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The recent Federal Trade Commission (FTC) and Department of Justice (DOJ) action against Monument Inc. for selling patient data, is just the tip of the iceberg. Monument Inc. positions itself as a treatment provider (the website home page says it provides "therapy" for alcoholism) but in its extensive terms of use, it says it is not a treatment provider. And in fact, since the FTC/DOJ action last week, Monument radically changed its website, removing the offending promise of "confidentiality" which it breached, but still selling services (lowest price $15/month). [ABSTRACT FROM AUTHOR]

In an August 8 letter to the Federal Trade Commission (FTC), the Legal Action Center (LAC) and the Opioid Policy Institute (OPI) urged the agency to clarify and strengthen its proposal to modernize the Health Breach Notification Rule (HBNR). The proposal by the FTC, published in the Federal Register on June 9 (https://www.federalregister.gov/documents/2023/06/09/2023‐12148/health‐breach‐notification‐rule), does not adequately cover substance use disorders (SUDs), but rather refers to categories and silos like "physical health" and "mental health." This leaves interventions for SUDs — and drug use itself — in a "regulatory and policy blind spot," according to the letter, a copy of which was obtained by ADAW. [ABSTRACT FROM AUTHOR]

The most recent proposal of changes to 42 CFR Part 2, the federal regulation protecting confidentiality of substance use disorder (SUD) treatment records, chips away yet again at what began 12 years ago as a gutting of the rule. ADAW has covered every change. For more information, go to the website (www.alcoholismdrugabuseweekly.com) and use the search function. You will find abstracts of every story; subscribers will find full text. [ABSTRACT FROM AUTHOR]

A week after the federal Department of Health and Human Services (HHS) issued a final rule liberalizing treatment for opioid use disorder (OUD) in opioid treatment programs, it issued a less patient‐friendly rule. ADAW has written about 400 articles on confidentiality and substance use disorder treatment, an area that has seen continued erosion since 2010 when the government started acceding to claims that requiring a patient to consent to the release of his or her substance use disorder (SUD) treatment information in a digital age (think "Electronic Health Record") would be just too inconvenient. The most recent step came in the Federal Register issued Feb. 8, which changes the confidentiality rules to align with those of HIPAA. The rule, through the HHS Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 ("Part 2"), which protect the privacy of patients' SUD treatment records. In a press release about the rule, HHS said this: "Specifically, today's final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes." [ABSTRACT FROM AUTHOR]

In a far‐ranging interview with Elinore McCance‐Katz, M.D., Ph.D., outgoing assistant secretary of the Department of Health and Human Services, ADAW last week learned about the rationale for the most recent final rule on 42 CFR Part 2, the confidentiality regulation regarding substance use disorder (SUD) treatment, the future of flexibility for methadone and buprenorphine rules, what she views as top achievements of the past four years and more. [ABSTRACT FROM AUTHOR]

On Friday, Aug. 14, the final rule for 42 CFR Part 2 took effect (see "42 CFR Part 2 final rule: OTP input into PDMP, more enforcement and easier," ADAW, July 20, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32778). One provision would allow opioid treatment programs (OTPs) to put patient information into the state prescription drug monitoring program (PDMP), something that was banned in 2011 by the Substance Abuse and Mental Health Services Administration (SAMHSA), which promulgates the confidentiality regulation and issued the final rule. The final rule would put methadone information into the PDMP for the first time when coming from OTPs (methadone dispensed for pain has always gone into the PDMP). It would mean doctors could look up information on any patient and find out if he or she is taking methadone. Those in favor of the provision, including the American Society of Addiction Medicine and even some OTPs, think that it's important for physicians to know what medications a patient is on, and apparently don't trust patients to disclose this information to treating providers. Those opposed note that PDMP data is utilized by many, including law enforcement. [ABSTRACT FROM AUTHOR]

