After complaining about 42 CFR Part 2, the regulation requiring patients to consent to release of their substance use disorder (SUD) treatment records, for years, but saying that Congress had to fix it, the Substance Abuse and Mental Health Services Administration (SAMHSA) is on the brink of changing the regulation.
The latest attack on 42 CFR Part 2 comes from the agency that promulgates it: SAMHSA, which wants to make information‐sharing easier, based on the preview of a proposed rule.
After complaining about 42 CFR Part 2, the regulation requiring patients to consent to release of their substance use disorder (SUD) treatment records, for years, but saying that Congress had to fix it, the Substance Abuse and Mental Health Services Administration (SAMHSA) is on the brink of changing the regulation.
"We don't know what the change will say, so we can't comment on it," was a common reaction from sources we called. But since Elinore McCance‐Katz, M.D., Ph.D., who heads SAMHSA, has been publicly in favor of getting rid of the regulation, as have a growing number of organizations (most recently the American Medical Association; see "AMA delegates vote to align 42 CFR Part 2 with HIPAA," ADAW, June 17), the change is expected to be toward weakening it.
The consent provision, which is basically all that is left after SAMHSA repeatedly used subregulatory tactics (see "SAMHSA stops short of aligning 42 CFR Part 2 with HIPAA, but questions remain," ADAW, Jan. 8, 2018), is required by statute, so that indeed would need to be changed by Congress, according to Paul Samuels, director and president of the Legal Action Center.
According to the SAMHSA proposal, titled "Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders," the agency "is proposing broad changes to Confidentiality of Alcohol and Drug Abuse Patient Records, 42 Code of Federal Regulations (CFR) 2, also known as 42 CFR part 2 to remove barriers to coordinated care and permit additional sharing of information among providers and part 2 programs assisting patients with substance use disorders (SUDs)."
That's all it says, but it's clearly toward making it easier for all providers to see who is in treatment. Since the last bastion of patients covered under 42 CFR Part 2 is those in opioid treatment programs (OTPs), which use methadone, this change would likely enable those patients' medical information to be viewed by all medical providers, and subject to the same confidentiality requirements. These requirements, currently covered under the Health Insurance Portability and Accountability Act (HIPAA), are very loose, and do not give the patient the right to consent to their release to anyone. Most patients have to sign a blanket disclosure form just for a routine checkup.
For the proposal, go to https://
The law authorizing the statute, 42 USC 290dd‐2, has "some specificity," said H. Westley Clark, M.D., J.D., Dean's Executive Professor at Santa Clara University, and former director of the Center for Substance Abuse Treatment at SAMHSA. The regulation is more flexible. "But the tradition the government has given itself is protecting the vulnerable," he said.
This administration, it appears, is moving in a different direction. In the name of care integration and coordination, SAMHSA is retreating from the support of the vulnerable.
Will there be lawsuits against treatment providers who disclose information that results in adverse consequences to their patients? Most likely, but the government will wait for that to happen.
When proponents of making 42 CFR Part 2 like HIPAA talk about their own interpretation, it's important to remember that HIPAA is not mandatory. "It allows the holder of the information to disclose or not disclose," noted Clark.
As always, Clark said that if providers really want to know a patient's SUD history, they should just ask. If the patients trust you, they will tell you.
But what the industry — as opposed to individual clinicians, who do care about their patients — wants to see is a registry, said Clark. "They want methadone reported. They want a registry of anybody who's had an SUD problem," he said. This would be available to law enforcement, insurance and others. All this while 94% of patients who need treatment aren't getting it, said Clark. This would just erect another barrier to treatment. But it would also mean doctors don't even need to ask. Just look it up on the computer. And this is what many patients — and, we hear, physicians themselves — are rebelling against.
It's also important to remember that the National Association of Addiction Treatment Providers and the American Society of Addiction Medicine, who want to weaken 42 CFR Part 2, have members who "don't like to be sued, especially when personal liability may be an issue," said Clark.
"While most treatment providers were covered by HIPAA, 42 CFR Part 2 offered them additional protection against inappropriate disclosure," he said. "With alignment, providers will have to think more seriously about HIPAA. Thus, they should be aware of the federal fines and the growing issue of state liability issues derived from HIPAA violations."
He noted that this is not "scaremongering or fearmongering," but rather, it is reality. And both patients and providers have the same thing at stake: loss of enthusiasm for getting treatment. "I think you can ethically balance the interests of the providers against the interests of the patients. At many places, they converge," Clark told ADAW.
"For instance, third‐party liability for harms that an overmedicated patient causes is a reality," he said. "Many of the providers patients are undercapitalized as a result of their substance use and cannot offer the deep pockets that a plaintiff's attorney seeks; so the provider becomes the target."
And there are civil matters with which many treatment providers have had little experience. These were previously avoided because they required patient consent under 42 CFR Part 2, but would not under HIPAA. "Yet, the patient can find a plaintiff's attorney who litigates on contingency," said Clark. "This is of concern to the provider, because the cost of doing business goes up with increased risk." As he noted, "Liability insurance is not free." "[SAMHSA] is proposing broad changes to Confidentiality of Alcohol and Drug Abuse Patient Records, 42 Code of Federal Regulations (CFR) 2, also known as 42 CFR part 2 to remove barriers to coordinated care and permit additional sharing of information among providers and part 2 programs assisting patients with substance use disorders (SUDs)." Office of Management and Budget
If a patient is told that their treatment will be confidential, it better be true. "As soon as you lie, then you have your own liability issues," said Clark.
On the other side (favoring changing 42 CFR Part 2) is a slew of providers and organizations, including Richard Saitz, M.D., Professor at Boston University School of Public Health, who told ADAW last week: "I fully understand that patients with addiction are stigmatized and discriminated against, and that can lead to poor care and harm. But separate health records and rules, and separate uncoordinated care, perpetuate poor unsafe care, the idea that addiction is not a health condition like others and stigma. To address that, CFR 42 Part 2 should change such that the records for people with addiction are treated similarly to those with other health conditions, in which patients consent to record releases. Changes should allow for clinicians caring for patients who consent to receive that care to access their full health record while doing so."
By Alison Knopf
Reported by Author
