Supreme Court Effectively Ends OSHA Vaccination Emergency Temporary Standard

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In a 6-3 decision issued on January 13, 2022, the Supreme Court reimposed a legal stay that prevents OSHA from enforcing its vaccination Emergency Temporary Standard (ETS). And while the matter is being sent back to the 6th Circuit Court of Appeals for further review, the conclusions drawn by the Court almost certainly means the end of the ETS.

How did we get here?

The ETS was formally published on November 5, 2021, with initial compliance dates of December 5, 2021, and January 4, 2022. Shortly thereafter, the 5th Circuit Court of Appeals issued a legal stay that put the ETS on pause and temporarily prevented OSHA from enforcing it. There were numerous legal challenges to the ETS, which were quickly consolidated and given to the 6th Circuit Court of Appeals for adjudication. The 6th Circuit lifted the legal stay and allowed OSHA to move forward with enforcement. In response, OSHA issued new compliance dates of January 10, 2022, and February 9, 2022, while the case was appealed to the Supreme Court.

What did the Supreme Court say?

The primary question before the Supreme Court was whether the scope of the vaccine ETS exceeded the statutory authority given to OSHA to issue emergency temporary standards. The Court started its analysis by acknowledging that OSHA has the power to regulate occupational risks and dangers. It then asked the question whether the ETS targeted occupational hazards, or whether it was actually regulating public health more broadly, which would exceed OSHA’s authority. While the court recognized that OSHA has the power to regulate COVID-19 risks in environments that may be uniquely susceptible to transmission (such as COVID-19 research labs, cramped workspaces, etc.), it concluded that the breadth of the ETS went beyond clearly identifiable occupational hazards, and thus was tantamount to an impermissible public health measure:

Although COVID-19 is a risk that occurs in many workplaces, it is not an occupational hazard in most. COVID-19 can and does spread at home, in schools, during sporting events, and everywhere else that people gather. That kind of universal risk is no different from the day-to-day dangers that [we] all face from crime, air pollution, or any number of communicable diseases. Permitting OSHA to regulate the hazards of daily life—simply because most Americans have jobs and face those same risks while on the clock—would significantly expand OSHA’s regulatory authority without clear congressional authorization.

As a result, the Court decided that the parties opposing the ETS “are likely to succeed on the merits of their claim that [OSHA] lacked authority to impose the mandate”, so it reimposed the stay and sent the matter back down to the 6th Circuit for further review of the merits of the case. However, the Supreme Court’s reasoning and analysis all but ensures that the 6th Circuit will come to the same conclusion.

What does this mean for employers?

Employers will no longer have to comply with the ETS, which means that they will now have greater latitude to decide what COVID-related practices are best for their workplaces. Employers that have already started complying with the provisions of the ETS can continue to do so, if they choose, or they can discontinue some or all of the measures they’ve adopted at this point. Employers that were holding off on compliance while waiting for the Supreme Court’s decision will now have to decide whether they want to modify any of their existing safety practices. As employers make these decisions, a few things should factor into the consideration process:

  • The Supreme Court’s focus was on whether OSHA exceeded its statutory authority, which has nothing to do with what workplace practices individual employers can choose to adopt. As a result, the decision does not impact the vaccination, testing, and masking practices options that employers can choose from.
  • OSHA still has authority under its General Duty Clause to inspect and penalize what it considers to be unsafe COVID-related practices, although its scope and power under the General Duty clause is much narrower than under the ETS. Indeed, in response to the Supreme Court’s decision,OSHA has put employers on noticeof its continuing commitment to address COVID-19 safety in the workplace:

    Regardless of the ultimate outcome of these proceedings, OSHA will do everything in its existing authority to hold businesses accountable for protecting workers, including under the COVID-19 National Emphasis Program and General Duty Clause.
  • States that have approved state OSHA programs could independently choose to pursue implementation of their own versions of the ETS, and even states without their own OSHA programs may have Departments of Health or other agencies that have made specific recommendations for COVID-related workplace safety practices.
  • Employers covered by the vaccination mandates imposed on federal contractors (the federal contractor mandate) and certain recipients of Medicare and/or Medicaid funds (the CMS mandate) may still have to comply with those requirements, sincein a separate opinionthe Supreme Court upheld the CMS mandate and is expected to eventually weigh-in on the federal contractor mandate.
  • In other words, the ETS was not the only variable that might influence employer practices, which means that employers should be mindful as they decide what COVID-related practices to adopt going forward. In doing so, it will be important to work with trusted advisors and vendors to help make the best decisions for each workplace.

