It has come to my attention that Alcoholism and Drug Abuse Weekly (ADAW) has been covering issues pertaining to the privacy of substance use treatment records for years. Though they make very little reference to the research-related issues and suppression of Medicare and Medicaid data for research purposes (the focus of the blogging by me and Nicholas Bagley), some of the ADAW’s stories in this area include content worth sharing. It’s relevant to the broader context in which those research issues arise. Below are my quotes and, in brackets, my notes and additional thoughts.
From March 8, 2010:
- “[In January 2010] a group of lawyers and physicians got together under the leadership of Eric Goplerud, Ph.D., to propose changes to a federal law governing substance abuse treatment records. […] Goplerud’s group recommended
creating an exception to the requirement that substance abuse treatment programs must obtain the consent of patients before releasing any information about those patients — a requirement codified in the Confidentiality of Alcohol and Drug Abuse Patient Records regulation almost 40 years ago.” - [The focus, according to ADAW’s reporting is on the practical and clinical challenges in the electronic medical record age that arise in maintaining the strict confidentiality regulations currently require. Note that, though not unrelated, this is not principally a concern for research with Medicare and Medicaid data.]
- “A key argument used by Goplerud’s group is based on what they call ‘patient safety.’ They say that health care providers need to know about a patient’s addiction and medication history in order to provide quality care.”
- “[Faced with opposition from patient advocacy groups, Goplerud] backed down somewhat.” “Passion is high among patient advocates.”
- “H. Westley Clark, M.D., [then] director of the Center for Substance Abuse Treatment [CSAT] and the agency’s point person on 42 CFR Part 2 [the relevant regulations, described here and in prior posts], cancelled a planned interview with ADAW after CSAT’s parent agency, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a virtual press blackout on the topic.”
From October 24, 2011:
- [Supporting Goplerud’s point above,] “Because methadone and buprenorphine can have adverse effects when mixed with other controlled substances, it’s important for OTPs [opioid treatment programs] including office-based physicians dispensing the first dose of buprenorphine to find out whether these patients are getting prescriptions for controlled substances such as benzodiazepines or opioids from other sources, said the September 27 ‘Dear Colleague’ letter, from [then] CSAT director H. Westley Clark, M.D.”
- [But, contradicting this,] “In the letter, Clark, a lawyer, also said that OTPs should not input data about their patients into the PDMPs [prescription drug monitoring programs], because this would violate 42 CFR Part 2, a federal regulation which protects the privacy of patients in substance abuse treatment.”
From September 23, 2013:
- “The secret is out: treatment record confidentiality for substance abuse patients is no longer a sure thing. ‘It’s getting in our way,’ [said] SAMHSA Administrator Pam Hyde.”
- “SAMHSA has been pressed by many others who have not liked the confidentiality law.” Yet, “[o]ver the course of several years, SAMHSA has steadfastly clung to the law and implementing regulations for 42 CFR Part 2. […] At SAMHSA, the guiding force behind preserving 42 CFR Part 2 has been H. Westley Clark, M.D., [then] director of the Center for Substance Abuse Treatment and a lawyer as well as a physician.”
- “But more than three years ago, the electronic health record (EHR) that is codified in the Affordable Care Act threatened that regulation.”
- “Researchers say that their work is ‘crippled’ by the law’s requirements.” [As far as I’ve seen, this is one of the few mentions of researchers, maybe the only one in ADAW’s reporting in this area.]
