FAQs about Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation

FAQS ABOUT AFFORDABLE CARE ACT

IMPLEMENTATION PART 51, FAMILIES FIRST

CORONAVIRUS RESPONSE ACT AND

CORONAVIRUS AID, RELIEF, AND ECONOMIC

SECURITY ACT IMPLEMENTATION

January 10, 2022

Set out below are Frequently Asked Questions (FAQs) regarding implementation of the Families

First Coronavirus Response Act (FFCRA), the Coronavirus Aid, Relief, and Economic Security

Act (CARES Act), and the Affordable Care Act. These FAQs have been prepared jointly by the

Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the

Departments). Like previously issued FAQs (available at

https://www.dol.gov/agencies/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-

and-advisers/aca-implementation-faqs and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-

and-FAQs#Affordable_Care_Act), these FAQs answer questions from stakeholders to help

people understand the law and benefit from it, as intended.

COVID-19 DIAGNOSTIC TESTING

The FFCRA was enacted on March 18, 2020.

Section 6001 of the FFCRA generally requires

group health plans and health insurance issuers offering group or individual health insurance

coverage, including grandfathered health plans, to provide benefits for certain items and services

related to testing for the detection of SARS-CoV-2 (the virus that causes coronavirus disease

2019 (COVID-19)) or the diagnosis of COVID-19, when those items or services are furnished on

or after March 18, 2020, and during the applicable emergency period.

Under the FFCRA, plans

Pub. L. No. 116-127 (2020).

On January 31, 2020, HHS Secretary Alex M. Azar II declared that as of January 27, 2020, a public health

emergency exists nationwide as the result of the 2019 novel coronavirus. See HHS Office of the Assistant Secretary

for Preparedness and Response, Determination of the HHS Secretary that a Public Health Emergency Exists,

available at https://ww

w.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx. On October 15, 2021,

the HHS Secretary renewed the COVID-19 public health emergency declaration, effective October 18, 2021, that

was previously renewed on April 21, 2020, July 23, 2020, October 2, 2020, January 7, 2021, April 15, 2021, and

July 19, 2021. See HHS Office of the Assistant Secretary for Preparedness and Response, Renewal of Determination

That A Public Health Emergency Exists, available at

https://w

ww.phe.gov/emergency/news/healthactions/phe/Pages/COVDI-15Oct21.aspx. The HHS Secretary may

extend the public health emergency declaration for subsequent 90-day periods for as long as the public health

emergency continues to exist, and may terminate the declaration whenever he determines that the public health

emergency has ceased to exist. On January 22, 2021, Acting HHS Secretary Norris Cochran sent a letter to

governors announcing that HHS has determined that the public health emergency will likely remain in place for the

entirety of 2021, and when a decision is made to terminate the declaration or let it expire, HHS will provide states

with 60 days’ notice prior to termination.

and issuers must provide this coverage without imposing any cost-sharing requirements

(including deductibles, copayments, and coinsurance), prior authorization, or other medical

management requirements.

The CARES Act was enacted on March 27, 2020.

Section 3201 of the CARES Act amended

section 6001 of the FFCRA to include a broader range of diagnostic items and services that plans

and issuers must cover without any cost-sharing requirements, prior authorization, or other

medical management requirements.

Section 3202(a) of the CARES Act requires plans and

issuers providing coverage to reimburse a provider that has a negotiated rate with the plan or

issuer for COVID-19 diagnostic testing an amount that equals that negotiated rate; or, if the plan

or issuer does not have a negotiated rate with such provider, the cash price for such service that

is listed by the provider on a public website. (The plan or issuer may negotiate a rate with the

provider that is lower than the cash price.) Additionally, during the public health emergency

related to COVID-19 declared under section 319 of the Public Health Service Act (PHS Act),

section 3202(b) of the CARES Act and implementing regulations at 45 CFR Part 182 require

providers of diagnostic tests for COVID-19 to make public the cash price of a COVID-19

diagnostic test on the provider’s public internet website or face potential enforcement action

including civil monetary penalties.

Under section 6001(c) of the FFCRA, the Departments are authorized to implement the

requirements of section 6001 of the FFCRA through sub-regulatory guidance, program

instruction, or otherwise. The Departments have previously issued four sets of FAQs to

implement provisions of the FFCRA and CARES Act and to address other health coverage issues

related to COVID-19.

Due to the urgent need to continue to facilitate the nation’s response to

the public health emergency posed by COVID-19, the Departments believe that this guidance is

a statement of policy not subject to the notice and comment requirements of the Administrative

Procedure Act (APA).

For the same reasons, the Departments additionally find that, even if this

guidance were subject to the public participation provisions of the APA, prior notice and

Pub. L. No. 116-136 (2020).

For purposes of this document, references to section 6001 of the FFCRA include the amendments made by section

3201 of the CARES Act, unless otherwise specified.

See FAQs about Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security

Act Implementation Part 42 (Apr. 11, 2020), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-

ebsa/our-activities/resource-center/faqs/aca-part-42.pdf and https://www.cms.gov/files/document/FFCRA-Part-42-

FAQs.pdf (FAQs Part 42); FAQs about Families First Coronavirus Response Act and Coronavirus Aid, Relief, and

Economic Security Act Implementation Part 43 (June 23, 2020), available at

https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf and

https://www.cms.gov/files/document/FFCRA-Part-43-FAQs.pdf (FAQs Part 43); FAQs about Families First

Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 44 (Feb.

