The federal government’s move to ditch confidentiality regulations for substance use disorder treatment will increase patients’ exposure to law enforcement investigations, despite claims to the contrary.
The Substance Abuse and Mental Health Services Administration (SAMHSA) is pushing through a proposal that would allow the courts to seize all patient records in the investigation of a serious crime—not just those of the patient who allegedly committed the crime. In addition, it is redefining “serious crime” to include “drug trafficking,” which it doesn’t define. It could be conflated with drug use.
The proposal was published in a Notice of Proposed Rulemaking (NPRM) in the Federal Register on August 26. It is one of two NPRMs published that day which would make deep cuts into protections for substance use disorder (SUD) treatment records.
Filter reported on the first NPRM on August 23; it would open up patient records to many entities and allow opioid treatment programs (OTPs, or methadone clinics) to put records into prescription drug monitoring programs (PDMPs). That proposal has a public comment period ending October 25.
The second NPRM, pertaining to law enforcement, has a much shorter comment period, ending September 25; one expert told Filter that this could be illegal.
It applies to section 2.63 of the existing 42 CFR Part 2 confidentiality regulation—the section governing the circumstances in which a court order can authorize disclosure. Section 2.63 currently permits disclosure if it is “necessary in connection with investigation or prosecution of an extremely serious crime allegedly committed by the patient. [My emphasis.]”
SAMHSA’s NPRM seeks to nix that requirement, allowing courts to authorize disclosure “even if the extremely serious crime was not allegedly committed by the patient.”
Now why would the Trump administration want to do that?
Filter asked SAMHSA whether the Department of Justice (DOJ) requested this change, but received no response by publication time.
Many in the addiction-recovery community are frightened at this prospect.
“We enter treatment to seek help and get into recovery, and expect to do so in a protected environment—not to have our information used to prosecute us, our families or others,” Bill Stauffer, executive director of the Pennsylvania Recovery Organizations Alliance, told Filter. “I would be hard-pressed to think of anyone who has used illegal drugs who would seek help when their patient records become the tools of law enforcement.”
Expanding Law Enforcement’s Powers
Language giving courts permission to seize records in the case of a serious crime was added to 42 CFR Part 2 back in 1987. The requirement that only records of a patient alleged to have committed a serious crime could be seized was added in 2017.
SAMHSA now says in the NPRM that the 2017 language was added “erroneously,” and that’s why it proposes removing it. The agency gives only one other reason for the change: the overdose crisis.
“In short, all patient records could be screened for evidence of wrongdoing by the patient, the program or people the patient knows.”
Another change makes it clear that law enforcement plans to go into treatment programs to ferret out drug trafficking.
“For the first time in the history of 42 C Part 2, the explanatory language in the preamble of the [proposed] section 2.63 extends its interpretation to drugs,” H. Westley Clark, MD, JD, former director of SAMHSA’s Center for Substance Abuse Treatment, told Filter. “The historical language focused on serious crimes of violence or child abuse. Now HHS [the Department of Health and Human Services, of which SAMHSA is part] and DOJ want the courts to authorize using patient records to go on fishing expeditions in search of drug trafficking at or from Part 2 programs.”
The preamble states:
HHS believes reverting to the previous language for this section is necessary to help reduce and deter drug trafficking at or from part 2 programs, and thereby to prevent the occurrence of extremely serious crimes from interfering with the delivery by part 2 programs of high quality, medically necessary treatment to patients with substance use disorders. It may be necessary to examine confidential communications of a part 2 program to investigate and prosecute, if warranted, individuals other than a patient who engage in drug trafficking related to the drug abuse crisis. Specifically, these records may be necessary to establish that the part 2 program or an affiliated medical professional is trafficking drugs rather than providing appropriate treatment for substance abuse.
Clark noted that the preamble “makes it clear that drug-related crimes don’t have to be committed by the patient” for the patient’s records to be seized. “In short, all patient records could be screened for evidence of wrongdoing by the patient, the Part 2 program or people the patient knows.”
And the preamble shows, said Clark, that “SAMHSA and DOJ believe that patient records can be used to investigate or prosecute the Part 2 program. This, then, is a fishing expedition.”
Treatment providers who backed proposals to revise 42 CFR Part 2, thinking it would just mean they could find out who was taking methadone, may therefore be in for a nasty surprise. They could be the ones investigated.
The American Association for the Treatment of Opioid Dependence, Faces and Voices of Recovery, and Treatment Communities of America are among the organizations opposed to any changes that affect patient confidentiality and that discourage people from entering treatment.
Buprenorphine Patients in the Crosshairs
Both buprenorphine and methadone providers can be targeted under the proposed change, said Clark. The proposed preamble notes that SUD treatment programs have increased as a result of the overdose crisis, which in Clark’s interpretation “makes it clear that buprenorphine clinicians are also the intended targets of this fishing expedition.”
While both OTPs and buprenorphine prescribers are potential targets, it’s buprenorphine prescribers whose numbers have swelled the most. There are currently about 1,600 OTPs and 16,000 buprenorphine prescribers in the US.
Currently, all OTPs are covered by 42 CFR Part 2’s privacy rules. Some buprenorphine prescribers who also have other patients would not be –the regulation only applies to programs which put themselves forward as addiction treatment providers. But the largest ones—those with 100-275 patients—would be “hard pressed not to be considered Part 2 programs,” said Clark, who is Dean’s Executive Professor at Santa Clara University. In addition, those with fewer than 100 patients but whose buprenorphine census is greater than their primary care census could also be covered, he said.
