SAMHSA Stifles Public Comment on Expanding Cops’ Powers Over MAT Patients

    Technical problems. That’s the reason the Substance Abuse and Mental Health Services Administration (SAMHSA) gives for its commenting website being down almost every day of the public comment period—which started August 26 and ends September 25—for its proposal to give sweeping new powers to law enforcement over MAT patients.

    From monitoring the site over the past few weeks, I can confirm that anyone trying to log in will need the patience of a saint. A September 13 letter from the American Medical Association (AMA) to SAMHSA (provided in full at the bottom of this article) reiterated this complaint.

    SAMHSA’s notice of proposed rulemaking (NPRM) proposes to allow law enforcement to have access to all patient records if it is investigating an alleged serious crime committed by a patient⁠—or by a person known to the patient. It would also change the definition of “serious crime” to include “drug trafficking”—with the potential to be interpreted as anything related to drugs.

    As H. Westley Clark, MD, JD, dean’s executive professor at Santa Clara University and former director of SAMHSA’s Center for Substance Abuse Treatment, told Filter in reaction to the proposal: “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.”

    There are multiple things wrong with SAMHSA’s rulemaking process here:

    1. SAMHSA disingenuously claims that the revised language to allow law enforcement access to all patient records in treatment programs covered by the 42 CFR Part 2 privacy regulation merely corrects a “technical error” in previous language. That’s demonstrably untrue when it will add to the real-world powers of law enforcement to this extent.

    2. The law enforcement proposal was released at the same time as another, much broader NPRM regarding sharing patient records within health care by dropping 42 CFR Part 2—something also disastrous to patients and treatment. By issuing two proposals at once, SAMHSA arguably seeks to reduce the attention that can be focused on each.

    3. The comment period for the law enforcement NPRM was only 30 days. (The period for the other NPRM is 60 days.) Thirty days is far too short a time to allow for such an important change, as the AMA letter to SAMHSA reflected: “[We] urge the Administration to extend the comment deadline to the normal 60 days required of most federal rulemaking.”

    4. SAMHSA issued the law enforcement proposal on August 26, the Monday before the Labor Day holidaya favored tactic by regulatory agencies trying to push something through quietly.

    5. At a media level, SAMHSA has only discussed the broader NPRM. Many stakeholders weren’t even aware of the fact that SAMHSA was proposing to allow law enforcement access to all patient records in substance use disorder treatment programs. 

     

    In this context, there was much confusion in the field about the two NPRMs. But even after the dust had settledand Filter highlighted the second NPRM, prompting statements against it from organizations such as the Drug Policy Alliancethe American Society of Addiction Medicine (ASAM) was dragging its feet on responding. 

    The internal ASAM committee reviewing the matter has until 5 pm on September 24 to make its decision on how to respond, Kelly M Corredor, director of advocacy and government relations for ASAM, told Filter on September 24. “We will submit the final comment letter for the NPRM tomorrow.” (ASAM also had not seen the AMA letter, which I shared with Corredor.)

    ASAM’s timing is problematic because its members, who look to their leadership for guidance, won’t get to see ASAM’s position in time to make comments of their own. The American Medical Association will also hold off on filing its comment until September 25, creating the same problems for AMA membership. 

    Still, if the last 29 days are any guide, the comments website may well be down anyway.

    The bottom line, as many experts and advocates have stressed, is that if patients think their records will be accessible to law enforcement, they may not go to treatment at all. 

    In order to highlight public comments that have frequently been obscured by SAMHSA’s “technical problems,” Filter has pulled out some of the comments submitted to-dateall are vociferously opposed to the SAMHSA’s plan to enhance law enforcement powers at the expense of patients’ rights. We’ll list a selection below.

     

    Sample Public Comments on SAMHSA’s Proposal

    From Michael Miller, PhD (not Mike Miller, MD, of ASAM):

    “The proposed change to consent requirements, allowing consenting to disclosure of treatment records to a named agency without naming specific individuals as the recipient, I support. The requirement of naming non-treatment providing individuals is overly burdensome and problematic. Case in point: A court referred client consents and names the judge, as is now required. Unknown to the program, there is a change of judge, making the original consent invalid. The court issues a subpoena, to which the program cannot respond without getting a new consent (which won’t be given if drug tests are positive), or issuing a court order in accordance with the rule. The requirement should allow the initial consent to be the court having jurisdiction of the case.