The final rule "modernizing" the country's confidentiality regulation, which originally required treatment providers to obtain patients' consent in writing to the release of their substance use disorder (SUD) treatment information, was published last week. Consent for release of information would apply to a broad category of health care operations, care coordination and case management. And methadone patients could have their treatment information put into state data systems; since 2011, that has not been allowed. Finally, the freedom of law enforcement to place and use confidential informants inside treatment programs has been expanded. [ABSTRACT FROM AUTHOR]

When the demise of the federal law and regulation protecting substance use disorder (SUD) treatment record confidentiality was quickly sealed with the passages of the Coronavirus Aid, Relief, and Economic Security (CARES) Act March 27 (see "CARES Act eliminates most of 42 CFR Part 2," ADAW, April 6, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32678), the Legal Action Center (LAC) was right there with patients, as it still is, decrying the loss of this important safeguard. Now, however, it's time for the law firm to do what it does best — work to get the language as good as it can be in what will be the new regulation. In an overview of the CARES Act amendments regarding confidentiality released by LAC last week, this important point was made: Those amendments don't take effect until March 27, 2021. [ABSTRACT FROM AUTHOR]

Two major events this month in the confidentiality arena are laying the groundwork for forcing the federal government to keep 42 CFR Part 2 on the books. One was a report about how addiction treatment "apps" do not safeguard privacy. Another was a letter from the Legal Action Center (LAC) to the Department of Health and Human Services (HHS) detailing why the regulation and its enforcement are essential. [ABSTRACT FROM AUTHOR]

H. Westley Clark, M.D., J.D., is the former director of the Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency that has proposed to amend 42 CFR Part 2, the regulation protecting the confidentiality of alcohol and drug abuse treatment patient records. In a massive notice of proposed rulemaking (NPRM) published Aug. 26 (see ADAW, Sept. 9), SAMHSA proposed to remove the ban against giving opioid treatment program (OTP) patient data — methadone being the key medication — to prescription drug monitoring programs (PDMPs). That ban was instituted by Clark himself when, as CSAT director, he issued a "Dear Colleague Letter" to OTPs telling them they should not give patient medication data to the PDMP, but rather should check the PDMP to see what medications their patients are on. The rationale for the letter was the same as the rationale for opposition to SAMHSA's NPRM: Patients would not want to go to treatment if they knew their methadone information could be shared without their consent. [ABSTRACT FROM AUTHOR]

The second of two proposals by the Substance Abuse and Mental Health Services Administration (SAMHSA) to weaken the confidentiality of substance use disorder (SUD) treatment records under 42 CFR Part 2 has a comment period deadline of Oct. 25. This is the longer Notice of Proposed Rulemaking (NPRM), which has one provision that is alarming to opioid treatment programs (OTPs) and their patients: One would remove the ban against giving OTP patient data to prescription drug monitoring programs (PDMPs). [ABSTRACT FROM AUTHOR]

In two separate proposals, the Substance Abuse and Mental Health Services Administration (SAMHSA) last month proposed radical changes to the confidentiality of substance use disorder (SUD) treatment records under 42 CFR Part 2. Both were in a Notice of Proposed Rulemaking (NPRM) and were published in the Federal Register Aug. 26. [ABSTRACT FROM AUTHOR]

In less than 2 weeks, treatment providers and patients will see what happens to confidentiality. The final rule issued last month on 42 CFR Part 2 ("42 CFR Part 2 final rule: OTP input into PDMP, more law enforcement," ADAW, July 20, https://onlinelibrary.wiley.com/doi/full/10.1002/adaw.32778) will take effect. We talked to the lead private organization on this regulation last week about how we got here and where we're going next. [ABSTRACT FROM AUTHOR]

The quiet and rapid end of the federal law protecting substance use disorder (SUD) treatment record confidentiality came on March 27 with the Coronavirus Aid, Relief, and Economic Security (CARES) Act (see "CARES Act eliminates most of 42 CFR Part 2," ADAW, April 6, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32678). Bear in mind that the regulation is still in effect until next March. But once the law was passed, it didn't take long for history to be rewritten. [ABSTRACT FROM AUTHOR]