26, 2021), available at https://w

ww.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-

center/faqs/aca-part-44.pdf and https://www.cms.gov/files/document/faqs-part-44.pdf (FAQs Part 44); and FAQs

about Affordable Care Act Implementation Part 50, Health Insurance Portability and Accountability Act and

Coronavirus Aid, Relief, and Economic Security Act Implementation (Oct. 4, 2021), available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-50.pdf and

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-50.pdf (FAQs Part 50).

5 U.S.C. § 553(b)(A).

comment for this guidance is impracticable and/or contrary to the public interest, and there is

good cause to issue this guidance without prior public comment and without a delayed effective

date.

In June 2020, the Departments issued FAQs Part 43. In FAQs Part 43, Q4, the Departments

stated that plans and issuers are required under section 6001 of the FFCRA to cover COVID-19

tests intended for at-home testing, when the test is ordered by an attending health care provider

who has determined that the test is medically appropriate for the individual based on current

accepted standards of medical practice and the test otherwise meets the statutory criteria under

the FFCRA.

In issuing FAQs Part 43, the Departments noted that, as of the date of publication of that

document, the Food and Drug Administration (FDA) had not yet authorized any COVID-19

diagnostic tests to be completely used and processed at home.

However, since June 2020, when

FAQs Part 43 were issued, the FDA has authorized additional diagnostic tests for COVID-19,

including tests that can be self-administered and self-read at home or elsewhere without the

involvement of a health care provider, sometimes referred to as self-tests or at-home tests.

These at-home diagnostic tests are now available either by prescription or over-the-counter

(OTC) (without either a prescription or individualized clinical assessment by a health care

provider), through pharmacies, retail stores, and online retailers.

On December 2, 2021, President Biden announced that the Departments would issue guidance by

January 15, 2022, to clarify that individuals who purchase OTC COVID-19 diagnostic tests

(referred to as OTC COVID-19 tests throughout this document) during the public health

emergency will be able to seek reimbursement from their plan or issuer.

These FAQs provide

that guidance. The Departments have evaluated the requirements of section 6001 of the FFCRA

and the implementing guidance issued to date and have determined that it is appropriate to issue

these FAQs. Testing is critically important to help reduce the spread of SARS-CoV-2, as well as

to quickly diagnose SARS-CoV-2 infection and COVID-19 so that it can be effectively treated.

5 U.S.C. § 553(b)(B) and (d)(3). Good cause exists for the same reasons underlying the issuance of the March 13,

2020 Proclamation on Declaring a National Emergency Concerning the Coronavirus Disease 2019 (COVID-19)

Outbreak and the determination, under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency

Assistance Act, 42 U.S.C. § 5121 et seq., that a national emergency exists nationwide as a result of the COVID-19

pandemic, and the same reasons underlying the issuance of the January 31, 2020 declaration that a public health

emergency exists, under section 319 of the PHS Act.

See https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf and

https://www.cms.gov/files/document/FFCRA-Part-43-FAQs.pdf.

Id. at footnote 8.

The FDA provides information on which at-home tests are authorized for use at https://www.fda.gov/medical-

devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-

euas.

President Biden Announces New Actions to Protect Americans Against the Delta and Omicron Variants as We

Battle COVID-⁠19 this Winter (Dec. 2, 2021), available at

https://www.whitehouse.gov/briefing-room/statements-

releases/2021/12/02/fact-sheet-president-biden-announces-new-actions-to-protect-americans-against-the-delta-and-

omicron-variants-as-we-battle-covid-19-this-winter/.

In light of FDA authorization of at-home tests available OTC, to remove financial barriers and

expand access to COVID-19 testing, and to ensure consistency with section 6001 of the FFCRA,

the Departments are issuing this guidance to clarify that individuals who purchase OTC COVID-

19 tests during the public health emergency will be able to seek reimbursement from their plan or

issuer. The Departments are updating their guidance to generally require coverage of OTC

COVID-19 tests under section 6001 of the FFCRA, with or without an order or individualized

clinical assessment by an attending health care provider, as described below.

Q1: Under section 6001 of the FFCRA, are plans and issuers required to cover OTC

COVID-19 tests available without an order or individualized clinical assessment by a

health care provider?

Yes. Plans and issuers must cover OTC COVID-19 tests that meet the statutory criteria under

section 6001(a)(1) of the FFCRA,

including tests obtained without the involvement of a health

care provider.

Consistent with section 6001 of the FFCRA, this coverage must be provided

without imposing any cost-sharing requirements, prior authorization, or other medical

management requirements. In this context, with respect to OTC COVID-19 tests obtained

without a health care provider’s involvement, the Departments interpret the relevant FFCRA and

CARES Act provisions to require coverage without out-of-pocket expense to the participant,

beneficiary, or enrollee for the cost of the test (unless a plan or issuer meets the conditions for

the safe harbors described in Q2 and Q3).

