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Regulatory Update – COVID-19 FAQs Part 43

United States Capitol

(Source: Information Provided by Associated Benefits Consulting’s Attorney
Chip Kerby of The Liberte’ Group)

The DOL, IRS and HHS recently issued another set of FAQs (Part 43) providing further details on the COVID-19 testing mandate. Like the Part 42 FAQs issued in April, the Part 43 FAQs discuss the requirements of section 6001 of the Families First Coronavirus Response Act (FFCRA), as amended by section 3201 of the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). These laws require group health plans to cover COVID-19 diagnostic tests and related provider charges without cost-sharing or other restrictions. The link to the entire 18 pages (and 39 footnotes), is here –
https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf

The “cliff notes” version is below (shorter, more-to-the-point answers).

Footnote 6 – The agencies drop a very important clarification in footnote 6. The law requires group health plans to cover COVID-19 tests without cost-sharing or “other restrictions.” Footnote 6 says that the prohibited “other restrictions” include a medical necessity review. What this seems to mean is that the COVID-19 testing mandate essentially overrides a fundamental requirement in almost every group health plan; namely, the requirement that a covered service must be medically necessary.

#1 - Are self-insured group health plans required to comply with the requirements of section 6001 of the FFCRA?
Yes (and, as they told us in FAQs Part 42, excepted benefits, short-term limited duration insurance and plans covering less than 2 current employees aren’t required to comply).
#2 - How can a plan or issuer determine which COVID-19 tests are required to be covered under section 6001(a)(1) of the FFCRA?

The law requires COVID-19 tests to be covered without cost sharing if the tests fall into any one of four buckets:

· Bucket A – Tests that the FDA has approved, cleared or authorized (including emergency use authorizations). The agencies tell us that, to date, no COVID-19 tests have been fully approved or cleared by the FDA. The COVID-19 tests that have received emergency use authorization from the FDA are listed here: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

· Bucket B – Tests for which a developer has requested, or intends to request, an emergency use authorization from the FDA (and which hasn’t been denied or withdrawn). The agencies say the FDA will post the names of these entities on the FDA’s website at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#offeringtests . The agencies also say that group health plans and their administrators can ask a clinical laboratory or manufacturer to provide documentation of an emergency use authorization request, and asking for this documentation doesn’t violate the prohibition on “other restrictions.”

· Bucket C – Tests that are developed in and authorized by States that have notified HHS that they intend to review the tests. The agencies say the States that have provided this notice to FDA are listed here:https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#offeringtests . As I write this, the listed States include Connecticut, Maryland, Mississippi, Nevada, New Jersey, New York and Washington.

· Bucket D – Tests that HHS has determined to be appropriate. The agencies say there are no such tests at this time.

