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Arielle Lusardi

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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 and Human Services Office of Inspector General (HHS-OIG) recently published a Special Fraud Alert warning health care providers (e.g., prescribers, pharmacies, durable medical equipment providers, clinical laboratories) to steer clear of certain telemedicine arrangements and outlining seven “suspect” characteristics that may present heightened risk of fraud and abuse.

The alert coincides with a third round of criminal “telemedicine takedowns” announced by the Department of Justice (DOJ)  in the last several years, reflecting DOJ’s continued focus on identifying and dismantling fraudulent arrangements that exploit telemedicine technologies and related regulatory flexibilities in the wake of the COVID-19 pandemic.

Telemedicine technologies have created a multitude of opportunities for growth and innovation within the health care industry and are well-positioned to become an ongoing cornerstone of our health care delivery system. However, given the increased level of regulatory scrutiny of telemedicine arrangements, providers and telehealth technology companies, including drug and device manufacturers that offer telemedicine technologies (e.g., platforms, mobile applications) for prescribers and patients that facilitate virtual care,  should carefully plan and closely evaluate existing arrangements to ensure compliance with applicable state and federal laws and avoid implication amongst the recent uptick in enforcement.Continue Reading Telehealth Under Scrutiny: OIG Special Fraud Alert and DOJ Enforcement Highlights Suspect Characteristics Associated with High-Risk Telemedicine Arrangements

On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic.

The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic…

After nearly a full year of public comment consideration, last week, the U.S. Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) announced and published a Final Rule and Fact Sheet addressing 42 C.F.R. Part 2 (Part 2). Generally speaking, Part 2 affords privacy protections to patient records pertaining…

Shortly after President Trump declared a national emergency related to COVID-19, CMS issued blanket waivers under section 1135 of the Social Security Act that are intended to ensure there are sufficient health care items and services available to meet the increased need, as well as reduce related administrative burdens on health care providers.

Our comprehensive…