Section 6001 of the FFCRA does not require a plan or issuer to provide coverage by reimbursing

sellers of OTC COVID-19 tests directly (also referred to in this document as “direct coverage”);

a plan or issuer may instead require a participant, beneficiary, or enrollee who purchases an OTC

COVID-19 test to submit a claim for reimbursement to the plan or issuer (in accordance with the

plan’s or issuer’s reasonable internal claims procedures, consistent with applicable federal and

state law). However, plans and issuers are strongly encouraged to provide direct coverage for

OTC COVID-19 tests to participants, beneficiaries, and enrollees by reimbursing sellers directly

without requiring participants, beneficiaries, or enrollees to provide upfront payment and seek

reimbursement.

This FAQ modifies guidance previously provided by the Departments

such that the

requirement to cover COVID-19 tests under section 6001 of the FFCRA with respect to OTC

Section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act, describes in vitro diagnostic

tests for the detection of SARS-CoV-2 or the diagnosis of COVID-19 that (A) are approved, cleared, or authorized

under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act; (B) the developer has

requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and

Cosmetic Act, unless and until the emergency use authorization request under such section 564 has been denied or

the developer of such test does not submit a request under such section within a reasonable timeframe; (C) are

developed in and authorized by a state that has notified the Secretary of HHS of its intention to review tests intended

to diagnose COVID–19; or (D) are other tests that the Secretary of HHS determines appropriate in guidance.

FAQs Part 43, Q4 is superseded. FAQs Part 42, Q6 and FAQs Part 43, Q3 and Q6 continue to apply with respect

to tests that require the order of a health care provider under the applicable FDA authorization or approval, but are

COVID-19 tests is no longer limited only to situations in which the individual has an order or

individualized clinical assessment from a health care provider. This updated guidance requires

coverage, without an order or individualized clinical assessment from a health care provider,

only with respect to OTC COVID-19 tests that do not require a health care provider’s order

under the applicable FDA authorization, clearance, or approval. This FAQ does not modify

previous guidance

addressing coverage for purposes not primarily intended for individualized

diagnosis or treatment of COVID-19, including the guidance that states that plans and issuers are

not required to provide coverage of testing (including an OTC COVID-19 test) that is for

employment purposes.

Q2: If a plan or issuer provides direct coverage of OTC COVID-19 tests, may it limit

coverage to only tests that are provided through preferred pharmacies or other retailers?

No. However, a plan or issuer may limit reimbursement for OTC COVID-19 tests in a manner

that meets the conditions of the safe harbor described in this Q2. A reimbursement structure that

removes barriers associated with upfront costs will facilitate access to COVID-19 tests and,

therefore, also improve health equity. At the same time, the Departments are of the view that it is

important to ensure that participants, beneficiaries, and enrollees can receive reasonable

reimbursement for OTC COVID-19 tests purchased from pharmacies or other retailers of their

choice.

Therefore, the Departments will not take enforcement action related to coverage of OTC

COVID-19 tests against any plan or issuer that provides coverage of OTC COVID-19 tests

purchased by participants, beneficiaries, and enrollees during the public health emergency by

arranging for direct coverage of OTC COVID-19 tests that meet the statutory criteria under

section 6001(a)(1) of the FFCRA through both its pharmacy network and a direct-to-consumer

shipping program, and otherwise limits reimbursement for OTC COVID-19 tests from non-

preferred pharmacies or other retailers to no less than the actual price, or $12 per test (whichever

is lower).

Plans and issuers may elect to provide more generous reimbursement up to the

actual price of the test. Additionally, under this safe harbor, the direct-to-consumer shipping

program may be provided through one or more in-network provider(s) or another entity

designated by the plan or issuer.

For purposes of this safe harbor, direct coverage of OTC COVID-19 tests means that a

participant, beneficiary, or enrollee is not required to seek reimbursement post-purchase; instead,

the plan or issuer must make the systems and technology changes necessary to process the plan’s

or issuer’s payment to the preferred pharmacy or retailer directly (including the direct-to-

superseded to the extent inconsistent with this guidance with respect to OTC COVID-19 tests or other tests that do

not require a health care provider’s order.

See FAQs Part 44, Q2, available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-

center/faqs/aca-part-44.pdf and https://www.cms.gov/files/document/faqs-part-44.pdf.

The Departments recognize that some OTC COVID-19 tests are sold in packages containing more than one test.

If a plan or issuer limits reimbursement for OTC COVID-19 tests from non-preferred sellers, pharmacies, or

retailers to $12 per test, as allowed under Q2, the plan or issuer must calculate the reimbursement based on the

number of tests in a package.

consumer shipping program) with no upfront out-of-pocket expenditure by the participant,

beneficiary, or enrollee. Under this safe harbor (and consistent with the general requirement as

stated in Q1), plans or issuers may not impose any prior authorization or other medical

management requirements on participants, beneficiaries, or enrollees that obtain applicable OTC

COVID-19 tests via such a direct coverage program, or otherwise. In providing OTC COVID-19

tests through its direct coverage program, a plan or issuer must take reasonable steps to ensure

that participants, beneficiaries, and enrollees have adequate access to OTC COVID-19 tests,

through an adequate number of retail locations (including both in-person and online locations).

