Comment: Proposed § 164.508 listed examples of activities that would have required authorization, which included disclosure by sale, rental, or barter. Some commenters requested clarification that this provision is not intended to affect mergers, sale, or similar transactions dealing with entire companies or their individual divisions. A few commenters stated that covered entities should be allowed to sell protected health information, including claims data, as an asset of the covered entity.
Response: We clarify in the definition of health care operations that a covered entity may sell or transfer its assets, including protected health information, to a successor in interest that is or will become a covered entity. See § 164.501 and the corresponding preamble discussion regarding this change. We believe this change meets commenters' business needs without compromising individuals' privacy interests.
Comment: Some commenters supported the requirement for covered entities to obtain authorization for the sale, rental, or barter of protected health information. Some commenters argued that protected health information should never be bought or sold by anyone, even with the individual's authorization.
Response: We removed the reference to sale, rental, or barter in the final rule because we determined that the term was overly broad. For example, if a researcher reimbursed a provider for the cost of configuring health data to be disclosed under the research provisions at § 164.512(i), there may have been ambiguity that this was a sale and, therefore, required authorizations from the individuals who were the subjects of the information. We clarify in the final rule that if the use or disclosure is otherwise permitted or required under the rule without authorization, such authorization is not required simply because the disclosure is made by sale, rental, or barter.
Comment: Many commenters expressed concerns that their health information will be sold to pharmaceutical companies.
Response: Although we have removed the reference to sale, rental or barter, the final rule generally would not permit the sale of protected health information to a pharmaceutical company without the authorization of individuals who are the subjects of the information. In some cases, a covered entity could disclose protected health information to a pharmaceutical company for research purposes if the disclosure met the requirements of § 164.512(i).
Comment: Public response to the concept of providing additional protections for psychotherapy notes was divided. Many individuals and most providers, particularly mental health practitioners, advocated requiring consent for use or disclosure of all or most protected health information, but particularly sensitive information such as mental health information, not necessarily limited to psychotherapy notes. Others thought there should be special protections for psychotherapy information based on the federal psychotherapist-patient privilege created by the U.S. Supreme Court in Jaffee v. Redmond and the need for an atmosphere of trust between therapist and patient that is required for effective psychotherapy. Several consumer groups recommended prohibiting disclosure of psychotherapy notes for payment purposes.
Some commenters, however, saw no need for special protections for psychotherapy communications and thought that the rules should apply the same protections for all individually identifiable information. Other commenters who advocated for no special protections based their opposition on the difficulty in drawing a distinction between physical and mental health and that special protections should be left to the states. Many health plans and employers did not support additional protections for psychotherapy notes because they stated they need access to this information to assess the adequacy of treatment, the severity of a patient's condition, the extent of a disability, or the ability to monitor the effectiveness of an individual's mental health care and eligibility for benefits. Other commenters, many from insurance companies, cited the need to have psychotherapy notes to detect fraud.
A few commenters said that it was not necessary to provide additional protections to psychotherapy notes because the "minimum necessary" provisions of the NPRM provide sufficient protections.
Response: In the final rule, a covered entity generally must obtain an authorization for disclosure of psychotherapy notes, or for use by a person other than the person who created the psychotherapy notes. This authorization is specific to psychotherapy notes and is in addition to the consent an individual may have given for the use or disclosure of other protected health information to carry out treatment, payment, and health care operations. This additional level of individual control provides greater protection than a general application of the "minimum necessary" rule. Nothing in this regulation weakens existing rules applicable to mental health information that provide more stringent protections. We do not intend to alter the holding in Jaffee v. Redmond.
Generally, we have not treated sensitive information differently from other protected health information; however, we have provided additional protections for psychotherapy notes because of Jaffee v. Redmond and the unique role of this type of information. There are few reasons why other health care entities should need access to psychotherapy notes, and in those cases, the individual is in the best position to determine if the notes should be disclosed. As we have defined them, psychotherapy notes are primarily of use to the mental health professional who wrote them, maintained separately from the medical record, and not involved in the documentation necessary to carry out treatment, payment, or health care operations. Since psychotherapy notes have been defined to exclude information that health plans would typically need to process a claim for benefits, special authorization for payment purposes should be rare. Unlike information shared with other health care providers for the purposes of treatment, psychotherapy notes are more detailed and subjective and are today subject to unique privacy and record retention practices. In fact, it is this separate existence and isolated use that allows us to grant the extra protection without causing an undue burden on the health care system.