    The proposed changes to 42CFR Part 2 section 2.36 are unnecessary and highly problematic. The rationale that the change is necessary in order to reduce and deter drug trafficking at or from Part 2 programs is simply invalid. Programs can under the current rule report to law enforcement crimes on the premises, so no change to report that on part of SUD patients is unnecessary. The current rule also provides for law enforcement to be able to investigate the agency or provider itself, upon obtaining a court order. This oversight is fair, reasonable and important as a check against abuse.

    Finally, the proposed change to this section is detrimental in two ways: 1. it will certainly result in persons who need treatment not seeking it if they know that doing so will subject themselves to prosecution; this defeats to premises that it should not be riskier to enter treatment than to stay on the street. Need it be mentioned that remaining on the street results in continued crime, while being in SUD treatment reduces crime. The proposed change will increase, not decrease street crime. 2. Many who provide treatment, dedicated to being treatment professional and not law enforcement agents, will simply not enter incriminating information into the record, thereby diminishing the quality and integrity of the record; and that is if they are even told such information by SUD patients who have with this change an incentive to withhold information from their treating professional. Can you imagine the impact of a law the resulted in you, a cancer patient, withholding information from your oncologist?”

     

    From David Lisonbee, president/ CEO of Twin Town Treatment Centers in California:

    “I wish to oppose the proposed changes to Section 2.63(a)(2) in the recent NPRM, and ask that SAMHSA not change this section of the current rule. This proposed change is a fundamental and substantive change to privacy regulations that will allow personal health information to be shared outside the healthcare system for criminal justice purposes. For the first time in history, drug trafficking is being specifically included as a serious crime in this proposed rule. The definition of serious crimes has historically been limited to violent crimes such as rape and murder. Since dependence on illegal drugs almost by definition involves some form of illegal drug activity, which could easily be classified as drug trafficking, the criminalization of substance use disorders is not the answer to this public health crisis.

    Use of records for investigating and prosecuting alleged crimes beyond the patient (e.g., family, friends, associates, treatment providers and researchers) has never been included in the past. The language in section 2.63(a)(2) must remain as stated in the current rule limiting such court ordered release of records to very serious crimes allegedly committed by the client.

    If [this] proposed language remains in the proposed rule change, the only way that a person can avoid potential investigation and prosecution is to not to go into treatment. Twelve-step programs, Oxford Houses, and other self-help programs that operate off the grid would be the only rational option for anyone trying to protect their privacy and seek help.

    This proposed change is not in line with the best interests of society or patients seeking treatment for substance use disorders and their families. A change of this nature will deter people in need of treatment from seeking care out of fear of law enforcement involvement, which goes against the fundamental purpose of 42 CFR part 2. Part 2 was created to encourage people to seek care without fear of legal repercussions or stigma.

    SAMHSA should also extend the comment period immediately. The proposed change, which affects hundreds of thousands of people, is significant. This proposed rule change needed more than 30 days to analyze and respond to this NPRM.”

     

    From Bill Stauffer of Pennsylvania Recovery Organizations—Alliance, one of the most vocal defenders of 42 CFR Part 2: 

    “We are the Pennsylvania Recovery Organizations—Alliance, the statewide Substance Use Disorder (SUD) Recovery Community Organization for the state of Pennsylvania, with over 5,000 members. PRO-A is adamantly opposed to the proposed rule changes within RIN 0930-AA30 to Section 2.63 of 42 CFR Part II. This proposed change is a fundamental and substantive change to our privacy regulations. It would allow highly sensitive information, including historic illegal drug conduct of patients and family members to be to be used to prosecute them.

    For the first time in history, drug trafficking has been specifically included as a serious crime in this proposed rule. This is the criminalization of substance use treatment and runs contrary to both the language and intent of 42 USC 290dd, which limits actions to good cause court orders focused on “the need to avert a substantial risk of death or serious bodily harm”—clearly not drug trafficking. This proposed language would result in treatment becoming a tool of law enforcement to prosecute patients or others (family, friends and associates).

