Managed care is the predominant Medicaid delivery system in most states, with over two-thirds of beneficiaries enrolled in comprehensive risk-based managed care organizations as of July 2019, and millions of others covered by limited-benefit risk-based plans or primary care case management programs. On November 13, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized revisions to the Medicaid managed care regulations which were proposed in November 2018. CMS previously finalized a major revision to these regulations in 2016, under the Obama Administration. A few months after taking office, the HHS Secretary and CMS Administrator under the Trump Administration released a letter to state governors noting their plan to conduct a “full review of [Medicaid] managed care regulations to prioritize beneficiary outcomes and state priorities.” CMS then released a June 2017 Informational Bulletin, indicating it would use “enforcement discretion” to work with states on achieving compliance with many provisions of the 2016 final rule while the rule was under review.

Most of the new provisions take effect on December 14, 2020, which means that the incoming Biden Administration would have to issue a new notice of proposed rule-making, with a reasonable justification for any changes, to modify the new rule. The changes, including modifications to network adequacy standards and relaxed requirements for accessibility of written health plan materials for people with disabilities and Limited English Proficiency, take effect in the midst of the COVID-19 public health emergency, when states are using various Medicaid emergency authorities to facilitate access to coverage and care during the pandemic.

The November 2020 final rule is not a wholesale revision of the 2016 regulations but adopts changes in areas including network adequacy, beneficiary protections, quality oversight, and rates and payment. Most changes were finalized as originally proposed with very few changes between the Trump Administration’s proposed to final rule. Key changes between the new Trump Administration rule and prior Obama Administration rule include the following:

Network adequacy. The 2020 final rule removes the requirement that states use time and distance standards to ensure provider network adequacy and instead lets states choose any quantitative standard.

Beneficiary protections. The 2020 final rule relaxes requirements for accessibility of written materials for people with disabilities and those with limited English proficiency; modifies some provider directory requirements; and changes the timeframe within which plans must tell enrollees that a provider is leaving the network. It also lets states shorten the timeframe for enrollees to request a state fair hearing and eliminates the requirement for enrollees to submit a written appeal after an oral appeal.

Quality oversight. The 2020 final rule revises the requirement that a state’s alternative managed care quality rating system (QRS) yield information substantially comparable to the CMS-developed QRS; clarifies that health plan encounter data must include allowed and paid amounts; allows but does not require states to broaden the definition of disability when addressing health disparities under states’ managed care quality strategies; and requires states to annually post online which health plans are exempt from external quality review.

Rates and payment. The 2020 final rule allows states to set capitation rate cell ranges instead of a single rate per cell. It also expressly prohibits states from varying capitation rates based on the amount of federal financial participation for covered populations in a manner that increases federal costs. Under the final rule, states also cannot retroactively add or modify risk-sharing mechanisms after the start of a rating period. The final rule recognizes two minimum fee schedules for directed payment arrangements from health plans to providers; codifies sub-regulatory guidance for multi-year approvals of value-based purchasing models; and allows states to make new supplemental provider pass-through payments for up to three years when transitioning populations or services from fee-for-service to managed care.

Introduction

On November 13, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized changes to the Medicaid managed care regulations.¹  CMS last revised these regulations in 2016 (“the 2016 final rule”) under the Obama Administration.²  The 2016 final rule represented a major revision and modernization of federal regulations in this area, which had not been updated since 2002.³  CMS’s major goals in issuing the 2016 final rule were to align Medicaid managed care requirements with other major health coverage programs where appropriate; enhance the beneficiary experience of care and strengthen beneficiary protections; strengthen actuarial soundness payment provisions and program integrity; and promote quality of care.⁴ 

In March 2017, the HHS Secretary and CMS Administrator under the Trump Administration released a letter to state governors noting the new Administration’s plan to conduct a “full review of [Medicaid] managed care regulations to prioritize beneficiary outcomes and state priorities.”⁵  CMS then released an Informational Bulletin in June 2017, indicating it would use “enforcement discretion” to work with states on achieving compliance with the 2016 final rule, except for specific areas that “have significant federal fiscal implications.”⁶  CMS’s stated goals in releasing the November 2018 Notice of Proposed Rulemaking (NPRM) to revise the 2016 final rule were to streamline the managed care regulatory framework; reduce state and federal administrative burden; support state flexibility; and promote transparency, flexibility, and innovation in care delivery. The new regulations are not a wholesale revision of the 2016 final rule, but they include changes in the following key areas, which are summarized in this issue brief and Table 1: network adequacy, beneficiary protections, quality oversight, and rate setting and payment.⁷  Most of the new provisions take effect on December 14, 2020. Exceptions are noted in the discussion below and Table 1. Most changes were finalized as originally proposed.

Background

According to the most current national data, as of July 1, 2019, 54.0 million Medicaid beneficiaries, or 69%, were enrolled in comprehensive risk-based managed care organizations (MCOs).⁸  As of July 1, 2019, 39 states and DC contract with MCOs; in many of these states, at least 75% of all beneficiaries are enrolled in these health plans.⁹  While MCOs are the predominant form of Medicaid managed care, millions of other beneficiaries receive at least some Medicaid services, such as behavioral health or dental care, through limited-benefit risk-based plans, known as prepaid inpatient health plans (PIHPs) and prepaid ambulatory health plans (PAHPs). Several million beneficiaries are also enrolled in primary care case management (PCCM) programs that range from basic managed fee-for-service (FFS) models to more enhanced models.¹⁰ 

Key Changes in the 2020 Final Rule

Network adequacy

The 2020 final rule removes the requirement that states use time and distance standards to ensure health plans’ provider network adequacy and instead allows states to choose another quantitative standard. Health plan efforts to recruit and maintain their provider networks can play a crucial role in determining enrollees’ ability to access covered services. The 2016 final rule required states to develop and enforce enrollee travel time and distance standards for certain specified provider types as well as additional providers to be determined by CMS, for health plan contracts beginning on or after July 2018. The new rule instead allows states to use an alternative standard such as minimum provider-to-enrollee ratios, maximum travel time or distance to providers, minimum percentage of contracting providers accepting new patients, maximum wait times for an appointment, or hours of operation requirements. The new rule also allows states to use any quantitative network adequacy standard for long-term services and supports providers to whom enrollees must travel to receive services, eliminating the requirement in the 2016 final rule for states to develop time and distance standards for these providers. Additionally, the new rule allows states to define the specialists to which network adequacy standards apply. Finally, the new rule eliminates the “other provider type” language, curtailing CMS’s ability to add to the list of providers subject to network adequacy standards without further rule-making.

Beneficiary protections

BENEFICIARY INFORMATION

The 2020 final rule relaxes the requirements for accessibility of written materials for people with disabilities and those with limited English proficiency. The 2016 final rule required taglines in large print and in locally prevalent non-English languages on all written materials (e.g., enrollee handbooks, provider directories, enrollee notices) to explain the availability of interpretation and translation services and to provide the toll-free choice counseling number and the plan’s toll-free customer service number, for plan contracts beginning on or after July 2017. The new rule only requires taglines on written materials for potential enrollees that “are critical to obtaining services.” The final rule also changes the definition of “large print” from at least 18-point font to font that is “conspicuously visible.”The 2020 final rule eliminates the requirement to identify in health plan provider directories whether a provider has completed cultural competence training and decreases the frequency of updating paper provider directories. The 2016 final rule required plan directories to indicate whether a provider has completed cultural competence training and specified that paper directories must be updated at least monthly, for plan contracts beginning on or after July 2017. The new rule only requires monthly updates to paper directories if a mobile-enabled, electronic directory is not available; otherwise, updates are required quarterly.

The 2020 final rule changes the timeframe within which plans must tell enrollees that their provider is leaving the plan network. The 2016 final rule required plans to make a good faith effort to give written notice of termination of a contracted provider to enrollees within 15 calendar days after receipt or issuance of the termination notice, for plan contracts beginning on or after July 2017. The new rule changes this requirement to the later of 30 calendar days prior to the effective termination date, or 15 calendar days after receipt or issuance of the termination notice.

APPEALS

The 2020 final rule allows states to shorten the timeframe within which an enrollee can request a state fair hearing to appeal a health plan decision to deny or terminate covered services. The 2016 final rule provided enrollees with 120 days from the plan’s notice of resolution of the internal plan appeal to request a state fair hearing, for contracts beginning on or after July 2017. The new rule lets states set the timeframe for enrollees to request a fair hearing between 90 to 120 days, to allow states to align this period with the timeframe for enrollees to appeal decisions covered under Medicaid fee-for-service.

