Comment: One comment suggested possible inconsistencies between the regulation and Medicare/Medicaid requirements, such as those under the Quality Improvement System for Managed Care. This commenter asked that HHS expand the definition of health care operations to include health promotion activities and avoid potential conflicts.
Response: We disagree that the privacy regulation would prohibit managed care plans operating in the Medicare or Medicaid programs from fulfilling their statutory obligations. To the extent a covered entity is required by law to use or disclose protected health information in a particular manner, the covered entity may make such a use or disclosure under § 164.512(a). Additionally, quality assessment and improvement activities come within the definition of "health care operations." Therefore, the specific example provided by the commenter would seem to be a permissible use or disclosure under § 164.502, even if it were not a use or disclosure "required by law."
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: If the Title XVIII of the Social Security Act requires the disclosure of psychotherapy notes, the final rule permits, but does not require, a covered entity to make such a disclosure under § 164.512(a). If, however, the Social Security Act does not require such disclosures, Medicare does not have the discretion to require the disclosure of psychotherapy notes as a public policy matter because the final rule provides that covered entities, with limited exceptions, must obtain an individual's authorization before disclosing psychotherapy notes. See § 164.508(a)(2).