ACA and IRA require vaccine coverage: but what about travel vaccines? | Tech US News

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The Affordable Care Act’s (ACA) requirement that private payers cover all vaccines recommended by the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) now applies to Medicaid and Part D of Medicare thanks to the Inflation Reduction Act, ensuring that nine out of ten Americans have vaccine coverage without cost sharing. The Centers for Medicare and Medicaid Services (CMS) has been careful to emphasize that Part D plans must cover travel vaccinations, but additional clarity is needed to provide equal access for Medicaid and privately insured beneficiaries. This is borne out by a previous analysis that found that most Americans with private insurance do not have health insurance coverage that includes travel vaccinations.

Coverage without cost sharing (first dollar coverage) is an especially important tool to ensure access to the vaccine. Non-coverage of unnecessary services and utilization management tools, such as patient cost-sharing, can achieve a desired reduction in potential overuse of health care services. However, preventive clinical services aimed at preventing the spread of disease, protecting public health, and saving health care dollars should presumably be incentivized. Any amount of out-of-pocket cost can deter a patient from choosing to receive a vaccine. Furthermore, it is well established that clarity of recommendations and vaccine coverage and out-of-pocket costs are essential to provider recommendations and patient acceptance of vaccines.

The ACA’s vaccine coverage requirement does not distinguish between travel vaccines and other vaccines. Under CMS implementing regulations, the ACA is interpreted to require coverage of those immunizations recommended by the ACIP for “routine use.” The rules go on to clarify that “routine use” means that it is “listed in the Centers for Disease Control and Prevention’s Immunization Programs.” Therefore, if the CDC places a vaccine on their immunization schedules, it must be covered.

The “gray area” of the CDC’s travel vaccine recommendations

CDC regularly and thoroughly reviews the structure, content, design, and even color scheme of its immunization schedule with ACIP during its public meetings. However, the schedule makes it clear whether travel vaccinations are included. In its notes, the schedule indicates that some vaccines (eg, hepatitis A, hepatitis B, measles, mumps, rubella, meningococcal, and polio) are recommended for international travelers, but the schedule’s notes are separate from its tables and not include a complete list of all vaccinations recommended for travel and omit those recommended for specific destinations. That information is stored elsewhere on the CDC website, creating a maze for travelers, encouraging them to make an appointment for vaccines that may not be covered, without making it clear that travel vaccines are covered.

The immunization schedule landing page lists “Vaccines in the Adult Immunization Schedule” that omits the recommended travel vaccines. According to the CDC’s “Travel Vaccines” page, travelers should make sure they are up to date on all “routine vaccines” and reference the measles vaccine. It then directs travelers to a series of pages explaining the recommended vaccinations for specific destinations before suggesting they make an appointment to receive the appropriate travel vaccinations. Following a different link for “Travel Vaccination Recommendations” leads to a page for “Traveller Health” which again emphasizes the importance of “routine vaccinations” and provides a range of additional information on traveler health. On another CDC page titled “Vaccines by Disease,” there is a table that lists “Vaccines Recommended for Travel and Some Specific Groups”: adenovirus, anthrax, cholera, Japanese encephalitis (JE), rabies, smallpox, tuberculosis, typhoid, and yellow fever . .

Each of the above vaccines has been recommended by ACIP to address a specific risk to travelers based on a review of the available evidence. Ensuring that these recommendations are represented in the form of a health insurance coverage policy helps facilitate rather than hinder their access. By their very nature, these recommendations are not so broad as to encourage unnecessary use and costs. Presuming that coverage should be excluded, however, defeats the purpose of recommending vaccines aimed at mitigating risks to travelers and preventing diseases from crossing our borders.

The CDC’s immunization schedule should clearly outline travel vaccine recommendations

There are two simple and legally supported paths for the CDC to clarify that travel vaccine coverage is required under the ACA:

The CDC could simply issue guidance clarifying that travel vaccines are indeed “in the program” and therefore must be covered under the ACA. This is not unprecedented. When I explained in 2019 that ACIP’s “shared clinical decision-making” recommendations were too vague and confusing for providers and payers, the CDC issued a set of FAQs that helpfully clarified: “This coverage requirement includes recommendations for shared clinical decision making when they have been adopted by the CDC and are listed in the immunization schedules.” Similar CDC guidance could designate the travel list as an integral part of the schedule itself and subject to coverage requirements.

CDC could also merge the previous list of recommended travel vaccines into the immunization schedule, which includes a table of recommended vaccines as it does for other routinely recommended vaccines, triggering the “scheduling” requirement.

CMS could also provide clarity and consistency in travel vaccine coverage

In its recent guidance to Part D sponsors to implement the new IRA zero cost-sharing policy for vaccines, CMS noted that the ACIP recommendations include those “for use in limited populations and circumstances for certain other vaccines that do not are in the CDC/ACIP Adult Immunization.” Schedule for routine immunization [including] populations and limited circumstances”. This language provides important and needed clarity for travel vaccine coverage that CMS could easily adopt and apply to commercial health insurance and Medicaid under the ACA.

Neglecting to clarify travel vaccine coverage requirements allows technicalities and semantics about the meaning of a “program” to prevent millions of American travelers from receiving potentially life-saving vaccines each year. Both CDC and CMS have the authority to provide this needed clarity through simple and clear guidance.

Author’s note

The author regularly advises clients, including vaccine manufacturers, on policy, legal and regulatory matters.

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