When Elinore McCance-Katz, M.D., assistant secretary for mental health and substance use at the Department of Health and Human Services (HHS), told the House Energy and Commerce Committee that changes were coming for 42 CFR Part 2, the regulation governing confidentiality of substance use disorder (SUD) treatment records (see ADAW, Oct. 30), she was referring to the Supplemental Notice of Proposed Rulemaking (SNPRM). The SNPRM was published in the Jan. 18 Federal Register, along with the final rule on 42 CFR Part 2 issued by HHS under President Obama Jan. 18 (see ADAW, Jan. 23).

Under 42 CFR Part 2, individual consent in writing is required before an SUD treatment provider receiving any federal funds can release information about a patient. The final rule kept the essential protections of consent. The SNPRM, however, creates an abbreviated alternative statement for the notice to accompany disclosure, and opens up disclosure to anyone involved in the vague term of “health care operations.”

Nobody is sure exactly what the supplemental rule will say. “It could fundamentally change how Part 2 operates,” said Paul N. Samuels, director and president of the Legal Action Center, in an interview last week.

The Legal Action Center has been at the forefront of 42 CFR Part 2 advocacy since before the rule was first promulgated in 1975. This summer, the Legal Action Center formed a coalition to protect patient privacy after the Partnership to Amend 42 CFR Part 2 was formed — a partnership that includes the American Society of Addiction Medicine (ASAM) and the Hazelden-Betty Ford Foundation (see ADAW, Aug. 7).

The Substance Abuse and Mental Health Services Administration (SAMHSA) said throughout the final rule issued last January that it would release subregulatory guidance. “We think it would be helpful for that guidance to be released,” said Karla Lopez, senior staff attorney with the Legal Action Center. “As far as we know, they’re still planning to do that,” she told ADAW.

And in fact, 42 CFR Part 2 has a very limited scope — providers who put themselves forward as treating SUDs. It does not apply, for example, to emergency department personnel who treat someone for an overdose; one myth is that these personnel are not allowed to disclose information about the patient to family members.

“We at the Legal Action Center are talking to whoever we can to find out what the specific concerns are that people have,” said Samuels. “We have worked closely with treatment providers on these issues for decades, and from our experience with them, treatment providers have routinely told us that obtaining consent at admission is not only possible, but to our understanding, it’s standard.”

There is so much confusion and misinformation that clarification is constantly needed. While the Association for Behavioral Health and Wellness, the organization leading the Partnership to Amend 42 CFR Part 2, calls the 42 CFR Part 2 rule “antiquated” and wants it to revert to the Health Insurance Portability and Accountability Act (HIPAA), the main concern seems to be with the technology (paper vs. digital). Unfortunately, stigma is as pervasive now as ever, and there is nothing antiquated about a patient not wanting his or her SUD treatment records made public.

And the Legal Action Center supports the need for integrated care. “We support whatever mechanisms can facilitate communication, as long as the core protections of Part 2 remain,” said Samuels. “We are very worried that reducing or removing Part 2 protection will scare many people away from entering the lifesaving treatment they need,” he told ADAW.

‘Inconvenience’ to EHRs

Opposition to 42 CFR Part 2 seems to be focused around electronic health records (EHRs). For more than 25 years, there were no complaints against the regulation, but in 2010, the EHR industry began to recognize that consents in writing could not easily fit into their systems. Since then, 42 CFR Part 2 has been under siege, with various arguments being used, including a call by some ASAM representatives to know about what patients are taking methadone. The American Association for the Treatment of Opioid Dependence and patient advocates have been the staunchest supporters of 42 CFR Part 2.

H. Westley Clark, M.D., who was responsible for the interpretation of 42 CFR Part 2 as director of the Center for Substance Abuse Treatment at SAMHSA, thinks the opioid epidemic is being used “as cover for business interests.” Clark, who is now Dean’s Executive Professor of Public Health at Santa Clara University, frequently describes 42 CFR Part 2 as an “inconvenience” to businesses like EHR vendors. “With regard to 42 CFR Part 2, only anecdote and passion are offered as justification for eviscerating fundamental interests of those who come seeking assistance from those with established interests,” he told ADAW last week. “Software vendors, the health care industry and professional associations know that the evidence for sweeping away the protections of 42 CFR Part 2 is scant,” he said. “The demand to include the boundless exception to 42 CFR Part 2 found in the health care operations rubric is evidence of the lack of respect for those with substance use disorders and the disregard for patient welfare and public safety.”

How will a clinician respond when a patient asks “Is my treatment confidential?” is an important question no one is asking, said Clark. “Those in the know will artfully say, ‘Yes, to the fullest extent of the law,’ capitalizing on an insincere twist and knowledge of, and the unwillingness to explain, the unlimited possibilities that the rubric ‘health care operations’ offers,” he said. “We may have to wait until people are harmed by social exclusion, whisper and rumor. Worse yet, we may have to wait to see how many people truly value their privacy by refusing treatment rather than expose themselves to the vagaries of the health care operations exception. This, the middle of an opioid epidemic, when treatment should be welcoming, not discouraging.”

The President’s Commission on Combating Drug Addiction and the Opioid Crisis (see ADAW, Nov. 6) also wants to move in the direction of opening up 42 CFR Part 2, Clark noted. “In addition, the hunt is on for those on methadone,” he said. However, many OTPs are “off the grid,” in terms of EHRs, he said.

“We remain very concerned that many of the electronic health networks do not seem to be compliant with Part 2,” said Samuels. “The law requires that Part 2 be followed, and technology should follow the law,” he said. “We need to protect patient confidentiality.”

The Overdose Prevention and Patient Safety Act (H.R. 3545) would specifically align 42 CFR Part 2 with HIPAA, by allowing sharing of SUD records. The original sponsor, Rep. Tim Murphy (R-Pennsylvania), is no longer in office after a scandal (see ADAW, October 23). The lead Democrat sponsor is Rep. Earl Blumenauer (D-Oregon).

SAMHSA expects to release the supplemental final rule in early winter, ADAW has learned.