The 2020 final rule also eliminates the requirement for beneficiaries to submit a written, signed appeal after an oral appeal is submitted. The 2016 final rule required enrollees to submit a written, signed appeal following an oral appeal, for contracts beginning on or after July 2017.

Quality oversight

QUALITY RATING SYSTEM

The 2020 final rule revises the requirement that states’ alternative managed care quality rating systems (QRS) yield information substantially comparable to the CMS-developed QRS, instead requiring this only “to the extent feasible.” CMS is to develop performance measures and a methodology for a managed care QRS framework to rate health plans and enable comparisons across states.¹¹  States also can implement an alternative QRS with CMS approval. Under the new rule, a state’s alternative QRS must include the mandatory performance measures to be established by CMS, although the alternative QRS has to yield information substantially comparable to the CMS-developed QRS only to the extent feasible. CMS will issue sub-regulatory guidance specifying the criteria and process for determining “substantial comparability.” CMS did not finalized its proposal that would have eliminated the requirement that states obtain prior approval from CMS before implementing an alternative QRS.

ENCOUNTER DATA

The 2020 final rule clarifies that health plan submission of encounter data must include allowed and paid amounts. CMS underscored the importance of these data for monitoring and administration of the Medicaid program, particularly for capitation rate setting and review, financial management, program integrity, and utilization analysis. The 2016 final rule conditioned federal matching funds for Medicaid managed care payments to states on state reporting of validated, complete, and timely enrollee encounter data, for contracts beginning on or after July 2018.

QUALITY STRATEGY

The 2020 final rule allows states to expand the definition of “disability status” when addressing health disparities in the state’s managed care quality strategy.  Under the 2016 final rule, states must have a written quality strategy for assessing and improving the quality of care and services furnished by health plans and PCCM entities, for health plan contracts effective on or after July 2018. Among other elements, state quality strategies must describe their plans to reduce health disparities based on certain demographic factors including disability. The 2016 regulations identified enrollees with a disability based on whether they qualify for Medicaid in a disability-related eligibility pathway, and the new rule requires states to adopt this standard at minimum in their definition of disability status. Under the 2020 final rule, states must include in their quality strategy the state’s definition of disability status and how the state will determine whether an enrollee meets that standard, including the data sources used. This change is effective for all quality strategies submitted after July 1, 2021. CMS proposed but did not finalize a broader definition of “disability,” which would not have been limited to individuals who qualify for Medicaid based on a disability and would have recognized that enrollees with disabilities may qualify for Medicaid on another basis (such as low income).

EXTERNAL QUALITY REVIEW

The 2020 final rule requires that states annually post online which health plans are exempt from external quality review (EQR) and specify when the exemption began. Under the 2016 final rule, states must ensure that a qualified organization performs an annual EQR for each health plan or PCCM entity to assess quality, timeliness, and access to health care services, for contracts beginning on or after July 2018. CMS also adopted a requirement for states to identify exempted plans in their annual EQR technical report, effective for all reports submitted on or after July 1, 2021.

Rate setting and payment

CAPITATION RATE DEVELOPMENT

The 2020 final rule allows states to set capitation rate cell ranges¹²  instead of a single rate per cell, effective for rating periods beginning on or after July 1, 2021. The allowable range is 5 percent, or +/- 2.5 percent from the midpoint. The 2016 final rule required a single rate per cell for contracts beginning on or after July 2016. In support of the change, CMS noted that the single rate requirement could diminish a state’s ability to obtain the best rates. To address concerns about transparency, state websites must post certain information about the development of rate ranges.¹³  States also must document the rates payable to health plans at points within the range prior to the start of the rating period. CMS will provide additional guidance on how to implement this requirement. The final rule also allows states to change capitation rates within the range up to 1 percent during the rating year without submitting a new rate certification, if the change is consistent with a modification of the health plan contract and other rate development criteria are met.

The 2020 final rule expressly prohibits states from varying capitation rates based on the amount of federal financial participation for a covered population in a manner that increases federal costs. CMS did not finalize its proposed list of certain rate development practices that increase federal costs and therefore are prohibited. While CMS continues to believe that those practices generally increase federal costs, it acknowledged that it cannot predict every future scenario where such practices nevertheless could be actuarially appropriate.¹⁴  The final rule clarifies that rate development standards must be based on actual cost differences in providing covered services to covered populations and that compliance with this requirement is evaluated program-wide, across all managed care contracts and covered populations. During rate review, CMS may require states to provide written documentation and justification that any differences in the assumptions, methodologies, and factors used to develop capitation rates represent actual cost differences based on the characteristics or mix of covered services or populations.

The 2020 final rule clarifies that states may adjust certified capitation rates within a rating period by +/-1.5%, without submitting a revised rate certification or justification to CMS. CMS has determined that rates will remain actuarially sound if adjusted within this range. Under the final rule, CMS can specifically request supporting documentation from states. Notably, states that choose to use rate ranges as described above, instead of a single rate per cell, cannot also apply the +/-1.5% rate adjustment provision. In addition, the 2020 final rule provides that CMS will issue guidance at least annually that describes the federal standards for capitation rate development and related documentation requirements.

The 2020 final rule prohibits states from retroactively adding or modifying risk-sharing mechanisms after the start of the rating period.¹⁵  CMS also requires states to document risk-sharing mechanisms in health plan contracts and rate certification documents prior to the start of the rating period. In the preamble to the final rule, CMS noted that states can adopt retroactive rate adjustments (as opposed to changes to risk-sharing mechanisms) when necessary to address disease outbreaks, launches of high-cost prescription drugs, or other unforeseen circumstances that increase benefit costs mid-year.¹⁶ 

PAYMENT

The 2020 final rule recognizes two distinct minimum fee schedules for states’ directed payment arrangements from health plans to providers. The 2016 final rule allowed states to adopt a minimum or maximum fee schedule for health plan payments to network providers that provide a particular service, for contracts beginning on or after July 2017. The first minimum fee schedule adopted by the new final rule applies to directed payment arrangements that use state plan approved rates. These rates are defined as amounts calculated for specific services provided to an individual under the approved state plan methodology and excluding supplemental payments. The other minimum fee schedule adopted by the new final rule applies to directed payment arrangements that use rates other than state plan approved rates for network providers that provide a particular service. CMS did not finalize its proposal that would have allowed states to direct plans to adopt a cost-based rate, a Medicare equivalent rate, a commercial rate, or another market-based rate. The 2020 final rule also eliminates the requirement for CMS prior approval of states’ directed payment arrangements based on state plan approved rates, as CMS believes this is duplicative of the state plan amendment process. Minimum fee schedules are approved for one rating period at a time.

CMS proposed but did not finalize changes that would have allowed states to direct the amount or frequency of plan expenditures to providers as part of delivery system or payment reform initiatives; these activities remain prohibited as established under the 2016 rule.  While CMS initially believed that prohibiting states from directing the amount or frequency of health plan expenditures may have created unintended barriers to the implementation of innovative payment models, like global payment initiatives, it ultimately decided that health plans should retain discretion in managing risk and their provider contracts, even when states require plans to adopt specific parameters for provider payment through delivery system or payment reform initiatives.

The 2020 final rule codifies sub-regulatory policy guidance governing multi-year approvals of value-based purchasing models or those tied to larger delivery system reform efforts. Specifically, the final regulation adopts the criteria in the November 2017 CMCS Informational Bulletin. Approvals are for one rating period unless the state explicitly describes the arrangement as multi-year, describes its implementation and evaluation plan, and affirms that it will not make changes to payment methodology or magnitude without prior CMS approval. The 2016 final rule described states’ authority to require managed care plans to implement value-based purchasing models for provider payment (such as pay-for-performance arrangements, bundled payments, or other models intended to reward value over volume) or participate in multi-payer or Medicaid-specific delivery system reform or performance improvement initiatives. In the preamble to the 2020 final rule, CMS said that it is reviewing state-directed payments because it has seen state proposals for significant changes to provider reimbursement that could affect program spending and may issue further guidance or regulations based on its review.

