(2) Definitions. In this section—

1. (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.
2. (ii) Complainant means any individual, or their authorized representative, who files a complaint as defined in paragraph (a)(2)(i) of this section.

3. (b) Complaints process.

   1. (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. (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:

      1. (i) Explanations of benefits;
      2. (ii) Processed claims;
      3. (iii) Information about the health care provider, facility, or provider of air ambulance services involved;
      4. (iv) Information about the group health plan or health insurance issuer covering the individual;
      5. (v) Information to support a determination regarding whether the service was an emergency service or non-emergency service;
      6. (vi) The summary plan description, policy, certificate, contract of insurance, membership booklet, outline of coverage, or other evidence of coverage the plan or issuer provides to participants, beneficiaries, or enrollees;
      7. (vii) Documents regarding the facts in the complaint in the possession of, or otherwise attainable by, the complainant; or
      8. (viii) Any other information HHS may need to make a determination of facts for an investigation.

   3. (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—

      1. (i) Refer the complainant to another appropriate Federal or State resolution process;
      2. (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;
      3. (iii) Refer the plan or issuer for an investigation for enforcement action under 45 CFR part 150; or
      4. (iv) Provide the complainant with an explanation of the resolution of the complaint and any corrective action taken.