Rethinking Access To Immunizations After COVID-19: Assuring A Vaccine Safety Net For All Americans – healthaffairs.org

At the start of the COVID-19 pandemic, even before effective vaccines were developed, lawmakers raised concerns about the affordability of vaccines, fearing that cost would be a barrier to access. Although lawmakers have appropriated billions of dollars in funding to make immunizations available for free, once the public health emergency ends and COVID-19 immunizations likely evolve into a system of periodic boosters, the longer-term question of immunization financing will loom.

To get the nation through an unprecedented emergency, Congress effectively bypassed the existing system of insurance-reliant immunization coverage in favor of a population-based financing model aimed at assuring a stable supply of vaccines and ready access to free immunizations. The federal government entered into bulk purchase agreements with manufacturers that guaranteed large-scale purchase and distribution. This strategy, along with other governmental investments, has played an essential role in securing a viable supply of a novel vaccine during a pandemic and ready access to immunization across the entire population.

With COVID-19 case numbers subsiding in the first quarter of 2022, the discussion of policy measures needed to prepare for the next pandemic has begun. The experience of the COVID-19 pandemic hopefully also will inform longer-term thinking about how to make the health care system work better and not only in a time of crisis. One key step would be adoption of policies that can undergird public and private insurance coverage to ensure ongoing universal vaccine financing for all people who lack insurance or whose insurance offers insufficient immunization coverage. Congress effectively has done this for children younger than age 18 through the Vaccines for Children (VFC) program. President Joe Biden’s FY23 budget would extend this promise to all Americans with the creation of a vaccine safety net.  

The Basic Vaccine Coverage Framework And Its Gaps

Perhaps the most notable policy steps toward comprehensive vaccine coverage have been the VFC program, enacted in 1993, and the Affordable Care Act (ACA) immunization guarantee. The VFC program assures free, recommended immunizations for children who are uninsured, certain underinsured children, children enrolled in Medicaid and American Indian or Alaska Native—half of all children. The ACA guarantees that virtually all privately insured people, as well as people insured as a result of the ACA Medicaid expansion, are covered without cost sharing for all Advisory Committee on Immunization Practices (ACIP) recommended immunizations.

Together, these two legal guarantees have been incredibly effective. According to the Centers for Disease Control and Prevention (CDC), the VFC program has led to immunization compliance levels among children that surpass 90 percent, thereby avoiding 322 million illnesses, 21 million hospitalizations, and 732,000 deaths to date. Officials estimate the resulting net savings at $295 billion in direct costs and $1.38 trillion in total societal costs. The ACA preventive services coverage guarantee has enabled over more than 151 million insured individuals to secure preventive services at no cost, including vaccines.

Despite these important legal advances, work remains. The ACA does not assure coverage when people receive preventive services from out-of-network providers, which may be necessary especially when, as we have seen with COVID-19, a public health emergency triggers an urgent need for rapid access to vaccines. This access problem may be especially acute in communities whose health plans offer narrow provider networks that make it more difficult to find an in-network provider.

Neither the VFC nor the ACA guarantee applies to Medicaid beneficiaries ages 18 and older insured through Medicaid as traditional program beneficiaries—low-income caretaker relatives of children, adults with disabilities, pregnant women, and the elderly. For these populations, state Medicaid agencies have a choice as to whether to offer all ACIP-recommended immunization coverage without cost sharing. While many may do so, the likelihood of gaps in immunization coverage is high. One study found that only 22 out of 51 Medicaid programs covered all recommended adult immunizations; of those, only 14 provided coverage without patient cost sharing. Furthermore, there is no Medicaid coverage for the more than two million low-income, working-age adults who live in the 12 states that have chosen not to expand Medicaid.

Medicare also does not provide comprehensive vaccine coverage. In the hodgepodge way that incremental health reform tends to happen in the US, some recommended vaccines are covered under Medicare Part B without cost sharing, while all other vaccines are covered under Medicare Part D and therefore subject to cost sharing.

