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The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule governing the use of medications for the treatment of opioid use disorder (OUD). In the rule, the first major update in 20 years, the agency made permanent some of the telehealth flexibilities that were put into place to respond to the COVID-19 pandemic and made a number of other changes similarly aimed at improving patient access to and reducing stigma of OUD treatment.

Additionally, with this rule, SAMHSA updated accreditation and certification requirements for opioid treatment programs (OTPs) as required by the Consolidated Appropriations Act, 2023 (CAA). The rule, which was printed in the Federal Register on February 2, 2024, takes effect April 2, 2024, and has a compliance date of October 2, 2024.Continue Reading SAMHSA Finalizes Major Update to Rules Governing Opioid Treatment Program Requirements

The Department of Health and Human Services recently issued a proposed rule that would streamline the federal regulations governing the confidentiality of substance use disorder (SUD) patient records at 42 CFR Part 2 (Part 2) with the Health Insurance Portability and Accountability Act and its implementing regulations (HIPAA). Comments on the proposed rule are due to HHS by January 31, 2023

For years, health care providers regulated by both Part 2 and HIPAA and their patients, have wrestled with the inconsistencies across these two privacy frameworks. Part 2, for example, currently imposes different patient consent requirements and disclosure restrictions on Part 2-protected SUD treatment records (Part 2 Records) than HIPAA, even though such records often constitute protected health information (PHI) as well. The inconsistencies (and in some cases, conflicts) between HIPAA and Part 2 requirements have created barriers to information sharing and confusion and compliance challenges for entities regulated under both frameworks, which in turn have unnecessarily impeded treatment access and care coordination.

As noted in the HHS fact sheet and the press release issued by the Substance Abuse and Mental Health Services Administration (SAMHSA), the proposed rule would, if finalized, enhance care coordination, afford patients a formal right of access to their SUD records, and extend HIPAA’s breach notification standards to Part 2-regulated providers and information. The proposed rule would also allow health care providers to align internal privacy compliance programs, the importance of which is underscored by another proposal to impose the same HIPAA civil and criminal penalties on regulated providers for noncompliance with Part 2 regulations. Continue Reading HHS proposes update to Part 2 confidentiality regulations to align with HIPAA

The Department of Health & Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed revisions to federal rules governing the confidentiality of patient records created by federally-assisted substance use disorder (SUD) treatment programs.  The proposed rule is intended to support coordinated care among providers that treat patients with SUDs, while maintaining…

The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule addressing the disclosure of substance use disorder patient records that is intended to facilitate health care activities while protecting patient privacy.  The final rule identifies the circumstances under which lawful holders of patient identifying-information may disclose such information to their contractors, …

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff…

A new Substance Abuse and Mental Health Services Administration (SAMHSA) final rule is intended to modernize federal regulations governing the confidentiality of substance abuse records. SAMHSA explains in the preamble that it the agency “wants to ensure that patients with substance use disorders have the ability to participate in, and benefit from health system delivery…

On September 27, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule establishing annual reporting requirements for certain practitioners who prescribe buprenorphine-based medication-assisted treatment for opioid disorders under the Controlled Substances Act. As previously reported, SAMHSA published a rule on July 8, 2016 that expanded from 100 to 275 the…

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance Abuse and Mental Health Services Administration (SAMHSA) has published a final rule to expand from 100 to 275 the number of patients that qualified practitioners may treat with buprenorphine, a medication to treat opioid use disorder. Furthermore, as noted in a separate post, the proposed 2017 OPPS rule would remove certain pain management questions from consideration for purposes of Hospital Value-Based Purchasing (VBP) Program payment adjustments “to mitigate even the perception that there is financial pressure to overprescribe opioids.” In addition, HHS announced its research priorities regarding opioid misuse and pain treatment, and the Indian Health Service adopted a requirement that prescribers and pharmacists check state Prescription Drug Monitoring Program (PDMP) databases before prescribing or dispensing opioids for pain.

These actions come as the OIG has highlighted significant Medicare Part D spending on commonly abused opioids, which the OIG estimates exceeded $4 billion in 2015. In fact, almost one in three Medicare Part D beneficiaries received a commonly abused opioid in 2015, according to the OIG. The OIG recommends that CMS take additional actions to prevent opioid abuse within the Medicare program, signaling the potential for additional policies in this area.

In another related development, this month both the House and Senate approved the conference report to accompany S 524, the Comprehensive Addiction and Recovery Act. Among many other things, the bipartisan legislation would:
Continue Reading Obama Administration, Congress Take Steps to Fight Opioid Epidemic

The Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule on February 9, 2016 that is intended to modernize regulations governing the confidentiality of substance abuse records to ensure that patients with substance use disorders have the ability to participate in new integrated health care models that emphasize coordinated care while addressing…