Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more
Appropriations Update. As appropriators continue to finalize the 12 funding bills for fiscal year (FY) 2024 – which began on October 1, 2023 – a series of stopgap CRs have been needed to avoid a government shutdown. This...more
On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), released final rule (Final Rule)...more
House Passes Legislation to Prohibit Use of QALYs in All Federal Health Programs. The House passed H.R. 485, the Protecting Health Care for All Patients Act of 2023, a bill designed to prohibit the use of QALYs and similar...more
On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes...more
House Energy and Commerce Committee Holds Hearing on Healthcare Costs. The hearing included discussion on what factors are causing cost increases for individuals, for the healthcare sector, and for federal health programs...more
As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the...more
Congress Works to Meet Imminent Funding Deadlines. Speaker of the House Johnson (R-LA) and Senate Majority Leader Schumer (D-NY) announced an agreement on top-line spending levels to fund the government for the remainder of...more
This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more
The United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have further extended flexibilities that allow providers to prescribe controlled substances...more
The House and Senate were both in session this week, with healthcare activity at the committee level. The House Energy and Commerce Committee held a hearing on innovation and a markup of 15 healthcare bills. The Senate...more
Reversing previously proposed rules, the DEA recently issued new guidance allowing the continued use of telehealth when prescribing controlled substances following the end of the Covid-19 public health emergency (“PHE”)....more
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan...more
Two days ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule extending...more
Recognizing the urgent need to increase access to mental health and substance use services for young people, Congress is taking significant legislative steps to strengthen the federal government’s response to the nationwide...more
Annual overdose deaths in the U.S. reached an all-time high of 100,000 last year and overdose remains the second-leading cause of death for people between the ages of 10 and 14. In an attempt to address the rising number of...more
In response to the opioid crisis, the Substance Abuse and Mental Health Services Administration (SAMHSA) in collaboration with the Office of the National Coordinator (ONC) recently issued two fact sheets to provide clarity on...more
The 21st Century Cures Act (Act), enacted in December 2016, has received widespread coverage for funding biomedical research and streamlining the drug approval process. The Act also includes the Helping Families in Mental...more