Vaccine Coverage, Pricing, and Reimbursement in the U.S. | KFF
Several COVID-19 vaccines are now in Phase 3 trials, and $10 billion of government money has been invested in vaccine research, development, manufacturing, and distribution. As part of this effort, the federal government has prepaid for hundreds of millions of doses of multiple COVID-19 vaccines, and in some cases has the option to purchase more. These government-purchased doses will be distributed free of charge to providers who will then administer the vaccine(s) under the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination program. 1 once distributed, people will be able to get covid-19 19 vaccine(s) without having to pay any cost-sharing, due, in part, to changes made by congress and cms to the laws and regulations that normally govern coverage of safe for vaccines. Applicable laws and regulations for other vaccines vary by program and type of insurance coverage; Some people qualify for all CDC-recommended vaccines with no cost-sharing, while others may face cost-sharing or gaps in coverage. As part of any campaign to promote COVID-19 vaccines, it will be important to ensure that patients realize that the access and affordability challenges they may have faced for other vaccines should not be an issue for the COVID-19 vaccine. covid-19.
This summary explains how vaccines are covered and paid for through government programs and different types of insurance, including information about specific policies in place for a COVID-19 vaccine. We describe vaccine coverage, patient cost sharing, and pricing in Medicare; private medical insurance; the Vaccines for Children (vfc) program; health insurance; Section 317 of the Public Health Services Act, which is the federal program that provides immunizations for uninsured adults; and the Department of Veterans Affairs (VA). Our summary also includes general information about how the CDC develops vaccine recommendations, as many of the federal vaccine coverage requirements currently in place are tied to those recommendations. the brief also includes three tables. Table 1 provides the price per vaccine regimen that the us. uu. the government has already bought. Table 2 summarizes how vaccine prices are set under each program or type of insurance, and Table 3 compares the vaccine list prices with the prices paid by the Children’s Vaccine Program and Section 317, the administration of vaccines. veterans, as well as prices paid by Medicare Part B and Medicare Part D (not counting reimbursements).
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the cdc’s advisory committee on immunization practices (acip) is a federal advisory committee that develops recommendations on how to use vaccines to control disease in the united states, taking into account “consideration of the epidemiology and burden of disease, vaccine safety, vaccine efficacy and effectiveness, quality of evidence reviewed, economic analyses, and implementation issues.” Acip recommendations are reviewed by the CDC director and, if adopted, they are published as official cdc/department of health and human services recommendations in the morbidity and mortality weekly report (mmwr).legal requirements for vaccine coverage are often linked to acip recommendations.
acip makes vaccine recommendations for children and adults. In cases where multiple manufacturers make a vaccine for a given disease, the Acip does not normally recommend one manufacturer’s vaccine over another, but there are exceptions. for example, the recombinant shingles vaccine (sold under the brand name shingrix) was recommended in preference to the live shingles vaccine (sold under the brand name zostavax).
medication
Medicare covers immunizations for more than 60 million people age 65 and older and young adults with long-term disabilities in both Part B (which primarily covers outpatient care, including injected or infused drugs delivered in doctor’s offices) and Part B. in part d (which covers retail prescription drugs). this separation of coverage of vaccines under medicare is due to the fact that there were legal requirements for coverage of a small number of vaccines under part b before the 2006 start of the part d benefit, which is delivered through prescription drug plans that contract with medicare vaccines that were previously covered under part b are still covered under that part of medicare, while others are covered under part d.
Vaccines against influenza, pneumococcal disease, and Hepatitis B (for patients at high or intermediate risk) and vaccines necessary to treat an injury or exposure to a disease are covered under Part B. all other commercially available vaccines needed to prevent disease are covered under medicare part d. Vaccine prices, provider reimbursement, and patient out-of-pocket costs vary on both sides of Medicare.
cost to patients
For influenza, pneumococcal pneumonia, and hepatitis B vaccines covered by Medicare Part B, patients currently face no cost sharing for either the vaccine itself or its administration. for other drugs and services covered by part b, medicare covers 80% of the cost and beneficiaries are responsible for the remaining 20%. the covid-19 vaccine cost sharing is discussed below. Most traditional Medicare beneficiaries have supplemental insurance, such as Medigap, employer-sponsored coverage, or Medicaid, that covers some or all of their coinsurance, but 6 million beneficiaries do not have supplemental insurance to cover these costs. The 24 million beneficiaries enrolled in Medicare Advantage plans are also responsible for cost-sharing requirements, which vary by plan.
