The Coronavirus Disease 2019 (COVID-19) pandemic is affecting communities around the world and throughout the United States, with case counts growing dailyCOVID-19 and Private Health Insurance August 24, 2020 Coverage: Frequently Asked Questions Vanessa C. Forsberg The United States is reporting some of the highest numbers of cases and deaths from the Analyst in Health Care Coronavirus Disease 2019 (COVID-19) pandemic globally, and the virus is affecting Financing communities nationwide. As private health insurance is the predominant source of health coverage in the United States, there is considerable congressional interest in understanding private health insurance coverage of health benefits related to COVID-19. This report addresses frequently asked questions about private health insurance covered benefits and consumer cost sharing related to COVID-19 testing, treatment, and a potential vaccine. It discusses recent legislation, explains relevant legislation enacted in 2020, references existing federal requirements and, discusses recent administrative interpretations of them in relation to COVID-19guidance, and notes state and private-sector actions.

Federal and state health insurance requirements may relate to covered benefits and consumer cost sharing, among many other topics. These requirements can vary by coverage type (i.e., individual coverage, fully insured small- and large-group coverage, and self-insured plans). Covered benefits, consumer costs, and other plan features may vary by plan within each type of coverage, subject to applicable federal and state requirements.

The following bullets summarize federal requirements related to coverage and cost sharing (which includes deductibles, coinsurance, and copayments) of COVID-19 testing, treatment, and vaccination. Additional details are addressed in the report, including the applicability of the requirements to different types of plans; whether the coverage requirements apply even when furnished by out-of-network providers; whether plans are allowed to impose prior authorization or other medical management techniques; and the applicable dates of any coverage requirements.

•  COVID-19 Testing. The Families First Coronavirus Response Act (FFCRA; P.L. 116-127), ), as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act; P.L. 116-136), ), requires most private health insurance plans to cover COVID-19 testing, administration of the test, and related items and services, as defined by the acts. This coverage must be provided without consumer cost sharing.
•  COVID-19 Treatment. There are no federal requirements that specifically require coverage of COVID-19 treatment. However, the existing federal requirement that certain plans cover a set of 10 categories of essential health benefits (EHB) is potentially relevant to coverage of COVID-19 treatment items and services, depending on state and plan variation with regard to implementation of this requirement. Even where treatment items and services are required to be covered as EHB, cost sharing could apply.
•  COVID-19 Vaccine. As of the date of this report, there is no vaccine against COVID-19 approved by the Food and Drug Administration (FDA) for use in the United States, although several candidates are in development. The CARES Act requires most plans to cover a COVID-19 vaccine, when available, without cost sharing, if it is recommended by the Advisory Committee on Immunization Practices (ACIP). Similarly, most plans must cover, without cost sharing, any other COVID-19 preventive services that are recommended for use by the United States Preventive Services Task Force (USPSTF).

Some states have also announced relevant requirements on the plans they regulate, and some insurers have reported that they will will cover certain relevant benefits. Several organizations are tracking these announcements, as noted in this report.

Congressional Research Service (CRS) experts on other topics related to private health insurance and COVID-19, including types of plans and coverage of benefits not addressed in this report, are listed in thethe Appendix for the benefit of congressional clients. For information on other COVID-19 issues, congressional clients can access the CRS Coronavirus Disease resources page at https://www.crs.gov/resources/coronavirus-disease-2019.

The Coronavirus Disease 2019 (COVID-19) pandemic is affecting communities around the world and throughout the United States, with case counts growing daily. Congressional Research Service link to page 4 link to page 5 link to page 6 link to page 9 link to page 9 link to page 12 link to page 12 link to page 12 link to page 14 link to page 14 link to page 15 link to page 15 link to page 16 link to page 7 link to page 7 link to page 18 link to page 17 link to page 20 FAQ: COVID-19 and Private Health Insurance Coverage Contents Introduction ................................................................................................................... 1 Background on Private Health Insurance ............................................................................ 2 FAQ: COVID-19 Covered Benefits and Cost Sharing ........................................................... 3 Are Plans Required to Cover COVID-19 Testing? .......................................................... 6 FFCRA and CARES Act........................................................................................ 6 State and Private-Sector Actions ............................................................................. 9 Are Plans Required to Cover COVID-19 Treatment?....................................................... 9 Essential Health Benefits Guidance on COVID-19 Coverage ...................................... 9 Certain Federal Requirements Related to Cost Sharing ............................................. 11 State and Private-Sector Actions ........................................................................... 11 Will Plans Be Required to Cover a COVID-19 Vaccine? ................................................ 12 CARES Act and Existing Preventive Services Coverage Requirements....................... 12 State and Private-Sector Actions ........................................................................... 13 Tables Table 1. Applicability of Federal COVID-19 Coverage Requirements to Private Health Insurance Plans ....................................................................................... 4 Table A-1. Resources for Further Questions About Private Health Insurance .......................... 15 Appendixes Appendix. Resources for Questions about Private Health Insurance and COVID-19 ................ 14 Contacts Author Information ....................................................................................................... 17 Congressional Research Service link to page 17 link to page 17 FAQ: COVID-19 and Private Health Insurance Coverage Introduction The United States is reporting some of the highest numbers of cases and deaths from the Coronavirus Disease 2019 (COVID-19) pandemic global y, and the virus is affecting communities nationwide. As private health insurance is the predominant source of health coverage in the United States,¹1 there is considerable congressional interest in understanding private health insurance coverage of health benefits related to COVID-19 diagnosis, treatment, and prevention.

