The long process of reviewing 42 CFR Part 2, the regulation that governs confidentiality of alcohol and drug abuse treatment records, is underway. The law and regulation date from the 1970s, and prohibit any substance use disorder (SUD) treatment provider receiving federal funds from disclosing the identity of any patient without the written consent—on paper—of the patient. It was working fine until the electronic medical record made paper consents inconvenient, and the Substance Abuse and Mental Health Services Administration (SAMHSA), which has oversight over the regulation, has been under pressure to change it. On June 11, SAMHSA held a “listening session” at which all sides were given an opportunity to speak at the day-long meeting.
The battle lines were drawn between opioid treatment programs (OTPs) and their patient advocates, as well as addiction recovery organizations like Faces and Voices of Recovery, the Legal Action Center, the State Associations of Addiction Services (SAAS), and NAMA-R, who want the rule to stay the way it is. Many electronic health record (EHR) vendors, mental health providers, and others say that the rule needs to be changed for a variety of reasons.
But whatever the reason—convenience of EHR data exchange and integration of behavioral and medical health care were cited most often—patients need to know that changes mean they would no longer have control over their own information. Under the current rule, which was adopted in 1975, treatment programs may not release any identifying information about a patient unless the patient gives written consent for that release, and the consent must say to whom the information can be disclosed. Redisclosure is not allowed.
Areas of Concern
Stigma
Comments from the American Association for the Treatment of Opioid Dependence (AATOD), focused on stigma. The comments, signed by AATOD president Mark Parrino, MPA, clearly state that the patients’ perspective is the most important—not the perspective of health care providers who think they know what’s best for these patients. The Legal Action Center made the same point in its comments: the patient views must come first. NAMA-R and Faces and Voices of Recovery represent the direct views of patients and people in recovery.
People with SUDs still face losing their jobs, their housing, the custody of their children, and their insurance, and face criminal arrest, prosecution, and incarceration, as well as discrimination in health care, the Legal Action Center said. AATOD agrees with this, and has had many reports that support it from OTPs and patient advocates.
About 41 percent of OTP patients are employed, according to AATOD, which represents more than 950 OTPs. Many of these patients talk to their counselors about whether they should tell their employers they are in methadone maintenance treatment. “This continues to be a sensitive topic since many patients are of the judgment that informing their employers of their involvement with methadone treatment will have negative consequences and potentially result in the loss of their job,” according to AATOD’s comments.
Criminal Justice
The criminal justice system, in particular, does not understand methadone maintenance, with few correctional facilities providing access to medications, noted AATOD. Patients who come before family court are frequently told that they can’t recover custody of their children unless they stop taking maintenance medication, and drug courts tell them they face jail time if they continue treatment. “This condition does not exist in the treatment of any other chronic disease in the U.S. where medications are used to treat the patient effectively and to preserve continued health,” noted AATOD.
In some cases, the only “crime” committed is being in treatment—which for pregnant women can mean losing custody of their babies. This is despite the fact that methadone and buprenorphine treatment are considered the best practices for pregnant patients who are opioid dependent.
Privacy
Some things have changed since 42 CFR Part 2 was first created. There are now electronic health records, health information exchanges, health homes, and accountable care organizations (ACOs). But what hasn’t changed is discrimination against people with SUDs, especially when they are in medication assisted treatment (MAT). That’s why the Health Insurance Portability and Accountability Act (HIPAA), which governs privacy of other medical records, isn’t enough, advocates said.
Clinicians who work in OTPs understand that they “are simply custodians of the individual patient’s care,” Mr. Parrino said in the AATOD comments. It is the patient who takes on the risk of entering and remaining in treatment, and the patient who takes on the risk of discrimination if that treatment is disclosed to others.
Deterring Treatment
If patients think their treatment will be disclosed, they will be far less likely to seek admission, people who know the addiction treatment field said. Moreover, stable patients will reconsider whether they want to continue in treatment.
Of particular concern are Prescription Monitoring Programs (PMPs), which are supported by AATOD as long as OTPs only access data from them. AATOD discourages OTPs from disclosing data about patients to PMPs, also called Prescription Drug Monitoring Programs (PDMPs). If PMPs, which are mainly managed by law enforcement agencies, have access to OTP patient information, patients would be deterred from seeking treatment.
As a signal of how serious the revising of 42 CFR Part 2 could be, one recommendation made at the June 11 listening session was to make all PMP data available to law enforcement organizations. In most cases the PMP is indeed under the aegis of law enforcement, not public health. “One such agency informed AATOD that they wanted access to confidential patient data for individuals participating in OTPs so they could cross match such data against outstanding warrants,” said Mr. Parrino.
The Other Side
Integration in Health Care
One of the main arguments for information sharing and weakening 42 CFR Part 2 comes from people, including physicians, who think that this is in the best interests of the patients, because integrated health care means the entire team can take care of a patient.
Many OTP patients don’t want to disclose their MAT status to medical professionals, and have told their OTP staff “about the change in attitude demonstrated by medical professionals” if they do disclose. “Until the medical professional is educated about methadone and addiction, methadone patients need the right to first develop a relationship with the physician or medical professional before they tell them they are a methadone patient in addiction treatment.”
Technology
EHRs—and especially, vendors—are advocating for dismantling 42 CFR Part 2 as it stands, to allow the free flow of all medical information, including SUDs, between medical providers and payers. But 42 CFR Part 2 can be updated to facilitate integration and communication in the EHR age, while still maintaining the core privacy protections of consent and prohibition against redisclosure. This is done by “data segmentation,” in which the SUD data is separate from the other medical information.
‘For the Good of the Patients’
The “for the good of the patients” argument was that of Eric Goplerud, PhD, who helped lead the “Patient Protection Coalition” that four years ago started working to weaken 42 CFR Part 2. He still feels that 42 CFR Part 2 should be abolished, either by legislation or regulatory guidance. In his comments that were filed, he agreed that people with SUDs suffer from stigma: “the general public is highly unwilling to work with, or socialize with alcoholics,” he writes, adding that “drug addicts” are the “most stigmatized.” Public opinion about mental illness, on the other hand, has “gotten more favorable.”
Dr. Goplerud is one of the leaders of the charge, starting four years ago, to do away with 42 CFR Part 2. He testified at the listening session as a private citizen, he told AT Forum.
Next Steps
It is unlikely that SAMHSA will ask Congress to change the law. What is more likely is that SAMHSA may propose subregulatory changes to 42 CFR Part 2. For OTP patients, the best possible outcome would be that there would be no changes made. Officials from SAMHSA who traditionally side with mental health providers are more likely to want to weaken the confidentiality provisions, as mental health providers and others who are entering the SUD treatment market don’t want to have to deal with the specialized consent issue. However, stalwart defenders of 42 CFR Part 2, like H. Westley Clark, MD, JD, who heads the Center for Substance Abuse Treatment (CSAT), are expected to continue to represent the voice of patients. If there are changes, they may be done through a rulemaking. Stay tuned.
When the comments are available online, they will be available at http://www.samhsa.gov/HealthPrivacy/
AATOD’s June 23 comments and response to the proposed confidentiality regulations are available online at:
http://www.aatod.org/wp-content/uploads/2014/07/SAMHSA-Confidentiality-Ltr062314.pdf