as mentioned above, all commercially available vaccines that are not covered under part b must be covered under part d. Unlike Part B, Part D plans have flexibility in determining how much members will have to pay for any drug on the formulary, including vaccines. (Part D members who receive Low Income Subsidies (LIS) generally pay relatively low amounts for vaccines and other covered drugs.) was $57, while the average cost share for adacel (tdap) was $24. Under Part D, cost sharing can take the form of fixed dollar copayments or coinsurance (ie, a percentage of the list price). patients do not pay separate cost-sharing amounts for the vaccine and its administration.
vaccine price
for influenza and pneumococcal vaccines covered by part b, medicare reimbursement is set at 95% of the average wholesale price (awp), except when administered in a hospital outpatient setting, in which case reimbursement is based on a reasonable cost. Medicare publishes an annual list of payment allowance limits for flu vaccines available in a given season. awp is a publicly available suggested price for a drug sold by a wholesaler to a pharmacy or other supplier. it is similar to a sticker price and is used as a starting point for negotiating payments to retail pharmacies. for other drugs covered by part b, the reimbursement is 106% of the average retail price (asp). asp is the average price for all non-federal buyers in the united states and includes volume discounts, early payment discounts, cash discounts, free items contingent upon any purchase requirements, chargebacks (other than chargebacks for discounts 340b) and reimbursements (other than reimbursements under the Medicaid drug reimbursement program). discounts and rebates included in asp are not counted in awp.
because the part d benefit is administered by private drug plans, sponsored by private insurers and pharmacy benefit managers (pbms), the price and reimbursement of vaccines will vary depending on negotiations between the manufacturers and the plans. This may result in different prices paid for the same vaccine by different Part D plan sponsors, and different cost sharing among those enrolled in Part D plans for the same vaccine. The size of rebates paid by manufacturers to PBMs and plans will depend in part on the competitive dynamics of each vaccine and how sensitive patients are to higher out-of-pocket costs if a vaccine is placed in a higher tier.
covid-19 vaccine requirements
Under the Cares Act and an attached Interim Final Rule2, Medicare beneficiaries will have coverage for COVID-19 vaccines through Medicare Part B at no cost-sharing (rather than the typical 20% coinsurance). This coverage applies whether the vaccine receives FDA authorization through an Emergency Use Authorization (USA) or is authorized under a Biological License Application (BLA). Covering a covid-19 vaccine under part b instead of part d will ensure broader coverage for the vaccine under medicare since not all beneficiaries are enrolled in a part d plan.
although medicare will not pay for initial doses of the covid-19 vaccine already purchased by the government, if medicare ultimately reimburses the vaccine, it will be reimbursed at 95% of awp.3 which is the same formula used for flu vaccines and pneumococcal.
private medical insurance
about 55% of people in the us. uu. they have private health insurance, and the vast majority of them are covered through employer-sponsored insurance. All non-grandfathered employer-sponsored health plans and insurance purchased individually in the marketplaces are subject to certain requirements and coverage standards included in the Affordable Care Act (ACA). ACA-compliant individual coverage purchased outside of the Marketplaces is also subject to those requirements. however, the trump administration has expanded access to short-term plans, which are not subject to any federal coverage standards.
cost to patients
Private health plans sponsored by employers and individuals subject to the aca’s preventive services coverage standards must provide coverage for individuals to receive the vaccines recommended by the acip without cost sharing. When a new vaccine is added to the Acip recommendations, plans must update their coverage once a new plan year begins after one year from the date the CDC adopts that recommendation.4 Specific requirements for the vaccine covid-19 are described below. Coverage of recommended vaccines is provided at no cost share, even for beneficiaries who have not met their deductible. short-term plans do not have to meet those standards and may require beneficiaries to pay cost-sharing for vaccines or may exclude recommended vaccines from coverage altogether.
vaccine price
There are no federal limits or rules on the price of vaccines or other prescription drugs on the private market. however, the inclusion of economic analysis in the development of acip recommendations may help reduce vaccine prices compared to other drugs where there is no equivalent federal use of such analysis.
