DOL issues additional guidance on free over-the-counter COVID tests | McAfee and Taft


This is a supplement to our January 16, 2022 article titled “Free over-the-counter COVID test (if you can find them)about new requirements related to health plans providing free over-the-counter COVID tests.

Last Friday, February 4, the U.S. Department of Labor issued additional guidance on this topic, which not only confirms that a direct-to-consumer program is necessary if a health plan wants to be able to limit out-of-pocket reimbursement network (OON) at $12, as we described in our January 16 article, but also brings some new features:

  • At least one direct-to-consumer shipping mechanism is usually required.
    “Q1: Do plans and issuers have flexibility in how they establish a direct-to-consumer program and direct coverage via an in-person network in order to qualify for the safe harbor set out in the FAQ, part 51, Q2? Yes. In response to issues raised by stakeholders, departments are revising the Safe Harbor requirements set out in FAQ Part 51, Q2, to ensure plans and issuers have significant flexibility in how they provide access to OTC COVID-19 testing under these requirements. In order to meet Safe Harbor requirements, plans and issuers must provide direct coverage by ensuring participants, beneficiaries and enrollees have adequate access to OTC COVID-19 testing at no upfront cost. For this purpose, Whether a plan or issuer provides adequate access through its direct coverage program will depend on the facts and circumstances, but will generally require that OTC COVID-19 tests be made available through at least a direct-to-consumer and consumer shipping mechanism. least one in-person mechanism. [The Departments recognize that there may be some limited circumstances in which a direct coverage program could provide adequate access, and therefore satisfy the requirements of the safe harbor, without establishing both a direct-to-consumer shipping mechanism and an in-person mechanism. For example, if a small employer’s plan covers only employees who live and work in a localized area, it could be possible that distribution at a nearby location constitutes adequate access to OTC COVID-19 tests without establishing a direct-to-consumer shipping mechanism.] “Direct coverage” can be provided through a number of mechanisms, including, but not limited to, a direct-to-consumer shipping program that allows orders to be placed online or over the phone; the plan’s or issuer’s pharmacy network; other non-pharmaceutical retailers (including through the distribution of coupons allowing enrollees to receive tests from certain retailers without cost sharing); and other OTC COVID-19 test distribution sites established by or on behalf of the plan or issuer (such as a self-driving or walk-in distribution site, including a site that operates independently of a pharmacy or other retailer). ”

McAfee and Taft Commentary: Since customers are not yet able to provide the direct-to-consumer shipping program, the bracketed language above – and the “number of mechanisms” language – is what we will be relying on , on a very temporary basis, to say that we are safe harbor compliant until the direct-to-consumer program is operational. It’s not clear that it works, but many other employers and PBMs have been working hard to get the direct-to-consumer shipping program in place since these guidelines were released so recently. The example provided above for a “limited circumstance” involving a “small employer” whose employees “live and work in a localized area” with no shipping mechanism available to consumers, cannot be used by large employers. to somehow try to circumvent the direct-to-consumer shipping requirement.