This report addresses frequently asked questions about covered benefits and consumer cost sharing related to COVID-19 testing, treatment, and a potential vaccine. It discusses recent legislation, references relevant explains relevant legislation enacted in 2020, references existing federal requirements and, discusses recent administrative interpretations of them in relation to COVID-19guidance, and notes state and private-sector actions. It begins with background information on types and regulation of private health insurance plans.

The Families First Coronavirus Response Act (FFCRA; P.L. 116-127)²)2 requires specified types of private health insurance plans to cover COVID-19 testing, administration of the test, and related items and services, without consumer cost sharing. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act; P.L. 116-136)³)3 further addresses private health insurance coverage of COVID-19 testing, and requires coverage of a potential vaccine and other preventive services without cost sharing, if they are recommended by specified federal entities. There are no federal requirements that specificallyspecifical y require coverage of COVID-19 treatment services. However, one or more existing federal requirements are potentiallypotential y relevant, as discussed in this report. Some states have also announced requirements related to covered benefits and consumer costs, and some insurers have reported that they will voluntarily wil voluntarily cover certain relevant benefits.

This report discusses most U.S. private health insurance plans'’ coverage of health care items and services related to COVID-19, but it generallygeneral y does not discuss the delivery of those services, insurers'insurers’ payments to health care providers, or private health insurance coverage of other benefits. The The Appendix lists Congressional Research Service (CRS) analysts who can discuss with congressional clients other topics of interest related to private health insurance and COVID-19, including types of plans and coverage of benefits not addressed in this report. Also beyond the scope of this report are public health coverage programs (e.g., Medicare); the domestic and international public health responses to COVID-19; and economic, human services, and other nonhealth issues. For further information on these topics, congressional clients can access the CRS Coronavirus Disease 2019 resources page at https://www.crs.gov/resources/coronavirus- disease-2019.

. The information in this report is current as of its publication date and may be superseded by subsequent congressional or administrative action. Congressional clients may contact the report author and/or the experts listed in thethe Appendix for questions about further developments. In 1 For more information and coverage estimates, see CRS In Focus IF10830, U.S. Health Care Coverage and Spending. 2 H.R. 6201 was signed into law as the Families First Coronavirus Response Act (FFCRA; P.L. 116-127) on March 18, 2020. See CRS Report R46316, Health Care Provisions in the Fam ilies First Coronavirus Response Act, P.L. 116 -127, for more information about the health provisions in the act. 3 H.R. 748 was signed into law as the Coronavirus Aid, Relief, and Economic Security Act (CARES Act; P.L. 116-136) on March 27, 2020. See CRS Report R46334, Selected Health Provisions in Title III of the CARES Act (P.L. 116 -136) for more information about the health provisions in the act. Congressional Research Service 1 link to page 17 link to page 17 FAQ: COVID-19 and Private Health Insurance Coverage for questions about further developments. In addition, Centers for Medicare & Medicaid Services (CMS) guidance related to private health insurance and COVID-19 is compiled on its website.⁴

4 Background on Private Health Insurance

The private health insurance market includes both the group market (largely made up of employer-sponsored insurance) and the individual market (which includes plans directly purchased from an insurer). The group market is divided into smallsmal - and large-group market segments; a small group is typicallytypical y defined as a group of up to 50 individuals (e.g., employees), and a large group is typicallytypical y defined as one with 51 or more individuals.⁵5 Employers and other group health plan sponsors may purchase coverage from an insurer in the smallsmal - and large-group markets (i.e., they may fully insure). Sponsors may instead finance coverage themselves (i.e., they may self-insure).⁶6 The individual and smallsmal -group markets include plans sold on and off the individual and small individual and smal -group health insurance exchanges, respectively.⁷

7 Covered benefits, consumer costs, and other plan features may vary by plan, subject to applicable federal and state requirements. The federal government may regulate all al the coverage types noted above (i.e., individual coverage, fully insured smallsmal - and large-group coverage, and self-insured group plans), and states may regulate all al but self-insured group plans. Federal and state requirements may vary by coverage type.⁸

8 This report focuses on private-sector plans explained above.⁹9 There are some variations of these coverage types, and there are other types of private health coverage arrangements, which may or may not be subject to the requirements discussed in this report, or for which there may be other policy questions related to COVID-19. These other coverage types are out of the scope of this report, but a number of them are identified in thethe Appendix, along with resources for further information.