The Departments note that whether there is adequate access should be determined based on all

relevant facts and circumstances, such as the locality of participants, beneficiaries, and enrollees

under the plan or coverage and current utilization of the plan’s or issuer’s pharmacy network by

its participants, beneficiaries, and enrollees. Furthermore, in implementing this safe harbor, plans

and issuers should keep in mind the general purpose of the safe harbor – which is to facilitate

consumer access and provide for a seamless experience in obtaining free OTC COVID-19 tests.

Accordingly, plans and issuers should ensure that participants, beneficiaries, and enrollees are

aware of key information needed to access OTC COVID-19 testing, such as dates of availability

of the direct coverage program and participating retailers or other locations.

The Departments note that, if a plan or issuer is relying on this safe harbor to meet its obligation

to cover OTC COVID-19 tests, but is at any time unable to meet the requirements of this safe

harbor (for example, if there are delays that are significantly longer than the amount of time it

takes to receive other items under the plan’s or issuer’s direct-to-consumer shipping program),

the plan or issuer would be required to provide coverage for OTC COVID-19 tests in a manner

that is otherwise consistent with the requirements described in this guidance. Specifically, a plan

or issuer that is unable to meet the requirements of this safe harbor could not deny coverage or

impose cost sharing (including setting limits on the amount of reimbursement for OTC COVID-

19 tests) with respect to any OTC COVID-19 tests, obtained by participants, beneficiaries, or

enrollees, that meet the statutory criteria under section 6001(a)(1) of the FFCRA during this

period, including those purchased from non-preferred sellers. Furthermore, this safe harbor

applies only with respect to the requirement to provide coverage of OTC COVID-19 tests that

are administered without a provider’s involvement or prescription; plans and issuers must

continue to provide coverage for COVID-19 tests that are administered with a provider’s

involvement or prescription, as required by section 6001 of the FFCRA and the Departments’

guidance, even when relying on this safe harbor. HHS encourages states to take an approach

similar to this safe harbor and will not consider a state to have failed to substantially enforce

section 6001 of the FFCRA if it takes such an approach.

Q3: If a plan or issuer otherwise provides coverage without cost sharing for COVID-19

diagnostic tests, may a plan or issuer set limits on the number or frequency of OTC

COVID-19 tests covered without cost sharing under a plan or coverage?

Yes, but only if the plan or issuer meets the conditions for the safe harbor described in this Q3.

The Departments are of the view that it is important to allow plans and issuers to implement

certain safeguards against problematic behaviors and ensure OTC COVID-19 tests are accessible

to everyone who needs them, when they need them. Furthermore, the Departments recognize an

individualized clinical assessment or a health care provider’s involvement in the administration

of a COVID-19 test may play a role in ensuring the appropriateness and proper utilization of

COVID-19 testing for diagnostic purposes and are of the view that additional safeguards are

warranted for OTC COVID-19 tests that are covered without such an assessment or provider’s

involvement.

Therefore, with respect to OTC COVID-19 tests purchased by participants, beneficiaries, and

enrollees during the public health emergency that are available without such an assessment or

provider’s involvement, the Departments will not take enforcement action against any plan or

issuer that, during the public health emergency, provides coverage without cost sharing for (and

does not impose prior authorization or other medical management requirements on) such OTC

COVID-19 tests, if the plan or issuer limits the number of OTC COVID-19 tests covered for

each participant, beneficiary, or enrollee to no less than 8 tests

per 30-day period (or per

calendar month).

Although the Departments are adopting this safe harbor, in part, to discourage behaviors that

could lead to future shortages, the Departments recognize that individuals may reasonably

purchase more OTC COVID-19 tests in a single day than they would use that day or week. The

Departments also recognize that multiple individuals covered as a family or household under the

same plan or coverage may need to be tested in a short period of time (for example, during a

quarantine period following exposure) and that individuals within a family may also experience

multiple needs for diagnostic testing in short periods of time. For these reasons, under this safe

harbor, a plan or issuer would be required to set the limit for at least 8 individual tests per 30-day

period (or per calendar month) per participant, beneficiary, or enrollee, but must not limit

participants, beneficiaries, or enrollees to a smaller number of these tests over a shorter period

(for example, limiting individuals to 4 tests per 15-day period), though plans and issuers may set

more generous limits.

The Departments note that this safe harbor applies only with respect to the coverage of OTC

COVID-19 tests that are administered without a provider’s involvement or prescription; plans

and issuers must continue to provide coverage for COVID-19 tests that are administered with a

provider’s involvement or prescription, as required by section 6001 of the FFCRA and the

Departments’ guidance, even when relying on this safe harbor. HHS encourages states to take an

approach similar to this safe harbor and will not consider a state to have failed to substantially

enforce section 6001 of the FFCRA if it takes such an approach.

The Departments recognize that some OTC COVID-19 tests are sold in packages containing more than one test.

In applying the quantity limit of 8, plans and issuers may count each test separately, even if multiple tests are sold in

one package.

Q4: When providing coverage of OTC COVID-19 tests, are plans and issuers permitted to

address suspected fraud and abuse?

