On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42
substance use disorder
HHS Proposes Rule to Align Part 2 Records and HIPAA
On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2) to implement statutory amendments passed under Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (42 U.S.C. 290dd-2). Comments are being accepted for 60 days from the date of publication.Continue Reading HHS Proposes Rule to Align Part 2 Records and HIPAA
Connecticut Legislature Passes Act to Help Address the Opioid Epidemic
On July 6, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-113 titled “An Act Concerning Opioids” (PA 21-113), which establishes pilot programs to help serve persons with opioid use disorder in urban, suburban, and rural communities, and requires the Commissioner of Public Health to issue and increase awareness of chronic pain treatment guidelines. PA 21-113 became effective on July 1, 2021.
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Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care
On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder (SUD) confidentiality regulations at 42 C.F.R. Part 2 (Part 2) with the needs of providers and patients, and to “facilitate the provision of well-coordinated care” for individuals with SUD.
Continue Reading Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care
2019 Physician Fee Schedule Rule Review: Use of Telehealth Expanded
Telehealth for Treatment of Substance Use Disorders
As part of the CY 2019 Medicare Physician Fee Schedule (PFS), the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period to expand the use of telehealth for the treatment of substance use disorders and co-occurring mental health disorders. Existing law provides for reimbursement of telehealth services only if the originating site is located in a rural health professional shortage area, is not in a metropolitan statistical area or is an entity that participates in a federal telemedicine demonstration project. The originating site must also be one of a specific type of facility, such as a hospital, physician’s office or skilled nursing facility. With respect to telehealth services used to treat a substance use disorder or co-occurring mental health disorders, the interim final rule removes the originating site geographic restrictions and permits a patient’s home to be an originating site. When the patient’s home is used as the originating site for telehealth services, Medicare will pay no facility fee. The interim final rule is effective for telehealth services performed on or after July 1, 2019. CMS is requesting comments on the interim final rule, and the comment period closes January 22, 2019.
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CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D
In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D program. CMS is particularly concerned with chronic overuse among beneficiaries taking high levels of prescription opioids (e.g., beneficiaries prescribed opioids with a 90 morphine milligram equivalent (MME) dose or higher per day), beneficiaries with multiple prescribers, and “opioid naïve” patients (i.e., patients newly prescribed opioids).
CMS’s strategies include consideration of a 7-day supply limit for initial fills of prescription opioids for the treatment of acute pain, potentially paired with a daily dose maximum (e.g., a limit of 50 MME). According to CMS, this type of restriction may reduce the number of leftover opioid pills available to an opioid naïve patient, which in turn can reduce the risk that the patient develops an “affinity” for opioids that can lead to misuse and diversion. CMS also proposes that Medicare Part D sponsors implement formulary-level opioid safety edits at the point-of-sale (POS) at pharmacies of 90 MME, which could only be overridden by a sponsor, and which may be paired with a 7-day supply allowance for initial opioid prescriptions for the treatment of acute pain.
Continue Reading CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D