It's been more than 10 years of patients fighting for 42 CFR Part 2, but overnight the regulation lost to COVID‐19. The CARES Act revises 42 CFR Part 2 (confidentiality of substance use disorder [SUD] patient records), eliminating consent except for the first time only, after which the information is up for grabs. [ABSTRACT FROM AUTHOR]

Leaving out the organizations that opposed the federal government's proposal to eliminate the confidentiality protections of 42 CFR Part 2, MITRE, the company contracted to create a "summary" of public comments, has produced a slideshow that relies on two dozen "prominent" organizations. These organizations exclude those that oppose the changes in the Notice of Proposed Rulemaking (NPRM) released by the Substance Abuse and Mental Health Services Administration (SAMHSA) on Aug. 26, 2019 (see "SAMHSA proposes significant changes to 42 CFR Part 2," ADAW, Sept. 9, 2019, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32473). [ABSTRACT FROM AUTHOR]

The article looks at some of the top stories published by the journal related to alcoholism and drug abuse in the U.S. during 2017. Topics mentioned include federal funding for the opioid crisis signed by U.S. Congress and U.S. President Barack Obama, legalization of marijuana, and counseling for methadone treatment patients.

A rulemaking on the proposed amendments to 42 CFR Part 2, the regulation governing confidentiality of substance use patient records, is still waiting in the wings. [ABSTRACT FROM AUTHOR]

The article reports that over 100 treatment and recovery organizations have joined a campaign to protect patient privacy rights to maintain the confidentiality of substance use disorder patients. Topics mentioned include the Overdose Prevention and Patient Safety Act, amendment of the Public Health Service Act, and preservation of the federal confidentiality rules known as 42 CFR Part 2.

The article focuses on 42 Code of Federal Regulations (CFR) Part 2, which intend to allow for better information sharing while balancing privacy rights for people seeking treatment for substance use issues. Topics include changes made in 42 CFR in order to align with Health Insurance Portability and Accountability Act; views of Corey Waller, from American Society of Addiction Medicine, on methadone clinic; and benefit of 42 CFR Part 2 as it allows patient to dictate who gets information.

The article focuses on the final ruling for the issuance of the new consent form for patients' confidential substance use disorder (SUD) treatment information under the regulations at title 42 of the Code of Federal Regulations (CFR) part 2 (42 CFR part 2) in the U.S. Highlights are given on the role of the Substance Abuse and Mental Health Services Administration (SAMHSA), the concept of treating provider relationship, and the Supplemental Notice of Proposed Rulemaking (SNPRM) provisions.

The article informs Substance Abuse and Mental Health Services Administration has announced to release confidentiality regulations requiring that substance use disorder patients give individualized consent. It mentions use of big data presents ethical and privacy problems for SUD patients. It also mentions the views of H. Westley Clark on the same.

The article discusses the House Energy and Commerce Committee's hearing of testimony on a discussion draft of a bill that would replace 42 CFR Part 2 of the Health Insurance Portability and Accountability Act (HIPAA), the confidentiality regulation requiring a substance use treatment provider to get patient consent before releasing the patient's records.

The article offers information on the hearing "The Opioid Crisis: The Role of Technology and Data in Preventing and Treating Addiction" by U.S. Senate Committee on Health, Education, Labor and Pensions. Topics discussed include use of data and technology on the opioid crisis; views of Patty Murray on the value of prescription drug monitoring programs; and use of predictive analytics for determining risk for addiction and overdose.

