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, 2020.1 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.2 Under the FFCRA, plans 
                                                            
1 Pub. L. No. 116-127 (2020). 
2 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://www.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://www.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. 
 
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  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, 2020.3 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.4 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 providers 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-19.5 Due to the urgent need to continue to facilitate the nations 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).6 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 
                                                            
3 Pub. L. No. 116-136 (2020). 
4 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. 
5 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://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 (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).  
6 5 U.S.C.  553(b)(A). 
 
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  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.7   
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.8   
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.9 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.10 
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. 11 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. 
                                                            
7 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. 
8 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. 
9 Id. at footnote 8. 
10 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. 
11 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/. 
 
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  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,12 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 providers 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 
plans or issuers 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 Departments13 such that the 
requirement to cover COVID-19 tests under section 6001 of the FFCRA with respect to OTC 
                                                            
12 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 COVID19; or (D) are other tests that the Secretary of HHS determines appropriate in guidance. 
13 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 
 
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  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 providers order 
under the applicable FDA authorization, clearance, or approval. This FAQ does not modify 
previous guidance14 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).15  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 plans 
or issuers 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 providers order. 
14 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. 
15 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.  
 
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  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 plans or issuers 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 plans or issuers 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 providers involvement or prescription; plans and issuers must 
continue to provide coverage for COVID-19 tests that are administered with a providers 
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 
 
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  to everyone who needs them, when they need them. Furthermore, the Departments recognize an 
individualized clinical assessment or a health care providers 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 providers 
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 
providers 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 tests16 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 providers involvement or prescription; plans 
and issuers must continue to provide coverage for COVID-19 tests that are administered with a 
providers 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. 
                                                            
16 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.  
 
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  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 individuals own personal use (or use by another participant, beneficiary, or enrollee 
who is covered under the plan or coverage as a member of the individuals 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 participants, beneficiarys, or enrollees 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 tests 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 
 
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  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 tests 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, Q9,17 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.  
                                                            
17 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. 
 
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  COVERAGE OF PREVENTIVE SERVICES 
PHS Act section 2713 and its implementing regulations relating to coverage of preventive 
services18 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:19 
  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;20 
  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.21 
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.22 
                                                            
18 26 CFR 54.9815-2713; 29 CFR 2590.715-2713; 45 CFR 147.130. 
19 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). 
20 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. 
21 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. 
22 See 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); 45 CFR 147.130(a)(4). 
 
10 
 
 
  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.23 These items and services include: 
  Required specialist consultation prior to the screening procedure;24 
  Bowel preparation medications prescribed for the screening procedure;25 
  Anesthesia services performed in connection with a preventive colonoscopy;26 
  Polyp removal performed during the screening procedure;27 and 
  Any pathology exam on a polyp biopsy performed as part of the screening 
procedure.28  
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.29 
Additionally, the Final Recommendation Statement provides with respect to direct visualization 
                                                            
23 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.). 
24 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 
25 See FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and 
Womens 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. 
26 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.  
27 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. 
28 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. 
29 https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening. 
 
11 
 
 
  tests: Abnormal findings identified by flexible sigmoidoscopy or CT colonography screening 
require follow-up colonoscopy for screening benefits to be achieved.30 
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.31 
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, 2022.32   
Coverage of FDA-approved Contraceptive Products Pursuant to HRSA Guidelines 
The currently applicable HRSA Womens 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,33 effective 
family planning practices and sterilization procedures to prevent unintended pregnancy and 
                                                            
30 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. 
31 Id. 
32 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). 
33 The Departments note that the FDA approves, clears, and grants contraceptive products and not methods. 
 
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  improve birth outcomes.34 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 
womens 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.35 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 individuals 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.36 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 patients 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 individuals 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., 
                                                            
34 https://www.hrsa.gov/womens-guidelines-2019. 
35 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. 
36 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. 
 
13 
 
 
  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 patients authorized representative).37 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.38  
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 individuals 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-exempt39 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 
individuals 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 
                                                            
37 See FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and 
Womens 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. 
38 A copy of the Medicare Part D Coverage Determination Request Form is available at 
https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/CoverageDeterminations-. 
39 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. 
 
14 
 
 
  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 individuals 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 individuals 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 plans or issuers 
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.40  
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 plans 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 
                                                            
40 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. 
 
15 
 
 
  by a non-federal public-sector employer-sponsored plan (such as a state or local government 
employee plan) and have concerns about their plans 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 phig@cms.hhs.gov for further assistance with a 
question or issue.
 
16