information. One coverage variation, grandfathered plans, is included in this report because it is explicitly referenced in legislation relevant to COVID-19 and private health insurance coverage. Grandfathered plans are individual or group plans in which at least one individual was enrolled as of enactment of the Patient Protection and Affordable Care Act (ACA; P.L. 111-148, as amended), , as amended), 4 See Centers for Medicare & Medicaid Services (CMS), T he Center for Consumer Information and Insurance Oversight (CCIIO), “ Coronavirus Disease 2019 (COVID-19) Guidance,” accessed April 28, 2020, at https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs#COVID-19. 5 In general, for purposes of health insurance requirements, small groups are those with 50 or fewer individuals (e.g., employees). States can also define them as having 100 or fewer individuals. T he definition of large group is 51 or more individuals, or 101 or more individuals, depending on the definition of small group. 6 Employers and other plan sponsors may purchase coverage from state-licensed insurers and offer it to their employees or other group members. Employers and other plan sponsors that obtain h ealth insurance plans in this way are referred to as being fully insured. Employers or other plan sponsors that self-insure set aside funds to pay for health benefits directly, and they bear the risk of covering medical expenses generated by the individuals covered under the self -insured plan. 7 T he health insurance exchanges are virtual marketplaces in which consumers and small businesses can shop for and purchase private health insurance coverage. For more information, see CRS Report R44065, Overview of Health Insurance Exchanges. 8 For more information about types of plans and regulation of them, see CRS Report R45146, Federal Requirements on Private Health Insurance Plans. 9 In terms of group coverage, this report focuses on group plans sponsored by private-sector employers and other sponsors. Some information in this report may also apply to federal, state, and local government employee group plans. See the Appe ndix for resources on federal employee and other types of government plans. Congressional Research Service 2 link to page 7 link to page 6 FAQ: COVID-19 and Private Health Insurance Coverage and which continue to meet certain criteria.10and which continue to meet certain criteria.¹⁰ Plans that maintain their grandfathered status are exempt from some, but not allal , federal requirements.

Another type of coverage, short-term, limited duration insurance (STLDI or STLD plans), is also included in this report, because it is explicitly excluded from a coverage definition cited by relevant legislation. STLDI is coverage, generallygeneral y sold in the individual market, which meets certain definitional criteria. The statutory definition of "individual “individual health insurance coverage" ” excludes STLDI; thus, STLDI is exempt from complying with all al federal health insurance requirements applicable to individual health insurance plans.¹¹

11 FAQ: COVID-19 Covered Benefits and Cost Sharing

The remainder of this report addresses private health insurance coverage of COVID-19 testing, treatment, and vaccination, when a vaccine becomes available. Where there are federal requirements related to such coverage, it is useful to understand the following:

•  Is the service or item required to be covered? If so, is cost sharing allowed?al owed? In In general, private health insurance cost sharing includes deductibles, coinsurance, and copayments.¹²
• 12  Are plans allowedal owed to impose prior authorization or other medical management requirements? For example, some insurers require that they (the insurer) provide prior authorization for routine hospital inpatient care, and/or require that primary care physicians provide approval or referrals for specialty care, as a condition for covering the care.¹³
• 13  Does the coverage requirement depend on how or where the service or item is furnished (e.g., by an in-network versus out-of-network provider)? Under private insurance, benefit coverage and consumer cost sharing is often contingent upon whether the service or item is furnished by a provider that the insurer has contracted with (i.e., whether that provider is in network for a given plan). In instances where a contract between an insurer and provider does not exist, the provider is considered out of network.¹⁴
• When does  When is the coverage requirement go into effect?
• in effect?  What types of plans are subject to the coverage requirement?

To the extent that information is available, these issues are addressed with regard to private health insurance coverage of COVID-19 testing, treatment, and vaccinationvaccination. Table 1 summarizes key information. 10 T he ACA was enacted on March 23, 2010. For more information about grandfathered plans, see CRS Report R46003, Applicability of Federal Requirem ents to Selected Health Coverage Arrangem ents. 11 See 42 U.S.C. §300gg-91(b)(5). For more information about ST LDI, see the report cited in footnote 10. 12 A deductible is the amount an insured consumer pays for covered health care services before coverage begins (with exceptions). Coinsurance is the share of costs, figured in percentage form, an insured consumer pays for a covered health service. A copaym ent is the fixed dollar amount an insured consumer pays for a covered health service. 13 For more information, see the appendix of CRS Report RL32237, Health Insurance: A Primer. 14 For more information, see the background section of CRS Report R46116, Surprise Billing in Private Health Insurance: Overview and Federal Policy Considerations. Congressional Research Service 3 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 link to page 8 Table 1. Applicability of Federal COVID-19 Coverage Requirements to Private Health Insurance Plans Group Marketc Medical Also Management Applies Fully Insurede Coverage and Cost-Sharing Approaches Out-of- Large Small Self- Individual Authority Requirements Allowed?a Network?b Time Frame Groupg Groupg Insuredf Marketd Testing COVID-19 testing, administration of the FFCRA enactment FFCRA §6001 test, and related items and services, as (March 18, 2020) (as amended by defined, must be covered without cost Prohibited Yes through declared √ (+GF)i √ (+GF)i √ (+GF)i √ (+GF)i CARES Act §3201) sharing. COVID-19 PHE.h Treatment 42 U.S.C. §18022; EHB requirements may apply to coverage of Permanent; existed CMS March 5, 2020, COVID-19 treatment services, subject to Al owed; may No prior to COVID-19 N.A. √ N.A. √ and March 12, 2020, state and plan variation. Cost sharing is vary by plan pandemic. guidancej possible and may vary by plan. Where EHB requirements are applicable, Permanent; existed 42 U.S.C. §18022 certain other requirements are also N.A. No prior to COVID-19 √k √ √k √ applicable, such as the limit on annual out- pandemic. of-pocket spending on EHB benefits. Vaccination COVID-19 vaccination items and services must be covered without cost sharing if 15 business days after recommended by ACIP. Other COVID-19 Al owed; may ACIP or USPSTF CARES Act §3203 preventive items and services must be vary by plan No recommendation; not √ √ √ √ covered without cost sharing if limited to declared recommended by the USPSTF.l COVID-19 PHE. Source: CRS analysis of relevant legislation, statute, regulation, and guidance. Notes: Checkmark (√) indicates that the requirement is applicable to that type of health plan. The variation (√ +GF) indicates that the requirement summarizes key information.