Yes. As stated in FAQs Part 44, Q2, although the FFCRA prohibits medical management of

coverage of COVID-19 diagnostic testing, plans and issuers may act to prevent, detect, and

address fraud and abuse. Examples of permissible activities include the following:

• A plan or issuer may take reasonable steps to ensure that an OTC COVID-19 test for

which a covered individual seeks coverage under the plan or coverage was purchased for

the individual’s own personal use (or use by another participant, beneficiary, or enrollee

who is covered under the plan or coverage as a member of the individual’s family),

provided that such steps do not create significant barriers for participants, beneficiaries,

and enrollees to obtain these tests. For example, a plan or issuer could require an

attestation, such as a signature on a brief attestation document, that the OTC COVID-19

test was purchased by the participant, beneficiary, or enrollee for personal use, not for

employment purposes, has not been (and will not be) reimbursed by another source, and

is not for resale. In contrast, the Departments are of the view that fraud and abuse

programs that require an individual to submit multiple documents or involve numerous

steps that unduly delay a participant’s, beneficiary’s, or enrollee’s access to, or

reimbursement for, OTC COVID-19 tests are not reasonable.

• A plan or issuer may require reasonable documentation of proof of purchase with a claim

for reimbursement for the cost of an OTC COVID-19 test. Examples of such

documentation could include the UPC code for the OTC COVID-19 test to verify that the

item is one for which coverage is required under section 6001 of FFCRA, and/or a receipt

from the seller of the test, documenting the date of purchase and the price of the OTC

COVID-19 test.

Q5: How can plans and issuers facilitate access to, effective use of, and prompt payment for

OTC COVID-19 tests?

The Departments recognize that participants, beneficiaries, and enrollees may benefit from

education, as well as other forms of consumer support, in order to access and use OTC COVID-

19 tests as intended. Plans and issuers may provide education and information resources to

support consumers seeking OTC COVID-19 testing, as long as such resources make clear that

the plan or issuer provides coverage for, including reimbursement of, all OTC COVID-19 tests

that meet the statutory criteria under section 6001(a)(1) of the FFCRA (subject to the safe

harbors in Q2 and Q3), and such information is consistent with the test’s emergency use

authorization (EUA), including:

• Guidance to support consumers’ efforts to access and effectively use OTC COVID-19

tests and information to explain the differences between OTC COVID-19 tests and tests

performed or ordered by a health care provider and/or processed in a laboratory

(including when different types of COVID-19 tests are appropriate based on guidance

from scientific entities like FDA, the National Institutes of Health, and the Centers for

Disease Control and Prevention (CDC));

• Quality information (including shelf life and expiration dates) for specific OTC COVID-

19 testing products, or information about reliability of OTC COVID-19 test results, such

as information from the test’s labeling or EUA summary about the expected test

performance (i.e., rate of false positives and false negatives) of specific tests and active

recalls of FDA-authorized, cleared, or approved OTC COVID-19 tests;

• How to obtain OTC COVID-19 tests directly from the plan or issuer or from designated

sellers that offer those tests at a lower cost, or that receive reimbursement directly from

the plan or issuer for the cost of an OTC COVID-19 test, resulting in no charges for the

participant, beneficiary, or enrollee at the time of purchase (such as those directly

covered by a plan or issuer through its pharmacy network and a direct-to-consumer

shipping program, pursuant to the enforcement safe harbor described in Q2); and

• How to submit a claim for reimbursement, including electronic and paper filing options,

the required information needed for such a claim, and a description of the documentation

that must be submitted in order for the plan or issuer to be able to process the claim

promptly and accurately.

Q6: When must plans and issuers begin providing coverage without cost-sharing, prior

authorization, or other medical management requirements for OTC COVID-19 tests

available without an order or individualized clinical assessment by a health care provider?

Plans and issuers must provide coverage without cost-sharing requirements, prior authorization,

or other medical management requirements in accordance with the requirements under section

6001 of the FFCRA with respect to OTC COVID-19 tests available without an order or

individualized clinical assessment by a health care provider purchased on or after January 15,

2022, and during the public health emergency. Coverage may, but is not required to, be provided

for OTC COVID-19 tests purchased without a provider order or individualized clinical

assessment before January 15, 2022.

The non-enforcement policies set forth in FAQs Part 42, Q9,

which permit plans and issuers to

amend the terms of a plan or coverage to add benefits, or reduce or eliminate cost sharing, for the

diagnosis and treatment of COVID-19 prior to satisfying any applicable notice-of-modification

requirements and without regard to otherwise applicable restrictions on mid-year changes to

health insurance coverage in the group and individual markets, continue to apply with respect to

changes made to comply with these updates related to coverage of OTC COVID-19 tests.

See https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-42.pdf and

https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf.