This document is designed to highlight various employee benefit matters of general interest to our readers. It is not intended to interpret laws or regulations, or to address specific client situations. You should not act or rely on any information contained herein without seeking the advice of an attorney or tax professional.

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Guidance Issued Expanding Coverage for COVID-19 Testing

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The Departments recently issued FAQ Part 51 requiring group health plans to cover, without cost-sharing, over-the-counter COVID-19 diagnostic tests obtained without the involvement of a health care provider, effective for tests purchased on or after January 15, 2022.

On January 10, 2022, the Departments of Labor, Health and Human Services, and the Treasury (together, the “Departments”) issued FAQ Part 51 requiring group health plans to cover, without cost-sharing, over-the-counter (“OTC”) COVID-19 diagnostic tests obtained without the involvement of a health care provider. This provision is effective for OTC COVID-19 tests purchased on or after January 15, 2022, and continues for the duration of the Public Health Emergency (currently set to expire January 16, 2022 – however another 90-day extension is expected).

Briefly:

  • Group health plans (and health insurance carriers) must cover diagnostic OTC COVID-19 tests obtained without the involvement of a health care provider without cost-sharing, prior authorization, or other medical management requirements.
  • Plans can either reimburse members for their OTC COVID-19 test purchases after manually submitting a claim, or the plan may arrange to pay the merchant directly (“direct coverage”) allowing plan members to receive the OTC COVID-19 tests with no cost sharing at the point-of-sale.
    • If the plan provides direct coverage, reimbursement for OTC COVID-19 tests purchased outside a preferred network may be limited to the lesser of $12/test or the actual cost of the test.
    • Plans that do not provide for direct coverage must reimburse the individual for the full cost of the test.
  • Plans must cover 8 individual at-home OTC COVID-19 tests per person enrolled in the plan per month. That means a covered family of 4 can obtain 32 tests per month for free.
  • Plans are not required to cover the cost of OTC COVID-19 tests for employment and surveillance purposes.

Frequently Asked Questions

Q: Are group health plans required to cover OTC COVID-19 tests without an order or individualized clinical assessment by a health care provider?

A: Yes. Beginning January 15, 2022, group health plans (and health insurance carriers) must cover diagnostic OTC COVID-19 tests obtained without the involvement of a health care provider without cost-sharing, prior authorization, or other medical management requirements.

Under the existing law, diagnostic OTC COVID-19 tests are covered without cost-sharing when an individual has an order or individualized clinical assessment from a health care provider. Such coverage remains in effect. The limits described in this article as they relate to OTC COVID-19 tests obtained without a health care provider (e.g., 8 tests/month, $12/test when direct coverage is an option) do not apply when an individual has an order or individualized clinical assessment from a health care provider.

Q: How is the coverage provided?

A: Plans and carriers may choose whether to provide “direct coverage” for OTC COVID-19 tests to participants by reimbursing sellers directly without requiring individuals to provide upfront payment or require participants to purchase the OTC COVID-19 test and then submit a claim for reimbursement from the plan.

The Departments strongly encourage plans and carriers to adopt a “direct coverage” approach.

Q: What is “direct coverage”?

A: Direct coverage for OTC COVID-19 tests means that a participant is not required to submit a claim to seek reimbursement from the plan for the purchase of the test. Instead, the plan makes systems and technology changes necessary to process the plan’s payment to the preferred pharmacy or retailer directly (including direct-to-consumer shipping programs) with no upfront out-of-pocket expenditure.

A plan must take reasonable steps to ensure that participants have sufficient access to OTC COVID-19 tests, through an adequate number of retail locations (including both in-person and online). Whether there is adequate access should be determined based on all relevant facts and circumstances, such as the locality of participants under the plan and current utilization of the plan’s pharmacy network. Plans should communicate with members to ensure that participants are aware of key information needed to access OTC COVID-19 tests, such as dates of availability of the direct coverage program and participating retailers or other locations.

If the plan is unable to meet the requirements of the direct coverage safe harbor, the plan must provide for the full reimbursement of OTC COVID-19 tests. This may occur, for example, when there are substantial delays for obtaining a COVID-19 test through a direct-to-consumer shipping program versus obtaining other items through this same program.

Q: Can the plan limit coverage only to OTC COVID-19 tests that are provided through preferred pharmacies or other retailers?

A: No. Generally, a plan or carrier may not limit coverage only to tests that are provided through preferred pharmacies and other retailers.

A plan that provides for direct coverage of OTC COVID-19 tests in accordance with the guidance may limit reimbursement for OTC COVID-19 tests from non-preferred pharmacies and other retailers to the lesser of (1) the actual price, or (2) $12/test.