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As with other drugs, rebates and other price concessions from drug manufacturers reduce the net price of vaccines in many cases, although the size of those price concessions varies depending on the competitive dynamics of each drug product along with other factors. Reimbursements and other price concessions are not made public, so we do not have data on the amount of reimbursements for vaccines, how much private plans pay for vaccines, and how prices vary from the list prices included in Table 3 Requirements for plans to cover vaccines without cost-sharing may limit their ability to negotiate large reimbursements for vaccines.
covid-19 vaccine requirements
The care law requires individual and employer-sponsored health plans subject to the aca’s preventive services standards to cover a coronavirus vaccine at no cost share 15 days after the acip recommends it. insurance faster than the longer period of time normally required for private health plans to incorporate a new acip recommendation. The guarantee is tied to the ACA provision that requires private insurers to cover vaccinations, so it could be nullified if the Supreme Court strikes down the ACA.
During the public health emergency, private health insurance plans will be required to cover all costs of a COVID-19 vaccine, even if administered by an out-of-network provider.6 the trump administration establishes that payment by medicare will be considered a reasonable fee for preventive services against the coronavirus, including the administration of a covid-19.7 vaccine in addition, vaccine providers cannot request any reimbursement, even through billing of the balance, of a recipient of the vaccine.8
vaccine program for children
The Vaccines for Children (VFC) Program is a federal entitlement for eligible children created by Congress in 1993 in response to a measles outbreak that spanned from 1989 to 1991. In 2020, the program had a budget of about of $4.8 billion. Under this program, CDC purchases vaccines directly from manufacturers and distributes them to licensees (ie, state health departments and some local health agencies). Those partners then distribute the vaccines free of charge to private medical practices and public health clinics registered as VFC providers. Acip-recommended vaccines are included in the VFC program. More than half of young children and a third of adolescents in the United States are eligible to receive vaccines through this program.9
children under the age of 19 are eligible for the vfc program if they are medicaid eligible, uninsured, or american indian or alaska native. children may also qualify if their insurance has a cap on coverage of vaccines that the child has exceeded or if their insurance does not cover all or certain vaccines.10 Those types of limitations on vaccine coverage are not allowed under the standards set by the aca,11 but some protected plans or short-term plans may include these limitations on vaccine coverage.
cost to patients
children receive free immunizations through the vfc program, but participating health care providers may charge for other services, including administration of immunizations and office visits. Fees for administration of vaccines are limited by regulation, and children cannot be denied a vaccine because they cannot afford the actual administration fee, but the VFC program allows providers to refuse to see children who qualify if they will not be paid for the office visit. for children with medicaid, the office visit and administration of immunizations are covered by medicaid with no cost-sharing.12 children who do not have insurance may be eligible for free or reduced-cost office visits and administration of immunizations through a community health center. additional cost-sharing protections for the covid-19 vaccine are discussed below.
vaccine price
the secretary of the department of health and human services (hhs) is authorized by statute to negotiate a discounted price for vaccines purchased under the vfc program.13 there is also an inflation-adjusted price cap for vaccines that were previously available in 1993 but there is no limit for newer vaccines. States may purchase additional vaccines at the VFC price for children who are not eligible for the program. Table 3 compares VFC vaccine prices with list prices and prices paid by other federal programs. On average, the price the CDC pays for vaccines purchased through the VFC program is 30% less than the list price. the level of discount off list price varies substantially, ranging from 15% below list price to 72% below list price.
when there are multiple manufacturers of a vaccine, the secretary of hhs is authorized to contract with more than one manufacturer. this can help avoid shortages if a supplier experiences supply chain issues. To help ensure a sufficient supply, the statute also requires the secretary to purchase an additional six months’ supply of vaccine beyond what would otherwise be needed.14
covid-19 vaccine requirements
the cdc will determine if covid-19 vaccines will be included in the vfc program.15 if they are included, then medicaid will cover the administration fee for medicaid eligible children.16 covid-19 vaccine administration costs for children Uninsured children can be reimbursed using the $175 billion provider relief fund created by the caregiving act, which the trump administration has declared it will use to cover vaccine-related administration costs for people who don’t they have insurance. as of November 10, 2020, about $30 billion remained in that fund. however, it is unclear how well that system will work given there have been challenges with a similar system for reimbursing treatment for uninsured covid-19 patients. It’s also unclear when a vaccine will be available for children. The Food and Drug Administration said Oct. 22 that it does not yet know if licensed or approved vaccine candidates will be recommended for children.