    Dependence on illegal drugs almost by definition involves some form of illegal drug activity, including drug trafficking. Thousands of people will either avoid treatment or withhold information during their care out of fear to share it. The proposed rule runs contrary to SAMHSA’s mission to “reduce the impact of substance abuse and mental illness on America’s communities.” Former patients are already alarmed that information in their records may be subject to legal scrutiny years after they have gotten their lives back. They could never have anticipated that they may have subjected themselves or their families to such potential legal sanctions when they consented to treatment in programs across America.

    The rule change may well exceed the governing statute 42 USC 290dd and should not be in the rule change process.Even if it is permissible under the rulemaking process, it is both significant and substantive, and in accordance with the Administrative Procedure Act (APA) of 1946 should not limited to a 30-day comment period. SAMHSA should extend the comment period immediately.”


    From Matthew Torrington, MD, an operator of a sober home:

    “I wish to oppose the proposed changes to Section 2.63(a)(2) in the recent NPRM, and ask that SAMHSA not change this section of the current rule. This proposed change is a fundamental and substantive change to privacy regulations that will allow personal health information to be shared outside the healthcare system for criminal justice purposes. For the first time in history, drug trafficking is being specifically included as a serious crime in this proposed rule. The definition of serious crimes has historically been limited to violent crimes such as rape and murder. Since dependence on illegal drugs almost by definition involves some form of illegal drug activity, which could easily be classified as drug trafficking, the criminalization of substance use disorders is not the answer to this public health crisis.

    Use of records for investigating and prosecuting alleged crimes beyond the patient (e.g., family, friends, associates, treatment providers and researchers) has never been included in the past. The language in section 2.63(a)(2) must remain as stated in the current rule limiting such court ordered release of records to very serious crimes allegedly committed by the client.

    If [this] proposed language remains in the proposed rule change, the only way that a person can avoid potential investigation and prosecution is to not to go into treatment. Twelve-step programs, Oxford Houses, and other self-help programs that operate off the grid would be the only rational option for anyone trying to protect their privacy and seek help.

    This proposed change is not in line with the best interests of society or patients seeking treatment for substance use disorders and their families. A change of this nature will deter people in need of treatment from seeking care out of fear of law enforcement involvement, which goes against the fundamental purpose of 42 CFR part 2. Part 2 was created to encourage people to seek care without fear of legal repercussions or stigma.

    SAMHSA should also extend the comment period immediately. The proposed change, which affects hundreds of thousands of people, is significant. This proposed rule change needed more than 30 days to analyze and respond to this NPRM.”

     

    From Hilary Jacobs of Lahey Health Systems:

    “I oppose the change to the regulation referenced above related to allowing 42CFR Part 2 records to be reviewed by law enforcement when the patient is not suspected of any crime. While I understand the seriousness of the opioid crisis, there are many other avenues available to law enforcement in the course of an investigation. The broad and vague language substantially weakens the protections intended in the original regulation and will serve as a deterrent to individuals seeking treatment.”

     

    From Zachary Talbott, an advocate for MAT patients who has owned and operated may OTPs (opioid treatment programs, or “methadone clinics”):

    “As both an individual in long-term, sustained medication assisted recovery as well as a social worker, alcohol & drug abuse counselor, and clinical supervisor who has operated opioid treatment programs (OTPs), worked in intensive outpatient substance use treatment services, and who now oversees behavioral health services across seven comprehensive office-based opioid treatment (OBOT) programs, I am EXTREMELY alarmed by this almost clandestine effort to broaden the interpretation of Section 2.63.

    Making changes that could result in law enforcement fishing expeditions will dissuade individuals from seeking care and encourage those currently enrolled in serviced to leave prematurely. Despite the talk of the opioid crisis in this NPRM, the outcome of this change could very well worsen the opioid crisis that has already claimed far too many lives.

    I ask that SAMHSA does not change this section or finalize this proposal.”