The 2020 final rule allows states to make new supplemental provider pass-through payments up to three years when states are transitioning populations or services from fee-for-service to managed care.¹⁷  This change takes effect for pass-through payments to hospitals, physicians, and nursing facilities in managed care rating periods starting on or after July 1, 2021. The provisions of the 2016 final rule that phase out existing pass-throughs of state supplemental provider payments in the capitation rates paid to managed care plans continue to apply. CMS believes that because supplemental payments are not tied to the provision of services covered under plan contracts, they therefore conflict with the actuarial soundness requirement.¹⁸  Specifically, the 2016 rule phases out pass-through payments that existed in contracts and rate certifications for the rating period including July 1, 2016 to hospitals from 2017-2027, and to physicians and nursing facilities from 2017-2022.

The 2020 final rule allows states to specify how health plans covering enrollees dually eligible for Medicare and Medicaid receive crossover claims, instead of requiring plans to have a coordination of benefits agreement and participate in the automated Medicare process. Crossover claims arise for dual eligible beneficiaries because Medicaid may cover the portion of the service charge that is not covered by Medicare. The 2016 final rule required health plans that cover dually eligible enrollees to participate in the Medicare automated crossover claim process in an effort to simplify billing for providers. The new rule allows states to retain that process or adopt an alternative process, such as the state forwarding crossover claims to the appropriate health plan. CMS said that some states indicated that an alternative process enables them to ensure that health plans receive only the claims for which they are responsible in situations where an enrollee is in more than one plan and/or FFS for different benefits or where the enrollee has changed plans.

CMS did not change the “institution for mental disease” (IMD) “in lieu of” authority codified in the 2016 final rule.¹⁹  CMS requested but did not receive any public comment on additional currently available data sources that it could review in support of any changes. Under the 2016 final rule, states can receive federal matching funds for capitation payments made to health plans on behalf of enrollees ages 21-64 who receive psychiatric or substance use disorder (SUD) inpatient or crisis residential services in an IMD for up to 15 days in a month, as services covered “in lieu of” those under the Medicaid state plan benefit package.²⁰  This is an exception to the general federal prohibition against Medicaid payments for services for non-elderly adults in IMDs. Instead of a regulatory change, CMS notes that states may continue to apply for Section 1115 demonstration waivers to receive federal Medicaid matching funds for longer IMD SUD stays.²¹  Additionally, the federal Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act created a new option from October 2019 through September 2023, for states to receive federal Medicaid payments for non-elderly adults with SUD in an IMD up to 30 days per year. In November 2018, CMS also issued new guidance inviting states to apply for Section 1115 waivers of the federal IMD payment exclusion for services for individuals with serious mental health conditions.²² 

Looking Ahead

Most provisions of the new rule take effect on December 14, 2020, which means that the incoming Biden Administration would have to issue a new notice of proposed rule-making, with a reasonable justification for any changes, in order to modify the 2020 final rule. While the new final rule is not a wholescale revision of the comprehensive 2016 final rule, it does make changes in key areas, including network adequacy standards, beneficiary information and appeals, quality oversight, and capitation rate development and provider payment. Federal rules governing Medicaid managed care are important as managed care remains the predominant care delivery system in most states. The changes, including modifications to network adequacy standards and relaxed requirements for accessibility of written health plan materials for people with disabilities and those with Limited English Proficiency, take effect in the midst of the COVID-19 public health emergency, at a time when states are using Medicaid emergency authorities to facilitate access to coverage and care during the pandemic.

1. 85 Fed. Reg. 72754-72844 (Nov. 13, 2020), https://www.govinfo.gov/content/pkg/FR-2020-11-13/pdf/2020-24758.pdf. The proposed changes were published at 83 Fed. Reg. 57264-57299 (Nov. 14, 2018), https://www.federalregister.gov/documents/2018/11/14/2018-24626/medicaid-program-medicaid-and-childrens-health-insurance-plan-chip-managed-care. ↩︎
2. 81 Fed. Reg. 27498-27901 (May 6, 2016), https://www.federalregister.gov/articles/2016/05/06/2016-09581/medicaidand-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-delivered. ↩︎
3. For a summary of the 2016 final rule, see KFF, CMS’s Final Rule on Medicaid Managed Care: A Summary of Major Provisions (June 2016), https://modern.kff.org/report-section/cmss-final-rule-on-medicaid-managed-care-issue-brief/. ↩︎
4. Most provisions were effective July 2016, although some provisions became effective later. See id.  ↩︎
5. Letter from HHS Sec’y Thomas E. Price and CMS Administrator Seema Verma to governors (March 14, 2017), https://www.hhs.gov/about/news/2017/03/14/secretary-price-and-cms-administrator-verma-take-first-joint-action.html. ↩︎
6. CMCS Informational Bulletin, Medicaid Managed Care Regulations with July 1, 2017 Compliance Dates (June 30, 2017), https://www.medicaid.gov/federal-policy-guidance/downloads/cib063017.pdf. ↩︎
7. The November 2020 final rule also includes some proposals related to CHIP which are outside of the scope of this brief. ↩︎
8. KFF analysis of the Centers for Medicare and Medicaid Services’ Medicaid Managed Care Enrollment Reports, 2020, https://modern.kff.org/other/state-indicator/total-medicaid-mco-enrollment/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D. ↩︎
9. KFF, State Health Facts, Share of Medicaid Population Covered under Different Delivery Systems (July 1, 2019), https://modern.kff.org/medicaid/state-indicator/share-of-medicaid-population-covered-under-different-delivery-systems/. ↩︎
10. This brief generally refers to “health plans.” Provisions in the proposed rule generally apply to MCOs, and some provisions also apply to PIHPs, PAHPs, and PCCM entities. ↩︎
11. CMS is continuing its stakeholder engagement process and plans a future quality rating system specific rulemaking. ↩︎
12. Rate cell ranges are allowed provided the following conditions are met: 1) the rate certification identifies and justifies the assumptions, data, and methods specific to the upper and lower bounds of the rate range; 2) both the upper and lower bounds of the rate range are certified as actuarially sound; 3) the upper bound does not exceed the lower bound multiplied by 1.05; 4) the rate certification documents the state’s criteria for paying health plans at different points within the rate range; and 5) the state does not use as criteria for payment for different points within the rate range the willingness or agreement of plans or their network providers to enter into intergovernmental transfer (IGT) agreements or the amount of funding plans or their network providers provide through IGT agreements. ↩︎
13. States must post the upper and lower bounds of each rate cell; a description of all assumptions that vary between the upper and lower bounds of each rate cell, including the specific assumptions used for the upper and lower bounds; and a description of the data and methodologies that vary between the upper and lower bounds of each rate cell, including the specific data and methodologies uses for the upper and lower bounds. ↩︎
14. These practices include 1) using a profit, operating, or risk margin to develop capitation rates that is higher than the margin used to develop capitation rates for the covered population, or contract, with the lowest average rate of FFP; 2) factoring into the development of capitation rates the additional cost of contractually required provider fee schedules or minimum levels of provider reimbursement, above the cost of similar provider fee schedules, or minimum levels of provider reimbursement, used to develop capitation rates for the covered population, or contract, with the lowest average rate of FFP; and 3) lowering the remittance threshold for a medical loss ratio for any covered population, or contract, below the threshold used for the covered population, or contract, with the lowest average rate of FFP. ↩︎
15. The 2020 final rule provides a non-exhaustive list of risk-sharing mechanisms, including reinsurance, risk corridors, and stop-loss limits. In the preamble to the 2020 final rule, CMS also confirmed that a minimum medical loss ratio with a remittance and additional restrictions on profits or contractual profit caps are considered risk-sharing mechanisms under the final rule. ↩︎
16. Retroactive rate adjustments must be supported by a rationale; the data, assumptions, and methodologies used to determine the magnitude of the adjustment must be adequately described in enough detail for CMS or an actuary to determine that the adjustment is reasonable; certified by an actuary in a revised rate certification; and submitted as a contract amendment for CMS approval. ↩︎
17. CMS clarified that disproportionate share hospital (DSH) and graduate medical education (GME) payments are not considered supplemental payments. ↩︎
18. On January 17, 2018 CMS posted a final rule clarifying pass-through payment transition periods and maximum allowable pass-through payments. See 82 Fed. Reg. 5415-5429 (Jan. 18, 2017), https://www.federalregister.gov/documents/2017/01/18/2017-00916/medicaid-program-the-use-of-new-or-increased-pass-through-payments-in-medicaid-managed-care-delivery. ↩︎
19. For background about the Medicaid IMD payment exclusion, see KFF, State Options for Medicaid Coverage of Inpatient Behavioral Health Services (Nov. 2019), https://modern.kff.org/medicaid/report/state-options-for-medicaid-coverage-of-inpatient-behavioral-health-services/. ↩︎
20. To receive federal matching funds for “in lieu of” services, a state must identify the services in the plan’s contract and determine that they are medically appropriate and cost-effective. In lieu of services are offered at plan option, and an enrollee cannot be required to use them. KFF, CMS’s Final Rule on Medicaid Managed Care:  A Summary of Major Provisions (June 2016), https://modern.kff.org/report-section/cmss-final-rule-on-medicaid-managed-care-issue-brief/. ↩︎
21. In July 2015, the CMS issued a state Medicaid director letter describing Section 1115 IMD SUD payment waivers. In November 2017, the CMS issued a state Medicaid director letter revising the 2015 guidance. For current IMD state waiver activity, see KFF, Medicaid Waiver Tracker:  Approved and Pending Section 1115 Waivers by State (Nov. 13, 2020), https://modern.kff.org/medicaid/issue-brief/medicaid-waiver-tracker-approved-and-pending-section-1115-waivers-by-state/. ↩︎
22. CMS, SMD #18-011, Opportunities to Design Innovative Service Delivery Systems for Adults with a Serious Mental Illness or Children with a Serious Emotional Disturbance (Nov. 13, 2018), https://www.medicaid.gov/federal-policy-guidance/downloads/smd18011.pdf.   ↩︎

