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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Rules and Regulations initiate a 30-day open negotiation period for purposes of determining the amount of total payment, the provider or facility may contact the appropriate person or office to initiate open negotiation, and that if the 30-day negotiation period does not result in a determination, generally, the provider or facility may initiate the independent dispute resolution process within 4 days after the end of the open negotiation period; and iv Contact information, including a telephone number and email address, for the appropriate person or office to initiate open negotiations for purposes of determining an amount of payment including cost sharing for such item or service.
2 In a timely manner upon request of the provider or facility:
i Information about whether the qualifying payment amount for items and services involved included contracted rates that were not on a feefor-service basis for those specific items and services and whether the qualifying payment amount for those items and services was determined using underlying fee schedule rates or a derived amount;
ii If a plan or issuer uses an eligible database under paragraph c3 of this section to determine the qualifying payment amount, information to identify which database was used; and iii If a related service code was used to determine the qualifying payment amount for an item or service billed under a new service code under paragraph c4i or ii of this section, information to identify the related service code; and iv If applicable, a statement that the plans or issuers contracted rates include risk-sharing, bonus, penalty, or other incentive-based or retrospective payments or payment adjustments for the items and services involved as applicable that were excluded for purposes of calculating the qualifying payment amount.
e Certain access fees to databases. In the case of a plan or issuer that, pursuant to this section, uses an eligible database to determine the qualifying payment amount for an item or service, the plan or issuer is responsible for any costs associated with accessing such database.
f Audits. The procedures described in part 150 of this subchapter apply with respect to ensuring that a plan or coverage is in compliance with the requirement of applying a qualifying payment amount under this subpart and ensuring that such amount so applied satisfies the requirements under this section, as applicable.

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g Applicability date. The provisions of this section are applicable with respect to plan years in the individual market, policy years beginning on or after January 1, 2022.
149.150 Complaints process for surprise medical bills regarding group health plans and group and individual health insurance coverage.

a Scope and definitions1 Scope.
This section establishes a process to receive and resolve complaints regarding information that a specific group health plan or health insurance issuer offering group or individual health insurance coverage may be failing to meet the requirements under this subpart, which may warrant an investigation.
2 Definitions. In this section i Complaint means a communication, written or oral, that indicates there has been a potential violation of the requirements under subpart B of this part, whether or not a violation actually occurred.
ii Complainant means any individual, or their authorized representative, who files a complaint as defined in paragraph a2i of this section.
b Complaints process. 1 HHS will consider the date a complaint is filed to be the date upon which HHS receives an oral or written statement that identifies information about the complaint sufficient to identify the parties involved and the action or inaction complained of.
2 HHS will notify complainants, by oral or written means, of receipt of the complaint no later than 60 business days after the complaint is received.
HHS will include a response acknowledging receipt of the complaint, notifying the complainant of their rights and obligations under the complaints process, and describing the next steps of the complaints resolution process. As part of the response, HHS may request additional information needed to process the complaint. Such additional information may include:
i Explanations of benefits;
ii Processed claims;
iii Information about the health care provider, facility, or provider of air ambulance services involved;
iv Information about the group health plan or health insurance issuer covering the individual;
v Information to support a determination regarding whether the service was an emergency service or non-emergency service;
vi The summary plan description, policy, certificate, contract of insurance, membership booklet, outline of
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coverage, or other evidence of coverage the plan or issuer provides to participants, beneficiaries, or enrollees;
vii Documents regarding the facts in the complaint in the possession of, or otherwise attainable by, the complainant; or viii Any other information HHS may need to make a determination of facts for an investigation.
3 HHS will make reasonable efforts consistent with agency practices to notify the complainant of the outcome of the complaint after the submission is processed through appropriate methods as determined by HHS. A complaint is considered processed after HHS has reviewed the complaint and accompanying information and made an outcome determination. Based on the nature of the complaint and the plan or issuer involved, HHS may i Refer the complainant to another appropriate Federal or State resolution process;
ii Notify the complainant and make reasonable efforts to refer the complainant to the appropriate State or Federal regulatory authority if HHS
receives a complaint where another entity has enforcement jurisdiction over the plan or issuer;
iii Refer the plan or issuer for an investigation for enforcement action under 45 CFR part 150; or iv Provide the complainant with an explanation of the resolution of the complaint and any corrective action taken.
Subpart CReserved Subpart DAdditional Patient Protections 149.310 Choice of health care professional.

a Choice of health care professional1 Designation of primary care provideri In general. If a group health plan, or a health insurance issuer offering group or individual health insurance coverage, requires or provides for designation by a participant, beneficiary, or enrollee of a participating primary care provider, then the plan or issuer must permit each participant, beneficiary, or enrollee to designate any participating primary care provider who is available to accept the participant, beneficiary, or enrollee. In such a case, the plan or issuer must comply with the rules of paragraph a4 of this section by informing each participant in the individual market, primary subscriber of the terms of the plan or health insurance coverage regarding designation of a primary care provider.

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