No Surprises Act – Required Notice – Food, Drugs, Health Care, Life Sciences



United States: Surprise Act – Notice Requirements

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On July 1, 2021, the Biden administration passed an interim final rule: Part 1 of the Requirements Related to Surprise Billing Act, with the aim of reducing the excessive costs that patients are required to pay with respect to surprise billing. The rule is expected to take effect on January 1, 2022 and will only affect those who are enrolled in insurance through their employers, as federal health programs already prohibit this type of billing.1


Surprise billing occurs when patients receive care from off-grid providers without their knowledge. This translates into higher prices for medical services that would otherwise be cheaper if provided by providers within their health plan network, forcing the patient to cover what was not covered by his insurance. According to CMS, in 2016, 42.8% of emergency room visit bills were subject to an off-grid bill, even though the visit was to a network hospital.2While some may believe that this only happens in emergency situations, it can also occur in non-emergency situations (i.e. someone involved in the patient’s care is not part of the network).

In addition to reducing these surprise costs, the rule also focuses on the following:

  1. No longer allow surprise invoicing in an emergency;
  2. Prohibit high cost sharing for emergency and non-emergency services (i.e. cost sharing cannot be higher for off-grid services than in-network cost sharing);
  3. Prohibit out-of-network charges for attendant care;
  4. Prohibit off-grid charges without notice (provide patients with plain language consumer advice).3

Notice to Consumers

Requiring off-network providers to notify potential patients that they are outside of the patient’s health plan network is a big part of the goal of the No Surprises Act. Essentially, patients can forgo paying off-grid prices for elective services as long as they consent, which is not allowed in emergency situations or for certain ancillary services (i.e. anesthesia) under the Act.4

First, providers and / or health facilities must have a
standard notice that can be given to patients outside the network when looking for services, that must be given to patients within seventy hours of the scheduled appointment or service (or three hours for same-day services). These notices should include the following:

  • A statement that the supplier (or facility) is off-grid;
  • An estimate of the cost of the services (which must be calculated in good faith); and
  • Information on the limitations of the management of prior authorizations / uses.5

This document must be given to the patient separately from any other document given to him, and must be available in fifteen (15) of the most common languages ​​where the provider is located (in addition to meeting the language requirements required by law) .6

In addition, if the notice is given for post-stabilization services, the notice must also include a list of network providers who can provide the necessary services, and a statement that the patient will be referred to a network provider at discretion.7

Finally, there is a requirement that states that off-grid providers must notify health plans when providing services to patients, and they must certify that they have met the required notification and consent requirements. These records must be kept for at leastseven years either by the provider or by the health establishment.8

The Department of Health and Human Services (“HHS”) is expected to offer additional guidance as the law’s effective date approaches, so stay tuned for more requirements from off-grid providers. regarding consumer opinion and consent.


1 CMS, What you need to know about the actions of the Biden-Harris administration to prevent surprise billing,(July 1, 2021),

2 CMS, Surprise billing requirements; Part I Provisional Final Rule with Comment Period (July 1, 2021),

3 CMS, HHS announces rule to protect consumers from surprise medical bills, (July 1, 2021),

4 AHA, Agencies publish first part of regulation banning surprise medical bill (July 2, 2021),

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The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

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