Several COVID-19 vaccines are now in phase 3 trials, and $10 billion in government money has been invested in the research, development, manufacturing, and distribution of vaccines. As part of this effort, the federal government has paid in advance 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 for free to providers who will then administer the vaccine(s) under the Centers for Disease Control and Prevention’s (CDC) COVID-19 Vaccination Program.¹  Once distributed, individuals will be able to get COVID-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 typically govern insurance coverage for vaccines. The laws and regulations in place for other vaccines vary by program and type of insurance coverage—with some people qualifying for all CDC recommended vaccines without cost sharing, while others may either face cost sharing or gaps in coverage. As part of any campaign to encourage COVID-19 vaccinations, it will be important to make sure patients realize that access and affordability challenges they may have faced for other vaccines should not be a problem for the COVID-19 vaccine.

This brief explains how vaccines are covered and paid for through government programs and different types of insurance, including information on specific policies put into place for a COVID-19 vaccine. We describe vaccine coverage, patient cost sharing, and pricing in Medicare; private health insurance; the Vaccines for Children Program (VFC); Medicaid; Section 317 of the Public Health Services Act, which is the federal program that provides vaccines for uninsured adults; and the Department of Veterans Affairs (VA). Our brief also includes background information on how the CDC develops vaccine recommendations, since 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 regimen of vaccines that the U.S. government has already purchased. Table 2 summarizes how vaccine prices are set in each program or type of insurance, and Table 3 compares vaccine list prices with prices paid by Vaccines for Children program and Section 317, the Veterans Administration, as well as prices paid by Medicare Part B and Medicare Part D (not accounting for rebates).

Medicare

Medicare covers vaccines for more than 60 million people ages 65 and older and younger adults with long-term disabilities under both Part B (which covers primarily outpatient care, including injected or infused drugs delivered in physician offices) and Part D (which covers retail prescription drugs). This separation of coverage for vaccines under Medicare is due to the fact that there were statutory requirements for coverage of a small number of vaccines under Part B before the 2006 start of the of the Part D benefit, which is delivered through prescription drug plans that contract with Medicare. Vaccines previously covered under Part B remain covered through that part of Medicare, while others are covered under Part D.

Vaccines for influenza, pneumococcal disease, and hepatitis B (for patients at high or intermediate risk), and vaccines needed to treat an injury or exposure to disease are covered under Part B. All other commercially available vaccines needed to prevent illness are covered under Medicare Part D. Vaccine pricing, provider reimbursement, and patient out-of-pocket costs vary under both parts of Medicare.

Cost to patients

For the influenza, pneumococcal pneumonia, and hepatitis B vaccines covered under Medicare Part B, patients currently face no cost sharing for either the vaccine itself or its administration. For other Part B covered drugs and services, Medicare covers 80% of the cost, and beneficiaries are responsible for the remaining 20%. Cost sharing for the COVID-19 vaccine is discussed below. The majority of beneficiaries in traditional Medicare have supplemental insurance—such as Medigap, employer sponsored coverage, or Medicaid—that covers some or all of the 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 across plans.

As mentioned above, all commercially available vaccines that are not covered under Part B are required to be covered under Part D. Unlike Part B, Part D plans have flexibility to determine how much enrollees will be required to pay for any given on-formulary drug, including vaccines. (Part D enrollees who receive low-income subsidies (LIS) generally pay relatively low amounts for vaccines and other covered drugs.) For example, in 2018, average cost sharing by non-LIS enrollees for a dose of Shingrix, the shingles vaccine, was $57, while average cost sharing for Adacel (Tdap) was $24. Under Part D, cost sharing can take the form of flat dollar copayments or coinsurance (i.e., a percentage of list price). Patients do not pay separate cost-sharing amounts for the vaccine and its administration.

Vaccine price

For the influenza and pneumococcal vaccines covered under Part B, Medicare reimbursement is set at 95% of the Average Wholesale Price (AWP), except when furnished in a hospital outpatient setting, in which case reimbursement is based on reasonable cost. Medicare publishes an annual list of payment allowance limits for the influenza vaccines available in a given season. AWP is a publicly available, suggested price for sales of a drug by a wholesaler to a pharmacy or other provider. It is akin to a sticker price and used as a starting point for negotiation for payments to retail pharmacies. For other Part B covered drugs, reimbursement is 106% of the Average Sales Price (ASP). ASP is the average price to all non-federal purchasers in the United States and includes volume discounts, prompt pay discounts, cash discounts, free goods that are contingent on any purchase requirement, chargebacks (other than chargebacks for 340B discounts), and rebates (other than rebates under the Medicaid drug rebate program). The discounts and rebates factored into ASP are not accounted for in AWP.

Because the Part D benefit is administered by private drug plans, which are sponsored by private insurers and pharmacy benefit managers (PBMs), vaccine pricing and reimbursement will vary depending on negotiations between manufacturers and plans. This can lead to different prices paid for the same vaccine by different Part D plan sponsors, and different cost sharing among enrollees across 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 for each vaccine and how price sensitive patients are to higher out-of-pocket costs if a vaccine is placed on a higher tier.

COVID-19 vaccine requirements

Under the CARES Act and an accompanying interim final rule² , Medicare beneficiaries will have coverage for COVID-19 vaccines through Medicare Part B with no cost sharing (rather than the typical 20% coinsurance). This coverage applies whether the vaccine receives FDA authorization through an Emergency Use Authorization (EUA) or is licensed under a Biologics License Application (BLA). Covering a COVID-19 vaccine under Part B rather than Part D will ensure broader coverage for the vaccine under Medicare since not all beneficiaries are enrolled in a Part D plan.

While Medicare will not pay for the initial doses of the COVID-19 vaccine already purchased by the government, if eventually the vaccine is reimbursed by Medicare, it will be reimbursed at 95% of AWP.³  That is the same formula used for influenza and pneumococcal vaccines.

Private Health Insurance

About 55% of people in the U.S. have private health insurance, and the vast majority of them are covered through employer-sponsored insurance. All non-grandfathered employer-sponsored health plans and individually purchased insurance from the Marketplaces are subject to certain coverage requirements and standards included in the Affordable Care Act (ACA). ACA-compliant individual coverage purchased off the marketplaces are subject to those requirements as well. However, the Trump Administration has expanded access to short-term plans, which are not subject to any federal coverage standards.

Cost to patients

Individual and employer-sponsored private health plans subject to the ACA’s preventive services coverage standards must provide coverage for individuals to receive vaccines that ACIP recommends without cost sharing. When a new vaccine is added to ACIP’s recommendations, plans must update their coverage once a new plan year starts following one year after the date when the CDC adopts that recommendation.⁴  Requirements specific to the COVID-19 vaccine are described below. Coverage for recommended vaccines is provided without cost sharing even for beneficiaries who have not reached their deductible. Short-term plans do not have to meet such standards and can require that beneficiaries pay cost sharing for vaccines or can exclude recommended vaccines from coverage altogether.