medicaid and chip
Preliminary data from July 2020 shows that Medicaid and Chip provide health insurance coverage to 75.5 million low-income Americans. Medicaid coverage for immunizations varies by age, eligibility pathway, and state. Immunizations are an optional benefit for certain adult populations, including low-income parents/caregivers, pregnant women, and those who are eligible due to advanced age or disability. for adults enrolled under aca’s medicaid expansion and other populations for whom the state chooses to provide an “alternative benefit plan,” your benefits are subject to certain requirements in aca, including coverage of acip-recommended vaccines at no cost share.17 There are separate coverage requirements for the COVID-19 vaccine during the time states receive enhanced federal funding under the Families First Coronavirus Response Act, and are discussed below.
all states provide some coverage of vaccines for adults enrolled in medicaid who aren’t covered as part of the aca’s medicaid expansion, but as of 2019, only about half of states covered all recommended immunizations by the acip.18 the aca provides an incentive for states to cover all recommended vaccines without cost-sharing for adults by providing a 1 percent increase in a state’s federal medical assistance percentage (fmap) for vaccine spending, and at least 12 states have implemented this option.19 states can choose to cover a vaccine as a pregnancy-related service only and not for other adults who do not receive an “alternative benefit plan.” otherwise, states that choose to cover immunizations must provide that coverage to all low-income parents/caregivers, persons eligible due to age or disability, and pregnant women eligible for full state plan benefits.20
Medicaid-eligible children under the age of 19, including those covered by a Medicaid Expansion Children’s Health Insurance (Chip) Program, are covered by the Children’s Vaccines Program, where they receive immunizations at no cost. Children covered by separate chip programs are not covered by childhood immunizations, but age-appropriate immunizations are a required chip benefit.
cost to patients
Federal medicaid rules allow states to impose nominal cost-sharing, but only for specific populations, and providers cannot refuse to provide a patient with a vaccine if they cannot pay their share of the cost.24 adults in the Medicaid expansion population and other populations for which the state chooses to provide an “alternative benefit plan” must receive preventive immunizations at no cost share. Other Medicaid populations generally exempt from cost-sharing include most children under the age of 18, most pregnant women, most children in foster care, people in share-of-cost institutions, people in hospice and people who receive services from indigenous health care providers; other adults may be subject to nominal charges at the option of the state.25 children under age 19 covered by medicaid or chip receive recommended immunizations at no cost-share, including office visit and administration.26,27 young adults covered by Medicaid ages 19-20 are eligible for the Early Periodic Screening Diagnostic and Treatment (epsdt) benefit, which includes immunization coverage, but may face cost-sharing at the state’s option if not enrolled in an alternative benefit plan .
vaccine price
Vaccines are excluded from the Medicaid Drug Reimbursement Program (MDRP). the mdrp requires that medicaid programs cover all fda-approved drugs from participating manufacturers in exchange for reimbursement to medicaid to offset the cost of prescription drugs.28 the program ensures that medicaid pays the lowest prices for drugs and provides access to medications for members. excluding vaccines from the mdrp has both cost and coverage implications, as states are not required to cover all vaccines and do not receive reimbursement, which is a significant offset to medicaid pharmacy expenses.
