Under Section 2713 of the Public Health Service Act as amended by the Affordable Care Act (ACA), commercial plans must cover and are prohibited from imposing cost sharing on preventive services and products receiving recommendations from federal bodies, including:

• Health Resources and Services Administration (HRSA): provides coverage guidelines for access to preventive services such as contraceptives, as directed by the ACA
• Advisory Committee of Immunization Practices (ACIP): provides advice and guidance on effective control of vaccine-preventable diseases
• U.S. Preventive Services Task Force (USPSTF): reviews the evidence of effectiveness and develops recommendations for clinical preventive services

Although Congress intended for Section 2713 to ensure coverage without cost sharing for recommended services and products, payers may inconsistently apply this directive to coverage policies in practice. CMS has promulgated basic implementing rules for Section 2713; however, it has provided no overarching guidance or further specificity to the recommending bodies or agencies on how their respective and varied recommendations should be put into effect by payers. Consequently, payers may not implement recommendations as intended by Congress, potentially resulting in inconsistent coverage of preventive services.

HRSA

Under Section 2713’s implementing rules, plans must cover all contraceptive services without cost sharing. In 2015, CMS clarified that plans may choose to cover only 1 form of contraception without cost sharing in each of the FDA-approved methods. This additional guidance provided payers and providers with clear coverage directives for HRSA-approved contraceptives.

ACIP

By contrast, plans must cover without cost sharing all ACIP-recommended vaccines listed on the CDC’s immunization schedule, which, unlike HRSA’s comprehensive guidelines, includes multiple products across disease categories.

Additionally, ACIP’s recommendations are often nuanced, referring to specific subpopulations or patient risk factors, or permissive, deferring to provider recommendations. As such, commercial plans have reported significant confusion regarding whether private insurance would cover category “B” vaccines, which are those recommended for individual clinical decision-making (e.g., meningococcal B vaccine).

Because of this lack of clarity, vaccine coverage under a category “B” ACIP recommendation can result in variability in patient access across health plans. For example, some large commercial payers limit coverage for vaccines given a category “B” recommendation. In some cases, payers provide vaccine coverage with no cost sharing only when an ACIP recommendation includes definitive language (e.g., “should”, “shall”, “is”), instead of a category “B” (“may”) recommendation, despite the Section 2713 requirement that plans cover all ACIP-recommended vaccines.

Without further regulatory guidance or clarity from the ACIP in future recommendations, payers will remain uncertain about how to appropriately cover vaccines.

USPSTF

Plans are prohibited from imposing cost sharing on recommended services receiving an “A” or “B” rating from the USPSTF.

A recent draft recommendation on HIV prevention and screening from USPSTF illustrates the ambiguity that payers may face in making coverage policy based on USPSTF’s recommendations. On November 20, the USPSTF issued draft “A” grade recommendations on both the prevention of human immunodeficiency virus (HIV) with PrEP and screening for HIV. It remains unclear whether the ancillary diagnostic tests that accompany PrEP and screening (e.g., renal function testing, serologic testing for hepatitis B and C virus, testing for other sexually transmitted infections, pregnancy testing when appropriate, and regular blood testing) would also be covered without cost sharing. Although the USPSTF acknowledges that these services are generally suggested, the draft recommendation does not explicitly include them under the PrEP “A” grade recommendation.

Moreover, if a service is billed together with an office visit and is the “primary purpose” of the patient’s stay, then the plan may not impose cost-sharing on the office visit itself. However, if a service is billed together with an office visit but is not the “primary purpose,” then the plan may impose cost-sharing requirements on the visit. This distinction demonstrates the challenge of managing ancillary services without clearer guidance, potentially creating access barriers that may undermine the intent of the grade “A” recommendation.

The ACA’s guiding regulatory language does not require the USPSTF to be more explicit in its language nor does it clarify which components of a recommendation are subject to Section 2713, leading to further payer confusion regarding coverage requirements.
USPSTF is accepting comments on its proposed HIV recommendations until December 26. Stakeholders should urge USPSTF to provide further clarity on whether ancillary services are included in its final recommendations.

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