COVERAGE OF PREVENTIVE SERVICES

PHS Act section 2713 and its implementing regulations relating to coverage of preventive

services

require non-grandfathered group health plans and health insurance issuers offering

non-grandfathered group or individual health insurance coverage to cover, without the

imposition of any cost-sharing requirements, the following items or services:

• Evidence-based items or services that have in effect a rating of “A” or “B” in the

current recommendations of the United States Preventive Services Task Force

(USPSTF) with respect to the individual involved, except for the recommendations of

the USPSTF regarding breast cancer screening, mammography, and prevention issued

in or around November 2009, which are not considered in effect for this purpose;

• Immunizations for routine use in children, adolescents, and adults that have in effect a

recommendation from the Advisory Committee on Immunization Practices (ACIP) of

the CDC with respect to the individual involved;

• With respect to infants, children, and adolescents, evidence-informed preventive care

and screenings provided for in comprehensive guidelines supported by the Health

Resources and Services Administration (HRSA); and

• With respect to women, preventive care and screenings provided for in

comprehensive guidelines supported by HRSA, to the extent not included in certain

recommendations of the USPSTF.

If a recommendation or guideline does not specify the frequency, method, treatment, or setting

for the provision of a recommended preventive service, then the plan or issuer may use

reasonable medical management techniques to determine any such coverage limitations.

26 CFR 54.9815-2713; 29 CFR 2590.715-2713; 45 CFR 147.130.

In addition, under section 3203 of the CARES Act and its implementing regulations, plans and issuers must cover,

without cost-sharing requirements, any qualifying coronavirus preventive service pursuant to section 2713(a) of the

PHS Act and its implementing regulations (or any successor regulations). The term “qualifying coronavirus

preventive service” means an item, service, or immunization that is intended to prevent or mitigate COVID-19 and

that is, with respect to the individual involved (1) an evidence-based item or service that has in effect a rating of “A”

or “B” in the current USPSTF recommendations; or (2) an immunization that has in effect a recommendation from

ACIP (regardless of whether the immunization is recommended for routine use). On November 6, 2020, the

Departments published interim final rules with a request for comments regarding this requirement, Additional Policy

and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (85 FR 71142).

The USPSTF published updated breast cancer screening recommendations in January 2016. However, section 223

of Division H of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260) requires that for purposes of PHS Act

section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and prevention issued

before 2009 remain in effect until January 1, 2023.

For accommodations and religious and moral exemptions with respect to coverage of certain recommended

contraceptive services, see 26 CFR 54.9815-2713A; 29 CFR 2590.715-2713A; 45 CFR 147.131 through 147.133.

See 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); 45 CFR 147.130(a)(4).

Coverage of Colonoscopies Pursuant to USPSTF Recommendations

In 2016, the USPSTF recommended with an “A” rating screening for colorectal cancer starting at

age 50 years and continuing until age 75 years. The Departments have issued several FAQs

clarifying that if a colonoscopy is scheduled and performed as a screening procedure pursuant to

the USPSTF recommendation, cost sharing may not be imposed for items and services that are

an integral part of performing the colonoscopy.

These items and services include:

• Required specialist consultation prior to the screening procedure;

• Bowel preparation medications prescribed for the screening procedure;

• Anesthesia services performed in connection with a preventive colonoscopy;

• Polyp removal performed during the screening procedure;

and

• Any pathology exam on a polyp biopsy performed as part of the screening

procedure.

On May 18, 2021, the USPSTF updated its recommendation for colorectal cancer screening. The

USPSTF continues to recommend with an “A” rating screening for colorectal cancer in all adults

aged 50 to 75 years and extended its recommendation with a “B” rating to adults aged 45 to 49

years. In its “Practice Considerations” section detailing screening strategies, the Final

Recommendation Statement provides: “When stool-based tests reveal abnormal results, follow-

up with colonoscopy is needed for further evaluation…. Positive results on stool-based screening

tests require follow-up with colonoscopy for the screening benefits to be achieved.”

Additionally, the Final Recommendation Statement provides with respect to direct visualization

See citations on bullet points below. See also 85 FR 71142, 71174 (Nov. 6, 2020) (stating “plans and issuers

subject to section 2713 of the PHS Act must cover, without cost sharing, items and services that are integral to the

furnishing of the recommended preventive service, regardless of whether the item or service is billed separately.”).

See FAQs about Affordable Care Act Implementation (Part XXIX) and Mental Health Parity Implementation

(Oct. 23, 2015), Q7, available at www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-

center/faqs/aca-part-xxix.pdf and www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-

XXIX.pdf

See FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and

Women’s Health and Cancer Rights Act Implementation (Apr. 20, 2016), Q1, available at

www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and

www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.

See FAQs about Affordable Care Act Implementation (Part XXVI) (May 11, 2015), Q7, available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf.

See FAQs about Affordable Care Act Implementation (Part XII) (Feb. 20, 2013), Q5, available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.

See FAQs about Affordable Care Act Implementation (Part XXIX) and Mental Health Parity Implementation

(Oct. 23, 2015), Q8, available at www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-

center/faqs/aca-part-xxix.pdf and www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-

XXIX.pdf.

https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.

tests: “Abnormal findings identified by flexible sigmoidoscopy or CT colonography screening

require follow-up colonoscopy for screening benefits to be achieved.”

Q7: Are plans and issuers required to cover, without the imposition of any cost sharing, a

follow-up colonoscopy conducted after a positive non-invasive stool-based screening test or

direct visualization test (e.g., sigmoidoscopy, CT colonography)?

