On April 4, 2024, a final rule published on February 2, 2024 (the Final Rule) went into effect that concerns medication for the treatment of opioid use disorder. The Final Rule, published by the Substance Abuse and Mental...more
On February 8, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) jointly issued a final rule to amend the...more
Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent...more
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) released its anticipated Final Rule last week. The Final Rule revises...more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more
There has been a notable emphasis on proactive enforcement of the privacy and security of protected health information in recent weeks as evidenced by multiple developments regarding compliance with the Health Insurance...more
The U.S. Department of Health & Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights (OCR), has announced a final rule (the Rule) updating the...more
On February 8, 2024, the federal Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 (Part 2) were revised in part to increase patient protection and streamline patient consent...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
The U.S. Department of Health & Human Services (HHS) through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights recently issued a Final Rule amending the Confidentiality of...more
This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....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
Telehealth experienced massive growth during the COVID-19 pandemic, due in no small part to various regulatory and reimbursement policies that federal agencies implemented following a declaration by the US Department of...more
On May 10, 2023, HHS announced that many telehealth and teleprescribing flexibilities will remain in place after the end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. Congress extended many telehealth...more
On December 2, 2022, the Office for Civil Rights (“OCR”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”) within the U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed...more
On November 28, 2022, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Substance Abuse Mental Health Services Administration (SAMHSA) announced a Notice of Proposed Rulemaking...more
Increasing mental health care needs for minors present a range of legal issues for children, parents, health care providers and health care payors. While state laws typically govern who has the power to consent to or refuse...more
Eye on Health Information Exchange, Data Privacy and Alignment of Federal Standards – Information Blocking, HIPAA Updates and Part 2 Flexibility As we struggle to emerge from the effects of the pandemic, several key federal...more
Over the last two months, the U.S. Department of Health and Human Services (“HHS”) published guidance regarding the enforcement of HIPAA and its privacy and security requirements in response to the COVID-19 public health...more
In the second episode of our series on the national opioid crisis, Gina Bertolini discusses the overlay of recent guidance concerning privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) and...more
On January 16, 2018, the Food and Drug Administration (FDA) issued a proposed rule entitled, Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and...more
This Week: Drug pricing remains a focus as CMS rolls out a demonstration project for Part B drugs... The Senate passes The Comprehensive Addiction and Recovery Act (CARA) and Senate Cures legislation moves forward... Senate...more