Comment: Many commenters suggested we prohibit disclosure of psychotherapy notes without authorization for uses and disclosures under proposed § 164.510 of the NPRM, or that protections should be extended to particular uses and disclosures, such as disclosures for public health, law enforcement, health oversight, and judicial and administrative proceedings. One of these commenters stated that the only purpose for which psychotherapy notes should be disclosed without authorization is for preventing or lessening a serious or imminent threat to health or safety (proposed §154.510(k)). Another commenter stated that the rule should allow disclosure of psychotherapy notes without authorization for this purpose, or as required by law in cases of abuse or neglect.
Other commenters did not want these protections to be extended to certain national priority activities. They claimed that information relative to psychotherapy is essential to states' activities to protect the public from dangerous mentally ill offenders and abusers, to deliver services to individuals who are unable to authorize release of health care information, and for public health assessments. One commenter requested clarification of when psychotherapy notes could be released in emergency circumstances. Several commenters stated that psychotherapy notes should not be disclosed for public health purposes.
Response: We agree with the commenters who suggested extending protections of psychotherapy notes and have limited the purposes for which psychotherapy notes may be disclosed without authorization for purposes other than treatment, payment, or health care operations. The final rule requires covered entities to obtain authorization to use or disclose psychotherapy notes for purposes listed in § 164.512, with the following exceptions: An authorization is not required for use or disclosure of psychotherapy notes when the use or disclosure is required for enforcement of this rule, in accordance with § 164.502(a)(2)(ii); when required by law, in accordance with § 164.512(a); when needed for oversight of the covered health care provider who created the psychotherapy notes, in accordance with § 164.512(d); when needed by a coroner or medical examiner, in accordance with § 164.512(g)(1); or when needed to avert a serious and imminent threat to health or safety, in accordance with § 164.512(j)(1)(i).
Comment: A commenter suggested that we follow the federal regulations governing confidentiality of alcohol and substance abuse records as a model for limited disclosure of psychotherapy notes for audits or evaluations. Under these regulations, a third party payor or a party providing financial assistance may access confidential records for auditing purposes if the party agrees in writing to keep the records secure and destroy any identifying information upon completion of the audit. (42 CFR Part 2)
Response: We agree that the federal regulations concerning alcohol and drug abuse provide a good model for protection of information. However, according to our fact-finding discussions, audit or evaluation should not require access to psychotherapy notes. Protected health information kept in the medical record about an individual should be sufficient for these purposes. The final rule does not require authorization for use or disclosure of psychotherapy notes when needed for oversight of the covered health care provider who created the psychotherapy notes.
Comment: A provider organization urged that the disclosure of psychotherapy notes be strictly prohibited except to the extent needed in litigation brought by the client against the mental health professional on the grounds of professional malpractice or disclosure in violation of this section.
Response: We agree that psychotherapy notes should be available for the defense of the provider who created the notes when the individual who is the subject of the notes puts the contents of the notes at issue in a legal case. In the final rule, we allow the provider to disclose the notes to his or her lawyer for the purpose of preparing a defense. Any other disclosure related to judicial and administrative proceedings is governed by § 164.512(e).
Comment: One commenter requested that we prohibit mental health information that has been disclosed from being re-disclosed without patient authorization.
Response: Psychotherapy notes may only be disclosed pursuant to an authorization, except under limited circumstances. Covered entities must adhere to the terms of authorization and not disclose psychotherapy notes to persons other than those identified as intended recipients or for other purposes. A covered entity that receives psychotherapy notes must adhere to the terms of this rule - including obtaining an authorization for any further use or disclosure. We do not have the authority, however, to prohibit non-covered entities from re-disclosing psychotherapy notes or any other protected health information.
Comment: A provider organization argued for inclusion of language in the final rule that specifies that real or perceived "ownership" of the mental health record does not negate the requirement that patients must specifically authorize the disclosure of their psychotherapy notes. They cited a July 1999 National Mental Health Association survey, which found that for purposes of utilization review, every managed care plan policy reviewed "maintains the right to access the full medical record (including detailed psychotherapy notes) of any consumer covered under its benefit plan at its whim." At least one of the major managed health plans surveyed considered the patient record to be the property of the health plan and governed by the health plan's policies.
Response: Although a covered entity may own a mental health record, the ability to use or disclose an individual's information is limited by state law and this rule. Under this rule, a mental health plan would not have access to psychotherapy notes created by a covered provider unless the individual who is the subject of the notes authorized disclosure to the health plan.
