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Caitlin Whyte: Metastar Health IT Radio is a podcast series that features consulting content experts and covers topics regarding the Wisconsin Medicaid EHR Incentive Program, promoting interoperability, formerly meaningful use, as well as a behavior health technical assistance initiative. Episodes covered will guide your practice clinic, hospital or hospital system through the complex Federal and State requirements of the PI program. Metastar has helped more than 2000 providers attest to promoting interoperability as Wisconsin's Regional Extension Center since 2010, and continues to provide at a station assistance and audit preparation as a consulting service. We are joined today by Julie Schmelzer, who brought nearly 20 years of social work experience to her project specialist role at Metastar. She supports practices and providers participating in the behavioral health Medicaid, HIT program. Today she's sharing with us information about the 42 CFR part two regulation, which protects medical records for individuals who have a substance use disorder. This is Metastar Health IT Radio. I'm your host, Caitlin Whyte. So, Julie, can you tell us what is 42 CFR part two?

Julie Schmelzer: Yes, of course. 42 CFR part two is a Department of Health and Human Services regulation governing the confidentiality of substance use disorder Patient records. It's part of the Public Health Services Act, which was originally issued in the 1970s and 42 CFR part two or part two as it's commonly called, became finalized in 1975 with several revisions since that time.

Host: So, you mentioned that 42 CFR part two, or as you said, part two refers to substance use disorder, patient records. Can you tell us what is meant by substance use disorders for these regulations?

Julie Schmelzer: Certainly. And I'm going to read it pretty closely to how the regulation states it. So under part two, a substance use disorder refers to a cluster of cognitive behavioral and physiological symptoms indicating that an individual continues using a substance despite significant substance related problems, such as impaired control, social impairment, risky use, and pharmacological tolerance and withdrawal. For the purposes of part two, this definition does not include tobacco or caffeine use. So Caitlin basically part two protects patient information from a covered or federally assisted part two program that could directly or indirectly identify an individual as having a current or past drug or alcohol problem, or has been a participant in a covered, or again, part two program for drug or alcohol treatment. And I should stress by covered part two program. It is a program that receives Federal assistance. For example, a program that qualifies for reimbursement from Medicare or Medicaid Federal programs.

Host: Remind us why part two is so important for individuals with a substance use disorder?

Julie Schmelzer: Sure. Historically, our society has had a lot of stigma when it comes to individuals who have substance use disorders. The original part two regulation was put into place to help these individuals feel protected against stigma. And in order to limit the discrimination and fear of prosecution they would have, in order for them to seek treatment. And as you can imagine, substance use disorder, diagnosis and treatment information cannot only be frowned upon in our society, but it can be held against an individual in certain situations, such as court hearings, custody battles, and even for some employment opportunities. Unfortunately, our society has not removed our stigma around individuals with substance use disorders, which continues to make part two relevant and important today. So, Caitlin, let me give you an example. If I have a diagnosis of alcohol use disorder, and I believe that my diagnoses and treatment information will negatively affect my ability to gain or maintain custody of my child, I am most likely going to avoid seeking treatment for my alcohol use disorder or be very hesitant to seek treatment at best. And avoiding treatment is so unfortunate since we have the knowledge and understanding to know that substance use disorders are acquired chronic illnesses and can be managed and can lead to long-term recovery.

Host: So how do behavioral health and healthcare providers know when the part two regulations apply to situations?

Julie Schmelzer: Yes. So remember part two applies to any individual provider or entity that is a federally assisted and a provider of alcohol drug abuse, diagnosis, treatment, or referral for treatment. And since most drug and alcohol treatment programs are federally assisted, this regulation would apply to treatment providers as well as specially licensed alcohol and drug abuse providers. Part two limits the circumstances of sharing information that could identify an individual who currently has a substance use disorder or who has had one in the past, unless that individual has given written consent to disclose their information. And it should be noted here that part two does not apply to general behavioral health medical records. So the Federal governments, substance abuse, mental health services administration, I know that's a mouthful or SAMHSA has information and frequently asked questions available to help providers know when part two needs to be followed.

And this information can be found on the SAMHSA website, which is www.samhsa.gov. SAMHSA also has fact sheets describing different scenarios that help both part two and non part two providers have a better understanding about these part two requirements. Now, Caitlin, as you can imagine with electronic health records and health information exchange, this can get a bit complicated. You know, we did not even imagine electronic health records back in the 1970s when 42 CFR part two was originally drafted. So in addition to SAMHSA the office of the National Coordinator for Health Information Technology, or the O N C has information on their website as well to further support providers as they navigate different part two situations, and that website is www.healthIT.gov. And I will add both of these website links are going to be available on the metastar.com/podcast website, which is M E T A S T A R.com/podcast.

