HHS Releases Surprise Medical Billing Interim Final Rules

Digital Debut

HHS Releases Surprise Medical Billing Interim Final Rules

The deadline to comment is in late summer

BY KARA NEWBURY | JULY 2021

The US Departments of Health & Human Services (HHS), Labor, and the Treasury, and the Office of Personnel Management issued “Requirements Related to Surprise Billing; Part I" on July 1, 2021. The deadline to comment on this interim final rule (IFR) is September 7, 2021.

This IFR is the first in a series of regulations to implement the No Surprises Act and is aimed at restricting excessive out-of-pocket costs to consumers from surprise billing and balance billing. Enacted on December 27, 2020, the No Surprises Act provides federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise bills arise most frequently.

According to a fact sheet, among other provisions, the interim final rules

  • Ban high out-of-network cost sharing for emergency and nonemergency services. Patient cost sharing, such as coinsurance or a deductible, cannot be higher than if such services were provided by an in-network doctor, and any coinsurance or deductible must be based on in-network provider rates.
  • Ban out-of-network charges for ancillary care, such as an anesthesiologist or assistant surgeon, at an in-network facility in all circumstances. The total amount to be paid to the provider or facility, including any cost sharing, is based on: (1) an amount determined by an applicable All-Payer Model Agreement under section 1115A of the Social Security Act; (2) if there is no such applicable All-Payer Model Agreement, an amount determined by a specified state law; (3) if there is no such applicable All-Payer Model Agreement or specified state law, an amount agreed upon by the plan or issuer and the provider or facility; or (4) if none of those three conditions apply, an amount determined by an independent dispute resolution (IDR) entity.
  • Ban other out-of-network charges without advance notice. Healthcare providers and facilities must provide patients with a plain-language consumer notice explaining that patient consent is required to receive care on an out-of-network basis before that provider can bill at the higher out-of-network rate.

Notice and Consent

Under the No Surprises Act and these interim final rules, the protections that limit cost sharing and prohibit balance billing do not apply to certain nonemergency services if the nonparticipating provider furnishing those items or services provides the patient with notice, the individual acknowledges receipt of the information in the notice, and the individual consents to waive the balance billing protections with respect to the nonparticipating providers named in the notice.

Healthcare providers and facilities must make publicly available, post on a public website and provide a one-page notice to individuals regarding: (1) the requirements and prohibitions applicable to the provider or facility under the Public Health Service Act (PHSA) and their implementing regulations; (2) any applicable state balance billing requirements; and (3) how to contact appropriate state and federal agencies if the individual believes the provider or facility has violated the requirements described in the notice.

Written notice

Providers and facilities are required to use a written notice specified by HHS in guidance. HHS released the Model Disclosure Notice Regarding Patient Protections Against Surprise Billing in supplementary documents. Providers and facilities will need to tailor the document to include specific information, such as identifying the nonparticipating provider and providing the good faith estimated amount.

Voluntary signed consent

The consent must be provided voluntarily, meaning that the individual has consented freely, without undue influence, fraud or duress. An incomplete consent document will be treated as a lack of consent and balance billing protections will still apply.

The consent document must be signed, including by electronic signature, by the individual or the individual’s authorized representative. The nonparticipating provider or participating healthcare facility on behalf of the nonparticipating provider, must provide the individual with a copy of the signed notice and consent in person or through mail or email, as selected by the individual.

Physically separate

The notice must be written and provided on paper or, as practicable, electronically, as selected by the individual. HHS is concerned that individuals might be less likely to review the notice carefully if it is embedded with other information, so the interim final rules require that the notice be provided with the consent document and together these documents be given physically separate from, and not attached to or incorporated into, any other documents.

Timing of the notice and consent

If an individual schedules an appointment for such items or services at least 72 hours before the date of the appointment, the provider or facility must provide the notice to the individual or their authorized representative no later than 72 hours before the date of the appointment. If an individual schedules an appointment for such items or services within 72 hours of the date of the appointment, the provider or facility must provide the notice to the individual or their authorized representative on the day that the appointment is made, but no later than three hours prior to furnishing items or services to which the notice and consent requirements apply.

HHS seeks comment on whether such a time limit is a reasonable approach, as well as whether the three hours’ time requirement should be shorter or longer to best ensure that consent is freely given while also facilitating timely access to care.

Good faith estimate

The notice must include the good faith estimated amount that such nonparticipating provider may charge the individual for the items and services involved, including any item or service that the nonparticipating provider reasonably expects to provide in conjunction with such items and services.

HHS seeks comment regarding the method by which this good faith estimated amount should be calculated and anticipates addressing this requirement in future rulemaking.

Consumer protections, such as the notice and consent requirements, take effect beginning January 1, 2022.

Later this year, the departments intend to issue regulations regarding the federal independent dispute resolution process, patient protections through transparency and the patient-provider dispute resolution process, and price comparison tools.

Read the March 2021 Advocacy Spotlight for more information on the No Surprises Act and its impact on ASCs.

Write Kara Newbury with questions.