CRS-5 FAQ: COVID-19 and Private Health Insurance Coverage Are Plans Required to Cover COVID-19 Testing?

FFCRA and CARES Act

Prior to the enactment of the FFCRA (P.L. 116-127), there were no federal requirements specificallyspecifical y mandating private health insurance coverage of items or services related to COVID-19 testing.

Section 6001 of the FFCRA, as amended, requires most private health insurance plans to cover COVID-19 testing, administration of the test, and related items and services, as defined in the act. Per FFCRA, theThe coverage must be provided without consumer cost sharing, including deductibles, copayments, or coinsurance. Prior authorization or other medical management requirements are prohibited.15 Theprohibited.¹⁵

The definition of testing that must be covered was expanded by Section 3201 of the CARES Act (P.L. 116-136). In addition, the Department of Labor (DOL), Department of Health and Human Services (HHS), and the Treasury issued an FAQ documentFAQ documents on April 11, 2020 (hereinafter, "Tri-Agency April 11 FAQ"),,16 and June 23, 2020,17 (hereinafter “Tri-Agency April 11 FAQ” and “Tri-Agency June 23 FAQ,” respectively) on the private health on the private health insurance coverage requirements in FFCRA and the CARES Act.¹⁶ Together, the acts and guidance18 Types of Tests, Related Items and Services, and Testing Settings FFCRA Section 6001(a)(1), as amended by the CARES Act Section 3201, describes the types of tests that must be covered, along with the administration of such tests. Together, the acts require coverage of in-vitro diagnostic tests (as defined in Food and Drug Administration [FDA] regulation)19 that detect SARS-CoV-2 or diagnose the virus that causes COVID-19 and are approved, cleared, or authorized for marketing by the agency or being marketed or clinical y used pursuant to an al owed flexibility in FDA guidance. The acts did not explicitly state whether this included serology testing.20 The Tri-Agency April 11 FAQ interpreted the coverage requirement as applying to diagnostic (i.e., molecular and antigen) and serological (i.e., antibody) tests. Together, the acts, as interpreted by the agencies through guidance, also require coverage without cost sharing of items require coverage of certain tests and services, as summarized below.

• Specified COVID-19 diagnostic tests, including both molecular (e.g., polymerase chain reaction, or PCR, tests) and serological tests (i.e., antibody tests), and the administration of such tests are covered.¹⁷
• "Items and services furnished to an individual during [visits, as specified specified types of visits; discussed below] that result in an order for or administration of [an applicable COVID-19 test], but only to the extent such items and services relate to the furnishing or ; see above], but only to the extent such items and services relate to the furnishing or 15 See the introduction to this section regarding cost sharing and prior authorization requirements. 16 Department of Labor (DOL), HHS, and T reasury, “ FAQS ABOUT FAMILIES FIRST CORONAVIRUS RESPONSE ACT AND CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURIT Y ACT IMPLEMENT AT ION PART 42,” April 11, 2020, at https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf. Hereinafter referred to as T ri-Agency April 11 FAQ. 17 DOL, HHS, and T reasury, “FAQS ABOUT FAMILIES FIRST CORONAVIRUS RESPONSE ACT AND CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURIT Y ACT IMPLEMENT ATION PART 43,” June 23, 2020, at https://www.cms.gov/files/document/FFCRA-Part -43-FAQs.pdf. Hereinafter referred to as T ri-Agency June 23 FAQ. 18 For a discussion of the agencies’ implementation authority and the fo rce of law of these documents, see “Are Plans Required to Cover T esting for Public Health Surveillance or Employment Purposes?” in CRS Report R46481, COVID-19 Testing: Frequently Asked Questions. 19 21 C.F.R. §809.3(a). 20 Although both serology tests and molecular and antigen diagnostic tests meet the regulatory definition of “in vitro diagnostic,” applicability to serology testing was not clear based only on the statutory language as it refers to detection and identification of the virus. Serology testing does not detect or identify the virus; rather, it detects antibodies. For more information, see “What Are the Different T ypes of COVID-19 T ests?” in CRS Report R46481, COVID-19 Testing: Frequently Asked Questions. Congressional Research Service 6 link to page 11 link to page 11 link to page 12 FAQ: COVID-19 and Private Health Insurance Coverage administration of such product or to the evaluation of such individual for purposes of determining the need of such individual for such product."¹⁸ This definition could encompass additional diagnostic testing associated with the visit. However, it would not encompass treatment for COVID-19-associated illnesses.

