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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations
extent a state law prevents the application of this section.

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149.620 Requirements for the patientprovider dispute resolution process.

a Scope and definitions1 Scope.
This section sets forth requirements for the patient-provider dispute resolution process, under which an uninsured or self-pay individual, with respect to eligible items or services under paragraph b of this section, may submit notification under paragraph c of this section to initiate the patientprovider dispute resolution process.
This section sets forth in paragraph d of this section the certification requirements for a dispute resolution entity to become a Selected Dispute Resolution SDR entity contracted to resolve the patient-provider dispute, and the process for HHS to select SDR
entities for patient-provider disputes under paragraph e of this section. This section sets forth in paragraph f the process and requirements regarding how SDR entities will determine the amount to be paid by an uninsured or self-pay individual to a provider or facility. This section also sets forth requirements for an administrative fee under paragraph g of this section and minimum requirements under paragraph h of this section for states that wish to establish processes for performing patientprovider dispute resolution in place of the Federal process.
2 Definitions. Unless otherwise stated, the definitions in 149.610a2
apply to this section. Definitions related to confidentiality set forth in 149.510a2, including the definitions for breach, individually identifiable health information IIHI, and unsecured IIHI also apply to this section. Additionally, for purposes of this section, the following definitions apply:
i Billed charges means the amount billed by a provider or facility for an item or service.
ii Substantially in excess means, with respect to the total billed charges by a provider or facility, an amount that is at least $400 more than the total amount of expected charges listed on the good faith estimate for the provider or facility.
iii Total billed charges means the total of billed charges, by a provider orfacility, for all primary items or services and all other items or services furnished in conjunction with the primary items or services to an uninsured or self-pay individual, regardless of whether such items or services were included in the good faith estimate.
b Eligibility for patient-provider dispute resolution1 In general. In
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general, an item or service provided by a convening provider, convening facility, co-provider, or co-facility is eligible for the patient-provider dispute resolution process if the total billed charges by the particular convening provider, convening facility, or coprovider or co-facility listed in the good faith estimate, are substantially in excess of the total expected charges for that specific provider or facility listed on the good faith estimate, as required under 149.610.
2 Special rule for co-provider or cofacility substitution. If a co-provider or co-facility that provided an estimate of the expected charge for an item or service in the good faith estimate is substituted for a different co-provider or co-facility, an item or service billed by the replacement co-provider or cofacility is eligible for dispute resolution if the billed charge is substantially in excess of the total expected charges included in the good faith estimate for the original co-provider or co-facility. If the replacement provider or facility provides the uninsured or self-pay individual with a new good faith estimate in accordance with 149.610b2, then the determination of whether an item or service billed by the replacement co-provider or cofacility is eligible for dispute resolution is based on whether the total billed charge for the replacement co-provider or co-facility is substantially in excess of the total expected charges included in the good faith estimate provided by the replacement co-provider or co-facility.
c Initiation of the Patient Provider dispute resolution process1 In general. With respect to an item or service that meets the requirements in paragraph b of this section, an uninsured or self-pay individual or their authorized representative, excluding any providers directly represented in the good faith estimate, providers associated with these providers, non-clinical staff associated with these providers, or individuals employed or associated with a facility that had included services in the good faith estimate may initiate the patientprovider dispute resolution process by submitting a notification initiation notice to HHS as specified in paragraph c2 of this section postmarked within 120 calendar days of receiving the initial bill containing charges for the item or service that is substantially in excess of the expected charges in the good faith estimate. In addition, the uninsured or self-pay individual must submit an administrative fee as described in paragraph g of this section to the SDR entity in an amount
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and in a manner that will be clarified in guidance by HHS.
2 Initiation noticei Content. The notice to initiate the patient-provider dispute resolution process must include:
A Information sufficient to identify the item or service under dispute, including the date the item or service was provided, and a description of the item or service;
B A copy of the provider or facility bill for the item and service under dispute the copy can be a photocopy or an electronic image so long as the document is readable;
C A copy of the good faith estimate for the item or service under dispute the copy can be a photocopy or an electronic image so long as the document is readable;
D If not included on the good faith estimate, contact information of the provider or facility involved, including, if available, name, email address, phone number, and mailing address;
E The State where the items or services in dispute were furnished; and F The uninsured or self-pay individuals communication preference, through the Federal IDR portal, or electronic or paper mail.
ii Manner. The uninsured or selfpay individual or their authorized representative must submit the initiation notice, to the Secretary by submitting the notice via the Federal IDR portal, electronically, or on paper, in the form and manner specified by the Secretary. The date of initiation of the patient-provider dispute resolution process will be the date the Secretary receives such initiation notice. In addition, the uninsured or self-pay individual must submit an administrative fee as described in paragraph g of this section to the SDR
entity in an amount and in a manner that will be clarified in guidance by HHS.
3 Notification of SDR entity receipt.
Upon receipt of the initiation notice described in paragraph c1 of this section, HHS will select an SDR entity according to the process described in paragraph e of this section. Upon selection, the SDR entity will, through the Federal IDR portal, or electronic or paper mail, notify the uninsured or self-pay individual, and the provider or facility that a patient-provider dispute resolution request has been received and is under review. Such notice shall also include:
i Sufficient information to identify the item or service under dispute;
ii The date the initiation notice was received;

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