42 CFR 426.500 - Procedure for filing an acceptable complaint concerning a provision (or provisions) of an NCD.
(c) Components of a valid complaint. A complaint must include the following:
(1) Beneficiary-identifying information:
(ii) Mailing address.
(iii) State of residence, if different from mailing address.
(iv) Telephone number, if any.
(v) Health Insurance Claim number, if applicable.
(vi) Email address, if applicable.
(2) If the beneficiary has a representative, the representative's indetifying information must include the following:
(iii) Telephone number.
(iv) E-mail address (if any)
(v) Copy of the written authorization to represent the beneficiary.
(3) Treating physician written statement. A copy of a written statement from the treating physician that the beneficiary needs the service that is the subject of the NCD. This statement may be in the form of a written order for the service or other documentation from the beneficiary's medical record (such as progress notes or discharge summary) indicating that the beneficiary needs the service.
(4) NCD-identifying information:
(i) Title of NCD being challenged.
(5) Aggrieved party statement. A statement from the aggrieved party explaining what service is needed and why the aggrieved party thinks that the provision(s) of the NCD is (are) not valid under the reasonableness standard.
(6) Clinical or scientific evidence.
(ii) Any documents or portions of documents that include proprietary data must be marked “proprietary data,” and include a legal basis for that assertion.
(iii) Proprietary data submitted by a manufacturer concerning a drug or device for which the manufacturer has submitted information to the Food and Drug Administration, must be considered and given substantive weight only when supported by an affidavit certifying that the submission contains true and correct copies of all data submitted by the manufacturer to the Food and Drug Administration in relation to that drug or device.
(d) Joint complaints -
(i) Each aggrieved party named in the joint complaint has a similar medical condition or there are other bases for combining the complaints.
(2) Components of a valid joint complaint. A joint complaint must contain the following information:
(iii) The documentation described in paragraphs (c)(3) and (c)(4) of this section.
(3) Timeliness of a joint complaint. Aggrieved parties, who choose to seek review of an NCD -