What do we tell clients about the privacy of their records? This is now harder to answer than ever before. There have been many changes to federal SUD privacy laws in recent years. We no longer can say with reliability that SUD records are private. In some instances, 42 CFR Part 2 (or simply Part II) records now only require initial consent. Information just flows out from there in compliance with the weaker HIPAA standard, which saw a 300% increase in data hacking or breaches (50 million Americans) in 2021. Providers are also largely unaware of their own liability when such breaches occur downstream from them as information flows out into the medical data river. [ABSTRACT FROM AUTHOR]

The article discusses the rewriting or markup of the mental health reform bill introduced by Representative Tim Murphy in June 2015 which would gut the Substance Abuse and Mental Health Services Administration (SAMHSA) and the confidentiality regulations governing substance use disorder (SUD). The markup is seen to resolve some of the differences so the bill can get out of the subcommittee and committee and to the floor for a vote.

The article discusses rulemaking on revising 42 CFR Part 2 regulation protecting the confidentiality of substance use disorders (SUD) treatment records in most programs in the U.S. as of October 2015. Topics covered include the mounting anxiety over changes to the federal confidentiality law, the administrative burden of data segmentation, and the individualized consent provision of the regulation.

The article presents information on the 42 CFR Part 2 regulation from the U.S. Substance Abuse & Mental Health Services Administration (SAMHSA), under which a patient will have to give written consent every time substance use disorders (SUD) treatment records are released, and redisclosure is not permitted. The regulation is being opposed by Health Information Exchanges (HIEs) and insurance companies; and it is stated that the 42 CFR Part 2 is actually weakening the consent provisions.

The article reports that the U.S. federal government has issued a proposed rule that will allow patients to give 'general consent' for disclosing their information throughout a hospital, health care system or an organization. Topics include key provisions in the proposed rule, role of the agency Substance Abuse and Mental Health Services Administration (SAMHSA) in promulgating the regulation, and concerns of executive director Joycelyn Woods regarding the harms of the privacy rule.

On June 16, the Office of Management and Budget (OMB) cleared the final rule for 42 CFR Part 2, the confidentiality regulation requiring substance use disorder patients to give consent before their treatment information is released. Under the proposed rule, released last August, methadone patient data could go into the prescription drug monitoring program, and other provisions were proposed that gut but do not eliminate the regulation entirely (see "SAMHSA proposes significant changes to 42 CFR Part 2," ADAW, Sept. 9, 2019, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32473). [ABSTRACT FROM AUTHOR]

Last month, the American Society of Addiction Medicine (ASAM) released a plan for advocacy, focusing on strengthening the addiction treatment workforce and standardizing the delivery of treatment. "We need comprehensive solutions to address such a complex problem," said Paul H. Earley, M.D., ASAM president, in releasing the plan. "With the Advocacy Roadmap as our guide, ASAM will continue to advocate for equitable access to and coverage for evidence‐based addiction treatment services, increased funding for addiction research, and better education among professionals and the public to challenge the stigma and discrimination surrounding individuals with addiction." Noting that there are still challenges in the field of addiction treatment, Earley said progress has been made, adding that "ASAM remains dedicated to treating addiction compassionately and effectively and, by doing so, saving lives." There are 6,000 physician members of ASAM. For the "roadmap," go to https://www.asam.org/docs/default‐source/advocacy/asam_report_feb2020_final.pdf?sfvrsn=f73f51c2_2. [ABSTRACT FROM AUTHOR]

The article discusses the removal of Medicaid, Medicare and State Children's Health Insurance Program (SCHIP) information on substance use disorders (SUDs) of patients as requested by the Substance Abuse and Mental Health Services Administration (SAMHSA) to the Center for Medicare and Medicaid Services (CMS) to avoid violation of 42 CFR Part 2 regulation that protects patient confidentiality. Topics include its consequence to research, and notice of proposed rulemaking (NPRM) on the regulation.

