March 25, 2013. Today, we continue going through the HIPAA Privacy Rule, section by section, as modified in the Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications of the HIPAA Rules, which was published in the Federal Register on January 25, 2013. The effective date of the Final Rule is March 26, 2013, and covered entities and business associates must comply by September 23, 2013.
We began a two-day examination of the modifications pertaining to 45 CFR 164.520: Notice of Privacy Practices for Protected Health Information on Friday, March 22, looking at Content of Notice in subsection (b). Today, we focus on modifications to 164.520(c): Implementation specifications: Provision of Notice, with modification in bold:
“(c) Implementation specifications: Provision of Notice. A covered entity must make the notice required by this section available on request to any person and to individuals as specified in paragraphs (c)(1) through (c)(3) of this section, as applicable.
(1) Specific requirements for health plans. (i) a health plan must provide notice:
(B) Thereafter, at the time of enrollment, to individuals who are new enrollees.
(v) If there is a material change to the notice:
(A) A health plan that posts its notice on its web site in accordance with paragraph (c)(3)(i) of this section [Specific requirements for electronic notice] must prominently post the change or its revised notice on its web site by the effective date of the material change to the notice, and provide the revised notice, or information about the material change and how to obtain the revised notice, in its next annual mailing to individuals then covered by the plan.
(B) A health plan that does not post its notice on a web site pursuant to paragraph (c)(3)(i) of this section must provide the revised notice, or information about the material change and how to obtain the revised notice, to individuals then covered by the plan within 60 days of the material revision to the notice.
We provide here the content of the Final Rule preamble that underpins the Notice of privacy practices for protected health information: Provision of Notice:
“Section 45 CFR 164.520(c)(1) of the final rule requires a health plan that currently posts its NPP on its Web site in accordance with164.520(c)(3)(i) to: (1) Prominently post the material change or its revised notice on its web site by the effective date of the material change to the notice (e.g., the compliance date of this final rule) and (2) provide the revised notice, or information about the material change and how to obtain the revised notice, in its next annual mailing to individuals then covered by the plan, such as at the beginning of the plan year or during the open enrollment period. Health plans that do not have customer service web sites are required to provide the revised NPP, or information about the material change and how to obtain the revised notice, to individuals covered by the plan within 60 days of the material revision to the notice. These requirements apply to all material changes including, where applicable, the rule change adopted pursuant to GINA to prohibit most health plans from using or disclosing genetic information for underwriting purposes.
“We believe these distribution requirements best balance the right of individuals to be informed of their privacy rights with the burden on health plans to provide the revised NPP. We also note that health plans should provide both paper- and web-based notices in a way accessible to all beneficiaries, including those individuals with disabilities. These modifications provide an avenue for an individual to be informed of material changes upon their effective date while better aligning the NPP distribution with health plans’ normal mailings to individuals.
“For health care providers, the final rule does not modify the current requirements to distribute revisions to the NPP. As such, 45 CFR 164.520(c)(2)(iv) requires that when a health care provider with a direct treatment relationship with an individual revises the NPP, the health care provider must make the NPP available upon request on or after the effective date of the revision and must comply with the requirements of 164.520(c)(2)(iii) to have the NPP available at the delivery site and to post the notice in a clear and prominent location. In response to several comments expressing concern about printing costs for new NPPs, we clarify that providers are not required to print and hand out a revised NPP to all individuals seeking treatment; providers must post the revised NPP in a clear and prominent location and have copies of the NPP at the delivery site for individuals to request to take with them. Providers are only required to give a copy of the NPP to, and obtain a good faith acknowledgment of receipt from, new patients. As a result, we do not believe that the current requirement is overly burdensome to providers, nor is it overly costly. We also clarify that while health care providers are required to post the NPP in a clear and prominent location at the delivery site, providers may post a summary of the notice in such a location as long as the full notice is immediately available (such as on a table directly under the posted summary) for individuals to pick up without any additional burden on their part. It would not be appropriate, however, to require the individual to have to ask the receptionist for a copy of the full NPP.
“To the extent that some covered entities have already revised their NPPs in response to the enactment of the HITECH Act or State law requirements, we clarify that as long as a covered entity’s current NPP is consistent with this final rule and individuals have been informed of all material revisions made to the NPP, the covered entity is not required to revise and distribute another NPP upon publication of this final rule. Finally, we note that to the extent a covered entity is required to comply with Section 504 of the Rehabilitation Act of 1973 or the Americans with Disabilities Act of 1990, the covered entity has an obligation to take steps that may be necessary to ensure effective communication with individuals with disabilities, which could include making the revised NPP or notice of material changes to the NPP available in alternate formats, such as Braille, large print, or audio.”
78 Federal Register 5625
Tomorrow is the effective date of the Final Rule discussed herein.