Should 42 CFR, Part 2 Be Aligned With HIPAA?

Executive Briefing | by | April 27, 2016


Monica E. Oss
Monica E. Oss

A couple of weeks ago, the Substance Abuse and Mental Health Services Administration (SAMHSA) proposed changes to the federal privacy rules for sharing information about addiction treatment under Title 42 of the Code of Federal Regulations, Part 2 (42 CFR) (see Substance Abuse Privacy Rules Could Be Changing). The new rules are likely in response to many stakeholders in the field (payers, health plans, provider organizations, etc.) and a need to facilitate “integrated care” models by making data sharing easier. The inability to share this data has created many challenges in both coordinated care management and value-based reimbursement models (for more, check out this preview of our April OPEN MINDS Management Newsletter article, The Dividing Line On Sharing Of Addiction Treatment Data).

The proposed modifications to 42 CFR, and our coverage of them, has garnered a lot of great responses from the industry thought leaders who “believe that the changes in the proposed rule do not go far enough and will continue to hinder consumer access to safe, effective, high quality, integrated care” (see April 22, 2016 Comments to SAMHSA, RE: SAMHSA 4162 – 20: Confidentiality of Substance Use Disorder Patient Records). Many of these thought leaders are looking for adoption of standards that align addiction treatment data sharing with the Health Insurance Portability and Accountability Act (HIPAA).

Pamela Greenberg

For more on this view, we recently spoke with Pamela Greenberg, President of The Association for Behavioral Health and Wellness (ABHW), who expressed the concern that the current “lack of conformity with HIPAA does not reflect the current realities of our health care delivery system and…does not provide a uniform standard of care.”

Why does the ABHW support a move to the HIPAA standard for treatment?

We support the HIPAA standard for treatment, payment, and health care operations. For those three, HIPAA has no authorization required. We believe the Part 2 authorization requirements are a barrier to quality and integrated care. Authorizations are often difficult to obtain and at the time a person is seeking care the provider may not be aware of all of the different entities that will be involved in the patient’s care.

Obtaining authorizations after a person has left the provider’s office can be difficult. The proposed rule’s inclusion of electronic consent will help in this regard. However, many of our Medicaid patients don’t have computers, are homeless, or move from place to place; and finding them to get their authorization once they’ve left the doctor’s office can be incredibly difficult, if not impossible.

Also, the proposed rule allows patients to disclose some, but not all, of their substance use information. This is problematic because the provider may only have some of the patient’s information (i.e. lab work) and not know that there is other information in the substance use record that hasn’t been disclosed to them. For example, take a dentist, who has just given a patient a root canal and wants to prescribe a narcotic pain medication. The dentist looks in the record and sees that the patient has had a drug screen and tested positive for opiates but does not see, because the patient hasn’t authorized full disclosure, that the patient just left an inpatient treatment facility where he was being treated for heroin addiction. That provider may prescribe a painkiller for that person which causes the patient to relapse.

Why doesn’t the proposed rule provide a uniform standard of care?

Part 2 currently applies to federally funded individuals or entities that “hold themselves out as providing, and provide, alcohol or drug abuse diagnosis, treatment or treatment referral” including units within a general medical facility that hold themselves out as providing these services. So, for somebody who is seeking care from a non-Part 2 provider the rules do not apply. This creates two standards of care. People being treated in non-Part 2 programs have their records protected in the same way medical and mental health records are protected, by the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) regulations.

Are there changes beyond the HIPAA standard that ABHW is seeking in the final rule?

Yes, there are other changes that SAMHSA can make in the final rule that will help move us toward better quality care for individuals being treated for a substance use disorder while respecting the goal of patient privacy. For example, the proposed rule allows population health management to be considered a qualified service organization (QSO). This means that the restrictions on disclosure do not apply to communications between the Part 2 program and a QSO regarding information needed by the QSO to provide services to the Part 2 program. We support this proposed change and would like to see it expanded to include care coordination. Additionally, the final rule can confirm that a consent form can be valid until death as was stated previously in FAQs. Finally, the final rule can allow for electronic signatures as is included in the proposed rule.

If legislative action is needed to achieve parity in privacy regulations then we are hoping that SAMHSA will explicitly state that in the final rule so that we can better work with Congress to remove these barriers to integrated care (for more from ABHW, check out Now Is The Time To Strengthen Protection Of Substance Use Records By Revisiting The Substance Use Privacy Law and SAMHSA 42 CFR Part 2 Comments).

Seamless and inexpensive data sharing will remain a critical issue for the success of care coordination programs. And for more on care coordination, join me at The 2016 OPEN MINDS Strategy & Innovation Institute and the session, “When You’ve Seen One Health Home, You’ve Seen One Health Home: The Provider Perspective On Health Homes,” delivered by OPEN MINDS senior associate Mitchell Berdie, Psy.D.; Tom Sebastian, MS, MPA, President & CEO, Compass Health; and Kathleen Clay, Health Home Director, Hudson River Healthcare, Inc.


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