States reimburse providers for administering vaccines, and reimbursement varies widely among states. states generally set payment rates for provider reimbursement through fee schedules and have ample flexibility within federal guidelines to determine payment rates.29 31 most state ffs fee schedules do a payment for administering the vaccine in addition to reimbursing the vaccine, and some states may reimburse an office visit fee.32 Due to this wide state variation, there is no single price paid for Medicaid; For example, one study found that as of 2019, FFS reimbursement for an HPV vaccine ranged from $5.27 in Missouri to $491.38 in Mississippi.33 It also found that, on average, Medicaid FFS reimbursed providers an amount greater than the price paid by CDC for the vaccines it purchases, and sometimes also greater than the manufacturer’s list price of a vaccine: For example, the median FFS reimbursement for Hepatitis B vaccines ranged between 188% and 251% of the price paid by the cdc for the vaccines and between 113% and 153% of the list price.34
covid-19 vaccine requirements
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Under the Families First Coronavirus Response Act, covid-19 testing and treatment coverage, including vaccines, at no cost share is required for states to access temporary enhanced federal funding for medicaid.35 all States have assumed this enhanced federal funding and are therefore subject to these requirements. Under these rules, states must also compensate Medicaid providers for an administrative fee or an office visit, even if the vaccine is provided free of charge.36 To receive enhanced federal funding, states must also provide ongoing coverage for individuals enrolled from March 18, 2020 through the end of the month in which the covid-19 public health emergency ends. recent cms guidance has reinterpreted the continuous coverage requirement to allow for some changes between eligibility categories, but beneficiaries cannot lose access to covid-19 testing and treatment services if this was included in their original coverage a as of March 18, 2020.37
covid-19 vaccine coverage requirements and enhanced federal funding are tied to states receiving enhanced federal matching funds during the covid public health emergency (phe) declaration -19 and only last until the end of the quarter in which the phe ends.38 This means that the requirements to cover a coronavirus vaccine at no cost to members will expire if the phe is not renewed. Medicaid’s regular rules for coverage and cost-sharing for vaccines (described above) will apply after the end of the PHE. hhs could continue to extend phe or congress could pass additional legislation extending maintenance of effort requirements for covid-19 vaccine coverage and increased federal funding or otherwise addressing covid-19 vaccine coverage medicaid covid-19.
Section 317 of the Public Health Services Act: Immunizations for Uninsured Adults
There is no federal entitlement program for uninsured adults to receive free vaccinations similar to the VFC program for children. however, the federal government purchases a limited number of vaccines directly for uninsured adults and other eligible adults through funds provided by section 317 of the Public Health Services Act. Section 317 is also used to provide funds to support public health infrastructure in the United States at the federal, state, and local levels, and more than three-fourths of the total program funds are used for that purpose. Section 317 is a discretionary program, and its total budget in 2020 was approximately $616 million.39 Some states supplement the federal funds they get from Section 317 with state funds to reach more people.
After the aca was passed, the cdc updated the eligibility criteria for adults to receive vaccines through section 317.40 beginning in 2012, adults are eligible for vaccines through section 317 if are uninsured, do not have coverage for vaccines, or are being vaccinated as part of a public health response, such as a mass vaccination campaign.41
cost to patients
Adults without insurance can get free immunizations at their state or local health department or community health center through section 317. Because section 317 is a discretionary program and your budget for each year is fixed, federal funding for adult uninsured vaccines does not automatically increase if the number of uninsured increases or the cost of vaccines increases. the limited amount of funds available for vaccines purchased through section 317 may be a contributing factor in lower flu vaccination rates for uninsured adults. While about 40% of adults ages 18 to 64 with public or private insurance got a flu shot in 2018, only 16% of uninsured adults did.
vaccine price
As with the VFC program, the CDC negotiates prices for vaccines purchased through Section 317. Table 3 lists the average prices the CDC pays for adult vaccines purchased through Section 317. , the cdc price is approximately 40% less than the list price. the level of discount off list price varies substantially, ranging from 24% below list price to 59% below list price. local entities that provide vaccines under section 317 may also have other funding sources that they use to pay for vaccines for people who do not have insurance and may purchase additional doses at the section 317 price.42 may also obtain free or discounted vaccines from pharmaceutical companies. manufacturer patient assistance programs.
covid-19 vaccine requirements
providers participating in the cdc covid-19 vaccination program contractually agree to administer a covid-19 vaccine regardless of a person’s ability to pay and regardless of their coverage status.43 this means that persons who The uninsured should be able to obtain the covid-19 vaccine from a broader range of providers than just those who participate in section 317. Providers who administer the covid-19 vaccine to people without insurance will be reimbursed for administration costs. of the vaccine through the $175 billion provider relief fund created by the Care Act. The Trump administration recently clarified that this fund will also be used to reimburse providers for people who have limited Medicaid benefits that don’t include vaccine coverage, such as people who only have coverage for COVID-19 testing or family planning services and supplies. .44 as of November 10, 2020, about $30 billion remained in the provider relief fund, and it’s also being used to pay for covid-19 treatment costs for people who don’t have insurance, as well as further aid broad for providers related to the pandemic. once the government has distributed the initial doses of covid-19 vaccine(s), additional funding may be needed through section 317 or other programs to ensure there are enough doses of vaccine to all people who do not have insurance if the vaccine is needed on an ongoing basis.