- “The regulations in 42 CFR Part 2 were created because patients in substance abuse treatment could be tracked down by law enforcement, even into the treatment programs. It has since served as a kind of guarantee that patients’ names couldn’t be turned over to employers, landlords, police and others without individualized consent. Patients in methadone treatment have relied on it to make sure their regular physicians didn’t discriminate against them and deny them pain medications. […] As articles in this newsletter have repeatedly shown, mothers who are taking legitimately prescribed opioids who give birth to babies with neonatal abstinence syndrome can still have their babies taken away. Homeless drug users, despite the administration’s Housing First policy, can still be denied subsidized housing. Legislatures across the country are calling for drug testing for welfare recipients. If the confidentiality of patient records is taken away, on the eve of healthcare reform, will that have a chilling effect on people’s decision to seek treatment? [… Without adequate protections,] [p]eople will avoid care, and the consequences will be felt by the larger community. Untreated problems beget more problems, [Dr. Clark said.]” [The problem is, if research is hampered, care suffers too. I’m sympathetic to these privacy concerns, but I do not think that preventing researchers’ access to taxpayer-funded Medicare/Medicaid treatment data — with strict privacy protection protocols and penalties for breaching them — is necessary. There has got to be another way.]
From October 21, 2013:
- “Renee Popovits, principal attorney with Popovits and Robinson, an Illinois-based law firm specializing in substance abuse treatment providers, is one of the leaders of the group that believes it’s time for a change in 42 CFR Part 2, the 40-year old regulation governing the confidentiality of alcohol and drug abuse treatment records. Specifically, the part of the regulation that requires patients to give individualized consent for each record release, stating to whom it is to be given, is not realistic given the technology of the Health Information Exchanges (HIEs), Popovits told ADAW.”
- [I’ve read that a similar problem arises for ACOs. In particular, they cannot see the substance use-related treatment from non-affiliated providers the cost of which they’re held accountable. Something is not right about that. Again, this is not principally a research issue, but clinical and health system financing ones.]
- “[W]hy do we have 42 CFR Part 2 and not something similar for other conditions?”
- “The confidentiality regulations governing medical records for the treatment of substance use disorders (SUDs), in force for more than 40 years, are being called into question by almost everyone in health care except for patient rights advocates.”
- “[P]atients are losing in the battle.” [This is terrible and wrong framing, even if patient advocacy groups feel that way. Nobody wants patients to lose. We want them to be reasonably protected while also helping their providers offer the best possible care and researchers to be able to do the work to improve that care. It’s not that patients do not deserve and need protection, it just has to be provided in a different way. The regs are outdated.] “The 42 CFR Part 2 regulations were first issued in 1975, and were last amended in 1987.”
- “Under 42 CFR Part 2, a patient must give explicit, written consent each time SUD treatment records are released; the consent must include to whom the records are released, and be for one time only.” [There are several problems: “written” is not information-age friendly, depending on interpretation; “to whom” can be a huge hurdle, since patients don’t always know exactly who their doctors are or will be; “one time” is also problematic.]
- “Four years ago, SAMHSA unequivocally said it wouldn’t change them [the regs]. In an August 4 public meeting on 42 CFR Part 2 that same year, Pamela Hyde, administrator of SAMHSA, and H. Westley Clark, M.D., director of SAMHSA’s Center for Substance Abuse Treatment, reiterated that 42 CFR Part 2 would not be revised in any way []. Since then, there have been indications that all is not well with SAMHSA and the confidentiality regulations.”
- “One common thread among the commenters who favor changing the regulations is that they promote stigma [because they single out substance use disorder as distinct from other medical conditions].”
- “Others in favor of revising the regulations are Richard Rosenthal, M.D., from the American Academy of Addiction Psychiatry; Mark Jones of SmartNet in Oklahoma; Eric Goplerud, Ph.D.; Al Guida of Netsmart; Oregon Behavioral Health; Maine-Health; Renee Popovits; many IT vendors; and more.” [Yes, I think at this point you can add many top researchers, among others, to this list.]
- [This issue includes long sections on civil rights and discrimination issues that I’m not quoting, but are worthwhile background. I stipulate that these are important and relevant. I do not believe that they imply researchers should never work with substance use-related claims data without consent (since that’s impractical for the millions of records I’m talking about).]
- [OK, one quote:] “The entire health IT system is now ‘designed for surveillance.'”
- “The short story is the sudden retirement, effective October 3, of H. Westley Clark, M.D., who for the past 16 years has been the director of the Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA).”
- “[H]e has been on the wrong side, politically speaking, of the debate on 42 CFR Part 2”