An “attending provider” is an individual who is licensed (or otherwise authorized) under applicable law, who is acting within the scope of the license (or authorization) and who is responsible for providing care to the patient. In an attempt to clarify what “responsible” means, the agencies say that a provider doesn’t need to be “directly” responsible for providing care to the patient as long as the provider makes an individualized clinical assessment to determine whether a COVID-19 test is medically appropriate for the individual in accordance with current accepted standards of medical practice.
#4 - Are plans and issuers required to cover COVID-19 tests intended for at-home testing under section 6001 of the FFCRA?
Yes. The agencies note that the FDA has authorized a COVID-19 test for home collection of specimens to be sent to a lab for processing and test reporting.
#5 - Is COVID-19 testing for surveillance or employment purposes required to be covered under section 6001 of the FFCRA?
No. The agencies say that the coverage mandate applies only for individualized diagnostic and treatment purposes. Testing conducted to screen for workplace health and safety or for public health surveillance is not subject to the mandate.
#6 - If an individual receives multiple diagnostic tests for COVID-19, are plans and issuers required to cover each test, as well as other applicable items and services?
Yes, as long as each test is for diagnostic purposes and (here come the magic words again) is “medically appropriate for the individual as determined by an attending health care provider in accordance with current accepted standards of medical practice.”
#7 - If a facility fee is charged for a visit that results in an order for or administration of a COVID-19 diagnostic test, must the plan or issuer also cover the facility fee without imposing cost-sharing requirements?
Yes. The agencies explain with the following example: “For example, if an individual is treated in the emergency room and the attending provider orders a number of services to determine whether a COVID-19 diagnostic test is appropriate, such as diagnostic test panels for influenza A and B and respiratory syncytial virus, as well as a chest x-ray, and ultimately orders a COVID-19 test, the plan or issuer must cover those related items and services without cost sharing, prior authorization, or other medical management requirements, including any physician fee charged to read the x-ray and any facility fee assessed in relation to those items and services.”
#8 - Do the reimbursement requirements of section 3202(a) of the CARES Act apply to any items and services other than diagnostic testing for COVID-19?
No. This section of the CARES Act says that group health plans or insurance carriers must reimburse providers either a negotiated rate or, if there is no negotiated rate, the cash price for the service listed on the provider’s public internet website. I read this to say this reimbursement requirement applies to both the provider’s charges and the related facility fees described in Q&A-7.
#9 - Does section 3202 of the CARES Act protect participants, beneficiaries, and enrollees from balance billing for a COVID-19 diagnostic test?
Yes. The agencies say the law precludes balance billing for COVID-19 testing. (I read this to say that balance billing is prohibited with respect to both the provider’s charges and the related facility fees described in Q&A-7).
#10 - How do the requirements of section 3202(a)(2) of the CARES Act interact with state balance billing laws regarding reimbursement for items and services furnished by out-of-network providers or providers that do not have a negotiated rate with a plan or issuer for COVID-19 tests?
In a convoluted answer, the agencies suggest that state balance billing laws may apply as long as the state laws don’t prevent the application of section 3202(a)(2). It might have been simpler to say that section 3202(a)(2) of the CARES Act preempts inconsistent state balance billing laws, but that’s the way they stated it.
#11 - How should plans and issuers determine a reimbursement rate for providers of COVID-19 testing if they do not have a negotiated rate with the provider and the provider has not made available on a public internet website the cash price of a COVID-19 diagnostic test, as required by section 3202(b) of the CARES Act?
The answer – go fight it out. The agencies recognize that the law doesn’t address the applicable reimbursement rate where: (a) there is no negotiated rate; and (b) the provider doesn’t post a cash price on a public internet website. In this situation, the agencies say only that the group health plan or health insurance carrier can attempt to negotiate a reimbursement rate. They also remind us that the CARES Act gives HHS the authority to impose civil monetary penalties on providers that don’t post the cash price of a COVID-19 diagnostic test on a public internet website.
#12 - If an individual receives a COVID-19 test in an emergency department of a hospital that is out-of-network, how do the requirements of section 3202(a) of the CARES Act interact with PHS Act section 2719A?
Short answer – the CARES Act requirement overrides the requirements of PHSA section 2719A. Longer answer – this question refers to an ACA provision (section 2719A) that requires group health plans and health insurance carriers to cover out-of-network emergency services at the same level of cost-sharing as in-network emergency services. This ACA provision goes on to say that the “same level of cost-sharing” requirement is satisfied if the plan or carrier pays the greatest of three amounts specified in regulations. But Q&A 12 instructs plans and carriers to ignore the 2719A requirements for purposes of determining the reimbursement required under section 3202(a) of the CARES Act.
#13 - In FAQs Part 42, the Departments announced temporary enforcement relief that allows plans and issuers to make changes to coverage to increase benefits, or reduce or eliminate cost sharing, for the diagnosis and treatment of COVID-19 or for telehealth and other remote care services more quickly than they would otherwise be able to under current law. May a plan or issuer also revoke these changes upon the expiration of the public health emergency related to COVID-19 without satisfying advance notice requirements?
Yes, as long as the group health plan or health insurance carrier provides notice of the changes “within a reasonable timeframe in advance of the reversal of the changes.” There is a lack of precision here; we don’t know what the phrase “reasonable timeframe” means and it’s an invitation for participant lawsuits.
#14 - In light of the COVID-19 pandemic, may a large employer offer coverage only for telehealth and other remote care services to employees who are not eligible for any other group health plan offered by the employer?
Yes. The agencies are providing limited regulatory relief for large employers (100+ employees) that want to offer telehealth services to employees who aren’t eligible for the employer’s other group health plans. These plans don’t have to comply with the group health plan requirements of Part 7 of ERISA, except for the following requirements – the rules prohibiting pre-existing condition exclusions, the rules prohibiting discrimination based on health status, the rules prohibiting rescissions and the rules requiring parity in mental health and substance use disorder benefits. The relief applies only for the duration of plan years beginning before the end of the public health emergency.
#15 - If a grandfathered group health plan or issuer of grandfathered group or individual health insurance coverage adds benefits, or reduces or eliminates cost-sharing requirements, for the diagnosis and treatment of COVID-19 or for telehealth and other remote care services during the public health or national emergency period related to COVID-19, will the plan or coverage lose its grandfather status solely because it later reverses these changes upon the expiration of the COVID-19 emergency period?
No. This is a very welcome answer for grandfathered health plans.
Yes. The agencies say they will temporarily exercise enforcement discretion and not take enforcement action against any group health plan or health insurance carrier that disregards the COVID-19 testing items and services for purposes of applying the two quantitative tests in the mental health parity regulations.
#17 - May a plan or issuer waive a standard for obtaining a reward (including any reasonable alternative standard) under a health-contingent wellness program if participants or beneficiaries are facing difficulty in meeting the standard as a result of circumstances related to COVID-19?
Yes, as long as the waiver is offered to all similarly situated individuals.
#18 - What are the potential consequences of delaying the individual coverage HRA notice to the extent permitted by EBSA Notice 2020-01?
The agencies tell us that delaying the required individual coverage HRA notice (as permitted by EBSA Notice 2020-01) may: (1) cause an individual to miss an opportunity to enroll in individual coverage or Medicare coverage; and (2) affect an individual’s eligibility for premium tax credits.

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Charles
Charles K. “Chip” Kerby III

Chip is an attorney and the founder of Liberté Group LLC, a Washington, DC firm specializing in federal laws affecting the design and administration of ERISA health and welfare benefit plans. The firm works with plan sponsors, service providers, law firms and consulting groups, focusing on plan documentation, compliance issues, vendor contracts and legislative/regulatory developments. With over 40 years of experience, Chip’s approach to problem solving is collaborative and solution-based.

Chip’s prior experience in Washington includes stints as a partner with McDermott, Will & Emery, a principal in Mercer’s Washington Resource Group, a senior manager at PriceWaterhouse, an associate at Miller & Chevalier and an assistant branch chief and attorney-advisor in the Chief Counsel’s office of the IRS.

Chip is admitted to practice in the District of Columbia. He served as an adjunct professor at Georgetown University Law Center co-teaching a graduate LLM course entitled “Health and Welfare Benefit Plans; Tax and ERISA Aspects.” Chip is a fellow of the American College of Employee Benefits Counsel, and speaks and writes on employee benefit issues.

Education

  • Georgetown University Law Center, L.L.M. in Taxation, 1983
  • Washington and Lee University School of Law, J.D., cum laude, 1978
  • University of Delaware, B.A., magna cum laude, 1975

Contact Information
Please contact Chip by telephone (202-756-2459) or by email (chip@libertegroup.com)