Yes. A plan or issuer must cover and may not impose cost sharing with respect to a colonoscopy

conducted after a positive non-invasive stool-based screening test or direct visualization

screening test for colorectal cancer for individuals described in the USPSTF recommendation.

As stated in the May 18, 2021 USPSTF recommendation, the follow-up colonoscopy is an

integral part of the preventive screening without which the screening would not be complete.

The follow-up colonoscopy after a positive non-invasive stool-based screening test or direct

visualization screening test is therefore required to be covered without cost sharing in accordance

with the requirements of PHS Act section 2713 and its implementing regulations.

Q8: When must plans and issuers begin providing coverage without cost sharing for a

follow-up colonoscopy after a positive non-invasive stool-based screening test or direct

visualization test based on the new USPSTF recommendation?

Plans and issuers must provide coverage without cost sharing consistent with the May 18, 2021

USPSTF recommendation regarding colorectal cancer screening and in accordance with the

requirements under PHS Act section 2713 for plan years (in the individual market, policy years)

beginning on or after the date that is one year after the date the recommendation was issued. In

this case, the recommendation is considered to have been issued as of May 31, 2021, so plans

and issuers must provide coverage without cost sharing for plan or policy years beginning on or

after May 31, 2022.

Coverage of FDA-approved Contraceptive Products Pursuant to HRSA Guidelines

The currently applicable HRSA Women’s Preventive Services Guidelines (HRSA Guidelines),

as updated on December 17, 2019, include a guideline that adolescent and adult women have

access to the full range of female-controlled FDA-approved contraceptive methods,

effective

family planning practices and sterilization procedures to prevent unintended pregnancy and

In addition, in its “Supporting Evidence” section, the USPSTF Full Recommendation Statement states: “Several

comments requested that colonoscopy to follow up an abnormal noncolonoscopy screening test result be considered

part of screening. The USPSTF recognizes that the benefits of screening can only be fully achieved when follow-up

of abnormal screening test results is performed. The USPSTF added language to the Practice Considerations section

to clarify this.”

Id.

26 CFR 54.9815-2713(b); 29 CFR 2590.715-2713(b); 45 CFR 147.130(b). Generally, for purposes of section

2713 of the PHS Act, USPSTF recommendations are considered to be issued on the last day of the month in which

the USPSTF publishes or otherwise releases the recommendation. 75 FR 41726, 41729 (July 19, 2010).

The Departments note that the FDA approves, clears, and grants contraceptive products and not methods.

improve birth outcomes.

The currently applicable HRSA Guidelines state that contraceptive

care should include contraceptive counseling, initiation of contraceptive use, and follow-up care

(for example, management and evaluation as well as changes to, and removal or discontinuation

of, the contraceptive method), and that instruction in fertility awareness-based methods,

including the lactation amenorrhea method, should be provided for women desiring an

alternative method.

On February 20, 2013, the Departments issued an FAQ stating that the HRSA Guidelines ensure

women’s access to the full range of FDA-approved contraceptive methods including, but not

limited to barrier methods, hormonal methods, and implanted devices, as well as patient

education and counseling, as prescribed by a health care provider.

The FAQ further clarified

that plans and issuers may use reasonable medical management techniques to control costs and

promote efficient delivery of care, such as covering a generic drug without cost sharing and

imposing cost sharing for equivalent branded drugs. However, in these instances, the FAQ stated

that a plan or issuer must accommodate any individual for whom a particular drug (generic or

brand name) would be medically inappropriate, as determined by the individual’s health care

provider, by having a mechanism for waiving the otherwise applicable cost sharing for the brand

or non-preferred brand version.

On May 11, 2015, the Departments issued an FAQ clarifying that plans and issuers must cover,

without cost sharing, at least one form of contraception in each method that is identified by the

FDA in its Birth Control Guide.

The FAQ further clarified that, to the extent plans and issuers

use reasonable medical management techniques within a specified method of contraception,

plans and issuers must have an easily accessible, transparent, and sufficiently expedient

exception process that is not unduly burdensome on the individual (or provider or other

individual acting as a patient’s authorized representative) to ensure coverage without cost sharing

of any service or FDA-approved item within the specified method of contraception. An

additional FAQ stated that if an individual’s attending provider recommends a particular service

or FDA-approved item based on a determination of medical necessity with respect to that

individual, the plan or issuer must cover that service or item without cost sharing. The FAQ

makes clear that a plan or issuer must defer to the determination of the attending provider. The

FAQs stated that medical necessity may include considerations such as severity of side effects,

differences in permanence and reversibility of contraceptives, and ability to adhere to the

appropriate use of the item or service, as determined by the attending provider. The FAQs also

clarified that the exception process must provide for making a determination of the claim

according to a timeframe and in a manner that takes into account the nature of the claim (e.g.,

https://www.hrsa.gov/womens-guidelines-2019.

See FAQs about Affordable Care Act Implementation Part XII (Feb. 20, 2013), Q14, available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and

www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html.

See FAQs about Affordable Care Act Implementation Part XXVI (May 11, 2015), Q2 and Q3, available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf.

pre-service or post-service) and the medical exigencies involved for a claim involving urgent

care.