Vaccine price

There are no federal limits or rules regarding the price of vaccines or other prescription drugs in the private market. However, the inclusion of economic analysis in the development of ACIP recommendations may help to tamp down on prices for vaccines as compared to other medicines where there is no equivalent federal use of such analysis.

As with other medicines, rebates and other price concessions from drug manufacturers lower the net price of vaccines in many cases, although the size of those price concessions vary based on the competitive dynamics for each pharmaceutical product, along with other factors. Rebates and other price concessions are not made public, so we do not have data on the size of rebates for vaccines, how much the prices private plans pay for vaccines and how the prices vary from the list prices included in Table 3. It is possible that requirements for plans to cover vaccines without cost sharing may limit their ability to negotiate large rebates for vaccines.

COVID-19 vaccine requirements

The CARES Act requires that employer-sponsored and individual health plans subject to the ACA’s preventive services standards cover a coronavirus vaccine without cost sharing 15 days after it is recommended by ACIP.⁵  This will ensure that a coronavirus vaccine is covered by private insurance more quickly than the longer timeframe typically required for private health plans to incorporate a new ACIP recommendation. The guarantee is tied to the ACA provision requiring private insurers to cover vaccines, so it could be voided if the Supreme Court overturns the ACA.

During the public health emergency, private health insurance plans will be required to cover all the costs of a COVID-19 vaccine even if an out-of-network provider administers it.⁶  The Trump Administration’s interim final rule states that Medicare’s payment rate will be considered a reasonable rate for coronavirus preventive services, including administration of a COVID-19 vaccine.⁷  Additionally, vaccine providers may not seek any reimbursement, including through balance billing, from a vaccine recipient.⁸ 

Vaccines for Children Program

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 extended from 1989 through 1991. In 2020, the program had a budget of about $4.8 billion. Under this program, the CDC purchases vaccines directly from manufacturers and distributes them to grantees (i.e. state health departments and some local health agencies). Those partners then distribute the vaccines at no charge to private physicians’ offices and public health clinics registered as VFC providers. Vaccines recommended by ACIP are included in the VFC program. More than half of young children and one-third of adolescents in the United States are eligible to receive vaccinations through this program.⁹ 

Children under age 19 are eligible for the VFC program if they are Medicaid-eligible, uninsured, or American Indian or Alaska Native. Children can also qualify if their insurance has a cap on vaccine coverage that the child has surpassed or if their insurance does not cover all or certain vaccines.¹⁰  Those types of limitations on vaccine coverage are not permitted under standards established by the ACA,¹¹  but some grandfathered plans or short-term plans may include these limitations on vaccine coverage.

Cost to patients

Children get vaccines for free through the VFC program, but participating health care providers can charge for other services including administering vaccines and office visits. The fees for vaccine administration are limited by regulation, and children cannot be denied a vaccine because they cannot afford the administration fee itself, but the VFC program allows providers to refuse to see qualifying children if the provider will not be paid for the office visit. For children with Medicaid, the office visit and vaccine administration are covered by Medicaid with no cost sharing.¹²  Children who are uninsured may be eligible for free or reduced cost office visits and vaccine administration 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 available in 1993 but no cap for newer vaccines. States can purchase additional vaccines at the VFC price for children who are not eligible for the program. Table 3 compares VFC prices for vaccines to the list prices and the prices paid by other federal programs. On average, the price the CDC pays for vaccines purchased through the VFC program is about 30% less than the list price. The level of discount off of the list price varies substantially and ranges 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 one provider experiences problems in the supply chain. To help ensure sufficient supply, the statute also requires the Secretary to purchase six months of additional vaccine supply beyond what would otherwise be required.¹⁴ 

COVID-19 vaccine requirements

The CDC will determine if COVID-19 vaccine(s) 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 uninsured children can be reimbursed using the $175 billion provider relief fund created by the CARES Act, which the Trump Administration has stated it will use to cover vaccine-related administration costs for people who are uninsured. As of November 10, 2020, about $30 billion remained in that fund. However, it is unclear how well that system will work given that there have been challenges with a similar system for reimbursing for treatment for uninsured COVID-19 patients. It also not clear when there will be a vaccine available to children. The Food and Drug Administration said on October 22 that they do not know yet if the vaccine candidate(s) authorized or approved will be recommended for children.

Medicaid and CHIP

Preliminary data for July 2020 show that Medicaid and CHIP provide health insurance coverage to 75.5 million low-income Americans. Medicaid coverage for vaccines varies based on age, eligibility pathway, and state. Vaccines are an optional benefit for certain adult populations, including low-income parent/caretakers, pregnant women, and persons who are eligible based on old age or a disability. For adults enrolled under the ACA’s Medicaid expansion and other populations for whom the state elects to provide an “alternative benefit plan,” their benefits are subject to certain requirements in the ACA, including coverage of ACIP-recommended vaccines with no cost sharing.¹⁷  There are separate coverage requirements for the COVID-19 vaccine during the time that states are receiving enhanced federal matching funds under the Families First Coronavirus Response Act, and those are discussed below.

All states provide some vaccine coverage for adults enrolled in Medicaid who are not covered as part of the ACA’s Medicaid expansion, but as of 2019, only about half of states covered all ACIP-recommended vaccines.¹⁸  The ACA provides an incentive to 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 vaccines must provide that coverage for all low-income parent/caretakers, people eligible based on old age or disability, and pregnant women eligible for full state plan benefits.²⁰ 

Medicaid-eligible children under 19—including those covered under a Medicaid-expansion Children’s Health Insurance Program (CHIP) program—are covered under the Vaccines for Children Program, where they receive vaccinations at no cost. Children covered by separate CHIP programs are not covered by Vaccines for Children, but age-appropriate vaccines are a required CHIP benefit.²¹  States must purchase vaccines for these children using CHIP funds, not Vaccines for Children funding.^22 ,23 

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 vaccine to a patient if they cannot pay their share of costs.²⁴  Adults in the Medicaid expansion population, and other populations for whom the state elects to provide an “alternative benefit plan,” must receive preventive vaccines with no cost sharing. Other Medicaid populations generally exempt from cost sharing include most children under 18, most pregnant women, most children in foster care, people in institutions with a share of cost, people in hospice, and people receiving Indian health care provider services; other adults may be subject to nominal charges at state option.²⁵  Children under 19 covered by Medicaid or CHIP receive recommended vaccines without cost sharing, including the office visit and administration.^26 ,27  Young adults covered by Medicaid aged 19-20 are eligible for the Early, Periodic, Screening, Diagnostic, and Treatment (EPSDT) benefit, which includes vaccine coverage, but they may face cost sharing at state option if they are not enrolled in an alternative benefit plan.

Vaccine price

Vaccines are excluded from the Medicaid Drug Rebate Program (MDRP). The MDRP requires Medicaid programs to cover all FDA-approved drugs from participating manufacturers in exchange for rebates to Medicaid to offset the cost of prescription drugs.²⁸  The program ensures Medicaid pays among the lowest prices for drugs and provides access to medications for enrollees. Excluding vaccines from the MDRP has both cost and coverage implications, as states are not required to cover all vaccines and do not receive rebates, which are a significant offset to Medicaid pharmacy spending.