Drug Enforcement Administration agents have already visited buprenorphine prescribers under the DATA 2000 (the law allowing buprenorphine to be prescribed for opioid use disorder), said Clark. However, “This new 2.63 interpretation would allow other law enforcement entities greater access to patient records and prescriber activity.”
It would “give law enforcement an additional tool, beyond the PDMP,” he added, and “the administrative burden, fear of law enforcement audits, and anxiety due to the new 2.63 interpretation would certainly give prescribers pause.”
“If you use SUD records to investigate or prosecute, you allow SUD treatment to induce patients to incriminate themselves. This is certainly unethical.”
According to a slide-show provided by SAMHSA administrator Elinore McCance-Katz, MD, PhD last week, there are currently 450,247 patients on methadone and 648,864 patients on buprenorphine. The large number of patients and programs affected by the proposed revision means that the 30-day public comment period is not long enough, Clark said. In fact, he believes this short commenting period violates the Administrative Procedures Act.
Under the proposed change, treatment programs will have to explain to prospective patients that what they disclose during treatment could be used as evidence against them.
“If you use the patient’s SUD records to investigate or prosecute drug-related crime, you allow SUD treatment to induce patients to incriminate themselves,” said Clark. “This is certainly unethical.”
Clark outlined the following hypothetical examples of how he believes the rule change could be deployed by law enforcement:
- * Local police observe what appears to be drug dealing in the parking lot of an OTP. They get a court order to examine the medical record of patient X to determine if he is the one dealing drugs or buying drugs.
- * Patient Y receives prescribed buprenorphine. She discovers that she is one of those people who only needs it every other day, so she sells her excess pills to her friends. The DEA becomes aware of this, and petitions a court to examine patient Y’s SUD treatment records to determine if she has admitted her behavior to her treatment provider, or if she has incriminated another patient during those conversations.
- * Dr. Z works at the OTP. The local DEA agent knows that Dr. Z is himself in recovery from opioid use disorder, and sympathetic to his patients. The DEA agent wants to make sure that Dr. Z is not diverting buprenorphine or methadone from his patients, so he petitions a court to look at the SUD treatment records of all of Dr. Z’s patients.
“Clinicians should be alarmed by this almost clandestine effort to broaden the interpretation of Section 2.63,” summarized Clark. It also raises questions, he added, about whether the American Society of Addiction Medicine, which supports SAMHSA’s proposals, has “missed the implications of the section 2.63 NPRM in their zeal to change the larger 42 CFR Part 2.”
ASAM did not respond to Filter’s request for comment by publication time.
So why would such a law enforcement-oriented proposal be issued by HHS/SAMHSA, a health agency? I asked Richard G. Frank, PhD, who was HHS assistant secretary for planning and evaluation in the Obama administration.
“That has to do with the way the statute was written,” said Frank, who is now the Margaret T. Morris Professor of Health Economics at Harvard Medical School. He pointed out that the statute gave regulatory authority to HHS.
If the Department of Justice wanted the change made, why wouldn’t SAMHSA just say so, instead of claiming it had added the language in 2017 “erroneously”?
“Usually there’s a desire not to air one’s dirty laundry,” replied Frank.
But during the comment period, he said, these questions should be raised. “Legally, SAMHSA needs to respond to each of those issues.”
“The Administrative Procedures Act process of notice and comment makes it unlikely that the 2017 language was in error,” said Clark. “The 2017 rule had to be vetted by OMB, HHS and others, in addition to SAMHSA. Clearly, the Obama administration had no objection.”
If the intent were simply to “correct” a nominal error, Clark added, the simultaneous addition of a substantive change, such as adding drug trafficking to the list of “serious crimes,” would not have occurred.
“Seen in the best light, SAMHSA may have inadvertently opened a backdoor to use patient records to investigate and prosecute drug-related crimes,” he continued.
“I believe that because the insertion of drug trafficking is a substantial change from the 1987 language that SAMHSA appears to revere, there should have been at least a 60-day period of review and that this section 2.63 NPRM should have been included in the larger revamping of the proposed Part 2 NPRM. In short, I contend that this 2.63 NPRM violates the Administrative Procedures Act because of the substantial change, the abbreviated notice and comment time period, the large number of entities affected, and the need to harmonize 2.63 with other sections such as 2.67 [the section that governs use of undercover law enforcement agents and informants in treatment programs].”
By using two different NPRMs, issued on the same day, to address critical aspects of 42 CFR Part 2, SAMHSA is depriving affected entities of a fair opportunity to address these critical issues, Clark concluded.
“This will create an unprecedented situation.”
Other opponents of SAMHSA’s changes will be trying to get their voices heard during the very brief commenting period for the proposal.
Mark W. Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), a membership organization of OTPs, told Filter that the rule would embolden enforcement authorities to “go back to their earlier ways of prosecuting patients.”
“SAMHSA is seeking to radically expand access to substance use disorder patient records to law enforcement,” said recovery advocate Bill Stauffer. “This will create an unprecedented situation, in which virtually all SUD patient records would be subject to fishing expeditions to discover illegal conduct and prosecute family and associates of the person seeking help.”