Patchy public insurance patterns among adults who depend on Medicare and Medicaid likely exacerbate the problem of relatively low adult immunization rates. More than 30 million people—13.9 percent of US adults ages 18–64—have no insurance coverage. For uninsured adults, there is no safety-net immunization funding system comparable to the VFC program that protects uninsured children. In 2019, the Section 317 program, which provides immunization infrastructural support and limited free doses for uninsured adults to states, spent $178.7 million on purchase of vaccines for uninsured adults. Section 317, however, is not an entitlement program and does not automatically provide an access guarantee.

The government’s bulk purchase approach briefly patched the above gaps by providing COVID-19 vaccines for free, reimbursing providers for their administration even where a source of coverage was lacking, and forbidding patient out-of-pocket costs. It should now do the same for other vaccines.

The Demonstrated Need For A Comprehensive Safety Net

Adult immunization rates were concerningly low prior to the pandemic, and delayed care has made the situation worse. An analysis by Avalere Health found that from January 2020 to July 2021, publicly and privately insured adolescents and adults potentially missed 37.1 million recommended non-COVID-19 vaccine doses.

Fourteen states have adopted programs known as “Universal Purchase” or “Universal Select” (collectively, UP), providing state-purchased access to some or all recommended vaccines to all children in the state. A subset of these states also purchased vaccines for all adults in the state. UP vaccine purchase occurs at a discounted price through contracts otherwise intended for the VFC and Section 317 programs. Other varied state approaches include superseding private sources of coverage and assessing plans for the cost of the program and disallowing provider use of private vaccine stock. These programs have fueled past industry opposition because they supplant vaccine purchase at private-sector list prices.

An industry-backed study over a 19-year period hypothesized that UP programs fell short of increasing access to recommended vaccines and suggested instead that “policymakers seeking to increase vaccination rates would do well to consider other policies such as addressing provider practice issues and vaccine hesitancy.” In contrast, state-level advocates have underscored the importance of New Hampshire’s UP program in “allow[ing] state health officials to manage the supply of vaccines, thereby lowering providers’ administrative costs and ensuring that the state can quickly supply vaccines to vulnerable patient groups during emergencies or vaccine shortages.” The common ground between industry and public health here is that purchasing vaccines is insufficient to put them in arms and funding is critical to enlist and incentivize a large number and broad base of providers.

In 2019, Section 317’s combined national, state, and local operating costs and vaccine purchase expenditures were a little more than $1 billion. But this did “not cover all the needs of immunization programs (for example, extended clinic hours, sufficient staff, or public communications about the availability and importance of vaccinations).” It was under these circumstances that the CDC and states were thrust into an operational overhaul of vaccine programs to meet the challenges of making COVID-19 vaccines accessible. In addition to enlisting tens of thousands of providers and retail pharmacies, states created and managed previously nonexistent mass immunization sites and scheduling and verification systems. Consequently, more than 500 million doses of COVID-19 vaccines have been administered as of March 2022.

Designing A Sustainable Vaccine Safety Net

With the experience of the pandemic in mind, the CDC articulated in its FY2022 budget justification the need for a “comprehensive adult immunization program.” Among other things, it called for a program that “[i]ncreases and sustains uptake of recommended adult immunizations; [and] begins to close health disparities within and across groups who have been economically/socially marginalized.”

The Biden administration has gone further in its FY2023 request, articulating a vision for a Vaccines for Adults program, making immunization infrastructure investments, extending VFC to all children younger than the age of 19 enrolled in Children’s Health Insurance Program (CHIP), and consolidating vaccine coverage for older adults under Medicare Part B.

Creation of a well-designed vaccine safety-net program as articulated in the president’s budget holds the promise of providing a public source of vaccine coverage for the approximately 20 million uninsured adults between the ages of 18–64. It should also create meaningful infrastructure that will go far in immunizing all Americans across the lifespan, regardless of insurance coverage or setting of care. I provide several suggestions below for its success.