States reimburse providers for administering vaccines, and reimbursement varies widely across states. States generally set payment rates for provider reimbursement through fee schedules and have broad flexibility within federal guidelines to determine payment rates.²⁹  Payment rates for vaccines provided through fee-for-service (FFS) Medicaid may differ from those provided through managed care.^30 ,31  Most states’ FFS fee schedules make a payment for vaccine administration in addition to reimbursing for the vaccine, and some states may reimburse for an office visit fee.³²  Due to this wide state variation, there is no one price paid by 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 the CDC for vaccines that it purchases and also sometimes greater than manufacturer list price of a vaccine: for example, median FFS reimbursement for Hepatitis B vaccines ranged from 188% to 251% of the price paid by the CDC for vaccines and from 113% to 153% of list price.³⁴ 

COVID-19 vaccine requirements

Under the Families First Coronavirus Response Act, coverage of testing and treatment for COVID-19, including vaccines, is required with no cost sharing in order for states to access temporary enhanced federal funding for Medicaid.³⁵  All states have taken up this enhanced federal funding and are therefore subject to these requirements. Under these rules, states also must compensate Medicaid providers for an administration fee or office visit, even if the vaccine is provided free of charge.³⁶  To receive enhanced federal funding, states must also provide continuous coverage for individuals enrolled as of 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 some changes between eligibility categories, but beneficiaries may not lose access to COVID-19 testing and treatment services if this was included in their original coverage on or after March 18, 2020.³⁷ 

The enhanced federal funding and COVID-19 vaccine coverage requirements are tied to states’ receipt of enhanced federal matching funds during the COVID-19 Public Health Emergency (PHE) declaration and only last through the end of the quarter in which the PHE ends.³⁸  This means requirements to cover a coronavirus vaccine at no cost to enrollees will expire if the PHE is not renewed. Regular Medicaid rules regarding coverage of and cost sharing for vaccines (described above) will apply after the end of the PHE. HHS could continue to extend the PHE or Congress could pass additional legislation extending maintenance of effort requirements for COVID-19 vaccine coverage and enhanced federal funding or otherwise addressing Medicaid COVID-19 vaccine coverage.

Section 317 of the Public Health Services Act: Vaccines for Uninsured Adults

There is no federal entitlement program for uninsured adults to receive free vaccines similar to the VFC program for children. However, the federal government purchases a limited number of vaccines directly for uninsured and other qualifying adults through funding that comes from Section 317 of the Public Health Services Act. Section 317 is also used to provide funding to support public health infrastructure in the United States at the federal and state and local levels, and more than three-quarters of the program’s total funding is used for that purpose. Section 317 is a discretionary program, and its total budget in 2020 was about $616 million.³⁹  Some states supplement the federal funding they get from Section 317 with state funds in order to reach more people.

After the ACA was passed, the CDC updated the eligibility criteria for adults to get vaccines through Section 317.⁴⁰  As of 2012, adults are eligible for vaccines through Section 317 if they 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

Uninsured adults may be able to get free vaccines from their state or local health department or a community health center through Section 317. Because Section 317 is a discretionary program and its budget for each year is fixed, federal funding for vaccines for uninsured adults does not increase automatically if the number of uninsured increases or if the cost of vaccines increases. The limited amount of funding available for vaccines purchased through Section 317 may be one factor contributing to lower influenza vaccination rates for uninsured adults. While about 40% of adults 18-64 with private or public insurance got the flu vaccine in 2018, just 16% of uninsured adults did so.

Vaccine price

As under the VFC program, the CDC negotiates prices for vaccines purchased through Section 317. Table 3 lists the prices the CDC pays for vaccines for adults purchased through Section 317. On average, the CDC price is about 40% less than the list price. The level of discount off of the list price varies substantially and ranges from 24% below list price to 59% below list price. Local entities providing vaccines under Section 317 may also have other sources of funding they use to pay for vaccines for people who are uninsured and can purchase additional doses at the Section 317 price.⁴²  They also may be able to obtain free or discounted vaccines from pharmaceutical manufacturers’ patient assistance programs.

COVID-19 vaccine requirements

Providers that participate in the CDC COVID-19 Vaccination Program contractually agree to administer a COVID-19 vaccine regardless of an individual’s ability to pay and regardless of their coverage status.⁴³  This means that people who are uninsured should be able to get the COVID-19 vaccine from a wider range of providers than just those that participate in Section 317. Providers that administer the COVID-19 vaccine to the uninsured will be reimbursed for vaccine administration costs through the $175 billion provider relief fund created by the CARES Act. The Trump Administration recently clarified that this fund will also be used to reimburse providers for people who have limited Medicaid benefits that do not include vaccine coverage, such as individuals 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 is also being used to pay for COVID-19 treatment costs for people who are uninsured, as well as broader provider relief related to the pandemic. Once the government has distributed the initial doses of COVID-19 vaccine(s), more funding may be needed through Section 317 or other programs to ensure there are sufficient vaccine doses for everyone who is uninsured if the vaccine is needed on an ongoing basis.

Additional outreach from trusted sources may also be needed to reach people are uninsured since they are less likely to have a usual source of care than those who are insured. It will be important for people who are uninsured to understand both the importance of getting a vaccine once one is 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 appropriate education and outreach to people who are uninsured.

Department of Veterans Affairs

The Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA) is an integrated health care delivery system serving qualifying veterans. The VHA estimates that in 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 from military service. Veterans generally must also meet minimum service requirements; however, exceptions are made for certain circumstances, including discharge due to service-connected disabilities.⁴⁶ 

Cost to patients

The VA health system does not charge cost sharing for preventive care, including vaccinations.⁴⁷ 

Vaccine price

In order to participate in Medicaid and Medicare Part B, drug manufacturers must sell their medicines at a discount to the VA, along with the other three of the “Big Four” government agencies (U.S. Department of Defense, U.S. Public Health Service, and U.S. Coast Guard). The VA is in some cases able to negotiate even steeper discounts in return for preferential placement on its drug formulary. The “Big Four” price is the lower of two prices determined by formula:

• Federal Ceiling Price: A minimum 24% discount off the “non-Federal Average Manufacturer Price” (non-FAMP) plus additional discounts if non-FAMP rises faster than inflation. The non-FAMP is the average price paid to manufacturers by wholesalers for drugs distributed to non-federal purchasers. The price takes into account any price reductions given to wholesalers, but does not account for rebates to PBMs or other third parties. A statutory formula requires additional discounts, if necessary, to prevent the federal ceiling price from rising faster than the rate of inflation.
• Federal Supply Schedule (FSS) Price: The VA negotiates FSS prices with manufacturers on the basis of the prices that manufacturers charge their most-favored commercial customers under similar terms and conditions. During multiyear contracts, the FSS price may not increase faster than inflation.

These statutory discounts result in an average discount of about 40% off of 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 solely consisting of preventive screening and vaccinations (e.g., influenza vaccination, pneumococcal vaccination).”⁴⁸  There are currently no VA-specific requirements related to a COVID-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 brief, 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 to insurance requirements were needed in order to ensure access to a COVID-19 vaccine with no cost sharing once a vaccine is approved and available. For other vaccines, there are no universal standards to ensure that ACIP-recommended vaccines are available to everyone with no cost for either the vaccine or its administration.

There is also no one system for vaccine pricing. HHS negotiates the price of vaccines directly with manufacturers and purchases vaccines through the Vaccines for Children Program and Section 317. Other vaccine prices are largely set by a mix of statutory 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 remains unclear how many additional doses of COVID-19 vaccines may eventually be needed, by when, and how long immunity will last under a COVID-19 vaccine. If, in the future, the COVID-19 vaccine becomes a regular, annual vaccine, it is expected that it would eventually be covered through the same programs and types of insurance that are currently used to pay for other vaccines. If concerns arise about the eventual cost of COVID-19 vaccine(s) or other vaccines to federal and state governments and private payers, policymakers may look to rules that already govern vaccine pricing and reimbursement in different markets to leverage the government’s buying power.