Example:

Plan provides direct coverage

If a plan has set up a network of preferred stores, pharmacies, and online retailers at which a participant can obtain a test with no out-of-pocket expense at the point-of-sale, the participant can still obtain tests from other retailers outside of that network. The plan may reimburse at a rate of up to $12 per individual test (or the cost of the test, if less than $12).

Plan does not provide direct coverage

If a plan has not set up a network of preferred stores, pharmacies, and online retailers at which a participant can obtain a test with no out-of-pocket expense at the point-of-sale, the participant will be reimbursed the full cost of the test. For example, the participant buys a two-pack of tests for $34, the plan would reimburse $34 (as opposed to $24 had the plan set up a network for individuals to obtain the test without an out-of-pocket expense).

Q: How many OTC COVID-19 tests must the plan provide without cost-sharing?

A: A plan or carrier may limit the number of OTC COVID-19 tests purchased by a participant without the involvement of a health care provider to no less than 8 tests per 30-day period (or per calendar month). For a covered family of 4, this means the plan must provide for up to 32 tests in a month.

Q: What is the effective date?

A: Plans and carriers are required to cover OTC COVID-19 tests purchased on or after January 15, 2022. Plans and carriers may, but are not required to, provide such coverage for OTC tests purchased before January 15, 2022.

The guidance confirms that the non-enforcement relief for mid-year changes to an SBC remains available with respect to this change.

Q: Are plans permitted to address suspected fraud or abuse?

A: Yes. Plans and carriers may take reasonable steps to prevent, detect, and address fraud and abuse.

For example, a plan may require:

  • An attestation that the OTC COVID-19 test was purchased by the participant for personal use, not for employment purposes, has not been (and will not be) reimbursed by another source, and is not for resale.
  • Documentation of proof of purchase with a claim for reimbursement for the cost of an OTC COVID-19 test (e.g., the UPC code for the OTC COVID-19 test and/or a receipt from the seller of the test, documenting the date of purchase and the price of the OTC COVID-19 test).

Q: Are plans required to cover OTC COVID-19 tests that are for employment purposes?

A: No. Consistent with earlier guidance, plans are not required to provide coverage of testing (including an OTC COVID-19 test) that is for employment purposes.

Q: How can plans facilitate access to, effective use of, and prompt payment for OTC COVID-19 tests?

A: Plans and carriers may provide education and information resources to support consumers seeking OTC COVID-19 testing, provided the resources make clear that the plan or carrier provides coverage for, including reimbursement of, all OTC COVID-19 tests under the guidance. This may include:

  • information on the difference between OTC COVID-19 tests and other tests ordered by a provider or processed in a laboratory,
  • quality and reliability information for specific testing products,
  • how to obtain a test directly from the plan without cost-sharing (the direct coverage option, if applicable), and
  • how to submit a claim (paper or electronically) and receive reimbursement directly from the plan.

Employer Action

Employers should:

  • Discuss this expanded coverage with their carriers and TPAs, including whether the carrier or plan will provide for direct coverage of OTC COVID-19 tests.
  • Consider notifying participants of the expanded coverage and how to obtain free OTC COVID-19 tests.

This document is designed to highlight various employee benefit matters of general interest to our readers. It is not intended to interpret laws or regulations, or to address specific client situations. You should not act or rely on any information contained herein without seeking the advice of an attorney or tax professional.

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New York Adopts Final Regulations for Paid Sick Leave

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The New York State Department of Labor has adopted final regulations for the state’s paid sick leave law. The regulations are unchanged from the proposed regulations issued Dec. 9, 2020, and are broken down into definitions, documentation, employee count and accruals.

Notably, the regulations define “net income” and “preventative care,” allow employers to require supporting documentation for leave of three consecutive days, and explain how to count employees for purposes of the law.

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First Guidance on Surprise Medical Billing Issued

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On July 13, 2021, the Departments of Health and Human Services (“HHS”), Labor (“DOL”), and the Treasury (collectively, “the Departments”) jointly published an interim final rule implementing provisions of the No Surprises Act (“NSA”). This is the first set of regulations to address the NSA (“Part I Regulations”); additional rules are forthcoming, including guidance on the Independent Dispute Resolution (“IDR”) process.