The coverage requirements apply to the specified items and services when furnished at visits including to health care provider offices, urgent care centers, emergency rooms, and "nontraditional" settings, 21 Per an example provided in guidance, if the individual’s attending provider determines that other tests (e.g., influenza tests, blood tests, etc.) should be performed during a visit … to determine the need of such individual for COVID-19 diagnostic testing, and the visit results in an order for, or administratio n of, COVID-19 diagnostic testing, the plan or issuer must provide coverage for the related tests under section 6001(a) of the FFCRA.22 In addition, consumers must not face cost-sharing for “facility fees” or other fees, to the extent they are related to COVID-19 testing or related items and services that are required to be covered under FFCRA Section 6001.23 The coverage requirements do not apply to any services or items furnished at a testing visit that are not related to COVID-19 (e.g., if someone received testing or treatment for an unrelated condition at the same visit). In addition, the law and guidance do not explicitly address coverage and cost-sharing for the “related” items and services discussed above if the individual does not ultimately receive the test.24 The requirements also do not encompass treatment for il nesses associated with COVID-19.25 Per FFCRA Section 6001(a)(2), the coverage requirements apply to the specified items and services, discussed above, when furnished at visits including to health care provider offices (including in-person and telehealth visits), urgent care centers, and emergency rooms. Per the Tri-Agency April 11 FAQ, the requirements also apply at “nontraditional” settings, “including drive-through screening and testing sites where licensed health care providers are administering COVID-19 diagnostic testing.”26 Also see “Testing for Public Health Surveil ance or Employment Purposes” in this report. In addition, guidance indicates that the coverage requirements apply to at-home COVID-19 tests, including at-home swab kits that may be sent to a lab for processing, when such tests are “ordered by an attending health care provider who has determined that the test is medical y appropriate for the individual,” as specified in guidance.27 21 FFCRA §6001(a)(2). Also see the T ri-Agency April 11 FAQ, including questions five, six, and eight. 22 T ri-Agency April 11 FAQ, question five. 23 For more information, see the T ri-Agency June 23 FAQ, question seven, including its footnote 16. 24 Per the T ri-Agency April 11 FAQ, question five, the coverage of related items and services is required when “the visit results in an order for, or administration of, COVID-19 diagnostic testing.” T his language also appears in FFCRA Section 6001(a)(2). T he statute and guidance do not explicitly address whether the coverage requirements apply if an individual receives the related items and services, even for purposes of determining the need for COVID -19 testing, but does not actually receive a COVID-19 test. Other federal and/or state requirements could be applicable. 25 See “Are Plans Required to Cover COVID-19 T reatment?” in this report for more information. 26 See T ri-Agency April 11 FAQ, question eight , regarding “nontraditional” visits. Also see question 13 for more information about telehealth visits. 27 T ri-Agency June 23 FAQ, question four. Also see question three regarding “attending providers.” Congressional Research Service 7 link to page 5 FAQ: COVID-19 and Private Health Insurance Coverage Timing of Requirements and Applicability to Different Types of Plans through testing sites. The requirements apply to both in-person and telehealth visits.¹⁹

FFCRA does not specify whether its coverage requirements apply when the test is furnished by an out-of-network provider. However Section 3202 of the CARES Act addresses insurer payments to in-network and out-of-network providers.²⁰ In addition, the Tri-Agency April 11 FAQ clarifies that the FFCRA coverage requirements apply both in network and out of network.²¹

The coverage requirements in FFCRA apply only to the specified items and services that are furnished during the COVID-19 public health emergency period described in that act, as of the date the FFCRA was enacted (March 18, 2020).²²

28 These requirements apply to individual health insurance coverage and to smallsmal - and large-group plans, whether fully insured or self-insured.29 This includes grandfathered individual or group plans, which are exempt from certain other federal private health insurance requirements. Per the definition of individual health insurance coverage cited in the act, the requirements do not apply to STLDI.30 Testing for Public Health Surveillance or Employment Purposes For further discussion of this topic, see “Are Plans Required to Cover Testing for Public Health Surveil ance or Employment Purposes?” in CRS Report R46481, COVID-19 Testing: Frequently Asked Questions. That report also addresses coverage of repeated testing and testing of asymptomatic individuals. The Tri-Agency April 11 FAQ interpreted FFCRA Section 6001 as compel ing plans to cover testing only “when medical y appropriate for the individual, as determined by the individual’s attending healthcare provider in accordance with accepted standards of current medical practice.”31 The guidance did not further outline the circumstances in which COVID-19 tests were “medical y appropriate”; however, under the agencies’ interpretation, the availability of covered testing appeared contingent upon a medical decision by a health care provider responsible for providing care to a specific patient. The Tri-Agency June 23 FAQ addressed coverage of COVID-19 testing for surveil ance or employment purposes. In this guidance, the agencies specified that testing conducted to screen for general workplace health and safety (such as employee ‘return-to-work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope of section 6001 of the FFCRA.32 Out-of-Network Testing FFCRA does not specify whether its coverage requirements apply when the test is furnished by an out-of-network provider. However, Section 3202 of the CARES Act addresses insurer payments 28 Some coverage requirements in FFCRA and the CARES Act refer to the “emergency period” or similar construction. T his refers to the public health emergency declared with respect to the COVID-19 outbreak by HHS Secretary Alex Azar on January 31, 2020, effective as of January 27, pursuant to §319 of the Public Health Service Act (PHSA). Hence, the emergency period began on January 27, 2020, and remains in effect as long as the declaration, or any renewal of it, is in effect. See “Duration of Emergency Period” in CRS Report R46316, Health Care Provisions in the Fam ilies First Coronavirus Response Act, P.L. 116 -127, for more information. 29 T he requirements are technically applicable to group health plans and health insurers offering individual and group health insurance coverage. In this report, references to “plans” include applicable plans and insurers. 30 See “Background on Private Health Insurance” regarding these types of plans, including grandfathered plans and ST LDI. 31 T ri-Agency April 11 FAQ, question six. 32 T ri-Agency June 23 FAQ, question five. Congressional Research Service 8 FAQ: COVID-19 and Private Health Insurance Coverage to in-network and out-of-network providers. In addition, the Tri-Agency April 11 FAQ clarifies that the FFCRA coverage requirements apply both in network and out of network.33 For further discussion of coverage and provider reimbursement requirements applicable to out-of- network testing and “balance bil ing” by out-of-network providers, see “What Coverage and Provider Reimbursement Requirements Apply to Out-of-Network Testing?” and “Are Out-of-Network Providers Al owed to Balance Bil Patients for COVID-19 Testing and Other Related Items and Services?” in CRS Report R46481, COVID-19 Testing: Frequently Asked Questions. State and Private-Sector Actions Before and since the enactment of FFCRAto STLDI.²³

