More than three years ago, a group of physicians and lawyers tried to do away with 42 CFR Part 2, as the Confidentiality of Alcohol and Drug Abuse Patient Records regulation is known. The 40-year-old rule prohibits substance abuse treatment programs from giving any identifying information about patients to anyone unless the patient gives individualized, written consent.

For decades, the regulation was considered an ironclad protection against law enforcement in particular, but also employers, the media, healthcare providers and anyone else, finding out whether someone was in substance abuse treatment. Congress enacted it because without such protections, people would not go to treatment — e.g., law enforcement in New York City went into methadone clinics after patients, a practice that was stopped by 42 CFR Part 2, which gave treatment providers the authority to block such intrusions (see ADAW, March 8, 2010).

Protecting those and other intrusions is still the mission of 42 CFR Part 2 — it is not going away. The physicians and lawyers who wanted it eliminated three years ago have either given up or taken their fight behind the scenes, along with other players. The Substance Abuse and Mental Health Administration (SAMHSA), which promulgates the rule, views confidentiality as important to the person seeking recovery, and especially so at a time when treatment is expanding and people need to be encouraged to engage in it, H. Westley Clark, M.D., director of SAMHSA’s Center for Substance Abuse Treatment (CSAT), told ADAW last week. Clark is the government-wide spokesman for 42 CFR Part 2; he has met with stakeholders and consistently stood up for the rights of patients to privacy.

Although many groups — including primary care providers, health information technology/electronic health record vendors and insurance companies — have been asking SAMHSA for years to eliminate or change 42 CFR Part 2, Clark continues to assert that technology and confidentiality can coexist. But as the calls for reform of the rule grow more heated, with the approaching implementation of the Affordable Care Act and its requirements for integrated healthcare, Clark acknowledges that the balance may be shifting. At the same time, he asserts that 42 CFR Part 2 and the consent provision are the best way to encourage patients to seek treatment.

Convenience vs. privacy

“What we’re trying to do is maintain pathways to treatment,” Clark told ADAW. We asked whether “administrative convenience” is becoming more important than a patient’s right to choose confidentiality. “Congress understood that there are negative consequences that can function as impediments to people getting into treatment,” he said. “The question in 2013 is, do those consequences still apply? If they don’t, then the balance should shift toward administrative convenience. If they do, will the issue delay the entry of individuals into treatment?”

Clark, a lawyer who often responds to questions with questions of his own, during a half-hour interview seemed to muse about whether 42 CFR Part 2 is still necessary, and then to discuss discrimination. “If you have a history of misuse of substances, and have been in recovery for three years, can that information be used to your detriment?” he asked. Looked at from another perspective, he asked, “If you are a treatment provider and tell a prospective client their employer can find out they are in treatment, will that client engage?”

In balancing these questions, Clark said it’s important to “err on the side of the status quo” — which is 42 CFR Part 2 in its current form. If changes are made in 42 CFR Part 2, it will be hard to go back, said Clark. “If we do that, we can’t undo it,” he said. “So we have to exercise a degree of caution before we rush in to make any precipitous changes.” Vendors are making arguments for convenience, he said, “but you have to ask if this would have a deleterious effect on the individuals we are trying to get into treatment.”

In fact, he said, there are no surveys of patients to determine whether confidentiality is a motivating factor for people to enter treatment. “We do know from the OTP perspective that there are middle-class people who self-pay,” he said. “They do that because if you pay out of pocket, you can determine who gets that information.” In other words, they don’t want to go through insurance, even if it covers the treatment, because they don’t want anyone to know.

Although the police may no longer go into treatment programs to find drug dealers, that does not mean 42 CFR Part 2 is not needed, said Katie O’Neill, vice president of the Legal Action Center, which helped draft the original regulations and wrote the SAMHSA FAQ upholding 42 CFR Part 2 since the 2010 call to rescind them. “It happened historically,” she said of the police raids. “The fact they haven’t done it is a tribute to the success of and need for 42 CFR Part 2.”

People do have a right to be concerned about confidentiality, said Clark. “There are still sanctions imposed on individuals who use illicit drugs,” he said. Even for patients in treatment, with methadone, for example, there are risks. “Mothers risk losing their babies,” he said. He questioned whether the balance has shifted, despite the fact that police may not enter treatment programs asking for a roster of patients anymore.

The data-segmentation solution

Clark is still working with the Department of Veterans Affairs and the Office of the National Coordinator on a data-segmentation project that would do exactly what 42 CFR Part 2 does with written consent with electronic health records (see ADAW, September 24, 2012). And it would go even further.

“Data segmentation means the client can identify information clusters that they don’t want to share,” said Clark. With data segmentation, the question of patient control over their information — not only substance abuse, but mental illness, AIDS and HIV, sexually transmitted diseases, and more — could be put to rest, said Clark. The big problem is cost. If the federal government comes up with a solution it can share, or be used in the public domain, then vendors will be able to include it in their products. “We continue to believe we can find a non-proprietary solution that we would hope software vendors would adopt,” said Clark.

Who must comply?

Providers who are not “putting themselves forward” as alcohol and drug abuse treatment programs are not covered under 42 CFR Part 2, said Clark. So an internal medicine physician would be able to share information, including substance abuse screening and treatment information, without consent. However, that physician would not be able to get information about a patient from a treatment program unless that program had obtained consent.

Any program that is assisted by the federal government must abide by the rule, and that is a very broad definition, including virtually all substance abuse treatment programs, said Clark.

SAMHSA does not have the authority to enforce 42 CFR Part 2; that is up to the Department of Justice. Anyone who violates it is subject to a fine of not more than $500 for the first case, and not more than $5,000 for each subsequent case. If a patient feels there has been a violation, that patient could go to a U.S. Attorney and file a complaint. “This hasn’t happened very often,” said O’Neill.

Clark stressed that addiction is not like other diseases. “We’re often dealing with substances that are proscribed by law and proscribed by social convention and have a deleterious impact,” he said.

“We realize that we’re dealing with a very complex situation, and we certainly want people to get the best care,” said Clark. “The whole purpose of 42 CFR Part 2 is not to endanger clients.” Many of the freestanding programs don’t have the IT functions to share information electronically, even if they were able to obtain the individualized consent, he added. “That remains a bottleneck,” he said.

Part of motivational interviewing — engaging patients in treatment — is telling them that their confidentiality will be protected. “Treatment helps families, and it helps the larger society,” said Clark. “We’re not simply talking about convenience of institutions or programs or groups,” he said. “We’re talking about larger public policy.”

Also see ADAW, June 21, 2010; August 9, 2010; and December 19, 2011.