     

    H. Westley Clark, MD, JD, MPH, dean’s executive professor of Public Health at Santa Clara University, and former Director of SAMHSA’s Center for Substance Abuse Treatment, submitted a long and detailed statement (provided in full below), which opened as follows:

    I wish to oppose the proposed changes to Section 2.63(a)(2) in the recent NPRM, and ask that SAMHSA not change this section of the current rule. This proposed change is a fundamental and substantive change to privacy regulations that will allow personal health information to be shared outside the healthcare system for criminal justice purposes.

     

    From Sharon Levy, MD, president of the nonprofit AMERSA (Association for Multidisciplinary Education and Research in Substance use and Addiction):

    “…Addiction nearly always involves some form of illegal drug activity that could easily be classified as drug trafficking. The criminalization of substance use disorders is not the answer to this public health crisis. The government says this change is needed to help prosecute health care providers who are contributing to the national crisis in overdose deaths by trafficking in drugs. However, we fear this change will contribute to more deaths by deterring people from seeking and receiving life-saving treatment. We base our concerns as a non-profit professional organization whose members have a long history advocating evidence-based treatment and prevention efforts for persons with or at risk of substance use disorders. Founded in 1976, AMERSA’s mission is to improve health and well-being through interdisciplinary leadership in substance use education, research, clinical care and policy. We represent multiple healthcare professions including, but not limited to, physicians, nurses, social workers, psychologists, dentists, pharmacists, and public health professionals. Many of us serve on the frontlines of the opioid epidemic as federally funded scientists, teachers, treatment providers, and expert public health consultants, including to SAMHSA. We are extremely concerned that this proposed regulation would permit courts to authorize the release of treatment records of people who are not alleged to have committed any crime – for example, families and friends of the person being investigated. Use of records for investigating and prosecuting alleged crimes beyond the patient (e.g., family, friends, associates, treatment providers and researchers) has never been included in the past. This invasion of privacy puts people at risk of discrimination in employment and other arenas because of the stigma existing in our society toward people who use drugs. Moreover, the proposed change will deter people in need of treatment from seeking care out of fear of law enforcement involvement. These outcomes go against the fundamental purpose of 42 CFR part 2, which was created to encourage people to seek care without fear of legal repercussions or stigma. If the proposed language remains in the proposed rule change, the only way that a person can avoid potential investigation and prosecution is to not enter treatment. At a time in history when more than 130 Americans die each day from opioid overdose and there are effective medications for the treatment of opioid use disorder, AMERSA cannot support a proposed rule change that will push patients away from life-saving and evidence-based treatment and prevention that is offered in our healthcare system. “

     

    From Timothy Justice, a patient: 

    “I have two decades of recovery through Methadone Maintenance Treatment but have lost no fewer than three good jobs due to employers finding out. This is why now on disability my income is so poor. Making this info easily available with the stigma involved is seriously detrimental to people.”

     

    From recovery activist Randy Anderson, who also works in law enforcement:

    “I cannot believe that your agency which is charged with protecting my rights wants to expose my SUD record(s) to those that have little or no training about substance use disorder. I demand that the protections that 42 CFR Part 2 offer me remain intact and unchanged. As a person who will be directly impacted by this I firmly object. I disclosed information while in treatment for my substance use disorder that I don’t want another person to ever see. I would not have asked for help for my disease if I knew that my records would not remain strictly confidential. This change will only further stigmatize an already highly stigmatized population and will deter people from seeking help and ultimately cause more deaths.”

     

    There were also many anonymous comments. One commenter who signed his name, Marc Jellinek, kept it simple: 

    “Keep law enforcement out of my healthcare records.”

     

    The September 13 letter from the American Medical Association to SAMHSA:

    2019-9-13 Azar Extension of Comment Period for Confidential Communication

     

    Full comment from H. Westley Clark:

    Westley_Clark_Court_Auth_disclosure_of_SUD_records_for_serious_crimes-submitted (1)

    Photo by Oladimeji Ajegbile via Pexels

    • Alison Knopf

      Alison has written about substance use for more than 30 years. She has also written for many years about medical coding. A freelance writer, she is also the editor of Alcoholism & Drug Abuse Weekly, and managing editor of Child & Adolescent Psychopharmacology Update and Child & Adolescent Behavior Letter—all published by WILEY. She also writes for Addiction Treatment Forum.

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