State and Private-Sector Actions

In recent weeks, some states have announced coverage requirements, and some insurers have clarified or expanded their policies, regarding coverage of COVID-19 testing, among other services.²⁴34 However, states cannot regulate self-insured plans, and insurer announcements do not necessarily apply to those plans either. FFCRA does apply to self-insured group plans in addition to the other plan types discussed above.

To the extent that state requirements about or plans'’ voluntary coverage of COVID-19 testing did not extend as far as FFCRA and CARES Act requirements, the federal laws supersede them. However, state requirements and plans'’ voluntary coverage may exceed applicable federal requirements, as long as they do not prevent the implementation of any federal requirements.²⁵

35 A state or local department of health or other administrative agency may announce requirements or guidelines regarding testing certain populations or testing for certain public health purposes. However, this does not necessarily mean insurers in that state are required to cover such testing, although that would be the case if the state department of insurance or other relevant agency also requires such coverage or if federal requirements are applicable. This is because it is the state department of insurance, not the state department of health, which regulates insurance. Even though federal law now requires most plans to cover specified COVID-19 testing services without cost sharing, it may be useful for consumers to contact their insurers or plan sponsors to understand their coverage. Subject to applicable federal and state requirements, coverage of the COVID-19 test and related services and items may vary by plan.

Are Plans Required to Cover COVID-19 Treatment?

Essential Health Benefits Guidance on COVID-19 Coverage

Although FFCRA requires certain plans to cover specified COVID-19 testing services without cost sharing, neither FFCRA nor the CARES Act mandates coverage of COVID-19 treatment services. There is no federal requirement specifically 33 T ri-Agency April 11 FAQ, question seven. Furthermore, question nine of the T ri-Agency June 23 FAQ clarifies that out-of-network providers are generally precluded from directly billing a patient for the difference between provider’s charge for COVID-19 testing and the amount reimbursed by the health plan (i.e., balance billing). However, a provider is not prevented from balance billing for other items and services unless there is an applicable state law or other prohibition (e.g., pursuant to the terms of the Provider Relief Fund). For background on this funding, see CRS Insight IN11438, The COVID-19 Health Care Provider Relief Fund. 34 Several organizations are tracking these announcements by states and/or insurers. See, for examp le, the National Association of Insurance Commissioners (NAIC) at https://content.naic.org/naic_coronavirus_info.htm, and the Association of Health Insurance Plans (AHIP) at https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/. 35 See, for example, the introduction of the Tri-Agency April 11 FAQ. Congressional Research Service 9 FAQ: COVID-19 and Private Health Insurance Coverage services. There is no federal requirement specifical y mandating private health insurance coverage of items or services related to COVID-19 treatment. However, one or more existing federal requirements are potentiallypotential y relevant, subject to state implementation and plan variation.

There is a federal statutory requirement that certain plans cover a core set of 10 categories of essential health benefits (EHB).²⁶36 However, states, rather than the federal government, generally general y specify the benefit coverage requirements within those categories. Current regulation allowsal ows each state to select an EHB-benchmark plan. The benchmark plan serves as a reference plan on which plans subject to EHB requirements must substantiallysubstantial y base their benefits packages. Because states select their own EHB-benchmark plans, there is considerable variation in EHB coverage from state to state.²⁷

37 On March 5, 2020, and March 12, 2020, CMS issued guidance addressing the potential relevance of EHB requirements to coverage of COVID-19 treatment, among other benefits, subject to variation in states'’ EHB-benchmark plan designations.²⁸38 According to the March 12 document, "all “al 51 EHB-benchmark plans currently provide coverage for the diagnosis and treatment of COVID-19"” (emphasis added), but coverage of specific benefits within the 10 categories of EHB (e.g., hospitalization, laboratory services) may vary by state and by plan.

The March 12 document suggests that coverage of medicallymedical y necessary hospitalizations would include coverage of medicallymedical y necessary isolation and quarantine during the hospital admission, subject to state and plan variation. Quarantine in other settings, such as at home, is not a medical benefit. The document notes, "“however, other medical benefits that occur in the home that are required by and under the supervision of a medical provider, such as home health care or telemedicine, may be covered as EHB,"” subject to state and plan variation.

