The COVID-19 pandemic has coincided with worsening mental health across the country, and California is no exception. Not surprisingly, Governor Gavin Newsom signed into law multiple pieces of mental health treatment related...more
As we highlighted earlier this month, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. These documents are not typically released at the same time,...more
In regulations published on April 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued two new documents containing guidance primarily on the Medicare Advantage (MA) program and on the Medicare prescription...more
Welcome back from a much needed recess following the conclusion to 2017 (yes, three months after the calendar flipped). Congress will be in session nine of the next eleven weeks with numerous issues on the table ranging from...more
Opioid Funding Overview - In 2016, through the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act, Congress authorized roughly $1.4 billion in spending to combat the opioid crisis....more
In the sixth episode of our series on the national opioid crisis, Lauren Perry discusses some of the legal obligations for providers who prescribe controlled substances as treatment for substance abuse disorders....more
In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including...more
Outlook for This Week in the Nation's Capital - FY18 Omnibus Wrap-up: On Thursday, Appropriations Subcommittees had to report any unresolved issues up to the Full Committee and while the work largely appears to be done,...more
In the third episode of our series on the national opioid crisis, Amanda Makki and Corbin Santo provide an overview of how the Trump Administration and Congress may address the opioid epidemic this year....more
President Donald Trump on February 12, 2018, submitted his budget request to Congress for Fiscal Year (FY) 2019. The President's full budget calls for approximately $4.4 trillion in total spending. Much of the budget seeks...more
Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance...more
On January 22, 2018, the Drug Enforcement Administration (DEA) issued a final rule entitled, Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs...more
Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more
On November 16, 2017, the Centers for Medicare & Medicaid Services(“CMS”) published for public inspection a proposed rule that would impact a variety of Medicare Part C and Part D program provisions. The proposed rule, ...more
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more
Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the...more
With 24 bipartisan cosponsors in the Senate, the emerging Alexander-Murray stabilization package is a significant step forward in the health reform debate. However, after months of dominating the airwaves, health care is now...more
On Friday, July 22, President Obama signed the Comprehensive Addiction and Recovery Act of 2016 (CARA). Following on federal, state and local trends, CARA seeks to expand access for persons needing opioid treatment....more