In proposed § 164.516(c)(4), we would require a covered plan or provider to provide the individual with a written statement in plain language of the reason for the denial and permit the individual to file a written statement of disagreement with the decision to deny the request.
The statement prepared by covered plan or provider would be required explain the basis for the denial. The statement would include a description of how the individual may complain to the covered plan or provider as provided in § 164.518(d). The statement would include the name and number of the contact person within the plan or provider who is responsible for receiving complaints. The statement also would include information regarding filing a complaint with the Secretary pursuant to § 164.522(b)(1), including the mailing address and any forms that may be available. Finally, the statement would explain that the individual has the right to file a written statement of disagreement that would be maintained with the disputed information and the procedure for filing such a statement of disagreement.
If the individual chooses to file a statement of disagreement, then the covered plan or provider must retain a copy of the statement with the protected health information in dispute. The covered plan or provider could require that the statement be a reasonable length, provided that the individual has reasonable opportunity to state the nature of the disagreement and offer his or her version of accurate and complete information. In all subsequent disclosures of the information requested to be amended or corrected, the covered plan or provider would be required to include a copy of its statement of the basis for denial and, if provided by the individual, a copy of his or her statement of disagreement. If the statement submitted by the individual is unreasonably long, the covered plan or provider could include a summary in subsequent disclosures which reasonably explains the basis of the individual’s position. The covered plan or provider would also be permitted to provide a rebuttal to the individual’s statement of disagreement and include the rebuttal statement in any subsequent disclosures.
We considered requiring the covered plan or provider to provide a mechanism for appealing denials of amendment or correction but concluded that it would be too burdensome. We are soliciting comment on whether the approach we have adopted reasonably balances the burdens on covered plans or providers with the rights of individuals.