Briefly, as it relates to group health plans, the regulations:

  • Include protections to limit out-of-network (“OON”) cost-sharing and “balance billing” as they relate to emergency services, OON providers of air ambulance services, and non-emergency services performed by OON providers at in-network facilities (with limited exceptions).
  • Prescribe a formula to determine a participant’s cost-sharing for these services and how much the plan will pay to the provider for these services. Generally, this will be the lesser of a Qualified Payment Amount (“QPA”) or the provider’s billed charge, unless a state law or the All-Payer Model Agreement applies.
  • Describe new notification obligations, including posting information about the surprise medical bill protections on the plan’s website as well as including such information in the Explanations of Benefits (“EOBs”) issued with respect to these services.

These rules take effect for plan years beginning on or after January 1, 2022, and apply to all group health plans (including grandfathered plans), except:

  • Excepted benefits (e.g., dental and vision plans);
  • Short-term limited duration insurance;
  • HRAs and other account-based plans; and
  • Retiree plans (plans with fewer than 2 participants who are current employees).

For fully insured group health plans, the carrier will be responsible for compliance.

For self-funded group health plans, the plan sponsor is responsible and will need to work closely with third-party administrators (“TPAs”) to comply with these rules. TPAs will likely need to update plan documents to reflect the changes required under the NSA and could pass additional administrative costs on to plan sponsors.

The following highlights some of the additional details from these rules. It will be important to discuss implementation and compliance with TPAs. The Departments request comments on numerous aspects of the rule by September 7, 2021.

Background

As previously reported, with respect to group health plans (and health insurance carriers), the NSA provides protection as it relates to OON cost-sharing and “balance billing” with respect to:

  • Emergency services;
  • Non-emergency services delivered by OON providers at in-network facilities, and
  • OON air ambulance services.

“Balance billing” refers to the practice of an OON provider billing a patient the difference between (1) the provider’s billed charges and (2) the amount collected from the plan (or carrier) plus any amounts previously collected from the patient (e.g., copays, coinsurance, or amounts paid toward the deductible).

The law also establishes a pathway for resolving payer-provider payment disputes using negotiation and arbitration. If entities are unable to come to an agreement, the IDR process requires each party to submit a final payment offer and the arbiter will select one of these offers as the final payment amount. The arbitrator’s decision is final and generally may not be appealed.

Generally, the requirements of the NSA apply to the items and services described above unless the state has an “All-Payer Model Agreement” (“APMA”) (used by Maryland, Pennsylvania and Vermont) or state balance billing law (including Delaware, Massachusetts and Pennsylvania that applies.

In general, self-funded ERISA group health plans will be subject to the requirements of the NSA (versus state law or APMA). However, where state law allows, a plan sponsor may voluntarily “opt-in” to a state’s balance billing protections that provide a method for determining the cost-sharing amount or total amount payable under such a plan (versus the NSA). Currently four states – Nevada, New Jersey, Virginia and Washington – provide such an option. A plan that opts in to such a state law must do so for all items and services to which the state law applies.

Self-funded plans that opt-in to the state law must prominently display in their plan materials describing the coverage of OON items and services a statement that the plan has opted into a specified state law, identify the state (or states), and include a general description of the items and services provided by OON facilities and providers that are covered by the specified state law.

Interim Final Rules

General Requirements

With respect to OON emergency services, non-emergency services furnished by an OON provider in an in-network facility and OON air ambulance services, the NSA requires the services be provided:

  • without cost-sharing requirements that are greater than those that would apply if the services were provided in-network;
  • by calculating cost-sharing requirements as if the total amount that would have been charged for the services were equal to the “recognized amount” for such services; and
  • by counting any cost-sharing payments toward any in-network deductible or out-of-pocket maximum (“OOPM”) (including the annual limit on cost-sharing).

Emergency Services

If a group health plan provides coverage for emergency services in a hospital’s emergency department (or an independent free-standing emergency department), the coverage must be provided:

  • without any prior authorization;
  • regardless of whether the provider furnishing the emergency services is an in-network provider (or facility);
  • without limiting what constitutes an emergency medical condition solely based on diagnosis codes; and
  • without regard to any other term or condition of coverage, other than:
    • an exclusion or coordination of benefit;
    • a waiting period; or
    • applicable cost-sharing.

The Departments are concerned that some plans (and carriers) currently deny coverage of certain services provided in the hospital’s emergency department by determining whether the care involves an emergency medical condition based solely on the final diagnosis code. The interim final rules clarify that all pertinent documentation must be considered and should focus on the presenting symptoms and not final diagnosis when evaluating claims for emergency services.

The regulations further clarify that:

  • Post-stabilization services are considered emergency services subject to the NSA unless certain conditions are satisfied.
  • A plan that covers emergency services is prohibited from denying benefits to a participant with an emergency medical condition that receives emergency services based on a general plan exclusion.

