As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription...more
The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more
As the regulation of artificial intelligence (AI) tools in healthcare settings rapidly evolves, state medical boards and related agencies are at the forefront of development and enforcement. While some states have taken...more
The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more
4/24/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
National Security ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Supply Chain
Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
Bipartisan efforts to lower prescription drug costs remains a core focus for the US Congress. Effective October 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has announced the follow-on cohort for its...more
340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies,...more
In response to rising prescription costs and overall state-level healthcare spending, numerous states, including Maryland and Oregon, have established prescription drug affordability review boards (PDABs) to review certain...more
Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government....more
Medicare Part B enrollees as of July 1, 2024 will experience savings on coinsurance for 64 drugs selected by the Biden administration. Pursuant to the Inflation Reduction Act and its Medicare Prescription Drug Inflation...more
Pharmaceutical drug pricing and reimbursement continues to make headlines nationwide. In a recent development, Maryland’s Prescription Drug Affordability Board (PDAB) finalized its list of selected drugs for affordability...more
In what is being touted as a significant win for pharmaceutical drug manufacturers, the DC Circuit affirmed on May 21, 2024 that Section 340B of the Public Health Service Act does not categorically prohibit manufacturers from...more
The Centers for Medicare & Medicaid Services on May 3, 2024, released its draft guidance on administration of the Medicare Drug Price Negotiation Program for initial price applicability year 2027. The program—established by...more
Spurred by a March 5, 2024 citizen petition to the Food and Drug Administration (FDA), a flurry of class action complaints have been filed claiming that drug makers failed to warn consumers about the presence of benzene in...more
Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more
The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued long awaited updates to the regulations at 42 CFR Part 2...more
New York expanded its existing efforts at monitoring and understanding prescription drug prices by enacting legislation addressing prescription drug price transparency. Effective June 19, 2024, S.599-A/A.1707 amends the New...more
Digital health—that is, medical care enhanced or made possible by the use of technology—has changed the landscape of healthcare in America. Innovation in this sector is at an all-time high and 2024 will no doubt see greater...more
The US Centers for Medicare & Medicaid Services (CMS) has implemented a final rule, effective November 13, 2023, designed to enhance the oversight of hospice providers throughout the United States and increase regulatory...more
The US Drug Enforcement Administration (DEA) issued a temporary rule on October 6, 2023 extending COVID-19–era flexibilities through December 31, 2024. With this extension, the DEA will continue to waive provisions under the...more
If your organization has faced a Medicare audit in the last decade, you may have experienced a significant delay in the Medicare appeals process due to a monumental backlog of claims pending in front of administrative law...more
Connecticut will bolster its existing prescription drug reporting and transparency regime with new requirements on pharmaceutical sales representative registration and updates to existing manufacturer transparency reporting,...more
The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently evaluated the risks associated with certain intraoperative neuromonitoring (IONM) services arrangements in its release of...more
Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more