The March 12 document confirms that "“exact coverage details and cost-sharing amounts for individual individual services may vary by plan, and some plans may require prior authorization before these services are covered."” In other words, even where certain treatment items and services are required to be covered as EHB in a state, cost-sharing and medical management requirements 36 T he 10 categories of essential health benefits (EHB) are ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care. 37 For information about the process for defining the EHB in each state that is in place for plan years beginning before 2020, see CRS Report R44163, The Patient Protection and Affordable Care Act’s Essential Health Benefits (EHB) . On April 17, 2018, HHS issued a final rule that modifies the process for defining the EHB for plan years beginning in 2020. For more information, see Department of Health and Human Services, “ HHS Notice of Benefit and Payment Parameters for 2019,” 83 Federal Register 16930, April 17, 2018. 38 Centers for Medicare & Medicaid Services, “FAQs on Essential Health Benefit Coverage and the Coronavirus (COVID-19),” March 12, 2020, at https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/EHB-Benchmark-Coverage-of-COVID-19.pdf. T he March 5, 2020, document has similar content: CMS, “ Information Related to COVID–19 Individual and Small Group Market Insurance Coverage,” at https://www.cms.gov/files/document/03052020-individual-small-market -covid-19-fact-sheet.pdf. These fact sheets each also addressed policy considerations related to private health insurance coverage of COVID-19 testing and vaccination. T he enactment of FFCRA and the CARES Act have likely superseded much of the information in these documents regarding such coverage of testing and vaccination, but as of the date of this report, the documents are still relevant with regard to coverage of COVID-19 treatment. Congressional Research Service 10 link to page 14 link to page 5 link to page 12 FAQ: COVID-19 and Private Health Insurance Coverage required to be covered as EHB in a state, cost-sharing and medical management requirements could apply, subject to applicable federal and state requirements. In addition, cost sharing and other coverage details may vary for services furnished by out-of-network providers.²⁹

39 Individual and fully insured smallsmal -group plans are subject to EHB requirements. Large-group plans, self-insured plans, grandfathered plans, and STLDI are not.³⁰

40 Whether or not certain treatment services are defined as EHB in a state, other state benefit coverage requirements may be relevant to COVID-19 treatment. Plans may also voluntarily cover benefits. See "“State and Private-Sector Actions",” below.

Certain Federal Requirements Related to Cost Sharing

Other existing federal requirements are also relevant to consumer cost sharing on COVID-19 treatment services, to the extent that such treatments are covered by the consumer'’s plan, and largely to the extent that they are defined by a state as EHB.

For example, plans must comply with annual limitslimits on consumers'’ out-of-pocket spending (i.e., cost sharing, including deductibles, coinsurance, and copayments) on in-network coverage of the EHB.³¹ EHB.41 If certain treatment services are defined as EHB in a state, and are furnished by an in-network provider, consumers'’ out-of-pocket costs for the plan year would be limited as discussed below. If certain treatment services are not defined as EHB in a state, and/or are furnished by out- of-network providers, this out-of-pocket maximum would not necessarily apply.

In 2020, the out-of-pocket limits cannot exceed $8,150 for self-only coverage and $16,300 for coverage other than self-only. This means that once a consumer has spent up to that amount in cost sharing on applicable in-network benefits, the plan would cover 100% of remaining applicable costs for the plan year.

The out-of-pocket maximum applies to individual health insurance coverage and to smallsmal - and large-group plans, whether fully insured or self-insured.³²42 The requirement does not apply to grandfathered plans or STLDI.

State and Private-Sector Actions

As stated above, in recent weeks, some states have announced coverage requirements related to COVID-19 testing services and items, and some insurers have clarified or expanded their policies to include relevant coverage.³³43 Some of these state and insurer statements also address coverage of treatment services. However, as discussed above, states cannot regulate self-insured plans, and insurer announcements do not necessarily apply to those plans either.

39 However, see CRS Insight IN11438, The COVID-19 Health Care Provider Relief Fund regarding the prohibition on Provider Relief Fund recipients from balance billing consumers for “ all care for a presumptive or actual case of COVID-19.” 40 See “Background on Private Health Insurance” regarding these types of plans, including grandfathered plans and ST LDI. 41 42 U.S.C. §18022. For more information on this requirement, and on other federal cost -sharing requirements that may similarly be relevant (prohibition on lifetime limits and annual limits; minimum actuarial value requirements), see CRS Report R45146, Federal Requirem ents on Private Health Insurance Plans. 42 Certain types of plans—self-insured plans and plans offered in the large-group market—must comply with this requirement even though they are not required to cover the EHB. HHS has indicated that such plans must use a permissible definition of EHB (including any state-selected EHB benchmark plans) to determine whether they comply with the requirement. 43 See footnote 34 regarding organizations that are tracking such activity. Congressional Research Service 11 link to page 14 FAQ: COVID-19 and Private Health Insurance Coverage Coverage, cost sharing, and the application of medical management techniques (e.g., prior authorization) can vary by plan, subject to applicable federal and state requirements. It may be useful for consumers to contact their insurers or plan sponsors to understand their coverage of services and items related to COVID-19 treatment.

Will Plans Be Required to Cover a COVID-19 Vaccine?

CARES Act and Existing Preventive Services Coverage Requirements

As of the date of this report, there is no vaccine against COVID-19 approved by the Food and Drug Administration (FDA) for use in the United States, although several candidates are in development. Prior to the enactment of the CARES Act, there were no federal requirements specificallyspecifical y mandating private health insurance coverage of items or services related to a COVID- 19 vaccine.