Notice & Consent Exception for Non-Ancillary Services

In the case of non-emergency, non-ancillary services performed by an OON provider at certain in-network facilities, an exception to the prohibition on surprise medical billing may be permissible when the provider gives the patient advance oral and written notification and receives the patient’s signed consent. The rules provide the specific content, method and timing of the notice and consent communications and provides substantial detail on each of these components.

This exception does not apply to ancillary services. For this purpose, ancillary services include items and services:

  • related to emergency medicine, anesthesiology, pathology, radiology, and neonatology, whether provided by a physician or non-physician practitioner;
  • provided by assistant surgeons, hospitalists, and intensivists; diagnostic services, including radiology and laboratory services;
  • that are diagnostic, including radiology and laboratory services; and
  • provided by an OON provider, only if there is no in-network provider who can furnish such item or service at such facility.

In addition, the exception does not apply for items or services furnished because of unforeseen, urgent medical needs that arise at the time a service is furnished for which an OON provider otherwise satisfied the notice and consent requirements.

Cost-Sharing Calculations

Cost-sharing is what the participant or beneficiary must pay for a covered item or service under the terms of the group health plan (e.g., copayments, coinsurance, and amounts paid towards deductibles). Generally, cost-sharing does not include premium payments, balance billing by OON providers, or the cost of items or services that are not covered under the plan.

The participant’s cost-sharing for OON emergency services and for non-emergency services furnished by an OON provider in an in-network facility is calculated based on the “recognized amount” for such services. Unless the APMA or a state law applies, the recognized amount is the lesser of the “Qualified Payment Amount” (“QPA”), or the amount billed by the provider or facility. If the APMA or state law applies, the recognized amount is determined by the APMA or specified state law. With respect to OON air ambulance providers, APMA and state laws generally do not apply. Cost-sharing is determined based on the lesser of the QPA or the billed amount.

Qualified Payment Amount

The QPA is the median of the contracted rates for a particular item or service plus an inflation adjustment. The rules around calculating the QPA are complicated and described in much detail in the regulations, including various special rules that apply (e.g., related to anesthesiology, new plans, and limited data). Briefly, the QPA is determined by:

  1. Calculating a median contracted rate by arranging in order from least to greatest the contracted rates of all group health plans of the plan sponsor in the same insurance market for the same or similar item or service that is provided by a provider in the same or similar specialty or facility of the same or similar facility type and provided in the geographic region in which the item or service is furnished and selecting the middle number.
  2. Adding an inflation adjustment (to be announced by the Departments annually).

Notably, for self-funded plans, the regulations define the “insurance market” as all self-insured group health plans of the plan sponsor or, at the option of the plan sponsor, all self-insured group health plans administered by the same entity that is responsible for calculating the QPA on behalf of the plan (in most cases, the TPA).

Plan/Provider Payment Process

The plan will determine whether the services are covered by the plan. Within 30 days of receipt of a “clean claim,”1 the plan must send the provider an initial payment or notice of denial of the payment. The total amount paid by a plan for items and services is referred to as the “OON Rate.” Assuming APMA and state laws do not apply, the plan must make a total payment equal to one of the following amounts, less any cost sharing from the participant, beneficiary, or enrollee:

  • if the plan and the provider or facility have agreed on a payment amount, the agreed-on amount; or
  • if the parties (plan and provider) enter into the IDR process and do not agree on a payment amount before the date when the IDR entity makes a determination of the amount, the amount determined by the IDR entity.

If the APMA or state law applies, then the OON rates is determined by the APMA or specified state law.

If the payment is disputed, an IDR process will begin after a 30-day window for open negotiation. The regulations addressing the IDR process and IDR entities will be issued in later rulemaking.

Group Health Plan Disclosures

Group health plans (and health insurance carriers) must make publicly available, post on a public website of the plan or issuer and include on each EOB for an item or service with respect to which the NSA applies a notice of the protections under the NSA. If a state balance billing law applies, this must be included in the notice. A model notice may be found athttps://www.dol.gov/agencies/ebsa/laws-and-regulations/laws/no-surprises-act.

Employer Action

Employers should review these requirements with their carriers and TPAs for compliance effective with the first plan year that begins on or after January 1, 2022. As most of these requirements are functions of claim payment and adjudication, it will be important that vendors can support the changes required by the NSA. Self-funded health plans will want to ensure TPAs can meet these new requirements.

We expect additional guidance on the NSA, including the IDR process.

  1. For this purpose, a “clean claim” means the plan received the information necessary to adjudicate a claim for payment for such services.

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