Count National Institute on Drug Abuse Director Nora Volkow, M.D., among the enemies of 42 CFR Part 2. In an otherwise promising blog post showing interest in reducing the stigma of addiction and even of ongoing drug use, Volkow blamed confidentiality laws for limiting access to treatment. "Although treatment for addiction is becoming more integrated into medicine, it has faced major challenges on many fronts and requires overcoming health care providers' attitudinal barriers as well as hurdles arising in part from confidentiality protection laws that may limit gathering and sharing data on patients' use of illicit substances," she wrote in a blog post originally published in STAT. "When doctors don't ask about patients' drug use, they may miss information that is important to their care. Stigma also contributes to insurers setting restrictive limits on what they will cover for medications to treat substance use disorders." For her blog post, go to https://www.drugabuse.gov/about‐nida/noras‐blog/2021/08/punishing‐drug‐use‐heightens‐stigma‐addiction. [ABSTRACT FROM AUTHOR]

The article announces the retirement of H. Wesley Clark, M.D. from the U.S. agency Center for Substance Abuse Treatment.

The article discusses recommendations by the Legal Action Center (LAC) to the Substance Abuse and Mental Health Services Administration (SAMHSA) on changes to confidentiality regulation governing substance use disorder (SUD) treatment records (42 CFR Part 2). Focus should reportedly be given to patients as their rights and access to sensitive health information will be affected and to the development of technology that will help SUD patients maintain control over sensitive health records.

At last month's annual recovery conference of the Alcoholism and Substance Abuse Providers of New York State (ASAP), one of the speakers was Elinore McCance‐Katz, M.D., Ph.D., assistant secretary of the federal Department of Health and Human Services and head of the Substance Abuse and Mental Health Services Administration (SAMHSA), which had recently put forward two rulemakings aimed at weakening 42 CFR Part 2, the confidentiality regulation protecting substance use disorder patient records (see ADAW, Sept. 9). One of the proposals would eliminate the prohibition for opioid treatment programs (OTPs) putting their patient information on I‐STOP, the state's prescription monitoring program. This would mean that patients taking methadone for opioid use disorder would no longer have their confidentiality protected, and that other health care providers could immediately look them up to see if they are taking methadone. Key to 42 CFR Part 2 is consent: Patients must consent to the release of their information, with that consent stating to whom the information will be released. New York's consent form is even more specific, including a provision for releasing information — or not — to the electronic health record. (For the consent form, see right). [ABSTRACT FROM AUTHOR]

The push to eliminate 42 CFR Part 2 (the confidentiality regulation requiring that substance use disorder [SUD] patients consent to release of their treatment records) and replace it with the Health Insurance Portability and Accountability Act (HIPAA) continues, even as the federal government seeks to weaken HIPAA (see ADAW, Jan. 21, Jan. 28). This month, with the deadline for comments on the Request for Information (RFI) to weaken HIPAA, there was no letup from the opponents of 42 CFR Part 2 on hopes for a new bill in Congress. Last year, the American Medical Association was widely credited for stopping such a bill from going forward (see ADAW, Oct. 1, 2018). The reason that the field has fought to keep the regulation is simple: Patients would not want to seek treatment if they couldn't protect their privacy. [ABSTRACT FROM AUTHOR]

This article reports on the decision of the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) to no longer implement law on treatment record confidentiality for substance abuse patients. The move is aimed at addressing problems caused by the confidentiality law, which include complaints by insurance companies and physicians. Background on the law is included.

The article reports on efforts which primary care providers, health information technology/electronic health record vendors and insurance companies are making in 2013 to eliminate or change the U.S. Substance Abuse and Mental Health Administration's (SAMHSA's) Confidentiality of Alcohol and Drug Abuse Patient Records regulation, also known as 42 CFR Part 2. The views that H. Westley Clark, director of SAMHSA’s Center for Substance Abuse Treatment, has about 42 CFR Part 2, are discussed.

The article reports on a 2011 recommendation which the American Academy of Pediatrics made regarding teen drug screening. In the recommendation the organization stated that it felt that pediatricians should screen all adolescents using the Screening for Substance Use, Brief Intervention and/ or Referral to Treatment guidelines designed by the U.S. Substance Abuse and Mental Health Services Administration.