 

1. 85 Fed. Reg. 71142, 71175 (Nov. 6, 2020). ↩︎
2. H. R. 748 § 3713; 85 Fed. Reg. at 71146. ↩︎
3. 85 Fed. Reg. at 71147. ↩︎
4. 80 Fed. Reg. at 41322. ↩︎
5. H.R. 748 § 3203. ↩︎
6. 85 Fed. Reg. at 71175. ↩︎
7. 85 Fed. Reg. at 71175. ↩︎
8. 85 Fed. Reg. at 71175. ↩︎
9. Department of Health and Human Services, “Putting America’s Health First: FY 2021 President’s Budget for HHS,” p. 46. Available at: https://www.hhs.gov/sites/default/files/fy-2021-budget-in-brief.pdf?language=en ↩︎
10. Children whose health insurance covers the cost of vaccinations are not eligible for VFC vaccines, even if the vaccine is subject to the plan’s deductible. Underinsured children are eligible to receive vaccines only at Federally Qualified Health Centers or Rural Health Clinics. ↩︎
11. 42 U.S.C. § 300gg-13. ↩︎
12. Children enrolled in the Children’s Health Insurance Program through Medicaid expansion CHIP have the same coverage as other children with Medicaid. Children with separate CHIP coverage are considered to have private health insurance. A list of CHIP program names and the type of program in each state is available at https://modern.kff.org/other/state-indicator/chip-program-name-and-type/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D. ↩︎
13. 42 U.S.C. § 1396s (d)(3). ↩︎
14. 42 U.S.C. § 1396s (d)(6). ↩︎
15. 85 Fed. Reg. at 71149. ↩︎
16. 85 Fed. Reg. at 71149. ↩︎
17. 42 U.S.C. § § 1396a (k)(1); 1396u-7; 18022; 42 C.F.R. § 440.345 (d). ↩︎
18. 24 of 39 states in a CDC study. Granade CJ, McCord RF, Bhatti AA, Lindley MC. State Policies on Access to Vaccination Services for Low-Income Adults. JAMA Netw Open. 2020;3(4):e203316. doi:10.1001/jamanetworkopen.2020.3316 ↩︎
19. 12 of 44 states in a CDC study. Granade CJ, McCord RF, Bhatti AA, Lindley MC. State Policies on Access to Vaccination Services for Low-Income Adults. JAMA Netw Open. 2020;3(4):e203316. doi:10.1001/jamanetworkopen.2020.3316 ↩︎
20. Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 71142 (Nov. 6, 2020), https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency. ↩︎
21. CMS has stated vaccines are optional for pregnant women covered by CHIP, though it notes that all states covering this population do provide vaccines. Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 71142 (Nov. 6, 2020), https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency. ↩︎
22. https://www.medicaid.gov/chip/benefits/index.html ↩︎
23. https://www.medicaid.gov/sites/default/files/2019-11/chip-vaccines.pdf ↩︎
24. 42 U.S.C. § § 1396a (a)(14); 1396o. ↩︎
25. https://modern.kff.org/medicaid/issue-brief/data-note-medicaids-role-in-providing-access-to-preventive-care-for-adults/ and http://files.kff.org/attachment/preventive-services-covered-by-private-health-plans-under-the-affordable-care-act-fact-sheet ↩︎
26. Medicaid-eligible children fall under VFC requirements. https://www.cms.gov/files/document/03052020-medicaid-covid-19-fact-sheet.pdf ↩︎
27. For children with CHIP, well-child visits including immunizations must be covered without “deductibles, coinsurance, or other cost sharing” 42 U.S.C. § 1397cc (c), (e). ↩︎
28. 42 U.S.C. § 1396r-8 (k)(2)-(4). ↩︎
29. Pursuant to 42 U.S.C. § 1396a (a)(30)(A), state Medicaid programs must ensure that provider payments are “consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers. . . .” ↩︎
30. Most states deliver services through capitated managed care, which means states make a set per member per month payment. https://modern.kff.org/medicaid/issue-brief/10-things-to-know-about-medicaid-managed-care/ ↩︎
31. Payment rates are set differently for FFS Medicaid and for managed care Medicaid. See https://www.macpac.gov/medicaid-101/provider-payment-and-delivery-systems/ ↩︎
32. 41 of 49 states make a payment under FFS Medicaid and the median payment is $13.62 Granade CJ, McCord RF, Bhatti AA, Lindley MC. State Policies on Access to Vaccination Services for Low-Income Adults. JAMA Netw Open. 2020;3(4):e203316. doi:10.1001/jamanetworkopen.2020.3316 ↩︎
33. Granade CJ, McCord RF, Bhatti AA, Lindley MC. State Policies on Access to Vaccination Services for Low-Income Adults. JAMA Netw Open. 2020;3(4):e203316. doi:10.1001/jamanetworkopen.2020.3316 ↩︎
34. Granade CJ, McCord RF, Bhatti AA, Lindley MC. State Policies on Access to Vaccination Services for Low-Income Adults. JAMA Netw Open. 2020;3(4):e203316. doi:10.1001/jamanetworkopen.2020.3316 ↩︎
35. This requirement does not apply to populations with limited benefit packages, for example, family planning services, TB-related services and the new COVID-19 testing group. Instead, CMS directs providers to seek reimbursement through the HRSA Provider Relief Fund. See Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 71142 (Nov. 6, 2020); https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency. ↩︎
36. Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 71142 (Nov. 6, 2020); https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency. ↩︎
37. Ibid. ↩︎
38. Enhanced federal funding and test/treatment requirements expire at the end of the quarter in which the PHE ends. See https://modern.kff.org/medicaid/issue-brief/medicaid-maintenance-of-eligibility-requirements-issues-to-watch-when-they-end/. ↩︎
39. Department of Health and Human Services, “Fiscal Year 2021 Centers for Disease Control and Prevention Justification of Estimates for Appropriation Committees,” page 51. Available at: https://www.cdc.gov/budget/documents/fy2021/FY-2021-CDC-congressional-justification.pdf ↩︎
40. Section 317 vaccines funds may be used for children in the following specific circumstances: to vaccinate newborns receiving the birth dose of hepatitis B prior to hospital discharge that are covered under bundled delivery or global delivery package (no routine services can be individually billed) that does not include hepatitis B vaccine and also fully insured infants of hepatitis B infected women. ↩︎
41. Adults not covered for vaccines and therefore eligible for Section 317 vaccines includes adults on Medicaid who do not have coverage for specific vaccines and are eligible for those vaccines through Section 317; adults living in correctional facilities and jails and household or sexual contacts of a hepatitis B infected individuals are also eligible for vaccines through Section 317. ↩︎
42. Institute of Medicine (US) Committee on the Immunization Finance Dissemination Workshops. Setting the Course: A Strategic Vision for Immunization: Part 2 Summary of the Austin Workshop. Washington (DC): National Academies Press (US); 2002. ↩︎
43. 85 Fed. Reg. at 71175. ↩︎
44. 85 Fed. Reg. at 71149. Limited Medicaid benefit packages that may not include vaccine coverage include pregnancy-related services only (in states where this benefit package is not considered minimum essential coverage); tuberculosis-related services only; family planning services only; medically needy services (in states where this benefit package is not considered minimum essential coverage); breast/cervical cancer services only; COVID-19 testing services only; and Section 1115 waivers that provide limited benefit packages such as those focused on the progression of a specific disease. ↩︎
45. Congressional Research Service, “Health Care for Veterans: Answers to Frequently Asked Questions,” March 4, 2020. ↩︎
46. Congressional Research Service, “Health Care for Veterans: Answers to Frequently Asked Questions,” March 4, 2020. ↩︎
47. 38 C.F.R. § 17.108 (e)(11). ↩︎
48. 38 C.F.R. § 17.108 (e)(11). ↩︎

Introduction

With the U.S. still in the midst of an escalating COVID-19 pandemic, attention to the race for a safe and effective COVID-19 vaccine has intensified. What is clear is that when vaccines do become available, ensuring equitable and rapid distribution to the U.S. population will present an unprecedented challenge. The Trump Administration, under Operation Warp Speed, has already purchased in advance hundreds of million doses of several vaccine candidates, two of which have already demonstrated significant efficacy in Phase 3 clinical trials, and has begun planning for what will be the largest scale vaccination distribution effort ever undertaken in the U.S. This task will soon be inherited by the incoming Biden Administration, which has established a COVID-19 Task Force and is already planning its response.

A limited number of COVID-19 vaccine doses may start to become available as early as December, with more doses available over time. State, territorial, and local governments, who already have primary authority over routine vaccination, will play an increasingly important role in the distribution of these vaccines as more doses become available. In preparation, the federal government has asked the 64 jurisdictional immunization programs (all 50 states and DC, 8 U.S. territories and freely associated Pacific states and five cities) that the Centers for Disease Control and Prevention (CDC) funds and works with to develop COVID-19 vaccine distribution plans based on an Interim Playbook. The Playbook includes planning assumptions for jurisdictions to follow and requested information in 15 key areas (see Box). First drafts of these plans were due by October 16.

CDC guidance and federal oversight could evolve over the next several months as vaccines become available and distribution begins. The Biden campaign and transition team have planned for a more prominent role for the federal government in the U.S. COVID-19 response, which would likely include more detailed federal guidance and a stronger federal hand in vaccine distribution, planning and implementation, even as state and local jurisdictions will remain responsible for much of this effort. A critical challenge facing vaccine distribution efforts will be funding. To date, only $200 million has been distributed to state, territorial, and local jurisdictions for vaccine preparedness, though it is estimated that at least $6-8 billion is needed. President-elect Biden has said his administration would seek to invest $25 billion in manufacturing and distribution, which would require Congressional action.