Additional outreach from trusted sources may also be needed to reach people who are uninsured, as they are less likely to have a regular source of care than people who do. It will be important for people who do not have insurance to understand the importance of getting vaccinated once it becomes available to them and that the vaccine will be available at no cost to them. Many of the COVID-19 vaccines in clinical trials require two doses, which will increase the importance of proper education and outreach for the uninsured.
department of veterans affairs
the department of veterans affairs (va) veterans health administration (vha) is an integrated health care delivery system serving eligible veterans. The VHA estimates that by 2020 it will provide care to more than 6 million patients.45 Eligibility for health care through the VA is based primarily on veteran status. veterans generally must also meet minimum service requirements; however, exceptions are made for certain circumstances, including termination due to service-connected disabilities.46
cost to patients
The health system does not charge cost-sharing for preventive care, including immunizations.47
vaccine price
To participate in Medicaid and Medicare Part B, drugmakers must sell their drugs at a discount to VA, along with the other three of the “big four” government agencies (U.S. Department of Defense, U.S. Department of Defense, US Public Health and US Coast Guard). In some cases, the VA may be able to negotiate even larger discounts in exchange for a preferred placement on your drug formulary. the “big four” price is the lower of two prices determined by the formula:
- Federal Maximum Price: A minimum discount of 24% off the “non-federal average manufacturer price” (non-famp) plus additional discounts if non-famp increases faster than the inflation. the non-famp is the average price wholesalers pay manufacturers for drugs distributed to non-federal purchasers. The price takes into account price reductions given to wholesalers, but does not take into account refunds to PBMs or other third parties. a legal formula requires additional discounts, if necessary, to prevent the federal maximum price from rising faster than the rate of inflation.
- Federal Supply Schedule (FSS) Pricing: The VA negotiates FSS prices with manufacturers based on the prices manufacturers charge their most favored commercial customers under similar terms and conditions. . During multi-year contracts, the price of FSS may not increase faster than inflation.
These legal discounts result in an average discount of about 40% off the list price, with discounts ranging from 24% to 63% (table 3).
covid-19 vaccine requirements
Under current regulations, the VA does not require cost sharing for “an outpatient visit consisting solely of preventive screening tests and immunizations (eg, influenza vaccination, pneumococcal vaccination).” -19 vaccine.
implications
The current focus on a covid-19 vaccine has fueled interest in issues related to vaccine coverage, pricing, and cost sharing. As described in this summary, vaccines for children and adults are provided through various programs and types of insurance, each with different rules for vaccines already on the market. This means that many changes in insurance requirements were needed to ensure access to a COVID-19 vaccine with no cost-sharing once the vaccine is approved and available. For other vaccines, there are no universal standards to ensure that Acip-recommended vaccines are available to everyone at no cost for either the vaccine or its administration.
There is also no single system for the price of vaccines. HHS negotiates the price of vaccines directly with manufacturers and purchases vaccines through the Children’s Vaccines Program and Section 317. Other vaccine prices are set largely through a combination of legal formulas, private negotiations, and state reimbursement decisions. in the case of medicaid.
The federal government has already paid for several hundred million doses of multiple COVID-19 vaccines through operation warp speed, even before clinical trials have been completed. Under the terms of Operation Warp Speed, the federal government has the option to purchase hundreds of millions of additional doses. it is unclear how many additional doses of covid-19 vaccines will eventually be needed, when, and how long immunity with a covid-19 vaccine will last. If, in the future, the COVID-19 vaccine becomes a regular annual vaccine, it is expected that it will eventually be covered through the same programs and types of insurance currently used to pay for other vaccines. If concerns about the ultimate cost of COVID-19 vaccine(s) or other vaccines arise for federal and state governments and private payers, policymakers can refer to the rules that already govern the price and reimbursement of vaccines. vaccines in different markets to take advantage of the purchasing power of the government.
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