However, per an existing federal requirement (§2713 of the Public Health Service Act [PHSA]) and its accompanying regulations, most plans must cover specified preventive health services without cost sharing.³⁴44 This includes any preventive service recommended with an A or B rating by the United States Preventive Services Task Force (USPSTF); or any immunization with a recommendation by the Advisory Committee on Immunization Practices (ACIP), adopted by the Centers for Disease Control and Prevention (CDC), for routine use for a given individual.³⁵45 These coverage requirements apply no sooner than one year after a new or revised recommendation is published.³⁶

published.46 Requirements of PHSA Section 2713 apply to individual health insurance coverage and to small- smal - and large-group plans, whether fully insured or self-insured. The requirements do not apply to grandfathered plans or to STLDI. By regulation, plans are generallygeneral y not required to cover preventive services furnished out of network.³⁷47 They are allowedal owed to use "“reasonable medical management"management” techniques, within provided guidelines. Cost sharing for office visits associated with a furnished preventive service may or may not be allowedal owed, as specified in regulation.³⁸

48 Section 3203 of the CARES Act requires specified plans—the same types as those subject to PHSA Section 2713—to cover a COVID-19 vaccine, when available, and potentiallypotential y other COVID-19 preventive services, if they are recommended by ACIP or USPSTF, respectively.³⁹ 49 44 §2713 was added to the PHSA (codified at 42 U.S.C. §300gg-13) and incorporated into the Employee Retirement Income Security Act (ERISA) and Int ernal Revenue Code (IRC) by the Patient Protection and Affordable Care Act (ACA; P.L. 111-148, as amended). Regulations are at 45 C.F.R. §147.130; 29 C.F.R. §2590.715-2713; and 26 C.F.R. §54.9815-2713. 45 For further discussion of this provision, see CRS Report R45146, Federal Requirements on Private Health Insurance Plans. For more information about the USPST F and ACIP, see https://uspreventiveservicestaskforce.org/uspstf/ and https://www.cdc.gov/vaccines/acip/index.html, respectively. For more information about the definition of “ routine” use, see Richard Hughes IV, Reed Maxim, and Alessandra Fix, “ Vague Vaccine Recommendations May Be Leading T o Lack Of Provider Clarity, Confusion Over Coverage,” Health Affairs, May 7, 2019. 46 Per 45 C.F.R. §147.130(b), such coverage is required “for plan years (in the individual market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued.” 47 However, see footnote 39 regarding a provider’s ability to bill the consumer for these services. 48 In general, whether cost sharing for office visits is allowed or prohibited depends on whether the preventive service or item was the primary purpose of the visit, and whether the service or item was billed or tracked separately from the office visit. See 45 C.F.R. §147.130(a)(2). Also see 45 C.F.R. §147.130(a)(3) regarding out-of-network coverage and (a)(4) regarding reasonable medical management. 49 CARES Act §3203 refers to, but does not amend, PHSA §2713. Congressional Research Service 12 link to page 9 link to page 9 link to page 12 FAQ: COVID-19 and Private Health Insurance Coverage This coverage must be provided without cost sharing. Section 3203 also applies an expedited effective date for the required coverage: 15 business days after an applicable ACIP or USPSTF recommendation is published. Otherwise, requirements of Section 3203 mirror the existing requirements under PHSA Section 2713. The requirement to cover COVID-19 vaccination and other preventive services is not time limited, whereas the FFCRA requirement to cover COVID-19 testing is limited to the duration of a declared COVID-19 public health emergency. See "Are “Are Plans Required to Cover COVID-19 Testing?"

” State and Private-Sector Actions

Some of the state and insurer announcements about coverage of COVID-19 benefits, discussed earlier in this report, reference coverage of a potential vaccine.⁴⁰50 However, pending development and approval of the vaccine, and pending the implementation of the CARES Act requirements related to COVID-19 vaccine coverage, it is premature to discuss potential variations in coverage of the vaccine at the state or plan level. It may still stil be useful for consumers to contact their insurers or plan sponsors to understand their coverage of services and items related to a potential COVID-19 vaccine.

50 See footnote 34. Congressional Research Service 13 FAQ: COVID-19 and Private Health Insurance Coverage Appendix. Resources for Questions about Private Health Insurance and COVID-19

This report has focused on coverage of COVID-19 testing, treatment, and vaccination by most types of private health insurance plans. CRS analysts are also available to congressional clients to discuss other topics of interest related to private health insurance and COVID-19, including

•  coverage of COVID-19 benefits by types of private plans not specifically specifical y addressed in this report;
•  other issues related to private coverage of COVID-19 benefits;
•  private coverage of certain other benefits of concern during this pandemic, or of services furnished via telehealth; and
•  issues related to private health insurance enrollment and premium payments.

The following table lists examples of such topics of interest, any relevant legislative or administrative resources, any relevant CRS resources, and names of appropriate CRS experts for the benefit of congressional clients. Besides the CRS reports listed below that provide background on relevant topics, also see CRS reports on health provisions in recent COVID-19 legislation:

• legislation and a CRS report that provides more detail on COVID-19 testing issues, including private health insurance coverage:  CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127, and
•  CRS Report R46334, Selected Health Provisions in Title III of the CARES Act (P.L. 116-136).

, and  CRS Report R46481, COVID-19 Testing: Frequently Asked Questions. The information in this report is current as of its publication date and may be superseded by subsequent congressional or administrative action. Congressional clients may contact the report author and/or experts listed below for questions about further developments. In addition, CMS guidance related to private health insurance and COVID-19 is compiled on its website.⁴¹