While the CDC has made executive summaries of these plans available, there is no central repository for the full plans. We therefore sought to collect plans available from all 50 states and DC, as of November 13, identifying 47 full state plans in total (linked in the “State Plans” tab). We then reviewed each plan to gauge how states described their vaccine distribution planning progress to date. Rather than assess every single component of these plans in detail we identified common themes and concerns across the state plans, in particular focusing on what states reported regarding their progress in the following key areas:

• identifying priority populations for vaccination in their state;
• identifying the network of providers in their state that will be responsible for administering vaccines;
• developing the data collection and reporting systems needed to track vaccine distribution progress; and
• laying out a communications strategy for the period before and during vaccination.

Where are States in their Planning?

Based on the information in their plans, states are in varying stages of preparation for distributing a COVID-19 vaccine. While all have established a task force or planning committee to steer these efforts, which include representatives from different sectors, some have been planning for several months while other states’ planning efforts have started more recently. Some states have already begun the process of signing up providers to administer COVID-19 vaccines and building out existing immunization registries, while others are still just developing plans to do the same. All reported, however, that these initial plans are to be considered drafts only, to be updated as more information from the federal government and about a vaccine itself was available. Specifically, almost all cited the need to know which vaccine(s) would be authorized or approved, and that they will look to further federal guidance and recommendations before some key decisions are made, such as finalizing which individuals will be targeted as priority populations. Several raised concerns about the lack of visibility regarding vaccine distributions that will be made directly from the federal government to certain providers in their states, such as large pharmacy chains. These concerns were raised before the November 12 announcement by the federal government that it will be distributing future COVID-19 vaccines directly to some independent pharmacies and multi-state pharmacy chains across the U.S., in parallel to state efforts to recruit vaccination providers. States also discussed lessons learned from previous vaccine distribution efforts such as H1N1 pandemic influenza, including the need to build flexibility into distribution plans when supply is unpredictable and tailoring messages and outreach to diverse populations, which are certain to be challenges for a COVID-19 vaccine as well. Finally, even recognizing the that states are in different states of readiness in terms of their distribution planning efforts, it is clear all state health departments are taking this responsibility seriously and are overseeing significant efforts to make progress in their preparations.

Priority Populations¹ 

Each state will have to determine exactly who will be first in line to receive the likely limited number of vaccine doses that will be made available initially. In their plans, almost every state reports they are relying heavily on guidance from the federal government to define who these priority populations are, drawing on recommendations from the National Academies of Medicine and also expecting additional guidance from the CDC’s Advisory Committee on Immunization Practices. Many states report they will shape their prioritization plans using locally-defined criteria as well. Every state plan highlights the following broad categories as being priority populations for Phase 1 efforts: health care workers, essential workers, and those at high risk (older people and those with pre-disposing health risk factors). Most plans recognize (and CDC indicated in its guidance) that there will likely not be enough vaccines at first for all individuals identified in these Phase 1 priority groups. Even so, plans show that some states are much further along in defining prioritization categories and enumerating the number of people that fall into those categories. For example:

• Less than half (19 of 47, or 40%) of state plans reviewed include a numerical estimate of the number of individuals in different priority populations; the majority of states report they are still developing their data sources and methodology to calculate the number in their priority groups.
• Some states report already developing specific estimates of the numbers of health care workers likely among the first individuals targeted for vaccination, while other states do not include these estimates, or mention that they are working on developing methods to identify the numbers to be targeted in this group.
• A majority of states (25 of 47, or 53%) have at least one mention of incorporating racial and/or ethnic minorities or health equity considerations in their targeting of priority populations. Some states expect to make racial and ethnic minorities an explicit priority population group, while others report using more general or indirect methods to do so, such as through use of the social vulnerability index (as was recommended by the NAM) and/or a Health Equity Team or Framework, as in the case of Arizona, California, Georgia, Louisiana, New Jersey, Ohio, and Vermont.

Providers

Each state will rely on a network of providers to administer the vaccines to individuals. These providers will likely include hospitals and doctors’ offices, pharmacies, health departments, federally qualified health centers, and other clinics that play a role in administering vaccines today. However, given the need to quickly vaccinate most residents, states will need to include additional partners, such as long-term care facilities, in the network and will potentially establish mass vaccination sites in public locations like schools and community centers. Prior to distribution and administration of vaccines, states will have to identify, vet, and approve hundreds to thousands of partners and site locations for vaccine delivery. According to the draft plans, states are at different points in the process of identifying these providers and expanding their network of providers needed to deliver vaccines to priority population groups. States that require providers to participate in immunization registries or those that already have most providers participating in these registries are further along in developing their provider networks, while other states report that they still need to start the process of enrolling providers.

• Less than a third (13 of 47, or 28%) of states’ plans provide an estimate of the number of vaccine providers in the state, and only six provide some estimate of the number of providers by type (though some of these are limited to only one provider type).
• About half (24 of 47, or 51%) report an estimate of the number of providers already participating in their immunization registries. A few states have also begun specific outreach to register as COVID-19 providers, although these efforts are in their beginning phases. At the same time, some states, particularly rural states, raise concerns about the lack of personnel to carry out vaccination in some areas, or how they will be able to send small enough batches of vaccines to be distributed by rural providers who may only be vaccinating a limited number of individuals.
• Only a subset (12 of 47, or 26%) of state plans specifically mention or consider providers that are needed to reach racial and ethnic minorities.
• Across plans, the most common types of providers that states report still needing to reach out to or incorporate as COVID-19 vaccine providers include: tribal providers, long-term care facilities, correctional facilities, and other types of adult care providers.

Data Collection and Reporting

All states have an immunization registry of one kind or another to track vaccinations administered by providers in their state. These registries range in terms of their comprehensiveness and reporting functionality. To incorporate the data collection and reporting needs for COVID-19 vaccination, many states are relying on (and often expanding) existing state-level immunization registries, while other states are developing new systems or using systems provided by the federal government. From the information in the draft plans, it is clear that some states are in a much better position in terms of their data collection and reporting capacity for COVID-19 vaccines, while others have more work to do to develop their systems, In addition, some common issues have been raised by states in their plans.

• Just over half (25 of 47, or 53% ) of state plans report having immunization registries/database systems in place that are described as being (at least fairly) comprehensive and reliable; in the other state plans that information is unclear. Most states report still having to develop or add functionality to their existing immunization registries to be prepared for COVID-19 vaccine administration.
• Most states report they will have no issues reporting the key data from their immunization registries to federal systems, though at least fifteen states report that data sharing agreements with federal partners are still being reviewed or remain in process.
• Several states raise concerns about the ability to report certain CDC-recommended data elements to federal systems or meet CDC time requirements for reporting. States also mention limitations in collecting race/ethnicity data on individuals vaccinated.
• Virtually all states’ plans incorporate expectations and procedures to report any vaccine adverse events through federal reporting systems such as the Vaccine Adverse Events Reporting System (VAERS).

Communications

Developing a communications plan before and during COVID-19 vaccination will be critical component of state planning. CDC requested that states outline how they will proactively design communication plans that anticipate and respond to the needs and concerns of different population groups. This includes the need to address misinformation and vaccine hesitancy, as well as crisis communications. Some states’ plans have very detailed explanations of their approach to communications across the vaccination phases, while others provide very little detail. Additionally, some state plans recognize the need to develop targeted messaging for vulnerable populations, while others do not.

• About half (23 of 47, or 49%) of plans specifically mention racial/ethnic minorities or vulnerable populations when discussing COVID-19 vaccine communication.
• Just over a third (18 of 47, or 38%) of state plans include at least a mention of addressing vaccine misinformation but most of these states do not provide specific strategies for countering misinformation.

Links to State Plans

1. While jurisdictions were asked to reach out to tribal nations within their respective areas for involvement in planning efforts, tribal nations have sovereign authority to provide for the health and welfare of their populations. This authority includes decisions around access to and distribution of the vaccine as well as establishing priority groups to receive the vaccine. We did not review state plans to assess their reported coordination efforts with tribal nations, including for outreach to tribal populations. ↩︎