Change to 42 C.F.R. Part 2? HIPAA & HITECH Act Blog by Jonathan P. Tomes

As substance abuse treatment providers know, 42 C.F.R. Part 2 “trumps”―that is, preempts―the HIPAA Privacy Rule because it gives more protection for substance abuse treatment records than HIPAA does. This extra protection is thought necessary to cause drug and alcohol abusers to seek treatment secure in the knowledge that the confidentiality of these particularly sensitive conditions will be protected.

The particular HIPAA rule at issue is the so-called “TPO” exception to patient privacy.  The TPO exception allows providers to share protected health information (“PHI”) with other covered entities when necessary for treatment, payment, or health care operations (normal parts of business, such as quality assurance, peer review, and the like) without patient consent. A potential substance abuse client could be scared off by the knowledge that his or her condition would be so shared with others without consent.

Currently, substance abuse clients must give affirmative, signed consent for their records to be shared with any other clinician for TPO. This rule should be included in a substance abuse treatment Notice of Privacy Practices. Thus, clients must give consent each time that the record is shared with a doctor outside the health system that originally treated them for substance abuse, including, for example, general primary care and pain management doctors.

Apparently, the change to the rule, which is currently being reviewed at the Office of Management and Budget (“OMB”), would allow a general consent for a clinician to share a substance abuse client’s PHI for TPO, and a separate consent for each disclosure would not be necessary.

The big issue about the rule is whether the client privacy concern that the records could be shared with an entity that they would not want it to be shared with without their knowledge unless they get an accounting (of course, by then, the PHI would have already been shared) is outweighed by the administrative efficiency benefit―that is, one consent at first versus multiple consents for each entity to whom the disclosure will be made.

Stay tuned for information on if/when the new rule goes into effect. EMR Legal will provide draft language for changing your Notice of Privacy Practices if/when the change comes out.

Yes, once again, I am here to try to sell things to keep you and us in business. Surely, after having read Jon’s blog items all these years, and especially today’s blog item, you recognize that you must keep your risk analysis up to date. If you need help with your risk analysis, either initially or for an update, Jon Tomes has written a Risk Analysis ToolKit to provide the structure and tools to help you complete the requirement under HIPAA. You and your risk analysis team can fill it out and document your decisions as to what is reasonable and appropriate for you to adopt in the way of policies and procedures and be done with it. Or you could send your completed risk analysis to Jon to review and render his professional opinion as the country’s leading HIPAA expert (IMO) as to whether it is sufficient to keep you from getting that free trip to Leavenworth or that very expensive trip to the bank. If you have Jon’s Compliance Guide to HIPAA and the DHHS Regulations, 6th edition, with the accompanying HIPAA Documents Resources Center CD, also 6th edition, you can find the Risk Analysis ToolKit on the CD. It is also available with a review by Jon at Also, Jon Tomes presented a webinar recently on “How to Do a HIPAA and HITECH Risk Analysis.” You can buy a recording of it at Jon is also writing a Risk Analysis Update ToolKit, which will be available for you in the near future on the Premium Member section of our website. Please stay tuned for our announcement when it is up and running for you there. Also, include in your risk analysis the lack of a business associate agreement if you are considering hiring a business associate or a downstream business associate.

If you need guidance on how to draft the policies and procedures that your risk analysis or your newly updated risk analysis has shown are reasonable and appropriate for your organization, Jon has also written The Complete HIPAA Policies and Procedures Guide, with the accompanying CD of several dozen HIPAA policies and procedures templates for you to adapt to your situation. That book also contains a chapter by me on how to write in general, but more specifically on how to write a good policy.

Make sure that you train your entire workforce on HIPAA in general and on the HIPAA policies and procedures according to who needs to know what to perform their duties for you. If you need handy HIPAA training in general, consider Jon’s training video and training manual in either of two forms available here: or Or you could hire Jon to present HIPAA training onsite to your workforce. Just contact him at or 816-527-3858.

Keep your written documentation of all of these HIPAA compliance efforts where you can find them easily and quickly if HHS shows up demanding your HIPAA compliance documentation. We recommend keeping all of it in Your Happy HIPAA Book. Jon included tabs in the three-ring binder for everything that you need to document and a checklist for each tab. I recommend adding the date that you check off each item in each checklist, as one of our clients suggested to us.

If you have had a security incident that you were unsure as to what exactly to do about, or if you are concerned that you may have one, consider reading Jon’s book How to Handle HIPAA and HITECH Act Breaches, Complaints, and Investigations: Everything You Need to Know.

A sample business associate agreement policy and a sample business associate agreement are posted in the Premium Member section of our website at

As always, thanks for reading Jon’s blog, buying his books and other HIPAA compliance tools, attending our seminars and webinars, and hiring Jon for HIPAA consulting and training. We wish you every success with your HIPAA compliance efforts.

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