The article focuses on controversial changes in the 42 Title 2 of the Code of Federal Regulations (CFR), and talks of efforts of the organization American Association for the Treatment of Opioid Dependence (AATOD), confidentiality regulation, and effect of House of Representatives' bill passing.

The article on a bill presented by the U.S. Representative Markwayne Mullin which requires a substance use treatment provider to get patient consent before releasing the patient's records, in pursuant to the Health Insurance Portability and Accountability Act. Topics discussed include bill challenged by the H. Westley Clark; list of partial list of cases involving confidentiality of information; and committee voting on the same.

The article focuses on the opposition of the Pennsylvania Recovery Organizations Alliance (PRO-A) on changes in the federal confidentiality regulation, 42 CFR Part 2. Topics mentioned include the ban on the release of information of the patient with substance use disorder without his signed consent, views of PRO-A executive director Bill Stauffer on the matter, and the reasons behind the opposition of the PRO-A on the House Resolution (H.R.) 3545, Overdose Prevention and Patient Safety Act.

The fight over 42 CFR Part 2 isn't over, even though it didn't get into the opioid bill — which was passed by the full Senate 98–1 on Oct. 2. Last week, Patrick Kennedy, former congressman from Rhode Island, hosted the launch of “Don't Deny Me,” in conjunction with the 10‐year anniversary of the Mental Health Parity and Addiction Equity Act. The focus was on integrating behavioral health care with the rest of medical care, with the goal of getting insurance coverage for addiction and mental disorders. Well, at this meeting, Elinore McCance‐Katz, M.D., Ph.D., assistant secretary of the Department of Health and Human Services, said, “There must be work done to align 42 CFR Part 2 and HIPAA.” She added that “you will see our administration work on this in the coming year,” and that doing this is “a huge piece of my own agenda” in coming to the Substance Abuse and Mental Health Services Administration. Afterward, Kennedy himself was dismissive of grants, saying, “We do not treat cancer with block grants.” For the webcast of the meeting, go to http://bit.ly/2zQVOvx. McCance‐Katz starts to speak right after the hour mark. [ABSTRACT FROM AUTHOR]

Editor's note: Many people breathed a sigh of relief when H.R. 6082 was not included in the opioid legislation that went through Congress this summer and was passed by the full Senate last week. But it's too early to stop fighting. Observers say that those who want to decimate the regulation are determined to find a way, whether it's through Congress or through the administration. Last week, Pamela Greenberg, executive director of the Association for Behavioral Health and Wellness (ABHW), posted on Twitter that Elinore McCance‐Katz, M.D., Ph.D., had said at the Oct. 3 launch of Patrick Kennedy's Don't Deny Me campaign that there would not be parity for mental illness and substance use disorders (SUDs) unless 42 CFR Part 2, the confidentiality regulation requiring patients to consent to the release of their SUD data, was replaced by the Health Insurance Portability and Accountability Act (HIPAA). Indeed, despite the passage of the opioid package by the full Senate on May 3, without any revisions to 42 CFR Part 2, what remains at the top of the ABHW webpage is the report of last spring's vote by the House of Representatives to replace it with HIPAA. Many in the field think the proponents of erasing 42 CFR Part 2 are pressing on to make this happen. Below is commentary from H. Westley Clark, M.D., J.D. [ABSTRACT FROM AUTHOR]

The article offers news brief related to recovery science, which includes discrimination of Robert D. Ashford due to his past addiction, and launch of the "Journal of Recovery Science".

The article presents the response of physician Melissa Stein to concerns about 42 CFR Part 2 changes which covers confidentiality of substance use disorder patient records.

The article presents the response of Allegra Schorr, the president of the Coalition of Medication Assisted Treatment Providers and Advocates, to an article by physician Melissa Stein on her opioid treatment program.

The article offers brief information on the deadline for submission of comments to the Substance Abuse and Mental Health Services Administration, which is on February 28, 2018 is noted.