  • Plan participants should be informed of key information.
    In order to facilitate consumer access and provide a seamless experience in obtaining OTC COVID-19 testing at no upfront cost, plans and issuers should ensure that participants, beneficiaries and enrollees are aware of the key information needed to access OTC COVID-19 Tests, such as tests available under the Direct Cover program, and whether the scheme or issuer offers different mechanisms for obtaining tests under its Direct Cover program, what tests are available under each mechanism.
  • The direct-to-consumer shipping mechanism can take different forms as long as individuals can order and get to their homes.
    This FAQ clarifies that a direct-to-consumer shipping mechanism is any program that provides direct OTC COVID-19 testing coverage for participants, beneficiaries, or enrollees without requiring the individual to obtain the test in person. A direct-to-consumer shipping mechanism may include online or telephone ordering and may be provided through a pharmacy or other retailer, plan or issuer directly, or any other entity in the name of the plan or the issuer. A direct-to-consumer program does not have to provide exclusive access through a single entity, as long as it allows a participant, beneficiary, or registrant to place an order for OTC testing. COVID-19 are sent to them directly. For example, if a plan or issuer has chosen to provide direct in-person coverage of OTC COVID-19 testing through specified retailers, and those retailers maintain online platforms where individuals can also order tests at deliver to them, departments will review the plan or issuer for providing a direct-to-consumer shipping mechanism.
  • Plan must pay shipping costs.
    When providing OTC COVID-19 testing through a direct-to-consumer program, plans and issuers must cover reasonable shipping costs related to covered OTC COVID-19 testing in a manner consistent with other items. or products provided by the plan or the issuer by courier. order.
  • The in-person mechanism must provide an adequate number of slots.
    When implementing an in-person mechanism, a scheme or issuer should ensure that participants, beneficiaries or enrollees have access to OTC COVID-19 testing through an adequate number of locations (which could include pharmacies and other retailers, or independent distribution sites set up by or on behalf of a plan or issuer). As the departments noted in the FAQ, Part 51, Q2, the existence of adequate access must be determined based on all relevant facts and circumstances, such as the locality of the participants, beneficiaries or enrollees. plan or coverage; current use of the Plan’s or Issuer’s pharmacy network by its Participants, Beneficiaries or Enrollees, when providing such coverage through a pharmacy network; and how the plan or issuer informs participants, beneficiaries, or enrollees of outlets, distribution sites, or other distribution mechanisms of the tests, as well as the tests available under the direct coverage program.
  • Tests should be used and processed without the involvement of a laboratory or other health care provider.
    To the extent that a COVID-19 test is not approved or permitted to be self-administered and self-read without the involvement of a health care provider (such as a test where a consumer collects a sample at home and sends the sample to be processed in a laboratory), the guidelines of the sphere of security do not apply.
  • A temporary shortage of supply will not destroy the ability to rely on the safe harbor (i.e. the $12 OON cap).
    The Ministries will not consider a plan or issuer to be non-compliant with the safe harbor rule of FAQ Part 51, Q2 if it has established a direct hedging program that meets the requirements of this safe harbor rule as revised by Q1 of this FAQ Part 52, but is temporarily unable to provide adequate access to the program due to a supply shortage. In this case, a plan or issuer that otherwise meets Safe Harbor requirements may continue to limit reimbursement to $12 per test (or the total cost of the test, whichever is lower) for OTC testing. COVID-19 purchased outside the direct market. hedging program.
  • Plan may prohibit reimbursement for tests obtained from an individual.
    To further discourage problematic behaviors that could limit consumer access, a plan or issuer may establish a policy that limits coverage for over-the-counter COVID-19 tests purchased without the intervention of a healthcare provider. to tests purchased from established retailers who would generally be expected to sell OTC COVID-19 tests. Specifically, plans and issuers may prohibit reimbursement for tests purchased by a participant, beneficiary, or enrollee from an individual through an in-person or online person-to-person sale, or from a seller who uses an online auction or resale. Marlet. Such a policy could include requiring reasonable proof-of-purchase documentation that clearly identifies the product and the seller, such as a UPC or other serial number, the seller’s original receipt from the test, or other documentation. for OTC COVID-19 testing to verify that the item is eligible for coverage under Section 6001 of the FFCRA, or a requirement that the participant, beneficiary, or enrollee certify that the test has not been (and will not) be refunded by any other source (including resale). If a plan or issuer implements a policy that prohibits reimbursement of OTC COVID-19 tests from certain resellers, the plan or issuer must provide information to participants, beneficiaries, or enrollees regarding the retailers from which the tests purchased are generally covered by the plan or issuer. and general information about the types of resellers for which participants, beneficiaries and enrollees are not eligible for reimbursement for tests purchased under the plan or coverage. This does not alter the requirement in FAQ Part 51, Q4 which prohibits a scheme or issuer from requiring individuals to submit multiple documents or implementing multiple steps that unduly delay access or reimbursement of a participant, beneficiary or enrollee in OTC COVID-19 trials.
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