Use The Vaccines For Children Program As A Model

VFC was enacted in 1993 as Section 1928 of the Social Security Act (within the Medicaid statute). It creates a coverage guarantee (entitlement) for children who are Medicaid-eligible, uninsured, underinsured, or American Indian or Alaska Native, while also creating a program that provides federally purchased vaccine doses to the states. VFC alleviates states’ fiscal burden for vaccine purchase. It also permits the Secretary to negotiate contracts with manufacturers, which has consistently provided the government with significantly discounted pricing. In exchange, states have established programs that are the backbone of pediatric immunization in this country, with approximately 86 percent of pediatricians enrolled. A vaccine safety-net program should likewise statutorily guarantee coverage within existing coverage gaps while offsetting costs to states.

The grant-in-aid approach employed by VFC also allows for the setting of a federal programmatic floor. This could include requiring adequacy of vaccine administration fees, immunization information systems improvements, data transparency, and other potential enhancements to vaccine infrastructure.

Provide Adequate State Incentives And Meaningful Infrastructure Investments

Rather than mere compliance with its obligation to cooperate with the states, the federal government should incentivize state participation in a vaccine safety net. Programs should be generous and permanent. The VFC is structured as such, but the ACA’s Medicaid expansion was not. As such, 12 years later policy makers are attempting to create adequate incentives to encourage state adoption. Congress has several options to incorporate financial support to states for vaccine safety-net program infrastructure. While the grant-in-aid approach to vaccine doses is important to create a coverage guarantee, infrastructure support could continue to occur through Section 317. However, Section 317, as currently structured, is subject to congressional appropriations, which provides a less reliable federal commitment.

Providing free vaccine product is insufficient to create a meaningful vaccine safety-net program, as demonstrated by the COVID-19 vaccine rollout. Congress and the CDC must provide states with the ability to sustain and continue expanding efforts to enroll, onboard, and educate providers, as well as the purchase of equipment and supplies, and ongoing program management.

Consideration must be given to the fact that adults receive care at a wider array of settings than children. Pediatric offices remain the predominant site of care for children, where annual well-child visits are a cornerstone of practice. Adults more frequently visit pharmacies or see a range of primary and specialty providers. States must be adequately equipped to work with this heterologous provider set in vaccine distribution.

Moreover, safety-net providers need particular attention. According to the Medicaid and CHIP Payment and Access Commission, safety-net providers have seen greater strain than other provider types during the pandemic. Compounding their already low operating margins, they often are subject to much lower Medicaid administration fees compared to private sources of coverage. A vaccine safety net should bolster these providers through additional back-office support and improved reimbursement.

Preserve Existing Sources Of Coverage

Consistent with VFC, a vaccine safety net should preserve the existing public-private system. Rather than converting existing private markets to public, a vaccine safety-net program can be structured to meet outstanding needs. Existing private and Medicare markets can be left intact, along with corresponding list prices that manufacturers view as important to sustaining market participation and innovation.

Perhaps the greatest shortcoming in the federal government’s COVID-19 rollout has been a near-total reliance on government-led distribution. While intended to ensure that the most vulnerable in our society—health care workers, the elderly, those with certain health risks—were prioritized when vaccines became available, this system lost the benefit of private-sector know-how and reach in later stages of rollout. Payers, wholesalers, distributors, and group purchasing organizations play an important role in getting vaccines to provider offices and in arms. A vaccine safety net should foster participation of all these organizations by avoiding displacement of existing private coverage.

A vaccine safety net could supplement other sources of coverage in certain instances where network coverage is unavailable or out-of-pocket costs remain an issue. Several promising state and local examples demonstrate this possibility. Texas, for example, has addressed the Medicare Part D out-of-pocket problem for seniors, while a number of states have implemented programs to recover reimbursement when vaccinating privately covered individuals.

Conclusion

The COVID-19 pandemic has demonstrated the possibility and necessity of greater federal and state investment in the finance and distribution of vaccines. Despite decades of national progress toward comprehensive vaccine coverage, gaps remain that inhibit access for seniors and low-income adults. Building on the example of the Vaccines for Children program, our country can go far in assuring complete access to vaccines across the lifespan through the creation of a vaccine safety net, as proposed in President Biden’s FY 2023 budget.

Author’s Note

Hughes was previously vice president of public policy with Moderna, which is a member of the Biotechnology Innovation Organization (BIO). BIO is in the process of establishing its position on these matters. The reviews reflected here are the author’s and not the views of Moderna or BIO.