Comment: Some commenters expressed concern regarding the burden created by having to obtain multiple authorizations and requested clarification as to whether separate authorization for use and disclosure of psychotherapy notes is required.
Response: For the reasons explained above, we retain in the final rule a requirement that a separate authorization must be obtained for most uses or disclosures of psychotherapy notes, including those for treatment, payment, and health care operations. The burden of such a requirement is extremely low, however, because under our definition of psychotherapy notes, the need for such authorization will be very rare.
Comment: One commenter stated that Medicare should not be able to require the disclosure of psychotherapy notes because it would destroy a practitioner's ability to treat patients effectively.
Response: We agree. As in the proposed rule, covered entities may not disclose psychotherapy notes for payment purposes without an authorization. If a specific provision of law requires the disclosure of these notes, a covered entity may make the disclosure under § 164.512(a). The final rule, however, does not require the disclosure of these notes to Medicare.
Comment: One commenter expressed concern that by filing a complaint an individual would be required to reveal sensitive information to the public. Another commenter suggested that complaints regarding noncompliance in regard to psychotherapy notes should be made to a panel of mental health professionals designated by the Secretary. This commenter also proposed that all patient information would be maintained as privileged, would not be revealed to the public, and would be kept under seal after the case is reviewed and closed.
Response: We appreciate this concern and the Secretary will ensure that individually identifiable health information and other personal information contained in complaints will not be available to the public. This Department seeks to protect the privacy of individuals to the fullest extent possible, while permitting the exchange of records required to fulfill its administrative and program responsibilities. The Freedom of Information Act, 5 U.S.C. 552, and the HHS implementing regulation, 45 CFR Part 5, protect records about individuals if the disclosure would constitute an unwarranted invasion of their personal privacy, as does the Privacy Act, 5 U.S.C. 552a. See the discussion of FOIA and the Privacy Act in the "Relationship to Other Federal Laws" section of the preamble. Information that the Secretary routinely withholds from the public in its current enforcement activities include individual names, addresses, and medical information. Additionally, the Secretary attempts to guard against the release of information that might involve a violation of personal privacy by someone being able to "read between the lines" and piece together items that would constitute information that normally would be protected from release to the public. In implementing the privacy rule, the Secretary will continue this practice of protecting personal information.
It is not clear whether the commenter with regard to the use of mental health professionals believes that such professionals should be involved because they would be best able to keep psychotherapy notes confidential or because such professionals can best understand the meaning or relevance of such notes. We anticipate that we would not have to obtain a copy or review psychotherapy notes in investigating most complaints regarding noncompliance in regard to such notes. There may be some cases in which a quick review of the notes may be needed, such as when we need to identify that the information a covered entity disclosed was in fact psychotherapy notes. If we need to obtain a copy of psychotherapy notes, we will keep these notes confidential and secure. Investigative staff will be trained in privacy to ensure that they fully respect the confidentiality of personal information. In addition, while the content of these notes is generally not relevant to violations under this rule, we will secure the expertise of mental health professionals if needed in reviewing psychotherapy notes.
Comment: A mental health organization recommended prohibiting health plans and covered health care providers from disclosing psychotherapy notes to coroners or medical examiners.
Response: In general, we have severely limited disclosures of psychotherapy notes without the individual's authorization. One case where the information may prove invaluable, but authorization by the individual is impossible and authorization by a surrogate is potentially contraindicated, is in the investigation of the death of the individual. The final rule allows for disclosures to coroners or medical examiners in this limited case.
Comment: One commenter recommended prohibiting disclosure without authorization of psychotherapy notes to government health data systems.
Response: The decision to eliminate the general provision permitting disclosures to government health data systems addresses this comment.
Comment: Several commenters were concerned that in practice, a treatment team in a mental health facility shares information about a patient in order to care for the patient and that the provision requiring authorization for use and disclosure of psychotherapy notes would expose almost all privileged information to disclosure. They requested that we add a provision that any authorization or disclosure under that statute shall not constitute a waiver of the psychotherapist-patient privilege.
Response: Because of the restricted definition we have adopted for psychotherapy notes, we do not expect that members of a team will share such information. Information shared in order to care for the patient is, by definition, not protected as psychotherapy notes. With respect to waiving privilege, however, we believe that the consents and authorizations described in §§ 164.506 and 164.508 should not be construed as waivers of a patient's evidentiary privilege. See the discussions under § 164.506 and "Relationship to Other Laws," above.