The Departments of Health and Human Services (HHS), Labor, Treasury, and the Office of Personnel Management issued the first interim final rule with comment period, in what is likely to be a series of rules, aimed at ending surprise medical bills from out-of-network providers.

These regulations, released on July 2, 2021, are being promulgated under the No Surprises Act signed into law by the Trump administration in December 2020 as part of the year-end Consolidated Appropriations Act, 2021. Although these regulations do not address significant portions of the No Surprises Act, they will still result in a number of new requirements for hospitals, health systems, ambulatory surgery centers, and other providers as well as commercial payors.

The interim final rule bans surprise billing for emergency services, which is generally defined consistently with the Emergency Medical Treatment and Labor Act, with a few exceptions.  For instance, the definition includes services provided after stabilization until the point of discharge, transfer, or the patient’s consent to be balance billed is obtained. The regulations require any plan that provides or covers emergency services to cover such emergency services without any prior authorization, regardless of whether the provider is in network, and regardless of any other term or condition of the plan or coverage other than the exclusion or coordination of benefits, a permitted affiliation, or waiting period. 

Further, the regulations limit cost-sharing for out-of-network services so that they are no higher than in-network services, and any permissible cost-sharing must count toward any in-network deductibles and out-of-pocket maximums. The interim rule also requires plans to make an initial interim payment to providers within thirty days of determining it has received a clean claim.

The regulations will generally permit patients to waive the balance billing protections if the provider notifies the patient of its status and obtains the patient’s consent prior to rendering services. This notice and consent process is subject to prescribed timing, content and language accessibility, and record-retention requirements as well as a standard notice that HHS will issue at a later date. To date, however, the notice must identify the provider as out of network, provide a good-faith estimate of charges for services that could reasonably be provided, including information on prior authorization or utilization-management limitations. The notice must also be separate from other forms when presented to the patient. Providers and facilities are also required to publicly publish information on patients’ rights with respect to balance billing.

Although the majority of these provisions will not be applicable until Jan. 1, 2022, providers and facilities should begin to consider the ramifications of these and other forthcoming regulations as they will likely require significant time to ensure proper and strategic implementation.