On April 20, 2016, the Departments issued an FAQ stating that if a plan or issuer utilizes

reasonable medical management techniques within a specified method of contraception,

the plan or issuer may develop and utilize a standard exception form and instructions as

part of its steps to ensure that it provides an easily accessible, transparent, and

sufficiently expedient exception process that is not unduly burdensome on the individual

or a provider (or other individual acting as a patient’s authorized representative).

The

FAQ suggested that the Medicare Part D Coverage Determination Request Form may

serve as a model for plans and issuers when developing a standard exception form.

The Departments are issuing the following FAQ in response to complaints and public

reports of potential violations of the contraceptive coverage requirement. This FAQ

makes clear that all FDA-approved cleared, or granted contraceptive products that are

determined by an individual’s medical provider to be medically appropriate for such

individual must be covered without-cost sharing, whether or not specifically identified in

the current FDA Birth Control Guide.

Q9: What is expected of non-exempt

plans and issuers regarding compliance with

the requirement to cover contraceptive services under PHS Act section 2713?

The Departments have received a number of complaints and reports that participants,

beneficiaries, and enrollees are being denied contraceptive coverage in violation of the

requirements under PHS Act section 2713. Examples include plans and issuers, as well

as their pharmacy benefits managers:

• Denying coverage for all or particular brand name contraceptives, even after the

individual’s attending provider determines and communicates to the plan or

issuer that a particular service or FDA-approved, cleared, or granted

contraceptive product is medically necessary with respect to that individual;

• Requiring individuals to fail first using numerous other services or FDA-

approved, cleared, or granted contraceptive products within the same method of

See FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and

Women’s Health and Cancer Rights Act Implementation (Apr. 20, 2016), Q2, available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf

and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.

A copy of the Medicare Part D Coverage Determination Request Form is available at

https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/CoverageDeterminations-

On November 15, 2018, the Departments published final regulations concerning religious exemptions at 83 FR

57536 and moral exemptions at 83 FR 57592, as well as accommodations regarding this coverage. On August 16,

2021, the Departments issued FAQs about Affordable Care Act Implementation Part 48, available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-48.pdf

and

https://www.cms.gov/files/document/faqs-part-48.pdf, in which the Departments indicated their intent to initiate

rulemaking within six months of that date to amend these final regulations.

contraception before the plan or issuer will approve coverage for the service or

FDA-approved, cleared, or granted contraceptive product that is medically

appropriate for the individual, as determined by the individual’s attending health

care provider;

• Requiring individuals to fail first using other services or FDA-approved, cleared,

or granted contraceptive products in other contraceptive methods before the plan

or issuer will approve coverage for a service or FDA-approved, cleared, or

granted contraceptive product in the contraceptive method that is medically

appropriate for the individual, as determined by the individual’s attending health

care provider; and

• Failing to provide an easily accessible, transparent, and sufficiently expedient

exception process that is not unduly burdensome (for example, requiring

individuals to appeal an adverse benefit determination using the plan’s or issuer’s

internal claims and appeals process as the means to obtain an exception).

The Departments are actively investigating these complaints and reports and may take

enforcement or other corrective actions. The Departments are also assessing what types of

changes to existing guidance or regulations may need to be made to better ensure individuals

receive the coverage to which they are entitled under the law and will issue additional guidance,

as warranted.

The Departments have also received stakeholder feedback that while the current 2019 version of

the HRSA Guidelines recommends coverage of the full range of female-controlled FDA-

approved contraceptive methods, the current FDA Birth Control Guide referenced in the

Departments’ prior guidance may not identify all and/or newer contraceptive products approved,

cleared, or granted by FDA, such as mobile apps for contraception based on fertility awareness.

As a result, plans and issuers may not be providing coverage for the full range of FDA-approved,

cleared, or granted contraceptive products in accordance with the current 2019 HRSA

Guidelines.

Plans and issuers subject to these requirements are reminded of their responsibility to fully

comply with the requirements under PHS Act section 2713 and the HRSA Guidelines, as

interpreted in the Departments’ implementing regulations and guidance, including the

requirement that, if an individual and their attending provider determine that a particular service

or FDA-approved, cleared, or granted contraceptive product is medically appropriate for the

individual (whether or not the item or service is identified in the current FDA Birth Control

Guide), the plan or issuer must cover that service or product without cost sharing.

Consumers that are covered by a private-sector, employer-sponsored group health plan and have

concerns about their plan’s compliance with these requirements may contact the Department of

Labor at askebsa.dol.gov or by calling toll free at 1-866-444-3272. Consumers that are covered

FDA News Release, “FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent

pregnancy,” (Aug. 10, 2018), available at

https://www.fda.gov/news-events/press-announcements/fda-allows-

marketing-first-direct-consumer-app-contraceptive-use-prevent-pregnancy.

by a non-federal public-sector employer-sponsored plan (such as a state or local government

employee plan) and have concerns about their plan’s compliance with these requirements may

contact the Health Insurance Assistance Team of the U.S. Center for Consumer Information and

Insurance Oversight at (888) 393-2789 or [email protected] for further assistance with a

question or issue.