Host: Can you tell us how part two is different from HIPAA?

Julie Schmelzer: Yes. That's a great question. As I mentioned, the part two regulation was finalized in 1975, HIPAA or the Health Information Portability and Accountability Act became law approximately 20 years later in 1996. But HIPAA does not include specific guidance around confidentiality of information for patients with substance use disorders. In other words, part two is separate from HIPAA for those specialized federally assisted part two providers. And part two has been described as an extra layer of protection for individuals with substance use disorders.

Host: Now, when you define part two, you mentioned that it has gone through some revisions. Can you talk more about that?

Julie Schmelzer: Of course. And I want to be clear that I'm not an attorney or someone qualified to provide legal guidance, but I'm happy to give you a brief history lesson. So since 1975 part two has been reviewed and revised several times back in 1987, again in 1995, and then recently in 2016, when SAMHSA proposed a new rule to take electronic health records into consideration. You know, and this was to suggest more flexibility for exchanging healthcare information, while continuing to protect those patients with substance use disorders. So in 2018, that final rule was implemented. Now, most recently updates were found to be needed because of a surge in opioid use disorder in our country. Therefore in August of 2019, SAMHSA proposed another revision of part two to better align with the opioid use crisis.

And this was to provide greater clarity for the comprehensive care team, treating those individuals with opioid use disorder. Now, if we go back to March 27th, 2020 of this year, the Coronavirus Aid Relief and Economic Security or CARES act was passed to provide emergency assistance to those affected by COVID-19. The cares act includes provisions around part two, which suggests even greater flexibility with sharing substance use disorder, patient records aligning that more closely with HIPAA. The cares provisions around part two cannot take effect until March 27th of 2021 or later. So if you're still with me as of August 14th of 2020 SAMHSA published a final rule based on that August, 2019 revision. SAMHSA really felt it was important to keep moving forward with the progress from the August, 2019 rule, instead of waiting until March or later in 2021 for the CARES act provision.

Host: With that reason August final rule. Can you give us an example of what has changed with part two?

Julie Schmelzer: Absolutely. And please keep in mind the basic framework for part two remains the same within the August, 2020 final rule. Some of the key changes were made to provide clarity and make information, sharing less burdensome and to improve the patient's comprehensive care, all the while still protecting the individual substance use disorder information. So one example, and this is based loosely on an example, that's on the SAMHSA website, I'm going to read from the August, 2020 final rule. It states, an individual with a substance use disorder diagnosis may consent disclosure of part two treatment records to an entity without having to name a specific recipient. So let's say I'm a patient with alcohol use disorder, and I want to share information from my part two provider with the Social Security Administration for my social security benefits prior to the August, 2020 final rule, a specific social security agent or employee would have needed to be identified on the part two consent form where now the consent form can simply say Social Security Administration. And as you can see, this continues to protect me the patient, with the alcohol use disorder. Since I am the person who has to sign that consent form to disclose any of my substance use disorder information, but this makes the process a little less burdensome since the timeliness of the benefits application may be expedited by that requirement of only having to say Social Security Administration instead of a specific person at that organization. And then waiting for that specific person to respond to the request.

Host: What will the changes to part two do to improve individual patient outcomes?

Julie Schmelzer: Well, Caitlin, the ultimate outcome of reforming part two has been to make it easier for individuals who have substance use disorders share this information with their providers and their entire medical team. The hope is that this will lead to seeking any needed treatment and working towards long-term recovery with that individual, trusting that this information will not create undue discrimination. Now, an even bigger improvement outcome would be for our society to learn more about substance use disorders as chronic health conditions and to remove the stigma we've had so long around individuals who have been diagnosed with and seek treatment for their substance use disorders.

Host: Great. Julie, any final thoughts about 42 CFR part two that we should keep in mind?

Julie Schmelzer: Yes. Caitlin. I want to point out again that the current final part two rule became effective on August 14th, 2020, and the CARES act provisions to part two cannot take effect until March 27th, 2021 or later again, since this might be a bit confusing, I would highly recommend going to SAMHSA's website at www.samhsa.gov or the website for the National Coordinator for Health IT at www.healthit.gov. Both of these websites can provide guidance around your specific 42 CFR part two questions. And I also want to point out that you should pay close attention to the State guidance around these Federal regulations. And you may also want to consult with your organization's legal counsel as needed

Host: A lot of information to take in here. We thank you so much, Julie, for your time. For more information on this topic and to access resources mentioned, please visit Metastar.com/podcast. That's M E T A star.com/podcast. If you enjoyed this episode, you can find more like it in our podcast library, and be sure to share it with others on your social channels. This is Metastar Health IT Radio. I'm your host, Caitlin Whyte. We'll see you next time.