falls short in its particularity, payors, not providers in their medical judgment, determine the requisite access to recommended preventive services.

The ACA's Reliance on Varied Preventive Services Recommending Bodies

Rather than statutorily prescribing under 2713 those particular preventive services that payors must...